Do existing real-world data sources generate suitable evidence for the HTA of medical devices in Europe? Mapping and critical appraisal.

Benedetta Pongiglione,Aleksandra Torbica,Saskia De Groot,Oriana Ciani,Rosanna Tarricone,Florian Dams,Hedwig Blommestein,Rudolf Blankart,Meilin Mollenkamp,Mike Drummond,Sarah Walker,Sándor Kovács

doi:10.1017/s0266462321000301

Abstract

Technological and computational advancements offer new tools for the collection and analysis of real-world data (RWD). Considering the substantial effort and resources devoted to collecting RWD, a greater return would be achieved if real-world evidence (RWE) was effectively used to support Health Technology Assessment (HTA) and decision making on medical technologies. A useful question is: To what extent are RWD suitable for generating RWE? We mapped existing RWD sources in Europe for three case studies: hip and knee arthroplasty, transcatheter aortic valve implantation (TAVI) and mitral valve repair (TMVR), and robotic surgery procedures. We provided a comprehensive assessment of their content and appropriateness for conducting the HTA of medical devices. The identification of RWD sources was performed combining a systematic search on PubMed with gray literature scoping, covering fifteen European countries. We identified seventy-one RWD sources on arthroplasties; ninety-five on TAVI and TMVR; and seventy-seven on robotic procedures. The number, content, and integrity of the sources varied dramatically across countries. Most sources included at least one health outcome (97.5%), with mortality and rehospitalization/reoperation the most common; 80% of sources included resource outcomes, with length of stay the most common, and comparators were available in almost 70% of sources. RWD sources bear the potential for the HTA of medical devices. The main challenges are data accessibility, a lack of standardization of health and economic outcomes, and inadequate comparators. These findings are crucial to enabling the incorporation of RWD into decision making and represent a readily available tool for getting acquainted with existing information sources.

Highlights

Over the last few decades, digital innovation has permitted the generation, collection, and storage of a large volume of health-related data that can be employed to track patients’ health and to monitor health service delivery and technologies during all stages of the lifecycle
In the Health Technology Assessment (HTA) glossary, evidence derived from real-world data (RWD) analyses is defined as realworld evidence (RWE)
RWE is important for medical devices because, for this class of technology, available clinical evidence is traditionally of a lower standard, at least when compared with drug technologies

Summary

Introduction

Over the last few decades, digital innovation has permitted the generation, collection, and storage of a large volume of health-related data that can be employed to track patients’ health and to monitor health service delivery and technologies during all stages of the lifecycle. RWD can be medical health records, registries, biobanks, administrative data, health surveys, observational studies, health insurance data, data generated from mobile applications, etc. The increasing availability of RWD has generated much attention in assessing whether, and if so to what extent, they can be used to generate clinical evidence regarding the usage, and potential benefits or risks, of medical technologies. In the Health Technology Assessment (HTA) glossary (htaglossary.net), evidence derived from RWD analyses is defined as realworld evidence (RWE). RWE is important for medical devices because, for this class of technology, available clinical evidence is traditionally of a lower standard, at least when compared with drug technologies. IP address: 54.89.245.193, on 02 Nov 2021 at 10:19:06, subject to the Cambridge Core terms of use, available at https://www.cambridge.org/core/terms.

Objectives

Methods

Results

Discussion

Conclusion