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
List of abbreviations:
PEDro (Physiotherapy Evidence Database), RCT (randomized controlled trial), SCOAR (Centralized Open-Access Rehabilitation database for Stroke), TIDieR (Template for Intervention Description and Replication)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: February 02, 2018
Footnotes
PROSPERO Registry No.: CRD42014009010.
Disclosures: none.
Identification
Copyright
© 2018 by the American Congress of Rehabilitation Medicine
ScienceDirect
Access this article on ScienceDirectLinked Article
- Specifying What We Study and Implement in Rehabilitation: Comments on the Reporting of Clinical ResearchArchives of Physical Medicine and RehabilitationVol. 99Issue 7
- PreviewSeveral guidelines have been published with the goal of increasing the usefulness of reports of clinical research. Although such guidelines may clarify key features of study design, the way in which rehabilitation treatments themselves are described continues to be problematic and limits the ability to replicate research, synthesize evidence across studies, or apply these treatments in practice. Lohse et al report little improvement in the description of rehabilitation treatments in recent years, with particular limitations in the description of comparison or standard-of-care treatments.
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