Specific instructions for estimating unclearly reported blinding status in randomized trials were reliable and valid

被引：131

作者：

Akl, Elie A. ^{[1
,2
,3
]}

Sun, Xin ^{[3
,4
]}

Busse, Jason W. ^{[3
,5
]}

Johnston, Bradley C. ^{[3
]}

Briel, Matthias ^{[3
,6
]}

Mulla, Sohail ^{[3
]}

You, John J. ^{[3
,7
]}

Bassler, Dirk ^{[8
,9
]}

Lamontagne, Francois ^{[10
]}

Vera, Claudio ^{[11
]}

Alshurafa, Mohamad ^{[3
]}

Katsios, Christina M. ^{[7
]}

Heels-Ansdell, Diane ^{[3
]}

Zhou, Qi ^{[3
]}

Mills, Ed ^{[3
]}

Guyatt, Gordon H. ^{[3
,7
]}

机构：

[1] SUNY Buffalo, Dept Med, Buffalo, NY 14215 USA

[2] SUNY Buffalo, Dept Family Med, Buffalo, NY 14215 USA

[3] McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON L8S 4K1, Canada

[4] Sichuan Univ, Dept Clin Epidemiol, W China Hosp, Chengdu 610064, Peoples R China

[5] Inst Work & Hlth, Toronto, ON M5G 2E9, Canada

[6] Univ Basel Hosp, Basel Inst Clin Epidemiol & Biostat, CH-4031 Basel, Switzerland

[7] McMaster Univ, Dept Med, Hamilton, ON L8S 4K1, Canada

[8] Univ Childrens Hosp Tuebingen, Dept Neonatol, Tubingen, Germany

[9] Univ Childrens Hosp Tuebingen, Ctr Pediat Clin Studies, Tubingen, Germany

[10] Univ Sherbrooke, Dept Med, Sherbrooke, PQ J1K 2R1, Canada

[11] Pontificia Univ Catolica Chile, Dept Obstet & Gynecol, Santiago, Chile

来源：

JOURNAL OF CLINICAL EPIDEMIOLOGY | 2012年 / 65卷 / 03期

基金：

中国国家自然科学基金; 瑞士国家科学基金会; 加拿大健康研究院;

关键词：

Methods; Research design; Bias; Randomized controlled trial; Systematic review; Clinical practice guideline;

D O I：

10.1016/j.jclinepi.2011.04.015

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

Objective: To test the reliability and validity of specific instructions to classify blinding, when unclearly reported in randomized trials, as "probably done" or "probably not done." Study Design and Setting: We assessed blinding of patients, health care providers, data collectors, outcome adjudicators, and data analysts in 233 randomized trials in duplicate and independently using detailed instructions. The response options were "definitely yes," "probably yes," "probably no," and "definitely no." We contacted authors for data verification (46% response). For each of the five questions, we assessed reliability by calculating the agreement between the two reviewers and validity by calculating the agreement between reviewers' consensus and verified data. Results: The percentage with unclear blinding status varied between 48.5% (patients) and 84.1% (data analysts). Reliability was moderate for blinding of outcome adjudicators (kappa = 0.52) and data analysts (kappa = 0.42) and substantial for blinding of patients (kappa = 0.71), providers (kappa = 0.68), and data collectors (kappa = 0.65). The raw agreement between the consensus record and the author-verified record varied from 84.1% (blinding of data analysts) to 100% (blinding of health care providers). Conclusion: With the possible exception of blinding of data analysts, use of "probably yes" and "probably no" instead of "unclear" may enhance the assessment of blinding in trials. (C) 2012 Elsevier Inc. All rights reserved.

引用

页码：262 / 267

页数：6

共 8 条

[1] LOST to follow-up Information in Trials (LOST-IT): a protocol on the potential impact [J].

Akl, Elie A. ;

Briel, Matthias ;

You, John J. ;

Lamontagne, Francois ;

Gangji, Azim ;

Cukierman-Yaffe, Tali ;

Alshurafa, Mohamad ;

Sun, Xin ;

Nerenberg, Kara A. ;

Johnston, Bradley C. ;

Vera, Claudio ;

Mills, Edward J. ;

Bassler, Dirk ;

Salazar, Arturo ;

Bhatnagar, Neera ;

Busse, Jason W. ;

Khalid, Zara ;

Walter, S. D. ;

Cook, Deborah J. ;

Schuenemann, Holger J. ;

Altman, Douglas G. ;

Guyatt, Gordon H. .

TRIALS, 2009, 10

[2]

[Anonymous], 2005, BMJ-BRIT MED J

[3] An observational study found that authors of randomized controlled trials frequently use concealment of randomization and blinding, despite the failure to report these methods [J].

Devereaux, PJ ;

Choi, PTL ;

El-Dika, S ;

Bhandari, M ;

Montori, VM ;

Schünemann, HJ ;

Garg, AX ;

Busse, JW ;

Heels-Ansdell, D ;

Ghali, WA ;

Manns, BJ ;

Guyatt, GH .

JOURNAL OF CLINICAL EPIDEMIOLOGY, 2004, 57 (12) :1232-1236

[4] Who is blinded in randomized clinical trials?: A study of 200 trials and a survey of authors [J].

Haahr, Mette Thorlund ;

Hrobjartsson, Asbjorn .

CLINICAL TRIALS, 2006, 3 (04) :360-365

[5]

Higgins J., 2008, Cochrane Handbook for Systematic Reviews of Interventions, DOI [10.1002/9780470712184, DOI 10.1002/9780470712184]

[6] MEASUREMENT OF OBSERVER AGREEMENT FOR CATEGORICAL DATA [J].

LANDIS, JR ;

KOCH, GG .

BIOMETRICS, 1977, 33 (01) :159-174

[7] In the dark - The reporting of blinding status in randomized controlled trials [J].

Montori, VM ;

Bhandari, M ;

Devereaux, PJ ;

Manns, BJ ;

Ghali, WA ;

Guyatt, GH .

JOURNAL OF CLINICAL EPIDEMIOLOGY, 2002, 55 (08) :787-790

[8]

Schulz KF, 2010, J CLIN EPIDEMIOL, V63, P834, DOI [10.1016/j.jclinepi.2010.02.005, 10.1136/bmj.c332, 10.1016/j.ijsu.2011.09.004, 10.4103/0976-500X.72352, 10.1136/bmj.c869, 10.1186/1741-7015-8-18]

← 1 →