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Analytic Challenges Arising from the STOP CRC Trial: Pragmatic Solutions for Pragmatic Problems.

EGEMS (Washington, DC)

Vollmer WM, Green BB, Coronado GD.
PMID: 26793738
EGEMS (Wash DC). 2015 Dec 09;3(1):1200. doi: 10.13063/2327-9214.1200. eCollection 2015.

CONTEXT: Pragmatic trials lack the relatively tight quality control of traditional efficacy studies and hence may pose added analytic challenges owing to the practical realities faced in carrying them out.CASE DESCRIPTION: STOP CRC is a cluster randomized trial testing...

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Vollmer WM, Green BB, Coronado GD. Analytic Challenges Arising from the STOP CRC Trial: Pragmatic Solutions for Pragmatic Problems. EGEMS (Wash DC). 2015;3(1):1200doi: 10.13063/2327-9214.1200.
Vollmer, W. M., Green, B. B., & Coronado, G. D. (2015). Analytic Challenges Arising from the STOP CRC Trial: Pragmatic Solutions for Pragmatic Problems. EGEMS (Washington, DC), 3(1), 1200. https://doi.org/10.13063/2327-9214.1200
Vollmer, William M, et al. "Analytic Challenges Arising from the STOP CRC Trial: Pragmatic Solutions for Pragmatic Problems." EGEMS (Washington, DC) vol. 3,1 (2015): 1200. doi: https://doi.org/10.13063/2327-9214.1200
Vollmer WM, Green BB, Coronado GD. Analytic Challenges Arising from the STOP CRC Trial: Pragmatic Solutions for Pragmatic Problems. EGEMS (Wash DC). 2015 Dec 09;3(1):1200. doi: 10.13063/2327-9214.1200. eCollection 2015. PMID: 26793738; PMCID: PMC4708092.
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Accounting for quality improvement during the conduct of embedded pragmatic clinical trials within healthcare systems: NIH Collaboratory case studies.

Healthcare (Amsterdam, Netherlands)

Tuzzio L, Meyers CM, Dember LM, Grudzen CR, Melnick ER, Staman KL, Huang SS, Richards J, DeBar L, Vazquez MA, Green BB, Coronado GD, Jarvik JG, Braciszewski J, Ho PM, Wells BL, James K, Toto R, D'Onofrio G, Volandes A, Kuklinski MR, Catalano RF, Sterling SA, Morse EF, Curtis L, Larson EB.
PMID: 34175091
Healthc (Amst). 2021 Jun;8:100432. doi: 10.1016/j.hjdsi.2020.100432. Epub 2021 Jun 23.

Embedded pragmatic clinical trials (ePCTs) and quality improvement (QI) activities often occur simultaneously within healthcare systems (HCSs). Embedded PCTs within HCSs are conducted to test interventions and provide evidence that may impact public health, health system operations, and quality...

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Tuzzio L, Meyers CM, Dember LM, et al. Accounting for quality improvement during the conduct of embedded pragmatic clinical trials within healthcare systems: NIH Collaboratory case studies. Healthc (Amst). 2021;8:100432doi: 10.1016/j.hjdsi.2020.100432.
Tuzzio, L., Meyers, C. M., Dember, L. M., Grudzen, C. R., Melnick, E. R., Staman, K. L., Huang, S. S., Richards, J., DeBar, L., Vazquez, M. A., Green, B. B., Coronado, G. D., Jarvik, J. G., Braciszewski, J., Ho, P. M., Wells, B. L., James, K., Toto, R., D'Onofrio, G., Volandes, A., Kuklinski, M. R., Catalano, R. F., Sterling, S. A., Morse, E. F., Curtis, L., & Larson, E. B. (2021). Accounting for quality improvement during the conduct of embedded pragmatic clinical trials within healthcare systems: NIH Collaboratory case studies. Healthcare (Amsterdam, Netherlands), 8100432. https://doi.org/10.1016/j.hjdsi.2020.100432
Tuzzio, Leah, et al. "Accounting for quality improvement during the conduct of embedded pragmatic clinical trials within healthcare systems: NIH Collaboratory case studies." Healthcare (Amsterdam, Netherlands) vol. 8 (2021): 100432. doi: https://doi.org/10.1016/j.hjdsi.2020.100432
Tuzzio L, Meyers CM, Dember LM, Grudzen CR, Melnick ER, Staman KL, Huang SS, Richards J, DeBar L, Vazquez MA, Green BB, Coronado GD, Jarvik JG, Braciszewski J, Ho PM, Wells BL, James K, Toto R, D'Onofrio G, Volandes A, Kuklinski MR, Catalano RF, Sterling SA, Morse EF, Curtis L, Larson EB. Accounting for quality improvement during the conduct of embedded pragmatic clinical trials within healthcare systems: NIH Collaboratory case studies. Healthc (Amst). 2021 Jun;8:100432. doi: 10.1016/j.hjdsi.2020.100432. Epub 2021 Jun 23. PMID: 34175091.
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Challenges in assessing population reach in a pragmatic trial.

Preventive medicine reports

Green BB, Vollmer WM, Keast E, Petrik AF, Coronado GD.
PMID: 31198661
Prev Med Rep. 2019 May 29;15:100910. doi: 10.1016/j.pmedr.2019.100910. eCollection 2019 Sep.

Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC) was a pragmatic cluster-randomized trial conducted at federally qualified health centers and designed to "Reach" as many unscreened patients as possible by directly mailing them fecal screening...

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Green BB, Vollmer WM, Keast E, et al. Challenges in assessing population reach in a pragmatic trial. Prev Med Rep. 2019;15:100910doi: 10.1016/j.pmedr.2019.100910.
Green, B. B., Vollmer, W. M., Keast, E., Petrik, A. F., & Coronado, G. D. (2019). Challenges in assessing population reach in a pragmatic trial. Preventive medicine reports, 15100910. https://doi.org/10.1016/j.pmedr.2019.100910
Green, Beverly B, et al. "Challenges in assessing population reach in a pragmatic trial." Preventive medicine reports vol. 15 (2019): 100910. doi: https://doi.org/10.1016/j.pmedr.2019.100910
Green BB, Vollmer WM, Keast E, Petrik AF, Coronado GD. Challenges in assessing population reach in a pragmatic trial. Prev Med Rep. 2019 May 29;15:100910. doi: 10.1016/j.pmedr.2019.100910. eCollection 2019 Sep. PMID: 31198661; PMCID: PMC6558213.
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Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory.

Journal of the American Medical Informatics Association : JAMIA

Richesson RL, Marsolo KS, Douthit BJ, Staman K, Ho PM, Dailey D, Boyd AD, McTigue KM, Ezenwa MO, Schlaeger JM, Patil CL, Faurot KR, Tuzzio L, Larson EB, O'Brien EC, Zigler CK, Lakin JR, Pressman AR, Braciszewski JM, Grudzen C, Fiol GD.
PMID: 34597383
J Am Med Inform Assoc. 2021 Nov 25;28(12):2626-2640. doi: 10.1093/jamia/ocab202.

OBJECTIVE: We identified challenges and solutions to using electronic health record (EHR) systems for the design and conduct of pragmatic research.MATERIALS AND METHODS: Since 2012, the Health Care Systems Research Collaboratory has served as the resource coordinating center for...

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Richesson RL, Marsolo KS, Douthit BJ, et al. Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory. J Am Med Inform Assoc. 2021;28(12):2626-2640doi: 10.1093/jamia/ocab202.
Richesson, R. L., Marsolo, K. S., Douthit, B. J., Staman, K., Ho, P. M., Dailey, D., Boyd, A. D., McTigue, K. M., Ezenwa, M. O., Schlaeger, J. M., Patil, C. L., Faurot, K. R., Tuzzio, L., Larson, E. B., O'Brien, E. C., Zigler, C. K., Lakin, J. R., Pressman, A. R., Braciszewski, J. M., Grudzen, C., & Fiol, G. D. (2021). Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory. Journal of the American Medical Informatics Association : JAMIA, 28(12), 2626-2640. https://doi.org/10.1093/jamia/ocab202
Richesson, Rachel L, et al. "Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory." Journal of the American Medical Informatics Association : JAMIA vol. 28,12 (2021): 2626-2640. doi: https://doi.org/10.1093/jamia/ocab202
Richesson RL, Marsolo KS, Douthit BJ, Staman K, Ho PM, Dailey D, Boyd AD, McTigue KM, Ezenwa MO, Schlaeger JM, Patil CL, Faurot KR, Tuzzio L, Larson EB, O'Brien EC, Zigler CK, Lakin JR, Pressman AR, Braciszewski JM, Grudzen C, Fiol GD. Enhancing the use of EHR systems for pragmatic embedded research: lessons from the NIH Health Care Systems Research Collaboratory. J Am Med Inform Assoc. 2021 Nov 25;28(12):2626-2640. doi: 10.1093/jamia/ocab202. PMID: 34597383; PMCID: PMC8633608.
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Health Policy to Promote Colorectal Cancer Screening: Improving Access and Aligning Federal and State Incentives.

Clinical researcher (Alexandria, Va.)

Coronado GD, Petrik AF, Bartelmann SE, Coyner LA, Coury J.
PMID: 27135047
Clin Res (Alex). 2015 Feb;29(1):50-55. doi: 10.14524/CR-14-0044. Epub 2015 Feb 01.

Since implementation of the Affordable Care Act, 7 million+ individuals are newly covered on state-managed Medicaid programs and millions more on subsidized commercial insurance plans. We describe Oregon's experience in including colorectal cancer (CRC) screening as a measure for...

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Coronado GD, Petrik AF, Bartelmann SE, et al. Health Policy to Promote Colorectal Cancer Screening: Improving Access and Aligning Federal and State Incentives. Clin Res (Alex). 2015;29(1):50-55doi: 10.14524/CR-14-0044.
Coronado, G. D., Petrik, A. F., Bartelmann, S. E., Coyner, L. A., & Coury, J. (2015). Health Policy to Promote Colorectal Cancer Screening: Improving Access and Aligning Federal and State Incentives. Clinical researcher (Alexandria, Va.), 29(1), 50-55. https://doi.org/10.14524/CR-14-0044
Coronado, Gloria D, et al. "Health Policy to Promote Colorectal Cancer Screening: Improving Access and Aligning Federal and State Incentives." Clinical researcher (Alexandria, Va.) vol. 29,1 (2015): 50-55. doi: https://doi.org/10.14524/CR-14-0044
Coronado GD, Petrik AF, Bartelmann SE, Coyner LA, Coury J. Health Policy to Promote Colorectal Cancer Screening: Improving Access and Aligning Federal and State Incentives. Clin Res (Alex). 2015 Feb;29(1):50-55. doi: 10.14524/CR-14-0044. Epub 2015 Feb 01. PMID: 27135047; PMCID: PMC4847543.
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Trials without tribulations: Minimizing the burden of pragmatic research on healthcare systems.

Healthcare (Amsterdam, Netherlands)

Larson EB, Tachibana C, Thompson E, Coronado GD, DeBar L, Dember LM, Honda S, Huang SS, Jarvik JG, Nelson C, Septimus E, Simon G, Johnson KE.
PMID: 27637816
Healthc (Amst). 2016 Sep;4(3):138-41. doi: 10.1016/j.hjdsi.2015.07.005. Epub 2015 Jul 29.

Pragmatic clinical trials are increasingly common because they have the potential to yield findings that are directly translatable to real-world healthcare settings. Pragmatic clinical trials need to integrate research into clinical workflow without placing an undue burden on the...

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Larson EB, Tachibana C, Thompson E, et al. Trials without tribulations: Minimizing the burden of pragmatic research on healthcare systems. Healthc (Amst). 2015;4(3):138-41doi: 10.1016/j.hjdsi.2015.07.005.
Larson, E. B., Tachibana, C., Thompson, E., Coronado, G. D., DeBar, L., Dember, L. M., Honda, S., Huang, S. S., Jarvik, J. G., Nelson, C., Septimus, E., Simon, G., & Johnson, K. E. (2016). Trials without tribulations: Minimizing the burden of pragmatic research on healthcare systems. Healthcare (Amsterdam, Netherlands), 4(3), 138-41. https://doi.org/10.1016/j.hjdsi.2015.07.005
Larson, Eric B, et al. "Trials without tribulations: Minimizing the burden of pragmatic research on healthcare systems." Healthcare (Amsterdam, Netherlands) vol. 4,3 (2016): 138-41. doi: https://doi.org/10.1016/j.hjdsi.2015.07.005
Larson EB, Tachibana C, Thompson E, Coronado GD, DeBar L, Dember LM, Honda S, Huang SS, Jarvik JG, Nelson C, Septimus E, Simon G, Johnson KE. Trials without tribulations: Minimizing the burden of pragmatic research on healthcare systems. Healthc (Amst). 2016 Sep;4(3):138-41. doi: 10.1016/j.hjdsi.2015.07.005. Epub 2015 Jul 29. PMID: 27637816; PMCID: PMC5027068.
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Reasons for non-response to a direct-mailed FIT kit program: lessons learned from a pragmatic colorectal-cancer screening study in a federally sponsored health center.

Translational behavioral medicine

Coronado GD, Schneider JL, Sanchez JJ, Petrik AF, Green B.
PMID: 25729454
Transl Behav Med. 2015 Mar;5(1):60-7. doi: 10.1007/s13142-014-0276-x.

Colorectal cancer screening rates are below optimal. As part of a pilot clinic-based pragmatic study aiming to raise rates of colorectal-cancer screening, we explored patients' reasons for not responding to a direct-mailed screening invitation. We conducted telephone interviews with...

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Coronado GD, Schneider JL, Sanchez JJ, et al. Reasons for non-response to a direct-mailed FIT kit program: lessons learned from a pragmatic colorectal-cancer screening study in a federally sponsored health center. Transl Behav Med. 2015;5(1):60-7doi: 10.1007/s13142-014-0276-x.
Coronado, G. D., Schneider, J. L., Sanchez, J. J., Petrik, A. F., & Green, B. (2015). Reasons for non-response to a direct-mailed FIT kit program: lessons learned from a pragmatic colorectal-cancer screening study in a federally sponsored health center. Translational behavioral medicine, 5(1), 60-7. https://doi.org/10.1007/s13142-014-0276-x
Coronado, Gloria D, et al. "Reasons for non-response to a direct-mailed FIT kit program: lessons learned from a pragmatic colorectal-cancer screening study in a federally sponsored health center." Translational behavioral medicine vol. 5,1 (2015): 60-7. doi: https://doi.org/10.1007/s13142-014-0276-x
Coronado GD, Schneider JL, Sanchez JJ, Petrik AF, Green B. Reasons for non-response to a direct-mailed FIT kit program: lessons learned from a pragmatic colorectal-cancer screening study in a federally sponsored health center. Transl Behav Med. 2015 Mar;5(1):60-7. doi: 10.1007/s13142-014-0276-x. PMID: 25729454; PMCID: PMC4332898.
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Mapping Multi-Site Clinic Workflows to Design Systems-Enabled Interventions.

EGEMS (Washington, DC)

Coronado GD, Retecki S, Petrik AF, Coury J, Aguirre J, Taplin SH, Burdick T, Green BB.
PMID: 29930961
EGEMS (Wash DC). 2017 Jun 14;5(1):13. doi: 10.5334/egems.219.

OBJECTIVE: Variations in processes for different clinics and health systems can dramatically change the way preventive interventions are implemented. We present a method for documenting these variations using workflow diagrams and demonstrate how understanding workflow aided an electronic health...

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Coronado GD, Retecki S, Petrik AF, et al. Mapping Multi-Site Clinic Workflows to Design Systems-Enabled Interventions. EGEMS (Wash DC). 2017;5(1):13doi: 10.5334/egems.219.
Coronado, G. D., Retecki, S., Petrik, A. F., Coury, J., Aguirre, J., Taplin, S. H., Burdick, T., & Green, B. B. (2017). Mapping Multi-Site Clinic Workflows to Design Systems-Enabled Interventions. EGEMS (Washington, DC), 5(1), 13. https://doi.org/10.5334/egems.219
Coronado, Gloria D, et al. "Mapping Multi-Site Clinic Workflows to Design Systems-Enabled Interventions." EGEMS (Washington, DC) vol. 5,1 (2017): 13. doi: https://doi.org/10.5334/egems.219
Coronado GD, Retecki S, Petrik AF, Coury J, Aguirre J, Taplin SH, Burdick T, Green BB. Mapping Multi-Site Clinic Workflows to Design Systems-Enabled Interventions. EGEMS (Wash DC). 2017 Jun 14;5(1):13. doi: 10.5334/egems.219. PMID: 29930961; PMCID: PMC5994949.
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Effectiveness of automated and live phone reminders after mailed-FIT outreach in a pilot randomized trial.

Preventive medicine reports

Nielson CM, Rivelli JS, Fuoco MJ, Gawlik VR, Jimenez R, Petrik AF, Coronado GD.
PMID: 30364785
Prev Med Rep. 2018 Oct 17;12:210-213. doi: 10.1016/j.pmedr.2018.10.012. eCollection 2018 Dec.

The effectiveness of annual mailed fecal immunochemical testing (FIT) outreach is highest when return rates are optimized, which is aided by patient reminders. In a pilot patient-randomized controlled trial in two western Washington clinics of the Sea Mar Community...

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Nielson CM, Rivelli JS, Fuoco MJ, et al. Effectiveness of automated and live phone reminders after mailed-FIT outreach in a pilot randomized trial. Prev Med Rep. 2018;12:210-213doi: 10.1016/j.pmedr.2018.10.012.
Nielson, C. M., Rivelli, J. S., Fuoco, M. J., Gawlik, V. R., Jimenez, R., Petrik, A. F., & Coronado, G. D. (2018). Effectiveness of automated and live phone reminders after mailed-FIT outreach in a pilot randomized trial. Preventive medicine reports, 12210-213. https://doi.org/10.1016/j.pmedr.2018.10.012
Nielson, Carrie M, et al. "Effectiveness of automated and live phone reminders after mailed-FIT outreach in a pilot randomized trial." Preventive medicine reports vol. 12 (2018): 210-213. doi: https://doi.org/10.1016/j.pmedr.2018.10.012
Nielson CM, Rivelli JS, Fuoco MJ, Gawlik VR, Jimenez R, Petrik AF, Coronado GD. Effectiveness of automated and live phone reminders after mailed-FIT outreach in a pilot randomized trial. Prev Med Rep. 2018 Oct 17;12:210-213. doi: 10.1016/j.pmedr.2018.10.012. eCollection 2018 Dec. PMID: 30364785; PMCID: PMC6199768.
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Using an Automated Data-driven, EHR-Embedded Program for Mailing FIT kits: Lessons from the STOP CRC Pilot Study.

Journal of general practice (Los Angeles, Calif.)

Coronado GD, Burdick T, Petrik A, Kapka T, Retecki S, Green B.
PMID: 25411657
J Gen Pract (Los Angel). 2014 Jan 05;2. doi: 10.4172/2329-9126.1000141.

BACKGROUND: The Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC) study is collaboration among two research institutions and health-systems partners. The main study, scheduled to begin in 2014, will assess effectiveness of an intervention program using electronic health...

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Coronado GD, Burdick T, Petrik A, et al. Using an Automated Data-driven, EHR-Embedded Program for Mailing FIT kits: Lessons from the STOP CRC Pilot Study. J Gen Pract (Los Angel). 2014;2doi: 10.4172/2329-9126.1000141.
Coronado, G. D., Burdick, T., Petrik, A., Kapka, T., Retecki, S., & Green, B. (2014). Using an Automated Data-driven, EHR-Embedded Program for Mailing FIT kits: Lessons from the STOP CRC Pilot Study. Journal of general practice (Los Angeles, Calif.), 2. https://doi.org/10.4172/2329-9126.1000141
Coronado, Gloria D, et al. "Using an Automated Data-driven, EHR-Embedded Program for Mailing FIT kits: Lessons from the STOP CRC Pilot Study." Journal of general practice (Los Angeles, Calif.) vol. 2 (2014). doi: https://doi.org/10.4172/2329-9126.1000141
Coronado GD, Burdick T, Petrik A, Kapka T, Retecki S, Green B. Using an Automated Data-driven, EHR-Embedded Program for Mailing FIT kits: Lessons from the STOP CRC Pilot Study. J Gen Pract (Los Angel). 2014 Jan 05;2. doi: 10.4172/2329-9126.1000141. PMID: 25411657; PMCID: PMC4233714.
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Preparing for the ICD-10-CM Transition: Automated Methods for Translating ICD Codes in Clinical Phenotype Definitions.

EGEMS (Washington, DC)

Fung KW, Richesson R, Smerek M, Pereira KC, Green BB, Patkar A, Clowse M, Bauck A, Bodenreider O.
PMID: 27195309
EGEMS (Wash DC). 2016 Apr 12;4(1):1211. doi: 10.13063/2327-9214.1211. eCollection 2016.

BACKGROUND: The national mandate for health systems to transition from ICD-9-CM to ICD-10-CM in October 2015 has an impact on research activities. Clinical phenotypes defined by ICD-9-CM codes need to be converted to ICD-10-CM, which has nearly four times...

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Fung KW, Richesson R, Smerek M, et al. Preparing for the ICD-10-CM Transition: Automated Methods for Translating ICD Codes in Clinical Phenotype Definitions. EGEMS (Wash DC). 2016;4(1):1211doi: 10.13063/2327-9214.1211.
Fung, K. W., Richesson, R., Smerek, M., Pereira, K. C., Green, B. B., Patkar, A., Clowse, M., Bauck, A., & Bodenreider, O. (2016). Preparing for the ICD-10-CM Transition: Automated Methods for Translating ICD Codes in Clinical Phenotype Definitions. EGEMS (Washington, DC), 4(1), 1211. https://doi.org/10.13063/2327-9214.1211
Fung, Kin Wah, et al. "Preparing for the ICD-10-CM Transition: Automated Methods for Translating ICD Codes in Clinical Phenotype Definitions." EGEMS (Washington, DC) vol. 4,1 (2016): 1211. doi: https://doi.org/10.13063/2327-9214.1211
Fung KW, Richesson R, Smerek M, Pereira KC, Green BB, Patkar A, Clowse M, Bauck A, Bodenreider O. Preparing for the ICD-10-CM Transition: Automated Methods for Translating ICD Codes in Clinical Phenotype Definitions. EGEMS (Wash DC). 2016 Apr 12;4(1):1211. doi: 10.13063/2327-9214.1211. eCollection 2016. PMID: 27195309; PMCID: PMC4862764.
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