成人斜视患者报告结局测评系统的构建及应用
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摘要
目的基于计算机自适应测试技术构建成人斜视患者报告结局测评系统,并评价临床应用效果。方法以患者报告结局国际开发标准作为方法学指南,采用质性研究、德尔菲法、Rasch模型等方法形成测评条目,基于计算机自适应测试技术建立测试系统,包括测评系统、统计相关和系统管理3大核心模块。将该系统应用于101例成人斜视患者(系统测评组),并与采用纸质版测评的对照组(100例)进行效果比较。结果系统测评组测评时间显著短于对照组,患者测评满意率及依从率显著高于对照组(P<0.05,P<0.01)。结论基于计算机自适应测试技术开发的成人斜视患者报告结局测评系统,可缩短测评时间,提高患者测评满意度和依从性。
Objective To develop patient-reported outcome(PRO)information system for adult strabismus based on computer adaptive testing(CAT),and to evaluate its application effect.Methods Following the guidance that was approved by the U.S.Food and Drug Administration for developing PRO instrument,we employed qualitative research,Delphi process and the Rasch model to establish the item pool,then we used CAT to create the information system which included three core modules as assessment,statistics,and system management.A total of 101 adults with strabismus were assessed by the information system(the system group)and effect was compared with 100 controls who were assessed using paper sheets(the control group).Results The system group used shorter time to assess,and had higher patient satisfaction and compliance with the assessment(P<0.05,P<0.01).Conclusion The CAT-assisted PRO information system can reduce assessment time and improve patient satisfaction and compliance.
Objective To develop patient-reported outcome(PRO)information system for adult strabismus based on computer adaptive testing(CAT),and to evaluate its application effect.Methods Following the guidance that was approved by the U.S.Food and Drug Administration for developing PRO instrument,we employed qualitative research,Delphi process and the Rasch model to establish the item pool,then we used CAT to create the information system which included three core modules as assessment,statistics,and system management.A total of 101 adults with strabismus were assessed by the information system(the system group)and effect was compared with 100 controls who were assessed using paper sheets(the control group).Results The system group used shorter time to assess,and had higher patient satisfaction and compliance with the assessment(P<0.05,P<0.01).Conclusion The CAT-assisted PRO information system can reduce assessment time and improve patient satisfaction and compliance.
引文
[1]卞薇,陈爽,王贞,等.中文版斜弱视患者生存质量量表的信度和效度检测[J].护理学杂志,2012,27(14):45-48.
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[3]Hood L,Friend S H.Predictive,personalized,preventive,participatory(P4)cancer medicine[J].Nat Rev Clin Oncol,2011,8(3):184-187.
[4]卞薇,彭雪娇,徐燕,等.中文版成人斜视患者生活质量量表的信度和效度[J].解放军护理杂志,2013,30(12):24-26.
[5]Khadka J,Fenwick E,Lamoureux E,et al.Methods to develop the eye-tem bank to measure ophthalmic quality of life[J].Optom Vis Sci,2016,93(12):1485-1494.
[6]李铭勇,张敏强,简小珠.计算机自适应测验中测验安全控制方法评述[J].心理科学进展,2010,18(8):1339-1348.
[7]Andrich D.Rasch models for measurement[M].California:Sage Publications,2011:124-132.
[8]卞薇,田旭,徐燕,等.基于决策树的成人斜视患者生存质量预测模型研究[J].护理学杂志,2016,31(16):23-26.
[9]Garway-Heath D F,Crabb D P,Glen F C.The direction of research into visual disability and quality of life in glaucoma[J].BMC Ophthalmol,2011,11(1):1-6.
[10]Khadka J,Mcalinden C,Pesudovs K.Quality assessment of ophthalmic questionnaires:review and recommendations[J].Optom Vis Sci,2013,90(8):720-744.
[11]Carle A C,Cella D,Cai L,et al.Advancing PROMIS′s methodology:results of the Third Patient-Reported Outcomes Measurement Information System(PROMIS(?))Psychometric Summit[J].Expert Rev Pharmacoecon Outcomes Res,2011,11(6):677-684.
[12]Fries J F,Krishnan E,Rose M,et al.Improved responsiveness and reduced sample size requirements of PRO-MIS physical function scales with item response theory[J].Arthritis Res Ther,2011,13(5):R147.
[2]U.S.Department of Health and Human Services FDA Center for Drug Evaluation and Research,U.S.Department of Health and Human Services FDA Center for Biologics Evaluation and Research,U.S.Department of Health and Human Services FDA Center for Devices and Radiological Health.Guidance for industry:patient-reported outcome measures:use in medical product development to support labeling claims:draft guidance[J].Health Qual Life Outcomes,2006,4:79.
[3]Hood L,Friend S H.Predictive,personalized,preventive,participatory(P4)cancer medicine[J].Nat Rev Clin Oncol,2011,8(3):184-187.
[4]卞薇,彭雪娇,徐燕,等.中文版成人斜视患者生活质量量表的信度和效度[J].解放军护理杂志,2013,30(12):24-26.
[5]Khadka J,Fenwick E,Lamoureux E,et al.Methods to develop the eye-tem bank to measure ophthalmic quality of life[J].Optom Vis Sci,2016,93(12):1485-1494.
[6]李铭勇,张敏强,简小珠.计算机自适应测验中测验安全控制方法评述[J].心理科学进展,2010,18(8):1339-1348.
[7]Andrich D.Rasch models for measurement[M].California:Sage Publications,2011:124-132.
[8]卞薇,田旭,徐燕,等.基于决策树的成人斜视患者生存质量预测模型研究[J].护理学杂志,2016,31(16):23-26.
[9]Garway-Heath D F,Crabb D P,Glen F C.The direction of research into visual disability and quality of life in glaucoma[J].BMC Ophthalmol,2011,11(1):1-6.
[10]Khadka J,Mcalinden C,Pesudovs K.Quality assessment of ophthalmic questionnaires:review and recommendations[J].Optom Vis Sci,2013,90(8):720-744.
[11]Carle A C,Cella D,Cai L,et al.Advancing PROMIS′s methodology:results of the Third Patient-Reported Outcomes Measurement Information System(PROMIS(?))Psychometric Summit[J].Expert Rev Pharmacoecon Outcomes Res,2011,11(6):677-684.
[12]Fries J F,Krishnan E,Rose M,et al.Improved responsiveness and reduced sample size requirements of PRO-MIS physical function scales with item response theory[J].Arthritis Res Ther,2011,13(5):R147.