What Does It Take to Transform Real‐World Data Into Real‐World Evidence?

Ramamoorthy, Anuradha; Huang, Shiew‐Mei

doi:10.1002/cpt.1486

Cited by 21 publications

(14 citation statements)

References 22 publications

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“…Investigators in both studies also used the SIDIAP database. Verifying that these diseases have been correctly diagnosed in patients’ health records not only reflects the quality of Health care in Catalonia but also validates the database for use in health research (Ramamoorthy & Huang, 2019).…”

Section: Discussionmentioning

confidence: 68%

Validity of Chronic Venous Disease Diagnoses and Epidemiology Using Validated Electronic Health Records From Primary Care: A Real‐World Data Analysis

Homs‐Romero

Romero-Collado

Soriano

et al. 2021

J of Nursing Scholarship

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Purpose The aim of this study was to evaluate the validity of lower limb chronic venous disease (CVD) diagnoses entered in a large electronic health record database in primary care in Catalonia, Spain; to investigate the reliability of these data for research purposes; and to estimate the prevalence and incidence of CVD, chronic venous insufficiency (CVI), and venous leg ulcer (VLU). Design Real‐world data analysis based on a large electronic health record database in primary care in Catalonia, Spain. Methods We used a primary care research database (Information System for the Development of Research in Primary Care [SIDIAP]), which contains anonymous data on some 5.8 million people from 279 primary care centers, accounting for more than 80% of the Catalonian population and 15% of the Spanish population. We evaluated the validity of the ICD‐10 codes for CVD in SIDIAP for 200 adult patients through the responses of 20 primary care physicians to a questionnaire. Findings The positive predictive value of CVD in SIDIAP was 89.95% (95% confidence interval [CI] 84.99–93.40). The prevalence rates for CVD, CVI, and VLU were 9.54% (95% CI 9.51–9.56), 3.87%, and 0.33%, respectively. The incidence rates for CVD, CVI, and VLU were 7.91/1,000 person‐years (95% CI 7.82–8.00), 3.37/1,000 person‐years (95% CI 3.31–3.43), and 0.23/1,000 person‐years (95% CI 0.21–0.24), respectively. Conclusions The Catalonian SIDIAP database contains valid CVD diagnoses. The prevalence and incidence rates found using real‐world data are low compared with those in the literature, possibly because CVD is an underdiagnosed entity. Clinical Relevance Real‐world data can inform clinicians on lower limb venous health in a population, show changes as individuals age, and reveal aspects where healthcare can be improved.

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Section: Discussionmentioning

confidence: 68%

Validity of Chronic Venous Disease Diagnoses and Epidemiology Using Validated Electronic Health Records From Primary Care: A Real‐World Data Analysis

Homs‐Romero

Romero-Collado

Soriano

et al. 2021

J of Nursing Scholarship

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“…These limitations have been long‐recognized in medical research; similarly, the collection of a large amount of health‐related data is by no means new, particularly in public health and epidemiology (eg, surveillance data). Yet, the exponential growth in the possibility to store, link, and analyse extremely large amount of data (“big data”), combined with the rising costs of RCTs (particularly cardiovascular outcome trials in type 2 diabetes) without the expected quality and quantity of scientific evidence to support healthcare decision, has driven in recent years a huge interest in “real‐world data” (RWD) and in the RWD‐generated evidence (“real‐world evidence,” RWE), in multiple areas of medicine …”

Section: Rwd and Rwe In Medicinementioning

confidence: 99%

The present and future scope of real‐world evidence research in diabetes: What questions can and cannot be answered and what might be possible in the future?

Zaccardi

Davies

Khunti

2020

Diabetes Obesity Metabolism

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The last decade has witnessed an exponential growth in the opportunities to collect and link health‐related data from multiple resources, including primary care, administrative, and device data. The availability of these “real‐world,” “big data” has fuelled also an intense methodological research into methods to handle them and extract actionable information. In medicine, the evidence generated from “real‐world data” (RWD), which are not purposely collected to answer biomedical questions, is commonly termed “real‐world evidence” (RWE). In this review, we focus on RWD and RWE in the area of diabetes research, highlighting their contributions in the last decade; and give some suggestions for future RWE diabetes research, by applying well‐established and less‐known tools to direct RWE diabetes research towards better personalized approaches to diabetes care. We underline the essential aspects to consider when using RWD and the key features limiting the translational potential of RWD in generating high‐quality and applicable RWE. Only if viewed in the context of other study designs and statistical methods, with its pros and cons carefully considered, RWE will exploit its full potential as a complementary or even, in some cases, substitutive source of evidence compared to the expensive evidence obtained from randomized controlled trials.

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“…9 Real-world data (RWD) have recently attracted attention by regulatory agencies as an additional approach to generate evidence in support of drug approvals. 10 In the current work, RWD from the National Health and Nutrition Examination Survey (NHANES) that summarized FN-BMD results in preand postmenopausal women, 11 combined with BMD data from elagolix phase III clinical trials in patients with endometriosis or uterine fibroids (UFs) who received placebo for a limited duration, were integrated to develop a modeling and simulation framework that describes longitudinal changes in BMD.…”

Section: Introductionmentioning

confidence: 99%

Integrating real‐world data and modeling to project changes in femoral neck bone mineral density and fracture risk in premenopausal women

Beck

Winzenborg

Gao

et al. 2021

Clinical Translational Sci

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What Does It Take to Transform Real‐World Data Into Real‐World Evidence?

Cited by 21 publications

References 22 publications

Validity of Chronic Venous Disease Diagnoses and Epidemiology Using Validated Electronic Health Records From Primary Care: A Real‐World Data Analysis

Validity of Chronic Venous Disease Diagnoses and Epidemiology Using Validated Electronic Health Records From Primary Care: A Real‐World Data Analysis

The present and future scope of real‐world evidence research in diabetes: What questions can and cannot be answered and what might be possible in the future?

Integrating real‐world data and modeling to project changes in femoral neck bone mineral density and fracture risk in premenopausal women

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