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Plethysmography: Safety, Effectiveness, and Clinical Utility in Diagnosing Vascular Disease

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Title: Plethysmography: Safety, Effectiveness, and Clinical Utility in Diagnosing Vascular Disease

Agency: Agency for Health Care Policy and Research/Center for Health Care Technology (formerly the Office of Health Technology Assessment).

Contact: Ann A. Graham, M.P.H., CRNA

Status: Technology Assessment: Published, 1996.

Language: English

Primary Objective: To evaluate the ability of plethysmography devices to predict the presence of flow reduction in the carotid and peripheral circulations.

Methods Used: Reviews of published literature, collection of information from interested public in response to a Federal Register notice of intent to undertake assessment.

Data Identification: Published literature identified by search of the MEDLINE database.

Study Selection: Published articles and textbooks, and solicited unpublished material addressing the clinical use of plethysmography for peripheral vascular disease. A total of 152 published articles were included in the assessment bibliography. All references were analyzed for appropriateness using the Sackett modification of McMaster University criteria, as well as criteria recommended by Rosenberg's adaptation for evaluation of studies analysing the accuracy of diagnostic tests, and the National Academy of Science's Institute of Medcine's recommendations for evaluating diagnostic technologies.

Data Extraction: Literature retrieval by search was evaluated for presence of bias and for safety and effectiveness of the device and its clinical utility, with greater weight given to clinical evaluations that used scientifically defensible methodology.

Key Findings: Some types of plethysmography appear to have value in providing functional information that an imaging test may not provide, but the likelihood of plethysmography being replaced by imaging systems is apparently high, particularly for carotid and peripheral arterial disease.

Conclusion: With the exception of impedance plethysmography, plethysmographic methods need to be validated in randomized, controlled, clinical studies that include long-term outcome measures to evaluate its clinical effectiveness in the diagnosis of venous and arterial diseases.

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