Core Outcome Measures in Effectiveness Trials

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

General Information

Abstract:
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.

Authors:
Hopkins, J. C. Howes, N. Chalmers, K. Savovic, J. Whale, K. Coulman, K. D. Welbourn, R. Whistance, R. N. Andrews, R. C. Byrne, J. P. Mahon, D. Blazeby, J. M.

Publication

Journal:
Obes Rev
Volume:
Issue:
Pages:
-
Year:
2014
DOI:
Further Study Information

Date:
Funding source(s):
This project was funded by the National Institute for Health

Health Area

Disease Category
Endocrine & metabolic

Disease Name
Diabetes mellitus
Obesity

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Surgery

Method(s)

Systematic review

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.


Stakeholders Involved

Clinical experts
Methodologists
Researchers

Study Type

Systematic review of outcomes measured in trials

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