Rehabilitation interventions in randomized controlled trials for low back pain: proof of statistical significance often is not relevant

Gianola, Silvia; Castellini, Greta; Corbetta, Davide; Moja, Lorenzo

doi:10.1186/s12955-019-1196-8

Cited by 14 publications

(6 citation statements)

References 25 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Indeed, only one RCT derived the MD est from the effect size found in a systematic review. In rehabilitation trials of low back pain, 48 % of the RCTs referenced the source to calculate the MD estimate and under half of the trials discussed the clinical relevance of treatment effects when results did not reach statistical significance [ 17 ]. In the similar vein, the ethics committee documents of RCTs in United Kingdom found that 43 % justified the treatment effect size and 12 % discussed the clinical importance of it [ 18 ].…”

Section: Discussionmentioning

confidence: 99%

Estimates of the mean difference in orthopaedic randomized trials: obligatory yet obscure

Raittio

Launonen

Mattila

et al. 2021

BMC Med Res Methodol

View full text Add to dashboard Cite

Background Randomized controlled trials in orthopaedics are powered to mainly find large effect sizes. A possible discrepancy between the estimated and the real mean difference is a challenge for statistical inference based on p-values. We explored the justifications of the mean difference estimates used in power calculations. The assessment of distribution of observations in the primary outcome and the possibility of ceiling effects were also assessed. Methods Systematic review of the randomized controlled trials with power calculations in eight clinical orthopaedic journals published between 2016 and 2019. Trials with one continuous primary outcome and 1:1 allocation were eligible. Rationales and references for the mean difference estimate were recorded from the Methods sections. The possibility of ceiling effect was addressed by the assessment of the weighted mean and standard deviation of the primary outcome and its elaboration in the Discussion section of each RCT where available. Results 264 trials were included in this study. Of these, 108 (41 %) trials provided some rationale or reference for the mean difference estimate. The most common rationales or references for the estimate of mean difference were minimal clinical important difference (16 %), observational studies on the same subject (8 %) and the ‘clinical relevance’ of the authors (6 %). In a third of the trials, the weighted mean plus 1 standard deviation of the primary outcome reached over the best value in the patient-reported outcome measure scale, indicating the possibility of ceiling effect in the outcome. Conclusions The chosen mean difference estimates in power calculations are rarely properly justified in orthopaedic trials. In general, trials with a patient-reported outcome measure as the primary outcome do not assess or report the possibility of the ceiling effect in the primary outcome or elaborate further in the Discussion section.

show abstract

Section: Discussionmentioning

confidence: 99%

Estimates of the mean difference in orthopaedic randomized trials: obligatory yet obscure

Raittio

Launonen

Mattila

et al. 2021

BMC Med Res Methodol

View full text Add to dashboard Cite

show abstract

“…), but above all increases the statistical power by increasing the number of participants [36]. It is worth mentioning here that one should distinguish between the statistically significant differences (that can be achieved with the inclusion of more patients), and the clinical relevance of the observed difference (independent of the sample size) [37]. Unfortunately, although they offer the highest level of evidence, it does not mean that the conclusions of meta-analyses cannot be biased [24].…”

Section: Challenges In Validation Of New Intervention and Suggestions...mentioning

confidence: 99%

Current Technology Developments Can Improve the Quality of Research and Level of Evidence for Rehabilitation Interventions

Bonnechère¹,

Timmermans²,

Michiels³

2022

Preprint

View full text Add to dashboard Cite

Important current limitations of the implementation of Evidence-Based Practice (EBP) in the rehabilitation field are related to the validation process of new technologies and interventions. Indeed, most of the strict guidelines that have been developed for the validation of new drugs (i.e., double or triple blinded, strict control of the doses and intensity) cannot – or only partially – be applied in rehabilitation. Well powered high quality randomized controlled trials are more difficult to organize in rehabilitation (e.g., longer duration of the intervention in rehabilitation, more difficult to standardize the intervention compared to drugs’ validation studies, limited funding’s since not sponsorized by big pharma companies), which reduces the possibility of conducting systematic reviews and meta-analyses, as currently high level of evidence is sparse. The current limitations of EBP in rehabilitation are presented in this paper and innovative solutions are suggested such as: technology-supported rehabilitation systems, continuous assessment, pragmatic trials, rehabilitation treatment specification systems, and advanced statistical methods, to tackle the limitations to increase the quality of the research in rehabilitation. The development and implementation of new technologies should increase the quality of research and the level of evidence supporting rehabilitation provided some adaptation in our research methodology.

show abstract

“…), but above all it increases the statistical power by increasing the number of participants [ 40 ]. It is worth mentioning that one should distinguish between statistically significant differences (that can be achieved with the inclusion of more patients) and the clinical relevance of the observed difference (independent of the sample size) [ 41 ]. Unfortunately, although they offer the highest level of evidence, it does not mean that the conclusions of meta-analyses cannot be biased [ 27 ].…”

Section: Current Situation and Limitations Of The Research And Its Tr...mentioning

confidence: 99%

Current Technology Developments Can Improve the Quality of Research and Level of Evidence for Rehabilitation Interventions: A Narrative Review

Bonnechère

Timmermans

Michiels

2023

Sensors

View full text Add to dashboard Cite

The current important limitations to the implementation of Evidence-Based Practice (EBP) in the rehabilitation field are related to the validation process of interventions. Indeed, most of the strict guidelines that have been developed for the validation of new drugs (i.e., double or triple blinded, strict control of the doses and intensity) cannot—or can only partially—be applied in rehabilitation. Well-powered, high-quality randomized controlled trials are more difficult to organize in rehabilitation (e.g., longer duration of the intervention in rehabilitation, more difficult to standardize the intervention compared to drug validation studies, limited funding since not sponsored by big pharma companies), which reduces the possibility of conducting systematic reviews and meta-analyses, as currently high levels of evidence are sparse. The current limitations of EBP in rehabilitation are presented in this narrative review, and innovative solutions are suggested, such as technology-supported rehabilitation systems, continuous assessment, pragmatic trials, rehabilitation treatment specification systems, and advanced statistical methods, to tackle the current limitations. The development and implementation of new technologies can increase the quality of research and the level of evidence supporting rehabilitation, provided some adaptations are made to our research methodology.

show abstract

Rehabilitation interventions in randomized controlled trials for low back pain: proof of statistical significance often is not relevant

Cited by 14 publications

References 25 publications

Estimates of the mean difference in orthopaedic randomized trials: obligatory yet obscure

Estimates of the mean difference in orthopaedic randomized trials: obligatory yet obscure

Current Technology Developments Can Improve the Quality of Research and Level of Evidence for Rehabilitation Interventions

Current Technology Developments Can Improve the Quality of Research and Level of Evidence for Rehabilitation Interventions: A Narrative Review

Contact Info

Product

Resources

About