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Using Electronic Data Capture for Cardiovascular Electrophysiology Invasive Procedures: An Important Step Towards Interoperable Clinical Registries

Mostafa Shanbehzadeh, Hadi Kazemi-Arpanahi, Hassan Bostan, Raoof Nopour
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Abstract

Introduction: The capture and integration of structured data from point of care into clinical registries has been a challenge. However, this effort is very important toward a qualitative patient care and research. Collection, organization and interpretation of clinical data can help to improve evidence-based medicine practices. Worksheets data capture are prevalent, but, not flexible, protected, workflow pleasant, and user friendly and do not support the creation of standardized and interoperable data. The aim of this study was to design and implement an Electronic Data Capture (EDC) instruments to be use in context of cardiovascular invasive procedures.

Material and Methods: This descriptive and developmental study conducted in three phases as follows. (1) data standardization according national and international data element templates published by specialized societies; (2) developing of an initial data collection and clinical research workflow (3), establishing of electronic case reports using Research Electronic Data Capture (REDCap) in accordance with the Health Insurance Portability and Accountability Act (HIPAA) privacy rule.

Results: Three case report forms was developed that included demographics, medical history, physical examination, laboratory tests, radiology examinations, Electrophysiology (EP) procedures, as well as medications and follow-up information. Data-entry validation criteria have been implementing in electronic data collection instrument to assure validity and precision when data enter in electronic form.

Conclusion: This paper describes the process used to create an EDC application. Data collection applications were successfully develop as an a priori step in a clinical research for assisting data collection and management in a case of cardiovascular EP invasive procedures.


 


References

Iturralde EC, Jardeleza MAB, Zamora-Racaza G, Penserga EG, Caro JD. Design and development of a registry system for primary vasculitis. International Conference on Information, Intelligence, Systems & Applications. IEEE; 2016.

Dunn Jr WD, Cobb J, Levey AI, Gutman DA. REDLetr: Workflow and tools to support the migration of legacy clinical data capture systems to REDCap. Int J Med Inform. 2016; 93: 103-10. PMID: 27396629 DOI: 10.1016/j.ijmedinf.2016.06.015

Hasmasanu MG, Bolboaca SD, Jäntschi L, Zaharie GC, Drugan TC. Design and implementation of data collection instruments for neonatology research. Applied Medical Informatics. 2014; 35(4): 35-44.

Barchard KA, Verenikina Y. Improving data accuracy: Selecting the best data checking technique. Computers in Human Behavior. 2013; 29(5): 1917-22.

Alavi CB, Massman JD. Selecting an electronic data capture system. Urology Practice. 2016; 3(3): 236-41.

Stey AM, Russell MM, Ko CY, Sacks GD, Dawes AJ, Gibbons MM. Clinical registries and quality measurement in surgery: A systematic review. Surgery. 2015; 157(2): 381-95. PMID: 25616951 DOI: 10.1016/j.surg.2014.08.097

van der Veer SN, de Keizer NF, Ravelli AC, Tenkink S, Jager KJ. Improving quality of care: A systematic review on how medical registries provide information feedback to health care providers. Int J Med Inform. 2010; 79(5): 305-23. PMID: 20189451 DOI: 10.1016/j.ijmedinf.2010.01.011

Hirata K, Imamura M, Fujiwara T, Fukui T, Furukawa T, Gotoh M, et al. Current status of site-specific cancer registry system for the clinical researches: aiming for future contribution by the assessment of present medical care. Int J Clin Oncol. 2019; 24(9): 1161-8. PMID: 31011913 DOI: 10.1007/s10147-019-01434-w

Mojarrab S, Rafei A, Akhondzadeh S, Jeddian A, Jafarpour M, Zendehdel K. Diseases and health outcomes registry systems in I.R.Iran: Successful initiative to improve public health programs, quality of care, and biomedical research. Arch Iran Med. 2017; 20(11): 696-703. PMID: 29480735

da Silva KR, Costa R, Crevelari ES, Lacerda MS, de Moraes Albertini CM, Martinelli Filho M, et al. Glocal clinical registries: Pacemaker registry design and implementation for global and local integration–methodology and case study. PloS one. 2013; 8(7): e71090. PMID: 23936257 DOI: 10.1371/journal.pone.0071090

Lee P, Chin K, Liew D, Stub D, Brennan AL, Lefkovits J, et al. Economic evaluation of clinical quality registries: A systematic review. BMJ open. 2019; 9(12): e030984. PMID: 31843824 DOI: 10.1136/bmjopen-2019-030984

Danckert B, Horsbøl TA, Andersen O, Dalton SO, Christensen J, Rasted M, et al. Registrations of patients with renal cell carcinoma in the nationwide Danish renal cancer database versus the Danish cancer registry: Data quality, completeness and survival (DaRenCa Study-3). Clin Epidemiol. 2020; 12: 807–14. PMID: 32801918 DOI: 10.2147/CLEP.S258755

Sajjadnia Z, Khayami R, Moosavi MR. Preprocessing breast cancer data to improve the data quality, diagnosis procedure, and medical care services. Cancer Inform. 2020; 19: 1176935120917955. PMID: 32528221 DOI: 10.1177/1176935120917955

Zutshi M, Aiello A, Fuerst A, Golcher H, Parc Y, Galandiuk S, et al. Reducing patient burden and improving data quality with the new cleveland clinic colorectal cancer quality of life questionnaire. Dis Colon Rectum. 2020; 63(4): 469-87. PMID: 32015285 DOI: 10.1097/DCR.0000000000001575

Gliklich RE, Leavy MB. Assessing real-world data quality: The application of patient registry quality criteria to real-world data and real-world evidence. Ther Innov Regul Sci. 2020; 54(2): 303-7. PMID: 32072577 DOI: 10.1007/s43441-019-00058-6

Jalloh MF, Namageyo-Funa A, Gleason B, Wallace AS, Friedman M, Sesay T, et al. Assessment of VaxTrac electronic immunization registry in an urban district in Sierra Leone: Implications for data quality, defaulter tracking, and policy. Vaccine. 2020; 38(39): 6103-11.

Orlandi BMM, Mejia OAV, Borgomoni GB, Goncharov M, Rocha KN, Bassolli L, et al. REPLICCAR II study: Data quality audit in the Paulista cardiovascular surgery registry. PloS one. 2020; 15(7): e0223343. PMID: 32649718 DOI: 10.1371/journal.pone.0223343

Jibb LA, Khan JS, Seth P, Lalloo C, Mulrooney L, Nicholson K, et al. Electronic data capture versus conventional data collection methods in clinical pain studies: Systematic review and meta-analysis. J Med Internet Res. 2020; 22(6): e16480. PMID: 32348259 DOI: 10.2196/16480

Rorie DA, Flynn RWV, Grieve K, Doney A, Mackenzie I, MacDonald TM, et al. Electronic case report forms and electronic data capture within clinical trials and pharmacoepidemiology. Br J Clin Pharmacol. 2017; 83(9): 1880-95. PMID: 28276585 DOI: 10.1111/bcp.13285

Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, et al. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019; 95: 103208. PMID: 31078660 DOI: 10.1016/j.jbi.2019.103208

Yamamoto K, Ota K, Akiya I, Shintani A. A pragmatic method for transforming clinical research data from the research electronic data capture "REDCap" to clinical data interchange standards consortium (CDISC) study data tabulation model (SDTM): Development and evaluation of REDCap2SDTM. J Biomed Inform. 2017; 70: 65-76. PMID: 28487263 DOI: 10.1016/j.jbi.2017.05.003

Bowman MA, Maxwell RA. A beginner's guide to avoiding protected health information (PHI) issues in clinical research: With how-to's in REDCap data management software. J Biomed Inform. 2018; 85: 49-55. PMID: 30017974 DOI: 10.1016/j.jbi.2018.07.008

Santarem MD, de Oliveira Dias P, dos Santos S, Rodrigues CG, Goldmeier S. Prospective clinical registry to evaluate clinical outcomes of hypertension patients in a multidisciplinary clinic. Journal of the International Society for Telemedicine and eHealth. 2017; 5: 47-51.

Pang X, Kozlowski N, Wu S, Jiang M, Huang Y, Mao P, et al. Construction and management of ARDS/sepsis registry with REDCap. J Thorac Dis. 2014; 6(9): 1293-9. PMID: 25276372 DOI: 10.3978/j.issn.2072-1439.2014.09.07

O'Keefe AL, Buss BF, Koirala S, Gleason MX, Mudgapalli A, Schwedhelm S. REDCap for biocontainment worker symptom monitoring. Health Secur. 2019; 17(1): 3-10. PMID: 30724610 DOI: 10.1089/hs.2018.0086

Read KB, LaPolla FWZ, Tolea MI, Galvin JE, Surkis A. Improving data collection, documentation, and workflow in a dementia screening study. J Med Libr Assoc. 2017; 105(2): 160-6. PMID: 28377680 DOI: 10.5195/jmla.2017.221

Dehmer GJ, Badhwar V, Bermudez EA, Cleveland JC, Cohen MG, D'Agostino RS, et al. 2020 AHA/ACC key data elements and definitions for coronary revascularization: A report of the American college of cardiology/ American heart association task force on clinical data standards (writing committee to develop clinical data standards for coronary revascularization). J Am Coll Cardiol. 2020; 75(16): 1975-2088. PMID: 32217040 DOI: 10.1016/j.jacc.2020.02.010

Choquet R, Maaroufi M, de Carrara A, Messiaen C, Luigi E, Landais P. A methodology for a minimum data set for rare diseases to support national centers of excellence for healthcare and research. J Am Med Inform Assoc. 2015; 22(1): 76-85. PMID: 25038198 DOI: 10.1136/amiajnl-2014-002794

Dixon BE, Vreeman DJ, Grannis SJ. The long road to semantic interoperability in support of public health: experiences from two states. J Biomed Inform. 2014; 49: 3-8. PMID: 24680985 DOI: 10.1016/j.jbi.2014.03.011

Janaswamy S, Kent RD. Semantic interoperability and data mapping in EHR systems. International Conference on Advanced Computing. IEEE; 2016.

Slotwiner DJ, Abraham RL, Al-Khatib SM, Anderson HV, Bunch TJ, Ferrara MG, et al. HRS white paper on interoperability of data from cardiac implantable electronic devices (CIEDs). Heart Rhythm. 2019; 16(9): e107-27. PMID: 31077801 DOI: 10.1016/j.hrthm.2019.05.002

Hur S, Lee J, Kim T, Choi JS, Kang M, Chang DK, et al. An Automated Fast Healthcare Interoperability Resources-Based 12-Lead Electrocardiogram Mobile Alert System for Suspected Acute Coronary Syndrome. Yonsei Med J. 2020; 61(5): 416-22. PMID: 32390365 DOI: 10.3349/ymj.2020.61.5.416

Liyanage H, Krause P, de Lusignan S. Using ontologies to improve semantic interoperability in health data. J Innov Health Inform. 2015; 22(2): 309-15. PMID: 26245245 DOI: 10.14236/jhi.v22i2.159

Crane S, Comer RS, Arenson AD, Draucker C. Using REDCap to facilitate web-based therapeutic intervention research. Nurs Res. 2019; 68(6): 483-7. PMID: 31693554 DOI: 10.1097/NNR.0000000000000367

Gadsden T, Bateman-Steel CR, Chaverot S, Ressler KA, Chee K, Redwood L, et al. Using a computerised database (REDCap) to monitor influenza vaccination coverage of healthcare workers and staff in South Eastern Sydney local health district. Aust Health Rev. 2020. Online ahead of print. PMID: 32853535 DOI: 10.1071/AH20006

Ahmad FA, Payne PRO, Lackey I, Komeshak R, Kenney K, Magnusen B, et al. Using REDCap and Apple ResearchKit to integrate patient questionnaires and clinical decision support into the electronic health record to improve sexually transmitted infection testing in the emergency department. J Am Med Inform Assoc. 2020; 27(2): 265-73. PMID: 31722414 DOI: 10.1093/jamia/ocz182

Fernández Lozano I, Osca Asensi J, Alzueta Rodríguez J. Spanish implantable cardioverter-defibrillator registry: 15th official report of the Spanish society of cardiology electrophysiology and arrhythmias section (2018). Rev Esp Cardiol (Engl Ed). 2019; 72(12): 1054-64. PMID: 31727564 DOI: 10.1016/j.rec.2019.10.002

Gonçalves H, Reis H, Bonhorst D. Portuguese national registry of cardiac electrophysiology (2015/2016). Revista portuguesa de cardiologia. 2020; 39(5): 237-41.

Parreira L. National registry of cardiac electrophysiology 2015/2016: Better late than never? Revista portuguesa de cardiologia. 2020; 39(5): 243-4.

Staziaki PV, Kim P, Vadvala HV, Ghoshhajra BB. Medical registry data collection efficiency: A crossover study comparing web-based electronic data capture and a standard spreadsheet. J Med Internet Res. 2016; 18(6): e141. PMID: 27277523 DOI: 10.2196/jmir.5576

Atalyan AV, Kolesnikova LI, Kolesnikov SI, Grjibovski AM, Suturina LV. Research electronic data capture (REDCap) for building and managing databases for population-based biomedical studies. Ekologiya Cheloveka (Human Ecology). 2019; 2: 52-9.

Tomko RL, Gray KM, Oppenheimer SR, Wahlquist AE, McClure EA. Using REDCap for ambulatory assessment: Implementation in a clinical trial for smoking cessation to augment in-person data collection. Am J Drug Alcohol Abuse. 2019; 45(1): 26-41. PMID: 29513609 DOI: 10.1080/00952990.2018.1437445

Griffon N, Pereira H, Djadi-Prat J, García MT, Testoni S, Cariou M, et al. Performances of a solution to semi-automatically fill eCRF with data from the electronic health record: Protocol for a prospective individual participant data meta-analysis. Stud Health Technol Inform. 2020; 270: 367-71. PMID: 32570408 DOI: 10.3233/SHTI200184

Vawdrey DK, Weng C, Herion D, Cimino JJ. Enhancing electronic health records to support clinical research. AMIA Jt Summits Transl Sci Proc. 2014; 2014: 102-8. PMID: 25954585

Brundin-Mather R, Soo A, Zuege DJ, Niven DJ, Fiest K, Doig CJ, et al. Secondary EMR data for quality improvement and research: A comparison of manual and electronic data collection from an integrated critical care electronic medical record system. J Crit Care. 2018; 47: 295-301. PMID: 30099330 DOI: 10.1016/j.jcrc.2018.07.021

Won B, Carey GB, Tan Y-HC, Bokhary U, Itkonen M, Szeto K, et al. The Chicago thoracic oncology database consortium: A multisite database initiative. Cureus. 2016; 8(3): e533. PMID: 27092293 DOI: 10.7759/cureus.533

Callen J. Evaluation research studies essential to ensuring health information systems meet the needs of users, including patients. Health Inf Manag. 2016; 45(1): 3-4. PMID: 27105480 DOI: 10.1177/1833358316639457

Haried P, Claybaugh C, Dai H. Evaluation of health information systems research in information systems research: A meta-analysis. Health Informatics J. 2019; 25(1): 186-202. PMID: 28441893 DOI: 10.1177/1460458217704259

Kragelund SH, Kjærsgaard M, Jensen-Fangel S, Leth RA, Ank N. Research electronic data capture (REDCap®) used as an audit tool with a built-in database. J Biomed Inform. 2018; 81: 112-8. PMID: 29649526 DOI: 10.1016/j.jbi.2018.04.005

Oremus M, Sharafoddini A, Morgano GP, Jin X, Xie F. A computer-assisted personal interview app in research electronic data capture for administering time trade-off surveys (REDCap): Development and pretest. JMIR Form Res. 2018; 2(1): e3. PMID: 30684429 DOI: 10.2196/formative.8202




DOI: http://dx.doi.org/10.30699/fhi.v9i1.236

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