THE REPORTING OF BLINDING IN PHYSICAL MEDICINE AND REHABILITATION RANDOMIZED CONTROLLED TRIALS: A SYSTEMATIC REVIEW

被引:30
作者
Villamar, Mauricio F. [1 ,2 ,3 ]
Contreras, Vanessa Suarez [1 ,2 ]
Kuntz, Richard E. [4 ]
Fregni, Felipe [1 ,2 ]
机构
[1] Spaulding Rehabil Hosp, Lab Neuromodulat, Dept Phys Med & Rehabil, Boston, MA 02114 USA
[2] Harvard Univ, Massachusetts Gen Hosp, Sch Med, Boston, MA USA
[3] Pontifical Catholic Univ Ecuador, Sch Med, Quito, Ecuador
[4] Medtronic Inc, Minneapolis, MN USA
关键词
blinding; clinical research; physical medicine; rehabilitation; randomized controlled trials as topic; CLINICAL-TRIALS; QUALITY; STIMULATION; METHODOLOGY; EXTENSION; MAINTAIN; EXAMPLE; IMPACT; SAMPLE; BIAS;
D O I
10.2340/16501977-1071
中图分类号
R49 [康复医学];
学科分类号
100215 ;
摘要
Objective: To conduct a systematic review evaluating the reporting of blinding in randomized controlled trials published in the field of Physical Medicine and Rehabilitation over two time periods. Data sources: We searched MEDLINE via PubMed for all randomized controlled trials published in American Journal of Physical Medicine and Rehabilitation, Archives of Physical Medicine and Rehabilitation, Clinical Rehabilitation, Disability and Rehabilitation and (Scandinavian) Journal of Rehabilitation Medicine in the years 2000 and 2010. Study selection: We initially identified 222 articles, and 139 (62.6%) met our selection criteria. Data extraction: Two independent investigators collected data regarding study characteristics and blinding from each article. Consistency of data extraction was evaluated. Data synthesis: When comparing articles from 2010 and 2000, the former showed significantly higher rates for reporting of blinding, explicitly describing key persons' blinding status, and discussing the absence of blinding as a study limitation. There was a trend for lower reporting among trials with positive outcomes. No improvement was observed in other CONSORT-enforced parameters. Conclusions: Although the reporting of blinding in Physical Medicine and Rehabilitation randomized controlled trials shows some improvement over the past decade, it still does not fulfill current recommendations. Given its critical role in determining internal validity, stricter enforcement of CONSORT guidelines is needed.
引用
收藏
页码:6 / 13
页数:8
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