Checklist: Guidance and key considerations for developing a statistical analysis section of an observational CER protocol

GuidanceKey ConsiderationsCheck
Describe the key variables of interest with regard to factors that determine appropriate statistical analysis.

Should discuss independent variables (when they are measured whether they are fixed or time-varying; e.g., exposures, confounders, effect modifiers).

Should discuss dependent variables or outcomes (continuous or categorical, single or repeated measure, time to event).

Should state if there will be a “multilevel” analysis (e.g., an analysis of effects of both practice-level and patient-level characteristics on outcome).

Propose descriptive analysis or graph according to treatment group.

Should include the available numbers per group, number missing for all key covariates, distributions or graphs that are needed to decide if transformation of data is needed or to determine an accurate functional form of the final model.

Should include all potential confounders and effect modifiers to assess initial covariate balance by study group.

Propose the model that will be used for primary and secondary analysis objectives.

Should take into account the design (independent vs. dependent observations, matched repeated measurement, clustered), objectives, functional form of model, fixed/time-varying followup period fixed and time-varying exposure and other covariates, assessment of effect modification/heterogeneity, type of outcome variables (categorical, ordinal, or continuous), censored data, and the degree of rarity of outcome and exposure.

Should propose a suitable approach for adjusting for confounding (e.g., multiple regression model, propensity scores, instrumental variable [as secondary or main analysis]).

From: Chapter 10, Considerations for Statistical Analysis

Cover of Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide
Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide.
Velentgas P, Dreyer NA, Nourjah P, et al., editors.
Copyright © 2013, Agency for Healthcare Research and Quality.

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