Multiple hospital organisational factors are associated with adverse patient outcomes post-hip fracture in England and Wales: the REDUCE record-linkage cohort study.

OBJECTIVES: Despite established standards and guidelines, substantial variation remains in the delivery of hip fracture care across the United Kingdom. We aimed to determine which hospital-level organisational factors predict adverse patient outcomes in the months following hip fracture. METHODS: We examined a national record-linkage cohort of 178,757 patients aged ≥60 years who sustained a hip fracture in England and Wales in 2016-19. Patient-level hospital admissions datasets, National Hip Fracture Database and mortality data were linked to metrics from 18 hospital-level organisational-level audits and reports. Multilevel models identified organisational factors, independent of patient case-mix, associated with three patient outcomes: length of hospital stay (LOS), 30-day all-cause mortality and emergency 30-day readmission. RESULTS: Across hospitals mean LOS ranged from 12 to 41.9 days, mean 30-day mortality from 3.7 to 10.4% and mean readmission rates from 3.7 to 30.3%, overall means were 21.4 days, 7.3% and 15.3%, respectively. In all, 22 organisational factors were independently associated with LOS; e.g. a hospital's ability to mobilise >90% of patients promptly after surgery predicted a 2-day shorter LOS (95% confidence interval [CI]: 1.2-2.6). Ten organisational factors were independently associated with 30-day mortality; e.g. discussion of patient experience feedback at clinical governance meetings and provision of prompt surgery to >80% of patients were each associated with 10% lower mortality (95%CI: 5-15%). Nine organisational factors were independently associated with readmissions; e.g. readmissions were 17% lower if hospitals reported how soon community therapy would start after discharge (95%CI: 9-24%). CONCLUSIONS: Receipt of hip fracture care should be reliable and equitable across the country. We have identified multiple, potentially modifiable, organisational factors associated with important patient outcomes following hip fracture.

The effectiveness of non-pharmacological sleep interventions for people with chronic pain: a systematic review and meta-analysis.

OBJECTIVE: About two thirds of people with chronic pain report problems sleeping. We aimed to evaluate the effectiveness of non-pharmacological sleep interventions for improving sleep in people with chronic pain. DESIGN: We conducted a systematic review of non-pharmacological and non-invasive interventions to improve sleep quality or duration for adults with chronic non-cancer pain evaluated in a randomised controlled trial. Our primary outcome of interest was sleep; secondary outcomes included pain, health-related quality of life, and psychological wellbeing. We searched the Cochrane Library, MEDLINE, Embase, PsycINFO and CINAHL from inception to April 2020. After screening, two reviewers evaluated articles and extracted data. Meta-analysis was conducted using a random effects model. Risk of bias was assessed with the Cochrane tool. RESULTS: We included 42 trials involving 3346 people randomised to 94 groups, of which 56 received an intervention targeting sleep. 10 studies were of fair and 32 of good methodological quality. Overall risk of bias was judged to be low in 11, high in 10 and unclear in 21 studies. In 9 studies with 385 people randomised, cognitive behavioural therapy for insomnia showed benefit post-treatment compared with controls for improved sleep quality, standardised mean difference - 1.23 (95%CI -1.76, - 0.70; p < 0.00001). The effect size was only slightly reduced in meta-analysis of 3 studies at low risk of bias. The difference between groups was lower at 3 and 6 months after treatment but still favoured cognitive behavioural therapy for insomnia. Pain, anxiety and depression were reduced post-treatment, but evidence of longer term benefit was lacking. There was no evidence that sleep hygiene interventions were effective in improving sleep and there was some evidence in comparative studies to suggest that cognitive behavioural therapy for insomnia was more effective than sleep hygiene. Numerous other interventions were evaluated in small numbers of studies, but evidence was insufficient to draw conclusions about effectiveness. CONCLUSIONS: Cognitive behavioural therapy for insomnia is an effective treatment to improve sleep for people with chronic pain, but further high-quality primary research is required to explore combined CBT content that will ensure additional improvements to pain, quality of life and psychological health and longer-term maintenance of benefits. Primary research is also needed to evaluate the effectiveness of interventions for which insufficient evidence exists. TRIAL REGISTRATION: PROSPERO registration number: CRD42019093799 .

Development of a Core Outcome Set for Clinical Effectiveness Trials in Esophageal Cancer Resection Surgery.

OBJECTIVE: Development of a core outcome set (COS) for clinical effectiveness trials in esophageal cancer resection surgery. BACKGROUND: Inconsistency and heterogeneity in outcome reporting after esophageal cancer resection surgery hampers comparison of trial results and undermines evidence synthesis. COSs provide an evidence-based approach to these challenges. METHODS: A long list of clinical and patient-reported outcomes was identified and categorized into outcome domains. Domains were operationalized into a questionnaire and patients and health professionals rated the importance of items from 1 (not important) to 9 (extremely important) in 2 Delphi survey rounds. Retained items were discussed at a consensus meeting and a final COS proposed. Professionals were surveyed to request endorsement of the COS. RESULTS: A total of 68 outcome domains were identified and operationalized into a questionnaire; 116 (91%) of consenting patients and 72 (77%) of health professionals completed round 1. Round 2 response rates remained high (87% patients, 93% professionals). Rounds 1 and 2 prioritized 43 and 19 items, respectively. Retained items were discussed at a patient consensus meeting and a final 10-item COS proposed, endorsed by 61/67 (91%) professionals and including: overall survival; in-hospital mortality; inoperability; need for another operation; respiratory complications; conduit necrosis and anastomotic leak; severe nutritional problems; ability to eat/drink; problems with acid indigestion or heartburn; and overall quality of life. CONCLUSIONS: The COS is recommended for all pragmatic clinical effectiveness trials in esophageal cancer resection surgery. Further work is needed to delineate the definitions and parameters and explore best methods for measuring the individual outcomes.

What are important outcomes of bariatric surgery? An in-depth analysis to inform the development of a core outcome set and a comparison between the views of surgeons and other health professionals (the BARIACT study).

BACKGROUND: Outcome reporting in bariatric surgery needs uniformity. A core outcome set is an agreed minimum set of outcomes reported in all studies of a particular condition, but members of the bariatric multidisciplinary team might value outcomes differently. The aim of this study was to summarise existing outcome reporting in bariatric surgery, to inform the development of a core outcome set, and to compare outcomes selected as important by type of health professional. METHODS: Outcomes reported in randomised controlled trials (RCTs) and large non-randomised studies, identified by a systematic review, were listed verbatim. Frequency of outcome reporting and uniformity of definition were assessed. A questionnaire to rate the importance of each outcome was completed by members of the bariatric multidisciplinary team. Responses to each item were scored as 1 (not essential) to 9 (absolutely essential). We ranked outcomes according to percentage deemed important (7-9) and according to respondents by type of health professional. FINDINGS: We identified 1088 individual outcomes from 90 studies (39 RCTs), grouped them into health domains, and presented them as a questionnaire with 131 items to 489 multidisciplinary team members. Most outcomes (n=920, 85%) were reported only once. The largest outcome domain was surgical complications, and 432 outcomes (42%) corresponded to an adverse event. Only a quarter of outcomes (n=461) were defined, and were often contradictory. For questionnaire responders (n=164, response rate 33·5%), most were surgeons (n=80, 48·8%), followed by dietitians (n=31, 18·9%), nurses (n=24, 14·6%), physicians (n=12, 7·3%), and others (n=16, 9·9%). Improvement in diabetes was the top outcome for all health professionals. Seven of the surgeon's top ten outcomes were adverse events, compared with three for other health professionals. Groups valued a measure of weight differently (third vs 15th for other health professionals and surgeons, respectively). INTERPRETATION: This study shows that the assessment of bariatric surgery focuses largely on adverse events and resolution of comorbidity, but that reporting is inconsistent and ill-defined. Substantial variation between the views of surgeons and those of other health professionals was evident. The next step is to provide feedback to participants and to survey their views again before a final consensus meeting to produce a core outcome set for the Benefits and Adverse events in BARIAtric surgery Clinical Trials (BARIACT) as a solution to this problem. FUNDING: National Institute for Health Research (NIHR), and the NIHR Health Technology Assessment programme. This work was also undertaken with the support of the MRC ConDuCT-II Hub (Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures, MR/K025643/1).

Quality of patient-reported outcome reporting across cancer randomized controlled trials according to the CONSORT patient-reported outcome extension: A pooled analysis of 557 trials.

BACKGROUND: The main objectives of this study were to identify the number of randomized controlled trials (RCTs) including a patient-reported outcome (PRO) endpoint across a wide range of cancer specialties and to evaluate the completeness of PRO reporting according to the Consolidated Standards of Reporting Trials (CONSORT) PRO extension. METHODS: RCTs with a PRO endpoint that had been performed across several cancer specialties and published between 2004 and 2013 were considered. Studies were evaluated on the basis of previously defined criteria, including the CONSORT PRO extension and the Cochrane Collaboration's tool for assessing the risk of bias of RCTs. Analyses were also conducted by the type of PRO endpoint (primary vs secondary) and by the cancer disease site. RESULTS: A total of 56,696 potentially eligible records were scrutinized, and 557 RCTs with a PRO evaluation, enrolling 254,677 patients overall, were identified. PROs were most frequently used in RCTs of breast (n = 123), lung (n = 85), and colorectal cancer (n = 66). Overall, PROs were secondary endpoints in 421 RCTs (76%). Four of 6 evaluated CONSORT PRO items were documented in less than 50% of the RCTs. The level of reporting was higher in RCTs with a PRO as a primary endpoint. The presence of a supplementary report was the only statistically significant factor associated with greater completeness of reporting for both RCTs with PROs as primary endpoints (ß = .19, P = .001) and RCTs with PROs as secondary endpoints (ß = .30, P < .001). CONCLUSIONS: Implementation of the CONSORT PRO extension is equally important across all cancer specialties. Its use can also contribute to revealing the robust PRO design of some studies, which might be obscured by poor outcome reporting.

Overcoming barriers to the implementation of patient-reported outcomes in cancer clinical trials: the PROMOTION Registry.

Every cancer treatment, irrespective of its clinical effectiveness, has an impact on patients' quality of life (QoL). Even recently developed targeted therapies might have side effects and significantly impact patients' QoL. Thus, understanding the advantages and disadvantages of different treatments from the patient's standpoint has become a must in clinical research and is highly valued by major stakeholders. Thousands of cancer patients are enrolled into randomized controlled trials (RCTs) each year and many complete patient-reported outcome (PRO) instruments to obtain patient-centered information as part of the assessment of the overall effectiveness of the new therapy. Some of these RCTs have generated high quality PRO evidence forming the basis for approval (or support to approval) of drugs by the US Food and Drug Administration. However, a consistent strategy to determine the quality of patient centered evidence presented in RCTs has until recently been lacking. One of the fundamental questions when including PROs in clinical research revolves around methodological robustness and consistency of outcome reporting. Cancer patients, physicians and healthcare system stakeholders need to rely on solid information to make the best possible choice regarding treatment. Therefore generating high-quality findings from PRO assessment in cancer trials is of paramount importance. In an effort to improve quality of PRO assessment and reporting in the near future, the Patient-Reported Outcome Measurements Over Time In ONcology (PROMOTION) Registry was developed. The scope of this Registry is to identify, track, analyse, and store information on all cancer RCTs that have included PROs, and assess the quality of their PRO assessments.

REST: a preoperative tailored sleep intervention for patients undergoing total knee replacement - feasibility study for a randomised controlled trial.

OBJECTIVES: To test the feasibility of a randomised controlled trial (RCT) of a novel preoperative tailored sleep intervention for patients undergoing total knee replacement. DESIGN: Feasibility two-arm two-centre RCT using 1:1 randomisation with an embedded qualitative study. SETTING: Two National Health Service (NHS) secondary care hospitals in England and Wales. PARTICIPANTS: Preoperative adult patients identified from total knee replacement waiting lists with disturbed sleep, defined as a score of 0-28 on the Sleep Condition Indicator questionnaire. INTERVENTION: The REST intervention is a preoperative tailored sleep assessment and behavioural intervention package delivered by an Extended Scope Practitioner (ESP), with a follow-up phone call 4 weeks postintervention. All participants received usual care as provided by the participating NHS hospitals. OUTCOME MEASURES: The primary aim was to assess the feasibility of conducting a full trial. Patient-reported outcomes were assessed at baseline, 1-week presurgery, and 3 months postsurgery. Data collected to determine feasibility included the number of eligible patients, recruitment rates and intervention adherence. Qualitative work explored the acceptability of the study processes and intervention delivery through interviews with ESPs and patients. RESULTS: Screening packs were posted to 378 patients and 57 patients were randomised. Of those randomised, 20 had surgery within the study timelines. An appointment was attended by 25/28 (89%) of participants randomised to the intervention. Follow-up outcomes measures were completed by 40/57 (70%) of participants presurgery and 15/57 (26%) postsurgery. Where outcome measures were completed, data completion rates were 80% or higher for outcomes at all time points, apart from the painDETECT: 86% complete at baseline, 72% at presurgery and 67% postsurgery. Interviews indicated that most participants found the study processes and intervention acceptable. CONCLUSIONS: This feasibility study has demonstrated that with some amendments to processes and design, an RCT to evaluate the clinical and cost-effectiveness of the REST intervention is feasible. TRIAL REGISTRATION NUMBER: ISRCTN14233189.

The Importance of Sleep for People With Chronic Pain: Current Insights and Evidence.

We are currently in the midst of a sleep crisis. Our current work and lifestyle environments are normalizing poor sleep with substantial negative impact on our health. Research on sleep has linked sleep deprivation to poorer mental health, obesity, cancer, diabetes, heart disease, and a myriad of other health conditions. Sleep deprivation is an even greater issues for people with musculoskeletal conditions and chronic pain. Between 67% and 88% of individuals with chronic pain experience sleep disruption and insomnia, and at least 50% of people with insomnia report chronic pain. The link between sleep and pain is well documented. Experimental, cohort, and longitudinal studies have all demonstrated that restricted sleep is linked to greater pain. Poor sleep therefore not only affects general health but has a direct impact on inflammation, pain response, and experience. Improving sleep in people living with musculoskeletal conditions and with chronic pain has the potential to deliver great benefit to many. This article describes the evidence base that can underpin such work, including research about the link between pain and sleep as well as theories and approaches to intervention that may help. © 2022 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

A Smartphone App for Supporting the Self-management of Daytime Urinary Incontinence in Adolescents: Development and Formative Evaluation Study of URApp.

BACKGROUND: Daytime urinary incontinence (UI) is common in childhood and often persists into adolescence. UI in adolescence is associated with a range of adverse outcomes, including depressive symptoms, peer victimization, poor self-image, and problems with peer relationships. The first-line conservative treatment for UI is bladder training (standard urotherapy) that aims to establish a regular fluid intake and a timed schedule for toilet visits. The success of bladder training is strongly dependent on good concordance, which can be challenging for young people. OBJECTIVE: This paper aims to describe the development of a smartphone app (URApp) that aims to improve concordance with bladder training in young people aged 11 to 19 years. METHODS: URApp was designed by using participatory co-design methods and was guided by the person-based approach to intervention design. The core app functions were based on clinical guidance and included setting a daily drinking goal that records fluid intake and toilet visits, setting reminders to drink fluids and go to the toilet, and recording progress toward drinking goals. The development of URApp comprised the following four stages: a review of current smartphone apps for UI, participatory co-design workshops with young people with UI for gathering user requirements and developing wireframes, the development of a URApp prototype, and the user testing of the prototype through qualitative interviews with 23 young people with UI or urgency aged 10 to 19 years and 8 clinicians. The app functions and additional functionalities for supporting concordance and behavior change were iteratively optimized throughout the app development process. RESULTS: Young people who tested URApp judged it to be a helpful way of supporting their concordance with a timed schedule for toilet visits and drinking. They reported high levels of acceptability and engagement. Preliminary findings indicated that some young people experienced improvements in their bladder symptoms, including a reduction in UI. Clinicians reported that URApp was clinically appropriate and aligned with the best practice guidelines for bladder training. URApp was deemed age appropriate, with all clinicians reporting that they would use it within their own clinics. Clinicians felt URApp would be of particular benefit to patients whose symptoms were not improving or those who were not engaging with their treatment plans. CONCLUSIONS: The next stage is to evaluate URApp in a range of settings, including pediatric continence clinics, primary care, and schools. This research is needed to test whether URApp is an effective (and cost-effective) solution for improving concordance with bladder training, reducing bladder symptoms, and improving the quality of life.

REducing unwarranted variation in the Delivery of high qUality hip fraCture services in England and Wales (REDUCE): protocol for a mixed-methods study.

INTRODUCTION: Substantial variation in the delivery of hip fracture care, and patient outcomes persists between hospitals, despite established UK national standards and guidelines. Patients' outcomes are partly explained by patient-level risk factors, but it is hypothesised that organisational-level factors account for the persistence of unwarranted variation in outcomes. The mixed-methods REducing unwarranted variation in the Delivery of high qUality hip fraCture services in England and Wales (REDUCE) study, aims to determine key organisational factors to target to improve patient care. METHODS AND ANALYSIS: Quantitative analysis will assess the outcomes of patients treated at 172 hospitals in England and Wales (2016-2019) using National Hip Fracture Database data combined with English Hospital Episodes Statistics; Patient Episode Database for Wales; Civil Registration (deaths) and multiple organisational-level audits to characterise each service provider. Statistical analyses will identify which organisational factors explain variation in patient outcomes, and typify care pathways with high-quality consistent patient outcomes. Documentary analysis of 20 anonymised British Orthopaedic Association hospital-initiated peer-review reports, and qualitative interviews with staff from four diverse UK hospitals providing hip fracture care, will identify barriers and facilitators to care delivery. The COVID-19 pandemic has posed a major challenge to the resilience of services and interviews will explore strategies used to adapt and innovate. This system-wide understanding will inform the development, in partnership with key national stakeholders, of an 'Implementation Toolkit' to inform and improve commissioning and delivery of hip fracture services. ETHICS AND DISSEMINATION: This study was approved: quantitative study by London, City and East Research Ethics Committee (20/LO/0101); and qualitative study by Faculty of Health Sciences University of Bristol Research Ethics Committee (Ref: 108284), National Health Service (NHS) Health Research Authority (20/HRA/71) and each NHS Trust provided Research and Development approval. Findings will be disseminated through scientific conferences, peer-reviewed journals and online workshops.

Fibromyalgia Self-Management: Mapping the behaviour change techniques used in a practice-based programme.

BACKGROUND: Fibromyalgia (FM) is a complex long-term condition associated with pain, fatigue and concentration difficulties. There is limited robust evidence for the effectiveness of pharmacological treatments for FM, with current guidelines recommending nonpharmacological interventions. The clinically developed Fibromyalgia Self-Management Programme (FSMP) is a nonpharmacological, multidisciplinary education group intervention. The FSMP aims to provide condition-specific, patient-centred education and exercise advice, supporting the development of core self-management skills. This research aimed to map the FSMP to a recommended behaviour change taxonomy (BCT). METHODS: Non-participatory observations of the 4- and 6-week FSMP were conducted. Detailed notes on the content of the course, therapist delivery and any additional content not included in the manual were recorded. Subsequently, semistructured interviews were conducted with both therapists (n = 4) and patients (n = 9). Observation and a review of the FSMP manual data were deductively coded to the BCT. Interview data were added to the framework. RESULTS: The review of the FSMP manual and observations of the course showed that the programme coded onto 12 of the 16 BCT domains, encompassing 22 behaviour change techniques. Both patient and therapist interviews indicated that patients made positive changes, including increased activity levels, pacing, better quality sleep and improved communication with family members. Patients reported improvements to symptoms as a result of attending the course. CONCLUSIONS: The FSMP utilises a range of behaviour change techniques. Patients who attend the course feel supported to make changes to their behaviour, enabling them to manage their symptoms more effectively.

Effectiveness and reporting standards of psychological interventions for improving short-term and long-term pain outcomes after total knee replacement: a systematic review.

OBJECTIVES: To assess the effectiveness and reporting standards of psychological interventions for improving outcomes after total knee replacement (TKR). DESIGN: Medline, Embase, and PsycINFO were searched from inception to up to 9 May 2019 with no language restrictions applied. Randomised controlled trials (RCTs) assessing the effectiveness of psychological interventions for short-term and long-term postoperative pain after TKR were included. Screening, data extraction, and assessment of methodological quality were performed in duplicate by two reviewers. The primary effectiveness outcome was postoperative pain severity and the primary harm outcome was serious adverse events. Secondary outcomes included function, quality of life, and psychological well-being. Reporting standards were assessed using the Template for Intervention Description and Replication (TIDieR) checklist for intervention reporting. RESULTS: 12 RCTs were included, with a total of 1299 participants. Psychological interventions comprised music therapy (five studies), guided imagery and music (one study), hypnosis (one study), progressive muscle relaxation with biofeedback (one study), pain coping skills programme (one study), cognitive-behavioural therapy (two studies), and a postoperative management programme (one study). Due to the high heterogeneity of interventions and poor reporting of harms data, it was not possible to make any definitive statements about the overall effectiveness or safety of psychology interventions for pain outcomes after TKR. CONCLUSION: Further evidence about the effectiveness of psychological interventions for improving pain outcomes after TKR is needed. The reporting of harm outcomes and intervention fidelity is currently poor and could be improved. Future work exploring the impact of intervention timing on effectiveness and whether different psychological approaches are needed to address acute postoperative pain and chronic postoperative pain would be of benefit. PROSPERO REGISTRATION NUMBER: CRD42018095100.

Left behind and left out: The impact of the school environment on young people with continence problems.

OBJECTIVES: To explore the impact of the secondary school environment on young people with continence problems. DESIGN: In-depth qualitative semi-structured interviews. METHODS: We interviewed 20 young people aged 11-19 years (11 female and nine male) with continence problems (daytime wetting, bedwetting, and/or soiling). Interviews were conducted by Skype (n = 11) and telephone (n = 9). Transcripts were analysed using inductive thematic analysis. RESULTS: We generated five main themes: (1) Boundaries of disclosure: friends and teachers; (2) Social consequences of avoidance and deceit; (3) Strict and oblivious gatekeepers; (4) Intimate actions in public spaces; and (5) Interrupted learning. CONCLUSION: Disclosure of continence problems at school to both friends and teachers was rare, due to the perceived stigma and fears of bullying and social isolation. The lack of disclosure to teachers and other school staff, such as pastoral care staff, creates challenges in how best to support these young people. Young people with continence problems require unrestricted access to private and adequate toilet facilities during the school day. There is a need for inclusive toilet access policies and improved toilet standards in schools. Addressing the challenges faced by young people with continence problems at school could help to remove the barriers to successful self-management of their symptoms. It is particularly concerning that young people with continence problems are at higher risk of academic underachievement. Increased support at school is needed to enable young people with continence problems to achieve their academic potential. Statement of Contribution What is already known on this subject? Continence problems are among the most common paediatric health problems Self-management of continence problems requires a structured schedule of fluid intake and bladder emptying Inadequate toilet facilities and restricted access make it difficult for young people to manage their incontinence What does this study add? Improvement is needed in teacher understanding of the needs of young people with continence problems Young people are reluctant to disclose continence problems due to perceived stigma and fear of social isolation Young people with continence problems may be at increased risk of academic underachievement.

'What does that mean?': a qualitative exploration of the primary and secondary clinical care experiences of young people with continence problems in the UK.

OBJECTIVES: To explore the clinical care experiences of young people with continence problems. DESIGN: In-depth semistructured qualitative interviews were conducted by Skype and telephone, with the addition of art-based participatory research techniques. Transcripts were analysed using inductive thematic analysis. SETTING: Primary and secondary care in the UK. PARTICIPANTS: We interviewed 20 participants (9 females, 11 males) aged 11-20 years. There were six participants with bedwetting alone, five with daytime wetting alone, five with combined (day and night) wetting and four with soiling. RESULTS: We identified four themes: appointment experiences, treatment experiences, engagement with treatment and internalisation and externalisation of the continence problem. Patient-focused appointments using age-appropriate language were highly desirable. Continuity of care was highlighted as an important aspect of positive clinical experiences; however, this was found to be rare with many participants seeing a different person on each visit. Participants had tried a wide range of treatments for their continence problems with varying degrees of success. Relapse and treatment failure were common. Experiencing relapse was distressing and diminished participants' belief in the success of future treatments and undermined adherence. Participants would be seen to adopt two opposing coping strategies for dealing with their continence problem- internalisation and externalisation. CONCLUSION: Incontinence in young people is challenging to manage. Young people may need to try a range of treatments before their symptoms improve. Due to challenges in treatment, there is an increased risk of poor adherence. During patient-focused appointments, clinicians should work to build rapport with patients and use age-appropriate language. Involving young people in their own care decisions is important. The way in which young people understand their continence problem can influence their coping strategies and adherence to treatment regimes.

Patient-reported outcomes in head and neck and thyroid cancer randomised controlled trials: A systematic review of completeness of reporting and impact on interpretation.

AIM: To determine the completeness of reporting of patient-reported outcomes (PROs) of head and neck cancer (HNC) and thyroid cancer randomised-controlled trials (RCTs) and identify PRO measures used. METHODS: A systematic literature search was conducted for HNC and thyroid cancer RCTs with PRO end-points (January 2004-June 2015). Two investigators independently extracted data, assessed adherence to the International Society for Quality of Life Research (ISOQOL) PRO reporting standards and concordance between hypotheses and PRO measures used. Data were entered into the Patient-Reported Outcomes Measurements Over Time in Oncology (PROMOTION) Registry. RESULTS: Sixty-six RCTs were included, 56 (85%) HNC and 10 (15%) thyroid cancer. Twenty-two (33%) included a primary and 44 (67%) included a secondary PRO end-point. A total of 40 unique PRO measures were used. Adherence to the ISOQOL PRO reporting standards was higher for RCTs with primary PRO end-points than for secondary PRO end-points: (mean adherence of 43% and 29% respectively). Completeness of PRO reporting did not improve with time: r = .13, p = .31. ISOQOL checklist items poorly reported included: PRO hypothesis (reported for eight RCTs, 12%), justification chosen of PRO measures (n = 16, 24%), rates of missing PRO data (n = 19, 29%), and generalisability of results (n = 12, 18%). Encouragingly, PROs were identified in 55 RCT abstracts (83%) and PRO results interpreted for 30 RCTs (45%). CONCLUSIONS: Reporting of PRO end-points was more comprehensive in RCTs with primary rather than secondary PRO end-points. Improvement is needed in the transparent reporting of PRO studies, particularly regarding data collection, analyses and generalisability of PRO results.

A Comparison of Health Professionals' and Patients' Views of the Importance of Outcomes of Bariatric Surgery.

BACKGROUND: A comprehensive evaluation of bariatric surgery is required to inform decision-making. This will include measures of benefit and risk. It is possible that stakeholders involved with surgery value these outcomes differently, although this has not previously been explored. This study aimed to investigate and compare how professionals and patients prioritise outcomes of bariatric surgery. METHODS: Systematic reviews and qualitative interviews created an exhaustive list of outcomes. This informed the development of a 130-item questionnaire, structured in four sections (complications of surgery; clinical effectiveness; signs, symptoms, and other measures; quality of life). Health professionals and patients rated the importance of each item on a 1-9 scale. Items rated 8-9 by at least 70 % of the participants were considered prioritised. Items prioritised in each section were compared between professionals and patients and interrater agreement assessed using kappa statistics (ĸ). RESULTS: One hundred sixty-eight out of four hundred fifty-nine professionals (36.6 %) and 90/465 patients (19.4 %) completed the questionnaire. Professionals and patients prioritised 18 and 25 items, respectively, with 10 overlapping items and 23 discordant items (ĸ 0.363). Examples of items prioritised by both included 'diabetes' and 'leakage from bowel joins'. Examples of discordant items included 're-admission rates' (professionals only) and 'excess skin' (patients only). Poor agreement was seen in the 'quality of life' section (0 overlapping items, 8 discordant, ĸ -0.036). CONCLUSIONS: Although there was some overlap of outcomes prioritised by professionals and patients, there were important differences. We recommend that the views of all relevant health professionals and patients are considered when deciding on outcomes to evaluate bariatric surgery.

Patient-reported outcomes in randomised controlled trials of colorectal cancer: an analysis determining the availability of robust data to inform clinical decision-making.

PURPOSE: Randomised controlled trials (RCTs) are the most robust study design measuring outcomes of colorectal cancer (CRC) treatments, but to influence clinical practice trial design and reporting of patient-reported outcomes (PROs) must be of high quality. Objectives of this study were as follows: to examine the quality of PRO reporting in RCTs of CRC treatment; to assess the availability of robust data to inform clinical decision-making; and to investigate whether quality of reporting improved over time. METHODS: A systematic review from January 2004-February 2012 identified RCTs of CRC treatment describing PROs. Relevant abstracts were screened and manuscripts obtained. Methodological quality was assessed using International Society for Quality of Life Research-patient-reported outcome reporting standards. Changes in reporting quality over time were established by comparison with previous data, and risk of bias was assessed with the Cochrane risk of bias tool. RESULTS: Sixty-six RCTs were identified, seven studies (10 %) reported survival benefit favouring the experimental treatment, 35 trials (53 %) identified differences in PROs between treatment groups, and the clinical significance of these differences was discussed in 19 studies (29 %). The most commonly reported treatment type was chemotherapy (n = 45; 68 %). Improvements over time in key methodological issues including the documentation of missing data and the discussion of the clinical significance of PROs were found. Thirteen trials (20 %) had high-quality reporting. CONCLUSIONS: Whilst improvements in PRO quality reporting over time were found, several recent studies still fail to robustly inform clinical practice. Quality of PRO reporting must continue to improve to maximise the clinical impact of PRO findings.

'Are you still on that stupid diet?': women's experiences of societal pressure and support regarding weight loss, and attitudes towards health policy intervention.

This study investigated how people's attitudes and motivations towards losing weight are influenced by societal pressures surrounding weight loss, their interaction with the obesogenic environment and individuals' attitudes and motivations towards weight. Semi-structured qualitative interviews were conducted with 10 women currently attending commercial weight-loss programmes. Participants experienced conflicting messages regarding weight norms, with the media portraying powerful social norms relating to thinness and beauty, and changes to the food environment and interactions with family and friends commonly undermining weight-loss activities and promoting increased consumption. Providing social and environmental support for the behaviours needed to produce weight loss may need to be a primary focus for obesity policy.