Table A1.
Section/Topic | Item | Checklist Item | Page | |
---|---|---|---|---|
Title and abstract | ||||
Title | 1 | D; V | Identify the study as developing and/or validating a multivariable prediction model, the target population, and the outcome to be predicted. | 1 |
Abstract | 2 | D; V | Provide a summary of objectives, study design, setting, participants, sample size, predictors, outcome, statistical analysis, results, and conclusions. | 2 |
Introduction | ||||
Background and objectives | 3a | D; V | Explain the medical context (including whether diagnostic or prognostic) and rationale for developing or validating the multivariable prediction model, including references to existing models. | 2–3 |
3b | D; V | Specify the objectives, including whether the study describes the development or validation of the model or both. | 3–5 | |
Methods | ||||
Source of data | 4a | D; V | Describe the study design or source of data (e.g., randomized trial, cohort, or registry data), separately for the development and validation datasets, if applicable. | 6–7 |
4b | D; V | Specify the key study dates, including start of accrual; end of accrual; and, if applicable, end of follow-up. | 6–7 | |
Participants | 5a | D; V | Specify key elements of the study setting (e.g., primary care, secondary care, general population), including number and location of centers. | 6–7 |
5b | D; V | Describe eligibility criteria for participants. | 6–7 Figure 3 and Figure 4 |
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5c | D; V | Give details of treatments received, if relevant. | n/a | |
Outcome | 6a | D; V | Clearly define the outcome that is predicted by the prediction model, including how and when assessed. | 8–12 |
6b | D; V | Report any actions to blind assessment of the outcome to be predicted. | 9–12 | |
Predictors | 7a | D; V | Clearly define all predictors used in developing the multivariable prediction model, including how and when they were measured. | 7–8 |
7b | D; V | Report any actions to blind assessment of predictors for the outcome and other predictors. | 7–8 | |
Sample size | 8 | D; V | Explain how the study size was arrived at. | 7–8 |
Missing data | 9 | D; V | Describe how missing data were handled (e.g., complete-case analysis, single imputation, multiple imputation) with details of any imputation method. | 7 |
Statistical analysis methods | 10a | D | Describe how predictors were handled in the analyses. | 7–8 |
10b | D | Specify type of model, all model-building procedures (including any predictor selection), and method for internal validation. | 4–5, 8 Figure 1 |
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10c | V | For validation, describe how the predictions were calculated. | 8 | |
10d | D; V | Specify all measures used to assess model performance and, if relevant, to compare multiple models. | 8 Figure 2 |
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10e | V | Describe any model updating (e.g., recalibration) arising from the validation, if done. | 8 | |
Risk groups | 11 | D; V | Provide details on how risk groups were created, if done. | 7 |
Development vs. validation | 12 | V | For validation, identify any differences from the development data in setting, eligibility criteria, outcome, and predictors. | 8 |
Results | ||||
Participants | 13a | D; V | 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. | Figure 3 and Figure 4 |
13b | D; V | Describe the characteristics of the participants (basic demographics, clinical features, available predictors), including the number of participants with missing data for predictors and outcome. | Figure 3 and Figure 4 | |
13c | V | For validation, show a comparison with the development data of the distribution of important variables (demographics, predictors, and outcome). | Table A2 and Table A3 | |
Model development | 14a | D | Specify the number of participants and outcome events in each analysis. | 7–8 |
14b | D | If done, report the unadjusted association between each candidate predictor and outcome. | 8–9 | |
Model specification | 15a | D | 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). | 10 |
15b | D | Explain how to use the prediction model. | 8–12 | |
Model performance | 16 | D; V | Report performance measures (with CIs) for the prediction model. | 11 Table 4 |
Model-updating | 17 | V | If done, report the results from any model updating (i.e., model specification, model performance). | 12–13 |
Discussion | ||||
Limitations | 18 | D; V | Discuss any limitations of the study (such as non-representative sample, few events per predictor, missing data). | 15 |
Interpretation | 19a | V | For validation, discuss the results with reference to performance in the development data, and any other validation data. | 13–14 |
19b | D; V | Give an overall interpretation of the results, considering objectives, limitations, results from similar studies, and other relevant evidence. | 14–15 | |
Implications | 20 | D; V | Discuss the potential clinical use of the model and implications for future research. | 14–15 |
Other information | ||||
Supplementary information | 21 | D; V | Provide information about the availability of supplementary resources, such as study protocol, web calculator, and datasets. | 16–18 |
Funding | 22 | D; V | Give the source of funding and the role of the funders for the present study. | 15 |
Items relevant only to the development of a prediction model are denoted by D, items relating solely to a validation of a prediction model are denoted by V, and items relating to both are denoted D; V.