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Examining Clinical Meaningfulness in Randomized Controlled Trials: Revisiting the Well Elderly II / David Schelly [i 1 més]

By: Schelly, David.
Material type: materialTypeLabelArticlePublisher: American Occupational Therapy Association Bethesda, Maryland Content type: Text Media type: informàtic Carrier type: recurs en líniaISSN: 02729490.Subject(s): Teràpia Ocupacional | Assaig clínic aleatoritzat i de controlOnline resources: Accés restringit usuaris EUIT
Contents:
Alisha Ohl
In: American Journal of Occupational Therapy 2019 GEN-FEB;73(1):7301205120p1-7301205120p13Summary: RESUM: OBJECTIVE. Randomized controlled trial (RCT) interventions often rely on p values, where statistical significance is assumed to provide evidence of an intervention effect. This study provides a secondary data analysis of the Well Elderly II RCT using multiple approaches that examine clinical meaningfulness. METHOD. We reanalyzed the Well Elderly II RCT using effect size, standard deviation, standard error of measurement, minimal difference, a fragility index, an assessment of poor scores at baseline, and an analysis with a small subgroup of participants removed. RESULTS. Although some participants improved on several scales, most stayed the same, and a small subset declined. Omitting a small subgroup of participants led to nonsignificant p values. CONCLUSION. There is evidence that disparities in baseline scores and regression to the mean may have created the appearance of an intervention effect. Our methods of considering clinical meaningfulness suggest improved approaches to analyzing RCT data.
List(s) this item appears in: Novetats bibliogràfiques. Articles. Març 2019
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Item type Current location Collection Call number Status Notes Date due Barcode
Journal article Journal article Escola Universitària d'Infermeria i Teràpia Ocupacional de Terrassa
Biblioteca
Paper Capses ordenades alfabèticament (Browse shelf) Exclòs de préstec Consulta a sala 0001017285763
Journal Journal Escola Universitària d'Infermeria i Teràpia Ocupacional de Terrassa
Biblioteca
Paper Capses ordenades alfabèticament (Browse shelf) Exclòs de préstec També consulta en línia 0000101709086

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Alisha Ohl

RESUM: OBJECTIVE. Randomized controlled trial (RCT) interventions often rely on p values, where statistical significance is assumed to provide evidence of an intervention effect. This study provides a secondary data analysis of the Well Elderly II RCT using multiple approaches that examine clinical meaningfulness.

METHOD. We reanalyzed the Well Elderly II RCT using effect size, standard deviation, standard error of measurement, minimal difference, a fragility index, an assessment of poor scores at baseline, and an analysis with a small subgroup of participants removed.

RESULTS. Although some participants improved on several scales, most stayed the same, and a small subset declined. Omitting a small subgroup of participants led to nonsignificant p values.

CONCLUSION. There is evidence that disparities in baseline scores and regression to the mean may have created the appearance of an intervention effect. Our methods of considering clinical meaningfulness suggest improved approaches to analyzing RCT data.

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