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Developing a Minimum Data Set (MDS) for Cardiac Electronic Implantable Devices Implantation

Hadi Kazemi-Arpanahi, Ali Vasheghani-Farahani, Abdolvahab Baradaran, Nilofar Mohammadzadeh, Marjan Ghazisaeedi.

Background: There is no established minimum data set (MDS) for cardiovascular implantable electronic devices (CIEDs), which have led to a lack of standardized assessment criteria in this field to ensure access to a reliable and coherent set of data. Objective: To establish the minimum data set of CIEDs implantation that enables consistency in data gathering, uniform data reporting and data exchange in clinical and research information systems. Methods: This descriptive and cross-sectional study was conducted in 2018. That comprised a literature review to provide an overview of cardiovascular documents, registries, guidelines and medical record forms to extract an initial draft of potential data elements then asked from experts to review the initial draft of variables to score the items according to the importance perceived by them based on a five-point Likert scale. The items scored as important or highly important by at least 75% of the experts were included in the final list of minimum data set. Results: Initial dataset were refined by experts and essential data elements was selected in eight data classes including administrative data, past medical history, sign and symptoms, physical examinations, laboratory results, procedure session, post procedure complications and discharge outcomes. For each category required variables and possible respondents where determined. Conclusions: The minimum dataset will facilitate standardized and effective data management of CIEDs implantation; and presents a platform for meaningful comparison across contexts.

Key words: Cardiovascular implantable electronic device, Pacemaker, Implantable cardioverter defibrillator, minimum data set.

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