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.”