Co-designing adult weight management services: a qualitative study exploring barriers, facilitators, and considerations for future commissioning.

BACKGROUND: Weight management services have not always benefitted everyone equally. People who live in more deprived areas, racially minoritised communities, those with complex additional needs (e.g., a physical or mental disability), and men are less likely to take part in weight management services. This can subsequently widen health inequalities. One way to counter this is to co-design services with under-served groups to better meet their needs. Using a case study approach, we explored how co-designed adult weight management services were developed, the barriers and facilitators to co-design, and the implications for future commissioning. METHODS: We selected four case studies of adult weight management services in Southwest England where co-design had been planned, representing a range of populations and settings. In each case, we recruited commissioners and providers of the services, and where possible, community members involved in co-design activities. Interviews were conducted online, audio-recorded, transcribed verbatim, and analysed using thematic analysis. RESULTS: We interviewed 18 participants (8 female; 10 male): seven commissioners, eight providers, and three community members involved in co-designing the services. The case studies used a range of co-design activities (planned and actualised), from light-touch to more in-depth approaches. In two case studies, co-design activities were planned but were not fully implemented due to organisational time or funding constraints. Co-design was viewed positively by participants as a way of creating more appropriate services and better engagement, thus potentially leading to reduced inequalities. Building relationships- with communities, individual community members, and with partner organisations- was critical for successful co-design and took time and effort. Short-term and unpredictable funding often hindered co-design efforts and could damage relationships with communities. Some commissioners raised concerns over the limited evidence for co-design, while others described having to embrace "a different way of thinking" when commissioning for co-design. CONCLUSIONS: Co-design is an increasingly popular approach to designing health in services but can be difficult to achieve within traditional funding and commissioning practices. Drawing on our case studies, we present key considerations for those wanting to co-design health services, noting the importance of building strong relationships, creating supportive organisational cultures, and developing the evidence base.

How surgical Trainee Research Collaboratives achieve success: a mixed methods study to develop trainee engagement strategies.

OBJECTIVES: This study aimed to understand the role of surgical Trainee Research Collaboratives (TRCs) in conducting randomised controlled trials and identify strategies to enhance trainee engagement in trials. DESIGN: This is a mixed methods study. We used observation of TRC meetings, semi-structured interviews and an online survey to explore trainees' motivations for engagement in trials and TRCs, including barriers and facilitators. Interviews were analysed thematically, alongside observation field notes. Survey responses were analysed using descriptive statistics. Strategies to enhance TRCs were developed at a workshop by 13 trial methodologists, surgical trainees, consultants and research nurses. SETTING: This study was conducted within a secondary care setting in the UK. PARTICIPANTS: The survey was sent to registered UK surgical trainees. TRC members and linked stakeholders across surgical specialties and UK regions were purposefully sampled for interviews. RESULTS: We observed 5 TRC meetings, conducted 32 semi-structured interviews and analysed 73 survey responses. TRCs can mobilise trainees thus gaining wider access to patients. Trainees engaged with TRCs to improve patient care, surgical evidence and to help progress their careers. Trainees valued the TRC infrastructure, research expertise and mentoring. Challenges for trainees included clinical and other priorities, limited time and confidence, and recognition, especially by authorship. Key TRC strategies were consultant support, initial simple rapid studies, transparency of involvement and recognition for trainees (including authorship policies) and working with Clinical Trials Units and research nurses. A 6 min digital story on YouTube disseminated these strategies. CONCLUSION: Trainee surgeons are mostly motivated to engage with trials and TRCs. Trainee engagement in TRCs can be enhanced through building relationships with key stakeholders, maximising multi-disciplinary working and offering training and career development opportunities.

Access to publicly funded weight management services in England using routine data from primary and secondary care (2007-2020): An observational cohort study.

BACKGROUND: Adults living with overweight/obesity are eligible for publicly funded weight management (WM) programmes according to national guidance. People with the most severe and complex obesity are eligible for bariatric surgery. Primary care plays a key role in identifying overweight/obesity and referring to WM interventions. This study aimed to (1) describe the primary care population in England who (a) are referred for WM interventions and (b) undergo bariatric surgery and (2) determine the patient and GP practice characteristics associated with both. METHODS AND FINDINGS: An observational cohort study was undertaken using routinely collected primary care data in England from the Clinical Practice Research Datalink linked with Hospital Episode Statistics. During the study period (January 2007 to June 2020), 1,811,587 adults met the inclusion criteria of a recording of overweight/obesity in primary care, of which 54.62% were female and 20.10% aged 45 to 54. Only 56,783 (3.13%) were referred to WM, and 3,701 (1.09% of those with severe and complex obesity) underwent bariatric surgery. Multivariable Poisson regression examined the associations of demographic, clinical, and regional characteristics on the likelihood of WM referral and bariatric surgery. Higher body mass index (BMI) and practice region had the strongest associations with both outcomes. People with BMI ≥40 kg/m2 were more than 6 times as likely to be referred for WM (10.05% of individuals) than BMI 25.0 to 29.9 kg/m2 (1.34%) (rate ratio (RR) 6.19, 95% confidence interval (CI) [5.99,6.40], p < 0.001). They were more than 5 times as likely to undergo bariatric surgery (3.98%) than BMI 35.0 to 40.0 kg/m2 with a comorbidity (0.53%) (RR 5.52, 95% CI [5.07,6.02], p < 0.001). Patients from practices in the West Midlands were the most likely to have a WM referral (5.40%) (RR 2.17, 95% CI [2.10,2.24], p < 0.001, compared with the North West, 2.89%), and practices from the East of England least likely (1.04%) (RR 0.43, 95% CI [0.41,0.46], p < 0.001, compared with North West). Patients from practices in London were the most likely to undergo bariatric surgery (2.15%), and practices in the North West the least likely (0.68%) (RR 3.29, 95% CI [2.88,3.76], p < 0.001, London compared with North West). Longer duration since diagnosis with severe and complex obesity (e.g., 1.67% of individuals diagnosed in 2007 versus 0.34% in 2015, RR 0.20, 95% CI [0.12,0.32], p < 0.001), and increasing comorbidities (e.g., 2.26% of individuals with 6+ comorbidities versus 1.39% with none (RR 8.79, 95% CI [7.16,10.79], p < 0.001) were also strongly associated with bariatric surgery. The main limitation is the reliance on overweight/obesity being recorded within primary care records to identify the study population. CONCLUSIONS: Between 2007 and 2020, a very small percentage of the primary care population eligible for WM referral or bariatric surgery according to national guidance received either. Higher BMI and GP practice region had the strongest associations with both. Regional inequalities may reflect differences in commissioning and provision of WM services across the country. Multi-stakeholder qualitative research is ongoing to understand the barriers to accessing WM services and potential solutions. Together with population-wide prevention strategies, improved access to WM interventions is needed to reduce obesity levels.

Development of a Bariatric Surgery Core Data Set for an International Registry.

PURPOSE: Bariatric and metabolic surgery is an effective treatment for severe and complex obesity; however, robust long-term data comparing operations is lacking. Clinical registries complement clinical trials in contributing to this evidence base. Agreement on standard data for bariatric registries is needed to facilitate comparisons. This study developed a Core Registry Set (CRS) - core data to include in bariatric surgery registries globally. MATERIALS AND METHODS: Relevant items were identified from a bariatric surgery research core outcome set, a registry data dictionary project, systematic literature searches, and a patient advisory group. This comprehensive list informed a questionnaire for a two-round Delphi survey with international health professionals. Participants rated each item's importance and received anonymized feedback in round 2. Using pre-defined criteria, items were then categorized for voting at a consensus meeting to agree the CRS. RESULTS: Items identified from all sources were grouped into 97 questionnaire items. Professionals (n = 272) from 56 countries participated in the round 1 survey of which 45% responded to round 2. Twenty-four professionals from 13 countries participated in the consensus meeting. Twelve items were voted into the CRS including demographic and bariatric procedure information, effectiveness, and safety outcomes. CONCLUSION: This CRS is the first step towards unifying bariatric surgery registries internationally. We recommend the CRS is included as a minimum dataset in all bariatric registries worldwide. Adoption of the CRS will enable meaningful international comparisons of bariatric operations. Future work will agree definitions and measures for the CRS including incorporating quality-of-life measures defined in a parallel project.

Variation and outcomes of liver-reducing dietary regimens before bariatric surgery: a national retrospective cohort study.

BACKGROUND: Liver-reducing diets (LRDs) are mandated prior to bariatric surgery, but there are no guidelines on their implementation. OBJECTIVE: To establish the variation and effectiveness of LRDs utilized in clinical practice. SETTING: A nationwide, multicenter, retrospective cohort study. METHODS: A total of 1699 adult patients across 14 bariatric centers in the United Kingdom were included. Multilevel logistic regression models were developed to examine factors predictive of 5% weight loss. RESULTS: Most centers (n = 9) prescribed an 800- to 1000-kcal diet, but the duration and formulation of diet was variable. Overall, 30.6% (n = 510) of patients achieved 5% weight loss during the LRD. After adjustment for preoperative weight, women had reduced odds (odds ratio [OR], .65; 95% confidence interval [CI], .48-.88; P = .005), while increasing age (OR, 1.01; 95% CI, 1.00-1.02; P = .043) and having type 2 diabetes (OR, 1.49; 95% CI, 1.16-1.92; P = .002) increased odds of 5% weight loss. A normal consistency food LRD (OR, .64; 95% CI, .42-.98; P = .041) and energy prescription of >1200 kcals/d (OR, .33; 95% CI, .13-.83; P = .019) reduced odds, while an LRD with a duration of 3 weeks (OR, 2.28; 95% CI, 1.02-5.09; P = .044) or greater increased odds of 5% weight loss. CONCLUSIONS: There is wide variation in how LRDs are delivered in clinical practice, highlighting the need for an evidence-based consensus. Our findings suggest the optimal LRD before bariatric surgery contains 800 to 1200 kcals/d over a duration of 3 to 4 weeks. Further research is required to determine the optimal formulation of LRD and whether women may require a lower-energy LRD than men.

Outcomes of the first global multidisciplinary consensus meeting including persons living with obesity to standardize patient-reported outcome measurement in obesity treatment research.

Quality of life is a key outcome that is not rigorously measured in obesity treatment research due to the lack of standardization of patient-reported outcomes (PROs) and PRO measures (PROMs). The S.Q.O.T. initiative was founded to Standardize Quality of life measurement in Obesity Treatment. A first face-to-face, international, multidisciplinary consensus meeting was conducted to identify the key PROs and preferred PROMs for obesity treatment research. It comprised of 35 people living with obesity (PLWO) and healthcare providers (HCPs). Formal presentations, nominal group techniques, and modified Delphi exercises were used to develop consensus-based recommendations. The following eight PROs were considered important: self-esteem, physical health/functioning, mental/psychological health, social health, eating, stigma, body image, and excess skin. Self-esteem was considered the most important PRO, particularly for PLWO, while physical health was perceived to be the most important among HCPs. For each PRO, one or more PROMs were selected, except for stigma. This consensus meeting was a first step toward standardizing PROs (what to measure) and PROMs (how to measure) in obesity treatment research. It provides an overview of the key PROs and a first selection of the PROMs that can be used to evaluate these PROs.

British Obesity and Metabolic Surgery Society Guidelines on perioperative and postoperative biochemical monitoring and micronutrient replacement for patients undergoing bariatric surgery-2020 update.

Bariatric surgery is recognized as the most clinically and cost-effective treatment for people with severe and complex obesity. Many people presenting for surgery have pre-existing low vitamin and mineral concentrations. The incidence of these may increase after bariatric surgery as all procedures potentially cause clinically significant micronutrient deficiencies. Therefore, preparation for surgery and long-term nutritional monitoring and follow-up are essential components of bariatric surgical care. These guidelines update the 2014 British Obesity and Metabolic Surgery Society nutritional guidelines. Since the 2014 guidelines, the working group has been expanded to include healthcare professionals working in specialist and non-specialist care as well as patient representatives. In addition, in these updated guidelines, the current evidence has been systematically reviewed for adults and adolescents undergoing the following procedures: adjustable gastric band, sleeve gastrectomy, Roux-en-Y gastric bypass and biliopancreatic diversion/duodenal switch. Using methods based on Scottish Intercollegiate Guidelines Network methodology, the levels of evidence and recommendations have been graded. These guidelines are comprehensive, encompassing preoperative and postoperative biochemical monitoring, vitamin and mineral supplementation and correction of nutrition deficiencies before, and following bariatric surgery, and make recommendations for safe clinical practice in the U.K. setting.

Health-Related Quality of Life in Bariatric and Metabolic Surgery.

PURPOSE OF REVIEW: This review describes the latest evidence for the impact of bariatric surgery on health-related quality of life (HRQL). RECENT FINDINGS: The impact of bariatric surgery on HRQL is less well-understood than its clinical effectiveness on weight and co-morbidities. Poor-quality study design and different HRQL measures challenge systematic reviews and meta-analyses. Available limited evidence suggests that physical aspects of HRQL may improve more than mental health aspects of HRQL after bariatric surgery, reaching maximal benefits 1-2 years post-surgery. Comparative HRQL analyses between bariatric procedures cannot be made due to a lack of randomised data. Qualitative research highlights the tensions patients experience after bariatric surgery, which provides insights to observed changes in HRQL. Standardized HRQL measures are being developed and agreed to improve future evidence synthesis. Two multi-centre randomised trials of bariatric surgical procedures including detailed HRQL assessment are in progress. It is hoped that the combination of comparative high-quality HRQL data and information from qualitative studies will provide new insights into patient well-being and health after bariatric surgery.

Patients' experiences of life after bariatric surgery and follow-up care: a qualitative study.

OBJECTIVES: Bariatric surgery is the most clinically effective treatment for people with severe and complex obesity, however, the psychosocial outcomes are less clear. Follow-up care after bariatric surgery is known to be important, but limited guidance exists on what this should entail, particularly related to psychological and social well-being. Patients' perspectives are valuable to inform the design of follow-up care. This study investigated patients' experiences of life after bariatric surgery including important aspects of follow-up care, in the long term. DESIGN: A qualitative study using semistructured individual interviews. A constant comparative approach was used to code data and identify themes and overarching concepts. SETTING: Bariatric surgery units of two publicly funded hospitals in the South of England. PARTICIPANTS: Seventeen adults (10 women) who underwent a primary operation for obesity (mean time since surgery 3.11 years, range 4 months to 9 years), including Roux-en-Y gastric bypass, adjustable gastric band and sleeve gastrectomy, agreed to participate in the interviews. RESULTS: Experiences of adapting to life following surgery were characterised by the concepts of 'normality' and 'ambivalence', while experiences of 'abandonment' and 'isolation' dominated participants' experiences of follow-up care. Patients highlighted the need for more flexible, longer-term follow-up care that addresses social and psychological difficulties postsurgery and integrates peer support. CONCLUSIONS: This research highlights unmet patient need for more accessible and holistic follow-up care that addresses the long-term multidimensional impact of bariatric surgery. Future research should investigate effective and acceptable follow-up care packages for patients undergoing bariatric surgery.

Protocol for a systematic review of reporting standards of anaesthetic interventions in randomised controlled trials.

INTRODUCTION: There is significant variation in how anaesthesia is defined and reported in clinical research. This lack of standardisation complicates the interpretation of published evidence and planning of future clinical trials. This systematic review will assess the reporting of anaesthesia as an intervention in randomised controlled trials (RCT) against the Consolidated Standards of Reporting Trials for Non-Pharmacological Treatments (CONSORT-NPT) framework. METHODS AND ANALYSIS: Online archives of the top six journals ranked by impact factor for anaesthesia and the top three general medicine and general surgery journals will be systematically hand searched over a 42-month time period to identify RCTs describing the use of anaesthetic interventions for any invasive procedure. All modes of anaesthesia and anaesthesia techniques will be included. All study data, including the type of anaesthetic intervention described, will be extracted in keeping with the CONSORT-NPT checklist. Descriptive statistics will be used to summarise general study details including types/modes of anaesthetic interventions, and reporting standards of the trials. ETHICS AND DISSEMINATION: No ethical approval is required. The results will be used to inform a funding application to formally standardise general, local, regional anaesthesia and sedation for use in clinical research. The systematic review will be disseminated via peer-reviewed manuscript and conferences. PROSPERO REGISTRATION NUMBER: CRD42019141670.

Impact of question order on prioritisation of outcomes in the development of a core outcome set: a randomised controlled trial.

BACKGROUND: Core outcome set (COS) developers increasingly employ Delphi surveys to elicit stakeholders' opinions of which outcomes to measure and report in trials of a particular condition or intervention. Research outside of Delphi surveys and COS development demonstrates that question order can affect response rates and lead to 'context effects', where prior questions determine an item's meaning and influence responses. This study examined the impact of question order within a Delphi survey for a COS for oesophageal cancer surgery. METHODS: A randomised controlled trial was nested within the Delphi survey. Patients and health professionals were randomised to receive a survey including clinical and patient-reported outcomes (PROs), where the PRO section appeared first or last. Participants rated (1-9) the importance of 68 items for inclusion in a COS (ratings 7-9 considered 'essential'). Analyses considered the impact of question order on: (1) survey response rates; (2) participants' responses; and (3) items retained at end of the survey. RESULTS: In total, 116 patients and 71 professionals returned completed surveys. Question order did not affect response rates among patients, but fewer professionals responded when clinical items appeared first (difference = 31.3%, 95% confidence interval [CI] = 13.6-48.9%, P = 0.001). Question order led to different context effects within patients and professionals. While patients rated clinical items highly, irrespective of question order, more PROs were rated essential when appearing last rather than first (difference = 23.7%, 95% CI = 10.5-40.8%). Among professionals, the greatest impact was on clinical items; a higher percentage rated essential when appearing last (difference = 11.6%, 95% CI = 0.0-23.3%). An interaction between question order and the percentage of PRO/clinical items rated essential was observed for patients (P = 0.025) but not professionals (P = 0.357). Items retained for further consideration at the end of the survey were dependent on question order, with discordant items (retained by one question order group only) observed in patients (18/68 [26%]) and professionals (20/68 [29%]). CONCLUSIONS: In the development of a COS, participants' ratings of potential outcomes within a Delphi survey depend on the context (order) in which the outcomes are asked, consequently impacting on the final COS. Initial piloting is recommended with consideration of the randomisation of items in the survey to reduce potential bias. TRIAL REGISTRATION: The randomised controlled trial reported within this paper was nested within the development of a core outcome set to investigate processes in core outcome set development. Outcomes were not health-related and trial registration was not therefore applicable.

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.

Patient experiences of outcomes of bariatric surgery: a systematic review and qualitative synthesis.

Although bariatric surgery is the most effective treatment for severe and complex obesity, less is known about its psychosocial impact. This systematic review synthesizes qualitative studies investigating the patient perspective of living with the outcomes of surgery. A total of 2,604 records were screened, and 33 studies were included. Data extraction and thematic synthesis yielded three overarching themes: control, normality and ambivalence. These were evident across eight organizing sub-themes describing areas of life impacted by surgery: weight, activities of daily living, physical health, psychological health, social relations, sexual life, body image and eating behaviour and relationship with food. Throughout all these areas, patients were striving for control and normality. Many of the changes experienced were positive and led to feeling more in control and 'normal'. Negative changes were also experienced, as well as changes that were neither positive nor negative but were nonetheless challenging and required adaptation. Thus, participants continued to strive for control and normality in some aspects of their lives for a considerable time, contributing to a sense of ambivalence in accounts of life after surgery. These findings demonstrate the importance of long-term support, particularly psychological and dietary, to help people negotiate these challenges and maintain positive changes achieved after bariatric surgery.

A Core Outcome Set for the Benefits and Adverse Events of Bariatric and Metabolic Surgery: The BARIACT Project.

BACKGROUND: Bariatric and metabolic surgery is used as a treatment for patients with severe and complex obesity. However, there is a need to improve outcome selection and reporting in bariatric surgery trials. A Core Outcome Set (COS), an agreed minimum set of outcomes reported in all studies of a specific condition, may achieve this. Here, we present the development of a COS for BARIAtric and metabolic surgery Clinical Trials-the BARIACT Study. METHODS AND FINDINGS: Outcomes identified from systematic reviews and patient interviews informed a questionnaire survey. Patients and health professionals were surveyed three times and asked to rate the importance of each item on a 1-9 scale. Delphi methods provided anonymised feedback to participants. Items not meeting predefined criteria were discarded between rounds. Remaining items were discussed at consensus meetings, held separately with patients and professionals, where the COS was agreed. Data sources identified 2,990 outcomes, which were used to develop a 130-item questionnaire. Round 1 response rates were moderate but subsequently improved to above 75% for other rounds. After rounds 2 and 3, 81 and 14 items were discarded, respectively, leaving 35 items for discussion at consensus meetings. The final COS included nine items: "weight," "diabetes status," "cardiovascular risk," "overall quality of life (QOL)," "mortality," "technical complications of the specific operation," "any re-operation/re-intervention," "dysphagia/regurgitation," and "micronutrient status." The main limitation of this study was that it was based in the United Kingdom only. CONCLUSIONS: The COS is recommended to be used as a minimum in all trials of bariatric and metabolic surgery. Adoption of the COS will improve data synthesis and the value of research data. Future work will establish methods for the measurement of the outcomes in the COS.

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.

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).

Fatty acids and lignans in unground whole flaxseed and sesame seed are bioavailable but have minimal antioxidant and lipid-lowering effects in postmenopausal women.

Fatty acids and lignans in ground flaxseed and sesame seed are absorbed, metabolized, and exert some health benefits in vivo. However, it is unclear if they are absorbed, metabolized, and exert health benefits when consumed as unground whole seed; therefore, it was investigated in this study. In a randomized crossover study, 16 postmenopausal women supplemented their diets with food bars containing either 25 g unground flaxseed, sesame seed, or their combination (12.5 g each) (flaxseed+sesame seed bar, FSB) for 4 wk each, separated by 4 wk washout periods. Total serum n-3 fatty acids increased with flaxseed (p<0.05) and FSB (p=0.064) while serum n-6 fatty acids increased with sesame seed (p<0.05). Urinary lignans increased similarly with all treatments (p<0.05). Plasma lipids and several antioxidant markers were unaffected by all treatments, except serum gamma-tocopherol (GT), which increased with both sesame seed (p<0.0001) and FSB (p<0.01). In conclusion, fatty acids and lignans from unground seed in food bars are absorbed and metabolized; however, except for serum GT, the 25 g unground seed is inadequate to induce changes in plasma lipids and several biomarkers of oxidative stress.

Whole sesame seed is as rich a source of mammalian lignan precursors as whole flaxseed.

The mammalian lignans enterolactone and enterodiol, which are produced by the microflora in the colon of humans and animals from precursors in foods, have been suggested to have potential anticancer effects. This study determined the production of mammalian lignans from precursors in food bars containing 25 g unground whole flaxseed (FB), sesame seed (SB), or their combination (FSB; 12.5 g each). In a randomized crossover study, healthy postmenopausal women supplemented their diets with the bars for 4 wk each separated by 4-wk washout periods, and urinary mammalian lignan excretion was measured at baseline and after 4 wk as a marker of mammalian lignan production. Results showed an increase with all treatments (65.1-81.0 mumol/day; P < 0.0001), which did not differ among treatments. Lignan excretion with the whole flaxseed was similar to results of other studies using ground flaxseed. An unidentified lignan metabolite was detected after consumption of SB and FSB but not of FB. Thus, we demonstrated for the first time that 1) precursors from unground whole flaxseed and sesame seed are converted by the bacterial flora in the colon to mammalian lignans and 2) sesame seed, alone and in combination with flaxseed, produces mammalian lignans equivalent to those obtained from flaxseed alone.