Evidence map›Paper›PMID 24996957›Full record

ArticleBMC medical research methodology2014

A simple ratio-based approach for power and sample size determination for 2-group comparison using Rasch models.

Véronique Sébille, Myriam Blanchin, Francis Guillemin, Bruno Falissard, Jean-Benoit Hardouin

Abstract read
In one paragraph

Article in BMC medical research methodology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Véronique SébilleEA 4275, Biostatistics, Pharmacoepidemiology and Subjective Measures in Health Sciences, University of Nantes, Nantes, France. veronique.sebille@univ-nantes.fr.
Myriam Blanchin
Francis Guillemin
Bruno Falissard
Jean-Benoit Hardouin

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite the widespread use of patient-reported Outcomes (PRO) in clinical studies, their design remains a challenge. Justification of study size is hardly provided, especially when a Rasch model is planned for analysing the data in a 2-group comparison study. The classical sample size formula (CLASSIC) for comparing normally distributed endpoints between two groups has shown to be inadequate in this setting (underestimated study sizes). A correction factor (RATIO) has been proposed to reach an adequate sample size from the CLASSIC when a Rasch model is intended to be used for analysis. The objective was to explore the impact of the parameters used for study design on the RATIO and to identify the most relevant to provide a simple method for sample size determination for Rasch modelling.

methodsA large combination of parameters used for study design was simulated using a Monte Carlo method: variance of the latent trait, group effect, sample size per group, number of items and items difficulty parameters. A linear regression model explaining the RATIO and including all the former parameters as covariates was fitted.

resultsThe most relevant parameters explaining the ratio's variations were the number of items and the variance of the latent trait (R2 = 99.4%).

conclusionsUsing the classical sample size formula adjusted with the proposed RATIO can provide a straightforward and reliable formula for sample size computation for 2-group comparison of PRO data using Rasch models.

Indexed as

Biomedical ResearchComputer SimulationResearch DesignData Interpretation, StatisticalHumansLinear ModelsMental HealthModels, StatisticalMonte Carlo MethodRegression AnalysisSample SizeTreatment Outcome

Identifiers

PMID24996957
PMCPMC4105835

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 OpenQuestion graph.