Establishment of a cohort study database of vertigo patients based on REDCap system and its follow-up applicatio
Xing Juanli1, He Dandan3, Wang Jie3, Zhu Hailu3, Gong Xiaoying3, Li Xinyang4, Liang Xuanyi2, Wang Mingxu2, Mi Baibing2, Ma Le3
1 Department of Otorhinolaryngology Head and Neck Surgery, the First Affiliated Hospital of Xi 'an Jiaotong University, Xi 'an 710061, China;
2 Department of Epidemiology and Biostatistics, School of Public Health, Xi'an Jiaotong University Health Science Center, Xi 'an 710061, China;
3 School of Public Health, Xi′an Jiaotong University College of Medicine, Xi 'an 710061, China;.
4 School of Nursing, Xi'an Jiaotong University College of Medicine, Xi 'an 710061, China
Abstract:It is of great significance to carry out high-quality follow-ups for the clinical treatment and in-depth study of vertigo patients. This study introduces the design and experience of the REDCap system to establish a special disease cohort of vertigo patients and long-term follow-up. An online survey form was designed to collect basic data of patients, and vertigo, dizziness, and disability assessment scale, balance confidence Scale, Pittsburgh Sleep Quality Scale, Hospital Anxiety and Depression Scale were integrated as the main outcome collection tools, and clinical examination results were imported by linking to hospital information system. Five event collection nodes were used before treatment, 1 month after treatment, 3 months after treatment, 6 months after treatment and 12 months after treatment to set and create the aforementioned data collection form, sort out and formulate the research quality control process, set and manage the authority of different researchers, and finally establish a specific disease cohort project for vertigo patients and collect follow-up data. As of 22 June 2022, data on 378 vertigo patients have been collected and further follow-up is planned. The practice found that the follow-up project of the specific disease queue established based on REDCap could realize the simultaneous input of multiple sites and multiple terminals, the realization of medical data entry, quality control and authority management, the construction of follow-up work calendar, and finally the establishment of high-quality and efficient research database. With a simple design process, easy operation, and complete information collection, it provides a free, convenient, efficient, and standardized project management and data collection tool for otolaryngologists to carry out vertigo-related clinical studies.
邢娟丽,何丹丹,王杰,朱海璐,巩晓颖,李欣阳,梁煊怡,王明旭,米白冰,马乐. 基于REDCap系统建立眩晕患者专病队列研究数据库及其随访应用[J]. 中国医院统计, 2023, 30(1): 11-18.
Xing Juanli, He Dandan, Wang Jie, Zhu Hailu, Gong Xiaoying, Li Xinyang, Liang Xuanyi, Wang Mingxu,Mi Baibing, Ma Le. Establishment of a cohort study database of vertigo patients based on REDCap system and its follow-up applicatio. journal1, 2023, 30(1): 11-18.
[1]NEUHAUSER H K. The epidemiology of dizziness and vertigo[J]. Handb Clin Neurol, 2016, 137:67-82. DOI: 10.1016/b978-0-444-63437-5.00005-4.
[2]DROS J, MAARSINGH O R, BEEM L, et al. Impact of dizziness on everyday life in older primary care patients: A cross-sectional study[J]. Health Qual Life Outcomes, 2011, 9:44. DOI: 10.1186/1477-7525-9-44.
[3]中国研究型医院学会眩晕医学专业委员会.眩晕医学学科建设标准[J].中国研究型医院,2022,9(2):14-16.DOI: 10.19450/j.cnki.jcrh.2022.02.004.
[4]中华医学会神经病学分会,中华神经科杂志编辑委员会.眩晕诊治专家共识[J].中华神经科杂志,2010,43(5):369-374.DOI: 10.3760/cma.j.issn.1006-7876.2010.05.016.
[5]Kahn M G, Brown J S, Chun A T, et al. Transparent reporting of data quality in distributed data networks. EGEMS (Wash DC). 2015,3(1):1052. doi: 10.13063/2327-9214.1052.
[6]杨秀芬,尤冉,马秀梅,等.以医院为基础的中心性浆液性脉络膜视网膜病变流行病学调查及危险因素的研究[J].山东大学耳鼻喉眼学报,2020,34(4):75-79.DOI: 10.6040/j.issn.1673-3770.1.2020.043.
[7]RIBOLI E, HUNT K J, SLIMANI N, et al. European Prospective Investigation into Cancer and Nutrition (EPIC):Study populations and data collection[J]. Public Health Nutr, 2002, 5(6b):1113-1124. DOI: 10.1079/phn2002394.
[8]HARRIS P A, 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]. J Biomed Inform, 2009, 42(2):377-381. DOI: 10.1016/j.jbi.2008.08.010.
[9]PATRIDGE E F, BARDYN T P. Research electronic data capture (REDCap)[J]. J Med Libr Assoc, 2018, 106(1):142-144. DOI: 10.5195/jmia.2018.319.
[10]Research Electronic Data Capture[EB/OL]. (2020-05-15)[2022-08-12].https: //www. project-redcap. org.
[11]DUNSTAN D A, SCOTT N. Norms for zung’s self-rating anxiety scale[J]. BMC Psychiatry, 2020, 20(1):90. DOI: 10.1186/s12888-019-2427-6.
[12]THRIEMER K, LEY B, AME S M, et al. Replacing paper data collection forms with electronic data entry in the field: Findings from a study of community-acquired bloodstream infections in Pemba, Zanzibar[J]. BMC Res Notes, 2012, 5:113. DOI: 10.1186/1756-0500-5-113.
[13]PAVLOVI? I, KERN T, MIKLAVCIC D. Comparison of paperbased and electronic data collection process in clinical trials: Costs simulation study[J]. Contemp Clin Trials, 2009, 30(4):300-316. DOI: 10.1016/j.cct.2009.03.008.
[14]PHILLIPS M, SARIA M, EISENBERG A, et al. Safety of commercial airflight in patients with brain tumors: A case series[J].J Neuro Oncol, 2018, 139(3):617-623. DOI: 10.1007/s11060-018-2905-6.
[15]MARROQUIN RIVERA A, ROSASROMERO J C, CASTRO S M, et al. Implementing a Redcap-based research data collection system for mental health[J]. Rev Colomb Psiquiatr (Engl Ed), 2021, 50(Suppl 1):110-115. DOI: 10.1016/j.rcpeng.2021.06.004.
[16]CRANE S, COMER R S, ARENSON A D, et al. Using REDCap to Facilitate Web-Based Therapeutic Intervention Reearch. Nurs Res. 2019,68(6):483-487. DOI: 10.1097/NNR.0000000000000367.
[17]HARRIS P A, TAYLOR R, MINOR B L, et al. The REDCap consortium: Building an international community of software platform partners[J]. J Biomed Inform, 2019, 95:103208. DOI: 10.1016/j.jbi.2019.103208.
[18]喻超,陈敬国,米白冰,等.基于REDCap嗅觉障碍患者交互式电子数据库的设计[J].山东大学耳鼻喉眼学报,2022,36(2):15-19.DOI: 10.6040/j.issn.1673-3770.0.2021.051.
[19]欧阳凤秀,热伊莱·塔伊尔,陈磊,等.REDCap在母婴干预队列数据采集及管理中的应用[J].上海交通大学学报(医学版),2020,40(9):1308-1314.DOI: 10.3969/j.issn.1674-8115.2020.09.023.
[20]侯倩,江真,刘卿,等.REDCap数据库在嗓音外科临床研究中的初步应用[J].中国耳鼻咽喉颅底外科杂志,2017,23(4):338-341.DOI: 10.11798/j.issn. 1007-1520.201704010.
[21]GLOBAL PAEDSURG RESEARCH COLLABORATION. Mortality from gastrointestinal congenital anomalies at 264 hospitals in 74 low-income, middle-income, and high-income countries: A multicentre, international, prospective cohort study[J]. Lancet, 2021, 398(10297):325-339. DOI: 10.1016/s0140-6736(21)00767-4.
[22]WITSELL D L, SCHULZ K A, MOORE K, et al. Implementation and testing of research infrastructure for practicebased research in hearing and communication disorders[J]. Otolaryngol Head Neck Surg, 2011, 145(4):565-571. DOI: 10.1177/0194599811406369.