Katie Whale

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

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.

Outcome reporting in bariatric surgery: An in-depth analysis to inform the development of a core outcome set, the BARIACT Study

Outcome reporting in bariatric surgery needs a core outcome set (COS), an agreed minimum set of outcomes reported in all studies of a particular condition. The aim of this study was to summarize outcome reporting in bariatric surgery to inform the development of a COS. Outcomes reported in randomized controlled trials (RCTs) and large non‐randomized studies identified by a systematic review were listed verbatim and categorized into domains, scrutinizing the frequency of outcome reporting and uniformity of definitions. Ninety studies (39 RCTs) identified 1,088 separate outcomes, grouped into nine domains with most (n = 920, 85%) reported only once. The largest outcome domain was ‘surgical complications’, and overall, 42% of outcomes corresponded to a theme of ‘adverse events’. Only a quarter of outcomes were defined, and where provided definitions, which were often contradictory. Percentage of excess weight loss was the main study outcome in 49 studies, but nearly 40% of weight loss outcomes were heterogeneous, thus not comparable. Outcomes of diverse bariatric operations focus largely on adverse events. Reporting is inconsistent and ill‐defined, limiting interpretation and comparison of published studies. Thus, we propose and are developing a COS for the surgical treatment of severe and complex obesity.

'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.

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.

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 surgeons 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).

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.

The importance of stakeholder selection in core outcome set development: how surveying different health professionals may influence outcome selection

Background Core outcome sets (COS) seek to overcome heterogeneity in outcome reporting by generating outcomes to be measured and reported as a minimum in all trials of specific conditions. Patients’ views are integral to this but less is understood about selecting which healthcare professionals to be involved. We examined whether differences in the health professionals surveyed influenced outcome selection in a COS.

Methodological overview of systematic reviews to establish the evidence base for emergency general surgery

The evidence for treatment decision‐making in emergency general surgery has not been summarized previously. The aim of this overview was to review the quantity and quality of systematic review evidence for the most common emergency surgical conditions.

Quality of Patient-Reported Outcome (PRO) Reporting Across Cancer Randomized Controlled Trials According to the CONSORT PRO Extension: A Pooled Analysis of 557 Trials

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.

‘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.