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Review
. 2019 Aug 22:3:16.
doi: 10.1186/s41512-019-0060-y. eCollection 2019.

Methodological standards for the development and evaluation of clinical prediction rules: a review of the literature

Laura E Cowley  1 , Daniel M Farewell  1 , Sabine Maguire  1 , Alison M Kemp  1
Affiliations
Review

Methodological standards for the development and evaluation of clinical prediction rules: a review of the literature

Laura E Cowley et al. Diagn Progn Res. .

Abstract

Clinical prediction rules (CPRs) that predict the absolute risk of a clinical condition or future outcome for individual patients are abundant in the medical literature; however, systematic reviews have demonstrated shortcomings in the methodological quality and reporting of prediction studies. To maximise the potential and clinical usefulness of CPRs, they must be rigorously developed and validated, and their impact on clinical practice and patient outcomes must be evaluated. This review aims to present a comprehensive overview of the stages involved in the development, validation and evaluation of CPRs, and to describe in detail the methodological standards required at each stage, illustrated with examples where appropriate. Important features of the study design, statistical analysis, modelling strategy, data collection, performance assessment, CPR presentation and reporting are discussed, in addition to other, often overlooked aspects such as the acceptability, cost-effectiveness and longer-term implementation of CPRs, and their comparison with clinical judgement. Although the development and evaluation of a robust, clinically useful CPR is anything but straightforward, adherence to the plethora of methodological standards, recommendations and frameworks at each stage will assist in the development of a rigorous CPR that has the potential to contribute usefully to clinical practice and decision-making and have a positive impact on patient care.

Keywords: Clinical prediction rule; Diagnosis; Impact studies; Implementation; Model development; Model reporting; Model validation; Prediction model; Prognosis; Risk model; Study design.

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Conflict of interest statement

Competing interestsThe authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
The three main stages in the development and evaluation of clinical prediction rules. Adapted from McGinn, 2016 [47]
Fig. 2
Fig. 2
The four phases of impact analysis for a clinical prediction rule. Reproduced with permission from Wallace et al. 2011 [33]
See this image and copyright information in PMC

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