Methodologic approaches in studies using real-world data to measure pediatric safety and effectiveness of vaccines administered to pregnant women: a scoping review protocol

Abstract Objective Real-world data (RWD), defined as routinely collected healthcare data, can be a potential catalyst for addressing challenges faced in clinical trials. We performed a scoping review of database-specific RWD applications within clinical trial contexts, synthesizing prominent uses and themes. Materials and Methods Querying 3 biomedical literature databases, research articles using electronic health records, administrative claims databases, or clinical registries either within a clinical trial or in tandem with methodology related to clinical trials were included. Articles were required to use at least 1 US RWD source. All abstract screening, full-text screening, and data extraction was performed by 1 reviewer. Two reviewers independently verified all decisions. Results Of 2020 screened articles, 89 qualified: 59 articles used electronic health records, 29 used administrative claims, and 26 used registries. Our synthesis was driven by the general life cycle of a clinical trial, culminating into 3 major themes: trial process tasks (51 articles); dissemination strategies (6); and generalizability assessments (34). Despite a diverse set of diseases studied, <10% of trials using RWD for trial process tasks evaluated medications or procedures (5/51). All articles highlighted data-related challenges, such as missing values. Discussion Database-specific RWD have been occasionally leveraged for various clinical trial tasks. We observed underuse of RWD within conducted medication or procedure trials, though it is subject to the confounder of implicit report of RWD use. Conclusion Enhanced incorporation of RWD should be further explored for medication or procedure trials, including better understanding of how to handle related data quality issues to facilitate RWD use.

Download Full-text

Assessing the practice of data quality evaluation in a national clinical data research network through a systematic scoping review in the era of real-world data

Journal of the American Medical Informatics Association ◽

10.1093/jamia/ocaa245 ◽

2020 ◽

Vol 27 (12) ◽

pp. 1999-2010

Author(s):

Jiang Bian ◽

Tianchen Lyu ◽

Alexander Loiacono ◽

Tonatiuh Mendoza Viramontes ◽

Gloria Lipori ◽

...

Keyword(s):

Data Quality ◽

Scoping Review ◽

Real World ◽

Assessment Methods ◽

Ease Of Use ◽

Research Network ◽

Assessment Practice ◽

Real World Data ◽

Patient Centered ◽

World Data

Abstract Objective To synthesize data quality (DQ) dimensions and assessment methods of real-world data, especially electronic health records, through a systematic scoping review and to assess the practice of DQ assessment in the national Patient-centered Clinical Research Network (PCORnet). Materials and Methods We started with 3 widely cited DQ literature—2 reviews from Chan et al (2010) and Weiskopf et al (2013a) and 1 DQ framework from Kahn et al (2016)—and expanded our review systematically to cover relevant articles published up to February 2020. We extracted DQ dimensions and assessment methods from these studies, mapped their relationships, and organized a synthesized summarization of existing DQ dimensions and assessment methods. We reviewed the data checks employed by the PCORnet and mapped them to the synthesized DQ dimensions and methods. Results We analyzed a total of 3 reviews, 20 DQ frameworks, and 226 DQ studies and extracted 14 DQ dimensions and 10 assessment methods. We found that completeness, concordance, and correctness/accuracy were commonly assessed. Element presence, validity check, and conformance were commonly used DQ assessment methods and were the main focuses of the PCORnet data checks. Discussion Definitions of DQ dimensions and methods were not consistent in the literature, and the DQ assessment practice was not evenly distributed (eg, usability and ease-of-use were rarely discussed). Challenges in DQ assessments, given the complex and heterogeneous nature of real-world data, exist. Conclusion The practice of DQ assessment is still limited in scope. Future work is warranted to generate understandable, executable, and reusable DQ measures.

Download Full-text