アブストラクト | BACKGROUND: Real world evidence (RWE) is becoming more frequently used in technology appraisals (TAs). This study sought to explore the use and acceptance of evidence from primary care databases, a key source of RWE in the UK, in National Institute for Health and Care Excellence (NICE) technology assessments and to provide recommendations regarding their use in future submissions. METHODS: A keyword search was conducted relating to the main primary care databases in the UK on the NICE website. All NICE TAs identified through this search were screened, assessed for duplication and information on the data source and the way the data was used in the submission were extracted. Comments by the evidence review group (ERG) and the appraisal committee were also extracted and reviewed. All data extraction was performed by two independent reviewers and all decisions were reached by consensus with an additional third reviewer. RESULTS: A total of 52 NICE TAs were identified, 47 used the General Practice Research Database /Clinical Practice Research Datalink (GPRD/CPRD) database, 10 used The Health Improvement Network (THIN) database and 3 used the QResearch databases. Data from primary care databases were used to support arguments regarding clinical need and current treatment in 33 NICE TAs while 36 were used to inform input parameters for economic models. The databases were sometimes used for more than one purpose. The data from the three data sources were generally well received by the ERGs/committees. Criticisms of the data typically occurred where the results had been repurposed from a published study or had not been applied appropriately. CONCLUSIONS: The potential of UK primary care databases in NICE submissions is increasingly being realised, particularly in informing the parameters of economic models. Purpose conducted studies are less likely to receive criticism from ERGs/committees, particularly when providing clinical input into cost effectiveness models. |
ジャーナル名 | BMC health services research |
Pubmed追加日 | 2020/7/24 |
投稿者 | Leahy, Thomas P; Ramagopalan, Sreeram; Sammon, Cormac |
組織名 | PHMR Ltd., Berkeley Works, Berkley Grove, London, NW1 8XY, UK.;Centre for Observational Research and Data Sciences, Bristol-Myers Squibb,;Uxbridge, U88 1DH, UK.;cormacsammon@phmr.com. |
Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/32698805/ |