British researchers have published a “core outcome set” (COS) comprising the nine most important outcomes in bariatric and metabolic surgery clinical trials, including the hoped-for benefits as well as complications.
In collaboration with healthcare providers and patients who underwent bariatric surgery, lead author Karen D. Coulman, PhD, RD, of the University of Bristol in England, and colleagues, identified those outcomes that should be measured and reported for all trials.
The final COS criteria, published in PLOS Medicine, include:
- Weight trajectory.
- Diabetes status.
- Overall quality of life.
- Mortality (30-day and long-term).
- Technical complications of the specific operation.
- Any re-operation/re-intervention and its classification of severity.
- Micronutrient status.
- Cardiovascular risk.
Coulman and colleagues emphasized that the recommended COS is “not meant to be restrictive, rather the minimum that should be reported.”
Because the benefits and risks of the most common surgeries, including sleeve gastrectomy, Roux-en-Y gastric bypass, and adjustable gastric band, vary so greatly, the authors’ goal was to standardize the reporting of patient outcomes among clinical trials. As a result, they hoped to “improve the quality of data” as well as “reduce outcome reporting bias” in order to help healthcare professionals and patients make the most informed decision on their course of treatment.