Real-World Evidence: A Review of Real-World Data Sources Used in Orthopaedic Research

Real-world evidence is increasingly being collected in our interconnected world. This information can provide insights on how medical products are impacting the daily lives of patients, translating into public health consequences. Understanding the demographic characteristics of patients contributing health information to real-world data sources is critical to determining the safety and effectiveness of medical products for specific populations. Race and ethnicity are recorded inconsistently in different real-world data sources, with many lacking reliable information on these variables. To better leverage all forms of real-world data to inform medical device evaluation, accurate and consistent collection of information from different racial and ethnic subgroups is necessary.

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An OMOP-CDM based pharmacovigilance data-processing pipeline (PDP) providing active surveillance for ADR signal detection from real-world data sources

BMC Medical Informatics and Decision Making ◽

10.1186/s12911-021-01520-y ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Hyunah Shin ◽

Suehyun Lee

Keyword(s):

Data Processing ◽

Active Surveillance ◽

Drug Safety ◽

Real World ◽

Reporting System ◽

Data Sources ◽

Real World Data ◽

World Data ◽

Processing Pipeline ◽

Real World Evidence

Abstract Background Adverse drug reactions (ADRs) are regarded as a major cause of death and a major contributor to public health costs. For the active surveillance of drug safety, the use of real-world data and real-world evidence as part of the overall pharmacovigilance process is important. In this regard, many studies apply the data-driven approaches to support pharmacovigilance. We developed a pharmacovigilance data-processing pipeline (PDP) that utilized electronic health records (EHR) and spontaneous reporting system (SRS) data to explore pharmacovigilance signals. Methods To this end, we integrated two medical data sources: Konyang University Hospital (KYUH) EHR and the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS). As part of the presented PDP, we converted EHR data on the Observation Medical Outcomes Partnership (OMOP) data model. To evaluate the ability of using the proposed PDP for pharmacovigilance purposes, we performed a statistical validation using drugs that induce ear disorders. Results To validate the presented PDP, we extracted six drugs from the EHR that were significantly involved in ADRs causing ear disorders: nortriptyline, (hazard ratio [HR] 8.06, 95% CI 2.41–26.91); metoclopramide (HR 3.35, 95% CI 3.01–3.74); doxycycline (HR 1.73, 95% CI 1.14–2.62); digoxin (HR 1.60, 95% CI 1.08–2.38); acetaminophen (HR 1.59, 95% CI 1.47–1.72); and sucralfate (HR 1.21, 95% CI 1.06–1.38). In FAERS, the strongest associations were found for nortriptyline (reporting odds ratio [ROR] 1.94, 95% CI 1.73–2.16), sucralfate (ROR 1.22, 95% CI 1.01–1.45), doxycycline (ROR 1.30, 95% CI 1.20–1.40), and hydroxyzine (ROR 1.17, 95% CI 1.06–1.29). We confirmed the results in a meta-analysis using random and fixed models for doxycycline, hydroxyzine, metoclopramide, nortriptyline, and sucralfate. Conclusions The proposed PDP could support active surveillance and the strengthening of potential ADR signals via real-world data sources. In addition, the PDP was able to generate real-world evidence for drug safety.

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PCP53 - A DIAGNOSTIC FRAMEWORK TO EVALUATE REAL-WORLD DATA SOURCES FOR REAL-WORLD EVIDENCE GENERATION

Value in Health ◽

10.1016/j.jval.2018.09.528 ◽

2018 ◽

Vol 21 ◽

pp. S89

Author(s):

L. Denysyk ◽

J. Doyle ◽

R. Sood

Keyword(s):

Real World ◽

Data Sources ◽

Real World Data ◽

World Data ◽

Real World Evidence ◽

Diagnostic Framework ◽

Evidence Generation

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Real-World Data and Real-World Evidence

Innovative Methods for Rare Disease Drug Development ◽

10.1201/9781003049364-8 ◽

2020 ◽

pp. 141-166

Author(s):

Shein-Chung Chow

Keyword(s):

Real World ◽

Real World Data ◽

World Data ◽

Real World Evidence

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Development of an Innovative Real-World Evidence Registry for the Herpes Simplex Virus: Case Study

JMIR Dermatology ◽

10.2196/16933 ◽

2020 ◽

Vol 3 (1) ◽

pp. e16933 ◽

Cited By ~ 2

Author(s):

Michelle Helena van Velthoven ◽

Ching Lam ◽

Caroline de Cock ◽

Terese Stenfors ◽

Hassan Chaudhury ◽

...

Keyword(s):

Herpes Simplex Virus ◽

Herpes Simplex ◽

Real World ◽

Physical Symptoms ◽

Use Cases ◽

Real World Data ◽

World Data ◽

Real World Evidence ◽

Simplex Virus

Background Infection with the herpes simplex virus (HSV) is common but not well understood. Furthermore, there remains a social stigma surrounding HSV that can have psychosocial implications for those infected. Despite many patients infected with HSV experiencing mild-to-severe physical symptoms, only one subeffective treatment is available. A registry collecting real-world data reported by individuals potentially infected with HSV could help patients to better understand and manage their condition. Objective This study aimed to report on the development of a registry to collect real-world data reported by people who might be infected with HSV. Methods A case study design was selected as it provides a systematic and in-depth approach to investigating the planning phase of the registry. The case study followed seven stages: plan, design, prepare, collect, analyze, create, and share. We carried out semistructured interviews with experts, which were thematically analyzed and used to build use cases for the proposed registry. These use cases will be used to generate detailed models of how a real-world evidence registry might be perceived and used by different users. Results The following key themes were identified in the interviews: (1) stigma and anonymity, (2) selection bias, (3) understanding treatment and outcome gaps, (4) lifestyle factors, (5) individualized versus population-level data, and (6) severe complications of HSV. We developed use cases for different types of users of the registry, including individuals with HSV, members of the public, researchers, and clinicians. Conclusions This case study revealed key considerations and insights for the development of an appropriate registry to collect real-world data reported by people who might be infected with HSV. Further development and testing of the registry with different users is required. The registry must also be evaluated for the feasibility and effectiveness of collecting data to support symptom management. This registry has the potential to contribute to the development of vaccines and treatments and provide insights into the impact of HSV on other conditions.

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