|
|||||
|
|
An observational study found that authors of randomized controlled trials frequently use concealment of randomization and blinding, despite the failure to report these methods |
|
| Authors: | Devereaux P J Choi Peter T-L El-Dika Samer Bhandari Mohit Montori Victor M Schünemann Holger J Garg Amit X Busse Jason W Heels-Ansdell Diane Ghali William A Manns Braden J Guyatt Gordon H |
| Institution: | aDepartment of Medicine, Department of Clinical Epidemiology and Biostatistics, Faculty of Health Sciences, McMaster University, Room 2C8, 1200 Main Street West, Hamilton, ON, L8N 3Z5, Canada bDepartment of Anesthesia and the Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, British Columbia, Canada cDepartment of Medicine, State University of New York at Buffalo, Buffalo, NY, USA dDepartment of Surgery, McMaster University, Hamilton, Ontario, Canada eDepartment of Medicine, Mayo Clinic, Rochester, MN, USA fDepartment of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada gDepartment of Social and Preventive Medicine, State University of New York at Buffalo, Buffalo, NY, USA hDepartments of Medicine and Epidemiology, University of Western Ontario, London, Ontario, Canada |
| Abstract: | BACKGROUND AND OBJECTIVE: Readers of randomized controlled trials (RCTs) commonly assume that what was not reported did not occur. We undertook an observational study to determine whether concealment of randomization or blinding was used in RCTs that failed to report these bias-reducing strategies. METHODS: We recorded the reporting of concealment of randomization and blinding in 105 RCTs. We subsequently contacted the authors and determined if they had used these methodological safeguards. RESULTS: We successfully obtained data from 98 authors. The authors in the full-text publications of these 98 RCTs failed to report the presence or absence of concealment of randomization in 55%, and the blinding status of participants in 26%, health care providers in 64%, data collectors in 84%, outcome assessors in 83%, and data analysts in 96%. In direct contact, authors frequently reported concealing randomization (96%; 95% confidence interval CI=87-100%), blinding participants (20%; 95% CI=7-41%), blinding health care providers (65%; 95% CI=52-77%), blinding data collectors (65%; 95% CI=53-75%), blinding outcome assessors (79%; 95% CI=69-87%), and blinding data analysts (50%; 95% CI=40-60%), despite not reporting the use of these methodological safeguards in their publications. CONCLUSIONS: Readers should not assume that bias-reducing procedures not reported in an RCT did not occur. |
| Keywords: | Randomized controlled trial Research methodology CONSORT statement Blinding Randomization |
| 本文献已被 ScienceDirect PubMed 等数据库收录！ | |