Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Coulman KD

PROVIDER: S-EPMC5127500 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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Publications

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

Coulman Karen D KD Hopkins James J Brookes Sara T ST Chalmers Katy K Main Barry B Owen-Smith Amanda A Andrews Robert C RC Byrne James J Donovan Jenny L JL Mazza Graziella G Reeves Barnaby C BC Rogers Chris A CA Thompson Janice L JL Welbourn Richard R Wordsworth Sarah S Blazeby Jane M JM

PLoS medicine 20161129 11

<h4>Background</h4>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.<h4>Methods and findings</h4>Outcomes identi ...[more]

PMID: 27898680

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Project description:BACKGROUND:Obesity is recognized as a classic risk factor for atherosclerosis and subsequent cardiovascular disease (CVD). Weight loss after bariatric surgery has been associated with reduced CV mortality and total mortality in obese patients. Our aim was to study the impact of bariatric surgery on CV risk profile, cardiac structure, and function postoperatively. RESULTS:This prospective longitudinal study included 100 morbidly obese patients at final analysis. All patients were subjected to full clinical, laboratory, and echocardiographic examination at baseline and 6?months after bariatric surgery. The mean age of study population was 37.2 ± 10.49 with BMI of 47 ± 6.82. Females represented 84%. Sleeve gastrectomy and Roux-en-Y gastric bypass were performed in 79% and 21%, respectively. Surgery-related mortality and morbidity were 0.94% and 4.7%, respectively. After 6?months, there were significant decreases in BMI, heart rate, SBP, DBP, and Framingham risk score (P < 0.0001). The prevalence of risk factors decreased as follows: hypertension 24% vs. 12%, P = 0.0005; DM 21% vs. 11%, P = 0.002; dyslipidemia 32% vs. 7%, P < 0.0001; and metabolic syndrome 54% vs. 26%, P < 0.0001. Highly significant (P < 0.0001) decrease in fasting PG and 2?h PP-PG, HbA1c, ASL, ALT, fasting total cholesterol, LDL, TG, and increase in HDL were observed after bariatric surgery. There were significant shortening in QTc interval (P = 0.009), decrease in LV dimensions and LV mass index (P < 0.0001), and increase in LV EF% (P = 0.0003). BMI at follow-up showed significant positive correlation with age, Framingham risk score, and preoperative BMI (r = 0.289, P = 0.0036; r = 0.37, P = 0.0054; and r = 0.31, P = 0.0081, respectively). CONCLUSION:In addition to enabling patients to achieve a substantial weight loss, bariatric surgery provides a myriad of health benefits. Weight reduction was associated with a favorable improvement in cardiovascular risk profile, cardiac structure, and function.

Project description:BACKGROUND:Qualitative narrative analysis and case studies form the majority of the current peer-reviewed literature about the benefits of professional volunteering or international placements for healthcare professionals. These often describe generalised outcomes that are difficult to define or have multiple meanings (such as 'communication skills' or 'leadership') and are therefore difficult to measure. However, there is an interest from employers, professional groups and individual volunteers in generating metrics for monitoring personal and professional development of volunteers and comparing different volunteering experiences in terms of their impact on the volunteers. In this paper, we describe two studies in which we (a) consolidated qualitative research and individual accounts into a core outcome set and (b) tested the core outcome set in a large group of global health stakeholders. METHOD:We conducted a systematic review and meta-synthesis of literature to extract outcomes of international placements and variables that may affect these outcomes. We presented these outcomes to 58 stakeholders in global health, employing a Delphi method to reach consensus about which were 'core' and which were likely to be developed through international volunteering. RESULTS:The systematic review of 55 papers generated 133 unique outcomes and 34 potential variables. One hundred fifty-six statements were then presented to the Delphi stakeholders, of which they agreed 116 were core to a wide variety of healthcare professional practice and likely to be developed through international experiences. The core outcomes (COs) were both negative and positive and included skills, knowledge, attitudes and outcomes for healthcare organisations. CONCLUSIONS:We summarised existing literature and stakeholder opinion into a core outcome set of 116 items that are core to healthcare professional practice and likely to be developed through international experiences. We identified, in the literature, a set of variables that could affect learning outcomes. The core outcome set will be used in a future study to develop a psychometric assessment tool.

Dataset Information

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

Background

Methods and findings

Conclusions

Publications

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

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