On the Reporting of Experimental and Control Therapies in Stroke Rehabilitation Trials: A Systematic Review

Keith R Lohse; Anupriya Pathania; Rebecca Wegman; Lara A Boyd; Catherine E Lang

doi:10.1016/j.apmr.2017.12.024

On the Reporting of Experimental and Control Therapies in Stroke Rehabilitation Trials: A Systematic Review

Arch Phys Med Rehabil. 2018 Jul;99(7):1424-1432. doi: 10.1016/j.apmr.2017.12.024. Epub 2018 Mar 2.

Authors

Keith R Lohse¹, Anupriya Pathania², Rebecca Wegman³, Lara A Boyd⁴, Catherine E Lang⁵

Affiliations

¹ Department of Health, Kinesiology, and Recreation, University of Utah, Salt Lake City, UT; Department of Physical Therapy and Athletic Training, University of Utah, Salt Lake City, UT; School of Kinesiology, Auburn University, Auburn, AL. Electronic address: rehabinformatics@gmail.com.
² Department of Health, Kinesiology, and Recreation, University of Utah, Salt Lake City, UT; Department of Physical Therapy and Athletic Training, University of Utah, Salt Lake City, UT; School of Kinesiology, Auburn University, Auburn, AL.
³ School of Kinesiology, Auburn University, Auburn, AL.
⁴ Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada.
⁵ Program in Physical Therapy, Program in Occupational Therapy, Department of Neurology, Washington University School of Medicine, St. Louis, MO.

PMID: 29412168
DOI: 10.1016/j.apmr.2017.12.024

Abstract

Objective: To use the Centralized Open-Access Rehabilitation database for Stroke to explore reporting of both experimental and control interventions in randomized controlled trials for stroke rehabilitation (including upper and lower extremity therapies).

Data sources: The Centralized Open-Access Rehabilitation database for Stroke was created from a search of MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Cumulative Index of Nursing and Allied Health from the earliest available date to May 31, 2014.

Study selection: A total of 2892 titles were reduced to 514 that were screened by full text. This screening left 215 randomized controlled trials in the database (489 independent groups representing 12,847 patients).

Data extraction: Using a mixture of qualitative and quantitative methods, we performed a text-based analysis of how the procedures of experimental and control therapies were described. Experimental and control groups were rated by 2 independent coders according to the Template for Intervention Description and Replication criteria.

Data synthesis: Linear mixed-effects regression with a random effect of study (groups nested within studies) showed that experimental groups had statistically more words in their procedures (mean, 271.8 words) than did control groups (mean, 154.8 words) (P<.001). Experimental groups had statistically more references in their procedures (mean, 1.60 references) than did control groups (mean, .82 references) (P<.001). Experimental groups also scored significantly higher on the total Template for Intervention Description and Replication checklist (mean score, 7.43 points) than did control groups (mean score, 5.23 points) (P<.001).

Conclusions: Control treatments in stroke motor rehabilitation trials are underdescribed relative to experimental treatments. These poor descriptions are especially problematic for "conventional" therapy control groups. Poor reporting is a threat to the internal validity and generalizability of clinical trial results. We recommend authors use preregistered protocols and established reporting criteria to improve transparency.

Keywords: Data reporting; Informatics; Rehabilitation; Research design; Stroke.

Publication types

Systematic Review

MeSH terms

Control Groups
Data Accuracy*
Databases, Factual
Female
Humans
Male
Randomized Controlled Trials as Topic / standards*
Regression Analysis
Rehabilitation Research / methods
Rehabilitation Research / standards*
Stroke Rehabilitation / methods
Stroke Rehabilitation / statistics & numerical data*