Common Problems, Common Data Model Solutions: Evidence Generation for Health Technology Assessment

被引:57
作者
Kent, Seamus [1 ]
Burn, Edward [2 ,3 ]
Dawoud, Dalia [1 ]
Jonsson, Pall [1 ]
Ostby, Jens Torup [4 ]
Hughes, Nigel [5 ]
Rijnbeek, Peter [6 ]
Bouvy, Jacoline C. [1 ]
机构
[1] Natl Inst Hlth & Care Excellence, London, England
[2] Univ Oxford, Ctr Stat Med, Nuffield Dept Orthopaed Rheumatol & Musculoskelet, Oxford, England
[3] Fdn Inst Univ Recerca Atencio Primaria Salut Jord, Barcelona, Spain
[4] Pfizer Inc, Oslo, Norway
[5] Janssen Res & Dev, Beerse, Belgium
[6] Erasmus Univ, Med Ctr, Dept Med Informat, Rotterdam, Netherlands
基金
欧盟地平线“2020”;
关键词
REAL-WORLD EVIDENCE; EUROPEAN NETWORK; SAFETY; OMOP; PHARMACEUTICALS; RECOMMENDATIONS; COLLABORATION; TRANSPARENCY; PATHWAYS; SURVIVAL;
D O I
10.1007/s40273-020-00981-9
中图分类号
F [经济];
学科分类号
02 ;
摘要
There is growing interest in using observational data to assess the safety, effectiveness, and cost effectiveness of medical technologies, but operational, technical, and methodological challenges limit its more widespread use. Common data models and federated data networks offer a potential solution to many of these problems. The open-source Observational and Medical Outcomes Partnerships (OMOP) common data model standardises the structure, format, and terminologies of otherwise disparate datasets, enabling the execution of common analytical code across a federated data network in which only code and aggregate results are shared. While common data models are increasingly used in regulatory decision making, relatively little attention has been given to their use in health technology assessment (HTA). We show that the common data model has the potential to facilitate access to relevant data, enable multidatabase studies to enhance statistical power and transfer results across populations and settings to meet the needs of local HTA decision makers, and validate findings. The use of open-source and standardised analytics improves transparency and reduces coding errors, thereby increasing confidence in the results. Further engagement from the HTA community is required to inform the appropriate standards for mapping data to the common data model and to design tools that can support evidence generation and decision making.
引用
收藏
页码:275 / 285
页数:11
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