Quality Assurance of Registries for Health Technology Assessment

Abstract

Objectives:The aim of this study was to identify guidelines and assessment tools used by health technology agencies for quality assurance of registries and investigate the current use of registry data by HTA organizations worldwide.Methods:As part of a European Network for Health Technology Assessment Joint Action work package, we undertook a literature search and sent a questionnaire to all partner organizations on the work package and all organizations listed in the International Society for Pharmaco-economics and Outcomes Research directory.Results:We identified thirteen relevant documents relating to quality assurance of registries. We received fifty-five responses from organizations representing twenty-one different countries, a response rate of 40.5 percent (43/110). Many agencies, particularly in Europe, are already drawing on a range of registries to provide data for their HTA. Less than half, however, use criteria or standards to assess the quality of registry data. Nearly all criteria or standards in use have been internally defined by organizations rather than referring to those produced by an external body. A comparison of internal and external standards identified consistency in several quality dimensions, which can be used as a starting point for the development of a standardized tool.Conclusion:The use of registry data is more prevalent than expected, strengthening the need for a standardized registry quality assessment tool. A user-friendly tool developed in conjunction with stakeholders will support the consistent application of approved quality standards, and reassure critics who have traditionally considered registry data to be unreliable.

Postlaunch evidence-generation studies for medical devices in Spain: the RedETS approach to integrate real-world evidence into decision making

“…An EUnetHTA survey examining the extent to which HTA agencies use sources of RWE such as registries (29) showed that, particularly in Europe, some agencies use clinical and administrative databases, besides clinical registries to gather additional data for HTA. Less than half, however, currently employ criteria for quality checking these data sources, in most cases defined by each organization rather than external bodies with standardized tools.…”

A Narrative Review and Proposed Framework for Using Health System Data with Systematic Reviews to Support Decision-making

“…In other examples, unpublished data were used to provide contextual information (other than effectiveness or harms/safety information), for example, to detail uptake of services, patient characteristics, epidemiology, natural history, or cost or data for cost-effectiveness analyses. [21][22][23][24][25] After completion of the review, the unpublished health system data can be used as a "data appendage" to help filter, interpret, and/or apply the review findings to an individual health system's practice. This may not involve the systematic reviewers themselves and could be performed by the health system using the systematic review.…”

“…33 Data quality is complex because it touches on multiple dimensions (e.g., data accuracy, data completeness, interpretability and accessibility of data, relevance of the data, timeliness of the data, coherence of the data, and mode of the data collection and how it impacts data quality) and can fluctuate over time and across data sources. 21 The issues centered on data quality are not unique to health system data but may be more problematic depending on the data source being used and the questions being asked.…”

Integrating Health System Data With Systematic Reviews: A Framework for When and How Unpublished Health System Data Can Be Used With Systematic Reviews

“…In other examples, unpublished data were used to provide contextual information (other than effectiveness or harms/safety information); for example, to detail uptake of services, patient characteristics, epidemiology, natural history, or cost or data for cost-effectiveness analyses. [19][20][21][22][23] In some instances, the rationale for using unpublished data was not evident and/or appeared opportunistic (i.e., researchers had access to their own unpublished data and included it because it was available), and was not applied to healthcare decision making. Overall the examples we identified applied clinical practice data or specific registry data from a single health system (e.g., Mayo Clinic) or regional or nationally representative data (e.g., clinical registries, hospital database).…”