Patient Selection |
State eligibility criteria |
State inclusion and exclusion criteria of study participants, including criteria concerning missing data |
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Report the number of individuals at each stage of the study |
Give reasons for exclusion at each stage |
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Indicate the amount of individuals discarded due to missingness at each stage of the study |
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Give consideration to selection bias introduced by exclusion criteria |
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May use a flowchart to summarise |
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Modelling and Covariate Selection |
Covariates |
Detail whether included as continuous or categorical and, if relevant, detail how the quantitative covariate was categorised |
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Consider departures from linearity for continuous covariates and state which transformation, if any, was used |
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State analysis model |
make it clear which method will be used to model the data |
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Covariate Selection |
describe the procedure used to reach the final model |
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this includes, but is not restricted to, missing data imputation, transformation of covariates, interactions between covariates or inclusion of covariates for a priori reasons |
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Results |
Provide unadjusted estimates and the final adjusted model |
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State the number of participants included in unadjusted and adjusted analyses |
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Missing Data |
Report the number of participants with missing data |
Report this for each covariate of interest or the number of complete data for the important covariates |
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Give reasons for missing values |
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Investigate if there are key differences between those observed and those with missing data - this may be compared across exposure/intervention groups. |
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Missing data methods (general) |
Which method was used to handle missing data? |
State clearly the method used |
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State any missing data assumptions that were made |
Such as whether the data are MCAR, MAR or MNAR |
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Sensitivity analysis |
Should investigate robustness of findings |
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Compare method with a complete-case analysis |
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If necessary, assess validity of methods if there are differences |
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Assess plausibility of missing data assumptions |
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Multiple Imputation |
Give details of the imputation model |
State the software used and key settings for imputation model |
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State the number of imputations used |
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State variables included in imputation model |
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State how non-normal or binary covariates were handled |
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Were interactions in analysis model included in imputation model? |
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If a large fraction of data are imputed, compare observed and imputed values |
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Missing data assumptions |
Discuss if variables included in the imputation model make MAR assumption plausible |
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Sensitivity analyses |
Compare MI results with CC results |
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Investigate departures from MAR assumption |
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If necessary, suggest explanations for why there are differences in results across sensitivity analyses |
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