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A framework for evidence evaluation and methodological issues in implantable device studies.
Med Care. 2010 Jun; 48(6 Suppl):S121-8.MC

Abstract

Implantable medical devices (IMD) are frequently used in interventional medicine. There are a host of complex methodological issues to consider in conducting device studies. A general conceptual framework for evidence evaluation is needed to help investigators conduct comparative studies in this setting. It is known that clinical trials of implants require study design planning and creative execution that are quite different from those in pharmaceutical setting. Important study design issues such as randomization, masking and allocation concealment require unique approaches for each device. In addition, device comparative studies must cope with sources of variability different from pharmaceutical studies. These include operator learning curve effects, hospital-operator-patient interactions, and issues related to device technical characteristics. Observational studies of IMDs are particularly challenging. Selection of comparison groups, adjusting for confounding and addressing learning curve issues needs careful planning. We propose a general framework for IMD evaluation and provide an outline of the methodological issues that require further discussion. We hope this article will inspire and help to inform those interested in advancing comparative safety and effectiveness of IMDs and to plan and pursue future methodological work in this area.

Authors+Show Affiliations

Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD 20993-0002, USA. art.sedrakyan@fda.hhs.govNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

20421824

Citation

Sedrakyan, Art, et al. "A Framework for Evidence Evaluation and Methodological Issues in Implantable Device Studies." Medical Care, vol. 48, no. 6 Suppl, 2010, pp. S121-8.
Sedrakyan A, Marinac-Dabic D, Normand SL, et al. A framework for evidence evaluation and methodological issues in implantable device studies. Med Care. 2010;48(6 Suppl):S121-8.
Sedrakyan, A., Marinac-Dabic, D., Normand, S. L., Mushlin, A., & Gross, T. (2010). A framework for evidence evaluation and methodological issues in implantable device studies. Medical Care, 48(6 Suppl), S121-8. https://doi.org/10.1097/MLR.0b013e3181d991c4
Sedrakyan A, et al. A Framework for Evidence Evaluation and Methodological Issues in Implantable Device Studies. Med Care. 2010;48(6 Suppl):S121-8. PubMed PMID: 20421824.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A framework for evidence evaluation and methodological issues in implantable device studies. AU - Sedrakyan,Art, AU - Marinac-Dabic,Danica, AU - Normand,Sharon-Lise T, AU - Mushlin,Alvin, AU - Gross,Tom, PY - 2010/4/28/entrez PY - 2010/4/28/pubmed PY - 2010/6/19/medline SP - S121 EP - 8 JF - Medical care JO - Med Care VL - 48 IS - 6 Suppl N2 - Implantable medical devices (IMD) are frequently used in interventional medicine. There are a host of complex methodological issues to consider in conducting device studies. A general conceptual framework for evidence evaluation is needed to help investigators conduct comparative studies in this setting. It is known that clinical trials of implants require study design planning and creative execution that are quite different from those in pharmaceutical setting. Important study design issues such as randomization, masking and allocation concealment require unique approaches for each device. In addition, device comparative studies must cope with sources of variability different from pharmaceutical studies. These include operator learning curve effects, hospital-operator-patient interactions, and issues related to device technical characteristics. Observational studies of IMDs are particularly challenging. Selection of comparison groups, adjusting for confounding and addressing learning curve issues needs careful planning. We propose a general framework for IMD evaluation and provide an outline of the methodological issues that require further discussion. We hope this article will inspire and help to inform those interested in advancing comparative safety and effectiveness of IMDs and to plan and pursue future methodological work in this area. SN - 1537-1948 UR - https://www.unboundmedicine.com/medline/citation/20421824/A_framework_for_evidence_evaluation_and_methodological_issues_in_implantable_device_studies_ L2 - https://doi.org/10.1097/MLR.0b013e3181d991c4 DB - PRIME DP - Unbound Medicine ER -