SynthesisHealth and quality of life outcomes2019
Rehabilitation interventions in randomized controlled trials for low back pain: proof of statistical significance often is not relevant.
Synthesis in Health and quality of life outcomes, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Kinesio taping for rotator cuff disease.The Cochrane database of systematic reviews · 2021Pooled it
- Estimates of the mean difference in orthopaedic randomized trials: obligatory yet obscure.BMC medical research methodology · 2021Pooled it
- Comparable Minimally Important Differences and Responsiveness of Brief Pain Inventory and PEG Pain Scales across 6 Trials.The journal of pain · 2024Article
- Improving Rehabilitation Research to Optimize Care and Outcomes for People with Chronic Primary Low Back Pain: Methodological and Reporting Recommendations from a WHO Systematic Review Series.Journal of occupational rehabilitation · 2023Article
- Current Technology Developments Can Improve the Quality of Research and Level of Evidence for Rehabilitation Interventions: A Narrative Review.Sensors (Basel, Switzerland) · 2023Review
- Kinesio taping application for rotator cuff disease: Beneficial or harmful? - A Cochrane Review summary with commentary.Turkish journal of physical medicine and rehabilitation · 2022Article
- Reporting of confidence intervals, achievement of intended sample size, and adjustment for multiple primary outcomes in randomised trials of physical therapy interventions: an analysis of 100 representatively sampled trials.Brazilian journal of physical therapyReview
- Clinical relevance of the effects of robotic rehabilitation for upper limb recovery after stroke in randomized studies: a systematic review with meta-analysis.Archives of physiotherapyReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
backgroundAn observed statistically significant difference between two interventions does not necessarily imply that this difference is clinically important for patients and clinicians. We aimed to assess if treatment effects of randomized controlled trials (RCTs) for low back pain (LBP) are statistically significant and clinically relevant, and if RCTs were powered to achieve clinically relevant differences on continuous outcomes.
methodsWe searched for all RCTs included in Cochrane Systematic Reviews focusing on the efficacy of rehabilitation interventions for LBP and published until April 2017. RCTs having sample size calculation and a planned minimal important difference were considered. In the primary analysis, we calculated the proportion of RCTs classified as "statistically significant and clinically relevant", "statistically significant but not clinically relevant", "not statistically significant but clinically relevant", and "not statistically significant and not clinically relevant". Then, we investigated how many times the mismatch between statistical significance and clinical relevance was due to inadequate power.
resultsFrom 20 eligible SRs including 101 RCTs, we identified 42 RCTs encompassing 81 intervention comparisons. Overall, 60% (25 RCTs) were statistically significant while only 36% (15 RCTs) were both statistically and clinically significant. Most trials (38%) did not discuss the clinical relevance of treatment effects when results did not reached statistical significance. Among trials with non-statistically significant findings, 60% did not reach the planned sample size, therefore being at risk to not detect an effect that is actually there (type II error).
conclusionOnly a minority of positive RCT findings was both statistically significant and clinically relevant. Scarce diligence or frank omissions of important tactic elements of RCTs, such as clinical relevance, and power, decrease the reliability of study findings to current practice.
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What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.