Abstract
BackgroundBariatric surgery may lead to symptomatic postprandial hypoglycaemia as a major side effect without established therapy so far. We aimed to develop an evidence-based study design of a clinical trial that tests treatment options and can provide useful patient-relevant evidence.MethodsWe searched systematically for guidance of core outcome sets to determine the most relevant types of outcomes and duration of such a trial. Our search comprised literature databases, a database of core outcome sets and self-help organizations. We then developed a simple online questionnaire based on interviews with German-speaking patients with postprandial hypoglycaemia after bariatric surgery. We recruited participants by reaching out to all German speaking endocrinologists in Switzerland and large Swiss bariatric centres. We asked for preferences regarding outcome types and acceptable duration of being included in a corresponding clinical trial.ResultsThe literature search did not identify evidence-based guidance for informing our study design. Experience of clinical and research routine as well as patient interviews helped in identifying potential outcomes and the design of an online questionnaire. Therein, a total of 29 persons started the questionnaire and 22 answered questions related to the primary outcome. Of these, 17 (77.3%) deemed quality of life more relevant as primary outcome than the rate of hypoglycaemic episodes. A trial length of four weeks or longer was regarded as acceptable for 19 of 21 respondents to this question (91.4%) and of six months or longer for 12 respondents (56%).ConclusionsIn situations with no other guidance, a simple questionnaire may help to inform trial design decisions. This study identifies a patient preference for “quality of life” as a primary outcome and supports the evidence-based conception of a patient-centred clinical trial in postbariatric hypoglycaemia.
Highlights
Bariatric surgery may lead to symptomatic postprandial hypoglycaemia as a major side effect without established therapy so far
We searched published articles that might address outcomes for clinical trials on postbariatric hypoglycaemia to identify outcome domains and to obtain a list of potential core outcome domains [27] with searches on PubMed using terms related to bariatric surgery and hypoglycaemia. as well as COMET initiative database, and Google scholar using the terms “patient-relevant outcome” or “patient-centered outcome” combined with “bariatric surgery”, “gastric bypass”, “sleeve gastrectomy”, “late-dumping” or “postprandial hypoglycaemia” excluding articles with the term “diabetes”
We presented to two of the most severely affected patients in our clinic with postprandial hypoglycaemia who agreed to support us for this project with their patient feedback to rank each item from 0 to 10
Summary
Bariatric surgery may lead to symptomatic postprandial hypoglycaemia as a major side effect without established therapy so far. We aimed to develop an evidence-based study design of a clinical trial that tests treatment options and can provide useful patient-relevant evidence. A recent exploratory trial with 12 patients after gastric bypass indicated that both the SGLT2-inhibitor empagliflozin and the IL-1 receptor antagonist anakinra may reduce postprandial insulin release and prevents hypoglycaemia [15]. These findings call for further evaluation in a larger randomized clinical trial. Selecting a primary outcome that appropriately reflects the needs of patients turned out to be a major challenge Such a trial would explore patient-relevant outcomes and improve the understanding of the underlying metabolic effects of the tested treatments that would mediate potential patient-centred benefits (such as glucose levels)
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