Population identification and eligibility

Source population → candidate records or participants → eligibility → exclusions → eligible population

Flow diagram

Population identification and eligibilityPopulation identification and eligibilityF1.S1Source populationF1.S2Identified candidatepopulationF1.S3Outside identificationcriteriaF1.S4Eligible populationF1.S5Ineligible populationF1.S6Eligibility unresolvedF1.N1Eligibility and exclusion rulesCriterionOperationaldefinitionSourceReason priorityCountCriterionF1.N2Population and count definitionF1.N3Eligibility evidence

Steps

Source population

Define unique population and source period; count people consistently.

Identified candidate population

Apply the initial identification rule and deduplicate before counting.

Outside identification criteria

Count source members not meeting the initial identification rule.

Eligible population

Apply eligibility criteria with a stated data cutoff.

Ineligible population

Use a mutually exclusive reason hierarchy when reconciling reasons.

Eligibility unresolved

Keep pending or insufficient-information cases distinct from confirmed exclusions.

Tables and supporting information

Eligibility and exclusion rules

Eligibility and exclusion rulesCriterionOperationaldefinitionSourceReason priorityCountCriterion

Reason-level counts require mutually exclusive categories; units are people.

Population and count definition

Record the source period, uniqueness rule and person-level denominator.

Eligibility evidence

Cite protocol criteria and validated operational definitions.

Sources