Skip to main content

Table 2 Framework used to guide the choice and definitions for data elements included in our clinical data collection tool

From: Evaluation of the quality of clinical data collection for a pan-Canadian cohort of children affected by inherited metabolic diseases: lessons learned from the Canadian Inherited Metabolic Diseases Research Network

 

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