Discontinuation of surgical versus nonsurgical clinical trials: an analysis of 88,498 trials.

BACKGROUND: It has been previously reported that over 20% of surgical trials will be discontinued prematurely raising ethical and financial concerns. Previous studies have been limited in scope owing to the need for manual review of selected trials. To date, there has been no broad analysis comparing surgical and nonsurgical registered clinical trials. MATERIALS AND METHODS: ClinicalTrials.gov was queried October 7, 2017 for all US trials from 2005 to 2017. Trials were assigned to surgical or nonsurgical groups by automated sorting. The sorting algorithm was validated by comparison with manual assignments made by blinded investigators. Comparisons were made between trial status, funding sources, and trial design. The reasons for discontinuation were examined and tabulated. RESULTS: The database search yielded 82,719 nonsurgical and 5779 surgical trials after automatic assignment. The algorithm for assignments had an overall accuracy of 87.99% and a positive likelihood ratio of 6.09 and negative likelihood ratio of 0.093. Significant differences existed in trial status (nonsurgical versus surgical: completed: 55.51% versus 39.49%, P < 0.001 and discontinued: 11.07% versus 15.97%, P < 0.001). Discontinuation due to poor recruitment was more commonly cited by surgical trials (44.65% versus 34.74% P < 0.001). Industry funding predicted discontinuation for all trials (odds ratio 1.63 P < 0.001) and surgical trials independently (OR 1.25 P = 0.041). Patient enrollment, reporting results, and NIH funding were all protective against discontinuation. CONCLUSIONS: Surgical trials are more likely to prematurely discontinue than nonsurgical trials. Industry funding independently predicts trial discontinuation. Poor recruitment is a major cause of early trial discontinuation for all trials and is more pronounced in surgical trials.

COVID-19 infection presenting with acute epiglottitis.

In this case report, we present a novel presentation of acute epiglottitis in a patient with severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) who presented to the emergency room in extremis and respiratory failure requiring emergent cricothyrotomy. Epiglottitis has become less common since the introduction and widespread use of the Haemophilus influenzae type B (Hib) vaccine. This reduction in cases has shifted demographics of the disease from the pediatric population towards adults with comorbid conditions. Interestingly there is a high degree of overlap between many of the comorbidities between epiglottitis and COVID-19. The novel severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2), also referred to as coronavirus disease 19 (COVID-19), has been reported to affect the gastrointestinal tract and neural tissue and has been implicated in necrotizing encephalitis. We report the first known case of the novel SARS-CoV-2 virus presenting with acute epiglottitis.