Discontinuation of surgical versus nonsurgical clinical trials: an analysis of 88,498 trials
| Autor: | Sumaiya Sarwar, Mazin Al-Kasspooles, Anne D. Walling, Alexander E. Fondaw, Tyler Mouw, Peter J. DiPasco, Suk W. Hong |
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| Rok vydání: | 2018 |
| Předmět: |
Male
Clinical Trials as Topic medicine.medical_specialty Databases Factual business.industry Patient Selection Industry funding Nih funding Odds ratio Likelihood ratios in diagnostic testing United States Discontinuation Clinical trial 03 medical and health sciences 0302 clinical medicine Surgical Procedures Operative 030225 pediatrics Internal medicine Early Termination of Clinical Trials medicine Humans Female Surgery 030212 general & internal medicine business |
| Zdroj: | Journal of Surgical Research. 227:151-157 |
| ISSN: | 0022-4804 |
| DOI: | 10.1016/j.jss.2018.02.039 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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