High risk device registries: Global value, costs, and sustainable funding.

BACKGROUND: Well-designed implant registries have been shown to be a worthwhile investment, from both a health and economic perspective. However, many registries do not attain desirable capture rates or lack sufficient funding, potentially leading to premature termination. This study aims to provide information about rarely discussed, yet pivotal topics regarding the long-term survival of implant registries, focusing on costs, funding models, and the role of stakeholders. METHODS: Worldwide, relatively recently developed breast device (BD) registries were compared to long-standing, orthopaedic (OD) and cardiovascular device (CD) registries. A standardised questionnaire was sent to the registries' designated representatives with key positions, discussing start-up costs, costs of maintenance, value of investment, governance, stakeholders, funding, and sustainability. RESULTS: Thirteen registries were included, originating from nine countries (seven BD registries, five OD registries, one CD registry). In general, start-up costs were comparable, and younger registries were more expensive to maintain. Numerous stakeholders showed interest in registry outcomes. However, only 50% of the registries reported a sustainable funding structure. CONCLUSION: This study provides a global perspective on implantable device registries. All registries provided important information, serving three unique purposes by evaluating the quality of healthcare provided, the quality of all registered devices, and processing recall information. Yet, only half of the registries were certain of sustainable funding, and thus their future existence. It is of utmost importance to bring this to the attention of all parties involved.

A Standard Set of Value-Based Patient-Centered Outcomes for Breast Cancer: The International Consortium for Health Outcomes Measurement (ICHOM) Initiative.

A major challenge in value-based health care is the lack of standardized health outcomes measurements, hindering optimal monitoring and comparison of the quality of health care across different settings globally. The International Consortium for Health Outcomes Measurement (ICHOM) assembled a multidisciplinary international working group, comprised of 26 health care providers and patient advocates, to develop a standard set of value-based patient-centered outcomes for breast cancer (BC). The working group convened via 8 teleconferences and completed a follow-up survey after each meeting. A modified 2-round Delphi method was used to achieve consensus on the outcomes and case-mix variables to be included. Patient focus group meetings (8 early or metastatic BC patients) and online anonymized surveys of 1225 multinational BC patients and survivors were also conducted to obtain patients' input. The standard set encompasses survival and cancer control, and disutility of care (eg, acute treatment complications) outcomes, to be collected through administrative data and/or clinical records. A combination of multiple patient-reported outcomes measurement (PROM) tools is recommended to capture long-term degree of health outcomes. Selected case-mix factors were recommended to be collected at baseline. The ICHOM will endeavor to achieve wide buy-in of this set and facilitate its implementation in routine clinical practice in various settings and institutions worldwide.