中文版美国国家眼科研究所视功能调查问卷共享电子数据库的构建
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摘要
目的构建低成本、标准化、可重复使用、便于数据交换、整合与共享的中文版国家眼科研究所视功能调查问卷(NEI-VFQ-25)电子数据库。方法按照标准操作规范在云平台部署(REDCap)数据库。在应用市场下载REDCap移动客户端,根据软件说明文档建立与网页端的关联。文献检索获得经验证且被授权使用的中文版NEI-VFQ-25问卷,使用REDCap在线数据库设计工具,按照国际数据交换标准设置数据字典。使用REDCap可视化工具设立数据质量实时核查规则、进行权限与角色配置。通过数据备份和系统安全巡检方式建立系统维护与数据安全策略。结果REDCap电子数据库部署成功,实现了中文版NEI-VFQ-25问卷的标准化采集,且无论有无网络均可使用。除网页版本外,还可基于移动客户端使用。数据库共享设置权限控制,应用于不同研究项目时生成独立的访问地址,并在数据采集、数据查看、数据下载方面设定各自独立的权限。数据的安全性、真实性、准确性、保密性及可溯源性均得到保证。结论中文版NEI-VFQ-25问卷电子数据库构建成功,用户友好化程度高,为临床研究者开展糖网、青光眼、白内障等低视力人群的视觉生活质量研究提供一个便利、高效、高质量及标准化的数据管理工具。
Objective To establish the shared Chinese version of the NEI-VFQ-25( National Eye Institute vision function questionare,NEI-VFQ) electronic database,which is low-cost,standardized,convenient for data exchange,integration and sharing. Methods Deployed Research electronic data( REDCap) database on cloud platform according to standard operation procedure. Downloaded the REDCap Mobile App from App Store and established the association with the web page according to description document. The verified Chinese version NEI-VFQ-25 questionnaire was obtained from literatures and authorized by author. Online Designer was used to establish standardized data dictionary according to the international data exchange standard( Clinical Data Interchange Standards Consortium,CDISC) and set up real-time edit check rules. User Rights module was used to configure privileges and roles. By means of data backup and system security patrol,system maintenance and data security strategy were established. Results REDCap electronic database was successfully deployed and the standardized data capture system of the Chinese version NEI-VFQ-25 was accomplished. And it could be used whether there was a network or not.In addition to the web page version,it can also be used based on mobile clients. Authorities were set up for database sharing. Every project could have uniform resource locator,and own independent authority for data collection,data view,data download,etc. Data security,authenticity,accuracy,patient privacy and traceability were guaranteed. Conclusion The shared Chinese version NEI-VFQ-25 electronic database provides a use friendly,convenient,efficient,high quality and standardized data management tool for the clinical researchers to carry out the study of visual quality of life.
Objective To establish the shared Chinese version of the NEI-VFQ-25( National Eye Institute vision function questionare,NEI-VFQ) electronic database,which is low-cost,standardized,convenient for data exchange,integration and sharing. Methods Deployed Research electronic data( REDCap) database on cloud platform according to standard operation procedure. Downloaded the REDCap Mobile App from App Store and established the association with the web page according to description document. The verified Chinese version NEI-VFQ-25 questionnaire was obtained from literatures and authorized by author. Online Designer was used to establish standardized data dictionary according to the international data exchange standard( Clinical Data Interchange Standards Consortium,CDISC) and set up real-time edit check rules. User Rights module was used to configure privileges and roles. By means of data backup and system security patrol,system maintenance and data security strategy were established. Results REDCap electronic database was successfully deployed and the standardized data capture system of the Chinese version NEI-VFQ-25 was accomplished. And it could be used whether there was a network or not.In addition to the web page version,it can also be used based on mobile clients. Authorities were set up for database sharing. Every project could have uniform resource locator,and own independent authority for data collection,data view,data download,etc. Data security,authenticity,accuracy,patient privacy and traceability were guaranteed. Conclusion The shared Chinese version NEI-VFQ-25 electronic database provides a use friendly,convenient,efficient,high quality and standardized data management tool for the clinical researchers to carry out the study of visual quality of life.
引文
[1]Obeid JS,Mcgraw CA,Minor BL,et al.Procurement of shared data instruments for Research Electronic Data Capture(REDCap)[J].J Biomed Inform,2013,46(2):259-265.
[2]Kennedy L,Craig AM.Global registries for measuring pharmacoeconomic and quality-of-life outcomes:focus on design and data collection,analysis and interpretation[J].Pharmacoeconomics,2004,22(9):551-568.
[3]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].J Biomed Inform,2009,42(2):377-381.
[4]Mangione CM,Berry S,Spritzer K,et al.Identifying the content area for the 51 item National Eye Institute Visual Function Questionnaire:results from focus groups with visually impaired persons[J].Archives of Ophthalmology,1998,116(2):227-233.
[5]Mangione CM,Lee PP,Gutierrez PR,et al.Development of the25 item National Eye Institute Visual Function Questionnaire[J].Archives of Ophthalmology,1998,116(11):1496-1499.
[6]Wang CW,Chan CL,Jin HY.Psychometric properties of the Chinese version of the 25 item National Eye Institute Visual Function Questionnaire[J].Optometry&Vision Science Official Publication of the American Academy of Optometry,2008,85(11):1091-1094.
[7]Blumenberg C,Barros AJ.Electronic data collection in epidemiological research.The use of REDCap in the Pelotas birth cohorts[J].Appl Clin Inform,2016,7(3):672-681.
[8]邹炼,胡金有,刘湘乡,等.REDCap软件在放疗质控中的应用[J].中国医疗器械杂志,2017,41(4):248-250.
[9]REDCap.[EB/OL].https://www.project-redcap.org,2018,12,24.
[10]孙葆忱.低视力患者生存质量与康复[M].北京:人民卫生出版社,2009:21.
[11]方积乾.生存质量测定方法及应用[M].北京:北京医科大学出版社,2000:34.
[12]Gardiner AM,Armstrong RA,Dunne MCM,et al.Correlation between visual function and visual ability in patients with uveitis[J].British Journal of Ophthalmology,2002,86(9):993-998.
[13]Group TW.The Development of the World Health Organization Quality of Life Assessment Instrument(the WHOQOL)[M].1994:41-57.
[14]孙玉环.基于EpiData与SAS系统的纸版问卷数据录入质量控制技巧[J].中国卫生统计,2012,29(4):607-608.
[15]曾素华.家庭护理干预对低视力患者社会支持、自我效能与生活质量的影响[D].南方医科大学,2016:44.
[16]李军花,赵云娥,朱俊,等.Re STOR多焦点人工晶状体植入术后远期视觉质量评价[J].中华实验眼科杂志,2009,27(6):543-544.
[17]Welker JA.Implementation of electronic data capture systems:barriers and solutions[J].Contemporary Clinical Trials,2007,28(3):329-336.
[18]Rorie DA,Flynn RWV,Grieve K,et al.Electronic case report forms and electronic data capture within clinical trials and pharmacoepidemiology[J].Br J Clin Pharmacol,2017,83(9):1880-1895.
[19]Yamamoto K.Introduction to Research Electronic Data Capture(REDCap)and REDCap2SDTM,a Conversion Tool to Facilitate Clinical Research Data Sharing[J].Brain Nerve,2017,69(7):848-855.
[20]Staziaki PV,Kim P,Vadvala HV,et al.Medical Registry Data Collection Efficiency:A Crossover Study Comparing Web-Based Electronic Data Capture and a Standard Spreadsheet[J].J Med Internet Res,2016,18(6):e141.
[21]Hu Y.Status of clinical research in China:The Lancet[J].Lancet,2011,377(9760):124-131.
[22]胡健萍,谢高强,姚晨.临床研究中电子数据质量控制的策略[J].中华医学科研管理杂志,2015,28(1):40-43.
[23]张芳丽,陶海.单病种数据库技术在眼科信息化管理中的应用进展[J].医学信息学杂志,2013,34(3):44-46.
[24]汪东生,黎晓新.眼科信息学的研究现状及发展前景[J].中华眼科杂志,2003,39(3):187-189.
[25]葛轶睿,李由,魏锐利.数据库技术在眼科信息化管理中的现状及发展趋势[J].中华实验眼科杂志,2008,26(8):630-632.
[26]汪东生,黎晓新.眼科电子病历网络信息系统的开发与应用[J].中华眼科杂志,2006,42(3):80-85.
[27]汪东生,黎晓新,谢昆青.眼科图像网络信息化的实现方案与技术研究[J].中华眼科杂志,2004,40(7):483-486.
[28]张琪,李建军,苏炳男,等.远程眼科阅片筛查疾病谱初步分析[J].眼科,2015,(4):220-225.
[29]瞿佳,梁远波.中心化眼科临床研究平台的建立:创新与实践[J].中华眼视光学与视觉科学杂志,2016,18(6):323-325.
[30]张西静.中西医结合眼科临床研究思路与方法探讨[J].中国中医眼科杂志,1993,3(3)145-148.
[31]许迅.重视和规范眼科临床研究和临床与基础相结合的研究[J].上海交通大学学报(医学版),2012,32(2):131-132.
[32]许迅,沈胤忱.重视和加强我国的眼科临床研究[J].中华实验眼科杂志,2017,35(1):1-4.
[33]Kunithala VK,Kabeer A,Vemula SK.Advance Oracle Clinical Software tool used in clinical research from patient data collection to data base lock[J].Clinical Research&Regulatory Affairs,2013,30(1-2):1-13.
[34]谢高强,李英山,姚晨.电子数据采集对我国临床研究的机遇和挑战[J].中国新药杂志,2013,(6):620-623.
[35]Franklin JD,Guidry A,Brinkley JF.A partnership approach for Electronic Data Capture in small-scale clinical trials[J].Journal of Biomedical Informatics,2011,44(Suppl 1):S103.
[2]Kennedy L,Craig AM.Global registries for measuring pharmacoeconomic and quality-of-life outcomes:focus on design and data collection,analysis and interpretation[J].Pharmacoeconomics,2004,22(9):551-568.
[3]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].J Biomed Inform,2009,42(2):377-381.
[4]Mangione CM,Berry S,Spritzer K,et al.Identifying the content area for the 51 item National Eye Institute Visual Function Questionnaire:results from focus groups with visually impaired persons[J].Archives of Ophthalmology,1998,116(2):227-233.
[5]Mangione CM,Lee PP,Gutierrez PR,et al.Development of the25 item National Eye Institute Visual Function Questionnaire[J].Archives of Ophthalmology,1998,116(11):1496-1499.
[6]Wang CW,Chan CL,Jin HY.Psychometric properties of the Chinese version of the 25 item National Eye Institute Visual Function Questionnaire[J].Optometry&Vision Science Official Publication of the American Academy of Optometry,2008,85(11):1091-1094.
[7]Blumenberg C,Barros AJ.Electronic data collection in epidemiological research.The use of REDCap in the Pelotas birth cohorts[J].Appl Clin Inform,2016,7(3):672-681.
[8]邹炼,胡金有,刘湘乡,等.REDCap软件在放疗质控中的应用[J].中国医疗器械杂志,2017,41(4):248-250.
[9]REDCap.[EB/OL].https://www.project-redcap.org,2018,12,24.
[10]孙葆忱.低视力患者生存质量与康复[M].北京:人民卫生出版社,2009:21.
[11]方积乾.生存质量测定方法及应用[M].北京:北京医科大学出版社,2000:34.
[12]Gardiner AM,Armstrong RA,Dunne MCM,et al.Correlation between visual function and visual ability in patients with uveitis[J].British Journal of Ophthalmology,2002,86(9):993-998.
[13]Group TW.The Development of the World Health Organization Quality of Life Assessment Instrument(the WHOQOL)[M].1994:41-57.
[14]孙玉环.基于EpiData与SAS系统的纸版问卷数据录入质量控制技巧[J].中国卫生统计,2012,29(4):607-608.
[15]曾素华.家庭护理干预对低视力患者社会支持、自我效能与生活质量的影响[D].南方医科大学,2016:44.
[16]李军花,赵云娥,朱俊,等.Re STOR多焦点人工晶状体植入术后远期视觉质量评价[J].中华实验眼科杂志,2009,27(6):543-544.
[17]Welker JA.Implementation of electronic data capture systems:barriers and solutions[J].Contemporary Clinical Trials,2007,28(3):329-336.
[18]Rorie DA,Flynn RWV,Grieve K,et al.Electronic case report forms and electronic data capture within clinical trials and pharmacoepidemiology[J].Br J Clin Pharmacol,2017,83(9):1880-1895.
[19]Yamamoto K.Introduction to Research Electronic Data Capture(REDCap)and REDCap2SDTM,a Conversion Tool to Facilitate Clinical Research Data Sharing[J].Brain Nerve,2017,69(7):848-855.
[20]Staziaki PV,Kim P,Vadvala HV,et al.Medical Registry Data Collection Efficiency:A Crossover Study Comparing Web-Based Electronic Data Capture and a Standard Spreadsheet[J].J Med Internet Res,2016,18(6):e141.
[21]Hu Y.Status of clinical research in China:The Lancet[J].Lancet,2011,377(9760):124-131.
[22]胡健萍,谢高强,姚晨.临床研究中电子数据质量控制的策略[J].中华医学科研管理杂志,2015,28(1):40-43.
[23]张芳丽,陶海.单病种数据库技术在眼科信息化管理中的应用进展[J].医学信息学杂志,2013,34(3):44-46.
[24]汪东生,黎晓新.眼科信息学的研究现状及发展前景[J].中华眼科杂志,2003,39(3):187-189.
[25]葛轶睿,李由,魏锐利.数据库技术在眼科信息化管理中的现状及发展趋势[J].中华实验眼科杂志,2008,26(8):630-632.
[26]汪东生,黎晓新.眼科电子病历网络信息系统的开发与应用[J].中华眼科杂志,2006,42(3):80-85.
[27]汪东生,黎晓新,谢昆青.眼科图像网络信息化的实现方案与技术研究[J].中华眼科杂志,2004,40(7):483-486.
[28]张琪,李建军,苏炳男,等.远程眼科阅片筛查疾病谱初步分析[J].眼科,2015,(4):220-225.
[29]瞿佳,梁远波.中心化眼科临床研究平台的建立:创新与实践[J].中华眼视光学与视觉科学杂志,2016,18(6):323-325.
[30]张西静.中西医结合眼科临床研究思路与方法探讨[J].中国中医眼科杂志,1993,3(3)145-148.
[31]许迅.重视和规范眼科临床研究和临床与基础相结合的研究[J].上海交通大学学报(医学版),2012,32(2):131-132.
[32]许迅,沈胤忱.重视和加强我国的眼科临床研究[J].中华实验眼科杂志,2017,35(1):1-4.
[33]Kunithala VK,Kabeer A,Vemula SK.Advance Oracle Clinical Software tool used in clinical research from patient data collection to data base lock[J].Clinical Research&Regulatory Affairs,2013,30(1-2):1-13.
[34]谢高强,李英山,姚晨.电子数据采集对我国临床研究的机遇和挑战[J].中国新药杂志,2013,(6):620-623.
[35]Franklin JD,Guidry A,Brinkley JF.A partnership approach for Electronic Data Capture in small-scale clinical trials[J].Journal of Biomedical Informatics,2011,44(Suppl 1):S103.