Tools and Methods for Real-World Evidence Generation: Pragmatic Trials, Electronic Consent, and Data Linkages

Jeffrey R Curtis; P Jeff Foster; Kenneth G Saag

doi:10.1016/j.rdc.2019.01.010

Tools and Methods for Real-World Evidence Generation: Pragmatic Trials, Electronic Consent, and Data Linkages

Rheum Dis Clin North Am. 2019 May;45(2):275-289. doi: 10.1016/j.rdc.2019.01.010.

Authors

Jeffrey R Curtis¹, P Jeff Foster², Kenneth G Saag²

Affiliations

¹ Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: jcurtis@uab.edu.
² Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, AL, USA.

Abstract

Real-world evidence requires use of new tools and methods to support efficient evidence generation. Among those tools are pragmatic trials, utilization of central/single institutional review board and electronic consent, and data linkages between diverse types of data sources (eg, a trial or registry to administrative claims or electronic medical record data). This article reviews these topics in the context of describing several exemplar use cases specific to rheumatology and provides perspective regarding both the promise and potential pitfalls in using these tools and approaches.

Keywords: Data linkage; Informed consent; Osteoporosis; Pragmatic trials; Real-world evidence; Rheumatoid arthritis.

Publication types

Research Support, N.I.H., Extramural
Review

MeSH terms

Evidence-Based Medicine / methods
Evidence-Based Medicine / trends
Humans
Information Storage and Retrieval / methods*
Informed Consent
Pragmatic Clinical Trials as Topic* / instrumentation
Pragmatic Clinical Trials as Topic* / methods
Research Design
Rheumatic Diseases* / epidemiology
Rheumatic Diseases* / therapy
Telemedicine*

Abstract

Publication types

MeSH terms

Grants and funding