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

Article Health Care Sciences & Services

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

Julie C. Lauffenburger et al.

Summary: Efforts to reduce inappropriate prescribing of high-risk medications to older adults have had limited success. This study aims to determine whether designing EHR tools using behavioral science principles can effectively reduce inappropriate prescribing and improve clinical outcomes in older adults. The NUDGE-EHR project utilizes a two-stage, 16-arm adaptive randomized pragmatic trial to identify the most effective EHR tool among primary care providers and their patients aged 65 years and older.

IMPLEMENTATION SCIENCE (2021)

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Article Medical Informatics

Real-World Data for Planning Eligibility Criteria and Enhancing Recruitment: Recommendations from the Clinical Trials Transformation Initiative

Scott R. Evans et al.

Summary: The increasing availability of RWD offers new opportunities for evidence generation and efficiency improvement in research, with sponsors using RWD for data-driven decisions and targeted recruitment strategies. The CTTI provides recommendations and resources for utilizing RWD in planning and recruiting for clinical trials, aiming to support researchers in engaging cross-functional teams and developing patient-centric recruitment approaches.

THERAPEUTIC INNOVATION & REGULATORY SCIENCE (2021)

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Article Health Care Sciences & Services

Rapid versus traditional qualitative analysis using the Consolidated Framework for Implementation Research (CFIR)

Andrea L. Nevedal et al.

Summary: The study compared a traditional deductive CFIR analysis approach with a new rapid deductive CFIR approach. The rapid deductive approach was found to be less time intensive and eliminated transcription costs, while still effective in meeting evaluation objectives and establishing rigor. Researchers should consider team expertise, level of detail needed, data mode, and advantages/disadvantages of using the CFIR when employing this approach.

IMPLEMENTATION SCIENCE (2021)

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Article Economics