Epidemiology and patients' self-reported knowledge of implantable medical devices: Results of a cross-sectional survey in Hungary

Áron Hölgyesi; Barbara Tóth; Miklós Kozlovszky; József Kuti; Miklós Weszl; György Balázs; Petra Baji; Levente Kovács; László Gulácsi; Zsombor Zrubka; Márta Péntek

doi:10.1371/journal.pone.0284577

Epidemiology and patients' self-reported knowledge of implantable medical devices: Results of a cross-sectional survey in Hungary

PLoS One. 2023 Apr 18;18(4):e0284577. doi: 10.1371/journal.pone.0284577. eCollection 2023.

Authors

Áron Hölgyesi¹, Barbara Tóth², Miklós Kozlovszky³, József Kuti⁴, Miklós Weszl⁵, György Balázs⁶, Petra Baji^{7

8}, Levente Kovács⁹, László Gulácsi^{10

11}, Zsombor Zrubka^{10

11}, Márta Péntek^{1

10}

Affiliations

¹ Doctoral School of Molecular Medicine, Semmelweis University, Budapest, Hungary.
² Doctoral School of Applied Informatics and Applied Mathemathics, Óbuda University, Budapest, Hungary.
³ BioTech Research Center, Óbuda University, Budapest, Hungary.
⁴ Antal Bejczy Center for Intelligent Robotics, Óbuda University, Budapest, Hungary.
⁵ Department of Translational Medicine, Semmelweis University, Budapest, Hungary.
⁶ EMKI-CERT Ltd., Budapest, Hungary.
⁷ Department of Health Economics, Corvinus University of Budapest, Budapest, Hungary.
⁸ Musculoskeletal Research Unit, University of Bristol, Bristol, United Kingdom.
⁹ Physiological Controls Research Center, University Research and Innovation Center, Óbuda University, Budapest, Hungary.
¹⁰ Health Economics Research Center, University Research and Innovation Center, Óbuda University, Budapest, Hungary.
¹¹ Corvinus Institute of Advanced Studies, Corvinus University of Budapest, Budapest, Hungary.

Abstract

Background: Implantable medical devices (IMDs) are medical instruments embedded inside the body. Well-informed and empowered patients living with IMDs are key players of improving IMD-related patient safety and health outcomes. However, little is known about IMD patients' epidemiology, characteristics, and current awareness levels. Our primary aim was to investigate the point and lifetime prevalence of patients living with IMDs. Patients' IMD-related knowledge and determinants of IMDs' impact on their life were also explored.

Methods: An online cross-sectional survey was conducted. Respondents' IMD history, whether they received instructions for use and IMD's overall impact on life were recorded by self-reports. Patients' knowledge about living with IMDs was assessed on visual analogue scales (VAS, 0-10). Shared decision-making was analyzed by the 9-item Shared Decision Making Questionnaire (SDM-Q-9). Descriptive statistics and subgroup comparisons between IMD wearers were performed for statistical differences. Significant determinants of IMD's overall impact on life were examined in linear regression analysis.

Results: In the total sample (N = 1400, mean age 58.1 ±11.1; female 53.7%), nearly one third of respondents were living with IMD (30.9%; 433/1400). Among them, the most frequent IMDs were tooth implants (30.9%) and intraocular lens (26.8%). Mean knowledge VAS scores were similar (range: 5.5 ±3.8-6.5 ±3.2) but differences by IMD types were observed. Patients who received instructions for use or reported better impact on life indicated higher self-reported knowledge. Regression confirmed that patients' knowledge was significant predictor of IMD's impact on life, but this effect was overwritten by the SDM-Q-9.

Conclusions: This first comprehensive epidemiological study on IMDs provides basic data for public health strategy planning alongside the implementation of MDR. Improved self-perceived outcomes were associated with higher knowledge hence education of patients receiving IMD deserves consideration. We suggest to investigate further the role of shared decision-making on IMD's overall impact on patients' life in future prospective studies.

Copyright: © 2023 Hölgyesi et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Aged
Cross-Sectional Studies
Decision Making, Shared*
Eye, Artificial*
Female
Humans
Hungary
Middle Aged
Self Report

Grants and funding

This research was supported by the Higher Education Institutional Excellence Program of the Ministry of Innovation and Technology in the framework of the 'Financial and Public Services' research project (TKP2020-NKA-02) at Corvinus University of Budapest. Financial interests: In connection with writing this article, ÁH, BT, LG, ZsZ and MP received grant support from the Higher Education Institutional Excellence Program of the Ministry of Innovation and Technology in the framework of the 'Financial and Public Services' research project (TKP2020-NKA-02) at Corvinus University of Budapest. During writing this article, BT, ZZ, PM and GL received funding from the National Research, Development, and Innovation Fund of Hungary, financed under the TKP2021-NKTA-36 funding scheme ('Development and evaluation of innovative and digital health technologies' project) at Óbuda University. Non-financial interests: MP is member of the EuroQol Group, a not-for-profit organization that develops and distributes instruments that assess and value health. Other authors declare that they have no conflict of interest. There were no additional internal or external funding received for this study. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.