| Demographics | Diagnosis | Clinical descriptors | Secondary diagnoses | Interventions | Covariates | Outcomes |
---|---|---|---|---|---|---|---|
Description | General patient information | Definition should be broad to reflect clinical heterogeneity and be as inclusive as possible of individuals with possible health issues related to this IMD | Variables informing diagnosis, tissue involvement, severity, and pathophysiology related to primary diagnosis and/or other acute/chronic diagnoses | Diagnoses resulting from complications of the primary diagnosis or related interventions, as well as apparently unrelated acute or chronic diagnoses | Exposures that are manipulated by care providers to change natural history | Other factors postulated to influence the outcome(s)/natural history | Variables reflecting the health and functional status of the patient, including patient/family-centred variables |