Optimal information size in trial sequential analysis of time-to-event outcomes reveals potentially inconclusive results because of the risk of random error.

Miladinovic, Branko; Mhaskar, Rahul; Hozo, Iztok; Kumar, Ambuj; Mahony, Helen; Djulbegovic, Benjamin

Miladinovic, Branko; Mhaskar, Rahul; Hozo, Iztok; Kumar, Ambuj; Mahony, Helen; Djulbegovic, Benjamin.

Afiliación

Miladinovic B; Center for Evidence Based Medicine and Health Outcomes Research, Department of Internal Medicine, Clinical and Translational Science Institute, Morsani College of Medicine, University of South Florida, 3515 East Fletcher Avenue, MDC 27, Tampa, FL 33612, USA. bmiladin@health.usf.edu

J Clin Epidemiol ; 66(6): 654-9, 2013 Jun.

Article en En | MEDLINE | ID: mdl-23403248

RESUMEN

OBJECTIVES: The current approach for evaluating the risk of random error in meta-analyses (MAs) using trial sequential analysis (TSA) can accommodate binary and continuous data but not time-to-event data. We conducted a TSA for time-to-event outcomes and applied the method to determine the risk of random error in MAs for treatments of multiple myeloma. STUDY DESIGN AND SETTING: Literature search identified 11 systematic reviews consisting of 23 MAs. Of the 23 MAs, 13 had overall survival and 10 had progression-free survival as outcome; 48% (11 of 23) reported statistically significant treatment effects. We calculated the optimal a priori diversity-adjusted information size (APDIS) based on the relative risk reduction of 15% and 25%. We also calculated the optimal low-bias information size (LBIS) and low-bias diversity-adjusted information size (LBDIS). RESULTS: Overall, under APDIS15%, 48% (11 of 23) of MAs were false negative (FN) and 17% (4 of 23) of MAs were false positive. Under APDIS25%, 34% (8 of 23) of MAs were false negative and 4% (1 of 23) of MAs were false positive. LBIS identified 30% (7 of 23) as false negative MAs and 4% (1 of 23) as false positive MAs, whereas LBDIS identified 52% (12 of 23) as false negative MAs and 4% (1 of 23) as false positive MAs. CONCLUSION: The new method demonstrates the possibility of incorporating time-to-event outcomes into TSA and reveals that some MAs have potentially inconclusive results.

Asunto(s)

Sesgo; Metaanálisis como Asunto; Mieloma Múltiple/epidemiología; Análisis de Supervivencia; Interpretación Estadística de Datos; Humanos; Mieloma Múltiple/terapia; Evaluación de Resultado en la Atención de Salud/estadística & datos numéricos; Ensayos Clínicos Controlados Aleatorios como Asunto/estadística & datos numéricos; Tamaño de la Muestra

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Sesgo / Análisis de Supervivencia / Metaanálisis como Asunto / Mieloma Múltiple Tipo de estudio: Clinical_trials / Etiology_studies / Evaluation_studies / Risk_factors_studies / Systematic_reviews Límite: Humans Idioma: En Revista: J Clin Epidemiol Asunto de la revista: EPIDEMIOLOGIA Año: 2013 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos

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