Randomized trials published in higher vs. lower impact journals differ in design, conduct, and analysis

被引:65
作者
Bala, Malgorzata M. [1 ]
Akl, Elie A. [2 ,3 ,4 ]
Sun, Xin [2 ,5 ]
Bassler, Dirk [6 ,7 ]
Mertz, Dominik [2 ,8 ]
Mejza, Filip [9 ]
Vandvik, Per Olav [10 ,11 ]
Malaga, German [12 ]
Johnston, Bradley C. [13 ,14 ,15 ]
Dahm, Philipp [16 ]
Alonso-Coello, Pablo [17 ]
Diaz-Granados, Natalia [2 ]
Srinathan, Sadeesh K. [18 ]
Hassouneh, Basil [2 ]
Briel, Matthias [2 ,19 ]
Busse, Jason W. [2 ,20 ]
You, John J. [2 ]
Walter, Stephen D. [2 ]
Altman, Douglas G. [21 ]
Guyatt, Gordon H. [2 ]
机构
[1] Jagiellonian Univ, Sch Med, Dept Internal Med 2, PL-31066 Krakow, Poland
[2] McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON L8S 4K1, Canada
[3] Amer Univ Beirut, Dept Internal Med, Beirut, Lebanon
[4] SUNY Buffalo, Dept Med, Buffalo, NY 14228 USA
[5] Kaiser Permanente NW, Ctr Hlth Res, Portland, OR 97227 USA
[6] Univ Childrens Hosp Tuebingen, Ctr Pediat Clin Studies, D-72076 Tubingen, Germany
[7] Univ Childrens Hosp Tuebingen, Dept Neonatol, D-72076 Tubingen, Germany
[8] McMaster Univ, Dept Med, Hamilton, ON L8S 4K1, Canada
[9] Jagiellonian Univ, Sch Med, Dept Pulm Dis, PL-31066 Krakow, Poland
[10] Norwegian Knowledge Ctr Hlth Serv, N-0130 Oslo, Norway
[11] Innlandet Hosp Trust, Dept Med, N-2819 Gjovik, Norway
[12] Univ Peruana Cayetano Heredia, CONEVID, Lima 31, Peru
[13] Hosp Sick Children, Res Inst, Toronto, ON M5G 1X8, Canada
[14] Univ Toronto, Dept Anesthesia & Pain Med, Toronto, ON M5T 3M6, Canada
[15] Univ Toronto, Inst Hlth Policy Management & Evaluat, Toronto, ON M5T 3M6, Canada
[16] Univ Florida, Coll Med, Hlth Sci Ctr, Dept Urol, Gainesville, FL 32610 USA
[17] Inst Biomed Res IIB Sant Pau, Iberoamer Cochrane Ctr, Barcelona 08041, Spain
[18] Univ Manitoba, Dept Surg, Winnipeg, MB R3A 1R9, Canada
[19] Univ Basel Hosp, Basel Inst Clin Epidemiol & Biostat, CH-4031 Basel, Switzerland
[20] McMaster Univ, Dept Anesthesia, Hamilton, ON L8S 4L8, Canada
[21] Univ Oxford, Wolfson Coll Annexe, Ctr Stat Med, Oxford OX2 6UD, England
基金
瑞士国家科学基金会; 加拿大健康研究院;
关键词
Systematic review; Randomized controlled trial; Data interpretation; Humans; Periodical; Research design; SUBGROUP ANALYSIS; CLINICAL-TRIALS; METHODOLOGICAL QUALITY; EMPIRICAL-EVIDENCE; OUTCOMES; BIAS; CONCEALMENT;
D O I
10.1016/j.jclinepi.2012.10.005
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
100404 [儿少卫生与妇幼保健学];
摘要
Objective: To compare methodological characteristics of randomized controlled trials (RCTs) published in higher vs. lower impact Core Clinical Journals. Study Design and Setting: We searched MEDLINE for RCTs published in 2007 in Core Clinical Journals. We randomly sampled 1,140 study reports in a 1:1 ratio in higher (five general medicine journals with the highest total citations in 2007) and lower impact journals. Results: Four hundred sixty-nine RCTs proved eligible: 219 in higher and 250 in lower impact journals. RCTs in higher vs. lower impact journals had larger sample sizes (median, 285 vs. 39), were more likely to receive industry funding (53% vs. 28%), declare concealment of allocation (66% vs. 36%), declare blinding of health care providers (53% vs. 41%) and outcome adjudicators (72% vs. 54%), report a patient-important primary outcome (69% vs. 50%), report subgroup analyses (64% vs. 26%), prespecify subgroup hypotheses (42% vs. 20%), and report a test for interaction (54% vs. 27%); P < 0.05 for all differences. Conclusion: RCTs published in higher impact journals were more likely to report methodological safeguards against bias and patient-important outcomes than those published in lower impact journals. However, sufficient limitations remain such that publication in a higher impact journal does not ensure low risk of bias. (C) 2013 Elsevier Inc. All rights reserved.
引用
收藏
页码:286 / 295
页数:10
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