Difficult clinical decisions in sleep apnea surgery: identifying priorities for future clinical trials

Background: A fundamental ethical principle for randomized clinical trials is to test clinical questions where equipoise (i.e., uncertainty) exists surrounding the correct treatment. We aimed to measure perceived importance, individual and collective community equipoise, and willingness to enroll patients in five potential trial targets (4 of which relate to pediatric patients) among otolaryngologists. Methods: Sixty otolaryngologists attending the 5^th South Pacific Otorhinolaryngology Forum Meeting in Fiji 2023 were surveyed using an electronic questionnaire. Equipoise was measured for all scenarios using three metrics. Metric 1: degree of importance measured using an ordinal scale. Metric 2: degree of clinical uncertainty measured using a bidirectional ordinal scale comparing two treatments. Responses were plotted in histograms and then categorized into three groups: (A) preferred treatment 1, (B) completely undecided, and (C) preferred treatment 2. The resulting proportions provide equipoise ratios: A:B:C. Metric 3: willingness to enroll patients in a randomized trial. Results: Forty-eight otolaryngologists were eligible and completed the questionnaire. Three of the five potential trial scenarios exhibited high importance, community equipoise and willingness to enroll in a randomized controlled trial (RCT). Conclusions: We identified three viable trial targets (2 pediatric, 1 adult) with perceived importance, equipoise and willingness to enroll patients in a RCT. Pediatric targets included multilevel upper airway surgery compared to device therapy post adenotonsillectomy with persistent symptomatic obstructive sleep apnea (OSA) [C = mild apnea-hypopnea index (AHI) ≤5, D = moderate-severe AHI ≥5]. The adult target compared addition of drug-induced sleep endoscopy (DISE) to clinical examination alone in assessment of persistent symptomatic OSA (E = AHI ≥5) post adenotonsillectomy.