Article type
Year
Abstract
Background:
Selection of appropriate outcome measures is crucial in clinical trials in order to minimize bias and allow for precise comparisons of effects between interventions.
Objectives:
We aimed to assess the frequency and completeness of outcome measures in randomized controlled trials (RCTs) included in Cochrane systematic reviews (SRs), focusing on rehabilitation interventions for mechanical low-back pain.
Methods:
We performed a cross-sectional study of all RCTs included in all Cochrane SRs (full-text) published in the Cochrane Database of Systematic Reviews in February 2013 that focused on evaluations of the efficacy and safety of rehabilitation interventions for mechanical low-back pain. Two authors independently evaluated the type and frequency of each outcome measure reported in the full-text of RCTs, the methods used to measure outcomes, and the proportion of outcomes fully replicable based on the reported information.
Results:
Our literature search identified 11 Cochrane SRs, including 185 RCTs. Across all RCTs, 36 different outcomes were investigated. Those most commonly reported were pain [n=164 RCTs (89%)] and disability [n=119 RCTs (62%)], which were measured by 66 and 44 measurement tools, respectively. Other frequently reported outcomes were range of motion [n=70 RCTs (38%)] and quality of life [n=45 RCTs (24%)]. The procedure of blinding assessment was reported in 52% of the RCTs for pain (n=85) and 44% of RCTs for disability (n=52). Pain, disability, range of motion, and quality of life outcomes were reported as fully replicable in 10% (n=17), 10% (n=12), 6% (n=4), and 7% (n=3) of the RCTs, respectively.
Conclusions:
A large number of outcome measures and a myriad of measurement instruments were used across all RCTs. The reporting was largely incomplete, suggesting better opportunities for the standardization of approaches and reporting.
Selection of appropriate outcome measures is crucial in clinical trials in order to minimize bias and allow for precise comparisons of effects between interventions.
Objectives:
We aimed to assess the frequency and completeness of outcome measures in randomized controlled trials (RCTs) included in Cochrane systematic reviews (SRs), focusing on rehabilitation interventions for mechanical low-back pain.
Methods:
We performed a cross-sectional study of all RCTs included in all Cochrane SRs (full-text) published in the Cochrane Database of Systematic Reviews in February 2013 that focused on evaluations of the efficacy and safety of rehabilitation interventions for mechanical low-back pain. Two authors independently evaluated the type and frequency of each outcome measure reported in the full-text of RCTs, the methods used to measure outcomes, and the proportion of outcomes fully replicable based on the reported information.
Results:
Our literature search identified 11 Cochrane SRs, including 185 RCTs. Across all RCTs, 36 different outcomes were investigated. Those most commonly reported were pain [n=164 RCTs (89%)] and disability [n=119 RCTs (62%)], which were measured by 66 and 44 measurement tools, respectively. Other frequently reported outcomes were range of motion [n=70 RCTs (38%)] and quality of life [n=45 RCTs (24%)]. The procedure of blinding assessment was reported in 52% of the RCTs for pain (n=85) and 44% of RCTs for disability (n=52). Pain, disability, range of motion, and quality of life outcomes were reported as fully replicable in 10% (n=17), 10% (n=12), 6% (n=4), and 7% (n=3) of the RCTs, respectively.
Conclusions:
A large number of outcome measures and a myriad of measurement instruments were used across all RCTs. The reporting was largely incomplete, suggesting better opportunities for the standardization of approaches and reporting.