A systematic review of orthopaedic manual therapy randomized clinical trials quality (original) (raw)
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Annals of internal medicine
Overwhelming evidence now indicates that the quality of reporting of randomized, controlled trials (RCTs) is less than optimal. Recent methodologic analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which boast the elimination of systematic error as their primary hallmark. Systematic error in RCTs reflects poor science, and poor science threatens proper ethical standards.
The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration
Annals of Internal Medicine, 2001
Overwhelming evidence now indicates that the quality of reporting of randomized, controlled trials (RCTs) is less than optimal. Recent methodologic analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which boast the elimination of systematic error as their primary hallmark. Systematic error in RCTs reflects poor science, and poor science threatens proper ethical standards.
BMC Medical Research Methodology, 2013
Background: Assessing the risk of bias of randomized controlled trials (RCTs) is crucial to understand how biases affect treatment effect estimates. A number of tools have been developed to evaluate risk of bias of RCTs; however, it is unknown how these tools compare to each other in the items included. The main objective of this study was to describe which individual items are included in RCT quality tools used in general health and physical therapy (PT) research, and how these items compare to those of the Cochrane Risk of Bias (RoB) tool. Methods: We used comprehensive literature searches and a systematic approach to identify tools that evaluated the methodological quality or risk of bias of RCTs in general health and PT research. We extracted individual items from all quality tools. We calculated the frequency of quality items used across tools and compared them to those in the RoB tool. Comparisons were made between general health and PT quality tools using Chi-squared tests. Results: In addition to the RoB tool, 26 quality tools were identified, with 19 being used in general health and seven in PT research. The total number of quality items included in general health research tools was 130, compared with 48 items across PT tools and seven items in the RoB tool. The most frequently included items in general health research tools (14/19, 74%) were inclusion and exclusion criteria, and appropriate statistical analysis. In contrast, the most frequent items included in PT tools (86%, 6/7) were: baseline comparability, blinding of investigator/assessor, and use of intention-to-treat analysis. Key items of the RoB tool (sequence generation and allocation concealment) were included in 71% (5/7) of PT tools, and 63% (12/19) and 37% (7/19) of general health research tools, respectively. Conclusions: There is extensive item variation across tools that evaluate the risk of bias of RCTs in health research. Results call for an in-depth analysis of items that should be used to assess risk of bias of RCTs. Further empirical evidence on the use of individual items and the psychometric properties of risk of bias tools is needed.
PEDro or Cochrane to Assess the Quality of Clinical Trials? A Meta-Epidemiological Study
PloS one, 2015
There is debate on how the methodological quality of clinical trials should be assessed. We compared trials of physical therapy (PT) judged to be of adequate quality based on summary scores from the Physiotherapy Evidence Database (PEDro) scale with trials judged to be of adequate quality by Cochrane Risk of Bias criteria. Meta-epidemiological study within Cochrane Database of Systematic Reviews. Meta-analyses of PT trials were identified in the Cochrane Database of Systematic Reviews. For each trial PeDro and Cochrane assessments were extracted from the PeDro and Cochrane databases. Adequate quality was defined as adequate generation of random sequence, concealment of allocation, and blinding of outcome assessors (Cochrane criteria) or as trials with a PEDro summary score ≥5 or ≥6 points. We combined trials of adequate quality using random-effects meta-analysis. Forty-one Cochrane reviews and 353 PT trials were included. All meta-analyses included trials with PEDro scores ≥5, 37 (9...
Scales to assess the quality of randomized controlled trials: a systematic review
Physical therapy, 2008
The methodological quality of randomized controlled trials (RCTs) is commonly evaluated in order to assess the risk of biased estimates of treatment effects. The purpose of this systematic review was to identify scales used to evaluate the methodological quality of RCTs in health care research and summarize the content, construction, development, and psychometric properties of these scales. Methods Extensive electronic database searches, along with a manual search, were performed. Results One hundred five relevant studies were identified. They accounted for 21 scales and their modifications. The majority of scales had not been rigorously developed or tested for validity and reliability. The Jadad Scale presented the best validity and reliability evidence; however, its validity for physical therapy trials has not been supported. Discussion and Conclusion Many scales are used to evaluate the methodological quality of RCTs, but most of these scales have not been adequately developed and have not been adequately tested for validity and reliability. A valid and reliable scale for the assessment of the methodological quality of physical therapy trials needs to be developed.
BMC research notes, 2015
Assessing methodological quality of primary studies is an essential component of systematic reviews. Following a systematic review which used a domain based system [United States Preventative Services Task Force (USPSTF)] to assess methodological quality, a commonly used numerical rating scale (Downs and Black) was also used to evaluate the included studies and comparisons were made between quality ratings assigned using the two different methods. Both tools were used to assess the 20 randomized and quasi-randomized controlled trials examining an exercise intervention for chronic musculoskeletal pain which were included in the review. Inter-rater reliability and levels of agreement were determined using intraclass correlation coefficients (ICC). Influence of quality on pooled effect size was examined by calculating the between group standardized mean difference (SMD). Inter-rater reliability indicated at least substantial levels of agreement for the USPSTF system (ICC 0.85; 95% CI 0...
Journal of Clinical Epidemiology, 2018
Objective: To compare A Measurement Tool to Assess Systematic Reviews (AMSTAR 2) with a tool to assess risk of bias in systematic reviews (ROBIS) in terms of validity, reliability, and applicability. Study Design and Setting: We analyzed 30 systematic reviews (SRs) that included randomized and nonrandomized studies, with Cochrane and non-Cochrane SRs sampled in 1:1 ratio. Four reviewers assessed independently all 30 SRs with AMSTAR 2, followed by RO-BIS. We calculated Fleiss' Kappa as a measure of inter-rater reliability (IRR) across 4 raters. Results: The IRR for scoring the overall confidence in the SRs with AMSTAR 2 and the overall domain in ROBIS was fair (AMSTAR 2: k 5 0.30, 95% [confidence interval] CI: 0.17 to 0.43; ROBIS: k 5 0.28, 95% CI: 0.13 to 0.42). AMSTAR 2 confidence in review ratings strongly correlated with the overall domain rating in ROBIS (Spearman r s 5 0.84). Mean time for scoring AMSTAR 2 was slightly higher than for ROBIS (18 vs. 16 min), with huge differences between the reviewers. Conclusion: Both AMSTAR 2 and ROBIS can be applied to SRs including both randomized controlled trials (RCTs) and non-RCTs. Measurement properties of ROBIS seemed not to be much different when comparing with other studies that include only SRs of RCTs.