Cross-sectional analysis of the reporting of continuous outcome measures and clinical significance of results in randomized trials of non-pharmacological interventions

Hoffmann, Tammy C., Thomas, Sarah T., Shin, Paul Ng Hung and Glasziou, Paul P. (2014) Cross-sectional analysis of the reporting of continuous outcome measures and clinical significance of results in randomized trials of non-pharmacological interventions. Trials, 15 1: 362.1-362.6. doi:10.1186/1745-6215-15-362


Author Hoffmann, Tammy C.
Thomas, Sarah T.
Shin, Paul Ng Hung
Glasziou, Paul P.
Title Cross-sectional analysis of the reporting of continuous outcome measures and clinical significance of results in randomized trials of non-pharmacological interventions
Journal name Trials   Check publisher's open access policy
ISSN 1745-6215
Publication date 2014-09-01
Sub-type Article (original research)
DOI 10.1186/1745-6215-15-362
Open Access Status DOI
Volume 15
Issue 1
Start page 362.1
End page 362.6
Total pages 6
Place of publication London, United Kingdom
Publisher BioMed Central
Collection year 2015
Language eng
Formatted abstract
Background: Reporting 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.

Methods: A 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.

Results: Across 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.

Conclusions: Scoring 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.
Keyword RCT
Continuous outcome measure
Clinical significance
Scoring
Reporting
Consort
Quality-of-Life
Sample-Size
Statement
Drugs
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2015 Collection
School of Health and Rehabilitation Sciences Publications
 
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