On reporting results from randomized controlled trials with recurrent events.
BMC Med Res Methodol
; 8: 35, 2008 May 30.
Article
in En
| MEDLINE
| ID: mdl-18513418
ABSTRACT
BACKGROUND:
Evidence-based medicine has been advanced by the use of standards for reporting the design and methodology of randomized controlled trials (RCT). Indeed, without this information it is difficult to assess the quality of evidence from an RCT. Although a variety of statistical methods are available for the analysis of recurrent events, reporting the effect of an intervention on outcomes that recur is an area that remains poorly understood in clinical research. The purpose of this paper is to outline guidelines for reporting results from RCTs where the outcome of interest is a recurrent event.METHODS:
We used a simulation study to relate an event process and results from analyses of the gamma-Poisson, independent-increment, conditional, and marginal Cox models. We reviewed the utility of regression models for the rate of a recurrent event by articulating the associated study questions, preenting the risk sets, and interpreting the regression coefficients.RESULTS:
Based on a single data set produced by simulation, we reported and contrasted results from statistical methods for evaluating treatment effect from an RCT with a recurrent outcome. We showed that each model has different study questions, assumptions, risk sets, and rate ratio interpretation, and so inferences should consider the appropriateness of the model for the RCT.CONCLUSION:
Our guidelines for reporting results from an RCT involving a recurrent event suggest that the study question and the objectives of the trial, such as assessing comparable groups and estimating effect size, should determine the statistical methods. The guidelines should allow clinical researchers to report appropriate measures from an RCT for understanding the effect of intervention on the occurrence of a recurrent event.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Accidental Falls
/
Randomized Controlled Trials as Topic
/
Data Interpretation, Statistical
Type of study:
Clinical_trials
/
Diagnostic_studies
/
Etiology_studies
/
Guideline
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Prognostic_studies
/
Risk_factors_studies
Limits:
Humans
Language:
En
Journal:
BMC Med Res Methodol
Journal subject:
MEDICINA
Year:
2008
Document type:
Article
Affiliation country:
Canada
Publication country:
ENGLAND
/
ESCOCIA
/
GB
/
GREAT BRITAIN
/
INGLATERRA
/
REINO UNIDO
/
SCOTLAND
/
UK
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UNITED KINGDOM