ArticleTrials2014
Cross-sectional analysis of the reporting of continuous outcome measures and clinical significance of results in randomized trials of non-pharmacological interventions.
Article in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 3 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, 3 syntheses or guidelines pooled it.
- Reporting of PPI and the MCID in phase III/IV randomised controlled trials-a systematic review.Trials · 2023Pooled it
- Rehabilitation interventions in randomized controlled trials for low back pain: proof of statistical significance often is not relevant.Health and quality of life outcomes · 2019Pooled it
- Clinical significance in pediatric oncology randomized controlled treatment trials: a systematic review.Trials · 2018Pooled it
- Poor statistical reporting, inadequate data presentation and spin persist despite editorial advice.PloS one · 2018Article
- Simple decision-tree tool to facilitate author identification of reporting guidelines during submission: a before-after study.Research integrity and peer review · 2017Article
- Is research quality in orthopedic manual therapy trials stagnating? Reflections and pathways for improving research quality and advance our profession.The Journal of manual & manipulative therapy · 2016Article
- Making research articles fit for purpose: structured reporting of key methods and findings.Trials · 2015Article
- 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
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
No grant is acknowledged in the PubMed record.
Abstract
backgroundReporting the scoring details of continuous outcome measures in randomized trials allows readers to interpret the size of any effect of the intervention. This study aimed to determine, in a sample of randomized trials: 1) the completeness of reporting of scoring details for continuous outcome measures, and 2) whether trial authors comment on the clinical significance of statistically significant trial results.
methodsA descriptive analysis of randomized trials of non-pharmacological interventions published during 2009 in the six leading general medical journals (n = 138), and which used at least one continuous outcome measure (n = 85). From each trial report, two authors independently extracted the following information about each continuous outcome measure: the reporting of its scoring details, presentation of its results, and the reporting and justification of the clinical significance of the results.
resultsAcross the 84 trials, we identified 336 continuous outcome measures. A total of 146 (44%) were published measures, 12 (4%) were adapted from published measures, 5 (1%) were developed for the trial, and 173 (51%) were 'conventional measures' for which scoring details are not necessary (such as weight). For 57 (35%) of the 163 non-conventional outcome measures no scoring details or reference to the outcome measure were provided in the trial report. Of the 159 outcome measures with a statistically significant result, clinical significance was not mentioned for 81 (51%) and was reported without any elaboration or justification for 39 (25%) of them.
conclusionsScoring details of continuous outcome measures used in this sample of randomized trials of non-pharmacological interventions were incompletely reported, which hampers interpretation of a trial's results. Complete reporting of scoring details is important when considering the clinical significance of the results. When deciding about an intervention, having this information may help clinicians in their conversations with patients about the possible benefits and harms, and their size, of the intervention.
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Registered trials
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