Oyinlola Jessie O, Campbell Jennifer, Kousoulis Antonis A
Clinical Practice Research Datalink (CPRD), Medicines and Healthcare products Regulatory Agency, 151 Buckingham Palace Road, Victoria London, SW1W 9SZ, UK.
BMC Health Serv Res. 2016 Jul 26;16:299. doi: 10.1186/s12913-016-1562-8.
There is currently limited evidence regarding the extent Real World Evidence (RWE) has directly impacted the health and social care systems. The aim of this review is to identify national guidelines or guidances published in England from 2000 onwards which have referenced studies using the governmental primary care data provider the Clinical Practice Research Datalink (CPRD).
The methodology recommended by Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) was followed. Four databases were searched and documents of interest were identified through a search algorithm containing keywords relevant to CPRD. A search diary was maintained with the inclusion/exclusion decisions which were performed by two independent reviewers.
Twenty-five guidance documents were included in the final review (following screening and assessment for eligibility), referencing 43 different CPRD/GPRD studies, all published since 2007. The documents covered 12 disease areas, with the majority (N =7) relevant to diseases of the Central Nervous system (CNS). The 43 studies provided evidence of disease epidemiology, incidence/prevalence, pharmacoepidemiology, pharmacovigilance and health utilisation.
A slow uptake of RWE in clinical and therapeutic guidelines (as provided by UK governmental structures) was noticed. However, there seems to be an increasing trend in the use of healthcare system data to inform clinical practice, especially as the real world validity of clinical trials is being questioned. In order to accommodate this increasing demand and meet the paradigm shift expected, organisations need to work together to enable or improve data access, undertake translational and relevant research and establish sources of reliable evidence.
目前，关于真实世界证据（RWE）对卫生和社会护理系统产生直接影响的程度，证据有限。本综述的目的是识别2000年起在英格兰发布的国家指南或指导意见，这些指南或意见引用了使用政府初级保健数据提供者临床实践研究数据链（CPRD）的研究。
遵循系统评价和荟萃分析的首选报告项目（PRISMA）推荐的方法。搜索了四个数据库，并通过包含与CPRD相关关键词的搜索算法识别了感兴趣的文档。由两名独立评审员进行纳入/排除决策，并维护搜索日志。
最终综述纳入了25份指导文件（经过筛选和资格评估），引用了43项不同的CPRD/GPRD研究，所有研究均自2007年以来发表。这些文件涵盖了12个疾病领域，其中大多数（N = 7）与中枢神经系统（CNS）疾病相关。这43项研究提供了疾病流行病学、发病率/患病率、药物流行病学、药物警戒和卫生利用方面的证据。
注意到真实世界证据在临床和治疗指南（如英国政府机构提供的指南）中的采用较为缓慢。然而，利用医疗保健系统数据为临床实践提供信息的趋势似乎正在增加，特别是在临床试验的真实世界有效性受到质疑的情况下。为了适应这种不断增长的需求并满足预期的范式转变，各组织需要共同努力，以实现或改善数据获取、开展转化研究和相关研究，并建立可靠证据来源。
