Section/topic | Item | Checklist item | Page |
---|---|---|---|
Title and abstract | |||
Title | 1 | Identify the study as developing and/or validating a multivariable prediction model, the target population, and the outcome to be predicted. | 1 |
Abstract | 2 | Provide a summary of objectives, study design, setting, participants, sample size, predictors, outcome, statistical analysis, results, and conclusions. | 2–3 |
Introduction | |||
Background and objectives | 3a | Explain the medical context (including whether diagnostic or prognostic) and rationale for developing or validating the multivariable prediction model, including references to existing models. | 3–4 |
3b | Specify the objectives, including whether the study describes the development or validation of the model or both. | 4–5 | |
Methods | |||
Source of data | 4a | Describe the study design or source of data (e.g. randomized trial, cohort, or registry data), separately for the development and validation data sets, if applicable. | 5 |
4b | Specify the key study dates, including start of accrual, end of accrual, and, if applicable, end of follow-up. | 5 | |
Participants | 5a | Specify key elements of the study setting (e.g. primary care, secondary care, general population) including number and location of centres. | 5–6 |
5b | Describe eligibility criteria for participants. | 5–6 | |
5c | Give details of treatments received, if relevant. | 5–6 | |
Outcome | 6a | Clearly define the outcome that is predicted by the prediction model, including how and when assessed. | 4,6 |
6b | Report any actions to blind assessment of the outcome to be predicted. | Not relevant | |
Predictors | 7a | Clearly define all predictors used in developing or validating the multivariable prediction model, including how and when they were measured. | 7, 13, 16, Fig. 1 |
7b | Report any actions to blind assessment of predictors for the outcome and other predictors. | Not relevant | |
Sample size | 8 | Explain how the study size was arrived at. | 8, 14 |
Missing data | 9 | Describe how missing data were handled (e.g. complete-case analysis, single imputation, multiple imputation) with details of any imputation method. | 9–10 |
Statistical analysis methods | 10a | Describe how predictors were handled in the analyses. | 7–10 |
10b | Specify type of model, all model-building procedures (including any predictor selection), and method for internal validation. | 7–10 | |
10d | Specify all measures used to assess model performance and, if relevant, to compare multiple models. | 10–12 | |
Risk groups | 11 | Provide details on how risk groups were created, if done. | Not relevant |
Results | |||
Participants | 13a | Describe the flow of participants through the study, including the number of participants with and without the outcome and, if applicable, a summary of the follow-up time. A diagram may be helpful. | Table 1 and Appendix Table 4 |
13b | Describe the characteristics of the participants (basic demographics, clinical features, available predictors), including the number of participants with missing data for predictors and outcome. | Table 1 and Appendix Table 4 | |
Model development | 14a | Specify the number of participants and outcome events in each analysis. | Table 1 and Appendix Table 4 |
14b | If done, report the unadjusted association between each candidate predictor and outcome. | Not relevant | |
Model specification | 15a | Present the full prediction model to allow predictions for individuals (i.e., all regression coefficients, and model intercept or baseline survival at a given time point). | Table 2 |
15b | Explain how to use the prediction model. | 13, 15 | |
Model performance | 16 | Report performance measures (with CIs) for the prediction model. | 13, Table 2 |
Discussion | |||
Limitations | 18 | Discuss any limitations of the study (such as nonrepresentative sample, few events per predictor, missing data). | 16–17 |
Interpretation | 19b | Give an overall interpretation of the results, considering objectives, limitations, and results from similar studies, and other relevant evidence. | 15–17 |
Implications | 20 | Discuss the potential clinical use of the model and implications for future research. | 15–17 |
Other information | |||
Supplementary information | 21 | Provide information about the availability of supplementary resources, such as study protocol, Web calculator, and data sets. | 12, 13, 15 |
Funding | 22 | Give the source of funding and the role of the funders for the present study. | 29 |