Use of health plan combined with registry data to predict clinical trial recruitment

Jeffrey R. Curtis, Nicole C. Wright, Fenglong Xie, Lang Chen, Jie Zhang, Kenneth G. Saag, Aseem Bharat, Joel Kremer, Stacey Cofield, Kevin Winthrop, Elizabeth Delzell

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Background Large pragmatic clinical trials (PCTs) are increasingly used to conduct comparative effectiveness research. In the context of planning a safety PCT of the live herpes zoster vaccine in rheumatoid arthritis (RA) patients aged ≥ 50 years receiving anti-tumor necrosis factor (TNF) therapy, we evaluated the use of health plan combined with registry data to assess the feasibility of recruiting the 4000 patients needed for the trial and to facilitate site selection. Methods Using national US data from Medicare, we identified older RA patients who received anti-TNF therapy in the last quarter of 2009. Extrapolations were made from the Medicare patient population to younger patients and those with other types of insurance using the Consortium of Rheumatology Researchers of North America (CORRONA) disease registry. Patients treating rheumatologists were grouped into practices and sorted by size from the greatest to the least number of eligible patients. Results Approximately 50,000 RA patients receiving anti-TNF therapy were identified in the Medicare data, distributed across 1980 physician practices. After augmenting Medicare data with information from CORRONA and extrapolating to younger patients and those with other types of insurance, more than 12,000 potentially eligible study subjects were identified from the 50 largest rheumatology practices. Conclusion Health plan and registry databases appear useful to assess feasibility of large pragmatic trials and to assist in selection of recruitment sites with the greatest number of potentially eligible patients. This novel approach is applicable to trials with simple inclusion/exclusion criteria that can be readily assessed in these data sources.

Original languageEnglish (US)
Pages (from-to)96-101
Number of pages6
JournalClinical Trials
Volume11
Issue number1
DOIs
StatePublished - Feb 2014

Fingerprint

Registries
Clinical Trials
Health
Pragmatic Clinical Trials
Medicare
Rheumatology
Rheumatoid Arthritis
Tumor Necrosis Factor-alpha
North America
Insurance
Herpes Zoster Vaccine
Comparative Effectiveness Research
Research Personnel
Information Storage and Retrieval
Therapeutics
Databases
Physicians
Safety
Population

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology

Cite this

Curtis, J. R., Wright, N. C., Xie, F., Chen, L., Zhang, J., Saag, K. G., ... Delzell, E. (2014). Use of health plan combined with registry data to predict clinical trial recruitment. Clinical Trials, 11(1), 96-101. https://doi.org/10.1177/1740774513512185

Use of health plan combined with registry data to predict clinical trial recruitment. / Curtis, Jeffrey R.; Wright, Nicole C.; Xie, Fenglong; Chen, Lang; Zhang, Jie; Saag, Kenneth G.; Bharat, Aseem; Kremer, Joel; Cofield, Stacey; Winthrop, Kevin; Delzell, Elizabeth.

In: Clinical Trials, Vol. 11, No. 1, 02.2014, p. 96-101.

Research output: Contribution to journalArticle

Curtis, JR, Wright, NC, Xie, F, Chen, L, Zhang, J, Saag, KG, Bharat, A, Kremer, J, Cofield, S, Winthrop, K & Delzell, E 2014, 'Use of health plan combined with registry data to predict clinical trial recruitment', Clinical Trials, vol. 11, no. 1, pp. 96-101. https://doi.org/10.1177/1740774513512185
Curtis, Jeffrey R. ; Wright, Nicole C. ; Xie, Fenglong ; Chen, Lang ; Zhang, Jie ; Saag, Kenneth G. ; Bharat, Aseem ; Kremer, Joel ; Cofield, Stacey ; Winthrop, Kevin ; Delzell, Elizabeth. / Use of health plan combined with registry data to predict clinical trial recruitment. In: Clinical Trials. 2014 ; Vol. 11, No. 1. pp. 96-101.
@article{eed602c849e641ae81cf92a6df558736,
title = "Use of health plan combined with registry data to predict clinical trial recruitment",
abstract = "Background Large pragmatic clinical trials (PCTs) are increasingly used to conduct comparative effectiveness research. In the context of planning a safety PCT of the live herpes zoster vaccine in rheumatoid arthritis (RA) patients aged ≥ 50 years receiving anti-tumor necrosis factor (TNF) therapy, we evaluated the use of health plan combined with registry data to assess the feasibility of recruiting the 4000 patients needed for the trial and to facilitate site selection. Methods Using national US data from Medicare, we identified older RA patients who received anti-TNF therapy in the last quarter of 2009. Extrapolations were made from the Medicare patient population to younger patients and those with other types of insurance using the Consortium of Rheumatology Researchers of North America (CORRONA) disease registry. Patients treating rheumatologists were grouped into practices and sorted by size from the greatest to the least number of eligible patients. Results Approximately 50,000 RA patients receiving anti-TNF therapy were identified in the Medicare data, distributed across 1980 physician practices. After augmenting Medicare data with information from CORRONA and extrapolating to younger patients and those with other types of insurance, more than 12,000 potentially eligible study subjects were identified from the 50 largest rheumatology practices. Conclusion Health plan and registry databases appear useful to assess feasibility of large pragmatic trials and to assist in selection of recruitment sites with the greatest number of potentially eligible patients. This novel approach is applicable to trials with simple inclusion/exclusion criteria that can be readily assessed in these data sources.",
author = "Curtis, {Jeffrey R.} and Wright, {Nicole C.} and Fenglong Xie and Lang Chen and Jie Zhang and Saag, {Kenneth G.} and Aseem Bharat and Joel Kremer and Stacey Cofield and Kevin Winthrop and Elizabeth Delzell",
year = "2014",
month = "2",
doi = "10.1177/1740774513512185",
language = "English (US)",
volume = "11",
pages = "96--101",
journal = "Clinical Trials",
issn = "1740-7745",
publisher = "SAGE Publications Ltd",
number = "1",

}

TY - JOUR

T1 - Use of health plan combined with registry data to predict clinical trial recruitment

AU - Curtis, Jeffrey R.

AU - Wright, Nicole C.

AU - Xie, Fenglong

AU - Chen, Lang

AU - Zhang, Jie

AU - Saag, Kenneth G.

AU - Bharat, Aseem

AU - Kremer, Joel

AU - Cofield, Stacey

AU - Winthrop, Kevin

AU - Delzell, Elizabeth

PY - 2014/2

Y1 - 2014/2

N2 - Background Large pragmatic clinical trials (PCTs) are increasingly used to conduct comparative effectiveness research. In the context of planning a safety PCT of the live herpes zoster vaccine in rheumatoid arthritis (RA) patients aged ≥ 50 years receiving anti-tumor necrosis factor (TNF) therapy, we evaluated the use of health plan combined with registry data to assess the feasibility of recruiting the 4000 patients needed for the trial and to facilitate site selection. Methods Using national US data from Medicare, we identified older RA patients who received anti-TNF therapy in the last quarter of 2009. Extrapolations were made from the Medicare patient population to younger patients and those with other types of insurance using the Consortium of Rheumatology Researchers of North America (CORRONA) disease registry. Patients treating rheumatologists were grouped into practices and sorted by size from the greatest to the least number of eligible patients. Results Approximately 50,000 RA patients receiving anti-TNF therapy were identified in the Medicare data, distributed across 1980 physician practices. After augmenting Medicare data with information from CORRONA and extrapolating to younger patients and those with other types of insurance, more than 12,000 potentially eligible study subjects were identified from the 50 largest rheumatology practices. Conclusion Health plan and registry databases appear useful to assess feasibility of large pragmatic trials and to assist in selection of recruitment sites with the greatest number of potentially eligible patients. This novel approach is applicable to trials with simple inclusion/exclusion criteria that can be readily assessed in these data sources.

AB - Background Large pragmatic clinical trials (PCTs) are increasingly used to conduct comparative effectiveness research. In the context of planning a safety PCT of the live herpes zoster vaccine in rheumatoid arthritis (RA) patients aged ≥ 50 years receiving anti-tumor necrosis factor (TNF) therapy, we evaluated the use of health plan combined with registry data to assess the feasibility of recruiting the 4000 patients needed for the trial and to facilitate site selection. Methods Using national US data from Medicare, we identified older RA patients who received anti-TNF therapy in the last quarter of 2009. Extrapolations were made from the Medicare patient population to younger patients and those with other types of insurance using the Consortium of Rheumatology Researchers of North America (CORRONA) disease registry. Patients treating rheumatologists were grouped into practices and sorted by size from the greatest to the least number of eligible patients. Results Approximately 50,000 RA patients receiving anti-TNF therapy were identified in the Medicare data, distributed across 1980 physician practices. After augmenting Medicare data with information from CORRONA and extrapolating to younger patients and those with other types of insurance, more than 12,000 potentially eligible study subjects were identified from the 50 largest rheumatology practices. Conclusion Health plan and registry databases appear useful to assess feasibility of large pragmatic trials and to assist in selection of recruitment sites with the greatest number of potentially eligible patients. This novel approach is applicable to trials with simple inclusion/exclusion criteria that can be readily assessed in these data sources.

UR - http://www.scopus.com/inward/record.url?scp=84893949171&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84893949171&partnerID=8YFLogxK

U2 - 10.1177/1740774513512185

DO - 10.1177/1740774513512185

M3 - Article

C2 - 24346611

AN - SCOPUS:84893949171

VL - 11

SP - 96

EP - 101

JO - Clinical Trials

JF - Clinical Trials

SN - 1740-7745

IS - 1

ER -