As the frequency of bariatric surgeries continues to rise, so does the need for reliable outcomes to guide clinical recommendations and patient expectations.
“There was a need to develop a core outcome set for bariatric and metabolic surgery given that current published studies have measured and reported a vast number of different outcomes, making comparison of studies and the amalgamation of evidence difficult,” Karen D. Coulman, a doctoral research fellow at the University of Bristol, UK, and study co-author, told EndocrineWeb.
Responding to the clear need for uniform reporting of clinical trial endpoints, a coalition of British clinicians and patients assessed outcomes data reported in bariatric and metabolic surgery clinical trials, known as the BARIACT study.1 Nine outcomes were identified as essential endpoints and became the minimum data required for reporting in all weight loss studies:
“Use of the core outcome set in future bariatric and metabolic surgery studies will mean that studies can more easily be compared and the data better used to inform clinical and patient decision-making,” said Dr. Coulman to EndocrineWeb.
According to Dr. Coulman, more long-term data from randomized controlled trials will continue to enable patients and healthcare providers to select the best type of surgery on a case-specific basis.
As the prevalence of type 2 diabetes (T2D) rises, so does the comorbidity of obesity, which affects more than 25% of those with diabetes.2 Metabolic and bariatric surgical procedures provide the most effective treatment for people who are obese and have T2D, offering remission for many and improvement for nearly all patients.2
However, there are a variety of bariatric and metabolic surgical options, including the adjustable gastric band, gastric sleeve, and gastric bypass; each procedure carries risks, which begs the question of which procedure is best.
In order to guide patients, clinicians would benefit from a data-driven understanding of success rates and common risks when considering how best to advise a patient who is considering surgery--or even whether surgery is appropriate at all.
The BARIACT study’s authors convened a coalition of 250 physicians, surgeons, nurses, anesthetists, psychologists, and dietitians, along with patients who had undergone bariatric and metabolic surgeries over the past 5 years.1
Initially, the authors generated a list of 2,990 potential outcomes and created questionnaires to administer to participants in 3 series, enabling the authors to sort through potential outcomes.
As a final step, participants attended a series of face-to-face meetings during which the potential outcomes were again considered and condensed until the minimum reported outcomes were narrowed to a final list of nine.
Scott A. Cunneen, MD, FACS, FASMBS, director of metabolic and bariatric surgery at Cedars-Sinai Medical Center in Los Angeles and an EndocrineWeb editorial board member, lauded the results of the BARIACT study as a useful tool in a physician’s arsenal.
“In essence, it would allow for better characterization of the performance of each operation in varying patient populations, as well as allow the physicians to assess how their team was performing versus the baseline data--better or worse,” he told EndocrineWeb.
Going forward, Dr. Cunneen suggests that physicians:
As the BARIACT core outcomes represent a minimum, rather than exclusive, set of reported endpoints, Dr. Cunneen encourages clinicians to continue monitoring, evaluating, and reassessing the outcomes for additional information, such as band slippage, sleep apnea, mobility, anxiety, and other outcomes that can offer valuable insights to improve patient-centered recommendations.
1. Coulman KD, Hopkins J. Brookes ST, et al, for the BARIACT Working Group. 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. Available at: http://dx.doi.org/10.1371/journal.pmed.1002187.
2. American Society for Metabolic and Bariatric Surgery. Surgery for diabetes. Available at: https://asmbs.org/patients/surgery-for-diabetes. Accessed on December 13, 2016.