Towards uniform case-identification criteria in observational studies on peripheral arterial disease: A scoping review.

OBJECTIVE: The diagnosis peripheral arterial disease (PAD) is commonly applied for symptoms related to atherosclerotic obstructions in the lower extremity, though its clinical manifestations range from an abnormal Ankle Brachial Index to critical limb ischemia. Subsequently, management and prognosis of PAD vary widely with the disease stage. A critical aspect is how this variation is addressed in administrative databases-based studies that rely on diagnosis codes for case identification. The objective of this scoping review is to inventory the identification strategies used in studies on PAD that rely on administrative databases, to map the pros and cons of the ICD codes applied, and propose a first outline for a consensus framework for case identification in administrative databases.

METHODS: Registry-based reports published between 2010 to 2021 were identified through a systematic PubMed search. Studies were sub-categorized on the basis of the expressed study focus: claudication, critical limb ischemia, or general peripheral arterial disease and the ICD code(s) applied for case identification mapped.

RESULTS: Ninety studies were identified, of which thirty-six (40%) did not specify the grade of PAD studied. Forty-nine (54%) articles specified PAD grade studied. Five (6%) articles specified different PAD subgroups in methods and baseline demographics, but not in further analyses. Mapping of the ICD codes applied for case identification for studies that specified the PAD grade studied indicated a remarkable heterogeneity, overlap, and inconsistency.

CONCLUSION: A large proportion of registry-based studies on PAD fails to define the study focus. In addition, inconsistent strategies are used for PAD case-identification in studies that report a focus. These findings challenge study validity, and interfere with inter-study comparison. This scoping review provides a first initiative for a consensus framework for standardized case selection in administrative studies on PAD. It is anticipated that more uniform coding will improve study validity, and facilitate inter-study comparisons.