Patient involvement to inform the design of a clinical trial in postbariatric hypoglycaemia
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(2020) 20:290
RESEARCH ARTICLE
Open Access
Patient involvement to inform the design of a clinical trial in postbariatric hypoglycaemia Matthias Hepprich1,2* , Marc Y. Donath1 and Lars G. Hemkens3,4,5
Abstract Background: 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. Methods: We 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 Germanspeaking 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. Results: The 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%). Conclusions: In 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. Keywords: Patient involvement, Postprandial hypoglycaemia, Late-dumping, Bariatric surgery, Outcome finding
Background Bariatric surgery is one of the most effective interventions to achieve long-term weight loss in patients with severe obesity, but frequently leads to serious side effects [1–3]. One of them is postprandial hypoglycaemia (PBH), * Correspondence: [email protected] 1 Division of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Petersgraben 4, 4053 Basel, Switzerland 2 Clinic of Endocrinology, Cantonal Hospital Olten, Basler Strasse 150, 4600 Olten, Switzerland Full list of author information is available at the end of the article
previously referred to as late-dumping, affecting in standardized test settings about 50% of patients with a gastric bypass [4–6] although it is frequently undiagnosed [7]. This may lead to a reduced quality of life [8], secondary weight ga
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