ArticleThe European journal of health economics : HEPAC : health economics in prevention and care2019
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?
Article in The European journal of health economics : HEPAC : health economics in prevention and care, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Use of Patient-Reported Outcome Measures and Patient-Reported Experience Measures Within Evaluation Studies of Telemedicine Applications: Systematic Review.Journal of medical Internet research · 2021Pooled it
- The Stanmore Limb Reconstruction Score : validation of a novel patient-reported outcome measure.Bone & joint open · 2026Article
- Achieved discharge outcome targets in patient-reported outcome measures after lower limb arthroplasty.Bone & joint research · 2025Article
- Catheter-Associated Urinary Tract Infections: Understanding the Interplay Between Bacterial Biofilm and Antimicrobial Resistance.International journal of molecular sciences · 2025Review
- Improving the Patient Experience in Breast Reconstruction: ERAS and Beyond.Journal of clinical medicine · 2025Review
- Evaluating the Population-Based Usage and Benefit of Digitally Collected Patient-Reported Outcomes and Experiences in Patients With Chronic Diseases: The PROMchronic Study Protocol.JMIR research protocols · 2024Article
- Identifying Existing Guidelines, Frameworks, Checklists, and Recommendations for Implementing Patient-Reported Outcome Measures: Protocol for a Scoping Review.JMIR research protocols · 2024Article
- Closing the value-based circle in shared decision-making: a digital framework for informing the shared decision-making process through patient reported outcome and experience measures.Frontiers in public health · 2024Article
- Application of Machine Learning to Improve Appropriateness of Treatment in an Orthopaedic Setting of Personalized Medicine.Journal of personalized medicine · 2022Article
- Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices).European heart journal. Quality of care & clinical outcomes · 2022Article
- 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.International journal of environmental research and public health · 2022Observational
- 1-year trajectories of patients undergoing primary total hip arthroplasty: Patient reported outcomes and resource needs according to education level.BMC musculoskeletal disorders · 2022Article
- Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices).EFORT open reviews · 2021Review
- Value-Based procurement for medical devices: A scoping review.Medical journal of the Islamic Republic of Iran · 2021Article
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe 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.
methodsTwelve device groups were searched in clinical trial registries to determine the frequency distribution of PROMs in related studies.
resultsResults 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.
conclusionThe 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.