Real-World Evidence — What Is It and What Can It Tell Us?

Sherman, Rachel E.; Anderson, Steven A.; Pan, Gerald J. Dal; Gray, Gerry; Gross, Thomas P.; Hunter, Nina L.; LaVange, Lisa M.; Marinac‐Dabic, Danica; Marks, Peter; Robb, Melissa A.; Shuren, Jeffrey; Temple, Robert; Woodcock, Janet; Yue, Lilly Q.; Califf, Robert M.

doi:10.1056/nejmsb1609216

Cited by 1,568 publications

(1,425 citation statements)

References 16 publications

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“…This type of real‐world data, collected from electronic administrative claims and medical records, is pragmatic in that it examines this patient population in the context of clinical practice 36, 37. It brings novel perspective to the healthcare costs and disease burden of this large population outside of clinical trials and may help to place the results of the ongoing cardiovascular outcomes trials into a real‐world perspective.…”

Section: Discussionmentioning

confidence: 99%

“…Observational studies often use existing data, rather than prospectively collected data, which can add to the uncertainty about findings and limit the usefulness of such data 37. Although claims data are valuable for examination of healthcare outcomes, treatment patterns, healthcare resource use, and costs, all claims databases have certain inherent limitations affecting generalizability because the claims are collected for the purpose of payment and not research.…”

Section: Discussionmentioning

confidence: 99%

“…With regard to statistical analyses, those reported herein should be evaluated in the context of the large sample size, which may indicate statistical significance for some parameters, even when differences are small and not clinically important. Real‐world studies may contain inaccurate recording of health events, missing data, and uncertainty about internal validity 37, 38. In the present study, laboratory test results during the follow‐up period were only available for a subset of patients.…”

Section: Discussionmentioning

confidence: 99%

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High Triglycerides Are Associated With Increased Cardiovascular Events, Medical Costs, and Resource Use: A Real‐World Administrative Claims Analysis of Statin‐Treated Patients With High Residual Cardiovascular Risk

Tóth

Granowitz

Hüll

et al. 2018

JAHA

122

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BackgroundThe American Heart Association recognizes high triglycerides as a cardiovascular risk factor.Methods and ResultsThis retrospective observational administrative claims analysis (Optum Research Database) included statin‐treated patients ≥45 years old with diabetes mellitus and/or atherosclerotic cardiovascular disease, triglycerides 2.26 to 5.64 mmol/L, and a propensity‐matched comparator cohort with triglycerides <1.69 mmol/L and high‐density lipoprotein cholesterol >1.04 mmol/L. In the high‐triglycerides cohort versus comparators (both n=10 990, 49% women), mean age was 61.7 versus 62.2 years and follow‐up was 41.3 versus 42.1 months, respectively. Multivariate analysis of composite major cardiovascular events demonstrated significantly increased risk in the high‐triglycerides (n=13 411 patients) versus comparator (n=32 506 patients) cohorts (hazard ratio [HR], 1.35; 95% confidence interval [CI], 1.225–1.485; P<0.001), with significantly higher risk for nonfatal myocardial infarction (HR, 1.35; 95% CI, 1.19–1.52; P<0.001), nonfatal stroke (HR, 1.27; 95% CI, 1.14–1.42; P<0.001), and need for coronary revascularization (HR, 1.51; 95% CI, 1.34–1.69; P<0.001), but not unstable angina or cardiovascular death. Increased cardiovascular risk in the high‐triglycerides versus comparator cohort was maintained, even with addition of non–high‐density lipoprotein cholesterol to the multivariate model and when analyzing high and low high‐density lipoprotein cholesterol subgroups. Average total healthcare cost per patient per month (cost ratio, 1.15; 95% CI, 1.084–1.210; P<0.001) and rate of occurrence of inpatient hospital stay (HR, 1.17; 95% CI, 1.113–1.223; P<0.001) were also significantly greater in the high‐triglycerides cohort.ConclusionsIn this real‐world analysis, patients with high cardiovascular risk and high triglycerides had worse composite cardiovascular and health economic outcomes than patients with well‐managed triglycerides and high‐density lipoprotein cholesterol >1.04 mmol/L.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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High Triglycerides Are Associated With Increased Cardiovascular Events, Medical Costs, and Resource Use: A Real‐World Administrative Claims Analysis of Statin‐Treated Patients With High Residual Cardiovascular Risk

Tóth

Granowitz

Hüll

et al. 2018

JAHA

122

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“…4 Critics of such studies also worry that the RWE literature is biased because of "data dredging" (ie, conducting multiple analyses until one provides the hoped-for result) and selective publication (ie, journals' preference for publishing positive results). [5][6][7][8] As a first step toward addressing these concerns, the ISPOR and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies.…”

mentioning

confidence: 99%

Good Practices for Real‐World Data Studies of Treatment and/or Comparative Effectiveness: Recommendations from the Joint ISPOR‐ISPE Special Task Force on Real‐World Evidence in Health Care Decision Making

Berger¹,

Sox

Willke³

et al. 2017

Value in Health

312

239

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Purpose: Real-world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials. RWE studies aim to improve health care decision making. Methods: The International Society for Pharmacoeconomics and Outcomes Research (ISPOR)and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies. Peer review by ISPOR/ISPE members and task force participants provided a consensus-building iterative process for the topics and framing of recommendations.Results: The ISPOR/ISPE Task Force recommendations cover seven topics such as study registration, replicability, and stakeholder involvement in RWE studies. These recommendations, in concert with earlier recommendations about study methodology, provide a trustworthy foundation for the expanded use of RWE in health care decision making. Conclusion:The focus of these recommendations is good procedural practices for studies that test a specific hypothesis in a specific population. We recognize that some of the recommendations in this report may not be widely adopted without appropriate incentives from decision makers, journal editors, and other key stakeholders. KEYWORDScomparative effectiveness, decision making, guidelines, pharmacoepidemiology, real-world data, treatment effectivenessThis is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

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“…Reuse of data for research may have the most far-reaching impact on the health of our citizens by not only speeding the design and execution of clinical trials [11] but also assisting in the discovery of new knowledge [12][13][14]. …”

Section: Actors Of Reuse Research and Patient Carementioning

confidence: 99%

Update on Data Reuse in Health Care

Safran¹

2017

Yearb Med Inform

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SummaryObjective: Reuse of clinical data has broad use in clinical, research, governmental, and business settings. This summary provides an update on the benefits, barriers to use with large clinical databases, policy frameworks that have been formulated, and challenges. Methods: This report highlights some recent publications on the diverse uses of clinical data and some policy initiatives to promote reuse. It also contains the opinions of the author. Results: Although many examples of the benefits of data reuse have been documented, this summary also reviews why the quality of clinical data needs to be the focus of future informatics work. Conclusion: The promise of reusing data outweighs potential risks, but concerns about privacy and the need to modernize our legal framework will be necessary to realize the full benefits of real-world evidence.

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Real-World Evidence — What Is It and What Can It Tell Us?

Cited by 1,568 publications

References 16 publications

High Triglycerides Are Associated With Increased Cardiovascular Events, Medical Costs, and Resource Use: A Real‐World Administrative Claims Analysis of Statin‐Treated Patients With High Residual Cardiovascular Risk

High Triglycerides Are Associated With Increased Cardiovascular Events, Medical Costs, and Resource Use: A Real‐World Administrative Claims Analysis of Statin‐Treated Patients With High Residual Cardiovascular Risk

Good Practices for Real‐World Data Studies of Treatment and/or Comparative Effectiveness: Recommendations from the Joint ISPOR‐ISPE Special Task Force on Real‐World Evidence in Health Care Decision Making

Update on Data Reuse in Health Care

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