Literature DB >> 27365013

Use of administrative data to increase the practicality of clinical trials: Insights from the Women's Health Initiative.

Garnet L Anderson1, Carolyn J Burns2, Joseph Larsen2, Pamela A Shaw3.   

Abstract

BACKGROUND: To reduce research costs in the context of pragmatic trials, consideration is given to using administrative data (Medicare claims) to ascertain clinical outcomes.
METHODS: In the historical context of the Women's Health Initiative, the correspondence between selected cardiovascular events derived from Medicare claims was compared to those documented and adjudicated in this large-scale prevention trial.
RESULTS: Classification performance varies somewhat by type of outcome, but hazard ratios and confidence intervals derived from the two data sources were quite comparable.
CONCLUSION: These encouraging results provided the needed support to launch a new embedded pragmatic trial of physical activity that will rely heavily on Medicare claims to ascertain cardiovascular disease incidence in the majority of those randomized.
© The Author(s) 2016.

Entities:  

Keywords:  Medicare linkage; Pragmatic trials; claims data; misclassification; mismeasured outcomes

Mesh:

Year:  2016        PMID: 27365013      PMCID: PMC5059108          DOI: 10.1177/1740774516656579

Source DB:  PubMed          Journal:  Clin Trials        ISSN: 1740-7745            Impact factor:   2.486


  28 in total

1.  Outcomes ascertainment and adjudication methods in the Women's Health Initiative.

Authors:  J David Curb; Anne McTiernan; Susan R Heckbert; Charles Kooperberg; Janet Stanford; Michael Nevitt; Karen C Johnson; Lori Proulx-Burns; Lisa Pastore; Michael Criqui; Sandra Daugherty
Journal:  Ann Epidemiol       Date:  2003-10       Impact factor: 3.797

2.  Evaluating the benefit of event adjudication of cardiovascular outcomes in large simple RCTs.

Authors:  Janice Pogue; Stephen D Walter; Salim Yusuf
Journal:  Clin Trials       Date:  2009-06       Impact factor: 2.486

3.  Viewpoint: Central adjudication of myocardial infarction in outcome-driven clinical trials--common patterns in TRITON, RECORD, and PLATO?

Authors:  Victor L Serebruany; Dan Atar
Journal:  Thromb Haemost       Date:  2012-07-26       Impact factor: 5.249

4.  Evaluation of Medicare claims data to ascertain peripheral vascular events in the Women's Health Initiative.

Authors:  Matthew W Mell; Mary Pettinger; Lori Proulx-Burns; Susan R Heckbert; Matthew A Allison; Michael H Criqui; Mark A Hlatky; Dale R Burwen
Journal:  J Vasc Surg       Date:  2014-03-11       Impact factor: 4.268

5.  Design of the Women's Health Initiative clinical trial and observational study. The Women's Health Initiative Study Group.

Authors: 
Journal:  Control Clin Trials       Date:  1998-02

6.  An audit strategy for progression-free survival.

Authors:  Lori E Dodd; Edward L Korn; Boris Freidlin; Robert Gray; Suman Bhattacharya
Journal:  Biometrics       Date:  2011-01-06       Impact factor: 2.571

7.  Estrogen plus progestin and breast cancer detection by means of mammography and breast biopsy.

Authors:  Rowan T Chlebowski; Garnet Anderson; Mary Pettinger; Dorothy Lane; Robert D Langer; Mary Ann Gilligan; Mary Ann Gillian; Brian W Walsh; Chu Chen; Anne McTiernan
Journal:  Arch Intern Med       Date:  2008-02-25

8.  Study of Cardiovascular Health Outcomes in the Era of Claims Data: The Cardiovascular Health Study.

Authors:  Bruce M Psaty; Joseph A Delaney; Alice M Arnold; Lesley H Curtis; Annette L Fitzpatrick; Susan R Heckbert; Barbara McKnight; Diane Ives; John S Gottdiener; Lewis H Kuller; W T Longstreth
Journal:  Circulation       Date:  2015-11-04       Impact factor: 29.690

9.  Enhancing Breast Cancer Recurrence Algorithms Through Selective Use of Medical Record Data.

Authors:  Candyce H Kroenke; Jessica Chubak; Lisa Johnson; Adrienne Castillo; Erin Weltzien; Bette J Caan
Journal:  J Natl Cancer Inst       Date:  2015-11-18       Impact factor: 13.506

10.  Use of Medicare data to identify coronary heart disease outcomes in the Women's Health Initiative.

Authors:  Mark A Hlatky; Roberta M Ray; Dale R Burwen; Karen L Margolis; Karen C Johnson; Anna Kucharska-Newton; JoAnn E Manson; Jennifer G Robinson; Monika M Safford; Matthew Allison; Themistocles L Assimes; Anthony A Bavry; Jeffrey Berger; Rhonda M Cooper-DeHoff; Susan R Heckbert; Wenjun Li; Simin Liu; Lisa W Martin; Marco V Perez; Hilary A Tindle; Wolfgang C Winkelmayer; Marcia L Stefanick
Journal:  Circ Cardiovasc Qual Outcomes       Date:  2014-01-07
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Review 1.  Contemporary use of real-world data for clinical trial conduct in the United States: a scoping review.

Authors:  James R Rogers; Junghwan Lee; Ziheng Zhou; Ying Kuen Cheung; George Hripcsak; Chunhua Weng
Journal:  J Am Med Inform Assoc       Date:  2021-01-15       Impact factor: 4.497

2.  The Women's Health Initiative (WHI) Life and Longevity After Cancer (LILAC) Study: Description and Baseline Characteristics of Participants.

Authors:  Electra D Paskett; Bette J Caan; Lisa Johnson; Brittany M Bernardo; Gregory S Young; Michael L Pennell; Roberta M Ray; Candyce H Kroenke; Peggy L Porter; Garnet L Anderson
Journal:  Cancer Epidemiol Biomarkers Prev       Date:  2018-01-29       Impact factor: 4.254

3.  Evaluating concordance between government administrative data and externally collected data among high-volume government health facilities in Uttar Pradesh, India.

Authors:  Beth S Phillips; Shreya Singhal; Shambhavi Mishra; Fnu Kajal; Sun Yu Cotter; May Sudhinaraset
Journal:  Glob Health Action       Date:  2019       Impact factor: 2.640

4.  Protocol for serious fall injury adjudication in the Strategies to Reduce Injuries and Develop Confidence in Elders (STRIDE) study.

Authors:  David A Ganz; Albert L Siu; Jay Magaziner; Nancy K Latham; Thomas G Travison; Nancy P Lorenze; Charles Lu; Rixin Wang; Erich J Greene; Cynthia L Stowe; Lea N Harvin; Katy L B Araujo; Jerry H Gurwitz; Yuri Agrawal; Rosaly Correa-De-Araujo; Peter Peduzzi; Thomas M Gill
Journal:  Inj Epidemiol       Date:  2019-04-15

5.  Factors associated with patient-reported likelihood of using online self-care interventions: a Scleroderma Patient-centered Intervention Network (SPIN) cohort study.

Authors:  Linda Kwakkenbos; Julie Cumin; Marie-Eve Carrier; Susan J Bartlett; Vanessa L Malcarne; Luc Mouthon; Warren R Nielson; François Rannou; Joep Welling; Brett D Thombs
Journal:  BMJ Open       Date:  2019-10-14       Impact factor: 2.692

6.  DIVERT-Collaboration Action Research and Evaluation (CARE) Trial Protocol: a multiprovincial pragmatic cluster randomised trial of cardiorespiratory management in home care.

Authors:  Andrew P Costa; Connie Schumacher; Aaron Jones; Darly Dash; Graham Campbell; Mats Junek; Gina Agarwal; Chaim M Bell; Veronique Boscart; Susan E Bronskill; David Feeny; Paul C Hébert; George A Heckman; John P Hirdes; Linda Lee; Robert S McKelvie; Lori Mitchell; Samir K Sinha; Joy Davis; Tammy Priddle; Joanne Rose; Roslyn Gillan; Deborah Mills; Dilys Haughton
Journal:  BMJ Open       Date:  2019-12-15       Impact factor: 2.692

7.  CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration.

Authors:  Linda Kwakkenbos; Mahrukh Imran; Stephen J McCall; Kimberly A McCord; Ole Fröbert; Lars G Hemkens; Merrick Zwarenstein; Clare Relton; Danielle B Rice; Sinéad M Langan; Eric I Benchimol; Lehana Thabane; Marion K Campbell; Margaret Sampson; David Erlinge; Helena M Verkooijen; David Moher; Isabelle Boutron; Philippe Ravaud; Jon Nicholl; Rudolf Uher; Maureen Sauvé; John Fletcher; David Torgerson; Chris Gale; Edmund Juszczak; Brett D Thombs
Journal:  BMJ       Date:  2021-04-29

8.  Methods and results used in the development of a consensus-driven extension to the Consolidated Standards of Reporting Trials (CONSORT) statement for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE).

Authors:  Mahrukh Imran; Linda Kwakkenbos; Stephen J McCall; Kimberly A McCord; Ole Fröbert; Lars G Hemkens; Merrick Zwarenstein; Clare Relton; Danielle B Rice; Sinéad M Langan; Eric I Benchimol; Lehana Thabane; Marion K Campbell; Margaret Sampson; David Erlinge; Helena M Verkooijen; David Moher; Isabelle Boutron; Philippe Ravaud; Jon Nicholl; Rudolf Uher; Maureen Sauvé; John Fletcher; David Torgerson; Chris Gale; Edmund Juszczak; Brett D Thombs
Journal:  BMJ Open       Date:  2021-04-29       Impact factor: 2.692

9.  Protocol for a scoping review to support development of a CONSORT extension for randomised controlled trials using cohorts and routinely collected health data.

Authors:  Linda Kwakkenbos; Mahrukh Imran; Kimberly A McCord; Margaret Sampson; Ole Fröbert; Chris Gale; Lars G Hemkens; Sinead M Langan; David Moher; Clare Relton; Merrick Zwarenstein; Eric I Benchimol; Isabelle Boutron; Marion K Campbell; David Erlinge; Sena Jawad; Philippe Ravaud; Danielle B Rice; Maureen Sauve; Tjeerd P van Staa; Lehana Thabane; Rudolf Uher; Helena M Verkooijen; Edmund Juszczak; Brett D Thombs
Journal:  BMJ Open       Date:  2018-08-05       Impact factor: 2.692

10.  Protocol for the development of a CONSORT extension for RCTs using cohorts and routinely collected health data.

Authors:  Linda Kwakkenbos; Edmund Juszczak; Lars G Hemkens; Margaret Sampson; Ole Fröbert; Clare Relton; Chris Gale; Merrick Zwarenstein; Sinéad M Langan; David Moher; Isabelle Boutron; Philippe Ravaud; Marion K Campbell; Kimberly A Mc Cord; Tjeerd P van Staa; Lehana Thabane; Rudolf Uher; Helena M Verkooijen; Eric I Benchimol; David Erlinge; Maureen Sauvé; David Torgerson; Brett D Thombs
Journal:  Res Integr Peer Rev       Date:  2018-10-29
  10 in total

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