Literature DB >> 32451964

Sample size calculation of clinical trials in geriatric medicine.

Graziella D'Arrigo1, Stefanos Roumeliotis1,2, Claudia Torino1, Giovanni Tripepi3.   

Abstract

A preliminary step when planning a randomized clinical trial (RCT) is the sample size calculation. This is the determination of the optimal number of patients which ensures an adequate power to the study to detect as statistically significant a certain between-arms difference, if any, in the frequency/magnitude of a specific endpoint. The sample size calculation is performed by specific calculators requiring as input variables the expected effect size, the alpha error (α), the beta error (β) and the allocation ratio, this latter being the ratio between the number of participants allocated to the arms of a RCT. Herein, we provide a series of examples of sample size calculation in the context of superiority RCTs in elderly.

Entities:  

Keywords:  Alpha error; Beta error; RCT; Randomized clinical trial; Sample size calculation; Study power

Year:  2020        PMID: 32451964     DOI: 10.1007/s40520-020-01595-z

Source DB:  PubMed          Journal:  Aging Clin Exp Res        ISSN: 1594-0667            Impact factor:   3.636


  3 in total

1.  Superiority, equivalence, and non-inferiority trials.

Authors:  Emmanuel Lesaffre
Journal:  Bull NYU Hosp Jt Dis       Date:  2008

2.  Eltrombopag versus placebo for low-risk myelodysplastic syndromes with thrombocytopenia (EQoL-MDS): phase 1 results of a single-blind, randomised, controlled, phase 2 superiority trial.

Authors:  Esther N Oliva; Caterina Alati; Valeria Santini; Antonella Poloni; Alfredo Molteni; Pasquale Niscola; Flavia Salvi; Grazia Sanpaolo; Enrico Balleari; Ulrich Germing; Pierre Fenaux; Aspasia Stamatoullas; Giuseppe A Palumbo; Prassede Salutari; Stefana Impera; Paolo Avanzini; Agostino Cortelezzi; Anna Marina Liberati; Paola Carluccio; Francesco Buccisano; Maria Teresa Voso; Stefano Mancini; Austin Kulasekararaj; Fortunato Morabito; Monica Bocchia; Patrizia Cufari; Maria Antonietta Aloe Spiriti; Irene Santacaterina; Maria Grazia D'Errigo; Irene Bova; Gina Zini; Roberto Latagliata
Journal:  Lancet Haematol       Date:  2017-02-03       Impact factor: 18.959

3.  Attrition in geriatric research: how important is it and how should it be dealt with?

Authors:  V Gardette; N Coley; O Toulza; S Andrieu
Journal:  J Nutr Health Aging       Date:  2007 May-Jun       Impact factor: 4.075

  3 in total

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