Tools to Assess the Risk of Bias and Reporting Quality of Randomized Controlled Trials in Rehabilitation

Arch Phys Med Rehabil. 2021 Aug;102(8):1606-1613. doi: 10.1016/j.apmr.2021.04.007. Epub 2021 May 11.


Objectives: (1) To determine whether new tools and items have been developed to evaluate the risk of bias (RoB) and reporting of randomized controlled trials (RCTs) in rehabilitation; (2) to determine which items are included in the existing reporting guidelines, and to create a matrix of items to report and conduct trials in rehabilitation as the first step for a starting a rigorous validation process.

Data sources: Searches were conducted in MEDLINE, EMBASE, and Cumulative Index to Nursing and Allied Health databases.

Study selection: Studies should describe a newly developed tool to evaluate the RoB or quality of reporting for RCTs in the area of rehabilitation.

Data extraction: (1) First, we extracted items from new tools identified by the electronic search strategies and then (2) we looked at the items provided by the Consolidated Standards of Reporting Trials statement and its relevant extensions. We determined whether these items were already included in our matrix of items. Items were classified based on methodological domains they accomplish, biases they were able to target, and whether they guide reporting or conduct.

Data synthesis: Among the 1596 citations found, 23 articles were potentially relevant. From these, only 3 new scales (National Institute for Complementary Medicine Acupuncture Network, Quality of reports on spa and balneotherapy [SPAC], Assessment of Study Quality and Reporting in Exercise) were found. In addition, the newly updated Cochrane RoB tool (RoB 2.0) was included. Our matrix contained 122 unique items for any rehabilitation area, 46 items (37.7%) were related to conduct, and 58 (47.5%) were related to the reporting; 18 (14.8%) were related to both. Overall, 76 new items were added among all domains.

Conclusions: Many individual and diverse items have been used to guide the reporting and conduct of rehabilitation trials. This indicates a great variability in number of items and an apparent lack of consensus on a core set of items to be used in rehabilitation. Future research should look into developing a core set of items for the rehabilitation field.

Keywords: Biases; Clinical Trials; Methodological study; Quality tool; Rehabilitation; Reporting quality; Risk of bias.

Publication types

  • Review

MeSH terms

  • Bias*
  • Humans
  • Randomized Controlled Trials as Topic / standards*
  • Rehabilitation Research / standards*
  • Research Design / standards*