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Is the trend of increasing use of patient-reported outcome measures in medical device studies the sign of shift towards value-based purchasing in Europe?

Author

Listed:
  • Miklós Weszl

    (Corvinus University of Budapest)

  • Fanni Rencz

    (Corvinus University of Budapest
    Hungarian Academy of Sciences)

  • Valentin Brodszky

    (Corvinus University of Budapest)

Abstract

Background The recent update of the European Union’s (EU) regulation on public procurement has created new opportunity for progress in the purchasing of medical devices by shifting towards focus on value from one purely on price. Patient-reported outcome measures (PROMs) may serve as additional tools for manufacturers to demonstrate value beyond traditional metrics of safety and performance and to differentiate their products in a market of increasing competition. The aim of our study was to investigate the extent to which PROMs are included in registered device studies in the EU and interpret the results in the context of the purchasing of medical devices. Methods Twelve device groups were searched in clinical trial registries to determine the frequency distribution of PROMs in related studies. Results Results indicate that clinical studies of the selected device categories are done predominately in the western EU nations and are increasingly including PROMs. In the United Kingdom 121 (65%) study, out of 186 included PROMs, and in Germany, 92 (52%) out of 178 between 1998 and 2018. Few device studies were done in the Central and Eastern European region, and out of 76 studies 27 (35%) included PROMs. Since there is no requirement to include PROMs in device studies for regulatory purposes, it seems probable that their increasing use is driven by competitive market pressures. Conclusion The trend of increasing use of PROMs might be driven by the demand of purchasers to demonstrate value of devices, but is manifested at different levels in various regions of the EU.

Suggested Citation

  • Miklós Weszl & Fanni Rencz & Valentin Brodszky, 2019. "Is the trend of increasing use of patient-reported outcome measures in medical device studies the sign of shift towards value-based purchasing in Europe?," The European Journal of Health Economics, Springer;Deutsche Gesellschaft für Gesundheitsökonomie (DGGÖ), vol. 20(1), pages 133-140, June.
  • Handle: RePEc:spr:eujhec:v:20:y:2019:i:1:d:10.1007_s10198-019-01070-1
    DOI: 10.1007/s10198-019-01070-1
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    Citations

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    Cited by:

    1. Beata GAVUROVA & Matus KUBAK & Martin MIKESKA, 2020. "The Efficiency Of Public Procurement In The Health Sector – The Platform On Sustainable Public Finances," REVISTA ADMINISTRATIE SI MANAGEMENT PUBLIC, Faculty of Administration and Public Management, Academy of Economic Studies, Bucharest, Romania, vol. 2020(35), pages 21-39, December.
    2. Luis Lassaletta & Miryam Calvino & Isabel Sanchez-Cuadrado & Piotr Henryk Skarzynski & Katarzyna B. Cywka & Natalia Czajka & Justyna Kutyba & Dayse Tavora-Vieira & Paul van de Heyning & Griet Mertens , 2022. "Using Generic and Disease-Specific Measures to Assess Quality of Life before and after 12 Months of Hearing Implant Use: A Prospective, Longitudinal, Multicenter, Observational Clinical Study," IJERPH, MDPI, vol. 19(5), pages 1-13, February.

    More about this item

    Keywords

    Medical device; Patient-reported outcome; Value-based purchasing; Europe;
    All these keywords.

    JEL classification:

    • I10 - Health, Education, and Welfare - - Health - - - General

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