Implementation of a Management Registry for Storing Clinical Data in a Research Centre

  • Suimara dos Santos Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia
  • Michelle Dornelles Santarém Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia
  • Clarissa Garcia Rodrigues Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia
  • Maria Antonieta Pereira de Moraes Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia
Keywords: RedCap, cardiology, clinical research, registry

Abstract

In clinical research, there is great concern about the storage and veracity of electronic data to ensure the accuracy of information. Objective: To implement a management registry for storing study data in the cardiovascular area, conducted in a clinical research centre. Methods: This is a retrospective registry and prospective joint study. An electronic database was developed using REDCap software. Data elements were standardised in accordance with the American College of Cardiology Foundation and American Heart Association. Data were extracted from research participants from the clinical studies conducted in our Institution with records of cardiovascular diagnosis that were monitored by the health team from 2009 to 2015. Results: The registry was composed of eight sections: demographic variables, diagnostic tests, laboratory tests, cardiovascular risk factors (CV), comorbidities and pharmacological treatment used, and outcome of patients. Each session consisted of sub-items, totalling 113 variables. Phase III (57.8%) and phase IV (36.8%) studies with mean follow-up of 2+4 years were predominant. We used data from 490 participants randomised to 25 studies, 63 percent men, aged 63 ą 10 years, hypertensive (81.4%), with dyslipidaemia (56.5%), and diabetes 48 (36.3%). Most had previous myocardial infarction (72.7%) and underwent coronary angioplasty (87.2%). Conclusion: The implementation of an electronic database of research on participants with cardiovascular disease was applicable and reproducible in clinical practice, being a low cost and very useful tool to store and share data from multicentre studies of medium and large scale.


References

Sung NS, Crowley WF Jr., Genel M, et al. Central challenges facing the national clinical research enterprise. JAMA 2003;289(10):1278-1287.

Usher RW. PhRMA BioResearch Monitoring Committee perspective on acceptable approaches for clinical trial monitoring. Drug Inf J 2010;44(4):477-483.

Bhatt DL, Drozda JP Jr., Shahian DM, et al. ACC/AHA/STS Statement on the future of registries and the performance measurement enterprise: a report of the American College of Cardiology/American Heart Association task force on performance measures and the Society of Thoracic Surgeons. J Am Coll Cardiol 2015;66(20):2230-2245.

Silva LR da, Laguardia J, Alves MRAB, et al. ReBEC in numbers: reflexos da política mandatória em pesquisa clínica na trajetória do Registro Brasileiro de Ensaios Clínicos. Notebooks BAD. 2014;2:1071-1114. Available at: http://www.ensaiosclinicos.gov.br accessed 18 June 2014.

Gasca-Hurtado GP, Losada BM. Taxonomía de riesgos de outsourcing de software. Ingeniare. Rev Chil ing. 2013;21(1):31-53. Available in http://dx.doi.org/10.4067/S0718-33052013000100005 accessed 29 July 2014.

McCourt et al. Data standards: at the intersection of sites, clinical research networks, and standards development initiatives. Drug Inform J 2007;41(3):393–404.

Contributors R-p. The R Project for Statistical Computing. 2014 Available in www.r-project.org accessed 18 June 2015.

Harris PA, Taylor R, Thielke R, et al. Research electronic data capture (REDCap) - A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42(2):377-381.

Cannon CP, Brindis RG, Chaitman BR, et al. 2013 ACCF/AHA Key data elements and definitions for measuring the clinical management and outcomes of patients with acute coronary syndromes and coronary artery disease. J Am.Coll. Cardiol 2013;61(9):992-1025.

Klipin M, Mare I, Hazelhurst S, Kramer B. The process of installing REDCap, a web based database supporting biomedical research: the first year. Appl Clin Inform 2014;5(4):916-29.

Carvalho ECA de, Jayanti MK, Batilana AP, et al. (2010) Standardizing clinical trials workflow representation in UML for international site comparison. Plos One 2010;5(11):1-8.

Silva KR da, Costa R, Crevelari ES, et al. Glocal Clinical Registries: Pacemaker Registry Design and Implementation for Global and Local Integration – Methodology and Case Study. Plos One 2018;8(7):e71090.

Anderson HV, Weintrub WS, Radford MJ, et al. Standardized cardiovascular data for clinical research, registries, and patient care: a report from the Data Standards Workgroup of the National Cardiovascular Research Infrastructure project. J Am Coll Cardiol 2013;61(18):1835-1846.

Published
2017-04-03
How to Cite
Santos, S., Santarém, M., Rodrigues, C., & Moraes, M. A. (2017). Implementation of a Management Registry for Storing Clinical Data in a Research Centre. Journal of the International Society for Telemedicine and EHealth, 5, (GKR);e48:(1-3). Retrieved from https://journals.ukzn.ac.za/index.php/JISfTeH/article/view/243
Section
Global Telemedicine and eHealth Updates. Knowledge Resources. Vol. 10, 2017

Most read articles by the same author(s)