Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Apr 13;29(5):798-804.
doi: 10.1093/jamia/ocac004.

Evaluating fitness-for-use of electronic health records in pragmatic clinical trials: reported practices and recommendations

Sudha R Raman  1   2 , Emily C O'Brien  1   2 , Bradley G Hammill  1   2 , Adam J Nelson  2   3 , Laura J Fish  4 , Lesley H Curtis  1   2 , Keith Marsolo  1   2
Affiliations

Evaluating fitness-for-use of electronic health records in pragmatic clinical trials: reported practices and recommendations

Sudha R Raman et al. J Am Med Inform Assoc. .

Abstract

Objective: To empirically explore how pragmatic clinical trials (PCTs) that used real-world data (RWD) assessed study-specific fitness-for-use.

Methods: We conducted interviews and surveys with PCT teams who used electronic health record (EHR) data to ascertain endpoints. The survey cataloged key concerns about RWD, activities used to assess data fitness-for-use, and related barriers encountered by study teams. Patterns and commonalities across trials were used to develop recommendations for study-specific fitness-for-use assessments.

Results: Of 15 invited trial teams, 7 interviews were conducted. Of 31 invited trials, 15 responded to the survey. Most respondents had prior experience using RWD (93%). Major concerns about EHR data were data reliability, missingness or incompleteness of EHR elements, variation in data quality across study sites, and presence of implausible or incorrect values. Although many PCTs conducted fitness-for-use activities (eg, data quality assessments, 11/14, 79%), less than a quarter did so before choosing a data source. Fitness-for-use activities, findings, and resulting study design changes were not often publically documented. Overall costs and personnel costs were barriers to fitness-for-use assessments.

Discussion: These results support three recommendations for PCTs that use EHR data for endpoint ascertainment. Trials should detail the rationale and plan for study-specific fitness-for-use activities, conduct study-specific fitness-for-use assessments early in the prestudy phase to inform study design changes before the trial begins, and share results of fitness-for-use assessments and description of relevant challenges and facilitators.

Conclusion: These recommendations can help researchers and end-users of real-world evidence improve characterization of RWD reliability and relevance in the PCT-specific context.

Keywords: data accuracy; electronic health records; pragmatic clinical trials as topic; research design.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Factors considered in decision to use EHR (n = 15). EHR: electronic health record.
Figure 2.
Figure 2.
Barriers to further fitness-for-use assessment (n = 8).
See this image and copyright information in PMC

References

    1. US Food and Drug Administration. Framework for FDA's real-world evidence program. 2018. https://www.fda.gov/media/120060/download. Accessed January 20, 2022.
    1. US Food and Drug Administration. Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. 2017. https://www.fda.gov/media/99447/download. Accessed January 20, 2022.
    1. Ma Q, Chung H, Shambhu S, et al. Administrative claims data to support pragmatic clinical trial outcome ascertainment on cardiovascular health. Clin Trials 2019; 16 (4): 419–30. - PubMed
    1. Pfaff E, Lee A, Bradford R, et al. Recruiting for a pragmatic trial using the electronic health record and patient portal: successes and lessons learned. J Am Med Inform Assoc 2019; 26 (1): 44–9. - PMC - PubMed
    1. Lauffenburger JC, Isaac T, Trippa L, et al. Rationale and design of the Novel Uses of adaptive Designs to Guide provider Engagement in Electronic Health Records (NUDGE-EHR) pragmatic adaptive randomized trial: a trial protocol. Implement Sci 2021; 16 (1): 9. - PMC - PubMed

Publication types