Professor Georgina Jones

BACKGROUND: Endometriosis is associated with the growth of endometrium in ectopic sites mainly within the pelvis. This results in inflammation and scarring, causing pain and impaired quality of life. Endometriotic lesions can be excised or ablated surgically, but the risk of recurrence is high. A Heath Technology Assessment commissioning call in 2011 sought applications for trials aimed at evaluating long-term effectiveness of postoperative, long-acting, reversible contraceptives (LARCs) in preventing recurrence of endometriosis. A survey of gynaecologists indicated that there was no consensus about which LARC (Levonorgestrel Intrauterine System (LNG-IUS) or depot medroxyprogesterone acetate injection (DMPA)) or comparator (combined oral contraceptive pill (COCP) or no treatment) should be evaluated. Hence, we designed a 'flexible-entry' internal pilot to assess whether a four-arm trial was feasible including a possible design adaption based on pilot findings. METHODS: In this pilot, women could be randomised to two, three or four treatment options provided that one was a LARC and one was a non-LARC. An assessment of feasibility based on recruitment to these options and a revised substantive trial design was considered by an independent oversight committee. RESULTS: The study ran for 1 year from April 2014 and 77 women were randomised. Only 5 (6%) women accepted randomisation to all groups, with 63 (82%) having a LARC preference and 55 (71%) a non-LARC preference. Four-way and three-way designs were ruled out with a two-way LARC versus COCP design, stratified by prerandomisation choice of LARC and optional subrandomisation to LNG-IUS versus DMPA considered a feasible substantive study. CONCLUSIONS: Multi-arm studies are potentially efficient as they can answer multiple questions simultaneously but are difficult to recruit to if there are strong patient or clinician preferences. A flexible approach to randomisation in a pilot phase can be used to assess feasibility of such studies and modify a trial design based on chosen recruitment options, but trialists should consider carefully any practical arrangements should groups need to be dropped during a study.

Abstract

Background: The role of public involvement (PI) in healthcare research is growing in importance and it is imperative that researchers continuously reflect on how to promote the inclusion of patients and service users in the design and delivery of research. PI offers a mechanism for end-users to be involved planning, executing, and reporting research that develops health outcome measures. Some patient groups, including people who have communication difficulties, may struggle to engage in the methods traditionally employed to promote PI engagement such as questionnaires and focus groups. Methods: This article describes a longitudinal case-study of a PI group, consisting of people who have communication difficulties, for a patient-reported outcome development project. Creative methods, informed by the participatory design principles of enacting, seeing and doing, were introduced stepwise into seven PI meetings. Data from video and visual minutes were used to evaluate the impact of the methods, following each group. Feedback, in the form of verbal and visual outputs taken directly from group meeting minutes, along with vignettes evidenced the impact of the methods on the project and group members.Results: Creative methods enabled the PI group members to meaningfully contribute in meetings, to interact dynamically and to engage with the aims and processes of the research project. Their involvement facilitated the development of accessible recruitment materials, informed data analysis and supported the dissemination of project outputs. Employing creative methods also enabled both PI group members and the academic team to reflect on their own roles within the research project and the impact that involvement in the PI group has had on their personal development and perspectives on research.Conclusion: The impact of using creative methods in PI for this PROM development project improved collaboration and understanding between PI members and the academic team. The meaningful engagement of people who have communication difficulties in PI generated a more accessible project in terms of both process and impact. Creativity has applicability beyond people whose communication is non-verbal; it should be harnessed by research teams to identify and breakdown barriers to involvement to develop outcome tools that reflect the diversity of our populations.

Evaluating clinical interventions is an important component of quality assurance and informs decision making about the funding and commissioning of health and care services. Patient-reported outcome measures (PROMs) are tools that evaluate health interventions from the perspective of people receiving care. There is no validated PROM tool that evaluates the impact of augmentative and alternative communication (AAC) interventions. The current study was designed to understand what outcomes are important to people who use aided AAC. The study aimed to generate measurement items and to confirm the conceptual framework for a PROM for AAC. Seventeen participants aged 14 to 72 who use AAC were recruited. Each participant contributed to a one-to-one interview, informed by a topic guide developed in collaboration with a group of people with experience of using AAC. The research team used framework analysis to map data into an analytic framework informed by previous research. Analysis resulted in the development 33 items within seven domains that constitute the content for a PROM for AAC. The domains were mapped onto two conceptual models: Participation, including the Family of Participation-Related Constructs (fPRC), and the Communication Capability Approach. This research contributes rigorously developed PROM content grounded in the voices of people who use AAC and offers two conceptual frameworks to guide future tool development. It also raises critical questions about the theoretical underpinnings of AAC interventions and the need for outcome measures that reflect the evolving aspirations of users. The findings have implications for clinical practice, service delivery, and the ethical development of person-centred outcome measures in AAC.

Background Childhood cancer treatment can cause subfertility in adulthood. Ovarian or testicular tissue preservation is a rapidly evolving field with significant potential benefits. However, the establishment of patient-centred reproductive survivorship pathways remains a challenge in clinical settings due to a lack of robust evidence to inform its development. Patient and public involvement and engagement (PPIE) consultation may help ensure that future studies align with patient needs and that tailored survivorship care pathways are developed for young people with preserved fertility tissue. Aim This PPIE consultation aimed to identify priority areas for future research that would support the development of a tailored survivorship care pathway for childhood cancer survivors who have preserved tissue for future fertility. Methods Recruitment occurred through national networks, including collaborations with advocacy groups such as Candlelighters and clinical networks. Data were collected via telephone or online unstructured interviews, with some supplementary email exchanges. Thematic analysis was used to identify emergent themes. The Guidance for Reporting Involvement of Patients and the Public (GRIPP)-2 guidelines were used to help guide PPIE. Setting An online focus group and/or a one-to-one interview with e-mail interactions. Participants In total, 12 unique participants took part in a focus group and/or interview. Participants included parents of children who had stored tissue, young adult cancer survivors with stored tissue and five clinicians from the leading National Health Service (NHS) centres in the UK. Results Six key themes emerged that highlighted unmet needs and priority areas for research: (1) Lack of communication and information; (2) unmet needs in follow-up care; (3) emotional impact and psychological support; (4) importance of patient and parental involvement; (5) desire for information and education; and (6) long-term concerns and support. Parents, young adults and healthcare clinicians found talking about fertility issues difficult. They noted that consistency of care, education resources and access to emotional support were important areas where improvements could be made. We used thematic analysis to help identify patterns in the data, and we used the Guidance for Reporting Involvement of Patients and the Public (GRIPP)-2 reporting guidelines for PPIE work. Conclusions PPIE provided valuable insights into the experiences of childhood cancer survivors with preserved fertility tissue, their parents and clinicians, highlighting priority areas to guide future research and ensure it addresses the concerns of care recipients. Our findings suggest that childhood cancer survivors who preserve tissue for future fertility need personalised follow-up care with information and psychological support. A larger sample of participants, studied using a qualitative research design, is needed to capture the full range of experiences, needs and preferences and to ensure that care is inclusive and relevant to the wider population.

© 2018, The International Urogynecological Association. Introduction and hypothesis: Anal incontinence following childbirth is prevalent and has a significant impact upon quality of life (QoL). Currently, there is no standard assessment for women after childbirth to identify these symptoms. This systematic review aimed to identify non-invasive modalities used to identify women with anal incontinence following childbirth and assess response and reporting rates of anal incontinence for these modalities. Methods: Ovid Medline, Allied and Complementary Medicine Database (AMED), Cumulative Index of Nursing and Allied Health Literature (CINAHL), Cochrane Collaboration, EMBASE and Web of Science databases were searched for studies using non-invasive modalities published from January 1966 to May 2018 to identify women with anal incontinence following childbirth. Study data including type of modality, response rates and reported prevalence of anal incontinence were extracted and critically appraised. Results: One hundred and nine studies were included from 1602 screened articles. Three types of non-invasive modalities were identified: validated questionnaires/symptom scales (n = 36 studies using 15 different instruments), non-validated questionnaires (n = 50 studies) and patient interviews (n = 23 studies). Mean response rates were 92% up to 6 weeks after childbirth. Non-personalised assessment modalities (validated and non-validated questionnaires) were associated with reporting of higher rates of anal incontinence compared with patient interview at all periods of follow-up after childbirth, which was statistically significant between 6 weeks and 1 year after childbirth (p < 0.05). Conclusions: This systematic review confirms that questionnaires can be used effectively after childbirth to identify women with anal incontinence. Given the methodological limitations associated with non-validated questionnaires, assessing all women following childbirth for pelvic-floor symptomatology, including anal incontinence, using validated questionnaires should be considered.

OBJECTIVE: To describe a new disease-specific questionnaire with established measurement properties that addresses the dimensions of health-related quality of life considered important to women with endometriosis. METHODS: The Endometriosis Health Profile-30 was developed in three stages. Stage 1 included open-ended exploratory interviews with 25 women to generate the items on the questionnaire. Stage 2 was an 87-item questionnaire administered in a postal survey to identify the most salient dimensions of health-related quality of life. In stage 3, the reliability and validity of the questionnaire were evaluated. RESULTS: The final instrument contained a core questionnaire with 30 items and five scales: pain, control and powerlessness, emotional well-being, social support, and self-image. Six modular parts consisting of 23 questions were also developed and measured the areas of sexual intercourse, work, relationship with children, feelings about the medical profession, treatment, and infertility. All the scales achieved high internal reliability, with Cronbach's α coefficient ranging from 0.83 to 0.93 (core questionnaire) and 0.79 to 0.96 (modules). The intraclass correlation coefficients to evaluate the test-retest reliability were high (range 0.88-0.98, P < .001). Content validity was demonstrated as the questionnaire was developed from interviews of patients rather than existing literature and clinical scales. Construct validity was assessed by correlating the Endometriosis Health Profile-30 scales with the relevant Short Form-36 scales. High correlations for all comparisons were found (-0.41 to -0.73). CONCLUSION: The Endometriosis Health Profile-30 is a reliable, valid, patient-generated instrument to measure the health-related quality of life of women with endometriosis. Its application in various health care settings will provide new and valuable information on the effect of endometriosis on health-related quality of life from the patients' perspective. © 2001 by the American College of Obstetricians and Gynecologists.

Objective: To explore and describe the impact of endometriosis upon quality of life. Setting: Nuffield Department of Obstetrics and Gynaecology, University of Oxford. Design: qualitative study. Sample: twenty-four women with a laparoscopic diagnosis of endometriosis. Methods: face to face, individual, in-depth interviews. Results: analysis of the data revealed 15 descriptive categories. Pain, physical functioning, role performance, social functioning, emotional well-being, relationship with the medical profession, treatment, sexual intercourse, energy and vitality, employment and infertility were found to be a particular concern for women with endometriosis. Physical appearance, lack of control and powerlessness, feelings of social isolation and concerns that their daughters might develop endometriosis were new areas found to be negatively affected by the condition. Conclusions: the impact of endometriosis-associated symptoms upon quality of life is multidimensional and more complex than just negatively affecting psychosocial parameters. Conducting in-depth interviews to explore the subjective experiences of patients with endometriosis enabled the diverse areas of quality of life to be identified. Adopting a qualitative methodology is essential for item generation on disease specific health status questionnaires.

Objectives: To evaluate the sensitivity to change of the Endometriosis Health Profile-30 (EHP-30) questionnaire. Setting: The Women's Center, John Radcliffe Hospital, Oxford. Design: Postal survey to 66 women undergoing conservative surgery for the treatment of endometriosis-associated pain. The EHP-30 and the Short Form-36 (SF-36) were administered 2 weeks before the operation, and 4 months post-operatively. At T2 a transition question was included to evaluate changes in patients health status. To evaluate responsiveness effect sizes, standardised response means, the index of responsiveness and the minimally and clinically important differences were calculated. Results: Forty (66.6%) patients returned the questionnaires at time 1 and 2. Overall less responsive effect size scores were found for the SF-36 (0.1-0.5) compared to the EHP-30 (-0.1-1.1) for all patients who had undergone treatment. Minimally important differences and the index of responsiveness were overall higher for the EHP-30 (0.4-2.0) compared to the SF-36 (0.1-1.0). Change scores for four of the five scales were significantly correlated with women's responses to the transition question. Conclusions: Results suggest that the EHP-30 is sensitive to change. Its application in clinical trials should prove beneficial in assessing the impact of medical and surgical interventions upon quality of life for women with endometriosis.

Introduction Existing tests for the prediction of preterm birth (PTB) are suboptimal – many exhibit poor predictive values. Electrical impedance spectroscopy (EIS) objectively quantifies the composition of the cervix. A prospective cohort study, funded by the MRC (DPFS scheme) has commenced in Sheffield to assess its potential predictive utility for preterm birth. Methods Employing an optimised prototype, 250 women at high risk of PTB will undergo spectroscopy readings at 20–22 and 26–28 weeks; 250 low risk women once at 20–22 weeks; and 100 symptomatic women following admission to hospital. To determine whether cervical impedance (CI) could prove a platform technique, we will also assess fetal fibronectin and ultrasound cervical length (CL). Concurrent qualitative and health economic studies will establish the acceptability of CI measurement. Results For asymptomatic women we will determine: the gestation at which CI measurement is most predictive of PTB; the optimum predictive electrical frequencies for CI assessment; the most predictive CI cut-off values; the predictive capacity of CI vs. ultrasound CL for PTB and whether a combination of both tests offers better predictive performance. The primary outcome is prediction of birth <37 weeks. Secondary outcomes include prediction of birth <32 weeks, birthweight <2500 g, premature rupture of membranes, NICU admission, composite perinatal morbidity/mortality, maternal hospitalisation, cost effectiveness/utility, tocolysis and cervical cerclage. For symptomatic women we will assess prediction of delivery within 1 and 2 weeks of assessment and delivery <37 weeks. Conclusions EIS is a promising clinical tool – our study will rigorously assess its role in the antenatal care of pregnant women.

Background and objective There can be adverse effects on health for mothers and fathers when a baby is born, but the focus on morbidity, such as depression detracts from the positive experiences of new parents. Efforts internationally to produce tools to measure postnatal health have focused on parenting stress, problems between couples and bonding. Other lengthy instruments may have limited value in clinical or research contexts. Aim To develop and psychometrically evaluate two instruments to accurately reflect the positive and negative aspects of postnatal health for mothers (M-PHI) and fathers (F-PHI) in the first postnatal year. Methods Two instruments were developed in four main stages: (1) Focus groups for postnatal women and questionnaire to fathers, (2) Qualitative interviews (separately for women and men), (3) Pilot survey, then main survey to 1000 women and separate survey of fathers including the 12-Item Short Form Health Survey (SF-12), Edinburgh Postnatal Depression Scale (EPDS) and Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), (4) Re-survey of mothers and fathers for completion within one week of returning the stage 3 survey questionnaire. Principal component analysis was used; internal reliability was measured using Cronbach's α; construct validity and criterion validity were tested using prehypothesised correlations with the SF-12, EPDS and WEMWBS. Results The mother's postnatal health instrument (M-PHI) contains positive scales: relationship with baby, social support, relationship with extended family, and negative scales: control over life, mood, role transition, sleep. plus some conditional items not relevant to all women: breast-feeding, physical health problem, relationship with partner, and sexual relationship. The father's postnatal health instrument (F-PHI) contains positive scales: relationship with baby, support from partner, support from friends, role as father; and negative scales: relationship with partner, and mood. The Cronbach's α values indicating good internal reliability ranged from 0.66 to 0.87 for the M-PHI and 0.72 to 0.90 for the F-PHI; the ICCs indicating high test-retest reliability ranged from 0.67 to 0.88 (p<0.001) for the M-PHI and 0.60 to 0.88 (p<0.001) for the F-PHI. Spearman's correlation coefficients indicated the strongest positive and negative correlations with the gold standard measures for mood, role transition and control over my life, supporting construct validity and criterion validity. Conclusions These two instruments, generated from the subjective feelings of parents have been found to be valid and reliable measures of the postnatal health of mothers and fathers in the first postnatal year. Further validation studies are recommended.

Introduction Delayed access to antenatal care (‘late booking’) has been linked to increased mortality and morbidity for mother and baby. The Confidential Enquiry into Maternal Deaths in the UK (2007) found that 17% of the women who died from Direct or Indirect causes booked for maternity care after 22 weeks gestation, had missed >4 routine antenatal visits or didn't seek care at all. Little explanatory qualitative research has been undertaken outside the USA. This study explored the reasons why women book late from (1) the perspectives of pregnant women who booked after 19 weeks gestation and (2) key maternity stakeholders involved in the care of antenatal women. Method Purposive sample of women booking >19 weeks gestation, from hospital, community and specialist antenatal clinics. Face-to-face, individual interviews in women's homes, hospital clinics and children's centres. Purposive and snowball sampling of midwives, doctors, social workers and link workers, from community and hospital settings. Interviewed individually and in small focus groups. All interviews were semi-structured, taped, transcribed, coded and organised using NVivo software and analysed using an inductive, thematic analysis. Results 80 women consented, 27 were interviewed. Greater diversity of women (age, parity, socioeconomic status, ethnicity) than stereotypical ‘late bookers’ reported elsewhere was found. Four key groups of women were identified with explanatory subthemes for late booking: (1) the ‘not knowers’ (absence of classic symptoms, misinterpreters, not believing pregnant); (2) the ‘knowers – avoiders’ (ambivalence, fear, DIY care); (3) the ‘knowers – postponers’ (fearful, on the move, undecided, not valuing antenatal care); (4) The ‘knowers – delayees’ (professional and system failures, knowledge and acceptance of the ‘system’). 42 stakeholders consented to interview; 8 focus groups and 9 individual interviews. Key themes were: a stereotypical view of socio-cultural and educational status of late bookers; lack of pregnancy planning and knowledge; ambivalence towards pregnancy/antenatal care; socio-cultural influences (chaotic lives, substance misuse, immigration, housing); vulnerability and support (influence of family and peers); fear, denial and avoidance (concealment, relationships with professionals, expectations); practical and organisational barriers to timely care. Conclusion In this largest UK qualitative study to date we identified service user and healthcare factors which delay access to antenatal care, including delayed diagnosis of pregnancy, poor reproductive health knowledge, contraceptive failure, lack of lay facilitation of engagement with antenatal care, and individual socio-cultural risk factors. These factors should be considered by service commissioners and health and social care practitioners in order to promote the provision of timely antenatal care for all women.

© 2018 The International Urogynecological Association Introduction and hypothesis: Understanding patients’ concerns and goals is essential for providing individualised care in urogynaecology. The study objectives were to undertake a content analysis of free-text concerns and goals recorded by patients using an electronic pelvic-floor questionnaire (ePAQ-PF) and measure how these related to self-reported symptom and health-related quality-of-life (HRQOL) data also recorded using ePAQ-PF. Methods: A total of 1996 consenting patients completed ePAQ-PF. Content analysis was undertaken of free-text responses to the item: ‘Considering the issues that currently concern you the most, what do you hope to achieve from any help, advice or treatment?’ Key content themes were identified by the lead researcher, and three researchers read and coded all recorded responses. Student’s t test was used to compare ePAQ-PF domain scores for patients reporting concerns in the relevant domain with those who did not. Results: In total, 63% of participants who completed the questionnaire, recorded at least one free-text item. Content analysis identified 1560 individual concerns coding into the 19 ePAQ-PF domains. Symptom scores were significantly higher for patients reporting free-text concerns in 18 domains (p < 0.05). Additional concerns relating specifically to body image were recorded by 11% of patients. Key areas of importance emerging for personal goals included cure/improvement, better understanding, incontinence pad use, sexual function and surgery. Conclusions: Free-text reporting in ePAQ-PF is utilised by patients and facilitates self-expression and discussion of issues impacting on HRQOL. The significant relationship between recorded free-text concerns and ePAQ-PF domain scores suggests convergent validity for the instrument. Development and psychometric testing of a domain to assess body image is proposed.

Worldwide, guidelines support the routine use of anaesthetic preoperative assessment (POA), a process that is frequently supported by pro formas and unvalidated questionnaires. Electronic questionnaires can provide reliable data. A local initiative has seen the development of a computerised electronic Personal Assessment Questionnaire (ePAQ).To develop and validate a novel electronic instrument for POA.The content and face validity were evaluated in 30 patients. The questionnaire was then modified and completed by a further 300 patients, evaluating the reliability of its items and scoring algorithms for BMI and American Society of Anesthesiologists (ASA) physical status. The study was approved by the South Yorkshire Regional Ethics Committee (REC 09/H1308/127).The study was conducted in a tertiary teaching hospital in the United Kingdom between January 2011 and February 2012 and was funded by a research grant from the Charitable Trustees of Sheffield Teaching Hospitals National Health Service Foundation Trust.A total of 330 patients aged 18 years or older, listed for surgery and able to read and understand English, were recruited. Neurosurgery; ear, nose and throat; orthopaedics; gynaecology; general and plastic surgery; ophthalmology and urology patients were included. All participants provided written consent.Validation including test-retest analysis, assessment of patient value and burden, assessment of accuracy, mean score difference of BMI estimation and comparison of inter-rater ASA grading.In all, 77% of patients reported that the ePAQ helped with communication, 99% that it was easy to complete and 98% that they would be happy to use it again. ePAQ preoperative assigned ASA grades matched consultant-assigned grades more frequently than nurse-assigned grades. Self-reported BMI classification was correct in 78% of patients and within one WHO category in a further 21%. Test-retest scores were good.Initial evaluation suggests that ePAQ is acceptable to patients. Data collected using the system were found to be reliable, and its intrinsic scoring systems for ASA and BMI are comparable with values assigned by clinicians.

BACKGROUND: Peripheral arterial disease (PAD) is generally associated with considerable morbidity and reduced quality of life. Patient-reported outcome measures (PROMs) provide important information about the burden of disease and impact of treatment in affected patients. OBJECTIVES: The objective of the review was to identify and appraise studies reporting the psychometric evaluation of PROMs administered to a specified population of patients with PAD with a view to recommending suitable PROMs. METHODS: A systematic review of peer-reviewed English language articles was undertaken to identify primary studies reporting psychometric properties of PROMs in English-speaking patients with various stages of PAD. Comprehensive searches were completed up until January 2015. Study selection, data extraction and quality assessment were undertaken independently by at least two researchers. Findings were presented as tabular and narrative summaries based on accepted guidance. RESULTS: Psychometric evaluation of 6 generic and 7 condition-specific PROMs reported in 14 studies contributed data to the review. The frequently reported measure was the SF-36 (n = 11 studies); others included the Walking Impairment Questionnaire (n = 8 studies), EQ-5D (n = 5 studies) and the Vascular Quality of Life Questionnaire (n = 3 studies). Studies included a diverse PAD population and varied in methodology, including approach to validation of PROMs. CONCLUSIONS: Various PROMs have been validated in patients with PAD but no study provided evidence of a full psychometric evaluation in the patient population. Careful selection is required to identify reliable and valid PROMs to use in clinical and research settings.

BACKGROUND: Decision-making in perianal Crohn's fistula (pCD) is preference sensitive. Patients use the internet to access healthcare information. The aim of this study was to assess the online information and patient decision aids relating to surgery for pCD. METHODS: A search of Google™ and the Decision Aids Library Inventory (DALI) was performed using a predefined search strategy. Patient-focussed sources providing information about pCD surgery were included in the analysis. Written health information was assessed using the International Patient Decision Aids Standards (IPDAS) and DISCERN criteria. The readability of the source content was assessed using the Flesch-Kincaid score. RESULTS: Of the 201 sources found, 187 were excluded, leaving 14 sources for analysis. Three sources were dedicated to pCD, and six sources mentioned pCD-specific outcomes. The most common surgical intervention reported was seton insertion (n = 13). The least common surgical intervention reported was proctectomy (n = 1). The mean IPDAS and DISCERN scores were 4.43 ± 1.65 out of 12 (range = 2-8) and 2.93 ± 0.73 out of 5 (range = 1-5), respectively. The mean reading ease was US college standard. CONCLUSIONS: We found no patient decision aids relating to surgery for pCD. The online sources relating to surgery for pCD are few, and their quality is poor, as seen in the low IPDAS and DISCERN scores. Less than half of the sources mentioned pCD-specific outcomes, and three sources were solely dedicated to providing information on pCD. Healthcare professionals should look to create a patient tool to assist decision-making in pCD.

Background: Guidance from the Royal College of Surgeons advocates patient use of on-line resources to assist in decision making. Our aim was to assess the quality of on-line resources to facilitate decision making for patients considering surgery for ulcerative colitis (UC). Methods: We undertook a systematic review based on PRISMA guidelines. This was registered on the PROSPERO database (CRD42016047177). We searched Google and repositories using several lay search terms for patient information discussing surgery for UC, published in English. Quality of content on websites was assessed using the validated DISCERN instrument and by minimum standards for decision aids (IPDASi v4.0 checklist). Decision aids were also assessed by the IPDAS checklist. Readability of written content was ascertained using the Flesch-Kincaid score. Results: Our searches identified 175 websites and one decision aid - 119 results were excluded at initial screen and 32 were excluded at full text assessment, leaving 25 sources for review. The mean Flesch-Kincaid score for websites was 44.9 (±9.73, range 28.1-61.4), suggesting material was difficult to read. No websites compared surgery to medical management or traded off patient preferences. The median IPDAS score was 5/12 (range 1-7). The median global score based on the DISCERN rating was 1/5 (range 1-5), identifying most websites as poor quality. The decision aid scored 9/12 on the IPDAS checklist, not meeting minimum standards. Conclusions: Available information for patients considering surgery for UC is generally low quality. The development of a new decision aid to support patients considering surgery for UC is recommended.

© 2017 Elsevier Inc. Background With the range of health information online, assessing the resources that patients access may improve the content of preoperative information. Our aim was to assess the content of the most viewed videos on YouTube related to surgery for ulcerative colitis (UC). Methods YouTube was searched for videos containing information on surgery for UC. The 50 most viewed videos were identified and user interaction analyzed. Upload source was classified as patient, individual health care professional (HCP), or hospital/professional association. Video content was categorized using an inductive thematic analysis on a purposive sample list of videos. The overarching theme of each video was classified once data saturation was achieved. Results Thirty videos were uploaded by patients, 15 by hospitals and 5 by HCPs. Seventeen videos (34%) discussed life after surgery. Sixteen of these were uploaded by patients who had previously undergone surgery for UC. No videos of this theme were uploaded by HCPs. Ten videos (20%) described a number of different operations. Other themes identified were alternative health therapies (12%), colonoscopy (12%), life with UC (8%), miscellaneous (8%), and education for HCPs (6%). Patient uploaded videos had significantly more comments (P = 0.0079), with 28% of comments on patient videos being users requesting further information. Conclusions Understanding the sequelae of surgery is most important to preoperative patients. There are a lack of professional videos addressing this topic on YouTube. HCPs must participate in the production of videos and adapt preoperative consultations to address common preoperative concerns.

Introduction: Patients considering surgery for ulcerative colitis face a difficult decision as surgery may or may not improve quality of life. NICE guidelines for UC emphasise the importance of providing quality pre-operative information to patients but note no quality studies for the desired content of this information. Our aim was to explore patient information preferences prior to undergoing surgery for ulcerative colitis. Method: Semi-structured interviews with patients who underwent an operation and patients who considered but declined an operation were conducted. Interviews explored informational preferences, with emphasis on pre-operative information given, pre-operative information desired but not received and retrospective informational desires. Interviews were transcribed and coded using an inductive thematic analysis using NVivo software. Data saturation was assessed after twelve interviews, with interviews continuing until saturation was achieved. Ethical approval was gained prior to interviews commencing (16/NW/0639). Results: A total of 16 interviews were conducted before data saturation was achieved (male n=7, female n=9). Eight patients declined surgery and eight opted for subtotal colectomy with; permanent end ileostomy (n=5), ileoanal pouch (n=3). A total of 4 themes and 14 subthemes were identified. Three dominant subthemes of informational shortcomings emerged: ‘long-term effects of surgery’, ‘practicalities of daily living’ and ‘long-term support’. Peer support was desired by patients but was infrequently supported by healthcare professionals. Conclusion: Current pre-operative information does not address patient informational needs. Surgical consultations should be adapted to suit patient preferences. Clinical practice may need to be altered to ensure patients are better supported following surgery.

BACKGROUND: The development of a patient-reported outcome measure (PROM) for polymyalgia rheumatica (PMR), a condition that causes pain, stiffness and disability, is necessary as there is no current validated disease-specific measure. Initial literature synthesis and qualitative research established a conceptual framework for the condition along with a list of symptoms and effects of PMR that patients felt were important to them. These findings were used to derive the candidate items for a patient-completed questionnaire. We aim to establish the face validity of this initial "long form" of a PROM. METHODS: People with a current or previous diagnosis of PMR were recruited both from the community and from rheumatology clinics. They were asked to complete the PMR questionnaire along with the QQ-10 questionnaire, which is a measure used to assess the face validity, feasibility and utility of patient healthcare questionnaires. RESULTS: A total of 28 participants with an age range of 59-85 years and a length of time since diagnosis from 4 months to 18 years completed the QQ-10. The overall mean "value" score was 79% (SD 12), and the mean "burden" score was 21% (SD 18). The free-text comments were analysed thematically and were found to focus on layout, content, where in the clinical pathway the questionnaire would be most beneficial, specific items missing and other areas for consideration. CONCLUSIONS: The high mean value score and low burden score indicate that the questionnaire has good face validity and is acceptable to patients. The questionnaire now needs to undergo further psychometric evaluation and refinement to develop the final tool for use in clinical practice and research.

Objective: Development of an electronic patient reported outcome measure (PROM) specifically designed for vulval-disorders. Psychometric testing of the components of the questionnaire which assess vulval symptoms, sexual function and quality of life (QoL). Method: Development and programming of the instrument (ePAQ-Vulva) was informed by national guidelines for the assessment of vulval-disorders, an expert panel and a survey of 61 vulval clinic patients. The PROM assesses frequency and impact of vulval symptoms, sexual function and QoL. It also records conditions and behaviours related to vulval-disorders and patient concerns/goals. Scale generation and psychometric testing were undertaken for the vulval symptoms, sexual function and QoL components of the PROM with 91 participants: descriptive statistics, factor analysis and internal reliability of identified domains, agreement between free-text and multiple-choice items to assess convergent validity and inter-rater reliability of picture items was assessed. Results: Descriptive statistics showed high floor effects for seven questionnaire items. Factor analysis identified five principal components. These were reviewed and amended to provide a putative domain structure of six domains. Internal reliability of these domains was assessed using Cronbach’s alpha, producing values of 0.715 to 0.917. Inter-rater reliability of the picture items produced a Kappa statistic of 0.405. Spearman’s rank showed moderate correlation between multiple choice answers and free-text concerns (r=0.364 – 0.462) in three of the six domains (Pain, Sex and Dyspareunia). Conclusions: ePAQ-Vulva offers the first patient reported outcome tool, specifically designed for vulval-disorders. The instrument requires further validation and testing, including evaluation of the stability, responsiveness and reliability.

Background: A variety of instruments have been used to assess outcomes for patients with venous leg ulcers. This study sought to identify, evaluate and recommend the most appropriate patient reported outcomes (PROMs) for English-speaking patients with venous leg ulcers (VLUs). Method: This systematic review used a two-staged approach. Electronic searches of major databases including MEDLINE were completed in October 2015 and then updated in July 2016. Additional studies were identified from citation checking. Study selection, data extraction and quality assessment were undertaken independently by at least two reviewers. Evaluation and summary of measurement properties of identified PROMs were undertaken using standard and adapted study-relevant criteria. Results: Ten studies with data for three generic PROMS and six condition-specific measures were identified. No generic PROM showed adequate content and criterion validity; however the EQ-5D, Nottingham Health Profile (NHP) and 12-item Health Survey Short-Form had good acceptability with scores ranging from 80% to 91%. In general, the EQ-5D showed poor responsiveness in patients with VLUs. Condition-specific PROMs demonstrated poor criterion and construct validity. Overall, good internal consistency was demonstrated for the Venous Leg Ulcer Quality of Life (VLU-QOL) and the Sheffield Preference-based Venous Ulcer questionnaire (SPVU-5D). Test re-test reliability was also satisfactory for SPVU-5D and VeLUSET measures. Conclusions: The NHP and VLU-QOL seemed the most suitable PROMs for use by clinicians. A valid condition-specific PROM is still required.

Delayed access to antenatal care in high income countries is associated with poor maternal, fetal and neonatal outcomes. The aim was to synthesise the diverse body of evidence around women's views of early antenatal care and barriers to attendance in such countries. Critical Interpretive Synthesis integrates the process of systematic review with the qualitative methods of meta-ethnography and grounded theory, with a focus on theory generation to inform policy, practice and future research.Database searches were conducted, supplemented with reference and citation tracking and website searching between February 2014 and April 2016. Qualitative data analysis methods were used to extract and summarise the key themes from each study. A taxonomy of constructs was created, with the synthesis developed to thread these together. Fifty-four papers were synthesised, including qualitative, quantitative, mixed method and systematic review, published between 1987 and 2016.Seventeen constructs around the core concept of 'acceptance of personal and public pregnancies' were produced. Acceptance of the 'personal' pregnancy considers the contribution of mindset in the recognition and acceptance of pregnancy, influenced by knowledge of pregnancy symptoms, pregnancy planning and desire. Acceptance of the 'public' pregnancy considers women's assessment of the social consequences of pregnancy, and the relevance and priority of antenatal care.Critical Interpretive Synthesis offers a systematic yet creative approach to the synthesis of diverse evidence. The findings offer new perspectives on women's perceptions of early pregnancy and attendance for care, which may be used to facilitate timely antenatal provision for all pregnant women.

Objective: To evaluate the impact of using a ‘virtual clinic’ on patient experience and cost in the care of women with urinary incontinence. Materials and Methods: Women, aged > 18 years referred to a urogynaecology unit were randomised to either (1) A Standard Clinic or (2) A Virtual Clinic. Both groups completed a validated, web-based interactive, patient-reported outome measure (ePAQ-Pelvic Floor), in advance of their appointment followed by either a telephone consultation (Virtual Clinic) or face-to-face consultation (Standard Care). The primary outcome was the mean ‘short-term outcome scale’ score on the Patient Experience Questionnaire (PEQ). Secondary Outcome Measures included the other domains of the PEQ (Communications, Emotions and Barriers), Client Satisfaction Questionnaire (CSQ), Short-Form 12 (SF-12), personal, societal and NHS costs. Results: 195 women were randomised: 98 received the intervention and 97 received standard care. The primary outcome showed a non-significant difference between the two study arms. No significant differences were also observed on the CSQ and SF-12. However, the intervention group showed significantly higher PEQ domain scores for Communications, Emotions and Barriers (including following adjustment for age and parity). Whilst standard care was overall more cost-effective, this was minimal (£38.04). The virtual clinic also significantly reduced consultation time (10.94 minutes, compared with a mean duration of 25.9 minutes respectively) and consultation costs compared to usual care (£31.75 versus £72.17 respectively), thus presenting potential cost-savings in out-patient management. Conclusions: The virtual clinical had no impact on the short-term dimension of the PEQ and overall was not as cost-effective as standard care, due to greater clinic re-attendances in this group. In the virtual clinic group, consultation times were briefer, communication experience was enhanced and personal costs lower. For medical conditions of a sensitive or intimate nature, a virtual clinic has potential to support patients to communicate with health professionals about their condition.

Fertility preservation in the female poses several challenges due to the invasive nature of the techniques available to achieve it. The guideline aims to bring together the evidence available for the measures for fertility preservation and their outcome. The guideline addresses fertility preservation for medical reasons and includes both oncological and non-oncological causes. The techniques that the guideline considers are: (i) embryo and oocyte cryopreservation; (ii) ovarian tissue cryopreservation; (iii) GnRH agonist suppression and (iv) ovarian transposition. Although ovarian tissue cryopreservation is still considered experimental, the availability of this technique is gaining momentum as more live births from auto-transplanted tissue are reported. The guideline also highlights use of current treatment modalities for benign and malignant conditions that have a better fertility sparing profile. The guideline recommends a multidisciplinary approach in counselling women and girls about the risk to their fertility and available techniques. The role of psychological support in assisting women and girls with decision-making is highlighted. The guideline also highlights the risks associated with these techniques. Women need to be medically fit to undergo invasive procedures. Fertility preservation techniques are appropriate when treatment has curative intent. Fertility preservation is a subject of on-going research on outcomes of different techniques and at the time of publication, studies are still likely to emerge adding to the available literature.

Colorectal Disease © 2019 The Association of Coloproctology of Great Britain and Ireland Aim: One in three patients with Crohn’s disease will develop a perianal fistula, but only a few achieve long-term healing. Treatment is both medical and surgical. Since there is no ‘best’ surgical procedure, patient preference is important in selecting the appropriate treatment for this condition. The aim of this study was to investigate the informational and decisional preferences of patients when surgical treatment is being considered. Method: Patients who had undergone surgery for Crohn's anal fistula underwent face-to-face semi-structured interviews. These explored the experience of treatments for fistula, of receiving information and of participation in decision-making. Transcripts were analysed by two investigators through inductive thematic analysis. Saturation was assessed for at 12 interviews and then after each subsequent interview. Results: Seventeen patients completed interviews, and saturation was achieved. Five themes were identified, of which two (desired information and decision-making) were relevant to this study. Other themes included experience of Crohn’s disease, experience of receiving information and procedure-specific comments. Participants wanted to have information on any risks, high-level outcomes (e.g. success), impact on day-to-day life and aftercare. Participants felt they did not always receive the information they needed to select the best treatment option. Participants felt uninvolved in treatment decisions and would have liked to trade off operations to reach their treatment goal. Conclusion: Information provided to patients about surgical treatment of Crohn’s perianal fistula does not meet their needs. Clinicians should address aftercare, impact on quality of life and the risks and benefits of the any proposed procedure.

© The Author(s) 2019. The aim of this descriptive epidemiological study of patients, referred to and selected for surgery at a UK tertiary hand centre, was to investigate patterns of common hand disorders and their impact on those individuals. A prospective collection of patient-reported outcome scores was carried out in patients before operation using the Patient Outcomes of Surgery Hand/Arm and the Euro-Qol 5 dimension three-level measures. Patient participation was voluntary and data collected over a 4-year period are discussed. Patient-reported outcome scores were calculated using appropriate algorithms. The results show correlation between the number of comorbidities and both symptoms and activity domains of the Patient Outcomes of Surgery Hand/Arm; higher symptom scores were seen in women. There was no increase in scores for older patients or those from more deprived areas. Population-based research using recognized patient-reported outcome measurement tools could aid future health service planning. Level of evidence: IV.

© 2015 Kapaya et al.Background: Published guidelines emphasise the need for early antenatal care to promote maternal and neonatal health. Inadequate engagement with antenatal care is associated with adverse pregnancy outcomes including maternal death. The factors that influence the uptake and utilisation of maternity care services are poorly understood. We retrospectively explore a large maternity database of births in a large referral UK hospital to capture the socio-demographic factors that influence late pregnancy booking, and then prospectively compare the stress and social support status of consenting early and late-booking women. Methods: Retrospective socio-demographic and clinical outcome data on 59,487 women were collected from the maternity database record of births between 2002 and 2010 at the Jessop Wing Hospital, Sheffield UK. In a follow-on prospective survey between October 2012 and May 2013 a convenience cohort of early and late bookers for antenatal care were then studied using validated scales for fetomaternal attachment, stress and anxiety, and social support. Results: In our retrospective study, pregnancy during the teenage years, higher parity, non-white ethnic background, unemployment and smoking were significantly associated with late access to antenatal services and poor fetal outcomes (P < 0.001). However, late booking per se did not predict adverse fetal outcomes, when socio-demographic factors were accounted for. A high index of multiple deprivation (IMD) score remained independently associated with late booking when confounding factors such as ethnicity and employment status were controlled for in the model (P = 0.03). Our prospective data demonstrated that women who book late were more likely to be unmarried (OR: 3.571, 95 % CI: 1.464-8.196, p = 0.005), of high parity (OR: 1.759, 95 % CI: 1.154-2.684, P = 0.009), and have lower social support than early bookers (P = 0.047). Conclusions: Of the many complex sociocultural factors that influence the timing of maternal engagement with antenatal care, multiple deprivation and poor social support remain key factors. Improving access to prenatal care requires in-depth exploration of the relationship between maternal psychosocial health indices, social support mechanisms and engagement with antenatal care. Findings from these studies should inform interventions aimed at improving access to care.

Background: Endometriosis is a common cause of chronic pelvic pain which can relapse after surgery, yet little research has been conducted on women's experience of medical treatments for prevention of recurrence and the influence of this on participation in clinical trials. Methods: This study explored women's past experiences with medical treatments for endometriosis symptoms and the impact this has on their motivation to enter the pilot phase of a post-conservative surgery clinical trial, PRE-EMPT: Preventing Recurrence of Endometriosis by Means of long acting Progestogen Therapy. Qualitative methodology was adopted, involving semi-structured interviews in three UK cities, and one focus group was used to collect data from women with a diagnosis of endometriosis participating in the PRE-EMPT trial. Results: Ten women were interviewed individually and four took part in the focus group discussion. Women's willingness to enter the PRE-EMPT trial was bound up with their previous experiences, present situation and future expectations of medication, as well as the control offered by flexible randomisation which allows the option to reject a particular treatment post-surgery. Conclusion: Women were strongly influenced by previous experience and personal circumstances in their decision to enter the PRE-EMPT trial. This decision was facilitated by the ability to 'opt out' of the treatment arm(s) they found unacceptable. This element of choice offered patients a sense of control in the randomisation process and has important implications for clinical trial design and recruitment.

Study Questio: NDoes surgical and low-dose progestin treatment differentially affect endometriosis-associated severe deep dyspareunia in terms of sexual functioning, psychological status and health-related quality of life? Summary Answer: Surgery and progestin treatment achieved essentially similar benefits at 12-month follow-up, but with different temporal trends.WHAT IS ALREADY KNOWNConservative surgery and hormonal therapies have been used independently for endometriosis-associated deep dyspareunia with inconsistent results.STUDY Design: , SIZE, DURATIONPatient preference, parallel cohort study with 12-month follow-up. The effect of conservative surgery at laparoscopy versus treatment with a low dose of norethisterone acetate per os (2.5 mg/day) in women with persistent/recurrent severe deep dyspareunia after first-line surgery was compared.PARTICIPANTS/MATERIALS AND SETTING, METHODSA total of 51 patients chose repeat surgery and 103 progestin treatment. Variations in sexual function, psychological well-being and quality of life were measured by means of the Female Sexual Function Index (FSFI), the Hospital Anxiety and Depression Scale (HADS) and the Endometriosis Health Profile-30 (EHP-30). Main Results and the Role of Chance: Four women in the surgery group and 21 women in the progestin group withdrew from the study for various reasons. Total FSFI scores, anxiety and depression scores and EHP-30 scores improved immediately after surgery, but worsened with time, whereas the effect during progestin use increased more gradually, but progressively, without overall significant between-group differences at 12-month follow-up. A tendency was observed towards a slightly better total FSFI score after surgery at the end of the study period.LIMITATIONS, REASONS FOR CAUTIONTreatments were not randomly allocated, and distribution of participants as well as of dropouts between study arms was unbalanced. However, the possibility of choosing the treatment allowed assessment of the maximum potential effect size of the interventions. Wider Implications of the Findings: Both surgery and medical treatment with progestins are valuable options for improving the detrimental impact of endometriosis-associated dyspareunia on sexual functioning and quality of life. Women should be aware of the pros and cons of both options to decide which one best suits their needs. Study Funding/Competing Interest: (S)This study was supported by a research grant from the University of Milan School of Medicine (PUR number 2009-ATE-0570). None of the authors have a conflict of interest. © 2013 The Author.

The aim of this study was to evaluate sexual function in women before and after tension-free vaginal tape (TVT) procedure. In this questionnaire-based study, 100 women undergoing TVT for stress incontinence were assessed preoperatively and 3 months postoperatively using a validated pelvic floor symptoms assessment questionnaire. The incidence and impact of TVT on orgasm incontinence, penetration incontinence, anxiety related to bladder problems during sex, avoidance of intercourse, and overall impact on sex life were assessed. Incontinence during intercourse was reported in 68% of women preoperatively. Following TVT, there were significant reductions in orgasm incontinence, penetration incontinence, anxiety regarding the bladder and sex, avoidance of sex, post-coital infection, and overall impact of lower urinary tract symptoms on sex. There was a non-significant reduction in partner avoidance of sex. TVT significantly improves the overall sex lives of women with stress urinary incontinence. Orgasm incontinence, penetration incontinence, post-coital infections, anxiety, and avoidance of sex are all reduced. © The International Urogynecological Association 2008.

This service evaluation aimed to appraise the delivery of a fertility preservation service for women with cancer which was established in 2005 as part of an Assisted Conception Unit. First, the ACU-database was interrogated between 08/2005 and 01/2017; revealing 174 women received referrals over the 12-year period with a steady referral increase each year. Demographic analyses revealed factors, such as being partnered, to be strong indicators of whether women would seek FP or not. To improve service provision, women who had consented to be contacted for audit, administrative and research purposes, received questionnaires to ascertain their perspectives on the FP decision-making process, their outcomes and ACU after-care. The majority perceived their experience as excellent due to the care they received from ACU staff, speed and efficiency in service delivery. The increasing number of referrals since 2005 is reassuring. However, this audit also highlighted shortcomings of the service, such as limited awareness of the fertility counselling service and lack of after-care. IMPACT STATEMENT What is already known on this subject? There has been an increase in women diagnosed with cancer undergoing fertility preservation (FP) before starting potential gonadotoxic treatment. Offering FP to these women is essential as the ability to have future children is often perceived as equally as important as survivorship, and a source of hope for the future. What do the results of this study add? This study presents a service evaluation, across a 12-year period, of delivering FP services to women with cancer in one UK Assisted Conception Unit (ACU). Women's experiences of the service were evaluated to enhance service delivery and make recommendations for clinical practice. What are the implications of these findings for clinical practice and/or future research? The current service evaluation demonstrated increased rates of FP referral over a 12-year period for women with cancer. While this increasing number is reassuring and reflecting increased awareness among professionals and patients; shortcomings in the care pathway were also found: women reported limited opportunity to see fertility counsellors and desired better after care. This information may also be of benefit to other ACUs seeking to enhance and improve service provision in the care of women with cancer, contemplating fertility preservation.

The purpose of our study was to evaluate a new region-specific outcome measure in hand and upper limb surgery: the Patient Outcomes of Surgery (POS)-Hand/Arm questionnaire using the generic Short Form Health Survey (SF)-36 questionnaire as a ‘gold standard’ comparative measure. The POS-Hand/Arm preop questionnaire and the SF-36 questionnaire were completed by 214 patients on the day of their hand or upper limb surgery; and a postop POS-Hand/Arm and the SF-36 questionnaire were completed by patients 3 months after their initial surgery. The POS-Hand/Arm questionnaire responses were psychometrically evaluated and it was shown to have high internal consistency; high total-item correlations; signification scale correlations with the SF-36; and a low proportion of missing data. The POS-Hand/Arm questionnaire is a psychometrically sound instrument that can be used pre- and post-surgery to evaluate patient-based outcomes for a wide range of conditions in hand and upper limb surgery.

© 2019 Elsevier B.V. Objective: Menstrual disorders, pelvic-pain and gynaecological hormonal conditions in women can have a significant impact on quality-of-life. Reliable assessment and monitoring of these intimate conditions is challenging. Patient reported outcome measures (PROMs) can be invaluable in providing objective assessment, but no comprehensive PROM assessing all of these conditions and their impact on quality of life is currently available. The purpose of this study was to develop and undertake initial psychometric testing of a comprehensive interactive electronic patient reported outcome measure for these conditions. Study design: A prototype electronic PROM (ePAQ-MPH) was developed following systematic literature review, semi structured interviews with 25 patients and expert panel review. Exploratory factor analysis was undertaken in 291 women attending a menstrual-disorders clinic; establishing a domain structure and enabling item reduction. Two validated PROMS (Women's Health Questionnaire and Menstrual Distress Questionnaire) were completed to assess criterion validity in 213 patients. Test-retest reliability was carried out in 30 women completing ePAQ-MPH at least one week apart. Patients' views on ‘Value’ and ‘Burden’ were assessed in 278 women using a validated 10-item survey measuring questionnaire utility (QQ-10). Confirmatory factor analysis (CFA) of the revised version of ePAQ-MPH following item reduction was undertaken in a different sample of 254 women. Results: Exploratory factor analysis identified 18 domains (Cronbach's α > 0.7) and 30 redundant items. Test-retest analysis found acceptable intra-class correlations of 0.6–0.9 (p < 0.05). Eight domains were compared with Menstrual Distress Questionnaire showing moderate or strong correlation in seven domains. Ten domains were compared with Women's Health Questionnaire, six of which showed moderate correlation. Mean QQ-10 Value and Burden scores were 76 and 25, respectively (SD=15.8 and 15.5). The mean completion time for ePAQ-MPH was 31 min. CFA of the revised version 2 instrument with 15 domains showed good model fit. Conclusions: Whilst wider psychometric testing of the revised version of ePAQ-MPH is required, including in different settings and in assessments of data quality and responsiveness, initial analysis provides some evidence for reliability, validity and acceptability of this multi-dimensional electronic PROM. ePAQ-MPH shows potential for both patient assessment and roles in service evaluation and research.

Objectives: To determine the amount of change over time on the five dimensions of the 40-item Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) that are subjectively meaningful to patients. Minimally important differences (MID), effect sizes (ES) and standardized response means (SRM) are calculated for respondents who indicate only a little change over the time of the study whilst mean change scores, ES and SRM statistics are calculated for those who indicated much change.

Design: Postal survey. Copies of the ALSAQ-40 were completed on two occasions three months apart. Respondents were also asked to indicate how much change they had experienced since baseline on each of the five domains of the questionnaire.

Setting: All patient members of the Motor Neurone Disease Association for England, Wales and Northern Ireland.

Subjects: Seven hundred and sixty-four patient members returned questionnaires at baseline and follow-up.

Results: For those reporting minor change since baseline results varied across dimensions. For example a MID was reflected in a change of 6.67 (SD 16.52) points for the Communication dimension, whilst for the Emotional functioning dimension the change was 2.67 (SD 15.45) points. Similarly ESs and SRMs varied considerably across dimensions. Mean change over time, ES and SRM statistics for those who reported that their health was much worse at follow-up were substantially larger: for example, mean changes ranged from 6.87 (SD 15.87) to 13.79 (SD 22.60).

Conclusions: Results indicate the minimum magnitude of change that is subjectively meaningful to patients. Results indicate that smaller changes than have been suggested previously as significant have a subjectively meaningful adverse effect upon patients.

Objective: To develop and validate a short form version of the Endometriosis Health Profile-30 questionnaire which consists of a 30-item core questionnaire and a 23 item modular questionnaire. Methods: Three studies were carried out to develop the Endometriosis Health Profile-5. Study 1: a short form version of the Endometriosis Health Profile-30 core questionnaire was developed. Study 2: the results were verified in a new data set. Study 3: a short form version of the 23 item modular questionnaire was produced. The modular questionnaire contains six dimensions which may not be applicable to every woman with endometriosis and is used to supplement the five scales on the core questionnaire when required. Results: The final instrument contained 11 items: five items from the core questionnaire and six items from the modular questionnaire. The 95% confidence intervals for Study 1 indicated that the scale scores overlapped with each item score and were confirmed in the second analysis (study 2). Each item was most highly correlated to its parent scale and less with the remaining four core questionnaire scales which was verified in study 2. In both studies all correlations were significant at the 0.01 level (two tailed test). Conclusion: The Endometriosis Health Profile-5 is a reliable and valid short form questionnaire which can also be supplemented with a short form version of the modular questionnaire when required. It will be especially useful in clinical settings where a short and economical endometriosis health status measure is required.

Background: We wished to evaluate the psychometric properties of the Polycystic Ovary Syndrome Questionnaire (PCOSQ), a questionnaire developed to measure the health-related quality of life (HRQoL) of women with polycystic ovary syndrome. Method: To assess reliability and validity, women recruited from an outpatient gynaecology clinic at the Jessop Wing, Royal Hallamshire Hospital, Sheffield completed two copies of the PCOSQ and the Short Form-36 (SF-36). Secondary factor analysis was carried out to verify the composition of the dimensions. Semi-structured interviews were conducted to assess face validity. Results: Of the 92 women who consented, 82 women (89%) returned questionnaires at time 1, and 69 women (75%) returned questionnaires at time 2. All five PCOSQ dimensions were internally reliable with Cronbach's α scores ranging from 0.70 to 0.97. Intra-class correlation coefficients to evaluate test-retest reliability were high (range 0.89-0.95, P < 0.001). Construct validity was demonstrated by high correlations for all comparisons of similar scales of the SF-36 and PCOSQ (0.49 and 0.54). Acne was identified as an important area of HRQoL missing from the questionnaire. Conclusions: The PCOSQ is a reliable instrument for measuring the HRQoL in women with PCOS. However, the validity of the questionnaire needs to be improved by incorporating a dimension on acne into the instrument.

Objective  To develop and evaluate a Web‐based, electronic pelvic floor symptoms assessment questionnaire (e‐PAQ)1 for women.

Design  A cross‐sectional study in primary and secondary care.

Setting  Two general practices, two community health clinics and a secondary care urogynaecology clinic.

Sample  A total of 432 women (204 in primary care and 228 in secondary care) were recruited between June 2003 and January 2004.

Methods  The e‐PAQ was located on a workstation (computer, touchscreen and printer). Women completed the e‐PAQ prior to their appointment. Untreated women in primary care were asked to return seven days later to complete the e‐PAQ a second time (test–retest).

Main outcome measures  Factor analysis, reliability, validity, patient satisfaction, completion times and system costs.

Results  In secondary care, factor analysis identified 14 domains within the four dimensions (urinary, bowel, vaginal and sexual symptoms) with internal consistency (Cronbach's alpha) ≥ 0.7 in 11 of these. In primary care, alpha values were all ≥ 0.7 and test–retest analysis found acceptable intraclass correlations of 0.50−0.95 (P < 0.001) for all domains. A measure of face validity and utility was gained using a nine‐item questionnaire, which yielded strongly positive patient views on relevance and acceptability.

Conclusions  The e‐PAQ offers a user‐friendly clinical tool, which provides valid and reliable data. The system offers comprehensive symptoms and quality of life evaluation and may enhance the clinical episode as well as the quality of care for women with pelvic floor disorders.

BACKGROUND: Health Related Quality of Life (HRQoL) studies on children with chronic illness such as thalassaemia are limited. We conducted the first study to investigate if children with thalassaemia have a lower quality of life in the four dimensions as measured using the PedsQL 4.0 generic Scale Score: physical, emotional, social and role (school) functioning compared to the healthy controls allowing for age, gender, ethnicity and household income. METHODS: The PedsQL 4.0 was administered to children receiving blood transfusions and treatments at Hospital Kuala Lumpur, Malaysia using PedsQL 4.0 generic Scale Score. Accordingly, the questionnaire was also administered to a control group of healthy school children. Socio-demographic data were also collected from patients and controls using an interview schedule designed for the study. RESULTS: Of the 96 thalassaemia patients approached, 78 gave consent to be interviewed giving a response rate of 81.3%. Out of 235 healthy controls approached, all agreed to participate giving a response rate of 100%. The mean age for the patients and schoolchildren is 11.9 and 13.2 years respectively. The age range for the patients and the schoolchildren is between 5 to 18 years and 7 to 18 years respectively. After controlling for age and demographic background, the thalassaemia patients reported having significantly lower quality of life than the healthy controls. CONCLUSION: Thalassaemia has a negative impact on perceived physical, emotional, social and school functioning in thalassaemia patients which was also found to be worse than the children's healthy counterparts. Continuing support of free desferal from the Ministry of Health should be given to these patients. More understanding and support especially from health authorities, school authorities and the society is essential to enhance their quality of life.

Backgound: To test the data quality, scaling assumptions and scoring algorithms underlying the Endometriosis Health Profile-30 (EHP-30) questionnaire: a questionnaire developed to measure the health-related quality of life (HRQoL) of women with endometriosis. Methods: A cross-sectional postal survey to 727 women with surgically confirmed endometriosis recruited from an existing genetic linkage study (OXEGENE), The National Endometriosis Society (NES), UK and the outpatient gynaecology clinics of the Women's Centre, John Radcliffe Hospital, Oxford. Tests of data quality included secondary factor analysis, internal reliability consistency, descriptive statistics of the data, missing data levels, floor and ceiling effects and corrected item to total correlation scores. Results: Six hundred and ten women (8 3.9%) returned the questionnaire. Secondary factor analysis verified the domain structure of the EHP-30. All 11 dimensions were internally reliable with Cronbach's α scores ranging from 0.80 to 0.96. Missing response rates ranged from 0.2 to 1.3%, and all items were found to be most highly correlated with their own (corrected) scale. Conclusions: Results confirmed the factor structure, scoring and scaling assumptions of the questionnaire. The high rate of data completeness indicated that the EHP-30 was acceptable and understandable to the respondents, thereby verifying its suitability for measuring the HRQoL of women with endometriosis. © 2006 Oxford University Press.

There is evidence that obesity is particularly stigmatised in Western societies. Studies suggest that this is related to the high visibility of the condition and the widespread belief that it is under personal control. Other work has demonstrated that obesity is associated with reduced quality of life across a range of dimensions. However, the bulk of these studies have been surveys employing generic standardised measures. The finer grained connections between the stigma of obesity and quality of life have not been studied in depth. There have not been any qualitative studies to develop theoretical understanding of an individual's awareness of the stigma of obesity, their strategies to manage it and the consequent impact on daily life. This paper will report on a qualitative study in which 28 individuals were interviewed in depth at home. The semi-structured interview explored perceptions of obesity, sensitivity to its stigma and its impact on quality of life. The findings show this group to be highly aware of the stigma of obesity with, for many, directly negative consequences for quality of life. A number of psychological and behavioural response strategies were evident in participants efforts to manage a potentially spoiled social identity. However, these strategies had mixed effects in protecting quality of life. Some participants faced a chronic sense of failure of personal responsibility with negative cognitions about what others thought of them. These impacted on other psychosocial aspects of life, particularly in certain social contexts. The presentation discusses these findings with respect to other research about obesity stigma. It highlights a number of critical issues for health, education and other sectors now providing interventions for obesity. It is important that the outcomes of these interventions with respect to stigma are studied. © Common Ground.

Background: Obesity has become a major public health issue and there is concern about the response of health services to patients who are obese. The perceptions of obese patients using primary care services have not been studied in depth. Aim: To explore obese patients' experiences and perceptions of support in primary care. Design of study: Qualitative study with semi-structured interviews conducted in participants' homes. Setting: Five general practices contrasting in socioeconomic populations in Sheffield. Method: Purposive sampling and semi-structured interviewing of 28 patients with a diverse range of ages, backgrounds, levels of obesity and experiences of primary care services. Results: Participants typically felt reluctance when presenting with concerns about weight and ambivalence about the services received. They also perceived there to be ambivalence and a lack of resources on the part of the health services. Participants showed a strong sense of personal responsibility about their condition and stigma-related cognitions were common. These contributed to their ambivalence about using services and their sensitivity to its features. Good relationships with primary care professionals and more intensive support partly ameliorated these effects. Conclusion: The challenges of improving access to and quality of primary care support in tackling obesity are made more complex by patients' ambivalence and other effects of the stigma associated with obesity. © British Journal of General Practice 2006.

Gynecologic cancers are major sources of mortality and morbidity. Although many review articles have reported on the impact of these diseases on health-related quality of life (HRQoL), none have reviewed the evidence in specific relation to the effect of treatment on HRQoL. Consequently, we systematically searched 4 electronic databases and hand-searched relevant reference lists and bibliographies to identify literature on this subject. Only 47 studies used a validated questionnaire to measure HRQoL. Although a meta-analysis was not possible, we found HRQoL rarely included as a treatment outcome, and when included assessment was often methodologically flawed. Seldom were pretreatment and posttreatment data collected or treatment regimes documented. Except for a few studies, analysis of HRQoL was conducted on small samples, excluding the cancer site and stage. Consequently, no definitive conclusions could be drawn and therefore we conclude with recommendations for the future reporting of HRQoL in gynecologic oncology studies. © 2006 Mosby, Inc. All rights reserved.

Objective: To summarize the literature describing the impact of uterine fibroids on health-related quality of life (HRQOL), the measures used to assess HRQOL, and related areas for future research. Methods: A search of three electronic databases (MEDLINE, Embase, and Current Contents) was performed, and 40 papers were identified referencing leiomyoma or uterine fibroids and (health-related) quality of life (HRQOL). Studies including women with benign gynecological conditions other than uterine fibroids were also reviewed. Results: The EQ-5D, SF-36, and related generic measures are used to assess HRQOL in women with diverse gynecological conditions, including uterine fibroids. The UFS-QOL, a condition-specific measure, provides scores on symptom severity and six HRQOL dimensions. All instruments consistently demonstrate that HRQOL is considerably impaired in women with symptomatic uterine fibroids and that appropriate treatment can lead to improved QOL. Conclusions: The published data on HRQOL associated with uterine fibroids report significantly lower HRQOL scores for women with fibroids than for women without this disorder. Additional research is needed to confirm these findings and provide greater detail describing the specific domains most affected by uterine fibroids. These advances are necessary to effectively compare new treatment modalities vs. standard invasive therapies, such as hysterectomy. © Mary Ann Liebert, Inc.

This case study explores the objective and psychologically perceived effects of the menstrual cycle and the use of a combined oral contraceptive pill on the singing performance of a western classical female singer. Objective measures of vocal parameters and hormonal concentrations were assessed during her natural menstrual cycle and during the use of an oral contraceptive pill. A diary was kept throughout the six months duration of the study and one lengthy semi-structured interview was also carried out with the singer, focussing on perceptions of her singing quality over the entire study. Aural analyses of the singing recordings were also undertaken by two independently qualified judges to see whether or not vocal changes were perceptible to listeners. The results suggest that: (i) hormonal variations during the natural menstrual cycle affected physiological and psychological aspects of the singer's performance; (ii) the pattern of vibration of the vocal folds seems to be more regular, and vocal control seems to be improved during oral contraceptive pill use; (iii) the singer reported better voice control during oral contraceptive pill use; (iv) listeners perceive intonation problems and wider vibrato during the natural menstrual cycle. This study suggests that further research on the effects of female sexual hormones on the singer's voice is necessary, and that female singers should be educated regarding these matters, in order to protect their voices and careers.

Objectives: To compare results on the 40-item Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-40) with those gained on the short-form five-item Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ-5) in a longitudinal study.

Design: Postal survey. Copies of the ALSAQ-40 which incorporates the five items of the ALSAQ-5, were completed on two occasions. Respondents were also asked to indicate how much change they had experienced since baseline on each of the five domains of the questionnaire.

Setting: The database of all patient members of the Motor Neurone Disease Association for England, Wales and Northern Ireland.

Subjects: Nine hundred and twenty-seven patient members returned questionnaires at baseline, and 764 completed questionnaires at both baseline and follow-up.

Results: Results on the five dimensions of the ALSAQ-40 and ALSAQ-5 were found to be highly correlated, and 95% confidence intervals on mean scores were found to overlap for each dimension. The instruments both provide a similar picture of change in terms of their responsiveness. For example, effect sizes were calculated for patients who claimed their health had deteriorated a little since baseline, and gave almost identical results (e.g. for the Physical functioning domain effect sizes of 0.12 and 0.11 were found on the long and short measures respectively).

Conclusions: Results suggests that the ALSAQ-5 provides similar results to the ALSAQ-40 yet with considerable economy. In instances where a very brief health status measure is required then the ALSAQ-5 may be the instrument of choice.

Endometriosis, menorrhagia, chronic pelvic pain, and polycystic ovary syndrome are major sources of psychologic morbidity and can negatively affect quality of life. Although comparative studies have been published on the measurement of health-related quality of life for gynecologic malignancies, a similar review for these benign gynecologic conditions has not been conducted. Consequently, we searched the literature systematically to identify the impact of symptoms and treatments for these conditions on health status and to report on the types and psychometric properties of the instruments used. Papers were retrieved by systematically searching 6 electronic databases and hand-searching relevant reference lists and bibliographies. Forty-six studies used a questionnaire to measure health status: 34 studies (74%) used standardized instruments; of these, 23 studies(68%) used generic tools. Although a meta analysis was not possible, it appears that women with chronic pelvic pain and conditions that are associated with pelvic pain (such as endometriosis) report worse health-related quality of life. Despite the development of disease-specific questionnaires, only 2 questionnaires were generated from interviews of patients with the condition of interest, and few questionnaires are being used to evaluate the outcomes of treatment on subjective health status. © 2002 Mosby, Inc.

Summary: The success of professional operatic singers depends upon the quality of their vocal mechanism. This is known to be sensitive to changes in the endocrine environment. Despite a widespread belief among singers that vocal quality changes according to the stage of the menstrual cycle, this has received little attention. In particular, the possibility that use of the contraceptive pill might stabilize vocal quality by "dampening" hormonal fluctuations has not previously been studied systematically. Here, we show that drospirenone containing oral contraceptive pill (Yasmin, Schering AG, West Sussex, UK) with antiandrogenic and antimineralocorticoid properties demonstrates a significant reduction in the irregularity of the pattern of vibration of the vocal folds during the performance of highly trained classical singers. This study constitutes the first double blind, randomized placebo controlled trial to assess the effects of the contraceptive pill on the patterns of vibration of the vocal folds during the performance of Western classical singing repertoire. © 2007 The Voice Foundation.

Objectives: Health status instruments, which measure the subjective functioning and well-being of respondents, are increasingly being used in international, multi-centre trials of new treatments. If the results of such trials in different countries are to be pooled, it is vitally important for researchers to know how comparable the instruments are across cultures. In this study, we evaluated the response rate, data quality, score reliability and scaling assumptions of the 30-item Endometriosis Health Profile (EHP-30) in the USA. Methods: Data were obtained from a multi-centre study which recruited 225 patients from 43 clinic sites in the United States of America. It was a randomised, evaluator-blinded, Phase III study. In the evaluation of the EHP-30 reported here, the two groups (Depot Medroxyprogesterone Acetate [DMPA] and Leuprolide Acetate [LA]) are combined, and analyses are based on the data gained at baseline. Questionnaires were self-completed by patients when they visited the clinics. Results: Data completeness was very high, with 97.33% of respondents completing all of the items on the EHP-30. Furthermore, there were no more than a maximum of two missing responses for any given item. No floor and ceiling effects were found for any of the dimensions of the questionnaire. Internal consistency reliability was high for all dimensions (alpha ranged from 0.84 to 0.91). The psychometric properties of the instrument, outlined in the development of the UK version, are supported in the American context. Conclusions: The data presented here suggest that the EHP-30 is a valid and reliable measure that can be appropriately and meaningfully used in studies that include respondents from the USA. © 2008 Springer Science+Business Media B.V.

In recent years there has been an increasing demand for the design, development and use of questionnaires that can assess patients' experiences of health and illness or their health-related quality of life (HRQoL). The application of these questionnaires in research and clinical practice provides information from the patient's perspective on the ways in which symptoms and treatments can affect their daily well-being and functioning. The aim of this paper is to report on the ways in which information on the HRQoL of women with polycystic ovary syndrome (PCOS) can be collected. With particular reference to PCOS-associated infertility, this paper will discuss the types of questionnaires that are currently available. It will discuss the benefits and limitations of the disease-specific PCOS questionnaire, and the other generic and condition-specific tools that have been used in the existing PCOS literature. Recommendations for future researchers interested in measuring HRQoL outcomes in women with PCOS-associated infertility are also made.

The symptoms typically associated with polycystic ovary syndrome (PCOS) such as acne, hirsutism, irregular menses, amenorrhoea, obesity and subfertility are a major source of psychological morbidity and can negatively affect quality of life (QoL). We systematically searched the literature to identify the impact of symptoms and treatments for PCOS on health-related QoL (HRQoL) and to report on the types and psychometric properties of the instruments used. Papers were retrieved by systematically searching four electronic databases and hand searching relevant reference lists and bibliographies. Nineteen papers used a standardized questionnaire to measure health status; of these 12 (63.2%) used generic tools and 8 (42%) used the disease-specific PCOS questionnaire. Although a meta-analysis was not possible, it appears that weight concerns have a particular negative impact upon HRQoL, although the role of body mass index in affecting HRQoL scores is inconclusive from the available evidence. Acne is the area least reported upon in terms of its impact upon HRQoL. With the exception of three studies, most of the research has focused upon adult women with PCOS. Despite the benefits of HRQoL measures in research, few are being used to evaluate the outcomes of treatment for PCOS upon the subjective health status of women with the condition. © The Author 2007. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved.

BACKGROUND: Recent initiatives have been introduced by the UK government into secondary schools to increase pupils' access to physical activity (PA). Despite this, not enough is known about pupils' levels of physical activity or whether the delivery of these initiatives in schools facilitates or creates a barrier for pupils' PA. The aim of this study was to gain an understanding of adolescents PA levels from the perspective of those responsible for delivering physical education (PE) in schools; heads of PE (HOPE) and heads of school (HS). METHODS: Seventeen semi-structured qualitative interviews were carried out with a snowball sample of HOPE and HS in schools in the Northwest and Southwest of England. Thematic data analysis using NVIVO was used to identify emergent themes. RESULTS: 17 core themes were generated, 12 of which confirmed the findings from similar research. However, five themes relating to 'ethos of performance/elitism', 'lower fitness leads to lower ability', 'undervaluing activities within PE dept' or school as a whole', 'role of the school' and 'PE department doing all it can' offer valuable new insight into the factors which may encourage or prevent PA inside or outside the curriculum. CONCLUSION: Despite many positive perceptions of the delivery of PE in schools, it is evident that barriers still exist within that delivery which discourages physical activity. More research is needed to particularly address the complex issues of elitism and the ethos of PA in schools.

The aim of this review was to identify the ways in which obesity affects the health-related quality of life (HRQoL) of postmenopausal women. This was considered important because a growing body of literature has identified obesity as a significant predictor for a poor psychological wellbeing and negative HRQoL, particularly in women, and because during the transition through the menopause women tend to accumulate more body weight. After searching eight electronic databases, only nine papers appeared meaningful. Although a meta-analysis was not possible, we found that a body mass index (BMI) >30 kg/m 2 was associated with a poor HRQoL in postmenopausal women; particularly in the areas associated with physical functioning, energy and vitality, and health perceptions. Thus, clinical management of obese postmenopausal women should focus on weight reduction and exercise in an attempt to improve wellbeing in these areas. However, the paucity of research, the different instruments chosen to measure HRQoL and the methodological limitations of the studies identified, prevented firm conclusions being made about whether the relationship between BMI and HRQoL is linear in postmenopausal women. Further research is needed to explore this relationship; particularly in comparison with underweight postmenopausal women and obese premenopausal women, where a few papers have identified these women as having a worse HRQoL than their obese postmenopausal counterparts. Other measures of central adiposity, including waist circumference and waist-hip ratio are recommended as useful supplemental measures to BMI in future studies.

Background: The aim of this meta-analysis was to investigate whether any difference exists in success rate of clinical outcomes of assisted reproductive technologies (ART) between women who actively smoke cigarettes at the time of treatment and those who do not. Methods: An intensive computerized search was conducted on published literature from eight databases, using search terms related to smoking, assisted reproduction and outcome measures. Eligible studies compared outcomes of ART between cigarette smoking patients and a control group of non-smoking patients and reported on live birth rate per cycle, clinical pregnancy rate per cycle, ectopic pregnancy rate per pregnancy or spontaneous miscarriage rate per pregnancy, and 21 studies were included in the meta-analyses. Pooled odds ratios (OR) and 95% confidence intervals (CI) were calculated for the data, and statistical heterogeneity was tested for using χ

2

2

Objectives: To evaluate factors influencing the outcome with tension-free vaginal tape (TVT). Study design: A prospective questionnaire survey of 100 women undergoing TVT between January 2006 and May 2007 for urodynamic stress incontinence. All women were assessed pre-operatively and 3 months post-operatively using a validated electronic pelvic floor symptoms assessment questionnaire (ePAQ). Using linear regression, the influence of age, severity of stress incontinence and pre-existing lower urinary tract symptoms (LUTS) were assessed on symptomatic improvement of stress urinary incontinence and on quality of life (QoL). Results: Women with more severe symptoms preoperatively had a significantly greater improvement in stress incontinence symptoms (p < 0.001) and quality of life (p = 0.016). Age and pre-existing LUTS were not associated with adverse outcomes with surgery in terms of improvement in stress incontinence or quality of life. Conclusions: Women with more severe stress urinary incontinence may expect greater improvement, both in their stress incontinence and their health-related quality of life (HRQoL) following a TVT. Age and coexisting lower urinary tract symptoms do not impact significantly on TVT outcomes in terms of the reduction in stress incontinence or improvement in HRQoL. © 2009 Elsevier Ireland Ltd. All rights reserved.

Abstract

Objective  To investigate health researchers’ attitudes to involving the public in research.

Background  Public involvement in research is encouraged by the Department of Health in the UK. Despite this, the number of health researchers actively involving the public in research appears to be limited. There is little research specifically addressing the attitudes of health researchers towards involving the public: how they interpret the policy, what motivates and de‐motivates them and what their experiences have been to date.

Design  A qualitative research design, using semi‐structured telephone interviews.

Setting and participants  Fifteen purposively sampled UK‐based University health researchers were the participants. Interviews were conducted over the telephone.

Findings  The participants suggested varying constructions of public involvement in research. Arguments based on moral and political principles and consequentialist arguments for involving the public in research were offered and most participants highlighted the potential benefits of involving the public. However, feelings of apprehension expressed by some participants imply that a number of researchers may still be uncomfortable with involving the public, as it presents a different way of working.

Objective  To assess the safety and efficacy of long‐term use of long‐acting GnRH agonist in women with chronic cyclical pelvic pain using immediate versus delayed add‐back hormonal replacement therapy (HRT).

Design  A prospective randomised trial.

Setting  Reproductive and Developmental Medicine, Academic Unit, University Teaching Hospital and NHS Hospitals.

Population  Thirty‐eight premenopausal women with chronic cyclical pelvic pain were recruited.

Methods  Women were given Zoladex 10.8 mg over 18 months and randomised to receive HRT (tibolone 2.5 mg) either immediately or after 6 months. Follow up was 12‐month post‐treatment.

Main outcome measures  Bone mineral density at 6 months, the end of treatment (18 months), and 12 months later, pain and quality of life.

Results  Women treated with immediate HRT add‐back showed less bone mineral density loss at 6 months and less vasomotor symptoms compared with those who had delayed HRT add‐back treatment. Long‐term follow up showed both groups experienced equivalent bone mineral density loss. Pain and health‐related quality‐of‐life assessment showed improvement in both groups but there was evidence of a return to baseline levels after ending treatment.

Conclusion  Long‐term use of GnRH agonist plus immediate add‐back HRT is a safe and acceptable approach to intractable cyclical pelvic pain. Given the delay in reactivation of the hypothalamo‐pituitary‐ovarian axis after long‐term suppression, an intermittent dose regime with GnRH agonist might warrant investigation.

A number of reports have suggested that academic medicine within the UK may be in decline. This article assesses the number and outcome of abstracts presented at consecutive British Society of Gastroenterology (BSG) meetings. All abstracts presented at the BSG between 1994 and 2002 were assessed (n=4,096). Full publication rates of abstracts were then compared between meetings. Other abstract characteristics were also analysed. There was a significant downward trend demonstrated for the percentage of abstracts going onto full publication (p=0.02). In 1994, 57.6% of abstracts were subsequently fully published but by 2002 this number had fallen to 30.7%. The results show that the number of abstracts at the BSG which are then fully published has fallen with a significant trend. This observation could be taken as an indicator that there is a decline in research activity within the UK gastroenterology community. © Royal College of Physicians, 2009. All rights reserved.

The objective of the study was to test the data quality, scaling assumptions and scoring algorithms underlying the electronic personal assessment questionnaire - pelvic floor (ePAQ-PF). A cross-sectional survey of 599 women with pelvic floor disorders was carried out. Tests of data quality included secondary factor analysis, internal reliability, descriptive statistics, levels of missing data, floor and ceiling effects, item-to-total correlation scores, item discriminant and convergent validity. Secondary factor analysis verified the domain structure of ePAQ-PF. All 19 domains were internally reliable with Cronbach's α scores ranging from 0.71 to 0.93. Missing response rates ranged from 0.2% to 1.3%, and all items were found to be most highly correlated with their own corrected scale. Results confirmed the factor structure, data quality and scoring and scaling assumptions of ePAQ-PF, thereby verifying its suitability for measuring symptoms, bother and quality of life in women with pelvic floor disorders. © The International Urogynecological Association 2008.

Objective: To investigate differences in characteristics of patients with endometriosis in the United States and the United Kingdom. Design: Patient questionnaire. Setting: Two university-based endometriosis referral centers. Patient(s): Women with surgically diagnosed endometriosis. Intervention(s): None. Main Outcome Measure(s): Patient demographics, menstrual and obstetric history, contraceptive use, medical history, risk factors, family history, endometriosis diagnosis, and current pain status and treatment. Result(s): Most demographic characteristics were similar between groups. However, patients in the United States were diagnosed at a younger age than were patients in the United Kingdom (25.6 ± 6.7 years vs. 28.0 ± 7.1 years) and more commonly presented with an ovarian mass. More U.K. women used oral contraceptives before diagnosis and were younger at first use. U.K. patients underwent fewer additional surgeries than U.S. patients but reported that surgery alone provided the best relief of symptoms, whereas most U.S. patients reported that surgical and medical therapy together provided the best relief of symptoms. Conclusion(s): The many similarities in demographics and symptoms among women with endometriosis in the U.S. and the U.K. support the universality of the disease process. Despite a variety of treatments, most patients from both groups still experienced pain from their endometriosis at the time of the survey. © 2002 by American Society for Reproductive Medicine.

OBJECTIVE: Standard pre-operative assessment at our institution involves a comprehensive history and examination by a nurse practitioner. An electronic pre-operative assessment questionnaire, ePAQ-PO® (ePAQ, Sheffield, UK) has previously been developed and validated. This study aimed to determine the impact of ePAQ-PO on nurse consultation times and patient satisfaction in low-risk patients. METHODS: The duration of pre-operative assessment consultation was recorded for American Society of Anesthesiology physical classification 1 and 2 patients undergoing pre-operative assessment by an electronic questionnaire (ePAQ-PO group) and standard face-to-face assessment by a nurse practitioner (standard group). Patients were also asked to complete an eight-item satisfaction questionnaire. Eighty-six patients were included (43 in each group). RESULTS: After adjusting for the duration of physical examination, median (IQR [min-max]) consultation time was longer in the standard compared to the ePAQ-PO group (25 (18-33 [10-49]) min vs. 12 (8-17 [4-45]) min, respectively; p <0.001). Response rate for the satisfaction questionnaire was 93%. There was no significant difference in patient satisfaction scores (38/39 in standard group vs. 39/41 in ePAQ-PO group were fully satisfied with their pre-operative assessment; p = 0.494). CONCLUSION: Pre-operative assessment using ePAQ-PO is associated with a significant reduction of over 50% in the duration of the assessment without impacting on patient satisfaction.

© 2018, Springer Nature Switzerland AG. Objectives: The aim of this study was to identify themes that determine health-related quality of life (HRQoL) in patients with carotid artery stenosis and identify the patient-reported outcome measures (PROMs) that best cover the identified themes. Methods: A systematic review of the main six databases from inception to September 2018 was undertaken to identify primary qualitative studies reporting on the HRQoL of patients with carotid artery stenosis. The quality of studies was assessed using the Critical Appraisal Skills Programme (CASP) criteria. Findings from the included studies were analysed using framework analysis methodology. The identified themes were mapped against the items/domains from the PROMs used previously in patients with carotid artery stenosis. Results: The systematic review identified four papers that fulfilled the inclusion criteria. The included papers reported the views of 62 patients with symptomatic carotid artery stenosis; 24 of the patients were awaiting assessment for intervention, 26 had carotid endarterectomy, and 12 were turned down for intervention and received best medical therapy. The overall quality of the included studies was good based on CASP criteria. Framework analysis identified 16 themes that were divided into five main domains: anxiety, impact on personal roles and activities, effect on independence, psychological impact, and symptoms. The best-fit generic and disease-specific PROMs were the Medical Outcomes Study 36-Item Short Form (SF-36®) and the Carotid Stenosis Specific Outcome Measure (CSSOM), respectively. None of the PROMs covered all the themes identified in the qualitative systematic review. Conclusion: The findings from the review identified the important themes that affect patients with carotid stenosis disease. The current generic and disease-specific PROMs do not cover all themes that impact the HRQoL of patients suffering with this disease. The proposed themes can be used to develop a new disease-specific PROM to measure HRQoL.

© 2018 John Wiley & Sons Ltd Aim: To identify the symptoms and quality of life impacts that are important from the perspective of patients with varicose veins and to compare identified themes to items in varicose vein patient-reported outcome measures (PROMs). Background: Varicose veins are common worldwide and are considered a chronic condition with implications for quality of life. Treatment is predominantly conservative; therefore, understanding patients’ experiences of living with varicose veins is important to inform the provision of clinical care. PROMs are often used to collect data about patients’ quality of life. Design: Thematic synthesis of qualitative research reported according to ENTREQ guidelines. Methods: Multiple electronic databases, including MEDLINE and CINAHL, were systematically searched to identify qualitative research examining experiences of adults with varicose veins. Thematic synthesis was then conducted on the included studies. Results: Three studies met the inclusion criteria; the quality of the studies was high. The range and intensity of reported symptoms and participant's experiences of living with varicose veins were varied. Five overarching themes were identified: physical, psychological and social impact of varicose veins, adapting to varicose veins and reasons for seeking treatment. The overall key theme to emerge was adaptation, with patients demonstrating how they adapted to the various impacts. Conclusion: This review demonstrates that varicose veins have a wide range of symptoms and may have a significant impact on quality of life; people made significant adaptations to enable them to live their lives as fully as possible. Relevance to Clinical Practice: Healthcare professionals need to be aware of the range of symptoms and their impact on quality of life. The use of PROMs to gather information about quality of life and symptoms is well established globally; however, PROMs currently used may not capture the full extent of the impact on patient's quality of life.

Colorectal Disease © 2018 The Association of Coloproctology of Great Britain and Ireland Aim: YouTube™ is an open-access, nonpeer-reviewed video-hosting site and is used as a source of publicly available healthcare information. This study aimed to assess the thematic content of the most viewed videos relating to surgery and Crohn's disease and to explore the viewer interactions with these videos. Method: A search of YouTube™ was carried out using one search string. The 50 most viewed videos were identified and categorized by source and content themes and assessed for viewer interactions. Video comments were used to describe the usefulness of the video content to viewers. Results: The majority of videos were uploaded by patients (n = 21).The remainder were uploaded by individual healthcare professionals (n = 9), hospital/speciality associations (n = 18) and industry (n = 2). The median number of likes for patient videos was significantly higher than for hospital/speciality association videos (P < 0.001). Patient videos received more comments praising the video content (n = 27) and more comments asking for further information (n = 14). The median number of likes for ‘experience of surgery’ (P < 0.001) and ‘experience of disease’ (P = 0.0015) themed videos were significantly higher than for ‘disease management’ themed videos. Conclusion: Crohn's disease patients use YouTube™ as a surgical information source. The content of patient-sourced videos focused on surgical and disease experience, suggesting that these themes are important to patients. Current patient developed videos provide limited information, as reflected by viewers requesting further information. Storytelling patient-centred videos combined with clinical evidence may be a good model for future videos.

© 2018 Springer International Publishing AG, part of Springer Nature Objectives: The aim of this study was to identify domains that determine quality of life in patients with peripheral arterial disease and find the patient-reported outcome measures that can examine the identified themes. Methods: A systematic review of all the main six databases was undertaken to identify primary qualitative studies reporting on the health and/or quality of life of patients with peripheral arterial disease. The quality of studies was assessed using the Critical Appraisal Skills Program criteria. Findings from the included studies were analysed using framework analysis methodology. The identified themes were mapped against the items/domains of validated patient-reported outcome measures used in patients with peripheral arterial disease. Results: The systematic review identified eight papers that fulfilled the inclusion criteria. The included papers reported the views of 186 patients with peripheral arterial disease including patients with intermittent claudication, critical ischaemia and amputation secondary to peripheral arterial disease. The overall quality of the included studies was good based on Critical Appraisal Skills Program criteria. Framework analysis identified 35 themes that were divided into six main groups: symptoms, impact on physical functioning, impact on social functioning, psychological impact, financial impact and process of care. The best-fit generic and disease-specific patient-reported outcome measures were the Nottingham Health Profile and the Vascular Quality of Life Questionnaire, respectively. None of the patient-reported outcome measures covered all the themes important to patients with peripheral arterial disease. Discussion: The findings from the review identified the important domains that affect patients living with peripheral arterial disease. None of the current generic and disease-specific patient-reported outcome measures provide a comprehensive measure for all themes that impact the daily living of patients with peripheral arterial disease.

This editorial introduces a new special series on the pilot and feasibility testing of patient-reported outcome measures (PROMs) in the on-line open access journal Pilot and Feasibility Studies. Pilot and feasibility studies are typically implemented to address issues of uncertainty before undertaking a larger definitive study such as a randomised controlled trial or large scale survey. This editorial considers the role that such pilot and feasibility testing plays in relation to the development, evaluation and implementation of PROMs. This is often an essential element of PROM research but is typically overlooked-especially within current methodological guidance, reporting space and also debate. This editorial aims to open up a dialogue about the role of pilot and feasibility testing in relation to PROMs. It highlights some of the areas in PROMs research where these types of studies have been carried out and discusses the ways in which the PROM community may be better supported and encouraged to integrate this element of the research process into their PROM-based work.

AIM: Urogynaecological conditions can have a significant impact on body image. Patient-reported outcome measures (PROMs) are widely used in urogynaecology to assess symptoms and their impact on quality of life. This systematic review aimed to identify currently available PROMs used to assess body image within a urogynaecological population and to identify the most psychometrically robust and appropriate PROM tools to use in this context. METHODS: Ovid Medline, AMED, CINAHL, Cochrane Collaboration, EMBASE and Web of Science databases were searched from January 1966 to November 2018 to identify studies that had administered a PROM to assess body image to patients diagnosed with a urogynaecological condition. The information extracted and critically appraised included study setting, PROM instrument used and the reported psychometric properties of the PROM. RESULTS: Seventeen studies were included from 3207 screened articles. Seven different PROMs used to assess body image in a urogynaecological population were identified. Two of these PROMs (Genital Self-Image Scale-20 and Body Image in Pelvic Organ Prolapse questionnaire) had good psychometric evidence for use, but this was only in the context of women with prolapse. Evidence for validity and reliability was limited for the other five PROMs identified. CONCLUSION: Further development and psychometric testing of PROMs to assess body image in urogynaecology, for both research purposes and clinical practice, are required. Further research is also required to investigate the relationship between body image and urogynaecological symptomatology, and developing valid, reliable and functional PROMs will be integral to this.

Background Vascular services is changing rapidly, having emerged as a new specialty with its own training and specialised techniques. This has resulted in the need for reconfiguration of services to provide adequate specialist provision and accessible and equitable services. Objectives To identify the effects of service configuration on practice, resource use and outcomes. To model potential changes in configuration. To identify and/or develop electronic data collection tools for collecting patient-reported outcome measures and other clinical information. To evaluate patient preferences for aspects of services other than health-related quality of life. Design This was a multiple methods study comprising multiple systematic literature reviews; the development of a new outcome measure for users of vascular services (the electronic Personal Assessment Questionnaire – Vascular) based on the reviews, qualitative studies and psychometric evaluation; a trade-off exercise to measure process utilities; Hospital Episode Statistics analysis; and the development of individual disease models and a metamodel of service configuration. Setting Specialist vascular inpatient services in England. Data sources Modelling and Hospital Episode Statistics analysis for all vascular inpatients in England from 2006 to 2018. Qualitative studies and electronic Personal Assessment Questionnaire – Vascular evaluation with vascular patients from the Sheffield area. The trade-off studies were based on a societal sample from across England. Interventions The data analysis, preference studies and modelling explored the effect of different potential arrangements for service provision on the resource use, workload and outcomes for all interventions in the three main areas of inpatient vascular treatment: peripheral arterial disease, abdominal aortic aneurysm and carotid artery disease. The electronic Personal Assessment Questionnaire – Vascular was evaluated as a potential tool for clinical data collection and outcome monitoring. Main outcome measures Systematic reviews assessed quality and psychometric properties of published outcome measures for vascular disease and the relationship between volume and outcome in vascular services. The electronic Personal Assessment Questionnaire – Vascular development considered face and construct validity, test–retest reliability and responsiveness. Models were validated using case studies from previous reconfigurations and comparisons with Hospital Episode Statistics data. Preference studies resulted in estimates of process utilities for aneurysm treatment and for travelling distances to access services. Results Systematic reviews provided evidence of an association between increasing volume of activity and improved outcomes for peripheral arterial disease, abdominal aortic aneurysm and carotid artery disease. Reviews of existing patient-reported outcome measures did not identify suitable condition-specific tools for incorporation in the electronic Personal Assessment Questionnaire – Vascular. Reviews of qualitative evidence, primary qualitative studies and a Delphi exercise identified the issues to be incorporated into the electronic Personal Assessment Questionnaire – Vascular, resulting in a questionnaire with one generic and three disease-specific domains. After initial item reduction, the final version has 55 items in eight scales and has acceptable psychometric properties. The preference studies showed strong preference for endovascular abdominal aortic aneurysm treatment (willingness to trade up to 0.135 quality-adjusted life-years) and for local services (up to 0.631 quality-adjusted life-years). A simulation model with a web-based interface was developed, incorporating disease-specific models for abdominal aortic aneurysm, peripheral arterial disease and carotid artery disease. This predicts the effects of specified reconfigurations on workload, resource use, outcomes and cost-effectiveness. Initial exploration suggested that further reconfiguration of services in England to accomplish high-volume centres would result in improved outcomes, within the bounds of cost-effectiveness usually considered acceptable in the NHS. Limitations The major source of evidence to populate the models was Hospital Episode Statistics data, which have limitations owing to the complexity of the data, deficiencies in the coding systems and variations in coding practice. The studies were not able to address all of the potential barriers to change where vascular services are not compliant with current NHS recommendations. Conclusions There is evidence of potential for improvement in the clinical effectiveness and cost-effectiveness of vascular services through further centralisation of sites where major vascular procedures are undertaken. Preferences for local services are strong, and this may be addressed through more integrated services, with a range of services being provided more locally. The use of a web-based tool for the collection of clinical data and patient-reported outcome measures is feasible and can provide outcome data for clinical use and service evaluation. Future work Further evaluation of the economic models in real-world situations where local vascular service reconfiguration is under consideration and of the barriers to change where vascular services do not meet NHS recommendations for service configuration is needed. Further work on the electronic Personal Assessment Questionnaire – Vascular is required to assess its acceptability and usefulness in clinical practice and to develop appropriate report formats for clinical use and service evaluation. Further studies to assess the implications of including non-health-related preferences for care processes, and location of services, in calculations of cost-effectiveness are required. Study registration This study is registered as PROSPERO CRD42016042570, CRD42016042573, CRD42016042574, CRD42016042576, CRD42016042575, CRD42014014850, CRD42015023877 and CRD42015024820. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 9, No. 5. See the NIHR Journals Library website for further project information.

Background: Within the UK, standard methods of economic evaluation centre on the maximisation of the quality-adjusted life-year (QALY). However, preference-based measures used to estimate QALYs may not be suited to all economic evaluations, as they routinely measure only health outcomes. Aim: This study used an economic evaluation alongside a clinical trial (EEACT) comparing patients’ preferences for a telephone versus a face-to-face consultation to incorporate process utility into cost-effectiveness analyses. Methods: An EEACT is described that generates QALYs using Short-form 6-dimension version 1 (SF-6Dv1) responses. These results exclude specific consideration of process utility. A health state valuation study is then reported that bolts a process domain onto the SF-6Dv1 using data obtained from the EEACT. These results therefore include the consideration of process utility. The results of the EEACT with and without process utility are then compared. Results: This study shows that the QALY, in its current form, does not capture patient benefits associated with the process of receiving healthcare. The EEACT illustrates this, showing a statistically significant difference between control and intervention groups for the patient experience questionnaire communication domain, indicating that patients preferred the intervention. This preference was not identified in the cost-effectiveness outcomes, and the point estimates lie in the north-west quadrant of the cost-effectiveness plane. The preference is captured after adding a communication domain. The point estimate moves to the north-east quadrant, where the intervention is more effective and more costly than the control. Conclusion: This study indicates that it is possible to capture patients’ preferences for processes associated with care, in a format compatible with the QALY.

STUDY OBJECTIVE: To characterize typical menstrual characteristics in a large sample of secondary school girls, as well as knowledge of typical (ie, normal) menstruation, endometriosis awareness, and educational needs. To establish whether self-reported atypical period symptoms indicate menstrual characteristics suggesting the need for further clinical review for a specialist opinion. DESIGN: Cross-sectional survey. SETTING: Secondary schools in West Midlands, England. PARTICIPANTS: A total of 442 girls, aged 15-19 years. INTERVENTIONS AND MAIN OUTCOME MEASURES: The questionnaire determined demographic characteristics, age at menarche, menstrual cycle patterns and experiences, awareness of endometriosis, and preferences for learning about it. RESULTS: Period pain was common (94%), with pain reported as moderate/severe (86%). Girls reported missing school due to their menstrual periods (23%), mainly because of pain. Most believed their period was typical (63%); however, 27% were unsure, and 30% did not know whether it was regular. Self-report of atypical periods was associated with symptoms suggesting need for clinical review and with consulting a doctor [χ²(2) = 36.272, P < .001)]. Only 8% could describe endometriosis, although 86% wanted to learn more about it. CONCLUSION: Most secondary school girls report dysmenorrhea. Although most girls reporting atypical periods had seen a doctor, more than one-fourth did not know whether their period was typical or regular. The majority do not have knowledge of endometriosis, contrasting with adolescents' familiarity with other common chronic conditions such as diabetes and epilepsy. We suggest menstrual health education (MHE) to improve knowledge of typical menstruation and pain treatment, aiding earlier identification of problematic period symptoms that might indicate underlying pathology.

OBJECTIVE: The aim of this paper is to describe the stages undertaken to generate the items and conceptual framework of a new electronic personal assessment questionnaire for vascular conditions. DESIGN: A mixed methods study: First a survey of vascular clinicians was completed to identify the most common conditions treated in vascular clinics and wards. Quantitative systematic reviews were done to identify validated patient-reported outcome measures (PROMs) for direct inclsuion in the new instrument. However, due to scarcity of validated PROMs, the items of the new instrument were mainly based on a large qualitative study of patients and systematic reviews of the qualitative evidence . This was followed by a quantitative clinicians' consensus study and, finally, a qualitative face validity study with patients. PARTICIPANTS: Vascular patients participated in the primary qualitative study and the face validity study. In the qualitative study, 55 patients were interviewed, and for the face validity, 19 patients gave feedback. Twelve clinicians completed the survey and 13 completed two cycles of the clinicians' consensus study. RESULTS: The items and scales in the electronic personal assessment questionnaire for vascular conditions (ePAQ-VAS) were generated based on the results of five systematic reviews evaluating existing PROMs for possible inclusion in ePAQ-VAS, five systematic reviews of qualitative evidence, a primary qualitative study involving 55 patients and clinicians' input. One hundred and sixty-eight items were initially generated, of which 59 were eliminated by the expert panel due to repetition. The instrument was divided into one generic and three disease-specific sections (abdominal aortic aneurysm, carotid artery disease and lower limb vascular conditions). In each section, items were grouped together into putative scales. Fifty-five items were grouped across eight scales; the remaining items were kept as individual items, because of relevance to service users. CONCLUSIONS: This multidimensional electronic questionnaire covers the most common vascular conditions. This is particularly important for patients presenting with mixed symptoms or multiple conditions. This tool captures symptomatology, health related quality of life (HRQoL) and other clinically relevant data, such as experience with services and comorbidities.

Background Acne (syn: acne vulgaris) ranks as the most common inflammatory dermatosis treated worldwide. Acne typically affects adolescents at a time when they are undergoing maximum physical and social transitions, although prevalence studies suggest it is starting earlier and lasting longer, particularly in female patients. According to global burden of disease studies, acne causes significant psychosocial impact. Hence, identifying mechanisms to accurately measure the impact of the disease is important. Adopting an approach to harmonize and standardize measurements is now recognized as an essential part of any clinical evaluation and allows for better comparison across studies and meta-analyses. Objective The Acne Core Outcome Research Network (ACORN) has identified relevant domains as part of a core outcome set of measures for use in clinical studies. One of these is health-related quality of life (HRQoL). The aim of this systematic review was to provide information to inform the identification of the impacts most important to people with acne. Methods A synthesis of available evidence on acne impacts was constructed from a systematic review of the literature, with searches conducted in the MEDLINE, EMBASE and PsychInfo databases. Results We identified 408 studies from 58 countries using 138 different instruments to detect the impacts of acne. Four of the five most commonly used instruments (Dermatology Life Quality Index [DLQI], Cardiff Acne Disability Index [CADI], Acne Quality of Life scale [Acne-QoL], Hospital Anxiety and Depression Scale [HADS] and Skindex-29) do not identify specific impacts but rather quantify to what extent acne affects HRQoL. Other studies identified one or more impacts using open-ended questions or tailor-made questionnaires. Conclusion This review serves as a rich data source for future efforts by groups such as ACORN (that include patients and health care providers) to develop a core set of outcome measurements for use in clinical trials.

Aim There are many surgical treatments used in Crohn's anal fistula, although none is perfect. Decisions about surgery in this condition may be preference sensitive. The aim of this study was to identify what information patients would like in order to make treatment decisions and to explore experiences of making decisions in this setting. Method A survey was designed based upon qualitative interviews and input from patients and clinicians. It included a long list of informational items to be ranked on a scale of importance, a control preference scale, the decision regret scale, and items exploring preferred information formats. This was distributed through 10 English hospitals to patients with recent surgical treatment for Crohn's anal fistula. Results were analysed using principal component analysis, to identify key informational needs, and other appropriate descriptive statistics. Results In total 92 questionnaires were returned (response rate 41.8%); 48 (52.5%) respondents were women and 54 (58.7%) had undergone seton insertion. Principal component analysis identified three information needs: wound and aftercare, effect on perianal symptoms, severity of surgery. Decision‐making preferences showed a desire to participate in decision‐making. Median decision regret score was 25/100 (i.e., low). The preferred format for sharing information to support decision‐making was from the surgeon, 80/92 (87.0%), and from a booklet, 58/92 (63.0%). Conclusion Key informational needs in this condition are wound and after care, effect on perianal symptoms, and severity of surgery. Patients would like this information to help engage in shared decision‐making.

BACKGROUND: Chronic cyclic pelvic pain (CCPP) affects women's quality of life and pituitary downregulation is often used for symptomatic relief. However, prolonged suppression of ovarian function is associated with menopausal side effects and can lead to osteoporosis. Currently, the use of gonadotropin releasing hormone agonists (GnRHa) for treatment of CCPP is usually restricted to 6-9 months, limiting their efficacy. There is limited information regarding safety and efficacy with longer-term use. The aim of this study is to examine the safety and efficacy of long-term (24 months) pituitary down-regulation with the GnRHa (Triptorelin SR) with add-back therapy (ABT) using Tibolone for symptom relief in women with CCPP. METHODS: A single-arm, prospective clinical trial at a Tertiary University Teaching Hospital of 27 patients receiving Triptorelin SR (11.25 mg) and Tibolone (2.5 mg). Outcomes measures were the safety of treatment assessed by clinical examination, haematological markers, liver and renal function tests and bone mineral density (BMD) at 12, 18 and 24 months as well as at 6 months post-treatment. Pain and health-related quality of life (HR-QoL) assessed using the endometriosis health profile (EHP-30) and chronic pain grade (CPG) questionnaires. RESULTS: There was no evidence for any significant harmful effects on any of the measured haematological, renal or liver function tests. Although results regarding the effect on BMD are not conclusive there is an increased risk of development of osteopaenia after 12 months of treatment. Pain and HRQoL assessments showed significant improvement during medication, but with deterioration after treatment cessation. CONCLUSION: Long- term Triptorelin plus Tibolone add-back therapy in women suffering from CCPP does not appear to be associated with significant serious adverse events apart from the possibility of deterioration in the BMD that needs to be monitored. This mode of therapy appears to be effective in pain relief and in improving quality of life over a 24-month period. TRIAL REGISTRATION: Clinical trials database NCT00735852.

INTRODUCTION: Urogynaecological conditions have been shown to negatively impact on body image in a number of previous studies. ePAQ-Pelvic Floor (ePAQ-PF) is a patient-reported outcome measure used in clinical practice to assess urogynaecological conditions and their impact on quality of life. This study aimed to develop and undertake initial psychometric testing of a new domain to assess urogynaecological body image within ePAQ-PF. METHODS: A patient involvement group, analysis of free-text data from ePAQ-PF and a systematic review of existing PROMs assessing urogynaecological body image informed the content of a new body-image domain within ePAQ-PF. This was administered to 208 patients who consented to the use of their anonymised ePAQ-PF responses for research purposes. These data underwent factor analysis, internal consistency reliability and item-total correlation testing. Evidence-based hypotheses were formulated to test construct validity. Criterion validity was assessed against the Body-image Scale (BIS). Patients completed a separate questionnaire (QQ-11) to measure the face validity of ePAQ-PF. RESULTS: Factor analysis revealed a four-item body-image domain with good internal consistency reliability (Cronbach's α = 0.899) and item-total correlation (Spearman's rank r > 0.40). ePAQ-PF body-image domain scores correlated significantly with the BIS scores (r = 0.501). Age, prolapse, sexual dysfunction, pelvic pain and urinary incontinence scores correlated significantly with body-image domain score. QQ-11 value scores demonstrated good acceptability. CONCLUSIONS: Body-image assessment should form part of routine care in urogynaecology. Preliminary results support the validity, reliability and functionality of the body-image domain in ePAQ-PF. Further psychometric testing of this is required, including tests of responsiveness and stability.

Purpose: To describe the development and psychometric testing of a new questionnaire to measure the burden of immunoglobulin treatment (Ig) from the perspective of patients with primary immunodeficiencies (PID). Patients and Methods: An online, cross-sectional survey was administered to PID patients across 10 countries (nine European and Canada) who were receiving either intravenous (IVIg) or subcutaneous (SCIg) immunoglobulin therapy. The range and distribution of the responses (ie, levels of missing data, floor and ceiling effects), exploratory factor analysis (using factor loadings of 0.4 or greater) and measures of internal consistency reliability (ie, Cronbach's alpha coefficient, inter-item and item-total correlations) were used to identify the domain and item pool. Results: In total, 472 patients completed the questionnaire, of which 395 were included in the analysis (32% underwent IVIg and 67% underwent SCIg). The final instrument contained 34 items across eight domains of treatment burden (time, organisation and planning, leisure and social, interpersonal relationships, employment and education, travel, consequences of treatment and emotional) and an additional Ig treatment burden global question at the end of the measure. All the scales achieved good internal reliability (Cronbach's alpha coefficient ranged from 0.70 to 0.85) and, with the exception of one item exceeded the minimum threshold of 0.35 for item-total correlations. Treatment burden was lower than anticipated across the different treatment routes and countries, although overall was more burdensome for patients undergoing IVIg compared to SCIg treatment. Conclusion: The IgBoT-35 appears to be a reliable, patient-generated questionnaire and may help to identify more individualised and preferred therapies for the PID patient when used in clinical practice. A new survey with a sample of US patients is currently being undertaken to further establish its validity and conceptual model. The overall Ig burden of treatment scores appeared to be low. PID patient preferences are important to guide treatment decisions and ensuring patients receive the right treatment at the right time.

Background This paper describes the development and validation of an electronic personal assessment questionnaire for vascular conditions (ePAQ‐VAS) that captures the symptomatology, quality of life and clinically relevant data of patients presenting to vascular services. Methods A two‐stage survey was conducted in patients attending a tertiary vascular department. Patients completed the ePAQ‐VAS remotely online, or on site using an electronic tablet. In the first stage of the survey, the responses were used to perform confirmatory factor analysis to assess the construct validity and remove redundant items. The internal reliability of disease‐specific scales was investigated. In the second stage of the survey, the acceptability, known‐group validity, test–retest reliability, and responsiveness of ePAQ‐VAS was assessed. Results In total, 721 patients completed ePAQ‐VAS. Their mean(s.d.) age was 63·5(15·7) years and 468 (64·9 per cent) were men. Some 553 patients (76·7 per cent) completed the questionnaire in clinic and the remainder completed the questionnaire online. The results of the confirmatory factor analysis confirmed the conceptual model for ePAQ‐VAS structure and eliminated six items. Internal reliability was acceptable for all the scales (Cronbach's α greater than 0·7). The test–retest reliability measured by the intraclass correlation coefficient ranged from 0·65 to 0·99. The results showed that the instrument was responsive over time with the standardized response mean ranging from 0·69 to 1·60. Conclusion ePAQ‐VAS is a holistic data‐collection process that is relevant to vascular service users and has potential to contribute to patient‐focused care and the collection of aggregate data for service evaluation. A demonstration version of the final version of ePAQ can be viewed at http://demo‐questionnaire.epaq.co.uk/home/project?id=VASC_1.7&page=1.

The year 2018 marked 40 years since the birth of Louise Brown, the first baby born as a result of pioneering in vitro fertilization (IVF) treatment. Since then, advances have seen a wide range of reproductive technologies emerge into clinical practice, including adjuvant treatments often referred to as IVF "add-ons." However, these "optional extras" have faced growing criticism, especially when they have often come at additional financial cost to the patient and have little evidence supporting their efficacy to improve pregnancy or birth rates. Despite this, according to the latest national patient survey by the Human Fertilisation and Embryology Authority, three quarters of patients who had fertility treatment in the United Kingdom in the past two years had at least one type of treatment add-on highlighting the growing demand for these interventions. This article uses a psychosocial perspective to consider the motivations behind patient and clinician behavior along with the wider societal and economic factors that may be impacting upon the increase in the use of adjuvant treatments in fertility clinics more widely. It suggests the reasons fertility patients use unproven "optional extras" are complex, with interpersonal, psychological, and social factors intertwining to generate an increase in the use of IVF add-ons.

Despite improved survival rates for childhood cancer, around 60% of survivors suffer lifelong health problems due to their treatment, including fertility issues which account for one third of these problems. Ovarian or testicular tissue cryopreservation can be offered to patients whose cancer treatment puts them at high risk of subsequent subfertility, but it presents unique challenges compared to standard methods of fertility preservation. We report the available information on the experiences of cancer survivors who preserved tissue for future fertility, to support the development of survivorship care informed by recipients’ perspectives and experiences to identify future research priorities. We conducted a scoping review following the recommendations of the Joanna Briggs Institute and the Systematic Reviews and Meta-Analyses Extension for Scoping Review (PRISMA-ScR). From 1956 unique records, 5 met our inclusion criteria. No literature was found reporting on the experiences of people who stored testicular tissue. We found that young women who had stored ovarian tissue faced complex emotional and ethical dilemmas in reproductive decisions post cancer and strongly desired their own biological children. This scoping review is the first to report beyond clinical outcomes by focusing specifically on the self-reported outcomes of patients who preserved ovarian tissue in early life after a cancer diagnosis. Separate consideration of the needs of patients with stored fertility tissue is needed to enable personalized survivorship care. Patient-reported outcomes are also needed from individuals with stored testicular tissue, parents who consented to their child's tissue storage, and the healthcare professionals involved in their care.

BACKGROUND: People who have communication difficulties may benefit from using augmentative and alternative communication (AAC). Understanding and measuring outcomes from the use of AAC is an important part of evaluating the impact of devices and services. Outcome measurement needs to reflect the changing nature of the impact of using AAC on an individual's ability to participate in activities of daily life. There is a limited understanding of the concepts that should inform the evaluation of outcomes from AAC device provision, nor how people's expectations from AAC may change over time. AIMS: To inform the development of a patient-reported outcome measure for AAC by understanding more about people's expectations from AAC and how these change over time. METHODS & PROCEDURES: A longitudinal qualitative research study was designed and carried out with seven participants over a period of 2 years. Participants were recruited from a regional specialist assessment service for AAC in the south-west of the UK. Four semi-structured interviews were carried out: (1) before assessment for AAC, (2) after assessment, (3) directly after provision of an AAC device and (4) between 6 and 12 months after provision. An original analytic method was used in this study that built on the principles of longitudinal interpretative phenomenology analysis, applied with a dialogic theoretical lens. This approach enabled the inclusion of a range of multimodal and embodied data collected to this study and allowed the research team to draw out salient themes across the cohort group while attending to the influence of time and context on experience. OUTCOMES & RESULTS: The results confirm and extend the three core concepts that were used to guide analysis: changes; contexts; future possibilities. The contextual and temporal influences on outcomes attainable from AAC for this cohort were also identified and illustrated through cross-case comparison. Deeper, analytic, and conceptual engagement with theory, which was then applied to analysis of the data, provided methodological rigour in the study. The results enhance our understanding of people's hopes and expectations from AAC and how these change over time. CONCLUSIONS & IMPLICATIONS: This qualitative longitudinal research study provides new insights into the journeys of people who experience communication disability, and the shifting nature of their sense of identity as they engage with, and learn from using, AAC. The study is significant as it attends to the dynamic nature of experience and how contextual and experiential factors influence people's hopes and expectations from AAC. The paper presents an original application of longitudinal qualitative research methodology with people who use AAC which can be further applied and tested in the field of communication disability research. WHAT THIS PAPER ADDS: What is already known on this subject We did not know the impact that time has on the concepts that have been identified to represent important outcomes from AAC. The existing concepts used to define outcomes from AAC were not adequately conceptualized to develop a patient-reported outcome measure. This study sought to extend our knowledge about outcomes from AAC. What this paper adds to the existing knowledge This study adds to the methodological toolkit available for qualitative inquiry in the field of communication disability research by presenting a longitudinal qualitative research methodology. It adds depth to our understanding of the concepts that underpin outcomes from AAC and highlights the dynamic nature of contexts and how this influences desired outcomes. What are the potential or actual clinical implications of this work? This longitudinal qualitative research study provides a broader perspective on the experience of getting AAC. It will enable clinicians to better navigate the contextual and transitionary factors that influence people's experience of acquiring AAC devices. The enhanced concepts described will also support clinical conversations that consider the wider facets of communication and what AAC can add to existing communicative tool kits beyond getting a message across.

Background In 2020, the long-lasting effects of the Covid-19 virus were not included in public messages of risks to public health. Long Covid emerged as a novel and enigmatic illness with a serious and life-changing impact. Long Covid is poorly explained by objective medical tests, leading to widespread disbelief and stigma associated with the condition. The aim of this organic research is to explore the physical and epistemic challenges of living with Long Covid. Methods Unlike any previous pandemic in history, online Covid communities and ‘citizen science’ have played a leading role in advancing our understanding of Long Covid. As patient-led research of this grassroots Covid community, a team approach to thematic analysis was undertaken of 66 patient stories submitted online to covid19-recovery.org at the beginning of the Covid-19 pandemic between April and September 2020. Results The overriding theme of the analysis highlights the complexities and challenges of living with Long Covid. Our distinct themes were identified: the life-changing impact of the condition, the importance of validation and how, for many, seeking alternatives was felt to be their only option. Conclusions Long Covid does not easily fit into the dominant evidence-based practice and the biomedical model of health, which rely on objective indicators of the disease process. Patient testimonies are vital to understanding and treating Long Covid, yet patients are frequently disbelieved, and their testimonies are not taken seriously leading to stigma and epistemic injustice, which introduces a lack of trust into the therapeutic relationship. Patient Contribution The research was undertaken in partnership with our consumer representative(s) and all findings and subsequent recommendations have been coproduced.

Background Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) has increasingly become a significant concern for patients. Focus thus far has been on understanding pathogenesis and establishing treatment pathways. There has been less attention on the assessment of long-term treatment outcomes. The purpose of this study was to perform a systematic review to assess published data on treatment outcomes for BIA-ALCL. Methods Using PRISMA guidelines, a systematic search of the literature was carried out from January 1997 to January 2021 using the Web of Science (PubMed) and Ovid Medline. Included in the review were any studies on the management and follow-up of patients, including disease status at a minimum of 18 months following treatment. Results A total of 39 articles matched the inclusion criteria. However, 94% of patients were managed with explantation and capsulectomy. Then, 39% of patients had adjuvant chemotherapy, 19% radiotherapy, 6% autologous stem cell transplant, and 4% immunotherapy. The mean follow-up was 19 months (range 3–36 months), and 69% of patients were reported to be alive at 18 months. The mainstay of treatment was surgical – en bloc capsulectomy with adjuvant treatment for advanced disease. Conclusions Robust survival data based on high-level evidence are challenging to establish in BIA-ALCL. Early diagnosis and en bloc capsulectomy with negative margins, whilst considering the need for adjuvant treatment, particularly targeted immune therapy in advanced disease represents the consistent forms of treatment. National databases, prospective studies, and treatment of patients in tertiary centres are all recommended to improve the quality of the research available in the management of BIA-ALCL.

Aim Patients admitted to hospital for abdominal surgery often experience gastrointestinal dysfunction. Many studies have reported outcomes following gastrointestinal dysfunction, yet there is no unified definition of recovery or a validated patient-reported outcome measure (PROM). The first stage of PROM development requires formation of a conceptual framework to identify key themes to patients. The aim of this study was to utilize semistructured interviews to identify core themes and concepts relevant to patients to facilitate development of a conceptual framework. Method Adult patients admitted to hospital for major gastrointestinal, urological or gynaecological surgery, in an emergency or elective setting, were eligible to participate. Patients treated nonoperatively for small bowel obstruction were also eligible. Interviews were conducted by telephone, audio-recorded, transcribed, coded and analysed using NVivo software by two researchers and reviewed by lay members of the steering group. Interviews continued until data saturation was reached. Ethical approval was gained prior to interviews (21/WA/0231). Results Twenty nine interviews were completed (17 men, median age 64 years) across three specialties (20 gastrointestinal, six gynaecological, three urological). Two overarching themes of ‘general recovery’ and ‘gastrointestinal symptoms’ were identified. General recovery included three themes: ‘life impact’, ‘mental impact’, including anxiety, and ‘physical impact’, including fatigue. Gastrointestinal symptoms included three themes: ‘abdominal symptoms’ such as pain, ‘diet and appetite’ and ‘expulsory function’, such as stool frequency. A total of 18 gastrointestinal symptoms were identified during patient recovery—many of which lasted several weeks following discharge. Conclusion This study reports a range of gastrointestinal and nongastrointestinal symptoms experienced by patients during early gastrointestinal recovery. Identified symptoms have been synthesized into a conceptual framework to enable development of a definitive PROM for early gastrointestinal recovery.

As speech and language therapists, we explored theories of communication and voice that are familiar to our profession and found them an inadequate basis on which to generate deep and rich analysis of the qualitative data from people who have communication difficulties and who use augmentative and alternative communication. Expanding our conceptual toolkit to include the work of John Shotter allowed us to reconceptualise voice and where it is emergent in dialogue. Reimaging voice will inform clinical and research praxis with people who have communication difficulties as it allows practitioners to attend more closely to the complexity and nuance inherent in interactions with this population. Our proposition is exemplified with excerpts from a single participant who has communication difficulties to illustrate the value of dialogic theory in praxis. This article presents a provocation for the wider academy of qualitative health research; do we have the concepts and tools to develop meaning with people whose lived experiences may also be hard to voice in monologues?

Objective Evaluate usability and utility of National Institute for Clinical Excellence (NICE) Patient Decision Aid's (PtDA's) for pelvic floor surgery. PtDA's reviewed were uterine prolapse, vault prolapse and stress urinary incontinence (SUI). Design Ten women given the PtDA's during routine clinical care were recruited from each cohort and underwent a semi‐structured interview with a clinical researcher. Setting Urogynaecology outpatients in an NHS tertiary teaching hospital. Population or Sample Women considering surgical management of uterine/vault prolapse or SUI. Exclusion criteria included those under 18, unable to communicate in English or not eligible for all surgical options discussed in the PtDA's. Methods A qualitative, semi‐structured interview evaluating women's opinions of the decision aid and the way in which they utilised the PtDA was conducted. The interviews were recorded and transcribed prior to undertaking thematic analysis utilising NVivo software. Main Outcome Measure The outcomes of interest were feedback for content, language, format and usage of the PtDA's and women's usage of PtDA's in decision‐making. Results Amendments suggested included removal of mesh from the SUI PtDA as this is not routinely available on the NHS and addition of a statement regarding the use of mesh in prolapse surgery. Additional anatomical diagrams were suggested. The need for a robust and regular update system was highlighted as was the provision of foreign language, audio and electronic versions. Conclusions PtDA's need updating to ensure relevant content. Clear, detailed and relevant information is required alongside active clinician engagement to reach a mutually agreeable treatment plan.

BACKGROUND: Reducing the rate of preterm birth is a cornerstone of global efforts to address child mortality, however existing screening tests offer imperfect prediction. Cervical electrical impedance spectroscopy (EIS) is a novel technique to quantify the ripening changes which precede labour. Mid-trimester EIS measurements have been shown to accurately predict preterm birth in asymptomatic women. This study aimed to comprehensively evaluate the acceptability of cervical EIS to low and high-risk women as part of a package of screening tests performed during a larger prospective trial. METHODS: In this parallel convergent mixed methods study, 40 women completed questionnaires before and after screening tests (EIS, cervical length measurement and fetal fibronectin quantification). Quantitative outcomes were anxiety levels before and after screening (Spielberger State Trait Anxiety Inventory, STAI-6), pain (Short Form McGill Pain Questionnaire) and ratings of EIS device appearance and test acceptability (visual analogue scales). Twenty-one women (11 high-risk, 10 low-risk) also attended a semi-structured qualitative interview. Interviews were recorded and transcribed, then thematic analysis was performed. A convergence coding matrix was constructed to enable triangulation of quantitative and qualitative results. RESULTS: High risk women demonstrated a significant reduction in anxiety following screening (mean STAI-6 score 34.5 vs. 29.0, p = 0.002). A similar trend was observed among low-risk participants. Ratings of pain, EIS device appearance and procedural acceptability did not differ between groups. Mean pain ratings were low (visual analogue scale 0.97 and 1.01), comparing favourably to published evaluations of conventional screening tests. Qualitative analysis provided insight into both the physical consequences and emotional experiences of screening. Additional determinants of the screening experience included device design, pre-existing perspectives on intimate examination, attitudes to knowledge in pregnancy and interaction with clinical staff. Finally, a range of practical considerations regarding wider use of EIS were identified, with valuable complementary detail regarding acceptability for use in antenatal care. CONCLUSIONS: Cervical EIS is well tolerated and acceptable to both low and high-risk women when performed as part of a multi-modal screening package. These results provide useful insights to inform the design of future study and screening protocols.

PURPOSE: This paper presents a review of the existing qualitative research literature concerning people's experience of communicating using augmentative and alternative communication (AAC). The aims of conducting this review were to find out more about the values and outcomes that are important to people about the AAC they use to support their communication. This review was conducted to provide a deeper understanding of these experiences to inform the development of a patient-reported outcome measure (PROM). MATERIALS AND METHODS: A qualitative evidence synthesis of existing qualitative research literature was undertaken to explore and appraise current knowledge about the experiences of people who use AAC. RESULTS: From 115 qualitative research reports 19 papers were identified that responded directly to the research question and aims of the review. Data were identified that could be organized within an a priori framework consisting of the constructs of values, outcomes, and context. CONCLUSION: The review has resulted in a deeper, analytical understanding of the experiences of people who require AAC. The results indicate a set of concepts that can be used to inform the development of a PROM. A PROM can be used to assist clinicians and researchers to better understand the perspectives of people who require AAC and evaluate interventions. The results also encourage professionals to reconsider the terminology and methods used when working alongside people who require AAC and to reflect on the multidimensional factors that influence people's experience of communication.IMPLICATIONS FOR REHABILITATIONPatient-reported outcome measures (PROMs) can be useful tools to support clinician-patient communication, facilitate shared decision making and establish priorities for rehabilitation.It can be difficult to engage people who have complex communication difficulties in decisions about the important outcomes to them from using augmentative and alternative communication (AAC).This qualitative evidence synthesis provides a deeper understanding of the experiences and perspectives of people who use AAC.The results will be used to inform the development of a PROM which can be used to facilitate shared decision-making, and evaluate AAC interventions from the perspective of the people who use these technologies.

Within this document we use the terms pregnant woman and women's health. However, it is important to acknowledge that it is not only people who identify as women for whom it is necessary to access care. Obstetric and gynaecology services and delivery of care must therefore be appropriate, inclusive and sensitive to the needs of those individuals whose gender identity does not align with the sex they were assigned at birth.

© 2015 Jones et al.Background: The introduction of home digital ovulation tests (OTs) has provided a simple solution for women wishing to optimise the timing of intercourse when trying to conceive. However, despite this, very little is understood about women's experiences of using these tests. Methods: We carried out qualitative, semi-structured telephone interviews with women who were seeking to conceive (not actively undergoing clinical investigation/fertility treatment) from the general UK population. The interviews were conducted following participation in a randomised controlled trial (RCT) in which participants were either provided with digital home OTs to assist in timing intercourse (n = 18) or advised to have intercourse every 2-3 days (n = 18). The interviews were digitally recorded, transcribed and then analysed using Framework analysis to identify the themes. Results: Data saturation was reached after 36 interviews. The use of the OT appeared to elicit 10 key themes, which could be described within the context of three overarching issues: 1) a positive impact (understanding the menstrual cycle, confirming when ovulating, emotional support, improving the relationship), 2) a negative impact (changing sex life and relationship with their partner, the emotional consequences of prolonged use, questions and uncertainty about what their results mean for them) and 3) the experiences of trying to conceive in general (use of clinical guidance and emotional experience). Conclusions: Overall, the use of home OTs were found to affect women's thoughts and feelings in multiple ways during attempts to conceive. Although some women reported a range of negative experiences when using OTs, they also reported similar negative experiences when trying to conceive without using the tests. However, there were many positive themes associated with OT use, including an increased understanding of the menstrual cycle, confirmation of ovulation timing and providing a source of help and support when trying to conceive. Overall, when women are trying to conceive, ensuring they have access to high-quality information, including use of OT, may be of benefit to help address some of the questions and uncertainties that were raised by the participants in this study. Trial registration number: NCT01084304.

Few studies have been concerned with the effects of combined oral contraceptive pills (OCP) on those who use their voices as a tool of trade. A cohort study involving 20 female professional voice users was carried out assessing irregularity of vocal fold vibration, based on: 1) period-to-period frequency peaks (CFx), and 2) period-to-period amplitude peaks (CAx) in the cycle-to-cycle excitation of the vocal tract. These vocal measures and blood samples were collected at three points of the menstrual cycle, for both natural and OCP cycles. No significant differences were found in vocal parameters assessed between the natural and OCP cycles. The intake of this OCP was not found to have a systematic effect on the vocal parameters studied. Based on these results the modern OCP preparations can be considered safe medications which do not have a negative effect on voice quality in professional voice users.

There is continuing debate concerning the relationship between cigarette smoking and premature ovarian failure. The aim of this retrospective data analysis was to investigate whether smoking has a measurable effect on early follicular serum concentrations of inhibin B hormone, FSH and anti-Müllerian hormone (AMH) in women of reproductive age. A database containing data on age, smoking status and serum concentrations of inhibin B, FSH and AMH was analysed. Pearson's correlation coefficient was calculated to determine the correlation between hormone concentrations and age. One-way analysis of variance was used to determine any significant difference in age between smoking categories and a univariate general linear model was used to compare geometric means and geometric mean ratios of hormone concentrations in relation to smoking status. Serum concentrations of inhibin B were significantly lower in women who had ever smoked cigarettes: F(2,332) = 3.371, P = 0.036. There was no statistically significant difference in FSH or AMH concentrations although a trend towards lower AMH concentrations in smokers was observed. This analysis provides evidence of an advancement of ovarian ageing in women who smoke cigarettes and is relevant to women of childbearing age who wish to avoid premature decline in fertility. © 2010, Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Purpose This cross-sectional study aimed to investigate the relationship between quality of life (QoL), physical activity (PA), diet and overweight status in children 11 to 15 years old. Study participants Participants (N = 1,771) children with self-reported physical activity and QoL outcome data. Methods Cross-sectional survey of four secondary schools, using the PedsQL and EQ-5D QoL instruments; the CAPANS physical activity instrument and a food intake screener questionnaire. Results The correlational analysis indicates little or no relationship between self-reported QoL, BMI and moderate to vigorous PA. We found no statistically significant differences between the two groups of children, who achieved the recommended PA guidelines and those who did not, on any of the dimensions of the PedsQL and the EQ-5D utility score. Only on the EQ-5D VAS dimensions score was there a statistically significant difference. Children who self-reported a BMI of overweight to obese had significantly lower QoL on both dimensions of the EQ-5D and every dimension of the PedsQL apart from School functioning. Conclusion Overall this study showed mixed results for pupils achieving the recommended targets for physical activity and diet and their relationship with QoL. Hence, further study into PA and diet and their effects on QoL is needed.

Introduction and hypothesis: The objective of this study is to determine the effect of posterior colporrhaphy on bowel symptoms. Methods: Comprehensive pelvic floor data were collected prospectively for 60 women undergoing posterior colporrhaphy. The electronic Personal Assessment Questionnaire-Pelvic Floor (ePAQ-PF) was completed at initial assessment and 3-6 months post-operatively. The bowel dimension of ePAQ-PF computes domain scores for IBS, constipation, evacuation, continence and QoL on a scale of 0-100. Preoperative bowel domain scores were compared with post-operative scores (Student t test). Results: Significant improvement was seen in bowel evacuation (42%), continence (37%) and bowel-related QoL (61%) scores. IBS score improved by 28%, but this did not reach significance. There was no significant change noted in constipation (0.5%). All individual symptoms relating to bowel evacuation and continence improved significantly other than painful evacuation and incontinence to solid stool. Conclusions: Bowel evacuation and continence improve significantly 3-6 months following posterior colporrhaphy and are associated with parallel improvement in QoL. © The International Urogynecological Association 2011.

Objective: To develop and establish the psychometric properties of an instrument to measure face validity, feasibility and utility of patient questionnaires used during health care. Design: Our instrument, QQ-10, is a 10-item self-completed questionnaire, which was developed during the evaluation of another questionnaire (ePAQ-PF), to assess patients' views on questionnaire use during health care. Setting: Urogynaecology Department, Royal Hallamshire Hospital, Sheffield, UK. Participants: The Sheffield maternity patient user group identified 10 key themes relating to patients' views on using questionnaires; these themes translated into 10 statements, each using the same 5-point Likert response scale. Intervention: Not applicable. Outcome Measures: Principal component analysis established the factor structure of our instrument. Internal reliability was assessed using Cronbach's alpha. Construct validity was assessed using Spearman's rho. Results: Factor analysis yielded two meaningful factors: Value and Burden, both achieving Cronbach's alpha scores >0.7. Significant correlations were found between scores for Value and communication experience and between scores for Burden and barriers to health care. Conclusions: Our instrument offers a valid, reliable measure of patients' views relating to value and burden of using health-related quality of life questionnaires. Its two domains show good internal reliability and with its free text items, it may offer a valuable, standardized assessment of face validity and utility of other questionnaires used in health care. © The Author 2012. Published by Oxford University Press in association with the International Society for Quality in Health Care; All rights reserved.

STUDY QUESTION: Does the use of a digital home ovulation test have any effect on the level of stress in women seeking to conceive? SUMMARY ANSWER: No difference was found in levels of stress between women using digital ovulation tests to time intercourse compared with women who were trying to conceive without any additional aids: in addition, their use did not negatively impact time to conception in users but may provide additional benefits, including an increased understanding of the menstrual cycle, reassurance and confidence in focusing conception attempts to the correct time in the cycle. WHAT IS KNOWN ALREADY: It has been suggested that timing of intercourse in such a way that it coincides with ovulation by using ovulation tests can lead to emotional distress; however, no study has been conducted to investigate this hypothesis specifically, until now. STUDY DESIGN, SIZE AND DURATION: The study was performed over two complete menstrual cycles as a prospective, randomized, controlled trial including quantitative and qualitative methods. The intervention (test) group were given digital ovulation tests to time intercourse to the most fertile time of the cycle and the control group were provided with the current National Institute for Health and Clinical Excellence guidelines for increasing the chances of conception (intercourse every 2-3 days) and asked not to use any additional methods to time when ovulation occurs. PARTICIPANTS/MATERIALS, SETTING AND METHODS: A total of 210 women who were seeking to conceive were recruited from the general UK population. A total of 115 women were randomized to the test group and 95 to the control group through block randomization. The positive and negative affect schedule (PANAS) and the Perceived Stress Scale (PSS) were used to measure subjective stress levels, the Short-Form 12 health survey was used as a measure of general health and well-being and urine samples were measured for biochemical markers of stress including urinary cortisol. Qualitative data were collected in the form of a telephone interview upon study completion. MAIN RESULTS AND THE ROLE OF CHANCE: There was no evidence for a difference either in total stress as measured using the PSS or in total positive or negative affect using the PANAS questionnaire between the test and control groups at any time point for the duration of the study. During cycle 1, for example, on Day 6, the difference in total stress score (test-control) was -0.62 [95% confidence interval (CI) -2.47 to 1.24] and on the day of the LH surge, it was 0.53 (95% CI -1.38 to 2.44). In addition, no correlation was observed between time trying to conceive and levels of stress, or between age and levels of stress, and no evidence was found to show that stress affected whether or not a pregnancy was achieved. There is also no evidence that the biochemistry measurements are related to whether a pregnancy was achieved or of a difference in biochemistry between the treatment groups. The use of digital ovulation tests did not negatively affect time to conception and with an adequately sized study, could potentially show improvement. To ensure that the results of this study were not affected by chance, we used a number of different methods for measuring stress, each of which had been independently validated. LIMITATIONS AND REASONS FOR CAUTION: Randomization occurred before the start of the study because of the need to provide the ovulation tests in readiness for Day 6 of the first cycle. As a consequence, a number of women fell pregnant during this period (22 and 13 in the test and control groups, respectively). A further 15 women were either lost to follow-up or withdrew consent prior to study start. Pregnancy rate was higher overall in the test group, so to ensure that there were sufficient data from women who failed to become pregnant in the test group, we implemented an additional biased recruitment. This second cohort may have been different from the first, although no significant differences were observed between the two phases of recruitment for any of the information collected upon admission to the study. WIDER IMPLICATIONS OF THE FINDINGS: Women who seek medical advice while trying to conceive should not be discouraged by health care professionals from using digital ovulation tests in order to time intercourse. The cohort of women recruited to this study initially had no evidence of infertility and were looking to conceive in a non-medical setting. A separate study to assess the impact of home ovulation tests in a subfertile population would be of interest and complementary to the present study. STUDY FUNDING/COMPETING INTERESTS: This study was funded by SPD Swiss Precision Diagnostics, GmbH, manufacturer of Clearblue(®) pregnancy and ovulation tests. SPD Development Company Ltd is a wholly owned subsidiary of SPD Swiss Precision Diagnostics GmbH; together referred to as SPD. TRIAL REGISTRATION NUMBER: NCT01084304 (www.clinicaltrials.gov).

OBJECTIVES:: A prospective, randomized controlled trial in women seeking to conceive examined the impact of using ovulation tests on self-reported levels of stress, psychological well-being, and quality of life in women with unexplained infertility. METHOD:: The test group used a home ovulation test to detect the day of ovulation, whereas the control group were provided with a predicted day of ovulation based on the average length of menstrual cycle reported during study recruitment. Volunteers collected their first morning urine samples to evaluate biochemical levels of stress (urinary cortisol and estrone-3-glucouronide) and completed questionnaires over two complete menstrual cycles. RESULTS:: Overall, the use of digital ovulation tests by sub-fertile women under medical care had negligible negative effects and no detectable positive benefit on psychological well-being, according to multiple measurements of stress by questionnaire and biochemical markers. No significant differences were found between groups for all stress measures at the various study time points, except in relation to "couple concordance" where the test group scored much higher than the control group (mean difference at end of study was 21.25 (95% confidence interval: 9.25, 33.25; P = 0.0015)). The maximum difference in log cortisol: creatinine ratio between the test and control groups was -0.28 (95% confidence interval: -0.69, 0.13). CONCLUSIONS:: These results do not support propositions that using digital ovulation tests can cause stress in women trying to conceive.

Purpose: To develop and psychometrically evaluate two questionnaires measuring both positive and negative postnatal health of mothers (M-PHI) and fathers (F-PHI) during the first year of parenting. Methods: The M-PHI and the F-PHI were developed in four stages. Stage 1: Postnatal women's focus group (M-PHI) and postnatal fathers' postal questionnaire (F-PHI); Stage 2: Qualitative interviews; Stage 3: Pilot postal survey and main postal survey; and Stage 4: Test-retest postal survey. Results: The M-PHI consisted of a 29-item core questionnaire with six main scales and five conditional scales. The F-PHI consisted of a 27-item questionnaire with six main scales. All scales achieved good internal reliability (Cronbach's α 0.66-0.87 for M-PHI, 0.72-0.90 for F-PHI). Intraclass correlation coefficients demonstrated high test-retest reliability (0.60-0.88). Correlation coefficients supported the criterion validity of the M-PHI and the F-PHI when tested against the Short-Form-12 (SF-12), Edinburgh Postnatal Depression Scale (EPDS) and the Warwick and Edinburgh Mental Well-Being Scale (WEMWBS). Conclusion: The M-PHI and F-PHI are valid, reliable, parent-generated instruments. These unique instruments will be invaluable for practitioners wishing to promote family-centred care and for trialists and other researchers requiring a validated instrument to measure both positive and negative health during the first postnatal year, as to date no such measurement has existed. © 2011 Springer Science+Business Media B.V.

BACKGROUND: Polycystic ovary syndrome (PCOS) is the most common chronic endocrine disorder affecting women of reproductive age. This study aimed to compare the HRQoL of South Asian and white Caucasian women with PCOS, given that it is particularly common among women of South Asian origin and they have been shown to have more severe symptoms. METHODS: The Polycystic Ovary Syndrome Questionnaire (PCOSQ) and the Short Form-36 (SF-36) were administered in a cross-sectional survey to 42 South Asian and 129 Caucasian women diagnosed with PCOS recruited from the gynaecology outpatient clinics of two university teaching hospitals in Sheffield and Leeds. Additional clinical data was abstracted from medical notes. Normative data, collected as part of the Oxford Health and Lifestyles II survey, was obtained to compare SF-36 results with ethnically matched women from the general UK population. Using the SF-36, normative HRQoL scores for women of South Asian origin were lower than for Caucasian women. Given this lower baseline we tested whether the same relationship holds true among those with PCOS. RESULTS: Although HRQoL scores for women with PCOS were lower than normative data for both groups, South Asian women with PCOS did not have poorer HRQoL than their Caucasian counterparts. For both the SF-36 and PCOSQ, mean scores were broadly the same for both Asian and Caucasian women. For both groups, the worst two HRQoL domains as measured on the PCOSQ were 'infertility' and 'weight', with respective scores of 35.3 and 42.3 for Asian women with PCOS compared to 38.6 and 35.4 for Caucasian women with PCOS. The highest scoring domain for South Asian women with PCOS was 'menstrual problems' (55.3), indicating best health, and was the only statistically significant difference from Caucasian women (p = 0.01). On the SF-36, the lowest scoring domain was 'Energy & Vitality' for Caucasian women with PCOS, but this was significantly higher for Asian women with PCOS (p = 0.01). The best health status for both groups was 'physical functioning', although this was significantly lower for South Asian women with PCOS (p = 0.005). Interestingly, only two domains differed significantly from the normative data for the Asian women with PCOS, while seven domains were significantly different for the Caucasian women with PCOS compared to their normative counterparts. CONCLUSIONS: The HRQoL differences that exist between South Asian and Caucasian women in the general population do not appear to be replicated amongst women with PCOS. PCOS reduces HRQoL to broadly similar levels, regardless of ethnicity and differences in the normative baseline HRQoL of these groups.

Researchers in the area of health and social care (both in Australia and internationally) are encouraged to involve consumers throughout the research process, often on ethical, political and methodological grounds, or simply as ‘good practice’. This article presents findings from a qualitative study in the UK of researchers’ experiences and views of consumer involvement in health research. Two main themes are presented. First, we explore the ‘know—do gap’ which relates to the tensions between researchers’ perceptions of the potential benefits of, and their actual practices in relation to, consumer involvement. Second, we focus on one of the reasons for this ‘know—do gap’, namely epistemological dissonance. Findings are linked to issues around consumerism in research, lay/professional knowledges, the (re)production of professional and consumer identities and the maintenance of boundaries between consumers and researchers.

Objective: To explore health-related quality of life (HRQoL) among adolescents with polycystic ovary syndrome (PCOS). Design: Qualitative study. Setting: Two out-patient gynecology clinics in Yorkshire, England. Participants: Fifteen young women diagnosed with PCOS were recruited. Methods: Semistructured interviews were carried out, transcribed verbatim, and subjected to thematic analysis using NVivo software version 2.0. Results: A few areas were identified where PCOS had a positive impact upon HRQoL (e.g., improved relationships). However, overall the condition had a negative impact upon HRQoL. Weight problems (in particular the difficulties associated with managing/maintaining weight) and body perceptions appeared to be the most significant contributors to a reduced HRQoL. Menstrual dysfunction, fertility issues, and hirsutism also had adverse affects on emotional well-being, self-perception (including poor body image, self-consciousness, & low self-esteem), social functioning, and sexual behavior. A number of participants described receiving insufficient information from health care professionals (HCPs) and negative experiences in relation to the diagnosis and management of their condition. Conclusion: Overall, PCOS has a negative impact on the HR QoL of adolescent girls with the condition. Emotional and social functioning appeared to be most affected rather than areas of physical functioning. Future research is needed to identify ways to improve communication between adolescents with PCOS and their HCPs, particularly around the diagnosis and potential for infertility. Finally, HCPs need to be more aware of the emotional impact of PCOS upon adolescents' HRQoL and of the potential for poor sexual health through risk-taking behaviors that may occur due to the potential loss of fertility. © 2011 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses.

Stress arousal may compromise the feedback regulation of the hypothalamo-pituitary-adrenal axis, releasing stress-related biomarkers and thereby affecting establishment of pregnancy. This study examined the relationship between stress and recurrent miscarriage (RM) and the impact of stress on establishment of pregnancy. The stress status of 45 patients with unexplained RM and 40 fertile women was investigated with the Fertility Problem Inventory (FPI), Perceived Stress Scale (PSS), Positive and Negative Affect Schedule, peripheral natural killer (NK) cells and cortisol. Patients with unexplained RM had significantly higher scores on the FPI (P < 0.05, adjusted OR 1.02), PSS (P < 0.05, adjusted OR 1.13) and Negative Affect scale (P < 0.05, adjusted OR 1.12) and lower scores on the Positive Affect scale (P < 0.05, adjusted OR 0.89) than fertile controls. Patients who had live births (n = 20) during the study period had significantly lower scores in the Positive Affect scale (P < 0.05, adjusted OR 1.17) than those who miscarried (n = 10). There was a little association between psychological stress measurements and biochemical stress measurements. These results suggest that stress is a risk factor of RM. Within women with RM, moderate stress appears to be associated with improved pregnancy outcome. The aim of this study was to examine the relationship between stress and recurrent miscarriage (RM) and the impact of stress on the establishment of a pregnancy. The stress status of 45 patients with unexplained RM and 40 fertile women was investigated with the Fertility Problem Inventory (FPI), Perceived Stress Scale (PSS), Positive and Negative Affect Schedule (PANAS) and biochemical stress measurements including peripheral natural killer (NK) cells and cortisol. Patients with unexplained RM had significantly higher scores as measured on the FPI (P < 0.05, adjusted OR 1.02), PSS (P < 0.05, adjusted OR 1.13), Negative Affect scale (P < 0.05, adjusted OR 1.12) and lower scores on the Positive Affect scale (P < 0.05, adjusted OR 0.89) than fertile controls after estimated ORs were adjusted for age and numbers of previous miscarriages. Patients who had live births (n = 20) during the study period had significantly lower scores as measured on the Positive Affect scale (P < 0.05, adjusted OR 1.17) than those who miscarried (n = 10) after adjustment had been made for age and numbers of previous miscarriages, suggesting that these patients had elevated levels of depression. There was an association between psychological stress measurements and biochemical stress measurements where the number of peripheral CD

bright

This study aimed to evaluate the responsiveness of the electronic Personal Assessment Questionnaire-Pelvic Floor (ePAQ-PF) in women undergoing surgery for pelvic floor disorders. Fifty-four women undergoing tension-free vaginal tape (TVT) and 47 women undergoing prolapse surgery completed ePAQ-PF at baseline and 3 months postoperatively. Responsiveness was calculated using effect sizes, standardized response means, responsiveness statistic, and minimally important difference. In the TVT group, the largest effect sizes were seen in the urinary domains for stress urinary incontinence (2.4), quality of life (2.2), and overactive bladder (0.9). In the prolapse group, the largest effect sizes were seen in the vaginal domains for prolapse (2.1) and quality of life (1.0). ePAQ-PF is responsive to change in women undergoing TVT or prolapse surgery in the salient and expected domains of stress incontinence and prolapse and quality of life and can be recommended for outcome measurement in this context. © The International Urogynecological Association 2009.

Abstract

BACKGROUND AND AIM: On the basis of retrospective studies, hysterectomy has been considered a risk factor for functional bowel disorders. The aim of this study was to prospectively evaluate the patients' bowel function and general health-related quality of life (QoL) before and after hysterectomy. Our hypothesis was that hysterectomy in properly selected patients can impact positively on the patients' self-reporting of their general health and bowel function. MATERIALS AND METHODS: A prospective longitudinal observational study was conducted in a university-based teaching hospital. Eighty-five patients who were scheduled for total abdominal hysterectomy for a nonmalignant cause completed the study. The main outcome measure was the patient's perception of her bowel function, which was assessed preoperatively and at 6, 12, 26 and 52 weeks postoperatively using the gastrointestinal quality of life questionnaire. The patient's general health was also assessed using a generic general health questionnaire (EQ5D and EQVAS). The effect of time on change in questionnaire score was assessed using mixed model repeated measures at a significance level of 0.05. RESULTS: The scores in the three questionnaires declined significantly at 6 weeks postoperatively as compared with those obtained preoperatively. However, there was a subsequent increase in the scores up to 12 months postoperatively. Smoking and use of laxative were identified as potential confounding variables. CONCLUSION: Apart from a transient negative effect, total abdominal hysterectomy improves the patient's gastrointestinal-related QoL, probably as part of general improvement in their QoL. © 2013 Wolters Kluwer Health | Lippincott Williams and Wilkins.

Introduction and hypothesis: Questionnaires for assessing health and related quality of life are increasingly advocated but little is known about women's views on them. The aim of the study was to understand women's experiences of using an electronic personal assessment questionnaire for pelvic floor disorders (ePAQ-PF) during the clinical episode. Methods: A qualitative study was performed in a tertiary referral centre for urogynaecology. Women who completed the electronic questionnaire (ePAQ-PF) before and after intervention for pelvic floor disorders were recruited. Semi-structured interviews were conducted in 20 women and the transcripts were analysed using a thematic approach to identify themes and categories. The main outcome measures were: (1) women's feelings about their experience of using the questionnaire and the impact it had on their clinical episode, (2) exploration of ways in which the questionnaire influenced communication, (3) influence of the questionnaire on anxiety and expectations relating to clinical care and (4) women's feelings about how the use of the questionnaire has affected their health and well-being. Results: Qualitative analysis identified eight themes relating to the burden and the benefit of questionnaire use with 'benefit' being the dominant theme. Women felt that the questionnaire improved their understanding of their condition, improved communication with clinicians and helped prepare them for clinical consultations, generally finding it relevant, easy and enjoyable to complete. Some women commented on the burden of questionnaire use and expressed concerns about its length and that it's closed multiple choice format was restrictive. Conclusions: The identified principal themes of enhanced communication and preparedness for clinical consultation provided by the questionnaire appeared to support improved focus and insight, which in turn contributed to the setting of realistic expectations. © 2013 The International Urogynecological Association.

Introduction and hypothesis The aim was to evaluate the relationship between age and the impact of pelvic floor disorders (PFD) using a multi-dimensional pelvic floor questionnaire Methods Questionnaire data on 4,311 women attending urogynaecology clinics with PFD were stratified by age into four groups: .35, 36.50, 51.65 and >65 years. The symptom frequency (ranging from 0 to 100) was divided in to mild (0.33), moderate (34.67), and severe (68.100) symptoms. Impact scores for equivalent levels of symptom frequency (mild, moderate and severe symptoms) were compared in women of different ages. Results Overall, bowel continence was associated with the greatest bother and constipation the least. Older women were significantly less bothered by mild to moderate urinary, bowel and vaginal symptoms (except IBS and vaginal capacity) than younger women. There was no difference in the impact of severe symptoms in different ages. In contrast, for sexual symptoms, there was a significant difference in the impact in older women for all grades of severity. Conclusions Women's views and attitudes towards symptoms are variable and age is a significant factor. In women attending urogynaecology clinics with pelvic floor symptoms the impact of most symptoms (particularly sexual dysfunction) become less bothersome with age. © The International Urogynecological Association 2013.

Purpose: (1) To determine the impact of treatment and recovery on the health-related quality of life (HRQoL) of endometrial cancer (EC) patients. (2) To explore how treatment types and delivery affect HRQoL and invite suggestions for improvement. Methods: Qualitative study. In-depth, semi-structured interviews at 3, 6, 9 or 12 months post-treatment were carried out with 22 women with stage IA to IVB EC who had undergone treatment at a tertiary referral centre for gynaecological cancers in Sheffield, UK. 21 were treated surgically and 4 received adjuvant treatment. Data were analysed using an inductive thematic approach. Results: Four dominant themes emerged regarding the treatment pathway: pre-treatment concerns, experience during treatment, post-treatment and survivorship issues. Expectations and understandings of EC and its treatment were often inaccurate. Proper explanations eased anxiety but were uncommon. Laparoscopic surgery was welcomed where offered but did not necessarily influence coping ability. Instead, women evaluated treatment impacts against their expectations. Treatments affected women's physical abilities, self-perception and relationships resulting in re-evaluation of lifestyle. Conclusions: The impact of treatment upon HRQoL for women with EC differs from other gynaecological cancers. Better information provision would enhance coping ability. Coping methods and expectations appear to influence HRQoL more than treatment modality. © 2013 Elsevier Ltd.

BACKGROUND: Delayed access to antenatal care ('late booking') has been linked to increased maternal and fetal mortality and morbidity. The aim of this qualitative study was to understand why some women are late to access antenatal care. METHODS: 27 women presenting after 19 completed weeks gestation for their first hospital booking appointment were interviewed, using a semi-structured format, in community and maternity hospital settings in South Yorkshire, United Kingdom. Interviews were transcribed verbatim and entered onto NVivo 8 software. An interdisciplinary, iterative, thematic analysis was undertaken. RESULTS: The late booking women were diverse in terms of: age (15-37 years); parity (0-4); socioeconomic status; educational attainment and ethnicity. Three key themes relating to late booking were identified from our data: 1) 'not knowing': realisation (absence of classic symptoms, misinterpretation); belief (age, subfertility, using contraception, lay hindrance); 2) 'knowing': avoidance (ambivalence, fear, self-care); postponement (fear, location, not valuing care, self-care); and 3) 'delayed' (professional and system failures, knowledge/empowerment issues). CONCLUSIONS: Whilst vulnerable groups are strongly represented in this study, women do not always fit a socio-cultural stereotype of a 'late booker'. We report a new taxonomy of more complex reasons for late antenatal booking than the prevalent concepts of denial, concealment and disadvantage. Explanatory sub-themes are also discussed, which relate to psychological, empowerment and socio-cultural factors. These include poor reproductive health knowledge and delayed recognition of pregnancy, the influence of a pregnancy 'mindset' and previous pregnancy experience, and the perceived value of antenatal care. The study also highlights deficiencies in early pregnancy diagnosis and service organisation. These issues should be considered by practitioners and service commissioners in order to promote timely antenatal care for all women.

Polycystic ovary syndrome (PCOS) is the most common chronic endocrine disorder affecting women of reproductive age. Depending on the definitions used for diagnosis, the prevalence of the condition is estimated to be between 4% and 25%. The two main sets of symptoms typically associated with PCOS are disruption to fertility resulting from irregular menses (oligomenorrhoea) or absence of menstruation (anovulation) and clinical signs of hyperandrogenism (including hirsutism, acne and alopecia). There may be secondary metabolic problems related to obesity and insulin resistance. This combination of outwardly visible and reproduction-inhibiting symptoms makes PCOS a particular distressing disorder suffered by a large number of women. For example, acne and hirsutism have been identified as major causes of social and emotional stress and psychological morbidity. Irregular menses and infertility issues have been suggested to cause tensions within the family, altered self-perception, impaired sexual functioning and problems in the workplace. As there is currently no cure, the management of PCOS is directed towards improving the woman's health-related quality of life (HRQoL) by means of alleviation of symptoms and prevention of long-term complications. From patients’ own perceptions, HRQoL provides the metric through which effectiveness of management of the disorder is assessed, rather than assessment of clinical efficacy. Given the nature of the condition, it is perhaps not surprising that in recent years there has been a growing interest in the impact of PCOS on the HRQoL of women with the condition.

Background The role of public involvement (PI) in healthcare research is growing in importance and it is imperative that researchers continuously reflect on how to promote the inclusion of patients and service users in the design and delivery of research. PI offers a mechanism for end-users to be involved planning, executing, and reporting research. Some patient groups, including people who have communication difficulties, may struggle to engage in the methods traditionally employed to promote PI engagement such as questionnaires and focus groups. Methods This article describes a longitudinal case-study of a PI group, consisting of people who have communication difficulties, for a patient-reported outcome development project. Creative methods, informed by the participatory design principles of enacting, seeing and doing, were introduced stepwise into seven PI meetings. Data from video and visual minutes were used to evaluate the impact of the methods, following each group. Feedback, in the form of verbal and visual outputs taken directly from group meeting minutes, along with vignettes evidenced the impact of the methods on the project and group members. Results Creative methods enabled the PI group members to successfully contribute in meetings, to interact dynamically and to engage with the aims and processes of the research project. Their involvement facilitated the development of accessible recruitment materials, informed data analysis and supported the dissemination of project outputs. Employing creative methods also enabled both PI group members and the academic team to reflect on their own roles within the research project and the impact that their active involvement in the PI group has had on their personal development and perspectives on research. Conclusion The impact of using creative methods in PI for this patient-reported outcome measure (PROM) development project improved collaboration and understanding between PI members and the academic team. The authentic engagement of people who have communication difficulties in PI generated a more accessible project in terms of both process and impact. Creativity has applicability beyond people whose communication is non-verbal; it should be harnessed by research teams to identify and breakdown barriers to involvement to develop outcome tools that reflect the diversity of our populations.

Background After major abdominal surgery, patients may experience significant gastrointestinal dysfunction, including postoperative ileus. Many clinical tools are used to measure this dysfunction, but there is no patient-reported outcome measure (PROM) specific to this group. The aim of this study was to develop a new PROM for this common condition. Methods A four-stage approach was undertaken. Stage 1 used semi-structured interviews with 29 patients to explore experiences of gastrointestinal recovery and develop a draft questionnaire. Stage 2 solicited feedback from 18 patients and 15 clinical experts on the face validity of the proposed tool using the Questionnaire on Questionnaires (QQ-10). Stage 3 recruited 297 patients to complete the questionnaire. Principal component analysis reduced the items and identified the domain structure. Test-retest reliability and a pilot assessment of responsiveness were assessed in stage 4 in a sample of 100 patients and in a sample of 68 patients respectively. Results The interviews generated 26 subthemes across gastrointestinal recovery and general well-being. An initial questionnaire containing 44 items was developed. The QQ-10 demonstrated high value and low burden, supporting face validity. Tests to reduce the items and identify the domain structure resulted in a 15-item questionnaire across four domains (nausea, eating, well-being, and bowels). Test-retest reliability showed intraclass correlation coefficient values ≥0.7 for all domains. Pilot responsiveness was demonstrated through differences in pre- and post-surgical scores. Conclusion PRO-diGI is a PROM for gastrointestinal dysfunction after major abdominal surgery that shows good psychometric properties and demonstrates face validity, reliability, and responsiveness. This now needs external validation to facilitate broader implementation.

© 2019, The Author(s). Purpose: People who have complex communication needs (CCN), and who use augmentative and alternative communication (AAC) to help them express themselves, can be difficult to engage in decision making about their healthcare. The purpose of this review was to identify what patient-reported outcome measures (PROMs) have been employed with people who use AAC. Of the tools identified, the review aimed to establish what conceptual frameworks were used and how the reports describe completion of the PROM. Methods: A systematic literature review was carried out. A pre-defined set of search terms was entered into five main health and education databases. Titles and abstracts were sifted for relevance. Full text papers were screened against inclusion/exclusion criteria. Data pertaining to the type and nature of the PROM used was extracted. Complementary data sources were analysed to construct a narrative synthesis of the papers identified. Results: Within 15 papers that met the review criteria, 25 PROMs were used with people who rely on AAC comprising of 15 separate measures. The conceptual frameworks for 12 of these tools were reported from which 62 items, or concepts being measured, were identified. Following synthesis of these items, 9 conceptual domains and 11 sub-domains were generated. Limited information was available about who completed the PROM nor how much, if any, support they received. Conclusions: No PROM that has been developed specifically for people who use AAC was identified by this review. Of the tools that have been used with people who use AAC, the concepts measured were broad and varied. The quality of reporting concerning who completed the PROM was limited, undermining the trustworthiness of many of the studies.

© 2019 Wolters Kluwer Health, Inc. All rights reserved. Clinical care is often directed at improving patient's quality of life, the effectiveness of which can be measured by objective or subjective outcomes. Surgical intervention, especially in plastic and reconstructive surgery, can often provide hard objective measures, for example, breast size reduction after bilateral reduction mammaplasty, or improved joint position/movement after Dupuytren's surgery. These measurements do not describe how a particular intervention affects the patient's life, from their point of view. Patient-reported outcome measures (PROMs) are validated questionnaires completed by patients about their health, functioning, health behaviors and quality of care. Patient-reported outcome measures reflect the patient's perspective and their use increases the meaningfulness of outcomes measured, for whatever purpose. There is therefore a growing interest in PROMs as part of routine clinical practice in the United Kingdom and worldwide. This article aims to provide an introduction of PROMs to plastic surgeons, a description of how PROMs are developed and scored, along with the most commonly used tools currently most applicable to plastic surgery. The benefits of PROMs on a local, regional, and national level are discussed, and we aim to set out how these tools can be used in auditing individual and departmental performance against national standards. We will also provide suggestions for sustainable use of PROMs in the clinical environment, advice on choosing the right outcome measure, and our views on electronic data collection, analysis, and interpretation of the results. Patient-reported outcome measures are highly relevant clinical practice and will undoubtedly with time become routine. We encourage plastic surgeons to explore the possibilities these tools can provide in helping improve the quality of care we deliver to our patients.

BACKGROUND: Varicose veins can affect quality of life. Patient-reported outcome measures (PROMs) provide a direct report from the patient about the impact of the disease without interpretation from clinicians or anyone else. The aim of this study was to examine the quality of the psychometric evidence for PROMs used in patients with varicose veins. METHODS: A systematic review was undertaken to identify studies that reported the psychometric properties of generic and disease-specific PROMs in patients with varicose veins. Literature searches were conducted in databases including MEDLINE, up to July 2016. The psychometric criteria used to assess these studies were adapted from published recommendations in accordance with US Food and Drug Administration guidance. RESULTS: Nine studies were included which reported on aspects of the development and/or validation of one generic (36-Item Short Form Health Survey, SF-36®) and three disease-specific (Aberdeen Varicose Vein Questionnaire, AVVQ; Varicose Veins Symptoms Questionnaire, VVSymQ®; Specific Quality-of-life and Outcome Response - Venous, SQOR-V) PROMs. The evidence from included studies provided data to support the construct validity, test-retest reliability and responsiveness of the AVVQ. However, its content validity, including weighting of the AVVQ questions, was biased and based on the opinion of clinicians, and the instrument had poor acceptability. VVSymQ® displayed good responsiveness and acceptability rates. SF-36® was considered to have satisfactory responsiveness and internal consistency. CONCLUSION: There is a scarcity of psychometric evidence for PROMs used in patients with varicose veins. These data suggest that AVVQ and SF-36® are the most rigorously evaluated PROMs in patients with varicose veins.

Background: The aim was to identify and evaluate existing patient reported outcome measures (PROMs) for use in patients with an abdominal aortic aneurysm (AAA) to inform the selection for use in surgical practice. Methods: Two systematic reviews were conducted: a systematic review to identify valid, reliable and acceptable PROMs for patients with AAA and a qualitative evidence synthesis to assess the relevance to patients of the identified PROMs items. PROMs studies were evaluated for their psychometric properties using established assessment criteria and their methodological quality using the COSMIN checklist. Qualitative studies were synthesised using framework analysis and identified concepts were then triangulated using a triangulation protocol with the item concepts of the identified PROMs. Results: Four PROMs from three studies were identified in the first review; the SF-36, the Australian Vascular Quality of Life Index, the AneurysmDQoL and AneurysmSRQ. None of the identified PROMs had undergone a rigorous psychometric evaluation within the AAA population. Four studies were included in the qualitative synthesis, from which 28 concepts important to patients with an AAA were identified. The AneurysmDQoL and the AneurysmSRQ together provided the most comprehensive assessment of these concepts. Fear of rupture, control, ability to forget about the condition and size of aneurysm were all concepts identified in the qualitative studies but not covered by items on the identified PROMs. Conclusion: Further research is needed to develop PROMs that are reliable, valid and acceptable to patients for use in surgical practice for AAA.

To systematically identify, evaluate and synthesize qualitative research that examined the symptoms and health-related quality of life themes that are important from the perspective of patients with venous leg ulceration.Venous leg ulceration is a common chronic condition; the symptoms and associated treatments have a negative effect on health-related quality of life. Qualitative research methods can provide insight into the personal experiences of patients with venous leg ulceration.Qualitative evidence synthesis (using framework synthesis).Multiple electronic databases including MEDLINE, EMBASE, PsycINFO and CINAHL were comprehensively searched from inception to November 2015.Systematic identification, quality assessment and synthesis of existing qualitative research were performed; framework synthesis was conducted on included studies. An inductive approach was used and emergent themes were identified. The final stage in the synthesis involved the development of new interpretations.Thirteen studies met the inclusion criteria; the overall quality of the included studies was good. Four overarching themes were identified; physical impact, psychological impact, social impact and treatment and, in these, further subthemes were identified. Ulcer and treatment-related pain, as well as odour and exudate appeared to have significant and direct negative effects on quality of life, with additional and cumulative effects on sleep, mobility and mood.The themes identified in this review should be considered by professionals providing services, care and treatment for venous leg ulcer patients and in the selection, or development, of patient-reported outcome measures for use with this population.

OBJECTIVE: Patient-reported outcome measures (PROMs) provide a way to measure the impact of a disease and its associated treatments on the quality of life from the patients' perspective. The aim of this review was to identify PROMs that have been developed and/or validated in patients with carotid artery stenosis (CAS) undergoing revascularisation and to assess their psychometric properties and examine suitability for research and clinical use. METHODS: Eight electronic databases including MEDLINE and CINAHL were searched using a two-stage search approach to identify studies reporting the development and/or validation of relevant PROMs in patients with CAS undergoing revascularisation. Supplementary citation searching and hand-searching reference lists of included studies were also undertaken. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) and Oxford criteria were used to assess the methodological quality of the included studies and the psychometric properties of the PROMs were evaluated using established assessment criteria RESULTS: Five studies reporting on six PROMs were included: 36-Item Short Form Health Survey (SF-36), Euro-QoL-5-Dimension Scale (EQ-5D), Hospital Anxiety and Depression Scale (HADS), Dizziness Handicap Inventory (DHI), Quality of life for carotid artery disease scale and a disease-specific PROM for CAS. The rigour of the psychometric assessment of the PROMs was variable with most only attempting to assess a single psychometric criterion. No study reported evidence on construct validity and test-retest reliability. Evidence for acceptability for the use of SF-36, EQ-5D and the disease-specific PROM were rated good in most studies. Only one study reported a Cronbach alpha score >0.70 as evidence of internal consistency. Overall, the psychometric evaluation of all included PROMs was rated as poor within the CAS population undergoing revascularisation. CONCLUSIONS: This review highlighted a lack of evidence in validated PROMs used for patients undergoing carotid artery revascularisation. As a result, the development and validation of a new PROM for this patient population is warranted in order to provide data which can supplement traditional clinical outcomes (stroke<30 days post-procedural, myocardial infarction and death) and capture changes in health status and quality of life to help inform treatment decisions.

Background Endometriosis affects 1 in 10 women, many of whom have surgery for persistent pain. Recurrence of symptoms following an operation is common. Although hormonal treatment can reduce this risk, there is uncertainty about the best option. Objectives To evaluate the clinical and cost-effectiveness of long-acting progestogen therapy compared with the combined oral contraceptive pill in preventing recurrence of endometriosis-related pain and quality of life. Design A multicentre, open, randomised trial with parallel economic evaluation. The final design was informed by a pilot study, qualitative exploration of women’s lived experience of endometriosis and a pretrial economic model. Setting Thirty-four United Kingdom hospitals. Participants Women of reproductive age undergoing conservative surgery for endometriosis. Interventions Long-acting progestogen reversible contraceptive (either 150 mg depot medroxyprogesterone acetate or 52 mg levonorgestrel-releasing intrauterine system) or combined oral contraceptive pill (30 µg ethinylestradiol, 150 µg levonorgestrel). Main outcome measures The primary outcome was the pain domain of the Endometriosis Health Profile-30 questionnaire at 36 months post randomisation. The economic evaluation estimated the cost per quality-adjusted life-years gained. Results Four hundred and five women were randomised to receive either long-acting reversible contraceptive (N = 205) or combined oral contraceptive pill (N = 200). Pain scores improved in both groups (24 and 23 points on average) compared with preoperative values but there was no difference between the two (adjusted mean difference: −0.8, 95% confidence interval −5.7 to 4.2; p = 0.76). The long-acting reversible contraceptive group underwent fewer surgical procedures or second-line treatments compared with the combined oral contraceptive group (73 vs. 97; hazard ratio 0.67, 95% confidence interval 0.44 to 1.00). The mean adjusted quality-adjusted life-year difference between two arms was 0.043 (95% confidence interval −0.069 to 0.152) in favour of the combined oral contraceptive pill, although this cost an additional £533 (95% confidence interval 52 to 983) per woman. Limitations Limitations include the absence of a no-treatment group and the fact that many women changed treatments over the 3 years of follow-up. Use of telephone follow-up to collect primary outcome data in those who failed to return questionnaires resulted in missing data for secondary outcomes. The COVID pandemic may have affected rates of further surgical treatment. Conclusions At 36 months, women allocated to either intervention had comparable levels of pain, with both groups showing around a 40% improvement from presurgical levels. Although the combined oral contraceptive was cost-effective at a threshold of £20,000 per quality-adjusted life-year, the difference between the two was marginal and lower rates of repeat surgery might make long-acting reversible contraceptives preferable to some women. Future work Future research needs to focus on evaluating newer hormonal preparations, a more holistic approach to symptom suppression and identification of biomarkers to diagnose endometriosis and its recurrence. Trial registration This trial is registered as ISRCTN97865475. https://doi.org/10.1186/ISRCTN97865475. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 11/114/01) and is published in full in Health Technology Assessment; Vol. 28, No. 55. See the NIHR Funding and Awards website for further award information. The NIHR recognises that people have diverse gender identities, and in this report, the word ‘woman’ is used to describe patients or individuals whose sex assigned at birth was female, whether they identify as female, male or non-binary.

Gestational Trophoblastic Disease (GTD) is a rare complication of pregnancy that can develop into cancer. Medical outcomes are well researched but evidence is required on the impact of GTD on health-related quality of life (HRQoL) to improve care. The review was conducted to determine the impact of GTD and its treatment on HRQoL and identify how HRQoL is measured and appropriateness of these measures. Quantitative studies found HRQoL in long-term survivors to be at or above population norms. GTD appeared to have a negative impact on HRQoL where patients experience physical, psychological and social sequelae related to the condition. Clinically significant levels of anxiety, depression, sexual dysfunction and fertility-related distress were found. The results should be treated with caution because the evidence base was limited to small heterogeneous samples, retrospective data and the wide range of measures used. Within the qualitative data, new themes emerged including nerve damage, fatigue, amenorrhea, and grief. Currently, these areas are not captured in patient reported outcome measures (PROMs) and the content may not be valid for this population. Further qualitative research could lead to development of a GTD specific PROM providing reliable, meaningful and valid assessments and allowing longitudinal data to be obtained.

It has been postulated, but not empirically validated, that breast implants may cause a range of systemic symptoms, recently aggregated into a syndrome termed Breast Implant Illness (BII). Research literature has focused on exploring these symptoms and possible aetiologies, however, it has not been formally recognised as a medical condition. The psychosocial experience of women who self-report BII is not well understood. This review aimed to synthesise findings from qualitative literature relating to BII. A systematic review and evidence synthesis of qualitative research was conducted and analysed using thematic synthesis. Searches were conducted in MEDLINE, CINHAL, Scopus, PsycINFO and secondary sources. Findings from nine studies were included, representing the experiences of women who had breast implants for reconstructive and cosmetic reasons. Four themes were identified: the decline in women’s psychosocial wellbeing, the search for answers to their ill health, a lack of solicitude from healthcare professionals and industry, and surgery viewed as both the problem and solution. Women reported an array of distressing challenges that affected their overall quality of life. Findings highlight the need for psychosocial support and enhancing the integration of patient-entered perspectives. Further research is warranted to understand how these women can be better supported.

Abstract

Introduction Many cancer treatments can result in reduced fertility, impacting survivors’ opportunities for biological parenthood. Fertility preservation (FP) methods for boys and young men, such as cryopreservation of testicular tissue or sperm, offer hope but are currently underused among young male patients with cancer. Despite guidelines recommending early discussion of fertility implications, many newly diagnosed males do not receive FP counselling or referral to fertility services. Male cancer survivors face a higher likelihood of infertility than their peers, yet focused FP decision-making support is lacking. This study aims to address this gap by developing and evaluating the first dedicated patient decision aid (PtDA) for boys and young male patients with cancer aged 11–25 years old, to help them make informed FP decisions before receiving cancer treatment. Methods and analysis The current study follows a multistage process: developing the PtDA, alpha testing for acceptability with former patients, parents and healthcare professionals, and beta testing in clinical settings to ensure effective integration into routine care. Using a combination of interviews and questionnaire data, this research will assess the PtDA’s acceptability and impact on decision-making. Ethics and dissemination This study has been prospectively registered on the Research Registry (10273). Ethics approval has been obtained from Leeds Beckett University and the National Health Service/Health Research Authority before undertaking data collection. The final resource will be disseminated widely and made freely available online via our dedicated Cancer, Fertility and Me website, for use in clinical and research practice.

Purpose: To evaluate patient information and clinical guidelines developed for women making fertility preservation choices before cancer treatment. As some cancer treatments increase women’s chance of infertility, oncology and fertility services provide information preparing women for fertility preservation procedures. Women report current resources are not sufficient to support their fertility preservation decisions during their cancer care. Method(s): An environmental scan of open-access decision support resources carried out using systematic review methods (December 2015). Three data sources were searched: internet (Google): healthcare decision support repositories (Decision Aids Library Inventory; Trips; NHS Evidence; National Guidelines Clearinghouse; Clinical Trials); shared decision making experts (SHARED-L distribution list). Inclusion criteria were, information about: women receiving cancer treatment; consequences cancer treatment on fertility; fertility preservation options; statements supporting women’s choices. The International Patient Decision Aid Standards (IPDAS) criteria informed the data extraction sheet developed to elicit information about resources’ content. Data were evaluated critically against these components, assessing resources’ validity to support actively people’s decision making between options. Result(s): Of the 116 patient decision aids and 42 clinical guidelines identified, 24 decision aids met the inclusion criteria. Resources varied in amount (2 – 90 pages) and type (pdf – App) of information. Most were rated as difficult to read (Flesch <60); few were endorsed independently (e.g. DALI, Crystal Mark). A third stated the resource’s purpose was to support women’s decision making; most aimed to inform and prepare women for fertility preservation and/or infertility procedures. Most resources provided questions for women to engage with health professionals rather than prompts and structures supporting deliberative thinking about which options fit best into their life now, and after cancer treatment (e.g. decision maps, parallel presentation options and attributes; risk figures, value clarification prompts). Most descriptions of cancer and infertility missed out information from one of the five schema people need when making sense of illness. Most resources met less than 50% of the IPDAS criteria. Conclusion(s): Resources provided information about fertility preservation and infertility treatment options; about 20% adhered to IPDAS guidance and readability standards. Most resources were designed for women with breast cancer after referral to infertility services. A decision aid supporting women’s deliberation about fertility preservation, or not, when receiving treatment for any cancer is likely to meet UK and international service needs.

© 2018 Jones, Vogt, Chambers, Clowes and Shrimpton. Background: Primary immunodeficiency disorders (PIDs) are a group of heterogeneous rare disorders, whereby the immune system is missing or not functioning adequately. For patients requiring treatment, the most common option is immunoglobulin replacement therapy (Ig). Treatment of PIDs is simultaneously associated with both improvements in health-related quality of life (HRQoL) and increased treatment burden. Objectives: This review sought to review studies investigating the burden of Ig treatment, synthesize evidence in relation to administration routes (subcutaneous or intravenous) and instruments used, as well as make recommendations for clinical and research applications in this area for patients aged 16 years and older. Methods: We searched Medline, EMBASE, and The Cochrane Library. Sifting of titles was performed by two reviewers, and the assessment of full-text articles by three. From a database which contained 3,770 unique results, 67 full texts were reviewed. Eventually, 17 studies were found to meet the inclusion criteria, and included in this review. Due to data heterogeneity, a narrative, descriptive synthesis of the evidence was undertaken. Results: Most studies were carried out in the USA/North America, used a prospective observational design and involved patients with common variable immune deficiency. Four studies measured the burden of receiving IVIg therapy and 13 measured SCIg therapy. A wide range of measures, primarily designed to measure aspects of treatment satisfaction (e.g., life quality index or a slightly modified version) and HRQoL (e.g., The Short Form-36) had been used. Conclusion: Lack of a parallel control group in most studies meant that changes in outcomes could be due to factors other than changes in the treatment regimen. However, overall, PID patients appeared to report little Ig treatment burden and were satisfied with either modality. However, patient preference appeared to be the delivery of the Ig treatment in the patient's home and SCIg was preferred after switching from IVIg therapy. Individual differences appeared to affect treatment preference and therefore understanding the decision support needs of PID patients facing IG treatment choices would be valuable. Using a questionnaire specifically designed to measure the burden of Ig treatment from the patient's perspective is recommended in future research.

© 2015 The Authors.Objective: To measure the long-term impact of surgical treatment for vulval cancer upon health-related quality of life and pelvic floor outcomes during the first year of therapy. Methods: Prospective, longitudinal, mixed-methods study. Twenty-three women aged >18 years with a new diagnosis of vulval cancer were recruited. The EORTC QLQ C30, SF-36 and an electronic pelvic floor assessment questionnaire (ePAQ-PF) were administered at baseline (pre-treatment) and 3, 6, 9 and 12 months post-treatment. Mixed effects repeated measures models (all adjusted for age and BMI) were used to investigate changes over time and differences between cancer stage. Qualitative interviews were carried out with 11 of the women and analysed using a thematic approach. Results: Mean age was 59.9 years (SD=15.3; range=23.8-86.6 yrs). Mean BMI was 30.0 (SD=4.5; range=24.4-38.2). Sixteen women had early (Stage 1 to 2B), and seven women had advanced stage disease (Stage 3 to 4B). Questionnaire scores revealed that physical and social functioning, fatigue, pain and general sex life were significantly worse at 12 months than pre-treatment (p=< 0.05). Qualitative analysis revealed multiple treatment side effects which were perceived as severe and enduring. Women with advanced vulval cancer had significantly worse SF-36 mental health scores at 12 months compared to women with early stage disease (p=0.037). Conclusions: Surgery for vulval cancer has long-term implications which can be persistent 12 months post-treatment. High rates of morbidity relating to lymphoedema and sexual function re-enforce the need for specialist clinics to support women who suffer these complications.

AIM: Approximately 20%-30% of patients with ulcerative colitis (UC) will undergo surgery during their disease course, the vast majority being elective due to chronic refractory disease. The risks of elective surgery are reported variably. The aim of this systematic review and meta-analysis is to summarize the outcomes after elective surgery for UC. METHODS: A systematic review was conducted that analysed studies reporting outcomes for elective surgery in the modern era (>2002). It was prospectively registered on the PROSPERO database (ref: CRD42018115513). Searches were performed of Embase and MEDLINE on 15 January 2019. Outcomes were split by operation performed. Primary outcome was quality of life; secondary outcomes were early, late and functional outcomes after surgery. Outcomes reported in five or more studies underwent a meta-analysis of incidence using random effects. Heterogeneity is reported with I2 , and publication bias was assessed using Doi plots and the Luis Furuya-Kanamori index. RESULTS: A total of 34 studies were included (11 774 patients). Quality of life was reported in 12 studies, with variable and contrasting results. Thirteen outcomes (eight early surgical complications, five functional outcomes) were included in the formal meta-analysis, all of which were outcomes for ileal pouch-anal anastomosis (IPAA). A further 71 outcomes were reported (50 IPAA, 21 end ileostomy). Only 14 of 84 outcomes received formal definitions, with high inter-study variation of definitions. CONCLUSION: Outcomes after elective surgery for UC are variably defined. This systematic review and meta-analysis highlights the range of reported incidences and provides practical information that facilitates shared decision making in clinical practice.

Background: Leishmaniasis is a globally important yet neglected parasitic disease transmitted by phlebotomine sand flies. With new candidate vaccines in or near the clinic, a controlled human challenge model (CHIM) using natural sand fly challenge would provide a method for early evaluation of prophylactic efficacy. Methods : We evaluated the biting frequency and adverse effects resulting from exposure of human volunteers to bites of either Phlebotomus papatasi or P. duboscqi, two natural vectors of Leishmania major. 12 healthy participants were recruited (mean age 40.2 ± 11.8 years) with no history of significant travel to regions where L. major-transmitting sand flies are prevalent. Participants were assigned to either vector by 1:1 allocation and exposed to five female sand flies for 30 minutes in a custom biting chamber. Bite frequency was recorded to confirm a bloodmeal was taken. Participant responses and safety outcomes were monitored using a visual analogue scale (VAS), clinical examination, and blood biochemistry. Focus groups were subsequently conducted to explore participant acceptability. Results: All participants had at least one successful sand fly bite with none reporting any serious adverse events, with median VAS scores of 0-1/10 out to day 21 post-sand fly bite. Corresponding assessment of sand flies confirmed that for each participant at least 1/5 sand flies had successfully taken a bloodmeal (overall mean 3.67±1.03 bites per participant). There was no significant difference between P. papatasi and P. duboscqi in the number of bites resulting from 5 sand flies applied to human participants (3.3±0.81 vs 3.00±1.27 bites per participant; p=0.56) .  In the two focus groups (n=5 per group), themes relating to positive participant-reported experiences of being bitten and the overall study, were identified. Conclusions: These results validate a protocol for achieving successful sand fly bites in humans that is safe, well-tolerated and acceptable for participants. Clinicaltrials.gov registration: NCT03999970 (27/06/2019).

Background To identify publicly available internet resources and assess their likelihood to support women making informed decisions about, and between, fertility preservation procedures before starting their cancer treatment. Methods A survey of publically available internet resources utilising an environmental scan method. Inclusion criteria were applied to hits from searches of three data sources (November 2015; repeated June 2017): Google (Chrome) for patient resources; repositories for clinical guidelines and projects; distribution email lists to contact patient decision aid experts. The Data Extraction Sheet applied to eligible resources elicited: resource characteristics; informed and shared decision making components; engagement health services. Results Four thousand eight hundred fifty one records were identified; 24 patient resources and 0 clinical guidelines met scan inclusion criteria. Most resources aimed to inform women with cancer about fertility preservation procedures and infertility treatment options, but not decision making between options. There was a lack of consistency about how health conditions, decision problems and treatment options were described, and resources were difficult to understand. Conclusions Unless developed as part of a patient decision aid project, resources did not include components to support proactively women’s fertility preservation decisions. Current guidelines help people deliver information relevant to treatment options within a single disease pathway; we identified five additional components for patient decision aid checklists to support more effectively people’s treatment decision making across health pathways, linking current with future health problems.

Introduction We describe the protocol for a recently funded three-year study (Yorkshire Cancer Research). Our aims are to develop a new evidence based fertility preservation (FP) decision aid (DA) and evaluate the impact of administering this resource at the point of cancer diagnosis/cancer treatment planning stage in oncology. While a few DAs exist to support the FP process, they are exclusively for breast cancer patients, and none have been developed for the UK female cancer population. Method A multi-centre prospective mixed-method observational study including teenage and adult women of reproductive age (16 years +) with a new diagnosis of any cancer attending cancer hospitals across two large Yorkshire cities. The study involves three stages: Stage 1 (Development of the DA), Stage 2 (Assessing the Learner Verification of the DA), Stage 3 (A quantitative and qualitative evaluation of the DA in routine clinical care). Results We are currently in Stage 1. NHS Research Ethics Committee approval has been granted. The content of the DA is being informed by a systematic literature review, an environmental scan of publically available literature, a previous three-year study carried out in Sheffield alongside clinical evidence from oncology and fertility guidelines and international patient decision aids standards. Discussion It is anticipated that our new DA will enable teenage and adult women to feel better supported and make more informed FP treatment decisions. It should also raise fertility awareness and improve the care of the women whilst they make FP choices and transition between oncology and fertility services.

BACKGROUND AND AIMS: The incidence of inflammatory bowel disease (IBD) diagnosed before adulthood is increasing worldwide. Transition from paediatric to adult healthcare requires certain skills. The aim of this study was to identify factors affecting these skills. METHODS: This review was registered on the PROSPERO database (CRD42019152272). Inclusion criteria: 1) studies of factors affecting transition readiness skills in patients with IBD 2) written in English 3) published since 1999. MEDLINE, CINAHL and PsychINFO databases were searched between 1999-2019. Quality was assessed using the Joanna Briggs Institute critical appraisal tools. RESULTS: Searches identified 822 papers. Sixteen papers were included. Age was positively associated with skills including disease knowledge and performing self-management behaviours (14 studies). Improvement often occurs at 18, however, skill deficiency may still remain. Increased self-efficacy (confidence) was associated with greater disease knowledge and performing self-management behaviours (3 studies). Self-efficacy was positively correlated with transition duration (2 studies) and health-related quality of life (r=0.57, p<0.001) (1 study), negatively correlated with depression (r=-0.57, p<0.001) and anxiety (r=-0.23, p=0.03) (1 study), and associated with higher education level (2 studies) and a family history of IBD (1 study). Females had higher self-management scores (3 studies), and greater healthcare satisfaction was significantly associated with higher knowledge (1 study). Greater transition communication improved knowledge, self-management, and overall transition readiness (2 studies). CONCLUSIONS: Potentially modifiable factors have been identified that could be supported in the transitioning IBD population to improve transition readiness. Identification of those with non-modifiable characteristics associated with poor readiness may aid targeted support.

Shared decision making (SDM) is acknowledged as the gold standard of healthcare communication, particularly relevant to preference-sensitive care such as breast cancer treatment. However, research on patients’ experiences shows a misalignment between clinicians’ goals and the rhetoric regarding patients’ empowerment during SDM for this treatment. This warrants detailed examination on the conversational dynamics of SDM, and this study aims to identify interactional features and social practices through which SDM is achieved. Fifteen audio recordings from adjuvant treatment breast cancer consultations were examined using the methodology of conversation analysis (CA), and recurrent patterns relevant for understanding SDM were identified. Boundary markers, rhetorical questioning and epistemic markers discouraged a shared orientation to patient participation, reinforcing perceived imbalanced doctor–patient power relations. Cues for SDM such as multi-turn utterances and spaces for transition were presented but not recognised by patients, resulting in sub-optimal two-way discussions about decision making. The findings also reveal that interactional practices were deployed that theoretically should have enabled patients to contribute to SDM. However, in reality these did not result in extended sequences of reciprocated contributions from practitioner and service user. SDM did not happen with the ease implied by current models, and the resultant interactions bore more similarity to expert-led, rather than collaborative, decision making

Introduction: Approximately 20%–30% of patients with ulcerative colitis (UC) require surgery, the majority of these being elective due to chronic symptoms refractory to medical treatment. The decision for surgery is difficult and dependent on patient preferences. Current resources for patients considering surgery have been found not to meet minimum international standards. The overall aim of the ‘DISCUSS’ study is to develop and evaluate a new patient decision aid (PtDA) for patients considering surgery for UC created in line with international minimum standards. Methods and analysis: This is a prospective mixed-methods study of adults (18+ years) who are considering surgical intervention for UC across two regional centres in Yorkshire, UK. This study is in three stages. In stage 1 we will develop the PtDA and its content via systematic reviews and a patient questionnaire. In stage 2 we will assess the face validity of the PtDA using mixed-methods on key stakeholders using both semistructured interviews and questionnaires, following which the PtDA will be refined. In stage 3 we will assess the acceptability of using the PtDA in clinical practice. This will use a mixed-methods approach on clinicians and patients who are considering undergoing elective surgery. Questionnaires including the Preparation for Decision-Making Scale, a measure of anxiety and decisional conflict will be analysed at two timepoints using paired sample t-tests and CIs. Interviews with patients and clinicians will be analysed using thematic analysis. Ethics and dissemination: Research ethics approval from North East–Tyne & Wear South Research Ethics Committee (Ref: 19/NE/0073) and Health Research Authority approval (Ref: 257044) have been granted. Results will be published in open access peer-reviewed journals, presented in conferences and distributed through the Crohn’s and Colitis UK charity. External endorsement will be sought from the International Patient Decision Aid Standards Collaboration inventory of PtDAs.

This paper describes the burden of receiving immunoglobulin (Ig) treatment from the perspective of patients diagnosed with a Primary Immunodeficiency (PID). Thirty semi-structured interviews with patients receiving intravenous (n=21) and subcutaneous immunoglobulin (n=9) therapy, either at home or in hospital were undertaken. Underpinned by a phenomenological theoretical framework, and using a qualitative, inductive thematic approach to prioritise patients’ concerns, we identified that Ig treatment requires considerable effort by the patient, particularly in relation to the amount of time, organization and planning that is needed. They also face numerous physical, social, relationship, emotional, role functioning, travelling, and financial challenges in their effort to undergo and maintain their infusions and care for their health. Some qualitative differences in treatment burden were noted between home and hospital settings which contributed to non-adherence to those regimes. Immunoglobulin treatment burden is complex and influenced by therapeutic mode and setting and the personal circumstances of the patient. As choice over treatment method appears to be mainly informed by lifestyle needs, PID patients may benefit from more information about these potential Ig lifestyle influences when selecting which form of treatment to take together with their health professional.

In the context of a cancer diagnosis, fertility preservation interventions are used to mitigate the potential impact of gonadotoxic cancer treatment upon fertility. They provide patients with cancer the option to freeze their reproductive material to have their own biological child following treatment. The evidence suggests some clinicians are less likely to have fertility preservation discussions with patients who have an aggressive or metastatic cancer which has a poor prognosis. Although this is contrary to current policy recommendations, there is a lack of guidance relating to offering fertility preservation in the context of a poor prognosis to support clinicians. Controversy surrounds posthumous reproduction, and whether the wishes of the cancer patient, when living and deceased should take precedence over others' wellbeing. We consider the question of whether cancer patients with a poor prognosis should be offered FP from an ethics perspective. We structure the paper around key arguments to which multiple ethical principles might pertain, first establishing a central argument in favour of offering fertility preservation based on respect for autonomy, before exploring counterarguments. We conclude by proposing that a defeasible assumption should be adopted in favour of offering fertility preservation to all cancer patients who might benefit from it. It is important to recognise that patients could benefit from fertility preservation in many ways, and these are not limited to having a parenting experience. The burden of proof rests on the clinician in collaboration with their multi-disciplinary team, to show that there are good grounds for withholding the offer.

AIM: People living with ulcerative colitis (UC) have two broad treatment avenues, namely medical or surgical therapy. The choice between these can depend on patient preference as well as the receipt of relevant information. The aim of this study was to define the informational needs of patients with UC. METHOD: A postal survey was designed to capture respondent demographics, treatment experienced within the previous 12 months and informational preferences by rating a long list of items. It was delivered through two hospitals that provide tertiary inflammatory bowel disease services. Descriptive analyses were performed to describe demographics and experiences. Principal component analysis was carried out using a varimax rotation to investigate informational needs. RESULTS: A total of 101 responses were returned (20.1% response rate). The median age of respondents was 45 years and the median time since diagnosis was 10 years. Control preferences skewed towards shared (42.6%) or patient-led but clinician-informed (35.6%). Decision regret was low for the population (median 12.5/100, range 0-100). Key informational needs related to medical therapy were benefits and risks of long-term therapy, burden of hospital attendance, reproductive health, need for steroid treatment and impact on personal life. For surgery, these were stoma information, effect on daily life, effect on sexual and reproductive health, risks and benefits and disruption of life due to surgery. CONCLUSION: This study has identified key areas for discussion when counselling patients about treatment decisions around medical therapy and surgery for UC.

BACKGROUND: There is a lack of standardised outcomes for haemorrhoidal disease making comparison between trials difficult. A need for a very well validated severity score is essential to facilitate meta-analysis of comparative studies, enabling evidence-based clinical practice. METHODS: The Hubble trial provides a large cohort of patients with haemorrhoidal disease randomised to rubber band ligation (RBL) or haemorrhoidal artery ligation. The haemorrhoid severity score (HSS) was collected on each patient at baseline, 6 weeks and 1 year after intervention. This allows for the responsiveness of the HSS instrument to be examined and compared with a more specific instrument, the Vaizey incontinence score (also collected). Responsiveness was tested using four methods (effect size, standardised response means (SRM), significance of change, and responsiveness statistic). RESULTS: The four tests of responsiveness demonstrated that the HSS was more responsive to changes in the patient's health status following both of the interventions compared to the Vaizey questionnaire. For example, between baseline and 6 weeks, the RBL intervention effect size scores and SRM calculations indicated a non-significant small amount of change (0.20 and 0.16 respectively). However, using the HSS, the effect size and SRM demonstrated a large magnitude of change (1.12 and 1.01, respectively) which was significant. Similar results were observed at 1 year. Significance of change scores and the index of responsiveness were also higher for the HSS questionnaire than the Vaizey across both treatment modalities. CONCLUSIONS: The HSS is a highly responsive tool for the detection of changes in haemorrhoid symptoms. It should form an essential patient-reported outcome tool for future studies on haemorrhoidal disease.

Background: Although fertility preservation (FP) treatment options have increased, the existing evidence suggests that many women with cancer do not feel well supported in making these decisions, but find them stressful and complex and fail to take up fertility care at this crucial time. Whilst existing reviews have all made important contributions to our understanding of the FP decision-making process, none of them examine solely and specifically these processes for women of reproductive age with a diagnosis of any cancer, leaving a gap in the knowledge base. Given the expectation that care is patient-centred, our review aims to address this gap which may be of help to those managing patients struggling to make difficult decisions in the often brief period before potentially sterilising cancer treatment is started. Objective and rationale: Underpinning this narrative review was the question “What factors hinder the decision-making process for women with any cancer and contemplating FP treatment?” Our objectives were to i) assess and summarise this existing literature, ii) identify the factors that hinder this decision-making process, iii) explore to what extent these factors may differ for women choosing different methods of FP, and iv) make recommendations for service delivery and future research. Search methods: A systematic search of the medical and social science literature from the 1st January 2005 up to the end of January 2016 was carried out using three electronic databases (Web of Science (PubMed), Ovid SP Medline and CINAHL via Ebsco). Included in the review were quantitative, qualitative and mixed-method studies. Reference lists of relevant papers were also hand searched. From the 983 papers identified, 46 papers were included. Quality assessment was undertaken using the Mixed Methods Appraisal Tool and thematic analysis was used to analyse the data. Outcomes: From the analysis, six key themes with 15 sub-themes emerged: 1) fertility information provision (lack of information, timing of the information, patient-provider communication); 2) fear concerning the perceived risks associated with pursuing FP (delaying cancer treatment, aggravating a hormone positive cancer, consequences of a future pregnancy); 3) non-referral from oncology (personal situation, having a hormone positive cancer, not a priority, transition between service issues); 4) the dilemma (in survival mode, whether to prioritise one treatment over another); 5) personal situation (parity, relationship status); and 6) costs (financial concerns). Wider implications: This review has found that a wide range of internal and external factors impact the FP decision-making process. Key external issues related to current service delivery such as the provision and timing of FP information, and lack of referral from oncology to the fertility clinic. However, internal issues such as women’s fears concerning the perceived risks associated with pursuing FP also hindered decision-making but these ‘risks’ were typically overestimated and non-evidence based. These findings suggest that the implementation of a range of decision support interventions may be of benefit within the clinical care pathway of FP and cancer. Women would benefit from the provision of more evidence-based FP information, ideally received at cancer diagnosis, in advance of seeing a fertility specialist, for example through the implementation of patient decision aids. Health care professionals in both oncology and fertility services may also benefit from the implementation of training programs and educational tools targeted at improving the communication skills needed to improve collaborative decision-making and deliver care that is patient-centred. Exploration of the current barriers, both intellectual and practical, that prevent some patients from accepting FP will help care providers to do better for their patients in the future. Finally, the extent to which a poor prognosis and moral, ethical and religious beliefs influence the FP decision-making process also warrant further research.

Abstract

Donor conception has become an increasingly socially acceptable way to deal with issues of male sterility or as a means to start a family for single women and same-sex couples. Sperm banks and fertility clinics offer a range of treatments, privately and on the NHS, but issues of accessibility and choice have led many donors and recipients to contact one another directly through connection websites and social media. While such websites are not illegal, they are unregulated. Previous research (McQuoid, 2015) suggests that recipients of online sperm may be at risk of abuse or harassment from donors when using such sites. This thesis applies a narrative approach to explore the occurrence of ‘morally challenging behaviour’ that sperm donors and recipients may have observed or experienced within the online sperm donation community. The aims of the research are to: 1) learn about donor perceptions of the kinds of norms and values that are sanctioned by the ‘online sperm donation community’ and the degree to which they condone or reject these behaviours; and 2) to discuss any ‘less than positive’ experiences recipients may have had whilst engaging with online sperm donors, the way in which they respond to difficult or traumatic experiences, and the endurance of their sense of self in such scenarios. Three prolific donors from the UK, USA and Australia respectively, and five UK-based recipients were interviewed in two separate studies using an adaptation of Brown et al.’s (1989) Real Life Moral Choice and Conflict Interview and Wengraf’s (2004) Biographical Narrative Interpretive Method. The interviews were analysed using Carol Gilligan’s Listening Guide Method of Psychological Inquiry (2015), which included four ‘listenings’ covering ‘narrative events,’ ‘the self,’ and the ‘listenings’ for the existence of two conflicting or contrapuntal voices (i.e., voices in counterpoint). Issues raised as part of the third and fourth listenings for the donors related to a rejection of fertility clinics, sexual motivations of donors, recipient screening and anonymity and, for the recipients, related to the acceptance/mitigation of risks, exploitation, harassment, and safety. The findings of these studies support McQuoid’s (2015) research which suggests that recipients may be at risk of abusive, threatening, or coercive behaviours from sperm donors in an unregulated context. This highlights the need for safeguarding and regulatory frameworks to protect recipients seeking to obtain sperm online.

In recent years, there has been a rapid increase in people using online, unregulated websites and social networking groups to look for potential sperm donors and recipients (Freeman et al., 2016). Online sperm donation has received negative media attention, and it is framed as inherently ‘risky’ in the official documentation provided by medical and regulatory bodies (Gilman & Nordqvist, 2023). Despite this, only a small number of studies have been conducted on the practice to date, and these have mostly focused on the motivations of donors. Thus far, no reviews have been undertaken to identify what is currently known about online sperm donation, and where the gaps are in the evidence base. Additionally, no studies have been able to ascertain the extent of online sperm donation and to explore the scope and nature of the online platforms which facilitate the practice. Finally, qualitative experiences of recipients who have, or are planning to conceive, via this route are largely absent. Therefore, this thesis comprises three studies which sought to respond to these gaps in the evidence base through a contextualist, feminist epistemological lens. The first study is a systematic review of academic and grey literature on the characteristics, motivations, and experiences of donors and recipients who have used online sperm donation. A total of 23 papers/ reports/ book chapters were included in the review, and the findings were synthesised thematically, going beyond the original descriptive findings to generate new analytical themes. The second study was an environmental scan, which identified and mapped the scope, nature and characteristics of 61 online platforms, comprising over 350,000 members, which facilitate contact between sperm donors and recipients. The third study prospectively explored the experiences of 11 recipients of online sperm donation through a qualitative, longitudinal methodology. Creative, digital, and narrative methods were brought together to form an in-depth, chronological picture of the participants’ narratives over the course of one year: from the beginning of their search for a donor through to pregnancy and (in one case) postpartum. Together, the findings from the three studies make a unique contribution to the scholarly understanding of online sperm donation. The findings support suggestions that online sperm donation is a rapidly growing practice that is changing the landscape of donor conception (Harper et al., 2017). In line with previous research, the findings highlight the stigma associated with donor conception, and suggest that shame and secrecy are even more pronounced in the context of online sperm donation. The thesis provides evidence to suggest that online sperm donation is intrinsically different from clinic-based donation, and the necessity to communicate and meet up with the donor raises issues of trust and power for those engaging in the practice. The most positive finding to come from this research, however, was that online sperm donation provides recipients with an opportunity to form new kinship connections and to achieve their family-building goals in what is currently a restrictive medico-legal context (Taylor et al., 2022). Theoretically, this thesis demonstrates the usefulness of a contextualist, feminist epistemological framework for exploring online sperm donation. Practically, the findings point to the need to make online spaces safer, to provide reliable information, to change and challenge the policy context, and to increase institutional inclusivity for those considering, and undertaking, this route to parenthood.

People with type 2 diabetes (T2DM) are more likely to develop cancer and experience poorer cancer-related outcomes. Despite this, women with diabetes are less likely to participate in cancer screening than women without diabetes. Previous research suggests there are diabetes-related barriers to cancer screening, but very few studies have sought to identify and characterise these barriers. The current PhD aimed to address this research gap, by advancing knowledge and understanding of diabetes-related barriers to cancer screening and potential intervention strategies. Study one undertook a novel, comprehensive systematic review of qualitative research, exploring barriers and facilitators to cancer screening among people living with any type of chronic illness or disability (n = 70 articles). The review revealed a paucity of studies examining bowel cancer screening, and which have been conducted outside the USA. Only one study exclusively examined cancer screening among people with diabetes. Consequently, study two conducted, for the first time, in-depth qualitative interviews examining views and experiences of cervical, breast and bowel cancer screening among women with T2DM in England (n = 25). Interviews identified several diabetes-related barriers and facilitators to cancer screening and potential ways to address and promote these, respectively. Study three developed a novel, brief written intervention (containing a threat and/or coping message), based on Protection Motivation Theory, to address lack of awareness of the T2DM-increased risk of bowel cancer (a key diabetes-related barrier identified in the interviews). An online randomised controlled experiment (n = 349) found no effects of the intervention on cancer screening intentions, likely due in part to a ceiling effect. However, the coping message significantly increased self-efficacy, and decreased response costs and perceived severity. Overall, the thesis findings elucidate how having diabetes can both heighten and add barriers to cancer screening and indicate multifaceted potential intervention targets and strategies to address these.

Background The National Institute of Health and Care Excellence in the United Kingdom have recommended the development of a patient-reported outcome measure (PROM) specific to surgery for pelvic organ prolapse (POP), stress urinary incontinence (SUI), and complications of pelvic mesh surgery (MC). Aims To identify all aspects of quality of life (QoL) that may be impacted by surgery for POP, SUI and MC, to inform the development of a new PROM. Method Thirty-one patients who had undergone surgery for POP, SUI and MC (ranging from &lt;6 months to &gt;5 years ago) were purposively recruited from various National Health Service (NHS) Trusts, as well as community support groups for the conditions. Semi-structured interviews were undertaken over the phone or via video-conferencing software, and a framework approach was employed to analyse the data. A Patient and Public Involvement group, comprising seven women who had undergone surgery for POP, SUI and/or MC, were consulted on various aspects of the study. Findings We identified nine themes for potential inclusion in the PROM. The themes are short-term impacts of surgery; long-term impacts on pre-surgery symptoms; pain and/or discomfort; impact on daily activities; social and leisure activities; emotional wellbeing; sexual activity; personal relationships; and work/education. While some participants showed improvements in these areas following surgery, it was also evident that for some, issues persisted, worsened, or developed post-surgery. Those in the sample who had previous surgery involving mesh reported worse QoL outcomes overall. Conclusion The impact of surgery for POP, SUI and MC on QoL is multidimensional and complex. It is recommended that a future PROM encompasses the potential for improvement of symptoms, the failure of surgery to improve symptoms, the development of new symptoms after surgery, and the consequential positive and negative impacts of surgery on activity, roles, psychological well-being and ultimately QoL, in both the short and long term.

There has been an increase in people using online, unregulated websites and social networking groups to look for potential sperm donors in the hope of becoming parents. This practice is facilitated by online platforms which have been designed to connect the two parties who are looking to receive or donate sperm. We aimed to systematically map the scope, nature and characteristics of the digital landscape of online sperm donation (OSD). Using 51 search terms on Google and Facebook, we found 52 English-speaking OSD platforms globally (9 websites, one app, and 43 Facebook groups), comprising over 340,000 users. Most platforms resembled dating websites, while Facebook groups were forum-based, with 60% moderated by at least one sperm donor. By engaging with the concepts of bio and emotional capitalism and technological affordances, this study highlights the ways in which OSD platforms commodify human relationships, while simultaneously providing new possibilities for family-making outside the increasingly commercialized fertility industry.

Background/Objectives: Pelvic organ prolapse (POP) is a common condition that significantly impacts quality of life. Research has focused largely on older women, while experiences of younger women remain relatively underexplored despite challenges unique to this population. Informed by the biopsychosocial model of illness, this study aims to assess the symptom burden, treatment goals, and information needs of younger women complaining of prolapse by analyzing questionnaire responses from an existing electronic Personal Assessment Questionnaire—Pelvic Floor (ePAQ-PF) dataset. Methods: Mixed-methods content analysis was conducted using free-text data from an anonymized multi-site ePAQ-PF dataset of 5717 responses collected across eight UK NHS trusts (2018–2022). A quantitative, deductive approach was first used to identify younger women (≤50 years old) with self-reported prolapse. ePAQ-PF scores for younger women with prolapse were compared with those aged >50 years, using Mann–Whitney tests. Free-text response data were analyzed inductively to qualitatively explore younger women’s symptom burden, treatment goals, and information needs. Results: Of the 1473 women with prolapse identified, 399 were aged ≤50 years. ePAQ-PF scores of the younger cohort demonstrated significantly greater symptom severity and bother than those aged >50, particularly in bowel, prolapse, vaginal, body image, and sexual health domains (p < adjusted threshold). Qualitative analysis undertaken to understand women’s concerns and priorities produced five health-related themes (physical health; functionality; psychosocial and emotional wellbeing; reproductive and sexual health; and healthcare journeys) and a sixth intersecting theme representing information needs. Conclusions: The findings highlight the substantial symptom burden of younger women with prolapse, as well as treatment goals and information needs specific to this population. The development of age-specific resources is identified as a requirement to support this group.

Purpose: To evaluate patient information and clinical guidelines developed for women making fertility preservation choices before cancer treatment. As some cancer treatments increase women’s chance of infertility, oncology and fertility services provide information preparing women for fertility preservation procedures. Women report current resources are not sufficient to support their fertility preservation decisions during their cancer care. Method(s): An environmental scan of open-access decision support resources carried out using systematic review methods (December 2015). Three data sources were searched: internet (Google): healthcare decision support repositories (Decision Aids Library Inventory; Trips; NHS Evidence; National Guidelines Clearinghouse; Clinical Trials); shared decision making experts (SHARED-L distribution list). Inclusion criteria were, information about: women receiving cancer treatment; consequences cancer treatment on fertility; fertility preservation options; statements supporting women’s choices. The International Patient Decision Aid Standards (IPDAS) criteria informed the data extraction sheet developed to elicit information about resources’ content. Data were evaluated critically against these components, assessing resources’ validity to support actively people’s decision making between options. Result(s): Of the 116 patient decision aids and 42 clinical guidelines identified, 24 decision aids met the inclusion criteria. Resources varied in amount (2 – 90 pages) and type (pdf – App) of information. Most were rated as difficult to read (Flesch <60); few were endorsed independently (e.g. DALI, Crystal Mark). A third stated the resource’s purpose was to support women’s decision making; most aimed to inform and prepare women for fertility preservation and/or infertility procedures. Most resources provided questions for women to engage with health professionals rather than prompts and structures supporting deliberative thinking about which options fit best into their life now, and after cancer treatment (e.g. decision maps, parallel presentation options and attributes; risk figures, value clarification prompts). Most descriptions of cancer and infertility missed out information from one of the five schema people need when making sense of illness. Most resources met less than 50% of the IPDAS criteria. Conclusion(s): Resources provided information about fertility preservation and infertility treatment options; about 20% adhered to IPDAS guidance and readability standards. Most resources were designed for women with breast cancer after referral to infertility services. A decision aid supporting women’s deliberation about fertility preservation, or not, when receiving treatment for any cancer is likely to meet UK and international service needs.

DECISION AIDS’ EFFICACY TO SUPPORT WOMEN AND YOUNG ADULT'S FERTILITY PRESERVATION CHOICES BEFORE CANCER TREATMENT: AN ENVIRONMENTAL SCAN. Neda Mahmoodi, Leeds Institute of Health Sciences, University of Leeds Hilary L Bekker, Leeds Institute of Health Sciences, University of Leeds Natalie V King, Leeds Institute of Health Sciences, University of Leeds Jane Hughes, Faculty of Health & Social Sciences, Leeds Beckett University Georgina Jones, Faculty of Health & Social Sciences, Leeds Beckett University On behalf of the Cancer, Fertility and Me research group. Introduction To evaluate patient information and clinical guidelines developed to support women (16+ years) making fertility preservation (FP) choices before cancer treatment. Some cancer treatments increase women’s chance of infertility, oncology and fertility services provide information preparing women for FP choices whilst managing cancer, yet some women feel unsupported. Method A systematic environmental scan of open-access decision support resources were carried out (December 2015). Three data sources were searched: internet (Google): healthcare decision support repositories (Decision Aids Library Inventory; Trips; NHS Evidence; National Guidelines Clearinghouse; Clinical Trials); shared decision making experts (SHARED-L distribution list). Inclusion criteria were: women receiving cancer treatment; cancer treatment options provided; FP options provided; statements supporting women’s decision making. The International Patient Decision Aid Standards (IPDAS) criteria informed the data extraction sheet developed to elicit information about resources’ content. Results 116 patient decision aids (DAs) and 42 clinical guidelines were identified; 24 DAs met the inclusion criteria. Resources varied in amount (2-90 pages) and type (pdf -App) of information. A third stated the resource’s purpose was to support women’s decision making. Most aimed to inform women for FP procedures; and provided questions for women to engage with health professionals rather than supporting deliberative thinking about which options best fit their life now, and after cancer treatment. About 20% adhered to IPDAS guidance. Discussion Resources provided information about FP and infertility treatment options. A DA supporting women’s deliberation about FP, or not, when receiving treatment for any cancer is likely to meet UK and international service needs.

ABSTRACT Objective: To explore the experiences of known egg donors and recipients in order to inform counselling practise. Background: Relatively little is known about known egg donation as a form of family-building in the UK, and on the experiences of individuals who have sought this form of donation. As such, there is a lack of guidance for fertility counselling in this area. Method: This was a cross-sectional, qualitative study. A purposive sample of four recipient women were recruited via a national support group for women experiencing Premature Ovarian Insufficiency (POI). Known egg donors (n = 3) and recipient men (n = 3) were recruited via a snowball sample, as identified by recipient women. In-depth interviews were conducted with participants. Interviews were transcribed and analysed using thematic analysis. Results: Four themes were generated from the data: 1) ‘Doing anything’: existing relationships as the motivation to donate; 2) ‘It was my duty’: feelings of obligation to donate and to receive; 3) ‘Woman-to-woman’: a woman-centred experience; and 4) ‘Going through this together’: changed versus unchanged relationships. Conclusions: The study highlights a number of implications in known egg donation, arising from the relationships involved. It is recommended that these implications are considered by infertility counsellors in the provision of counselling, and by those undergoing known egg donation when seeking information and support, before, during and after the donation.

Introduction: Women diagnosed with cancer and facing potentially sterilising cancer treatment have to make time-pressured decisions regarding fertility preservation with specialist fertility services whilst undergoing treatment of their cancer with oncology services. Oncologists identify a need for resources enabling them to support women’s fertility preservation decisions more effectively; women report wanting more specialist information to make these decisions. The overall aim of the ‘Cancer, Fertility and Me’ study is to develop and evaluate a new evidence-based patient decision aid (ptDA) for women with any cancer considering fertility preservation to address this unmet need. Methods and analysis: This is a prospective mixed-method observational study including women of reproductive age (16 years +) with a new diagnosis of any cancer across two regional cancer and fertility centres in Yorkshire, UK. The research involves three stages. In Stage 1 the aim is to develop the ptDA using a systematic method of evidence synthesis and multidisciplinary expert review of current clinical practice and patient information. In Stage 2, the aim is to assess the face validity of the ptDA. Feedback on its content and format will be ascertained using both questionnaires and interviews with patients, user groups and key stakeholders. Finally, in Stage 3 the acceptability of using this resource when integrated into usual cancer care pathways at the point of cancer diagnosis and treatment planning will be evaluated. This will involve a quantitative and qualitative evaluation of the ptDA in clinical practice. Measures chosen include using count data of the ptDAs administered in clinics and accessed online, decisional and patient-reported outcome measures and qualitative feedback. Quantitative data will be analysed using descriptive statistics, paired sample t tests and confidence intervals; interviews will be analysed using thematic analysis. Ethics and dissemination: Research Ethics Committee approval (Ref: 16/EM/0122) and Health Research Authority approval (Ref: 194751) has been granted. Findings will be published in open access peer-reviewed journals, presented at conferences for academic and health professional audiences, with feedback to health professionals and program managers. The Cancer, Fertility and Me ptDA will be disseminated via a diverse range of open-access media, study and charity websites, professional organisations and academic sources. External endorsement will be sought from the International Patient Decision Aid Standards (IPDAS) Collaboration inventory of ptDAs and other relevant professional organisations e.g. the British Fertility Society. Trial registration number: NCT02753296 (www.clinicaltrials.gov); pre-results.

Introduction Online sperm donation allows those hoping to conceive a baby (“recipients”) to meet prospective sperm donors online, via “connection” websites or social media. These sites offer some advantages to clinical donation (including lower costs and greater choice over donation arrangements) but previous research has suggested that these sites may also pose risks and challenges to those who use them. Therefore, the aim of this exploratory research was to better understand online sperm donation communities and the experiences of both recipients and donors, particularly with respect to situations that could be “morally challenging” or involve harm. Methods Three prolific donors and five recipients were interviewed using an in-depth narrative approach. Carol Gilligan's Listening Guide was employed to analyse the data. Results The findings demonstrated that the donors sought to find ways to maintain autonomy in their donating practices and were concerned about the character and parenting abilities of recipients, as well as the potential for recipients to make unwarranted complaints. The recipients were concerned about their safety and finding a donor they could trust, discussing issues relating to donor “dishonesty”, online abuse, and a lack of support from connection sites and related authorities. Both donors and recipients identified “morally challenging” behaviour relating to donor anonymity (donor use of fake online profiles or aliases) and the sexual motivations or (mis)conduct of some donors. The participants each discussed the ways in which they managed perceived risks. Discussion The degree to which the participants voiced their acceptance or rejection of challenging behaviour in online sperm donation communities varied across and within participants, highlighting the complexity of the way in which people interact in this environment. Further research is required to understand how this form of sperm donation can be as safe and supportive as possible, while also respecting the importance to donors and recipients of autonomy and choice when making donation arrangements.

Background: Women with a new cancer diagnosis face complex decisions about interventions aiming to preserve their fertility. Decision aids are more effective in supporting decision making than traditional information provision. We describe the development and field testing of a novel patient decision aid designed to support women to make fertility preservation treatment decisions around cancer diagnosis. Methods: A prospective, mixed-method, three stage study involving: 1) co-development of the resource in collaboration with a multi-disciplinary group of key stakeholders including oncology and fertility healthcare professionals and patient partners (n=24), 2) alpha testing with a group of cancer patients who had faced a fertility preservation treatment decision in the past (n=11), and oncology and fertility healthcare professionals and stakeholders (n=14) and, 3) beta testing with women in routine care who had received a recent diagnosis of cancer and were facing a fertility preservation treatment decision (n=41) and their oncology and fertility healthcare professionals (n=3). Ten service users recruited from a closed Breast Cancer Now Facebook group and the support group Cancer and Fertility UK also provided feedback on CFM via an online survey. Results: A 60-page paper prototype of the Cancer, Fertility and Me patient decision aid was initially developed. Alpha testing of the resource found that overall, it was acceptable to cancer patients, healthcare professionals and key stakeholders and it was considered a useful resource to support fertility preservation treatment decision-making. However, the healthcare professionals felt that the length of the patient decision aid, and elements of its content may be a barrier to its use. Subsequently, the prototype was reduced to 40 pages. During beta testing of the shortened version in routine care, women who received the resource described its positive impact on their ability to make fertility preservation decisions and support them at a stressful time. However, practical difficulties emerged which impacted upon its wider dissemination in clinical practice and limited some elements of the evaluation planned. Discussion: Women receiving the decision aid within the cancer treatment pathway found it helped them engage with decisions about fertility preservation, and make better informed, values-based care plans with oncology and fertility teams. More work is needed to address access and implementation of this resource as part of routine oncology care pathways.

Stroke survivors and informal caregivers experience high levels of stress and anxiety, linked to heightened risk of secondary stroke in survivors. Relaxation and mindfulness could reduce stress and anxiety; being most effective when tailored to the target populations. Aims of the PPI include to: (1) consult on possible alterations to an existing relaxation and mindfulness intervention, delivered via YouTube/DVD and (2) discuss relevance and preference of prompts and cues designed to facilitate the daily practice of the intervention. Eleven UK PPI contributors were consulted during 2020: four stroke survivors (F = 2, M = 2), three caregivers (F = 1, M = 2), and four HCPs (F = 4) (range = 23–63 years). Contributors watched the existing intervention and provided feedback via online discussions. Transcripts were analysed using thematic analysis. Five themes were identified, highlighting several necessary alterations to the intervention: “Who represents the stroke population?”; “The paradox of age”; “Specifically selected language”; “Visual presentation of the intervention”; and the “Audio qualities”. Contributors ranked the prompts and cues in order of preference with setting alarms and email alerts as the most popular. The PPI consultations resulted in several alterations enabling a revised version of the intervention. Including a PPI consultation at an early stage of the research improves the relevance and appropriateness of the research. The revised intervention is more representative of the stroke population thus more likely to be practised by survivors and caregivers, which will enhance the extent of effectiveness, reducing the risk of a secondary stroke.

There is evidence to suggest that online, unregulated sperm donation is growing in popularity and shifting the landscape of donor insemination. There is also anecdotal evidence that those searching for donors online (often referred to as ‘recipients’) may experience sexual harassment, homophobia and other forms of abuse from donors in both online and offline contexts. In response to this, we undertook a qualitative longitudinal (QL) study to explore the experiences of those searching for donors online. We recruited recipient individuals and couples who were at the start of their search for a donor, and interviewed them at 0, 6 and 12 months. This approach allowed us to capture the participants’ experiences of looking for a donor and attempting to conceive, through to pregnancy and the postpartum period. We brought creative, digital and traditional qualitative methods together to form an in-depth, chronological picture of the participant’s life over the course of the research. As Facebook is home to the largest number of dedicated online sperm donation groups, we saw an opportunity to create a Facebook group that was entirely separate from the donor-controlled spaces, where we could foster a sense of trust and community among recipients who often feel socially stigmatised, isolated, and are at risk of online victimisation. In this presentation, we will reflect on the benefits, drawbacks and ethical considerations associated with bringing participants of academic research together in an online space. We will discuss how Facebook groups can be of benefit to the participants themselves, as well as to those using QL approaches to research stigmatised populations. Finally, we will reflect on the use of Facebook as a methodological tool in QLR to gather multi-modal data, which can add richness and context to data collected through more traditional qualitative methods (e.g., narrative interviews).

Online, unregulated sperm donation has been hitting the headlines in recent years, but a question mark remains over the platforms powering the practice. Dr Francesca Taylor-Phillips, Professor Georgina Jones and Dr Rhys Turner-Moore investigate...

There is evidence to suggest that online, unregulated sperm donation is growing in popularity and shifting the landscape of donor insemination. There is also anecdotal evidence that those searching for donors online (often referred to as ‘recipients’) may experience sexual harassment, homophobia and other forms of abuse from donors in both online and offline contexts. In response to this pressing social issue, we undertook a qualitative longitudinal study to explore the experiences of those searching for donors online. We brought creative, digital and traditional qualitative methods together to form an in-depth, chronological picture of the participant’s life over the course of the research. As Facebook is home to the largest number of dedicated online sperm donation groups, we saw an opportunity to create a Facebook group that was entirely separate from the donor-controlled spaces, where we could foster a sense of trust and community among recipients who often feel socially stigmatised, isolated, and are at risk of online victimisation. In this presentation, we will reflect on the benefits and drawbacks of bringing participants of academic research together in an online space. We will discuss how Facebook groups may be of benefit to the participants themselves, as well as to those using qualitative longitudinal methods to research stigmatised populations. Finally, we will reflect on the use of Facebook as a method for gathering multi-modal data, which can add richness and context to data collected through more established qualitative methods (e.g., narrative interviews).

In recent years, there has been an increase in women obtaining donor sperm via unregulated websites and social media. In this article, we bring together the disparate evidence in this emerging field to consider whether restrictive UK policies and practices for regulated clinical donor insemination (DI) are a potential explanation for the growing use of the currently unregulated, online route to donor insemination. To this end, we examine the nature of the National Institute for Health and Care Excellence (NICE) guidelines, recent data provided by the Human Fertilisation and Embryology Authority (HFEA), and prior research on who uses online sperm donation and their reasons for doing so. In addition, we highlight why this issue is important by outlining some of the benefits and drawbacks of the unregulated route. We argue that, whilst there are many factors driving the unregulated route to DI, restrictive UK policies and practices for regulated DI might be one of these. We conclude that turning our attention to structural barriers, such as regulated DI policies and practices, is necessary to produce more definitive evidence of this potential issue, and that adopting a Reproductive Justice framework could lead to more equitable provision of regulated DI services.

We sought to find out if information about public funding for regulated donor insemination (DI) was available on UK fertility clinic websites, and if so, what information was provided for same-sex couples and single women; and if the available information was easily readable. The 'Choose a fertility clinic' pages of the Human Fertilisation and Embryology Authority (HFEA) website were used to identify all licensed fertility clinics in the UK, and any available text on public funding for DI treatment was extracted. The Flesch reading ease scores were calculated to determine the readability of the extracted text. Of the 52 clinics included in the synthesis, 23 mentioned public funding, and for 16 of these, it was unclear whether public funding was available. Six of the 23 clinics mentioned public funding for same-sex couples, and two mentioned public funding for single women. The Flesch reading ease scores indicated that none of the text about funding for DI treatment on any of the clinic websites met the NHS-advised level of readability for health information. Fertility clinic websites should specify whether they offer publicly funded treatment, and to whom, as well as clearly stating the eligibility criteria, using suitably readable language to communicate this.

BACKGROUND The Endometriosis Health Profiles (EHPs), the EHP-30 and EHP-5, are patient-reported outcome measures that were developed to measure the health-related quality of life (HRQoL) of women living with endometriosis. Prior to their development, a systematic review was undertaken which identified that the HRQoL of women living with endometriosis was poorly understood, with only three medical and one surgical study identified. OBJECTIVE AND RATIONALE The 20-year anniversary of the EHP-30 provided a timely opportunity to assess how the tools have been used and explore what the findings tell us about the impact of endometriosis and its associated treatments upon women’s QoL. Applying robust systematic review methodology, following PRISMA guidelines, we sought to answer: How many studies have used the EHP and for what purpose?; What are the demographic characteristics and international context of the studies?; What is the methodological nature and quality of the studies?; Which interventions have been assessed and what are the reported EHP outcomes?; and Can the EHP outcomes of these interventions be analysed using a meta-analysis and, if so, what do the results show? SEARCH METHODS The electronic databases MEDLINE, CINAHL, PsycINFO, PubMed, and Google Scholar were searched from the year the EHP was first published, in 2001 to 26 February 2020 using the search terms ‘EHP30’, ‘EHP5’, ‘EHP-30’, ‘EHP-5’, ‘endometriosis health profile 30’, and ‘endometriosis health profile 5’. We updated the searches on 9 April 2021. All included studies were quality assessed using the Mixed Methods Appraisal Tool (MMAT). OUTCOMES The review included 139 papers. In clinical intervention studies, the EHPs were deployed most frequently to measure the outcomes of medical (n = 35) and surgical (n = 21) treatment. The EHPs were also used in 13 other intervention studies, 29 non-interventional studies, 32 psychometric/cross cultural validation studies; six diagnostic studies, and in three other studies to measure outcomes in related conditions. They were mainly deployed in studies undertaken in Europe and North America. Overall, regardless of the nature of the intervention, most women reported improvements in HRQoL after treatment. Surgical interventions generally resulted in significant improvements for the longest amount of time. There was also evidence that when participants stopped taking medication their EHP scores worsened, perhaps reinforcing the temporary impact of medical treatment. Younger patients reported more negative impact upon their HRQoL. Further evidence using classical test theory to support the EHPs’ robust psychometric properties, including acceptability, dimensionality, reliability, validity (including cross-cultural), and responsiveness, was demonstrated, particularly for the EHP-30. Strikingly, using anchor-based methods, EHP-30 responsiveness studies demonstrate the largest mean changes in the ‘control and powerlessness’ domain post-intervention, followed by ‘pain’. MMAT outcomes indicated the quality of the papers was good, with the exception of five studies. A meta-analysis was not undertaken owing to the heterogeneity of the interventions and papers included in this review. WIDER IMPLICATIONS Women with endometriosis face a lifetime of surgical and/or medical interventions to keep the condition under control. Less invasive treatments that can lead to improved longer term physical and psycho-social outcomes are needed. The EHPs are reliable, valid, acceptable, and responsive tools, but more assessment of EHP outcomes using modern psychometric methods and in the context of women from ethnically diverse backgrounds and in routine clinical care would be beneficial. Given the brevity of the EHP-5, it may be the most appropriate version to use in routine clinical practice, whereas the longer EHP-30, which provides more granularity, is more appropriate for research.

Background This scoping review was undertaken as part of an NIHR-commissioned study, APPRAISE, to develop a patient-reported outcome measure (PROM) and experience measure (PREM) to assess outcomes relevant to surgery for pelvic organ prolapse (POP), stress urinary incontinence (SUI) and pelvic mesh complications surgery, with cross-cultural applicability. Objectives To identify PROMs and PREMs used to assess POP, SUI and mesh complication surgery; to compare the length, recall periods, response options of these tools and the outcomes/experiences assessed. Search Strategy Three databases searched from inception to September 2023 were screened by two independent reviewers. Selection Criteria Primary studies using subjective measures to assess POP, SUI and mesh complication surgery for women aged 16+ years were eligible for inclusion. Related systematic reviews were also reviewed. Data Collection and Analysis Data were extracted into a piloted electronic form by one reviewer and checked by a second. A narrative synthesis of the data was performed. Main Results Of the 2079 included primary studies, 1607 (77%) used a PROM with evidence of psychometric testing. Five hundred and twenty-two (25%) studies used one PROM; 1082 studies (52%) used two or more PROMs. One hundred and fifty-one measures were extracted; of these, condition-specific measures were the most highly cited. There was limited use of PROMs specific to surgery, mental health, body image and PREMs. Some outcomes (e.g., urinary symptoms, emotional wellbeing) are measured in a significantly higher proportion of PROMs than other outcomes. Conclusions Currently, no existing validated PROM evaluates all patient-reported outcomes relevant to surgery for POP, SUI or mesh complications.

OBJECTIVE: Women of childbearing age with new cancer diagnoses have to make rapid decisions about fertility preservation (FP) before starting cancer treatment (CT). The aim of the PreFer study was to explore this FP decision-making process and its impact on patient-reported outcomes (PROMs) and health-related quality of life (HRQoL). METHODS: A prospective, mixed-methods design was used (questionnaires, in-depth interviews). Interviews were analysed using Thematic Analysis. Fifty-eight women with new cancer diagnoses were recruited. Comparisons were made between women who declined FP referral in oncology (Group1) and women who chose referral (Group2). Group 2 was further split into those who had some FP (2A) and those who did not (2B). Questionnaires and PROMs were administered prior to and after the fertility consultation, before the start of CT and 3 months post CT. Interviews were conducted with 1 participants from Group 2. RESULTS: HRQoL was negatively affected, particularly depression. Women's lack of understanding about the relationship between cancer treatment and fertility were evident. Five themes emerged from the interviews as barriers and facilitators to the FP decision-making process. CONCLUSION: The results indicate that better information and support resources aimed at women to support their decision making are needed, such as patient decision-aids. Women from Group 1 were found to suffer significantly worse depression compared to the general UK population; highlighting the need for psychological support in the FP care-pathway and for research exploring the contributions of depression and hopelessness to the decision-making process.

In recent years, there has been an increase in people using websites, social media groups and mobile apps to connect with potential sperm donors or recipients. We undertook a systematic review of existing research which sought to: explore the characteristics, motivations and experiences of people who use online sperm donation platforms; assess the quality of the existing literature; identify gaps in the evidence base; and make recommendations for future research. Ten academic and grey literature databases and search engines (MEDLINE, CINAHL, PsycINFO, Scopus, Core, Google Scholar, Open Access Theses and Dissertations, NICE Evidence, Open Grey and Google) were searched in December 2019 and again in June 2024. The quality of the studies was assessed using the Mixed Methods Appraisal Tool and we undertook a thematic synthesis of the findings. The searches produced 18,614 results, of which 30 reports were included in the synthesis. The reports were published between 2010 and 2024, by authors from nine countries, and were qualitative (n = 19), quantitative (n = 7) and mixed methods (n = 4) in design. Four themes and two subthemes pertaining to participants’ motivations and experiences were constructed from the data. The themes demonstrate that OSD is an improvised practice that is laden with stigma and can produce imbalances of power between donors and recipients. The findings point to a need for further research, including prospective research, to be undertaken with more diverse samples, including populations in the Global South, Black and minority ethnic populations, and inexperienced donors.

Online sperm donation (OSD) facilitates recipient-donor connections through websites, social media, or mobile application software with the aim of enabling recipients to conceive with donated sperm (Taylor et al., 2023). Online sperm donation can be distinguished from 'regulated' donor conception, which takes place via clinics and is governed by codes of practice and, in some countries, legal frameworks (e.g., the Human Fertilisation and Embryology Authority in the UK). OSD is rapidly expanding, with over 60 English-language platforms hosting 350,000+ participants. These platforms, primarily managed by donors, vary in payment structures from free to fee-based, providing economic accessibility compared to clinics, but with new dynamics of power in family-making (Taylor et al., 2023). In this presentation, we will share preliminary findings from a one-year digital ethnography of six OSD sites. This was conducted as part of a larger ESRC-funded multi-phase and multi-method study into online sperm donation (see: https://www.theosdproject.com/). Five primary OSD sites were identified and selected using Taylor et al.’s (forthcoming) environmental scan of OSD platforms. A secondary, sixth site was identified during the digital ethnography. Consent to join the sites was obtained from the site owners. The research questions addressed in this presentation are: 1. How do OSD site owners and members create and maintain subcultural norms? 2. How is power enacted, reinforced, and/or resisted on OSD platforms? The types of data collected were: 1. the policies/guidelines from each site; 2. synchronous virtual interviews with five site owners; 3. asynchronous instant messaging interviews with site members; 4. fieldnotes from participating in the sites and researcher reflections. Qualitative data analysis involved collating, coding, and combining text to interpret meaning (e.g., Braun & Clarke, 2021). In this presentation, we will argue that the digital facilitation of sperm donation is not inherently harmful. This perspective challenges prevailing narratives in the media and some academic discourse regarding OSD. For example, warning people of 'fraudulent' or unethical donors and the health risks associated with OSD (e.g., Jewers, 2023). However, we also acknowledge the potential individual and socio-cultural implications of participation in OSD platforms and their creation and management, which may have harmful effects. Digital spaces are not "normatively neutral" (Stanfill, 2014, p. 1016); rather creators actively shape values, such as through policies or rules on member conduct (e.g., expectations for donor-recipient interactions) and online safety (e.g., guidelines for reporting to site moderators). Consequently, these digital spaces can influence ideals and norms about what is un/acceptable behaviour (e.g., whether it is acceptable for site members to offer or express a preference for sexual intercourse to conceive, rather than via artificial insemination) and these norms can be reinforced, accepted, and enacted, or resisted by site members. The preliminary findings from this study advance knowledge of digital lives/spaces and online governance, privacy, and safety.

In recent years, people looking for sperm (‘recipients’) and people providing sperm (‘donors’) are increasingly connecting via informal online platforms, such as websites and social networking sites. This growing practice – Online Sperm Donation (OSD) – has been accompanied by a proliferation of media articles and television programmes, with titles such as: “Seedy underbelly: social media sperm donors exposed”, “The frightening world of unregulated internet sperm donation sites” and Channel 4’s “4 Men, 175 Babies”. Despite growing concerns about the health, safety and legal risks associated with OSD, little is known about why people undertake it, and how those involved narrate their experiences of arriving at this route to parenthood. To this end, we present and discuss findings from two qualitative longitudinal studies: Phase One of the Online Sperm Donation Project (a four-year multidisciplinary project, funded by the Economic and Social Research Council), comprising 35 donors, recipients, partners and co-parents; and data from the first author’s PhD research, comprising 11 recipients/recipient couples. Both studies employed creative and narrative methods to provide rich insights into the participants’ lives over the course of their OSD journeys. In this paper, we present and discuss two salient and opposing narratives that participants oscillated between when articulating their experiences of arriving at OSD: ‘The Last Resort’ and ‘The First Choice’. The findings demonstrate that the rise of OSD reflects the restrictive NHS funding context and the commercialisation and medicalisation of the regulated fertility sector, as well as social and cultural shifts in family-making and kinship practices.

Background: In recent years, people looking for sperm (‘recipients’) and people providing sperm (‘donors’) are increasingly connecting via informal online platforms, such as websites, social networking sites and geolocation apps. This growing practice – Online Sperm Donation (OSD) – has been accompanied by a proliferation of media articles and television programmes which frame it as inherently risky, dangerous and ill-advised, and growing concerns from experts working in the fertility sector about the health, safety and legal risks involved. Objectives: In response, we sought to explore why people undertake OSD, and how donor, recipient and co-parent pathways to OSD are informed by dominant social, cultural and/or political narratives? Methods: We present and discuss findings from two qualitative longitudinal studies: Phase One of the Online Sperm Donation Project (a four-year multidisciplinary project, funded by the Economic and Social Research Council), comprising 35 donors, recipients, partners and co-parents; and data from the first author’s PhD research, comprising 11 recipients/recipient couples. Both studies employed creative and narrative methods to provide rich insights into the participants’ lives over the course of their OSD journeys, and both were guided by Public Involvement groups comprised of people involved in OSD (i.e. donors, recipients, site owners). Results and conclusions: Participants oscillated between two salient, but opposing narratives when articulating their pathways to OSD. ‘The Last Resort’ narrative frames OSD as an undesirable but necessary alternative, taken when clinical routes are inaccessible due to financial, medical, regulatory, or social barriers. By contrast, ‘The First Choice’ narrative reframes OSD as a preferred route to conception, valued for its potential to facilitate early disclosure to children about their donor, foster personal relationships and trust between parties, grant greater agency to donors, resist the perceived inaccessibility and commercialisation of fertility clinics, and enable a more intimate, less medicalised experience of conception.

People looking for sperm (‘recipients’) and people providing sperm (‘donors’) are increasingly connecting via informal online platforms, such as ‘connection websites’ and social networking sites. Typically, research has not focused on this route to conception. Little is known about how people involved in online sperm donation initiate, negotiate, sustain or end their relationships with each other, how power or influence operates within this context, or what the impacts of these influences might be. Previous research has suggested that abuses of power and morally challenging behaviour can occur. The first aim of this project is to explore the interpersonal relationships, power relations and potential abuses of power across the social ecology of online sperm donation. The second aim is to harness this new knowledge to explore the imagined ideal futures of those involved in online sperm donation and to work with them to start to realize these ideal futures. The project comprises three phases: (1) a two-year qualitative longitudinal study following the lives of prospective recipients, donors, and their partners via life story interviews, visual socio-ecological power narratives, and interaction logs; (2) a one-year digital ethnography of five online sperm donation sites; (3) action research workshops with recipients and their partners, donors and their partners, and platform owners, respectively. The multi-modal data will be analysed using narrative, discourse, and thematic analysis. The project will be carried out by a multi-disciplinary team, comprising academics and researchers with psychosocial, bioethical, medical, and legal expertise, and Public Involvement in Research members with lived experience of online sperm donation. The project will produce unique and holistic knowledge of online sperm donation and harness this knowledge to produce impacts across the social ecology that are identified by, and important to, those involved in online sperm donation.