Literature DB >> 30952398

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

Jeffrey R Curtis1, P Jeff Foster2, Kenneth G Saag2.   

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.
Copyright © 2019 Elsevier Inc. All rights reserved.

Entities:  

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

Mesh：

Year:  2019        PMID： 30952398      PMCID： PMC6499376          DOI： 10.1016/j.rdc.2019.01.010

Source DB:  PubMed          Journal:  Rheum Dis Clin North Am        ISSN： 0889-857X            Impact factor:   2.670


  43 in total

1.  A simple heuristic for blindfolded record linkage.

Authors:  Susan C Weber; Henry Lowe; Amar Das; Todd Ferris
Journal:  J Am Med Inform Assoc       Date:  2012-02-01       Impact factor: 4.497

2.  Generalizability of Patients With Rheumatoid Arthritis in Biologic Agent Clinical Trials.

Authors:  Priyanka Vashisht; Harlan Sayles; Amy C Cannella; Ted R Mikuls; Kaleb Michaud
Journal:  Arthritis Care Res (Hoboken)       Date:  2016-09-16       Impact factor: 4.794

3.  Tocilizumab and the Risk of Cardiovascular Disease: Direct Comparison Among Biologic Disease-Modifying Antirheumatic Drugs for Rheumatoid Arthritis Patients.

Authors:  Fenglong Xie; Huifeng Yun; Emily B Levitan; Paul Muntner; Jeffrey R Curtis
Journal:  Arthritis Care Res (Hoboken)       Date:  2019-08       Impact factor: 4.794

4.  Assessing the feasibility of the Effectiveness of Discontinuing Bisphosphonates trial: a pilot study.

Authors:  N C Wright; P J Foster; A S Mudano; J A Melnick; E M Lewiecki; W J Shergy; J R Curtis; G R Cutter; M I Danila; M L Kilgore; E C Lewis; S L Morgan; D T Redden; A H Warriner; K G Saag
Journal:  Osteoporos Int       Date:  2017-05-24       Impact factor: 4.507

5.  Magnitude and consequences of misclassification of incident hip fractures in large cohort studies: the Study of Osteoporotic Fractures and Medicare claims data.

Authors:  J T Schousboe; M L Paudel; B C Taylor; B A Virnig; J A Cauley; J R Curtis; K E Ensrud
Journal:  Osteoporos Int       Date:  2012-12-04       Impact factor: 4.507

6.  Derivation and preliminary validation of an administrative claims-based algorithm for the effectiveness of medications for rheumatoid arthritis.

Authors:  Jeffrey R Curtis; John W Baddley; Shuo Yang; Nivedita Patkar; Lang Chen; Elizabeth Delzell; Ted R Mikuls; Kenneth G Saag; Jasvinder Singh; Monika Safford; Grant W Cannon
Journal:  Arthritis Res Ther       Date:  2011-09-20       Impact factor: 5.156

7.  Cardiovascular Safety of Tocilizumab Versus Tumor Necrosis Factor Inhibitors in Patients With Rheumatoid Arthritis: A Multi-Database Cohort Study.

Authors:  Seoyoung C Kim; Daniel H Solomon; James R Rogers; Sara Gale; Micki Klearman; Khaled Sarsour; Sebastian Schneeweiss
Journal:  Arthritis Rheumatol       Date:  2017-04-28       Impact factor: 10.995

8.  A pragmatic randomized trial comparing tablet computer informed consent to traditional paper-based methods for an osteoporosis study.

Authors:  A H Warriner; P J Foster; A Mudano; N C Wright; M E Melton; S E Sattui; W Calmbach; J R Curtis; M Kilgore; C E Lewis; W Pace; K G Saag
Journal:  Contemp Clin Trials Commun       Date:  2016-02-17

9.  Improving the reporting of pragmatic trials: an extension of the CONSORT statement.

Authors:  Merrick Zwarenstein; Shaun Treweek; Joel J Gagnier; Douglas G Altman; Sean Tunis; Brian Haynes; Andrew D Oxman; David Moher
Journal:  BMJ       Date:  2008-11-11

10.  Chronic lung disease in U.S. Veterans with rheumatoid arthritis and the impact on survival.

Authors:  Bryant R England; Harlan Sayles; Kaleb Michaud; Geoffrey M Thiele; Jill A Poole; Liron Caplan; Brian C Sauer; Grant W Cannon; Andreas Reimold; Gail S Kerr; Joshua F Baker; Ted R Mikuls
Journal:  Clin Rheumatol       Date:  2018-10-02       Impact factor: 2.980
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  1 in total

1.  Advancing rapid adaptation for urgent public health crises: Using implementation science to facilitate effective and efficient responses.

Authors:  Andria B Eisman; Bo Kim; Ramzi G Salloum; Clayton J Shuman; Russell E Glasgow
Journal:  Front Public Health       Date:  2022-08-24
  1 in total

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