Dr Trish Holch

Background: An estimated 17,000 patients are treated annually in the UK with radical radiotherapy (RT) for pelvic cancer. New treatment approaches in RT have increased survivorship and changed the subjective toxicity profile for patients who experience acute and long-term pelvic-related adverse events (AE). Multi-disciplinary follow-up creates difficulty for monitoring and responding to these events during treatment and beyond. Originally developed for use in systemic oncology therapy eRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and aDvice) is an online system for patients to report AEs from home. eRAPID enables patient data to be integrated into the electronic patient records for use in clinical practice, provides patient management advice for mild and moderate AE and advice to contact the hospital for severe AE. The system has now been developed for pelvic RT patients, and we aim to test the intervention in a pilot study with staff and patients to inform a future randomised controlled trial (RCT). Methods: Eligible patients are those attending St James's University hospital cancer centre and The Christie Hospital Manchester undergoing pelvic radiotherapy+/-chemotherapy/hormonotherapy for prostate, lower gastrointestinal and gynaecological cancers. A prospective 1:1 randomised (intervention or usual care) parallel group design with repeated measures and mixed methods will be employed. We aim to recruit 168 patients following recommendations for sample size estimates for pilot studies. Participants using eRAPID will report AE (at least weekly) from home weekly for 6 weeks and 6 weeks post-treatment (12-week total) then at 18 and 24 weeks. Hospital staff will review eRAPID reports and use information during consultations. Notifications will be sent to the relevant clinical team when severe symptoms are reported. We will measure patient-reported outcomes using validated questionnaires (Functional Assessment in Cancer Therapy Scale-General (FACT-G), European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire (EORTC-QLQ-C30), process of care impact (hospital records of patient contacts and admissions) and economic variables (EQ5D-5L, patient use of resources)). Staff and patient experiences will be explored via semi-structured interviews. Discussion: The objectives are to establish feasibility, recruitment, integrity of the system and attrition rates, determine effect sizes and aid selection of the primary outcome measure for a future RCT. We will also refine the intervention by exploring staff and patient views. The overall goal of this complex intervention is to improve the safe delivery of cancer treatments, enhance patient care and standardise documentation of AE within the clinical datasets. Trial registration: ClinicalTrials.gov NCT02747264.

Aims Current literature suggests the information and support needs of oncology patients undergoing radical radiotherapy to the prostate often remain unmet and can impact quality of life. We aimed to explore the effectiveness of delivery and opportunities for service improvement, including a group based treatment review. Methods: Sixty prostate patients completing radical radiotherapy (mean age 70, range 47-79) in a UK cancer-centre completed a self-designed questionnaire assessing information and support.. To explore views on a group-based-treatment-review, 11% took part in a semi-structured interview. Descriptive data were computed and interviews transcribed and analysed thematically. Results: Eighty-seven percent were satisfied with information and support when delivered by radiographers. However, 26% were only ‘sometimes’ able to complete bladder-filling, suggesting information regarding treatment delays would improve this. 49% preferred both Doctor and Urology nurse reviews whereas 26% preferred nurse only. 70% stated their ‘concerns were always addressed’ by a nurse and 49% by a Doctor. Interviews revealed that a group review was generally acceptable with peer support an influencing factor. Findings: Overall patients felt their needs were being met. Suggestions for improvement (more information on preparation, side effects and delays) will be implemented locally. Future work will explore the feasibility of group reviews in patients undergoing radical radiotherapy to the prostate.

OBJECTIVES: There is an increasing interest in the quality of life (QoL) evaluation following video-assisted thoracoscopic anatomical lung resection or stereotactic ablative body radiotherapy for early-stage non-small-cell lung cancer (NSCLC). A qualitative interview study was conducted to gain insight into the optimal methods of assessing and discussing QoL in clinical practice. METHODS: A prospective observational longitudinal study of patients with early-stage NSCLC was conducted where repeated QoL measures were administered either online or on paper. A subset of participants was invited for qualitative interviews after the 6-month assessment or at the end of the study. The semi-structured interviews were transcribed verbatim and thematically analysed. RESULTS: Twenty-three patients were interviewed. Generally, patients were content with recruitment and data collection procedures. Most opted to complete the assessments on paper instead of online; this choice was influenced by the level of technology literacy. Some found the questionnaires too generic to reflect their experiences. Barriers to questionnaire completion were mostly practical, and many acknowledged benefits of QoL assessment including allowing them to express problems and health issues, and following changes over time. Generally, participants would like to discuss QoL results during clinical consultations, but reported this rarely happened. CONCLUSIONS: Lung cancer patient interviews confirm the acceptability of repeated QoL assessments, but online data capture is limited. Patients highlight the importance of discussing QoL aspects with their clinical team. Future strategies are needed to optimize the routine collection of patient-reported outcomes in clinical practice.

Key points To gain insight on UK professionals' experiences and views of the impact of the COVID‐19 pandemic on psycho‐oncology activity, the British Psychosocial Oncology Society (BPOS) conducted an online survey of members and UK colleagues Qualitative data from 94 respondents were analysed thematically. Key themes were summarised using the strengths, weaknesses, opportunities and threats (SWOT) framework Professionals reported severe disruptions in delivering clinical and supportive care to people affected by cancer and associated research activity. There were major concerns that the full impact of the pandemic is yet to be realised. In both care and research settings, the pandemic has also been an impetus for positive changes in working practices, technology adoption, reducing process barriers and fostering collaborations which has to potential to be sustained. To mitigate ongoing challenges, is it vital that cancer organisations work together to adapt and promote psycho‐oncology activity to maximise benefit for patients and professionals in the longer‐term.

BACKGROUND: In early-stage Non-Small Cell Lung Cancer (NSCLC) patients, little is known about how to measure patient participation in Shared-Decision Making (SDM). We examined the psychometric properties and clinical acceptability of the Decision Self-Efficacy scale (DSE) in a cohort of patients undergoing to Stereotactic Ablative Radiotherapy (SABR) or Video-assisted Thoracoscopic Surgery (VATS) to capture patient involvement in treatment decisions. METHODS: In the context of a prospective longitudinal study (Life after Lung Cancer-LiLAC) involving 244 patients with early-stage NSCLC, 158 (64.7%) patients completed the DSE either on paper or electronically online prior to treatment with SABR or VATS pulmonary resection. DSE psychometric properties were examined using: principal components analysis of item properties and internal structure, and internal construct validity; we also performed a sensitivity analysis according to Eastern Cooperative Oncology Group Performance Status (ECOG PS), gender, age and treatment received (VATS or SABR) difference. RESULTS: Exploratory factor analysis using polychoric correlations substantiated that the 11 item DSE is one scale accounting for 81% of the variance. We calculated a value of 0.96 for Cronbach's alpha for the total DSE score. DSE scores did not differ by gender (p = 0.37), between the two treatment groups (p = 0.09) and between younger and older patients (p = 0.4). However, patients with an ECOG PS > 1 have a DSE mean of 73.8 (SD 26) compared to patients with a PS 0-1 who have a DSE mean of 85.8 (SD 20.3 p = 0.002). CONCLUSION: Findings provide preliminary evidence for the reliability and validity of the DSE questionnaire in this population. However, future studies are warranted to identify the most appropriate SDM tool for clinical practice in the lung cancer treatment field.

PURPOSE Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) is an online eHealth system for patients to self-report symptoms during cancer treatment. It provides automated severity-dependent patient advice guiding self-management or medical contact and displays the reports in electronic patient records. This trial evaluated the impact of eRAPID on symptom control, healthcare use, patient self-efficacy, and quality of life (QOL) in a patient population treated predominantly with curative intent. METHODS Patients with colorectal, breast, or gynecological cancers commencing chemotherapy were randomly assigned to usual care (UC) or the addition of eRAPID (weekly online symptom reporting for 18 weeks). Primary outcome was symptom control (Functional Assessment of Cancer Therapy-General, Physical Well-Being subscale [FACT-PWB]) assessed at 6, 12, and 18 weeks. Secondary outcomes were processes of care (admissions or chemotherapy delivery), patient self-efficacy, and global quality of life (Functional Assessment of Cancer Therapy–General, EQ5D-VAS, and EORTC QLQ-C30 summary score). Multivariable mixed-effects repeated-measures models were used for analyses. Trial registration: ISRCTN88520246. RESULTS Participants were 508 consenting patients (73.6% of 690 eligible) and 55 health professionals. eRAPID compared to UC showed improved physical well-being at 6 (P = .028) and 12 (P = .039) weeks and no difference at 18 weeks (primary end point) (P = .69). Fewer eRAPID patients (47%) had clinically meaningful physical well-being deterioration than UC (56%) at 12 weeks. Subgroup analysis found benefit in the nonmetastatic group at 6 weeks (P = .0426), but not in metastatic disease. There were no differences for admissions or chemotherapy delivery. At 18 weeks, patients using eRAPID reported better self-efficacy (P = .007) and better health on EQ5D-VAS (P = .009). Average patient compliance with weekly symptom reporting was 64.7%. Patient adherence was associated with clinician's data use and improved FACT-PWB at 12 weeks. CONCLUSION Real-time monitoring with electronic patient-reported outcomes improved physical well-being (6 and 12 weeks) and self-efficacy (18 weeks) in a patient population predominantly treated with curative intent, without increasing hospital workload.

BACKGROUND: Lung cancer is increasingly a disease of the elderly and frail population with a median age of 70 years at diagnosis. Therefore, consideration of the impact of interventions on health-related quality of life (HRQOL) and not only absolute survival is especially important. For non-small cell lung cancer (NSCLC), video-assisted thoracoscopic surgery (VATS) has been gaining popularity over the last few decades, replacing traditional open lobectomies. For high-risk patients who are not deemed suitable for surgery, stereotactic ablative body radiotherapy (SABR) provides a potentially curative alternative. However, little is known about how VATS and SABR affect HRQOL measured using patient reported outcome measures (PROMs). The LiLAC study (Life after Lung Cancer) aims to explore HRQOL following intervention with VATS or SABR using validated PROMs and to pilot the use of an online questionnaire system (QTool) in this setting. We hope the results will aid both patients and clinicians in decision making and improve the management of post-intervention problems. METHODS: In total, 300 patients (150 VATS and 150 SABR) patients will be recruited over the study period. Patients will be approached prior to intervention and asked to complete baseline HRQOL questionnaires. They will be given access to the QTool online system and then in the 12 months following intervention will be asked to complete questionnaires (paper or online) at 4-time points. Answers will available for patients and clinicians to view throughout the study period. Clinical information (age, gender, co-morbidity, current medications and smoking status along with treatment-specific information) will also be collected. Primary outcome will be to detect changes of PROs (HRQOL and patient satisfaction) after VATS lung resections or SABR in early stage lung cancer patients. Secondary outcomes include correlation of patient's clinical data with HRQOL results to identify predictors of poor outcomes and exploration of patient and clinician views on the usefulness of QOL measurements. DISCUSSION: (I) This first study will primarily compare multiple patients reported outcomes for 12 months after VATS lobectomy and SABR in early stages NSCLC patients. We will explore the acceptability of an online assessment of the HRQOL in NSCLC patients. (II) The study is also focused on the patients' opinion during the shared decision-making process, which has rarely been investigated in surgical lung cancer patients. (III) This is not a randomised trial. As a consequence, inherent cohort selection bias and unknown or unaccounted confounders correlated with the outcome of interest may influence the results of the comparison between the treatment groups. (IV) LILAC is not looking at a direct comparison, but to depict the trajectory of recovery post-treatments and preservation or improvement of the HRQOL. This study has received ethical approval from NRES Yorkshire and the Humber- Leeds East Research Ethics Committee (REC Ref: 16/YH/0407). Results of this study will be shared with participating hospitals and made available to the academic community through submission for publication in international peer-reviewed journals and presentation at relevant national and international conferences. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02882750.

Study design Observational interventional pilot feasibility study Study objectives To review selected items for self-reporting of adverse events (AE) for acceptability, comprehension and clinical meaningfulness in a sample of breast, lung, renal, gynaecological and colorectal and cancer patients undergoing treatment at the Bexley Wing at St James’ University Hospital. The study will result in a bank of appropriate items reviewed for face and content validity, cultural relevance and comprehensively reflect local patient experience for remote self-report in the eRAPID project.

Key points

• To explore the COVID‐19 experiences of UK postgraduate research students (PGRs), the British Psychosocial Oncology Society (BPOS) conducted an online survey

• Twenty‐three respondents' qualitative data were analysed thematically and summarised using the strengths, weaknesses, opportunities, and threats (SWOT) framework

• COVID‐19 offered opportunities to develop online skills, resilience, and adaptability, whilst opening wellbeing conversations

• PGRs reported practical difficulties, social isolation, unhealthy work/life balance and concerns about future careers

• PGRs have had an unprecedented and continually evolving experience; BPOS and relevant institutions must continue to provide adequate support and development opportunities to safeguard their futures

Table of contentsS1 Using computerized adaptive testingTim CroudaceS2 Well-being: what is it, how does it compare to health and what are the implications of using it to inform health policyJohn BrazierO1 “Am I going to get better?”—Using PROMs to inform patients about the likely benefit of surgeryNils Gutacker, Andrew StreetO2 Identifying Patient Reported Outcome Measures for an electronic Personal Health RecordDan Robotham, Samantha Waterman, Diana Rose, Safarina Satkunanathan, Til WykesO3 Examining the change process over time qualitatively: transformative learning and response shiftNasrin Nasr, Pamela EnderbyO4 Developing a PROM to evaluate self-management in diabetes (HASMID): giving patients a voiceJill Carlton, Donna Rowen, Jackie Elliott, John Brazier, Katherine Stevens, Hasan Basarir, Alex LabeitO5 Development of the Primary Care Outcomes Questionnaire (PCOQ)Mairead Murphy, Sandra Hollinghurst, Chris SalisburyO6 Developing the PKEX score- a multimodal assessment tool for patients with shoulder problemsDominic Marley, James Wilson, Amy Barrat, Bibhas RoyO7 Applying multiple imputation to multi-item patient reported outcome measures: advantages and disadvantages of imputing at the item, sub-scale or score levelInes Rombach, Órlaith Burke, Crispin Jenkinson, Alastair Gray, Oliver Rivero-AriasO8 Integrating Patient Reported Outcome Measures (PROMs) into routine primary care for patients with multimorbidity: a feasibility studyIan Porter, Jaheeda Gangannagaripalli, Charlotte Bramwell, Jose M. ValderasO9 eRAPID: electronic self-report and management of adverse-events for pelvic radiotherapy (RT) patientsPatricia Holch, Susan Davidson, Jacki Routledge, Ann Henry, Kevin Franks, Alex Gilbert, Kate Absolom & Galina VelikovaO10 Patient reported outcomes (PROMs) based recommendation in clinical guidance for the management of chronic conditions in the United KingdomIan Porter, Jose M.ValderasO11 Cross-sectional and longitudinal parameter shifts in epidemiological data: measurement invariance and response shifts in cohort and survey data describing the UK’s Quality of LifeJan R. BoehnkeO12 Patient-reported outcomes within health technology decision making: current status and implications for future policyAndrew Trigg, Ruth HowellsO13 Can social care needs and well-being be explained by the EQ-5D? Analysis of Health Survey for England datasetJeshika Singh, Subhash Pokhrel, Louise LongworthO14 Where patients and policy meet: exploring individual-level use of the Long-Term Conditions Questionnaire (LTCQ)Caroline Potter, Cheryl Hunter, Laura Kelly, Elizabeth Gibbons, Julian Forder, Angela Coulter, Ray Fitzpatrick, Michele Peters

Background: Significant adverse events (AE) during cancer therapy disrupt treatment and escalate to emergency admissions. Approaches to improve the timeliness and accuracy of AE reporting may improve safety and reduce health service costs. Reporting AE via patient reported outcomes (PROs), can improve clinician-patient communication and making data available to clinicians in 'real-time' using electronic PROs (ePROs) could potentially transform clinical practice by providing easily accessible records to guide treatment decisions. This manuscript describes the development of eRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and aDvice) is a National Institute for Health Research-funded programme, a system for patients to self-report and manage AE online during and after cancer treatment. Materials and methods: A multidisciplinary team of IT experts, staff and patients developed using agile principles a secure web application interface (QStore) between an existing online questionnaire builder (QTool) displaying real-time ePRO data to clinicians in the electronic patient record at Leeds Teaching Hospitals NHS Trust. Hierarchical algorithms were developed corresponding to Common Terminology Criteria for Adverse Events grading using the QTool question dependency function. Patient advocates (N = 9), patients (N = 13), and staff (N = 19) usability tested the system reporting combinations of AE. Results: The eRAPID system allows patients to report AE from home on PC, tablet or any web enabled device securely during treatment. The system generates immediate self-management advice for low or moderate AE and for severe AE advice to contact the hospital immediately. Clinicians can view patient AE data in the electronic patient record and receive email notifications when patients report severe AE. Conclusions: Evaluation of the system in a randomised controlled trial in breast, gynaecological and colorectal cancer patients undergoing systemic therapy is currently underway. To adapt eRAPID for different treatment groups, pilot studies are being undertaken with patients receiving pelvic radiotherapy and upper gastrointestinal surgery. ISRCTN88520246.

Introduction: Video-assisted thoracoscopic (VATS) lung resection is the recommended curative treatment for early-stage non-small cell lung cancer (NSCLC). Patients considered at high surgical risk, are treated with stereotactic ablative body radiotherapy (SABR) as a lower morbidity alternative. This study aims to investigate the impact of SABR and VATS resection on patients’ quality of life (QoL) over the first year after treatment. Methods: A prospective longitudinal observational study recruiting early-stage NSCLC patients from a single UK centre. QoL was assessed with EORTC QLQ-C30 and Lung Cancer Module LC13 at baseline, 6 weeks and 3, 6 and 12 months post-treatment. Results: From 01.03.2017 till 01.03.2018, 244/281 patients (87%) consented to participate, 225 (95 SABR and 130 VATS) were included in the analysis. SABR patients had significantly worse baseline QoL scores than VATS patients, even after adjusting for preoperative clinical factors (C-30 Global Health mean: SABR = 53.8, VATS = 71.2; Physical Functioning mean: SABR = 57, VATS = 82.2; Fatigue mean: SABR = 43.5, VATS = 23.7; C30 Dyspnea mean: SABR = 49.5, VATS = 26.2). During the 12 months post SABR treatment patients’ QoL scores remained stable. In the VATS group, there was a deterioration 6-weeks after treatment in Role, Physical, Social Functions, Global Health, Fatigue, C30/LC13 Dyspnoea, Pain, Appetite loss, Constipation, LC13 Pain in Chest and Arms. The scores improved by 12 months without reaching the preoperative values. Conclusions: Although QoL outcomes for SABR and VATS are not comparable due to different medical selection criteria, the QoL impact of the two treatments during the first year showed different trends which will inform patients and clinicians during decision-making discussions.

Objectives Electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) is an online system developed to support patient care during cancer treatment by improving the detection and management of treatment-related symptoms. Patients can complete symptom reports from home and receive severity-based self-management advice, including notifications to contact the hospital for severe symptoms. Patient data are available in electronic records for staff to review. Prior to the commencement of a randomised controlled trial (RCT), field testing of the intervention was undertaken to troubleshoot practical issues with intervention integration in clinical practice. Design Observational clinical field testing. Setting Medical oncology breast service in a UK cancer centre. Participants 12 patients receiving chemotherapy for early breast cancer and 10 health professionals (oncologists and specialist nurses). Intervention Patients were asked to use the eRAPID intervention and complete weekly online symptom reports during four cycles of chemotherapy. Clinical staff were invited to access and use patient data in clinical assessments. Analysis Descriptive data on the frequency of online symptom report completion and severe symptom notifications were collated. Verbal and written feedback was collected from patients and staff and semistructured interviews were conducted to explore patient experiences. Interviews were transcribed and analysed thematically. Results The testing ran from January 2014 to March 2014. Feedback from patients and staff was largely positive. Patients described eRAPID as ‘reassuring’ and ‘comforting’ and valued the tailored management advice. Several changes were made to refine eRAPID. In particular, improvement of the clinical notification, patient reminder systems and changes to patient and staff training. Conclusions The field testing generated valuable results used to guide refinement of eRAPID prior to formal intervention evaluation. Feedback indicated that eRAPID has the potential to improve patients’ self-efficacy, knowledge and confidence with managing symptoms during treatment. A large-scale RCT is underway with data collection due to finish in October 2018.

PURPOSE: There is relatively limited large scale, long-term unified evidence to describe how quality of life (QoL) and functional outcomes are affected after polytrauma. The aim of this study is to review validated measures available to assess QoL and functional outcomes and make recommendations on how best to assess patents after major trauma. METHODS: PubMed and EMBASE databases were interrogated to identify suitable patient-reported outcome measures (PROMs) for use in major trauma, and current practice in their use globally. RESULTS: Overall, 81 papers met the criteria for inclusion and evaluation. Data from these were synthesised. A full set of validated PROMs tools were identified for patients with polytrauma, as well as critique of current tools available, allowing us to evaluate practice and recommend specific outcome measures for patients following polytrauma, and system changes needed to embed this in routine practice moving forward. CONCLUSION: To achieve optimal outcomes for patients with polytrauma, we will need to focus on what matters most to them, including their needs (and unmet needs). The use of appropriate PROMs allows evaluation and improvement in the care we can offer. Transformative effects have been noted in cases where they have been used to guide treatment, and if embedded as part of the wider system, it should lead to better overall outcomes. Accordingly, we have made recommendations to this effect. It is time to seize the day, bring these measures even further into our routine practice, and be part of shaping the future.

PURPOSE: Radiation therapy (RT) and chemoRT for pelvic cancers increase survival but are associated with serious treatment-related symptoms. Electronic-patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) is a secure online system for patients to self-report symptoms, generating immediate advice for hospital contact or self-management. This pilot study aimed to establish feasibility and acceptability of the system. METHODS AND MATERIALS: In a prospective 2-center randomized parallel-group pilot study, patients undergoing radical pelvic RT for prostate cancer (prostateRT) or chemoRT for lower gastrointestinal and gynecological cancers were randomized to usual care (UC) or eRAPID (weekly online symptom reporting for 12, 18, and 24 weeks). Primary outcomes were recruitment/attrition, study completion, and patient adherence. Secondary outcomes were effect on hospital services and performance of patient outcome measures. Missing data, floor/ceiling effects, and mean change scores were examined for Functional Assessment of Cancer Therapy (FACT-G), European Organisation for Research and Treatment of Cancer, Quality of Life (EORTC QLQ C-30), self-efficacy, and EuroQol (EQ5D). RESULTS: From 228 patients approached, 167 (73.2%) were consented and randomized (83, eRAPID; 84, UC; 87, prostateRT; 80, chemoRT); 150 of 167 completed 24 study weeks. Only 16 patients (9.6%) withdrew (10, eRAPID; 6, UC). In the eRAPID arm, completion rates were higher in patients treated with prostateRT compared with chemoRT (week 1, 93% vs 69%; week 2, 93% vs 68%; week 12, 69% vs 55%). Overall, over 50% of online reports triggered self-management advice for milder adverse events. Unscheduled hospital contact was low, with no difference between eRAPID and UC. Return rates for outcome measures were excellent in prostateRT (97%-91%; 6-24 weeks) but lower in chemoRT (95%-55%; 6-24 weeks). Missing data were low (1%-4.1%), ceiling effects were evident in EQ5D-5L, self-efficacy-scale, and FACT-Physical Wellbeing. At 6 weeks, the chemoRT-eRAPID group showed less deterioration in FACT-G, EORTC QLQ-C30, and EQ5D-Visual Analogue Scale than UC, after baseline adjustment. CONCLUSIONS: eRAPID was successfully added to UC at 2 cancer centers in different patient populations. Acceptability and feasibility were confirmed with excellent adherence by prostate patients, but lower by those undergoing chemoRT for gynecological cancers.

BACKGROUND: eRAPID (electronic patient self-Reporting of Adverse-events: Patient Information and aDvice) is an internet based system for patients to self-report symptoms and side effects (adverse events or AE) of cancer treatments. eRAPID allows AE reporting from home and patient reported data is accessible via Electronic Patient Records (EPR) for use in routine care. The system can generate alerts to clinical teams for severe AE and provides patient advice on managing mild AEs. The overall aims of eRAPID are to improve the safe delivery of cancer treatments, enhance patient care and standardise AE documentation. METHODS: The trial is a prospective randomised two-arm parallel group design study with repeated measures and mixed methods. Participants (adult patients with breast cancer on neo-adjuvant or adjuvant chemotherapy, colorectal and gynaecological cancer receiving chemotherapy) are randomised to receive the eRAPID intervention or usual care over 18 weeks of treatment. Participants in the intervention arm receive training in using the eRAPID system to provide routine weekly adverse event reports from home. Hospital staff can access eRAPID reports via the EPR and use the information during consultations or phone calls with patients. Prior to commencing the full trial an internal pilot phase was conducted (N = 87 participants) to assess recruitment procedures, consent and attrition rates, the integrity of the intervention information technology and establish procedures for collecting outcome data. The overall target sample for the trial is N = 504. The primary outcome of the trial is quality of life (FACT-G) with secondary outcomes including health economics (costs to patients and the NHS), process of care (e.g. contacts with the hospital, number of admissions, clinic appointments and changes to treatment/medications) and patient self-efficacy. Outcome data is collected at baseline, 6, 12, 18 weeks and 12 months. The intervention is also being evaluated via end of study interviews with patient participants and clinical staff. DISCUSSION: The pilot phase was completed in February 2016 and recruitment and attrition rates met criteria for continuing to the full trial. Recruitment recommenced in May 2016 and is planned to continue until December 2017. Overall findings will determine the value of the eRAPID intervention for supporting the care of patients receiving systemic cancer treatment. TRIAL REGISTRATION: Current Controlled Trials ISRCTN88520246 . Registered 11 September 2014.

Background Cancer is treated using multiple modalities (e.g. surgery, radiotherapy and systemic therapies) and is frequently associated with adverse events that affect treatment delivery and quality of life. Regular adverse event reporting could improve care and safety through timely detection and management. Information technology provides a feasible monitoring model, but applied research is needed. This research programme developed and evaluated an electronic system, called eRAPID, for cancer patients to remotely self-report adverse events. Objectives The objectives were to address the following research questions: is it feasible to collect adverse event data from patients’ homes and in clinics during cancer treatment? Can eRAPID be implemented in different hospitals and treatment settings? Will oncology health-care professionals review eRAPID reports for decision-making? When added to usual care, will the eRAPID intervention (i.e. self-reporting with tailored advice) lead to clinical benefits (e.g. better adverse event control, improved patient safety and experiences)? Will eRAPID be cost-effective? Design Five mixed-methods work packages were conducted, incorporating co-design with patients and health-care professionals: work package 1 – development and implementation of the electronic platform across hospital centres; work package 2 – development of patient-reported adverse event items and advice (systematic and scoping reviews, patient interviews, Delphi exercise); work package 3 – mapping health-care professionals and care pathways; work package 4 – feasibility pilot studies to assess patient and clinician acceptability; and work package 5 – a single-centre randomised controlled trial of systemic treatment with a full health economic assessment. Setting The setting was three UK cancer centres (in Leeds, Manchester and Bristol). Participants The intervention was developed and evaluated with patients and clinicians. The systemic randomised controlled trial included 508 participants who were starting treatment for breast, colorectal or gynaecological cancer and 55 health-care professionals. The radiotherapy feasibility pilot recruited 167 patients undergoing treatment for pelvic cancers. The surgical feasibility pilot included 40 gastrointestinal cancer patients. Intervention eRAPID is an online system that allows patients to complete adverse event/symptom reports from home or hospital. The system provides immediate severity-graded advice based on clinical algorithms to guide self-management or hospital contact. Adverse event data are transferred to electronic patient records for review by clinical teams. Patients complete an online symptom report every week and whenever they experience symptoms. Main outcome measures In systemic treatment, the primary outcome was Functional Assessment of Cancer Therapy – General, Physical Well-Being score assessed at 6, 12 and 18 weeks (primary end point). Secondary outcomes included cost-effectiveness assessed through the comparison of health-care costs and quality-adjusted life-years. Patient self-efficacy was measured (using the Self-Efficacy for Managing Chronic Diseases 6-item Scale). The radiotherapy pilot studied feasibility (recruitment and attrition rates) and selection of outcome measures. The surgical pilot examined symptom report completeness, system actions, barriers to using eRAPID and technical performance. Results eRAPID was successfully developed and introduced across the treatments and centres. The systemic randomised controlled trial found no statistically significant effect of eRAPID on the primary end point at 18 weeks. There was a significant effect at 6 weeks (adjusted difference least square means 1.08, 95% confidence interval 0.12 to 2.05; p = 0.028) and 12 weeks (adjusted difference least square means 1.01, 95% confidence interval 0.05 to 1.98; p = 0.0395). No between-arm differences were found for admissions or calls/visits to acute oncology or chemotherapy delivery. Health economic analyses over 18 weeks indicated no statistically significant difference between the cost of the eRAPID information technology system and the cost of usual care (£12.28, 95% confidence interval –£1240.91 to £1167.69; p > 0.05). Mean differences were small, with eRAPID having a 55% probability of being cost-effective at the National Institute for Health and Care Excellence-recommended cost-effectiveness threshold of £20,000 per quality-adjusted life-year gained. Patient self-efficacy was greater in the intervention arm (0.48, 95% confidence interval 0.13 to 0.83; p = 0.0073). Qualitative interviews indicated that many participants found eRAPID useful for support and guidance. Patient adherence to adverse-event symptom reporting was good (median compliance 72.2%). In the radiotherapy pilot, high levels of consent (73.2%) and low attrition rates (10%) were observed. Patient quality-of-life outcomes indicated a potential intervention benefit in chemoradiotherapy arms. In the surgical pilot, 40 out of 91 approached patients (44%) consented. Symptom report completion rates were high. Across the studies, clinician intervention engagement was varied. Both patient and staff feedback on the value of eRAPID was positive. Limitations The randomised controlled trial methodology led to small numbers of patients simultaneously using the intervention, thus reducing overall clinician exposure to and engagement with eRAPID. Furthermore, staff saw patients across both arms, introducing a contamination bias and potentially reducing the intervention effect. The health economic results were limited by numbers of missing data (e.g. for use of resources and EuroQol-5 Dimensions). Conclusions This research provides evidence that online symptom monitoring with inbuilt patient advice is acceptable to patients and clinical teams. Evidence of patient benefit was found, particularly during the early phases of treatment and in relation to self-efficacy. The findings will help improve the intervention and guide future trial designs. Future work Definitive trials in radiotherapy and surgical settings are suggested. Future research during systemic treatments could study self-report online interventions to replace elements of traditional follow-up care in the curative setting. Further research during modern targeted treatments (e.g. immunotherapy and small-molecule oral therapy) and in metastatic disease is recommended.

OBJECTIVES: Cervical cancer is 99.8% preventable when detected early; however, uptake of screening in the United Kingdom is at a 20-year low. Recently, a number of social media influencers have video logged about their experiences of cervical screening through narrative communication with their audience. Here we aimed to explore if accessing cervical screening information from a social media influencer can impact the theory of planned behaviour variables and predict intention to attend cervical screening appointments. DESIGN: Utilising a cross-sectional design a volunteer sample of 102 UK women (mean age = 28; SD = 3.10; range = 25-35) took part in an online questionnaire study. RESULTS: Hierarchical regression modelling revealed attitude as a significant predictor of intention to attend a cervical screening appointment and that social media influencers affect attitudes of their audience, indirectly influencing intention to attend. CONCLUSION: Health messages communicated by social media influencers are effective in promoting positive attitudes but not directly influence intention to attend towards cervical screening. Further research should explore influencer impact on attitudes towards this health behaviour with the ultimate aim of increasing attendance and consequently saving lives.

INTRODUCTION: The current service metrics used to evaluate quality in emergency care do not account for specific healthcare outcome goals for older people living with frailty. These have previously been classified under themes of 'Autonomy' and 'Functioning'. There is no person-reported outcome measure (PROM) for older people with frailty and emergency care needs. This study aimed to identify and co-produce recommendations for instruments potentially suitable for use in this population. METHODS: In this systematic review, we searched six databases for PROMs used between 2010 and 2021 by older people living with frailty receiving acute hospital care. Studies were reviewed against predefined eligibility criteria and appraised for quality using the COSMIN Risk of Bias checklist. Data were extracted to map instrument constructs against an existing framework of acute healthcare outcome goals. Instrument face and content validity were assessed by lay collaborators. Recommendations for instruments with potential emergency care suitability were formed through co-production. RESULTS: Of 9392 unique citations screened, we appraised the full texts of 158 studies. Nine studies were identified, evaluating nine PROMs. Quality of included studies ranged from 'doubtful' to 'very good'. Most instruments had strong evidence for measurement properties. PROMs mainly assessed 'Functioning' constructs, with limited coverage of 'Autonomy'. Five instruments were considered too burdensome for the emergency care setting or too specific for older people living with frailty. CONCLUSIONS: Four PROMs were recommended as potentially suitable for further validation with older people with frailty and emergency care needs: COOP/WONCA charts, EuroQol, McGill Quality of Life (Expanded), and Palliative care Outcome Scale.

PURPOSE: This study assessed the uptake of the CONsolidated Standards of Reporting Trials (CONSORT)-Patient-Reported Outcomes (PRO) statement; determined if use of CONSORT-PRO was associated with more complete reporting of PRO endpoints in randomised controlled trials (RCTs) and identified the extent to which high-impact journals publishing RCTs with PRO endpoints endorse CONSORT-PRO. METHODS: CONSORT-PRO citations were identified by systematically searching Medline, EMBASE and Google from 2013 (year CONSORT-PRO released) to 17 December 2015. RCTs that cited CONSORT-PRO (cases) were compared to a comparable control sample of RCTs in terms of adherence to CONSORT-PRO using t tests. General linear models assessed the relationship between CONSORT-PRO score and key, pre-specified variables. The 100 highest-impact journals that published RCTs with PRO endpoints (2014-2015) were identified via a systematic Medline search. Instructions for authors were reviewed to determine whether journals endorsed CONSORT-PRO. RESULTS: Total CONSORT-PRO scores ranged from 47 to 100% for cases and 25-96% for controls. Cases had significantly higher total CONSORT-PRO scores compared to controls: t = 2.64, p = 0.01. 'Citing CONSORT-PRO', 'journal endorsing CONSORT-PRO' and 'dedicated PRO paper' were significant predictors of higher CONSORT-PRO adherence score: R (2) = 0.48, p < 0.001. 11/100 top-ranked journals endorsed CONSORT-PRO in their instructions to authors, seven of these journals published RCTs included as cases in this study. CONCLUSION: This study demonstrated improved PRO reporting associated with journal endorsement and author use of the CONSORT-PRO extension. Despite growing awareness, more work is needed to promote appropriate use of CONSORT-PRO to improve completeness of reporting; in particular, stronger journal endorsement of CONSORT-PRO.

© 2016 Elsevier Inc. Purpose This review aimed to determine the clinician and patient reported outcome (PRO) instruments currently usedin randomized controlled trials (RCTs) of radical radiation therapy for nonmetastatic prostate cancer to report acute and late adverse events (AEs), review the quality of methodology and PRO reporting, and report the prevalence of acute and late AEs. Methods and Materials The MEDLINE, EMBASE, and Cochrane databases were searched between April and August 2014 according to the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement. Identified reports were reviewed according to the PRO Consolidated Standards of Reporting Trials (CONSORT) guidelines and the Cochrane Risk of Bias tool. In all, 1149 records were screened, and 21 articles were included in the final review. Results We determined the acute and late AEs for 9040 patients enrolled in 15 different RCTs. Only clinician reported instruments were used to report acute AEs < 3 months (eg, Radiation Therapy Oncology Group [RTOG] and Common Terminology Criteria for Adverse Events [CTCAE] ). For late clinician reporting, the Late Effects on Normal Tissues–Subjective, Objective, Management and Analytic scale and RTOG were used and were often augmented with additional items to provide comprehensive coverage of sexual functioning and anorectal symptoms. Some late AEs were reported (48% articles) using PROs (eg, ULCA-PCI [University of California, Los Angeles Prostate Cancer Index], FACT-G and P [Functional Assessment of Cancer Therapy General & Prostate Module], EORTC QLQC-30 + PR25 [European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire & Prostate Module]); however, a definitive “preferred” instrument was not evident. Discussion Our findings are at odds with recent movements toward including patient voices in reporting of AEs and patient engagement in clinical research. We recommend including PRO to evaluate radical radiation therapy before, during, and after the treatment to fully capture patient experiences, and we support the development of predictive models for late effects based on the severity of early toxicity. Conclusion Patient reporting of acute and late AEs is underrepresented in radiation therapy trials. We recommend working toward a consistent approach to PRO assessm ent of radiation therapy–related AEs.

BACKGROUND: PROs are valuable tools in clinical care to capture patients' perspectives of their health, symptoms and quality of life. However the COVID-19 pandemic has had profound impacts on all aspects of life, in particular healthcare and research. This study explores the views of UK and Irish health professionals, third sector and pharmaceutical industry representatives and academic researchers on the impact of COVID-19 on PRO collection, use and development in clinical practice. METHODS: A volunteer sample took part in a 10 question cross sectional qualitative survey, on the impact of COVID-19, administered online via Qualtrics. Demographic data was descriptively analysed, and the qualitative free text response data was subject to thematic analysis and summarised within the Strengths, Weaknesses, Opportunities and Threats (SWOT) framework. RESULTS: Forty nine participants took part located in a range of UK settings and professions. Participants highlighted staff strengths during the pandemic including colleagues' flexibility and ability to work collaboratively and the adoption of novel communication tools. Weaknesses were a lack of staff capacity to continue or start PRO projects and insufficient digital infrastructure to continue studies online. Opportunities included the added interest in PROs as useful outcomes, the value of electronic PROs for staff and patients particularly in relation to integration into systems and the electronic patient records. However, these opportunities came with an understanding that digital exclusion may be an issue for patient groups. Threats identified included that the majority of PRO research was stopped or delayed and funding streams were cut. CONCLUSIONS: Although most PRO research was on hold during the pandemic, the consensus from participants was that PROs as meaningful outcomes were valued more than ever. From the opportunities afforded by the pandemic the development of electronic PROs and their integration into electronic patient record systems and clinical practice could be a lasting legacy from the COVID-19 pandemic.

Abstract

The aim of this article is to present a succinct review and evaluation of the main areas of contention in the false memory debate and, from this basis, to suggest ways in which the best from both sides can be utilized. We examine the potential pitfalls of therapy in terms of the fallibility and suggestibility of autobiographical memory and therapists and therapeutic techniques as the architects of false memories. We then evaluate the case for false memory formation examining if some researchers hold misconceived views of psychotherapy, if experimental studies lack ecological validity, and the effect of trauma on memory. Finally, we explore how the potential pitfalls of therapy can be avoided in practice, reflecting on the usefulness of British Psychological Society guidelines, how clinicians can implement research findings, and how research on the false memory debate can be improved. We conclude that the way forward is researcher–clinician collaboration in the development of ecologically valid research paradigms. Copyright © 2004 John Wiley & Sons, Ltd.

Batterham et al. report that the gut peptide hormone PYY3-36 decreases food intake and body-weight gain in rodents, a discovery that has been heralded as potentially offering a new therapy for obesity. However, we have been unable to replicate their results. Although the reasons for this discrepancy remain undetermined, an effective anti-obesity drug ultimately must produce its effects across a range of situations. The fact that the findings of Batterham et al. cannot easily be replicated calls into question the potential value of an anti-obesity approach that is based on administration of PYY3-36.

The history of anti-obesity drug development is far from glorious, with transient magic bullets and only a handful of agents currently licensed for clinical use. In view of recent progress in our understanding of the multiplicity of signalling pathways involved in appetite regulation, and the resultant deluge of reports on the anorectic efficacy of novel therapies, it seems timely to stress the need to differentiate treatments that suppress intake by primary means from those that only indirectly achieve this endpoint. The current article reviews the conceptual history of the behavioural satiety sequence (BSS), also known as the behavioural sequence of satiety, post-ingestive satiety, and the postprandial satiety sequence. Early research confirmed that natural satiation, produced by a caloric load on the gut, is associated with a predictable transition from feeding through grooming to resting. Although many less naturalistic manipulations are also capable of reducing food intake, very few do so without disrupting the normal structure of this feeding cycle. Thus, while CCK and d-fenfluramine reduce intake by accelerating but otherwise maintaining the integrity of the BSS, other anorectic interventions disrupt the BSS through response competition (e.g. d-amphetamine), nausea/discomfort (e.g. lithium chloride) and/or interference with taste-mediated positive feedback (e.g. quinine adulteration of the diet). A substantial literature now strongly supports the specific involvement of serotonin 5-HT1B and 5-HT2C receptor subtypes in satiety and in the anorectic effect of agents such as fenfluramine and fluoxetine. Recent BSS analyses have also identified rather selective anorectic profiles for the dual noradrenaline and 5-HT reuptake inhibitor sibutramine, the orexin-1 receptor antagonist SB-334867, and the broad spectrum opioid receptor antagonist naloxone. However, similar analyses have offered little/no support for the anorectic potential of the gut peptide PYY3-36 while the acute anorectic efficacy of cannabinoid CB1 receptor antagonist/inverse agonists appears largely to be secondary to response competition. In contrast, studies with low-dose combinations of naloxone and CB1 receptor antagonist/inverse agonists have very recently confirmed the potential of drug polytherapies not only in appetite suppression but also in attenuating/eliminating unwanted side-effects. In sum, as BSS analysis offers a reliable means of differentiating the wheat (primary anorectics) from the chaff (secondary anorectics), it should form an integral part of early phase testing in any anti-obesity drug screening programme. © 2010 Elsevier Inc.

Abstract

Objective: Emotional distress (ED) is an under‐diagnosed problem in cancer patients and over the last decade a number of national guidelines have recommended an assessment and management model based on appropriate health professional response to a hierarchy of patient need. This study explores the views of cancer professionals regarding their current roles and responsibilities in the detection and management of ED, use of screening tools and access to expert psychological support.

Methods: Interviews with 23 professionals were conducted [6 clinical nurse specialists (CNS), 8 oncologists, 4 surgeons and 5 ward sisters] from hospitals in Yorkshire, UK. Data were evaluated using framework analysis.

Results: Detection of ED was seen to be the responsibility of the whole cancer team though nurses, particularly CNSs, are heavily depended upon to assess and manage distress. Experience of screening tools was limited and a number of reservations were expressed about routine implementation. A wide range of services are used to support distressed patients but a lack of referral guidance and access to specialist psychological care were reported to be a significant barrier to effective management.

Conclusions: Cancer professionals describe working within the fundamental principles of the guidance frameworks; however, access to specialist support do not appear to meet recommendations, leaving the CNS with considerable responsibility for the detection and management of ED. Support for ED may be improved by the introduction of routine screening along with appropriate training and implementation of referral guidelines to assist professionals in accessing specialist psychology services. Copyright © 2011 John Wiley & Sons, Ltd.

Background: In the UK, demonstration of patient and public involvement (PPI) is now a funding requirement. Despite advice being available to researchers regarding PPI, levels of engagement are variable. Patient involvement has been at the core of the Leeds Psychosocial Oncology and Clinical Practice Research Group since 2007 when a local Research Advisory Group (RAG) was established. In addition, we work with experienced patient advocates from national groups.Methods: The RAG is led by designated researchers who manage and communicate with members. The RAG is invited to twice yearly meetings with the full research team when study findings are disseminated and advice sought. The meetings are also an opportunity to socialise and thank members. Effective partnerships and engagement require good communication, building relationships over time and tailoring involvement to individuals’ skills and experience.Results: Patients have been involved in design, planning new projects and assisting with grant proposals; development, pilot testing of interview strategies and question generation, project steering groups and management teams, development of self-management advice for online patient portals; implementation, extensive beta testing of new questionnaire builder software to enable collection of online patient-reported outcomes (PRO) and study websites, cognitive interviews to develop PRO items; dissemination, co-authorship of papers and presentations, attendance/representation of the group at conferences.Conclusion: The involvement of patient advocates is integral to ensuring PRO development remains patient-centred. Having a co-operative, well-established local PPI group and nationally active patient collaborators has had a rewarding and significant impact on our research programmes.

BACKGROUND: In the USA, more than 7200 new cases of anal cancer were diagnosed in 2014 with incidence rising. Concurrent chemoradiotherapy improves cancer-related outcomes but has led to an increase in acute and late adverse events. Patient-reported outcomes (PRO) are increasingly included in trials as a surrogate measure for reporting of late adverse events. This study aimed to select the most effective PRO to use in clinical research and practice for anal cancer since no questionnaire specific for anal cancer has been developed. METHODS: A mixed methods approached was used. A systematic review estimated the frequency of use of PROs and clinician reporting instruments used in anal cancer trials including radiation treatment. Health professional semi-structured interviews explored preferred questionnaires and revealed missing items; analysis was done using the framework approach. Two symptom-based, validated questionnaires were selected and assessed by means of inductive content analysis to highlight discrepancies relevant to anal cancer. FINDINGS: 34 relevant studies reported on radiotherapy adverse events. For PROs, EORTC QLQ-C30 (n=5) and EORTC QLQ-CR38 (n=3) were used most frequently. RTOG/EORTC (n=17) and CTCAE (n=15) criteria were most commonly used for clinician reporting. EORTC QLQ-C30 and EORTC QLQ-CR38, and National Cancer Institute's (NCI) PRO-CTCAE were selected for further analysis. No consensus for questionnaire content or design was found through health professional interviews (n=8). Domains and codes relevant to anal cancer treatment were selected from interviews to inform questionnaire analysis. 27 domains and 60 codes were found in EORTC questionnaires, and 21 domains and 44 codes in NCI PRO-CTCAE. Four domains and 16 codes were not covered by EORTC systems including radiation skin reaction. Six domains and 45 codes were not covered by NCI PRO-CTCAE including vaginal stenosis and bowel urgency. INTERPRETATION: This study shows that there are gaps in the questionnaires commonly used to record adverse events using PROs for anal cancer. Expert opinion is valuable in highlighting relevant missing items but provides no consensus on design and wording preferences. For use in longitudinal follow-up of patients with anal cancer treated with (chemo)radiation, the EORTC-QLQ system has the fewest missing symptom items for use as a validated PRO in clinical research and practice. FUNDING: This abstract presents independent research funded by the National Institute for Health Research (NIHR).

Objectives Emotional distress, including depression, is an important issue for cancer patients and their families. Guidelines recommend the use of antidepressant drugs (ADs) for the management of depression in cancer. This study explores the views of oncology professionals about the inclusion of ADs in treatment plans. Design Semi-structured interview study. Data were analysed using framework analysis. Setting A specialist cancer centre and six district general hospitals across the Yorkshire Cancer Network. Participants 18 randomly selected professionals from lung, breast, urology and colorectal cancer teams: oncologists (n=8), surgeons (n=3), clinical nurse specialists (n=2) and ward nurses (n=5). Results Three main themes emerged relating to professionals’ attitudes, knowledge and behaviour. Positive attitudes were primarily expressed by nurses. However, negative views were expressed about the potential for over-reliance on ADs, and their use constituting ‘giving in’. Doctors reported a lack of confidence in the use of and knowledge about ADs with an associated reluctance to prescribe. The general practitioner (GP) was regarded as the most appropriate professional to prescribe ADs. Conclusions Cancer professionals highlighted a need for training in the appropriate use of ADs. Further, this research suggests that negative attitudes towards antidepressants may be a factor in their exclusion from treatment plans. The GP is seen to have a key prescribing role for AD therapy; however, it is unclear whether the GPs is asked to do this. This research raises questions about the adequacy of ADs in cancer care and to what extent the GP is able to meet this need

Summary

The neuropeptide Y (NPY)/peptide YY (PYY) system has been implicated in the physiology of obesity for several decades. More recently, Batterhamet al.2002 ignited enormous interest in PYY3‐36, an endogenous Y2‐receptor agonist, as a promising anti‐obesity compound. Despite this interest, there have been remarkably few subsequent reports reproducing or extending the initial findings, while at the same time studies finding no anti‐obesity effects have surfaced. Out of 41 different rodent studies conducted (in 16 independent labs worldwide), 33 (83%) were unable to reproduce the reported effects and obtained no change or sometimes increased food intake, despite use of the same experimental conditions (i.e. adaptation protocols, routes of drug administration and doses, rodent strains, diets, drug vendors, light cycles, room temperatures). Among studies by authors in the original study, procedural caveats are reported under which positive effects may be obtained. Currently, data speak against a sustained decrease in food intake, body fat, or body weight gain following PYY3‐36 administration and make the previously suggested role of the hypothalamic melanocortin system unlikely as is the existence of PYY deficiency in human obesity. We review the studies that are in the public domain which support or challenge PYY3‐36 as a potential anti‐obesity target.

OBJECTIVES: In 2010, St. James Institute of Oncology (Leeds, UK) created a new acute oncology service (AOS) consisting of a new admissions unit with a nurse-led telephone triage (TT) system. This audit cycle (March 2011 and June 2013) evaluated patient experiences of the reconfigured AOS and staff use of the TT system. METHODS: Patient views were elicited via a questionnaire and semi-structured interviews. The TT forms were analysed descriptively evaluating completion and data quality, reported symptoms and their severity and advice given (including admission rates). RESULTS: Patients (n = 40) reported high satisfaction with the new AOS. However, 56 % of patients delayed 2 days or more before contacting the unit. In 2011, 26 % of all the admitted patients were triaged via the TT system; 133 TT forms were completed. In June 2013, 49 % of the admitted patients were triaged; 264 forms were completed. The most commonly reported symptoms on the TT forms were pain, pyrexia/rigors/infection, diarrhoea, vomiting and dyspnoea. Half of the patients using the TT system were admitted (52 % in 2011, 49 % in 2013). CONCLUSIONS: Our audit provided evidence of successful implementation of the TT system with the number of TT forms doubling from 2011 to 2013. The new AOS was endorsed by patients, with the majority satisfied with the care they received.

Background: Standardized reporting of treatment-related adverse events (AE) is essential in clinical trials, usually achieved by using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) reported by clinicians. Patient-reported adverse events (PRAE) may add value to clinician assessments, providing patient perspective on subjective toxicity. We developed an online patient symptom report and self-management system for real-time reporting and managing AE during cancer treatment integrated with electronic patient records (eRAPID). As part of this program we developed a patient version of the CTCAE (version 4.0), rephrasing terminology into a self-report format. We explored patient understanding of these items via cognitive interviews. Material and method: Sixty patients (33 female, 27 male) undergoing treatment were purposively sampled by age, gender and tumor group (median age 61.5, range 35–84, 12 breast, 12 gynecological, 13 colorectal, 12 lung and 11 renal). Twenty-one PRAE items were completed on a touch-screen computer. Subsequent audio-recorded cognitive interviews and thematic analysis explored patients’ comprehension of items via verbal probing techniques during three interview rounds (n = 20 patients/round). Results: In total 33 item amendments were made; 29% related to question comprehension, 73% response option and 3% order effects. These amendments to phrasing and language improved patient understanding but maintained CTCAE grading and key medical information. Changes were endorsed by members of a patient advisory group (N = 11). Conclusion: Item adaptations resulted in a bank of consistently interpreted self-report AE items for use in future research program. In-depth analysis of items through cognitive interviews is an important step towards developing an internationally valid system for PRAE, thus improving patient safety and experiences during cancer treatment.

PURPOSE: A randomized controlled trial of online symptom monitoring during chemotherapy with electronic patient self-Reporting of Adverse-events: Patient Information and aDvice (eRAPID) system found improved symptom control and patient self-efficacy, without increasing hospital admissions and visits. The aim of this study was to evaluate the cost-effectiveness of the eRAPID eHealth intervention compared with usual care for patients receiving systemic treatment for colorectal, breast, or gynecologic cancers in the United Kingdom. METHODS: An embedded economic evaluation was conducted alongside the trial evaluating the effectiveness of eRAPID from health care provider and societal perspectives. Costs and quality-adjusted life-years (QALYs) of patients were compared over 18 weeks of the trial. Incremental cost-effectiveness ratios (ICERs) were estimated and compared with the National Institute for Health and Care Excellence cost-effectiveness threshold. Uncertainty around the ICER was explored using nonparametric bootstrapping and sensitivity analyses. Follow-up data were collected 12-months after random assignment for a subset of the study sample to conduct exploratory analysis of potential longer-term effects. RESULTS: Patients in the eRAPID group had the highest QALY gain and lowest costs over 18 weeks. Although differences were small and not statistically significant, eRAPID had a 55%-58% probability of being more cost-effective than usual care. Patient out-of-pocket costs were lower in the eRAPID group, indicating eRAPID may help patients access support needed within the National Health Service. Exploratory 12-months analysis showed small differences in costs and QALYs, with higher QALY gains in the eRAPID group but also higher costs. Exploratory subgroup analysis by disease status indicated that the eRAPID intervention was cost-effective for patients with early-stage cancers but not for patients with metastatic disease. CONCLUSION: Despite small differences in QALYs and costs, the analyses show potential cost-effectiveness of online symptom monitoring, when added to usual care, particularly during adjuvant systemic treatment for early-stage cancers.

Purpose/Objective: In the United Kingdom (UK) 3200 adults are diagnosed with cervix cancer per year, and 50% of cases are in people under 45 years [1] At diagnosis, 40% will have locally advanced disease (stage IIA, IIB, III and IV where the tumour is too extensive to be completely excised surgically) treated with a combination of external beam radiotherapy (EBRT), weekly Cisplatin (Chemotherapy) followed by brachytherapy [2]. Survival at 5 years ranges between 83% and 52% [3] and in 2011 it was estimated that 34,800 people are alive in the UK having been treated for cancer of the cervix [1]. Effective pelvic radiotherapy can result in long term treatment related toxicity [4, 5] with up to 50% of patients experiencing significant treatment related effects (gastrointestinal (GI), genitourinary (GU), sexual and neurological) that can have a devastating impact on quality of life (QoL) and psychological morbidity [ 6, 7]. As survival rates continue to increase, so does the significance of mitigation and improvement of management of the long-term effects of cancer treatment. This mixed methods systematic review aimed to identify the physical, psychological, and social consequences of treatment for patients who have completed chemoradiotherapy and brachytherapy for locally advanced cancer of the cervix. Material/Methods: PsycARTICLES, PsychINFO, PsycTESTS, MEDLINE and CINAHL complete databases were searched between 1990 and 2022. Eligibility criteria was formulated using the SPIDER (S – sample, PI - phenomenon of interest, D – design, E – evaluation, R - research type Framework) [8]. Only English language papers were included and those recruiting participants over 18 years old. The studies comprised: experimental, observational, content analysis, evaluations, systematic reviews, randomised control trials (RCTs) cross sectional studies including both retrospective and prospective designs. The protocol is registered on Prospero [9] according to the Preferred Reporting Items for Systematic Review for Protocols (PRISMA-P) 2015 [10]. The Mixed Methods Appraisal Tool [11] was utilised to appraise limitations and the risk of bias. Extracted data was tabularised and synthesised narratively. Interrater reliability of 10% of papers retrieved was established for final inclusion. Results: From 684 articles identified, 27 articles were included in the final review, Findings are discussed from 3997 patients enrolled in 20 studies, recruited from Europe, North and South America and Asia. Of the 27 papers 26 were quantitative, one was a qualitative paper and there were no mixed methods papers. Sixteen papers included clinician reported data, 2 included patient reported data, 7 included both, and 2 papers reported registry data Physical effects of treatment were recorded in papers where clinicians had graded toxicity according to the National Institute of Health / National cancer institute common toxicity criteria for adverse events (CTCAE) or The Radiation Therapy Oncology Group (RTOG) Late Radiation Morbidity Scoring Criteria [12,13]. In clinician reported papers Grade 3/4 GI toxicity was reported (diarrhoea, faecal incontinence, rectovaginal fistula, intestinal obstruction, and persistent rectal bleeding) GU toxicity (vesicovaginal fistula, vaginal narrowing and shortening, urinary incontinence and urgency) pelvic insufficiency fractures and chronic fatigue. In papers 2012 onwards grade 1-2 toxicity including faecal and urinary incontinence were more frequently recorded and reported. However, there was a paucity of information on the timing and onset of treatment related toxicity. The most commonly reported psychological consequences of treatment (anxiety and depression) were reported by patients using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-CX24 [14]. Psychological distress was also caused by reported changes in vaginal anatomy resulting in lower Female Sexual Function Index (FSFI) [15]. In terms of social functioning surprising little impact was recorded however the impact on the individual’s ability to carry out their roles in life was recorded. A high proportion of patients report chronic fatigue, and this is often a prominent factor in patients being unable to undertake paid work. Sexual functioning was also a significant factor in intimate relationships for patients following treatment. Conclusion: Here we have highlighted a range of physical, psychological and social long term toxicity resulting from radical radiotherapy treatment for cervix cancer. Grade 3/4 toxicity is frequently reported by clinicians; however, the heavy symptom burden of life altering grade 1/2 toxicity is of significant importance to patients, acknowledged by inclusion in clinician reported papers from 2012. This systematic review has highlighted the lack of data on the timing of the onset of symptoms caused by treatment related toxicity and also the importance of developing patient-reported adverse event questionnaires for radiotherapy patients [16,17]. Findings from this review will assist healthcare practitioners in developing effective interventions to maximise the QoL of life of those living with the consequences of cancer treatment.

Background Goldenhar Syndrome is a rare congenital condition, typically characterized by craniofacial abnormalities and vertebral malformations. Due to its rare and complex nature, the etiology is unconfirmed, resulting in parental uncertainty and subsequent emotional sequelae. Clinical manifestations have been researched but few studies have explored parental wellbeing and Quality of Life (QoL). In this qualitative study, we explore parental views of the challenges and lived experience of raising a child with Goldenhar Syndrome. Methods Ten biological parents (five mothers and five fathers), recruited at the Goldenhar UK Conference, took part in audio-recorded, semi-structured interviews. Interviews explored emotional wellbeing, views surrounding causation, support accessed, challenges faced, experience of stigma and future outlooks. Reflexive thematic analysis was employed, and transcripts were subject to deductive and inductive coding. Results Seven themes were identified: support networks (Goldenhar UK), rollercoaster of emotion; gendered coping; uncertainty; societal reactions; coping with challenge and acceptance. Conclusions This is the first-time the life perspectives of parents, raising a child with Goldenhar Syndrome, have been explored via interviews. We have unearthed prominent issues that impact parental QoL including isolation and distress at the point of diagnosis, and throughout the multidisciplinary health journey. We have also established significant indicators of the ongoing QoL challenges faced by young people with Goldenhar Syndrome. Future work is underway exploring these issues further with teenagers, young people and adults with Goldenhar to develop a conceptual framework of their QoL. This will be used to develop a bespoke patient reported outcome (PRO) to give voice to the challenges children and young adults face during their medical journey.

BACKGROUND: Increasingly, teenagers and young adults (TYAs) seek out health information online; however, it is not clear whether they possess electronic health (eHealth) literacy, defined as "the ability to select, appraise, and utilize good quality health information from the internet." A number of factors are included in the Lily model proposed by Norman and Skinner underpinning the development of eHealth literacy. It is important to understand which elements may influence the development of eHealth literacy in young people, as the current generation will continue to "Google it" when faced with a health problem throughout their lives. OBJECTIVE: The objectives of this study are to explore potential factors influencing young people's eHealth literacy and explore the underlying constructs of the eHealth Literacy Scale (eHEALS) in a population of UK university students. METHODS: A total of 188 undergraduate psychology students from a large UK University were recruited as an opportunity sample. Of these, 88.8% (167/188) of participants were female with a mean age of 20.13 (SD 2.16) years and the majority were White British (159/188, 84.6%). Employing a cross-sectional design TYAs completed the following measures exploring eHealth literacy (eHEALS): Irrational Health Belief Scale; Newest Vital Sign (NVS), a measure of functional health literacy; Need for Cognition Scale, a preference for effortful cognitive activity; and General Self-Efficacy (GSE) Scale, exploring personal agency and confidence. The eHEALS was also subject to exploratory factor analysis (EFA), for which in addition to the total variance explained, the scree plot, eigenvalues, and factor loadings were assessed to verify the structure. RESULTS: eHEALS and GSE were significantly positively correlated (r=0.28, P<.001) and hierarchical linear modeling revealed GSE as the significant predictor of scores on the eHEALS (F1,186=16.16, P<.001, R2=0.08), accounting for 8.0% of the variance. Other notable relationships were GSE and need for cognition (NFC) were also positively correlated (r=0.33, P<.001), and NFC and irrational health beliefs were significantly negatively correlated (r=-.14, P=.03). Using Spearman correlations, GSE and NVS (rs=0.14, P=.04) and NFC and NVS (rs=0.19, P=.003) were positively correlated. An EFA revealed the scale to be stable and identified a 2-factor structure related to information acquisition and information application. CONCLUSIONS: This is the first study in the UK to explore relationships between these key variables and verify the structure of the eHEALS in a TYA population in the UK. The findings that self-efficacy has a major influence firmly consolidate its status as fundamental to the development of eHealth literacy. Future studies will explore the influence of body image and the development of eHealth literacy in more diverse TYA populations.

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.

This guide has been written for new families from a parental perspective. It is based on the views and outlooks of Goldenhar parents, adults with Goldenhar and a small cohort of teenagers. The guide aims to provide information, practical advice, hope and reassurance for families. It may also be useful for medical professionals, educational practitioners and the general-public. As many of us know, being a new parent is exciting and challenging, but when a child is born with medical complications, additional needs and physical differences (which can be visible and invisible) this can present additional challenges and stress for new families. Please be assured that you are not alone, you are not the only one this has happened to, you are not to blame for these unexpected complications, and the future can be much brighter! Just like any other child, a child with Goldenhar has every possibility of being able to live a fulfilling and enjoyable life and they have every chance of growing into a healthy, happy and successful adult, able to have a career and life they choose for themselves. There are many success stories of Goldenhar adults who are graduates, authors, graphic designers, digital creators, lecturers, musicians, business developers and owners; and many people who have gone on to have families of their own. There are no limits to what your Goldenhar child could achieve in life!