Tim Pickles

ABSTRACT

Abstract

The CARe Burn Scales are a suite of burn-specific PROMs for adults, children, young people, and parents affected by burns. This study aimed to determine the responsiveness and minimal important difference (MID) values of the Adult Form for use in adult burn care and research. Participants were recruited by 11 UK Burn Services. They completed online or paper versions of the CARe Burn Scale –Adult Form and a set of appropriate comparison validated measures and anchor questions at baseline (T1, up to 4 weeks post-burn), 3 months (T2), and 6 months post-burn (T3). A total of 269 participants took part at baseline and 226 (84%) were retained at the 6-month follow-up. Spearman’s correlation analysis and effect sizes based on Cohen’s d thresholds were reported and MID values calculated. MID values were created for all subscales and ranged from 4–15. The CARe Burn Scale–Adult Form is responsive to change over time and can therefore be used to reliably inform the management of adults’ burn injury treatment and recovery. It is freely available for clinical and research use.

BACKGROUND: Urine culture at the point of care minimises delay between obtaining the sample and agar inoculation in a microbiology laboratory, and quantification and sensitivity results can be available more rapidly in primary care. OBJECTIVE: To identify the degree to which clinicians' interpretations of a point-of-care-test (POCT) urine culture (Flexicult™ SSI-Urinary Kit) agrees with laboratory culture in women presenting to primary care with symptoms of uncomplicated urinary tract infections (UTI). METHODS: Primary care clinicians used the Flexicult™-POCT, recorded their findings and took a photograph of the result, which was interpreted by microbiology laboratory technicians. Urine samples were additionally processed in routine care laboratories. Cross tabulations were used to identify important differences in organism identification, quantification and antibiotic susceptibility between these three sources of data. The influence of various laboratory definitions for UTI on culture were assessed. RESULTS: Primary care clinicians identified 202/289 urine samples (69.9%) as positive for UTI using the Flexicult™-POCT, whereas laboratory culture identified 94-190 (32.5-65.7%) as positive, depending on definition thresholds. 82.9% of samples identified positive for E. coli on laboratory culture were also considered positive for E. coli using the Flexicult™ -POCT, and susceptibilities were reasonably concordant. There were major discrepancies between laboratory staff interpretation of Flexicult™ photographs, clinicians' interpretation of the Flexicult™ test, and laboratory culture results. CONCLUSION: Flexicult™-POCT overestimated the positivity rate of urine samples for UTI when laboratory culture was used as the reference standard. However, it is unclear whether point-of-care or laboratory based urine culture provides the most valid diagnostic information.

Background

It is not clear which young children presenting acutely unwell to primary care should be investigated for urinary tract infection (UTI) and whether or not dipstick testing should be used to inform antibiotic treatment.

BACKGROUND: Antibiotic treatment recommendations based on susceptibility data from routinely submitted urine samples may be biased because of variation in sampling, laboratory procedures and inclusion of repeat samples, leading to uncertainty about empirical treatment. OBJECTIVE: To describe and compare susceptibilities of Escherichia coli cultured from routinely submitted samples, with E. coli causing urinary tract infection (UTI) from a cohort of systematically sampled, acutely unwell children. METHODS: Susceptibilities of 1458 E. coli isolates submitted during the course of routine primary care for children <5 years (routine care samples), compared to susceptibilities of 79 E. coli isolates causing UTI from 5107 children <5 years presenting to primary care with an acute illness [systematic sampling: the Diagnosis of Urinary Tract infection in Young children (DUTY) cohort]. RESULTS: The percentage of E. coli sensitive to antibiotics cultured from routinely submitted samples were as follows: amoxicillin 45.1% (95% confidence interval: 42.5-47.7%); co-amoxiclav using the lower systemic break point (BP) 86.6% (84.7-88.3%); cephalexin 95.1% (93.9-96.1%); trimethoprim 74.0% (71.7-76.2%) and nitrofurantoin 98.2% (97.4-98.8%). The percentage of E. coli sensitive to antibiotics cultured from systematically sampled DUTY urines considered to be positive for UTI were as follows: amoxicillin 50.6% (39.8-61.4%); co-amoxiclav using the systemic BP 83.5% (73.9-90.1%); co-amoxiclav using the urinary BP 94.9% (87.7-98.4%); cephalexin 98.7% (93.2-99.8%); trimethoprim 70.9% (60.1-80.0%); nitrofurantoin 100% (95.3-100.0%) and ciprofloxacin 96.2% (89.4-98.7%). CONCLUSION: Escherichia coli susceptibilities from routine and systematically obtained samples were similar. Most UTIs in preschool children remain susceptible to nitrofurantoin, co-amoxiclav and cephalexin.

Fissure sealant (FS) and fluoride varnish (FV) are effective in preventing dental caries when compared with a no-treatment control. However, the relative clinical effectiveness of these interventions is uncertain. The objective of the study was to compare the clinical effectiveness of FS and FV in preventing dental caries in first permanent molars (FPMs) in 6- to 7-y-olds. The study design was a randomized clinical trial, with 2 parallel arms. The setting was a targeted-population program that used mobile dental clinics in schools located within areas of high social and economic deprivation in South Wales. A total of 1,016 children were randomized 1:1 to receive either FS or FV. Resin-based FS was applied to caries-free FPMs and maintained at 6-mo intervals. FV was applied at baseline and at 6-mo intervals for 3 y. The main outcome measures were the proportion of children developing caries into dentine (D4-6MFT) on any 1 of up to 4 treated FPMs after 36 mo. At 36 mo, 835 (82%) children remained: 417 in the FS arm and 418 in the FV arm. A smaller proportion of children who received FV ( n = 73, 17.5%) versus FS ( n = 82, 19.6%) developed caries into dentine on at least 1 FPM (odds ratio [OR] = 0.84; 95% CI, 0.59 to 1.21; P = 0.35), a nonstatistically significant difference between FS and FV treatments. The results were similar when the number of newly decayed teeth (OR = 0.86; 95% CI, 0.60 to 1.22) and tooth surfaces (OR = 0.85; 95% CI, 0.59 to 1.21) were examined. In a community oral health program, semiannual application of FV resulted in caries prevention that was not significantly different from that obtained by applying and maintaining FS after 36 mo (EudraCT: 2010-023476-23; ISRCTN: ISRCTN17029222).

OBJECTIVE: To develop and validate the Evaluation of AGenda-mapping skilL Instrument (EAGL-I). METHODS: EAGL-I was constructed after a literature review and piloting. Simulated consultation recordings were collected in a workshop with third-year medical students at three time points: once pre-teaching, twice post-teaching. Three raters used EAGL-I to assess student agenda-mapping. We examined reliability, ability to detect change and predict full expression of patients' agendas. RESULTS: EAGL-I scores represented reliable assessment of agenda-mapping (Ep(2)=0.832; φ=0.675). Generalizability coefficients across items (Ep(2)=0.836) and raters (φ=0.797 two raters) were acceptable. A one-way repeated measure ANOVA with post hoc analysis found a statistically significant difference between the pre-teaching occasion of measurement and each post-teaching occasion (p<0.001) and no significant difference between the two post-teaching occasions (p=0.085). Multilevel logistic regression show scores predict expression of scripted hidden agendas irrespective of occasions, or patient scenario (n=60, p=0.005). CONCLUSION: Evidence of measure validation is shown. Reliability is optimised when two or more raters use EAGL-I and agenda-mapping has been taught. EAGL-I appears sensitive to change. Higher scores predict the likelihood that a patient will disclose their full agenda in a simulated environment. PRACTICE IMPLICATIONS: A validated tool for measuring agenda-mapping in teaching and research is now available.

Fumaric acid esters (FAEs) are licensed for the treatment of moderate-to-severe psoriasis in Germany but are also used off-label in many other countries. We conducted this systematic review to synthesize the highest-quality evidence for the benefits and risks of FAEs for psoriasis. Our primary outcomes were change in Psoriasis Area and Severity Index score and dropout rates due to adverse effects. Randomized controlled trials (RCTs) of FAEs or dimethylfumarate were included, with no restriction on age or psoriasis subtype. We searched the Cochrane Skin Group Specialised Register, CENTRAL in the Cochrane Library, Medline, Embase, LILACS and five trials registers, and hand searched six conference proceedings. Six RCTs with a total of 544 participants were included, four of which were published only as abstracts or brief reports, limiting study reporting. Five RCTs compared FAEs with placebo, and all demonstrated benefit in favour of FAEs. However, meta-analysis was possible only for PASI 50 response after 12-16 weeks, which was achieved by 64% of participants on FAEs compared with 14% on placebo: risk ratio (RR) 4·55, 95% confidence interval (CI) 2·80-7·40; two studies; 247 participants; low-quality evidence). There was no difference in dropout rates due to adverse effects (RR 5·36, 95% CI 0·28-102·12; one study; 27 participants; very low-quality evidence and wide CI). More participants experienced nuisance adverse effects with FAEs (76%) than with placebo (16%) (RR 4·72, 95% CI 2·45-9·08; one study; 99 participants; moderate-quality evidence), mainly abdominal pain, diarrhoea and flushing. One head-to-head study of very low-quality evidence comparing FAEs with methotrexate reported comparable efficacy and dropout rates, although FAEs caused more flushing. The evidence in this review was limited and must be interpreted with caution; studies with better design and outcome reporting are needed.

BACKGROUND: The prevalence of targeted and serendipitous treatment for, and associated recovery from, urinary tract infection (UTI) in pre-school children is unknown. AIM: To determine the frequency and suspicion of UTI in children who are acutely ill, along with details of antibiotic prescribing, its appropriateness, and whether that appropriateness impacted on symptom improvement and recovery. DESIGN AND SETTING: Prospective observational cohort study in primary care sites in urban and rural areas in England and Wales. METHOD: Systematic urine sampling from children aged <5 years presenting in primary care with acute illness with culture in NHS laboratories. RESULTS: Of 6079 children's urine samples, 339 (5.6%) met laboratory criteria for UTI and 162 (47.9%) were prescribed antibiotics at the initial consultation. In total, 576/7101 (8.1%) children were suspected of having a UTI prior to urine sampling, including 107 of the 338 with a UTI (clinician sensitivity 31.7%). Children with a laboratory-diagnosed UTI were more likely to be prescribed antibiotics when UTI was clinically suspected than when it was not (86.0% versus 30.3%, P<0.001). Of 231 children with unsuspected UTI, 70 (30.3%) received serendipitous antibiotics (that is, antibiotics prescribed for a different reason). Overall, 176 (52.1%) children with confirmed UTI did not receive any initial antibiotic. Organism sensitivity to the prescribed antibiotic was higher when UTI was suspected than when treated serendipitously (77.1% versus 26.0%; P<0.001). Children with UTI prescribed appropriate antibiotics at the initial consultation improved a little sooner than those with a UTI who were not prescribed appropriate antibiotics initially (3.5 days versus 4.0 days; P = 0.005). CONCLUSION: Over half of children with UTI on culture were not prescribed antibiotics at first presentation. Serendipitous UTI treatment was relatively common, but often inappropriate to the organism's sensitivity. Methods for improved targeting of antibiotic treatment in children who are acutely unwell are urgently needed.

Abstract

BACKGROUND: The added diagnostic utility of nappy pad urine samples and the proportion that are contaminated is unknown. AIM: To develop a clinical prediction rule for the diagnosis of urinary tract infection (UTI) based on sampling using the nappy pad method. DESIGN AND SETTING: Acutely unwell children <5 years presenting to 233 UK primary care sites. METHOD: Logistic regression to identify independent associations of symptoms, signs, and urine dipstick test results with UTI; diagnostic utility quantified as area under the receiver operator curves (AUROC). Nappy pad rule characteristics, AUROC, and contamination, compared with findings from clean-catch samples. RESULTS: Nappy pad samples were obtained from 3205 children (82% aged <2 years; 48% female), culture results were available for 2277 (71.0%) and 30 (1.3%) had a UTI on culture. Female sex, smelly urine, darker urine, and the absence of nappy rash were independently associated with a UTI, with an internally-validated, coefficient model AUROC of 0.81 (0.87 for clean-catch), which increased to 0.87 (0.90 for clean-catch) with the addition of dipstick results. GPs' 'working diagnosis' had an AUROC 0.63 (95% confidence intervals [CI] = 0.53 to 0.72). A total of 12.2% of nappy pad and 1.8% of clean-catch samples were 'frankly contaminated' (risk ratio 6.66; 95% CI = 4.95 to 8.96; P<0.001). CONCLUSION: Nappy pad urine culture results, with features that can be reported by parents and dipstick tests, can be clinically useful, but are less accurate and more often contaminated compared with clean-catch urine culture.

Abstract

BACKGROUND: Urolithiasis has a significant impact on patients' health-related quality of life (HRQoL). OBJECTIVE: To develop a core patient-reported outcome measure (PROM) using modern psychometric methods to quantify the impact of urolithiasis and different treatments. DESIGN, SETTING, AND PARTICIPANTS: Adult patients with urinary calculi, attending urology departments, covering all index categories and treatment spectrum, participated during different development phases. The pilot instrument was created from potential items (phases 1 and 2) within the conceptual framework. The instrument was pretested (phase 3) and then underwent psychometric evaluation in two parts (phases 4 and 5). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The validity and reliability of the new PROM were assessed using Rasch measurement theory (RUMM 2030 statistical software) and traditional analyses. RESULTS AND LIMITATIONS: In total, 683 patients (median age 51 yr, range 18-92 yr) participated during different phases. The initial 60-item draft (five scales) was completed by 212 patients (phase 4). A revised 25-item draft was produced after removal of unstable items. In the second field test, the revised version was evaluated by 369 patients. This led to the final Urinary Stones and Intervention Quality of Life (USIQoL; 15 items) with summated logit scores. The PROM includes three scales: pain with physical health (six items), psychosocial health (seven items) and work performance (two items). Lower scores indicate better outcomes. Results demonstrate that USIQoL is reliable (r ≥ 0.8) and internally consistent (α ≥ 0.7), and has good construct validity (good hypothesised correlations, r > 0.3) and satisfactory sensitivity to change (p < 0.01). All scales demonstrated unidimensionality with good item fit and person separation indices. A limitation is that USIQoL was developed in the English language within the UK population. CONCLUSIONS: USIQoL is a short, unidimensional, valid, and reliable PROM for assessing the HRQoL impact of urinary calculi and treatments. It is expected to serve as a core PROM across the entire spectrum of urolithiasis. PATIENT SUMMARY: Kidney stones are a common condition for which various treatment options are available. The condition and treatments have a significant impact on a patient's quality of life. This can be measured objectively using a valid and reliable patient-reported outcome measure (PROM) developed using modern methods. We have developed a PROM that provides helpful and accurate measurement useful for all stakeholders.

Abstract

Background

Fissure sealant (FS) and fluoride varnish (FV) have been shown to be effective in preventing dental caries when tested against a no-treatment control. However, the relative clinical effectiveness and cost-effectiveness of these interventions is unknown.

OBJECTIVE: To develop and evaluate a health-care communication training programme to help diabetes health-care professionals (HCPs) counsel their patients more skilfully, particularly in relation to behaviour change. DESIGN: The HCP training was assessed using a pragmatic, cluster randomised controlled trial. The primary and secondary analyses were intention-to-treat comparisons of outcomes using multilevel modelling to allow for cluster (service) and individual effects, and involved two-level linear models. SETTING: Twenty-six UK paediatric diabetes services. PARTICIPANTS: The training was delivered to HCPs (doctors, nurses, dietitians and psychologists) working in paediatric diabetes services and the effectiveness of this training was measured in 693 children aged 4-15 years and families after 1 year (95.3% follow-up). INTERVENTIONS: A blended learning programme was informed by a systematic review of the literature, telephone and questionnaire surveys of professional practice, focus groups with children and parents, experimental consultations and three developmental workshops involving a stakeholder group. The programme focused on agenda-setting, flexible styles of communication (particularly guiding) and a menu of strategies using web-based training and practical workshops. MAIN OUTCOME MEASURES: The primary trial outcome was a change in glycosylated haemoglobin (HbA1c) levels between the start and finish of a 12-month study period. Secondary trial outcomes included change in quality of life, other clinical [including body mass index (BMI)] and psychosocial measures (assessed at participant level as listed above) and cost (assessed at service level). In addition, patient details (HbA1c levels, height, weight, BMI, insulin regimen), health service contacts and patient-borne costs were recorded at each clinic visit, along with details of who patients consulted with, for how long, and whether or not patients consulted on their own at each visit. Patients and carers were also asked to complete an interim questionnaire assessing patient enablement (or feelings towards clinic visit for younger patients aged 7-10 years) at their first clinic visit following the start of the trial. The cost of the intervention included the cost of training intervention teams. RESULTS: Trained staff showed better skills than control subjects in agenda-setting and consultation strategies, which waned from 4 to 12 months. There was no effect on HbA1c levels (p = 0.5). Patients in intervention clinics experienced a loss of confidence in their ability to manage diabetes, whereas controls showed surprisingly reduced barriers (p = 0.03) and improved adherence (p = 0.05). Patients in intervention clinics reported short-term increased ability (p = 0.04) to cope with diabetes. Parents in the intervention arm experienced greater excitement (p = 0.03) about clinic visits and improved continuity of care (p = 0.01) without the adverse effects seen in their offspring. The mean cost of training was £13,145 per site or £2163 per trainee. There was no significant difference in total NHS costs (including training) between groups (p = 0.1). CONCLUSIONS: Diabetes HCPs can be trained to improve consultation skills, but these skills need reinforcing. Over 1 year, no benefits were seen in children, unlike parents, who may be better placed to support their offspring. Further modification of this training is required to improve outcomes that may need to be measured over a longer time to see effects. TRIAL REGISTRATION: Current Controlled Trials ISRCTN61568050. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 15, No. 29. See the HTA programme website for further project information.

Three-dimensional (3D) imaging technology has been widely used to analyse facial morphology and has revealed an influence of some medical conditions on craniofacial growth and morphology. The aim of the study is to investigate whether craniofacial morphology is different in atopic Caucasian children compared with controls. Study design included observational longitudinal cohort study. Atopy was diagnosed via skin-prick tests performed at 7.5 years of age. The cohort was followed to 15 years of age as part of the Avon Longitudinal Study of Parents and Children (ALSPAC). A total of 734 atopic and 2829 controls were identified. 3D laser surface facial scans were obtained at 15 years of age. Twenty-one reproducible facial landmarks (x, y, z co-ordinates) were identified on each facial scan. Inter-landmark distances and average facial shells for atopic and non-atopic children were compared with explore differences in face shape between the groups. Both total anterior face height (pg-g, pg-men) and mid-face height (Is-men, sn-men, n-sn) were longer (0.6 and 0.4mm respectively) in atopic children when compared with non-atopic children. No facial differences were detected in the transverse and antero-posterior relationships. Small but statistically significant differences were detected in the total and mid-face height between atopic and non-atopic children. No differences were detected in the transverse and antero-posterior relationships.

Abstract

Abstract

OBJECTIVE: To describe the evolution of the OMERACT Fellows Program (OM FP) and to evaluate the innovative changes implemented in the 2023 program. METHODS: The OM FP, the first of its kind in global rheumatology, was developed in 2000 to mentor early career researchers in methods and processes for reaching evidence-driven consensus for outcome measures in clinical studies. The OM FP has evolved through continuing iterations of face to face and online feedback. Key new features delivered in 2023 included e-learning modules, virtual introductory pre-meetings, increased networking with Patient Research Partners (PRPs), learning opportunities to give and receive personal feedback, ongoing performance feedback during the meeting from Fellow peers, PRPs, senior OMERACTers (members of the OMERACT community) and Emerging Leader mentors, involvement in pitching promotions, two-minute Lightning Talks in a plenary session and an embedded poster tour. An online survey was distributed after the meeting to evaluate the program. RESULTS: OM FP has included 208 fellows from 16 countries across 4 continents covering 47 different aspects of rheumatology outcomes since its inception. Over 50 % have remained engaged with OMERACT work. In 2023, 18 Fellows attended and 15 (83 %) completed the post-meeting survey. A dedicated OM FP was deemed important by all respondents, and 93 % would attend the meeting in future. The PRP/Fellow Connection Carousel and Lightning Talks were rated exceptional by 93 %. Key components to improve included clarification of expectations, overall workload, the Emerging Leaders Mentoring Program, and the content and duration of daily summary sessions. CONCLUSION: The innovations in the 2023 OM FP were well received by the majority of participants and supports early career rheumatology researchers to develop collaborations, skills and expertise in outcome measurement. Implementation of feedback from Fellows will enhance the program for future meetings, continuing to facilitate learning and succession planning within OMERACT.

Abstract

Background

Illicit drug use increases the risk of poor physical and mental health. There are few effective drug prevention interventions.

PURPOSE: Up to 50% of urinary tract infections (UTIs) in young children are missed in primary care. Urine culture is essential for diagnosis, but urine collection is often difficult. Our aim was to derive and internally validate a 2-step clinical rule using (1) symptoms and signs to select children for urine collection; and (2) symptoms, signs, and dipstick testing to guide antibiotic treatment. METHODS: We recruited acutely unwell children aged under 5 years from 233 primary care sites across England and Wales. Index tests were parent-reported symptoms, clinician-reported signs, urine dipstick results, and clinician opinion of UTI likelihood (clinical diagnosis before dipstick and culture). The reference standard was microbiologically confirmed UTI cultured from a clean-catch urine sample. We calculated sensitivity, specificity, and area under the receiver operator characteristic (AUROC) curve of coefficient-based (graded severity) and points-based (dichotomized) symptom/sign logistic regression models, and we then internally validated the AUROC using bootstrapping. RESULTS: Three thousand thirty-six children provided urine samples, and culture results were available for 2,740 (90%). Of these results, 60 (2.2%) were positive: the clinical diagnosis was 46.6% sensitive, with an AUROC of 0.77. Previous UTI, increasing pain/crying on passing urine, increasingly smelly urine, absence of severe cough, increasing clinician impression of severe illness, abdominal tenderness on examination, and normal findings on ear examination were associated with UTI. The validated coefficient- and points-based model AUROCs were 0.87 and 0.86, respectively, increasing to 0.90 and 0.90, respectively, by adding dipstick nitrites, leukocytes, and blood. CONCLUSIONS: A clinical rule based on symptoms and signs is superior to clinician diagnosis and performs well for identifying young children for noninvasive urine sampling. Dipstick results add further diagnostic value for empiric antibiotic treatment.

BACKGROUND: Psoriasis is a chronic inflammatory skin condition that can markedly reduce life quality. Several systemic therapies exist for moderate to severe psoriasis, including oral fumaric acid esters (FAE). These contain dimethyl fumarate (DMF), the main active ingredient, and monoethyl fumarate. FAE are licensed for psoriasis in Germany but used off-licence in many countries. OBJECTIVES: To assess the effects and safety of oral fumaric acid esters for psoriasis. SEARCH METHODS: We searched the following databases up to 7 May 2015: the Cochrane Skin Group Specialised Register, CENTRAL in the Cochrane Library (Issue 4, 2015), MEDLINE (from 1946), EMBASE (from 1974), and LILACS (from 1982). We searched five trials registers and checked the reference lists of included and excluded studies for further references to relevant randomised controlled trials. We handsearched six conference proceedings that were not already included in the Cochrane Skin Group Specialised Register. SELECTION CRITERIA: Randomised controlled trials (RCTs) of FAE, including DMF monotherapy, in individuals of any age and sex with a clinical diagnosis of psoriasis. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. Primary outcomes were improvement in Psoriasis Area and Severity Index (PASI) score and the proportion of participants discontinuing treatment due to adverse effects. MAIN RESULTS: We included 6 studies (2 full reports, 2 abstracts, 1 brief communication, and 1 letter), with a total of 544 participants. Risk of bias was unclear in several studies because of insufficient reporting. Five studies compared FAE with placebo, and one study compared FAE with methotrexate. All studies reported data at 12 to 16 weeks, and we identified no longer-term studies. When FAE were compared with placebo, we could not perform meta-analysis for the primary outcome of PASI score because the three studies that assessed this outcome reported the data differently, although all studies reported a significant reduction in PASI scores with FAE. Only 1 small study designed for psoriatic arthritis reported on the other primary outcome of participants discontinuing treatment due to adverse effects (2 of 13 participants on FAE compared with none of the 14 participants on placebo; risk ratio (RR) 5.36, 95% confidence interval (CI) 0.28 to 102.1; 27 participants; very low-quality evidence). However, these findings are uncertain due to indirectness and a very wide confidence interval. Two studies, containing 247 participants and both only reported as abstracts, allowed meta-analysis for PASI 50, which showed superiority of FAE over placebo (RR 4.55, 95% CI 2.80 to 7.40; low-quality evidence), with a combined PASI 50 of 64% in those given FAE compared with a PASI 50 of 14% for those on placebo, representing a number needed to treat to benefit of 2. The same studies reported more participants achieving PASI 75 with FAE, but we did not pool the data because of significant heterogeneity; none of the studies measured PASI 90. One study reported significant improvement in participants' quality of life (QoL) with FAE, measured with Skindex-29. However, we could not compute the mean difference because of insufficient reporting in the abstract. More participants experienced adverse effects, mainly gastrointestinal disturbance and flushing, on FAE (RR 4.72, 95% CI 2.45 to 9.08; 1 study, 99 participants; moderate-quality evidence), affecting 76% of participants given FAE and 16% of the placebo group (representing a number needed to treat to harm of 2). The other studies reported similar findings or did not report adverse effects fully.One study of 54 participants compared methotrexate (MTX) with FAE. PASI score at follow-up showed superiority of MTX (mean Difference (MD) 3.80, 95% CI 0.68 to 6.92; 51 participants; very low-quality evidence), but the difference was not significant after adjustment for baseline disease severity. The difference between groups for the proportion of participants who discontinued treatment due to adverse effects was uncertain because of imprecision (RR 0.19, 95% CI 0.02 to 1.53; 1 study, 51 participants; very low-quality evidence). Overall, the number of participants experiencing common nuisance adverse effects was not significantly different between the 2 groups, with 89% of the FAE group affected compared with 100% of the MTX group (RR 0.89, 95% CI 0.77 to 1.03; 54 participants; very low-quality evidence). Flushing was more frequent in those on FAE, with 13 out of 27 participants affected compared with 2 out of 27 given MTX. There was no significant difference in the number of participants who attained PASI 50, 75, and 90 in the 2 groups (very low-quality evidence) whereas this study did not measure the effect of treatments on QoL. The included studies reported no serious adverse effects of FAE and were too small and of limited duration to provide evidence about rare or delayed effects. AUTHORS' CONCLUSIONS: Evidence suggests that FAE are superior to placebo and possibly similar in efficacy to MTX for psoriasis; however, the evidence provided in this review was limited, and it must be noted that four out of six included studies were abstracts or brief reports, restricting study reporting. FAE are associated with nuisance adverse effects, including flushing and gastrointestinal disturbance, but short-term studies reported no serious adverse effects.

BACKGROUND: Urinary tract infections (UTI) are the most frequent bacterial infection affecting women and account for about 15% of antibiotics prescribed in primary care. However, some women with a UTI are not prescribed antibiotics or are prescribed the wrong antibiotics, while many women who do not have a microbiologically confirmed UTI are prescribed antibiotics. Inappropriate antibiotic prescribing unnecessarily increases the risk of side effects and the development of antibiotic resistance, and wastes resources. METHODS/DESIGN: 614 adult female patients will be recruited from four primary care research networks (Wales, England, Spain, the Netherlands) and individually randomised to either POCT guided care or the guideline-informed 'standard care' arm. Urine and stool samples (where possible) will be obtained at presentation (day 1) and two weeks later for microbiological analysis. All participants will be followed up on the course of their illness and their quality of life, using a 2 week self-completed symptom diary. At 3 months, a primary care notes review will be conducted for evidence of further evidence of treatment failures, recurrence, complications, hospitalisations and health service costs. DISCUSSION: Although the Flexicult™ POCT is used in some countries in routine primary care, it's clinical and cost effectiveness has never been evaluated in a randomised clinical trial. If shown to be effective, the use of this POCT could benefit individual sufferers and provide evidence for health care authorities to develop evidence based policies to combat the spread and impact of the unprecedented rise of infections caused by antibiotic resistant bacteria in Europe. TRIAL REGISTRATION NUMBER: ISRCTN65200697 (Registered 10 September 2013).

BACKGROUND: Smoking, excessive drinking, lack of exercise and a poor diet remain key causes of premature morbidity and mortality globally, yet it is not clear what proportion of patients attending for routine primary care are eligible for interventions about these behaviours, the extent to which they co-occur within individuals, and which individuals are at greatest risk for multiple unhealthy behaviours. The aim of the trial was to examine 'intervention eligibility' and co-occurrence of the 'big four' risky health behaviours - lack of exercise, smoking, an unhealthy diet and excessive drinking - in a primary care population. METHODS: Data were collected from adult patients consulting routinely in general practice across South Wales as part of the Pre-Empt study; a cluster randomised controlled trial. After giving consent, participants completed screening instruments, which included the following to assess eligibility for an intervention based on set thresholds: AUDIT-C (for alcohol), HSI (for smoking), IPAQ (for exercise) and a subset of DINE (for diet). The intervention following screening was based on which combination of risky behaviours the patient had. Descriptive statistics, χ2 tests for association and ordinal regressions were undertaken. RESULTS: Two thousand sixty seven patients were screened: mean age of 48.6 years, 61.9 % female and 42.8 % in a managerial or professional occupation. In terms of numbers of risky behaviours screened eligible for, two was the most common (43.6 %), with diet and exercise (27.2 %) being the most common combination. Insufficient exercise was the most common single risky behaviour (12.0 %). 21.8 % of patients would have been eligible for an intervention for three behaviours and 5.9 % for all four behaviours. Just 4.5 % of patients did not identify any risky behaviours. Women, older age groups and those in managerial or professional occupations were more likely to exhibit all four risky behaviours. CONCLUSION: Very few patients consulting for routine primary care screen ineligible for interventions about common unhealthy behaviours, and most engage in more than one of the major common unhealthy behaviours. Clinicians should be particularly alert to opportunities to engaging younger, non professional men and those with multi-morbidity about risky health behaviour. TRIAL REGISTRATION: ISRCTN22495456.

By relying on data from existing patient-reported outcome measures of quality of life, the true impact of skin conditions on patients' lives may be underestimated. This study systematically reviewed all dermatology-specific (used across skin conditions) patient-reported outcome measures and makes evidence-based recommendations for their use. The study protocol is registered on PROSPERO (CRD42018108829). PubMed, PsycInfo and CINAHL were searched from inception to 25 June 2018. The Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) criteria were used to assess the measurement properties and methodological quality of studies. A total of 12,925 abstracts were identified. Zero patient-reported outcome measures were assigned to category A (ready for use without further validation), 31 to category B (recommended for use, but only with further validation) and 5 to category C (not recommended for use). There is no gold-standard dermatology-specific patient-reported outcome measure that can be recommended or used without caution. A new measure that can comprehensively capture the impact of dermatological conditions on the patient's life is needed.

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Abstract

OBJECTIVE: Adaptive designs can enable highly sophisticated and efficient early phase trials, but the clinical inference from these trials is surrounded by complexity, and currently there is a paucity but steadily increasing amount of use of these designs in all fields of medicine. We aim to review early phase trials in RA to discover those that have used adaptive designs and benchmark trial characteristics. METHODS: From an OVID search for journal articles reporting the results of early phase trials in rheumatology, 35 studies were found, with 9 subsequently excluded; 11 were added from manual searches and 19 from searching the references. Study characteristics were extracted from the 56 papers (describing 62 trials), including the number of arms, number of patients, the primary outcome and when it was measured. RESULT: One early phase trial using an adaptive design was found. The benchmark early phase trial in RA is a phase II double-blinded randomized trial, with four arms (one control and three intervention), each with 34 patients, and ACR20 measured at 16 weeks as the primary outcome. CONCLUSION: The one adaptive design reviewed here, and a simulation study found in the search, both indicate that adaptive designs can be applied to early phase trials in RA. We have described the benchmark, which the efficiency of early phase trials using an adaptive design needs to exceed. These efficient designs could drive down numbers required, time for data collection and thus cost. Changes have been suggested, but more needs to be done.

BACKGROUND: Dental caries remains a significant public health problem, prevalence being linked to social and economic deprivation. Occlusal surfaces of first permanent molars are the most susceptible site in the developing permanent dentition. Cochrane reviews have shown pit and fissure sealants (PFS) and fluoride varnish (FV) to be effective over no intervention in preventing caries. However, the comparative cost and effectiveness of these treatments is uncertain. The primary aim of the trial described in this protocol is to compare the clinical effectiveness of PFS and FV in preventing dental caries in first permanent molars in 6-7 year-olds. Secondary aims include: establishing the costs and the relative cost-effectiveness of PFS and FV delivered in a community/school setting; examining the impact of PFS and FV on children and their parents/carers in terms of quality of life/treatment acceptability measures; and examining the implementation of treatment in a community setting. METHODS/DESIGN: The trial design comprises a randomised, assessor-blinded, two-arm, parallel group trial in 6-7 year old schoolchildren. Clinical procedures and assessments will be performed at 66 primary schools, in deprived areas in South Wales. Treatments will be delivered via a mobile dental clinic. In total, 920 children will be recruited (460 per trial arm). At baseline and annually for 36 months dental caries will be recorded using the International Caries Detection and Assessment System (ICDAS) by trained and calibrated dentists. PFS and FV will be applied by trained dental hygienists. The FV will be applied at baseline, 6, 12, 18, 24 and 30 months. The PFS will be applied at baseline and re-examined at 6, 12, 18, 24, and 30 months, and will be re-applied if the existing sealant has become detached/is insufficient. The economic analysis will estimate the costs of providing the PFS versus FV. The process evaluation will assess implementation and acceptability through acceptability scales, a schools questionnaire and interviews with children, parents, dentists, dental nurses and school staff. The primary outcome measure will be the proportion of children developing new caries on any one of up to four treated first permanent molars. DISCUSSION: The objectives of this study have been identified by the National Institute for Health Research as one of importance to the National Health Service in the UK. The results of this trial will provide guidance on which of these technologies should be adopted for the prevention of dental decay in the most susceptible tooth-surface in the most at risk children. TRIAL REGISTRATIONS: ISRCTN ref: ISRCTN17029222 EudraCT: 2010-023476-23 UKCRN ref: 9273.

OBJECTIVE: To evaluate the effectiveness on glycaemic control of a training programme in consultation skills for paediatric diabetes teams. DESIGN: Pragmatic cluster randomised controlled trial. SETTING: 26 UK secondary and tertiary care paediatric diabetes services. PARTICIPANTS: 79 healthcare practitioners (13 teams) trained in the intervention (359 young people with type 1 diabetes aged 4-15 years and their main carers) and 13 teams allocated to the control group (334 children and their main carers). INTERVENTION: Talking Diabetes programme, which promotes shared agenda setting and guiding communication style, through flexible menu of consultation strategies to support patient led behaviour change. MAIN OUTCOME MEASURES: The primary outcome was glycated haemoglobin (HbA(1c)) level one year after training. Secondary outcomes were clinical measures (hypoglycaemic episodes, body mass index, insulin regimen), general and diabetes specific quality of life, self reported and proxy reported self care and enablement, perceptions of the diabetes team, self reported and carer reported importance of, and confidence in, undertaking diabetes self management measured over one year. Analysis was by intention to treat. An integrated process evaluation included audio recording a sample of 86 routine consultations to assess skills shortly after training (intervention group) and at one year follow-up (intervention and control group). Two key domains of skill assessment were use of the guiding communication style and shared agenda setting. RESULTS: 660/693 patients (95.2%) provided blood samples at follow-up. Training diabetes care teams had no effect on HbA(1c) levels (intervention effect 0.01, 95% confidence interval -0.02 to 0.04, P=0.5), even after adjusting for age and sex of the participants. At follow-up, trained staff (n=29) were more capable than controls (n=29) in guiding (difference in means 1.14, P<0.001) and agenda setting (difference in proportions 0.45, 95% confidence interval 0.22 to 0.62). Although skills waned over time for the trained practitioners, the reduction was not significant for either guiding (difference in means -0.33, P=0.128) or use of agenda setting (difference in proportions -0.20, -0.42 to 0.05). 390 patients (56%) and 441 carers (64%) completed follow-up questionnaires. Some aspects of diabetes specific quality of life improved in controls: reduced problems with treatment barriers (mean difference -4.6, 95% confidence interval -8.5 to -0.6, P=0.03) and with treatment adherence (-3.1, -6.3 to -0.01, P=0.05). Short term ability to cope with diabetes increased in patients in intervention clinics (10.4, 0.5 to 20.4, P=0.04). Carers in the intervention arm reported greater excitement about clinic visits (1.9, 1.05 to 3.43, P=0.03) and improved continuity of care (0.2, 0.1 to 0.3, P=0.01). CONCLUSIONS: Improving glycaemic control in children attending specialist diabetes clinics may not be possible through brief, team-wide training in consultation skills. TRIAL REGISTRATION: Current Controlled Trials ISRCTN61568050.

OBJECTIVES: To evaluate the effect of training primary care health professionals in behaviour change counselling on the proportion of patients self reporting change in four risk behaviours (smoking, alcohol use, exercise, and healthy eating). DESIGN: Cluster randomised trial with general practices as the unit of randomisation. SETTING: General practices in Wales. PARTICIPANTS: 53 general practitioners and practice nurses from 27 general practices (one each at all but one practice) recruited 1827 patients who screened positive for at least one risky behaviour. INTERVENTION: Behaviour change counselling was developed from motivational interviewing to enable clinicians to enhance patients' motivation to change health related behaviour. Clinicians were trained using a blended learning programme called Talking Lifestyles. MAIN OUTCOME MEASURES: Proportion of patients who reported making beneficial changes in at least one of the four risky behaviours at three months. RESULTS: 1308 patients from 13 intervention and 1496 from 14 control practices were approached: 76% and 72% respectively agreed to participate, with 831 (84%) and 996 (92%) respectively screening eligible for an intervention. There was no effect on the primary outcome (beneficial change in behaviour) at three months (362 (44%) v 404 (41%), odds ratio 1.12 (95% CI 0.90 to 1.39)) or on biochemical or biometric measures at 12 months. More patients who had consulted with trained clinicians recalled consultation discussion about a health behaviour (724/795 (91%) v 531/966 (55%), odds ratio 12.44 (5.85 to 26.46)) and intended to change (599/831 (72%) v 491/996 (49%), odds ratio 2.88 (2.05 to 4.05)). More intervention practice patients reported making an attempt to change (328 (39%) v 317 (32%), odds ratio 1.40 (1.15 to 1.70)), a sustained behaviour change at three months (288 (35%) v 280 (28%), odds ratio 1.36 (1.11 to 1.65)), and reported slightly greater improvements in healthy eating at three and 12 months, plus improved activity at 12 months. Training cost £1597 per practice. DISCUSSION: Training primary care clinicians in behaviour change counselling using a brief blended learning programme did not increase patients reported beneficial behaviour change at three months or improve biometric and a biochemical measure at 12 months, but it did increase patients' recollection of discussing behaviour change with their clinicians, intentions to change, attempts to change, and perceptions of having made a lasting change at three months. Enduring behaviour change and improvements in biometric measures are unlikely after a single routine consultation with a clinician trained in behaviour change counselling without additional intervention. TRIAL REGISTRATION: ISRCTN 22495456.

OBJECTIVES: Increased cardiovascular risk in rheumatoid arthritis (RA) is well established. Examining traditional cardiovascular risk factors alone underestimates cardiovascular risk in RA. Systematic inflammation, measured by erythrocyte sedimentation rate or C-reactive protein is also a major risk factor. However, the contribution of traditional cardiovascular risk factors (such as obesity and hyperlipidaemia) compared to inflammation is uncertain in psoriatic arthritis (PsA) and RA. We examine the incidence of major adverse cardiac events (MACE) among patients with RA, PsA psoriasis, and controls adjusting for risk factors, inflammation and disease modifying anti-rheumatic drug treatment, to better define cardiovascular risk. METHODS: Using the Secure Anonymised Information Linkage databank, comprising routinely collected Welsh health data from 1999 to 2013, the incidence and first occurrence of a MACE in individuals with RA (n = 8650), PsA (n = 2128) and psoriasis (n = 24,630) compared to controls (n = 11,87,706) was investigated. RESULTS: Traditional cardiovascular risk factors are higher in RA, PsA and psoriasis than controls. After adjusting for these factors, additional cardiovascular risk was only significantly increased in female RA patients (HR = 1.3; 95% CI: 1.0-1.7; p = 0.05) and psoriasis (HR = 1.2; 95% CI: 1.0-1.4; p = 0.02) but not statistically significant for PsA (HR = 1.5; 95% CI: 0.9-2.5; p = 0.13). ESR and CRP were increased in patients with RA but not in patients with psoriasis. CONCLUSION: Additional increased cardiovascular risk was observed in female RA and psoriasis but not PsA. Systematic inflammation is higher in RA but not psoriasis, indicating that there are varying mediators of cardiovascular risk across these conditions.

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OBJECTIVES: To compare the validity of diagnosis of urinary tract infection (UTI) through urine culture between samples processed in routine health service laboratories and those processed in a research laboratory. POPULATION AND METHODS: We conducted a prospective diagnostic cohort study in 4808 acutely ill children aged <5 years attending UK primary health care. UTI, defined as pure/predominant growth ≥105 CFU/mL of a uropathogen (the reference standard), was diagnosed at routine health service laboratories and a central research laboratory by culture of urine samples. We calculated areas under the receiver-operator curve (AUC) for UTI predicted by pre-specified symptoms, signs and dipstick test results (the "index test"), separately according to whether samples were obtained by clean catch or nappy (diaper) pads. RESULTS: 251 (5.2%) and 88 (1.8%) children were classified as UTI positive by health service and research laboratories respectively. Agreement between laboratories was moderate (kappa = 0.36; 95% confidence interval [CI] 0.29, 0.43), and better for clean catch (0.54; 0.45, 0.63) than nappy pad samples (0.20; 0.12, 0.28). In clean catch samples, the AUC was lower for health service laboratories (AUC = 0.75; 95% CI 0.69, 0.80) than the research laboratory (0.86; 0.79, 0.92). Values of AUC were lower in nappy pad samples (0.65 [0.61, 0.70] and 0.79 [0.70, 0.88] for health service and research laboratory positivity, respectively) than clean catch samples. CONCLUSIONS: The agreement of microbiological diagnosis of UTI comparing routine health service laboratories with a research laboratory was moderate for clean catch samples and poor for nappy pad samples and reliability is lower for nappy pad than for clean catch samples. Positive results from the research laboratory appear more likely to reflect real UTIs than those from routine health service laboratories, many of which (particularly from nappy pad samples) could be due to contamination. Health service laboratories should consider adopting procedures used in the research laboratory for paediatric urine samples. Primary care clinicians should try to obtain clean catch samples, even in very young children.

BACKGROUND: Smoking, excessive alcohol consumption, lack of exercise and an unhealthy diet are the key modifiable factors contributing to premature morbidity and mortality in the developed world. Brief interventions in health care consultations can be effective in changing single health behaviours. General Practice holds considerable potential for primary prevention through modifying patients' multiple risk behaviours, but feasible, acceptable and effective interventions are poorly developed, and uptake by practitioners is low. Through a process of theoretical development, modeling and exploratory trials, we have developed an intervention called Behaviour Change Counselling (BCC) derived from Motivational Interviewing (MI). This paper describes the protocol for an evaluation of a training intervention (the Talking Lifestyles Programme) which will enable practitioners to routinely use BCC during consultations for the above four risk behaviours. METHODS/DESIGN: This cluster randomised controlled efficacy trial (RCT) will evaluate the outcomes and costs of this training intervention for General Practitioners (GPs) and nurses. Training methods will include: a practice-based seminar, online self-directed learning, and reflecting on video recorded and simulated consultations. The intervention will be evaluated in 29 practices in Wales, UK; two clinicians will take part (one GP and one nurse) from each practice. In intervention practices both clinicians will receive training. The aim is to recruit 2000 patients into the study with an expected 30% drop out. The primary outcome will be the proportion of patients making changes in one or more of the four behaviours at three months. Results will be compared for patients seeing clinicians trained in BCC with patients seeing non-BCC trained clinicians. Economic and process evaluations will also be conducted. DISCUSSION: Opportunistic engagement by health professionals potentially represents a cost effective medical intervention. This study integrates an existing, innovative intervention method with an innovative training model to enable clinicians to routinely use BCC, providing them with new tools to encourage and support people to make healthier choices. This trial will evaluate effectiveness in primary care and determine costs of the intervention.

Patient-Reported Outcome Measures (PROMs) identify vital information about patient needs and therapeutic progress. This paper outlines the development and validation of the CARe Burn Scale-Adult Form: a PROM that assesses quality of life in adults living with a burn injury. Eleven patients, 10 family members and 4 health professional interviews, and a systematic review informed the development of a conceptual framework and a draft measure. Cognitive debriefing interviews conducted with three adult burn patients, one family member, and eight health professionals provided feedback to ascertain content validity of the measure. The measure was then field tested with 304 adult burn patients. Rasch psychometric analysis was conducted for scale reduction, and traditional psychometric analyses provided a comparison with other measures. Further psychometric testing with an additional 118 adult burn patients tested the shortened CARe Burn Scale in relation to other quality of life PROMs. The conceptual framework outlined 14 domains; 12 of which fulfilled Rasch and traditional psychometric analyses. Two individual scales did not fulfill the Rasch criteria and were retained as checklists. Individual CARe Burn Scales correlated moderately-to-highly with other quality of life scales measuring similar constructs, and had low-to-no correlations with dissimilar constructs and the majority of sociodemographic factors, indicating evidence of concurrent and divergent validity. The CARe Burn Scale-Adult Form can help identify patient needs and provides burns-specialist health professionals with a tool to assess quality of life and therapeutic progress after a burn event and related treatment.

BACKGROUND: There is a trend towards greater patient involvement in healthcare decisions. Although screening is usually perceived as good for the health of the population, there are risks associated with the tests involved. Achieving both adequate involvement of consumers and informed decision making are now seen as important goals for screening programmes. Personalised risk estimates have been shown to be effective methods of risk communication. OBJECTIVES: To assess the effects of personalised risk communication on informed decision making by individuals taking screening tests. We also assess individual components that constitute informed decisions. SEARCH METHODS: Two authors searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2012), MEDLINE (OvidSP), EMBASE (OvidSP), CINAHL (EbscoHOST) and PsycINFO (OvidSP) without language restrictions. We searched from 2006 to March 2012. The date ranges for the previous searches were from 1989 to December 2005 for PsycINFO and from 1985 to December 2005 for other databases. For the original version of this review, we also searched CancerLit  and Science Citation Index (March 2001). We also reviewed the reference lists and conducted citation searches of included studies and other systematic reviews in the field, to identify any studies missed during the initial search. SELECTION CRITERIA: Randomised controlled trials incorporating an intervention with a 'personalised risk communication element' for individuals undergoing screening procedures, and reporting measures of informed decisions and also cognitive, affective, or behavioural outcomes addressing the decision by such individuals, of whether or not to undergo screening. DATA COLLECTION AND ANALYSIS: Two authors independently assessed each included trial for risk of bias, and extracted data. We extracted data about the nature and setting of interventions, and relevant outcome data. We used standard statistical methods to combine data using RevMan version 5, including analysis according to different levels of detail of personalised risk communication, different conditions for screening, and studies based only on high-risk participants rather than people at 'average' risk.  MAIN RESULTS: We included 41 studies involving 28,700 people. Nineteen new studies were identified in this update, adding to the 22 studies included in the previous two iterations of the review. Three studies measured informed decision with regard to the uptake of screening following personalised risk communication as a part of their intervention. All of these three studies were at low risk of bias and there was strong evidence that the interventions enhanced informed decision making, although with heterogeneous results. Overall 45.2% (592/1309) of participants who received personalised risk information made informed choices, compared to 20.2% (229/1135) of participants who received generic risk information. The overall odds ratios (ORs) for informed decision were 4.48 (95% confidence interval (CI) 3.62 to 5.53 for fixed effect) and 3.65 (95% CI 2.13 to 6.23 for random effects). Nine studies measured increase in knowledge, using different scales. All of these studies showed an increase in knowledge with personalised risk communication. In three studies the interventions showed a trend towards more accurate risk perception, but the evidence was of poor quality. Four out of six studies reported non-significant changes in anxiety following personalised risk communication to the participants. Overall there was a small non-significant decrease in the anxiety scores. Most studies (32/41) measured the uptake of screening tests following interventions. Our results (OR 1.15 (95% CI 1.02 to 1.29)) constitute low quality evidence, consistent with a small effect, that personalised risk communication in which a risk score was provided (6 studies) or the participants were given their categorised risk (6 studies), increases uptake of screening tests.  AUTHORS' CONCLUSIONS: There is strong evidence from three trials that personalised risk estimates incorporated within communication interventions for screening programmes enhance informed choices. However the evidence for increasing the uptake of such screening tests with similar interventions is weak, and it is not clear if this increase is associated with informed choices. Studies included a diverse range of screening programmes. Therefore, data from this review do not allow us to draw conclusions about the best interventions to deliver personalised risk communication for enhancing informed decisions. The results are dominated by findings from the topic area of mammography and colorectal cancer. Caution is therefore required in generalising from these results, and particularly for clinical topics other than mammography and colorectal cancer screening.

Background Illicit drug use increases the risk of poor physical and mental health. Few effective school-based drug prevention interventions are available. We adapted an effective school-based peer-led smoking prevention intervention (ASSIST) to deliver information from the UK national drug education website, FRANK Methods We conducted a four-arm pilot cluster-randomised control trial of 1567 students aged 12–13 years in 12 schools in Wales. Three schools each (mean number students per year 131) were randomly allocated to: ASSIST+FRANK, FRANK friends, ASSIST, or usual practice which may or may not include drug eduation. ASSIST+FRANK is a peer-led smoking prevention intervention in UK Year 8 (ASSIST) followed by a drug prevention adjunct in Year 9 (+FRANK). FRANK friends is a stand-alone peer-led drug prevention intervention in Year 9. ASSIST involves 2 days off-site training, plus four follow-up sessions. +FRANK involves 1 day off-site training plus 3 follow-ups. FRANK friends involves 2 days off-site training and four follow-ups. Influential students were trained to disseminate information on the risks of drug use and minimising harms. Primary outcome was the acceptability of the +FRANK and FRANK friends, which was assessed through interviews with students, staff, parents, and intervention staff (n=66), structured observations of delivery (195), exploratory effectiveness analysis (multilevel logistic models), and estimated costs. Secondary outcome was the lifetime use of any illicit drugs at 18 months. Intention-to-treat analyses were conducted unmasked to the intervention allocation. This trial was approved by Cardiff University School of Social Sciences Research Ethics Committee (SREC/ 1103; ISRCTN 14415936). Findings All 12 schools were recruited, randomised, and retained (ASSIST+FRANK 419 students, FRANK friends 440, ASSIST 347, usual practice 361). At the 18 month follow-up the student retention rate was 93% (1460/1567). +FRANK and FRANK friends were acceptable to students, teachers, and parents, and delivered as intended, but FRANK friends was preferred over +FRANK. Some staff felt pressured to meet all the learning objectives for +FRANK in 1 day training versus 2 days in FRANK friends. There could also have been a lack of novelty for +FRANK peer supporters since they had previously experienced the ASSIST intervention. The odds of lifetime drug use at 18 months was marginally lower in both the +FRANK arm and the FRANK friends arm than in the usual practice arm (38 [12·4%] of 307 vs 34 [13·4%] of 254 [odds ratio 0·96, 95% CI 0·58–1·59] and 30 [9·3%] vs 34 [13·4%] [0·70, 0·39–1·24], respectively). The estimated cost per school was £1942 for +FRANK and £3041 for FRANK friends. All progression criteria were met. Interpretation Although both interventions were acceptable to students, teachers, and parents, FRANK friends was preferred over +FRANK. There is, therefore, sufficient evidence to warrant a full-scale cluster-randomised controlled trial of FRANK friends. Funding National Institute for Health Research Public Health Research programme (for the research), Public Health Wales (for the intervention delivery).

BACKGROUND: There is good evidence that trauma-focused therapies for Post-Traumatic Stress Disorder are effective. However, they are not always feasible to deliver due a shortage of trained therapists and demands on the patient. An online trauma-focused Guided Self-Help (GSH) programme which could overcome these barriers has shown promise in a pilot study. This study will be the first to evaluate GSH against standard face-to-face therapy to assess its suitability for use in the NHS. METHODS: The study is a large-scale multi-centre pragmatic randomised controlled non-inferiority trial, with assessors masked to treatment allocation. One hundred and ninety-two participants will be randomly allocated to receive either face-to-face trauma-focused cognitive behaviour therapy (TFCBT) or trauma-focused online guided self-help (GSH). The primary outcome will be the severity of symptoms of PTSD over the previous week as measured by the Clinician Administered PTSD Scale for DSM5 (CAPS-5) at 16 weeks post-randomisation. Secondary outcome measures include PTSD symptoms over the previous month as measured by the CAPS-5 at 52 weeks plus the Impact of Event Scale - revised (IES-R), Work and Social Adjustment Scale (WSAS), Patient Health Questionnaire-9 (PHQ-9), General Anxiety Disorder-7 (GAD-7), Alcohol Use Disorders Test (AUDIT-O), Multidimensional Scale for Perceived Social Support (MSPSS), short Post-Traumatic Cognitions Inventory (PTCI), Insomnia Severity Index (ISI) and General Self Efficacy Scale (GSES) measured at 16 and 52 weeks post-randomisation. Changes in health-related quality of life will be measured by the EQ-5D and the level of healthcare resource utilisation for health economic analysis will be determined by an amended version of the Client Socio-Demographic and Service Receipt Inventory European Version. The Client Satisfaction Questionnaire (CSQ) will be collected at 16 weeks post-randomisation to evaluate treatment satisfaction. DISCUSSION: This study will be the first to compare online GSH with usual face-to-face therapy for PTSD. The strengths are that it will test a rigorously developed intervention in a real world setting to inform NHS commissioning. The potential challenges of delivering such a pragmatic study may include participant recruitment, retention and adherence, therapist retention, and fidelity of intervention delivery. TRIAL REGISTRATION: ISRCTN13697710 registered on 20/12/2016.

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BACKGROUND: Despite policy interest, an ethical imperative, and evidence of the benefits of patient decision support tools, the adoption of shared decision making (SDM) in day-to-day clinical practice remains slow and is inhibited by barriers that include culture and attitudes; resources and time pressures. Patient decision support tools often require high levels of health and computer literacy. Option Grids are one-page evidence-based summaries of the available condition-specific treatment options, listing patients' frequently asked questions. They are designed to be sufficiently brief and accessible enough to support a better dialogue between patients and clinicians during routine consultations. This paper describes a study to assess whether an Option Grid for osteoarthritis of the knee (OA of the knee) facilitates SDM, and explores the use of Option Grids by patients disadvantaged by language or poor health literacy. METHODS/DESIGN: This will be a stepped wedge exploratory trial involving 72 patients with OA of the knee referred from primary medical care to a specialist musculoskeletal service in Oldham. Six physiotherapists will sequentially join the trial and consult with six patients using usual care procedures. After a period of brief training in using the Option Grid, the same six physiotherapists will consult with six further patients using an Option Grid in the consultation. The primary outcome will be efficacy of the Option Grid in facilitating SDM as measured by observational scores using the OPTION scale. Comparisons will be made between patients who have received the Option Grid and those who received usual care. A Decision Quality Measure (DQM) will assess quality of decision making. The health literacy of patients will be measured using the REALM-R instrument. Consultations will be observed and audio-recorded. Interviews will be conducted with the physiotherapists, patients and any interpreters present to explore their views of using the Option Grid. DISCUSSION: Option Grids offer a potential solution to the barriers to implementing traditional decision aids into routine clinical practice. The study will assess whether Option Grids can facilitate SDM in day-to-day clinical practice and explore their use with patients disadvantaged by language or poor health literacy. TRIAL REGISTRATION: Current Controlled Trials ISRCTN94871417.

BACKGROUND: Pain after major lower limb amputation for peripheral arterial disease (PAD) is a significant problem. A perineural catheter (PNC) can be placed adjacent to the major nerve at the time of amputation with a continuous local anaesthetic infusion given postoperatively to try and reduce pain. Although low-quality observational data suggest that PNC usage reduces postoperative opioid requirements, there are limited data regarding its effect on pain. The aim of PLACEMENT is to explore the feasibility of running an effectiveness trial to assess the impact of a PNC with continuous local anaesthetic infusion, inserted at the time of amputation, on short and medium-term postoperative outcomes. METHODS/DESIGN: Fifty patients undergoing a major lower limb amputation (below or above the knee) for PAD will be recruited from two centres. Patients will be randomised in a 1:1 ratio to receive standard postoperative analgesia, with or without insertion of a PNC and local anaesthetic infusion for the first 5 postoperative days. Outcome data will be captured for the first 5 days, including pain scores (primary outcome, captured three times a day), opioid use, nausea or vomiting, itching, dizziness and complications. Patients will be contacted 2 and 6 months after surgery to assess quality of life, phantom limb pain, chronic stump pain and total healthcare costs. Semi-structured interviews will be conducted with at least 10 patients (dependent on saturation of analytic themes on preliminary coding) purposefully sampled to achieve variation in site and study arm. Interviews will explore patients' perception of post-amputation pain and its treatment, and experience of study processes. Semi-structured interviews with 5-10 health professionals will explore feasibility, fidelity, and acceptability of the study. Data from this pilot will be used to assess feasibility of, and estimate parameters to calculate the sample size for an effectiveness trial. Full ethical approval has been granted (Wales Research Ethics Committee 3 reference number 16/WA/0353). DISCUSSION: PLACEMENT will be the first study to explore the feasibility of running an effectiveness trial on PNC usage for postoperative pain in amputees, and provide parameters to calculate the appropriate sample size for this study. TRIAL REGISTRATION: ISRCTN.com, ISRCTN85710690 . Registered on 21 October 2016. European Clinical Trials Database (EudraCT), 2016-003544-37. Registered on 24 August 2016.

ABSTRACT

Objective: To evaluate whether introducing tools, specifically designed for use in clinical encounters, namely Option Grids, into a clinical practice setting leads to higher levels of shared decision making. Methods: A stepped wedge trial design where 6 physiotherapists at an interface clinic in Oldham, UK, were sequentially instructed in how to use an Option Grid for osteoarthritis of the knee. Patients with suspected or confirmed osteoarthritis of the knee were recruited, six per clinician prior to instruction, and six per clinician afterwards. We measured shared decision making, patient knowledge, and readiness to decide. Results: A total of 72 patients were recruited; 36 were allocated to the intervention group. There was an 8.4 point (95% CI 4.4 to 12.2) increase in the Observer OPTION score (range 0-100) in the intervention group. The mean gain in knowledge was 0.9 points (score range 0-5, 95% CI, 0.3 to 1.5). There was no increase in encounter duration. Conclusion: Shared decision making increased when clinicians used the knee osteoarthritis Option Grid. Practice Implications: Tools designed to support collaboration and deliberation about treatment options lead to increased levels of shared decision making.

A PROM is a measure of patient needs and therapeutic progress. This paper outlines the validation of the CARe Burn Scale: Parent/Caregiver Form, a PROM that measures quality of life in parents/caregivers supporting a child with a burn injury. A literature review and interviews with sixteen parents and six burns health professionals informed the development of the PROM conceptual framework/draft form. Cognitive debriefing interviews with five parents and seven burns-specialist health professionals provided feedback to ascertain content validity, and two-hundred and four parents/caregivers took part in the field testing. Rasch measurement theory (RMT) analyses and internal consistency tests were conducted to create a shortened version and for psychometric validation. The final conceptual framework included eight domains/individual scales: Physical Well-being, Confidence with Managing Burn Wound/Scar Treatments, Social Situations, Partner Relationship, Self-worth, Negative Mood, Parent Concerns about the Appearance of their Child’s Burn Wounds/Scars, and Positive Growth. Seven scales had solutions from RMT analyses and passed internal consistency criteria. Confidence with Managing Burn Wound/Scar Treatments did not fit the Rasch model but was retained as a checklist based on theoretical insight. The CARe Burn Scale: Parent/Caregiver Form is the first and only burn-specific PROM that assesses parents’ own health needs when caring for a child with a burn.

Patient-reported outcomes collected in THESEUS study can be used to estimate a minimal important difference of 1 for a current pain numeric rating scale in a sample of patients with hidradenitis suppurativa.

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Background

Guided self-help has been shown to be effective for other mental conditions and, if effective for post-traumatic stress disorder, would offer a time-efficient and accessible treatment option, with the potential to reduce waiting times and costs.

Background: Ulceration is a recognized risk factor for surgical site infection (SSI); however, the proportion of patients developing SSI after excision of an ulcerated skin cancer is unknown. Aim: To determine the proportion of participants with SSI after surgical excision of an ulcerated skin cancer. A secondary aim was to assess feasibility outcomes to inform the design of a randomized controlled trial to investigate the benefits and harms of perioperative antibiotics following excision of ulcerated tumours. Methods: This was a multicentre, prospective, observational study of patients undergoing excision of an ulcerated skin cancer between March 2019 and March 2020. Prior to surgical excision, surface swabs of the ulcerated tumours of participants recruited from one centre were undertaken to determine organism growth. At 4 weeks after surgery, all participants were e-mailed or posted the Wound Healing Questionnaire (WHQ) to determine whether they had developed SSI. Results: In total, 148 participants were recruited 105 (70.9%) males; mean ± SD age 77.1 ± 12.3 years. Primary outcome data were available for 116 (78.4%) participants, of whom 35 (30.2%) were identified as having an SSI using the WHQ with a cutoff score of 8, and 47 (40.5%) were identified with a cutoff score of 6. Using the modified WHQ in participants with wounds left to heal by secondary intention, 33 (28.4%) and 43 (37.1%) were identified to have SSI respectively. Conclusion: This prospective evaluation of SSI identified with the WHQ following excision of ulcerated skin cancers demonstrated a high proportion with SSI. The WHQ was acceptable to patients; however, further evaluation is required to ensure validity in assessing skin wounds.

The CARe Burn Scales are a portfolio of burn-specific PROMs for people affected by burns, including a Child Form (for children < 8 years (parent-proxy)), a Young Person Form (for young people aged 8–17 years), an Adult Form, and a Parent Form (for parents/carers of children aged 0–17 years). This study aimed to determine the responsiveness and minimal important difference (MID) values of the three scales developed for use in paediatric burn services and research. Participants were recruited by 15 UK Burn Services. Participants completed the appropriate CARe Burn Scale and a set of appropriate comparison validated measures, at three time points: 4 weeks (T1), 3 months (T2) and 6 months (T3) post-burn injury. Spearman’s correlation analysis and effect sizes based on Cohen’s d thresholds were reported and MID values were calculated. At baseline, 250 participants completed the Child Form, 69 completed the Young Person Form, and 320 completed the Parent Form. A total of 85–92% of participants were retained at follow up. The tested CARe Burn Scales were all responsive to change over time. MID values were created for all subscales and ranged from 2 to 11 for the Child Form, 3 to 14 for the Young Person Form and 3 to 10 for the Parent Form. The CARe Burn Scales for children, young people and parents are responsive to change over time. The scales are freely available for clinical and research use.

Abstract

Abstract

Objective: To educate and discuss pain mechanisms (nociceptive, neuropathic, nociplastic) illuminating its possible impact when measuring different outcomes, which may modify, confound and potentially bias the outcome measures applied across various aspects of Rheumatic Musculoskeletal Diseases (RMDs) clinical trials. Methods: In the plenary presentations, PM lectured on different pain mechanisms and impact on disease activity assessment. Data from two data sets of RMDs patients, which assessed the prevalence and impact of nociplastic pain were presented and reviewed. Audience breakout group sessions and polling were conducted. Results: Mixed pain etiologies may differentially influence disease activity assessment and therapeutic decision-making. Polling demonstrated a consensus on the need to assess different types of pain as a phenotype, as it constitutes an important contextual factor (a variable that is not an outcome of the trial, but needs to be recognized [and measured] to understand the study results), and to standardize across RMDs. Conclusion: There is need for a standardized pain measure that can differentiate underlying pain mechanisms.

Abstract