Mordin M, Buck PM, Castro C, Fernandez MM, Hollis KA, Ritchey ME. What does "Real World" evidence mean? A review of 2017 literature. Poster presented at the 2018 ISPOR 23rd Annual International Meeting; May 22, 2018. Baltimore, MD. [abstract] Value Health. 2018 May; 21(Suppl 1):S108. doi: 10.1016/j.jval.2018.04.736

OBJECTIVES: The use of the terms "Real world data" (RWD) or "real world evidence" (RWE) have become increasingly common in recent years. This review’s objective was to evaluate their use in 2017 publications.

METHODS: A review of English language 2017 titles and abstracts in Pubmed and Embase was performed. The search was broad and limited to “real world.” The following were extracted based on information in title/abstract: therapeutic area, exposure type, study design, primary outcome, timing of outcome, country and data source. Descriptive analyses were performed.

RESULTS: There were 1045 hits for "real world" publications in 2017. Of these, 315 were excluded because they lacked anabstract (n=93) or were not related to provision of health care (n=222); 730 remained in the analysis. Overall, most studies were retrospective (67%) vs. prospective (31%); 67% evaluated outcomes of a drug; 15% evaluated devices. The source for these RWD included medical records (32%), primary data collection (28%), claims/insurance/pharmacy data (12%), registries (10%), and other/not reported (19%). Real world data from over 50 countries were analyzed in the studies, with the US most frequently noted. Over half of the studies (n=415;57%) focused in 3 therapeutic areas: cardiovascular (n=168;23%), oncology (n=141;19%) and infectious disease (n=106;14%). Within these therapeutic areas, almost all infectious disease studies (92%) and most oncology studies (76%) evaluated outcomes of drugs. However, cardiovascular studies evaluated both drugs and devices almost equally (43% and 40% respectively). The primary outcome among most infectious disease studies (70%) was effectiveness. Cardiovascular and oncology disease studies evaluated effectiveness (48% and 42%, respectively) and treatment patterns (14%, and 18%, respectively).

CONCLUSIONS: RWD is crucial to demonstrate utilization, safety and effectiveness of health technologies outside clinical trials. Clarity of reporting is needed. The number and diversity of publications from 2017 reinforce the interest and importance of gathering this data.

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