Calculating the sample size required for developing a clinical prediction model

BMJ, vol. 368, pp. m441

Abstract

Clinical prediction models aim to predict outcomes in individuals, to inform diagnosis or prognosis in healthcare. Hundreds of prediction models are published in the medical literature each year, yet many are developed using a dataset that is too small for the total number of participants or outcome events. This leads to inaccurate predictions and consequently incorrect healthcare decisions for some individuals. In this article, the authors provide guidance on how to calculate the sample size required to develop a clinical prediction model.

Authors 9

1. Richard D Riley corresponding

   Keele University

   Affiliation as printed

   Centre for Prognosis Research, School of Primary, Community and Social Care, Keele University, Staffordshire ST5 5BG, UK r.riley@keele.ac.uk

   Centre for Prognosis Research, School of Primary, Community and Social Care, Keele University, Staffordshire ST5 5BG, UK

2. Joie Ensor

   Keele University

   Affiliation as printed

   Centre for Prognosis Research, School of Primary, Community and Social Care, Keele University, Staffordshire ST5 5BG, UK

3. Kym I E Snell

   Keele University

   Affiliation as printed

   Centre for Prognosis Research, School of Primary, Community and Social Care, Keele University, Staffordshire ST5 5BG, UK

4. Frank E. Harrell

   Vanderbilt University

   Affiliation as printed

   Department of Biostatistics, Vanderbilt University School of Medicine, Nashville TN, USA

5. Glen Philip Martin

   Manchester Academic Health Science Centre · University of Manchester

   Affiliation as printed

   Division of Informatics, Imaging and Data Science, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK

6. Johannes B. Reitsma

   University Medical Center Utrecht

   Affiliation as printed

   Julius Center for Health Sciences, University Medical Center Utrecht, Utrecht, Netherlands

7. Karel G.M. Moons

   University Medical Center Utrecht

   Affiliation as printed

   Julius Center for Health Sciences, University Medical Center Utrecht, Utrecht, Netherlands

8. Professor Gary S. Collins

   University of Oxford

   Affiliation as printed

   Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK

9. Maarten van Smeden Aachen Department of Clinical Epidemiology

   Leiden University Medical Center · University Medical Center Utrecht · University of Oxford

   Affiliation as printed

   Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK

   Department of Clinical Epidemiology, Leiden University Medical Center Leiden, Netherlands

   Julius Center for Health Sciences, University Medical Center Utrecht, Utrecht, Netherlands