Reduction in burden of illness: a new efficacy measure for prevention trials.
Stat Med
; 13(18): 1807-14, 1994 Sep 30.
Article
en En
| MEDLINE
| ID: mdl-7997714
A new efficacy measure is developed for use in prevention trials of interventions which may affect both disease incidence and disease severity. We assign a severity score to each incident case and sum severity scores over all incident cases within each treatment group to create a burden-of-illness score for each treatment group. Efficacy is evaluated by the difference between the burden-of-illness per randomized subject in the two randomized treatment groups. Since the numbers of summands in each burden-of-illness score is a random variable, standard methods of analysis are not directly applicable. The asymptotic distribution and sampling properties of the net reduction in the burden-of-illness score are derived for trials designed to stop either after a fixed length of follow-up or after the occurrence of a fixed number of cases. We illustrate the method with data from a clinical trial of a human rotavirus vaccine.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Prevención Primaria
/
Ensayos Clínicos Controlados Aleatorios como Asunto
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Modelos Estadísticos
Tipo de estudio:
Clinical_trials
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Etiology_studies
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Incidence_studies
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Prognostic_studies
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Risk_factors_studies
Límite:
Humans
Idioma:
En
Revista:
Stat Med
Año:
1994
Tipo del documento:
Article
Pais de publicación:
Reino Unido