Lessons learned in the use of clinical registry data in a multi-centre prospective study

The Pediatric Heart Network Residual Lesion Score Study

Carol J. Prospero, Felicia L. Trachtenberg, Victoria L. Pemberton, Sara K. Pasquali, Brett R. Anderson, Kathleen E. Ash, Jessica Bainton, Carolyn Dunbar-Masterson, Eric M. Graham, Michelle S. Hamstra, Danielle Hollenbeck-Pringle, Jeffrey P. Jacobs, Marshall L Jacobs, Rija John, Linda M. Lambert, Matthew E. Oster, Elizabeth Swan, Abigail Waldron, Meena Nathan

Research output: Contribution to journalArticle

Abstract

Background:Using existing data from clinical registries to support clinical trials and other prospective studies has the potential to improve research efficiency. However, little has been reported about staff experiences and lessons learned from implementation of this method in pediatric cardiology.Objectives:We describe the process of using existing registry data in the Pediatric Heart Network Residual Lesion Score Study, report stakeholders' perspectives, and provide recommendations to guide future studies using this methodology.Methods:The Residual Lesion Score Study, a 17-site prospective, observational study, piloted the use of existing local surgical registry data (collected for submission to the Society of Thoracic Surgeons-Congenital Heart Surgery Database) to supplement manual data collection. A survey regarding processes and perceptions was administered to study site and data coordinating center staff.Results:Survey response rate was 98% (54/55). Overall, 57% perceived that using registry data saved research staff time in the current study, and 74% perceived that it would save time in future studies; 55% noted significant upfront time in developing a methodology for extracting registry data. Survey recommendations included simplifying data extraction processes and tailoring to the needs of the study, understanding registry characteristics to maximise data quality and security, and involving all stakeholders in design and implementation processes.Conclusions:Use of existing registry data was perceived to save time and promote efficiency. Consideration must be given to the upfront investment of time and resources needed. Ongoing efforts focussed on automating and centralising data management may aid in further optimising this methodology for future studies.

Original languageEnglish (US)
JournalCardiology in the young
DOIs
StatePublished - Jan 1 2019

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Registries
Prospective Studies
Pediatrics
Computer Security
Cardiology
Research
Thoracic Surgery
Observational Studies
Clinical Trials
Databases
Surveys and Questionnaires

Keywords

  • prospective studies
  • registry data
  • Research efficiency

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Cardiology and Cardiovascular Medicine

Cite this

Lessons learned in the use of clinical registry data in a multi-centre prospective study : The Pediatric Heart Network Residual Lesion Score Study. / Prospero, Carol J.; Trachtenberg, Felicia L.; Pemberton, Victoria L.; Pasquali, Sara K.; Anderson, Brett R.; Ash, Kathleen E.; Bainton, Jessica; Dunbar-Masterson, Carolyn; Graham, Eric M.; Hamstra, Michelle S.; Hollenbeck-Pringle, Danielle; Jacobs, Jeffrey P.; Jacobs, Marshall L; John, Rija; Lambert, Linda M.; Oster, Matthew E.; Swan, Elizabeth; Waldron, Abigail; Nathan, Meena.

In: Cardiology in the young, 01.01.2019.

Research output: Contribution to journalArticle

Prospero, CJ, Trachtenberg, FL, Pemberton, VL, Pasquali, SK, Anderson, BR, Ash, KE, Bainton, J, Dunbar-Masterson, C, Graham, EM, Hamstra, MS, Hollenbeck-Pringle, D, Jacobs, JP, Jacobs, ML, John, R, Lambert, LM, Oster, ME, Swan, E, Waldron, A & Nathan, M 2019, 'Lessons learned in the use of clinical registry data in a multi-centre prospective study: The Pediatric Heart Network Residual Lesion Score Study', Cardiology in the young. https://doi.org/10.1017/S1047951119001148
Prospero, Carol J. ; Trachtenberg, Felicia L. ; Pemberton, Victoria L. ; Pasquali, Sara K. ; Anderson, Brett R. ; Ash, Kathleen E. ; Bainton, Jessica ; Dunbar-Masterson, Carolyn ; Graham, Eric M. ; Hamstra, Michelle S. ; Hollenbeck-Pringle, Danielle ; Jacobs, Jeffrey P. ; Jacobs, Marshall L ; John, Rija ; Lambert, Linda M. ; Oster, Matthew E. ; Swan, Elizabeth ; Waldron, Abigail ; Nathan, Meena. / Lessons learned in the use of clinical registry data in a multi-centre prospective study : The Pediatric Heart Network Residual Lesion Score Study. In: Cardiology in the young. 2019.
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abstract = "Background:Using existing data from clinical registries to support clinical trials and other prospective studies has the potential to improve research efficiency. However, little has been reported about staff experiences and lessons learned from implementation of this method in pediatric cardiology.Objectives:We describe the process of using existing registry data in the Pediatric Heart Network Residual Lesion Score Study, report stakeholders' perspectives, and provide recommendations to guide future studies using this methodology.Methods:The Residual Lesion Score Study, a 17-site prospective, observational study, piloted the use of existing local surgical registry data (collected for submission to the Society of Thoracic Surgeons-Congenital Heart Surgery Database) to supplement manual data collection. A survey regarding processes and perceptions was administered to study site and data coordinating center staff.Results:Survey response rate was 98{\%} (54/55). Overall, 57{\%} perceived that using registry data saved research staff time in the current study, and 74{\%} perceived that it would save time in future studies; 55{\%} noted significant upfront time in developing a methodology for extracting registry data. Survey recommendations included simplifying data extraction processes and tailoring to the needs of the study, understanding registry characteristics to maximise data quality and security, and involving all stakeholders in design and implementation processes.Conclusions:Use of existing registry data was perceived to save time and promote efficiency. Consideration must be given to the upfront investment of time and resources needed. Ongoing efforts focussed on automating and centralising data management may aid in further optimising this methodology for future studies.",
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T2 - The Pediatric Heart Network Residual Lesion Score Study

AU - Prospero, Carol J.

AU - Trachtenberg, Felicia L.

AU - Pemberton, Victoria L.

AU - Pasquali, Sara K.

AU - Anderson, Brett R.

AU - Ash, Kathleen E.

AU - Bainton, Jessica

AU - Dunbar-Masterson, Carolyn

AU - Graham, Eric M.

AU - Hamstra, Michelle S.

AU - Hollenbeck-Pringle, Danielle

AU - Jacobs, Jeffrey P.

AU - Jacobs, Marshall L

AU - John, Rija

AU - Lambert, Linda M.

AU - Oster, Matthew E.

AU - Swan, Elizabeth

AU - Waldron, Abigail

AU - Nathan, Meena

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N2 - Background:Using existing data from clinical registries to support clinical trials and other prospective studies has the potential to improve research efficiency. However, little has been reported about staff experiences and lessons learned from implementation of this method in pediatric cardiology.Objectives:We describe the process of using existing registry data in the Pediatric Heart Network Residual Lesion Score Study, report stakeholders' perspectives, and provide recommendations to guide future studies using this methodology.Methods:The Residual Lesion Score Study, a 17-site prospective, observational study, piloted the use of existing local surgical registry data (collected for submission to the Society of Thoracic Surgeons-Congenital Heart Surgery Database) to supplement manual data collection. A survey regarding processes and perceptions was administered to study site and data coordinating center staff.Results:Survey response rate was 98% (54/55). Overall, 57% perceived that using registry data saved research staff time in the current study, and 74% perceived that it would save time in future studies; 55% noted significant upfront time in developing a methodology for extracting registry data. Survey recommendations included simplifying data extraction processes and tailoring to the needs of the study, understanding registry characteristics to maximise data quality and security, and involving all stakeholders in design and implementation processes.Conclusions:Use of existing registry data was perceived to save time and promote efficiency. Consideration must be given to the upfront investment of time and resources needed. Ongoing efforts focussed on automating and centralising data management may aid in further optimising this methodology for future studies.

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