Study Identifies Most Important Bariatric, Metabolic Surgery Outcomes

A team of researchers have published a core outcome set (COS) that consists of the 9 most critical outcomes in bariatric and metabolic surgery clinical trials.

Noting a "need to improve outcome selection and reporting in bariatric surgery trials," investigators identified outcomes from systematic reviews and patient interviews conducted via a questionnaire survey. The team surveyed patients and health professionals 3 times, asking participants to rate the importance of each item on a scale of 1 to 9. Delphi methods provided anonymous feedback to participants, according to the authors, who note that items not meeting pre-defined criteria were discarded between rounds.

The remaining items were discussed in consensus meetings, which were held separately with patients and professionals. The COS was agreed upon during these meetings, according to the researchers, who used data sources to identify 2990 outcomes, which were used to develop the 130-item questionnaire. Round 1 response rates were "moderate, but subsequently improved to more than 75% for other rounds," they wrote. After rounds 2 and 3, 81 and 14 items were discarded, respectively, which left 35 items for discussion at consensus meetings.

Ultimately, the final COS included these 9 items: weight, diabetes status, overall quality of life, mortality (30-day and long-term), technical complications of the specific operation, any re-operation and/or re-intervention, dysphagia and/or regurgitation, and micronutrient status.

"The COS is recommended to be used as a minimum in all trials of bariatric and metabolic surgery," wrote the authors, who note that the study's main limitation was that it was based only in the UK "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."

—Mark McGraw

Reference

Coulman KD, Hopkins J, Brookes ST et al. A core outcome set for the benefits and adverse events of bariatric and metabolic surgery: The BARIACT Project [published online November 29, 2016]. PLOS Medicine. doi.org/10.1371/journal.pmed.1002187.