基于循证医学构建白内障患者报告结局条目池

doi:DOI:10.3760/cma.j.issn.1674-845X.2016.06.003

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Abstract

Objective Based on the principles of evidence-based medicine, the present study aimed to develop a cataract-specific item pool for the assessment of quality of life (QoL) in ophthalmic patients and the efficacy of specific therapy. Methods The item pool for patient reported outcomes (PROs) of cataract was established based on the guideline of the international PROs development process. Databases including PubMed, Embase, CNKI, WanFang Data, VIP, CBM were thoroughly searched. The items pool of PROs was established using the following steps: Confirm conceptual framework, identify extant items in cataract-specific instruments and the qualitative literature, select items and cross-cultural adaptation, focus groups and semi-structured interviews, item classification and selection, identify items stem and response options, expert review and revision of items, cognitive interviews and develop final version of instrument. Results The conceptual framework of item pool consists of vision-related activity limitation (VRAL) domain, vision symptoms domain and emotional well-being domain. After manual scanning for cataract-specific instruments, 19 questionnaires were extracted for the initial item pool development. After the original identification of items, focus groups and semi-structured interviews, item classification and selection, expert review and cognitive interviews, the number of items were 249, 204, 118 and 94, respectively. After cognitive interviews, all items were sorted into VRAL domain, vision symptoms domain and emotional well-being domain, which contained 41, 28 and 25 items, respectively. Total items utilized four response options. Conclusion Based on the principles of evidence-based medicine for PROs, the final item pool contained majority of the items under VRAL, vision symptoms and emotional well-being domains. Consequently, the language of items under each domain was simplified for interpretation by the patients, and possessed perfect content validity. This cataract-specific item pool has corrected the defects of PROs instruments in ophthalmology, and provided a formal reference for establishing item pools.

Key words： Evidence-based medicine Cataract Patient reported outcomes Item pool

Received: 07 March 2016

Fund:

Zhejiang Provincial & Ministry of Health Research Fund For Medical Sciences (WKJ-ZJ-1530); Scientific Research Fund of Zhejiang Provincial Kangenbei (2015ZHA-KEB206); Science and Technology Planning Project of Zhejiang Province (2016C33082)

Corresponding Authors: Wang Qinmei, Email: wqm6@mail.eye.ac.cn

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	Huang Jinhai
	Zhu Senmiao
	Gao Rongrong
	Tu Ruixue
	Zhu Rui
	Zheng Jingwei
	Yu Ayong
	Chen Haisi
	Li Yu
	Chen Shihao
	Xue Anquan
	Huang Fang
	Chen Xinhong
	Wang Qinmei

Cite this article:

Huang Jinhai,Zhu Senmiao,Gao Rongrong等. Development of cataract-specific item pool to measure patient-reported outcomes[J]. Chinese Journal of Optometry Ophthalmology and Visual science, 2016, 18(6): 326-332.

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http://www.cjoovs.com/EN/DOI:10.3760/cma.j.issn.1674-845X.2016.06.003 OR http://www.cjoovs.com/EN/Y2016/V18/I6/326

[1]	Pascolini D, Mariotti SP.Global estimates of visual impairment: 2010[J]. Br J Ophthalmol,2012,96(5):614-618. DOI:10.1136/bjophthalmol-2011-300539.
[2]	于强,李绍珍,陈和年,等. 视功能损害眼病患者生存质量量表的研究[J]. 中华眼科杂志,1997,(04):68-71.
[3]	Brémond-Gignac D, Tixier J, Missotten T, et al. Evaluation of the quality of life in ophthalmology[J]. Presse Med,2002,31(34):1607-1612.
[4]	Willke RJ, Burke LB, Erickson P. Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels[J]. Control Clin Trials,2004,25(6):535-552. DOI:10.1016/j.cct.2004.09.003.
[5]	Revicki DA, Regulatory Issues and Patient-Reported Outcomes Task Force for the International Society for Quality of Life Research. FDA draft guidance and health-outcomes research[J].Lancet,2007,369(9561):540-542. DOI:10.1016/S0140-6736(07)60250-5.
[6]	Khadka J, McAlinden C, Pesudovs K. Quality assessment of ophthalmic questionnaires: review and recommendations[J]. Optom Vis Sci,2013,90(8):720-744. DOI:0.1097/OPX.0000000000000001.
[7]	Lin X, Li M, Wang M, et al. Validation of Catquest-9SF questionnaire in a Chinese cataract population[J]. PLoS One,2014,9(8):e103860. DOI:10.1371/journal.pone.0103860.
[8]	Pesudovs K, Gothwal VK, Wright T, et al. Remediating serious flaws in the National Eye Institute Visual Function Questionnaire[J]. J Cataract Refract Surg,2010,36(5):718-732. DOI:10.1016/j.jcrs.2009.11.019.
[9]	Gothwal VK, Wright TA, Lamoureux EL, et al. Measuring outcomes of cataract surgery using the Visual Function Index-14[J]. J Cataract Refract Surg,2010,36(7):1181-1188. DOI:10.1016/j.jcrs.2010.01.029.
	[10] Khadka J, McAlinden C, Gothwal VK, et al. The importance of rating scale design in the measurement of patient-reported outcomes using questionnaires or item banks[J]. Invest Ophthalmol Vis Sci,2012,53(7):4042-4054. DOI:10.1167/iovs.12-9728.
	[11] Pesudovs K. Item banking: a generational change in patient-reported outcome measurement[J]. Optom Vis Sci,2010,87(4):285-293. DOI:10.1097/OPX.0b013e3181d408d7.
	[12] DeWalt DA, Rothrock N, Yount S, et al. Evaluation of item candidates: the PROMIS qualitative item review[J]. Med Care,2007,45(5 Suppl 1):S12-21. DOI:10.1097/01.mlr.0000254567.79743.e2.
	[13] Committee for Medicinal Products for Human Use. Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products[EB/OL]. (2005-07-27)[2015-01-05]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003637.pdf.
	[14] 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 and quality of life outcomes,2006,4:79.
	[15] Services USDoHaH, Administration FaD, (CDER), et al. Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims,2009. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.
	[16] 许军,张金华,罗仁,等. Delphi法在筛选亚健康评价指标体系中的应用研究[J]. 中华行为医学与脑科学杂志,2010,19(6):562-565. DOI:10.3760/cma.j.issn.1674-6554.2010.06.031.
	[17] Khadka J, McAlinden C, Craig JE, et al. Identifying content for the glaucoma-specific item bank to measure quality-of-life parameters[J]. J Glaucoma,2015,24(1):12-19. 10.1097/IJG.0b013e 318287ac11.
	[18] Fenwick EK, Pesudovs K, Khadka J, et al. Evaluation of item candidates for a diabetic retinopathy quality of life item bank[J]. Qual Life Res,2013,22(7):1851-1858. DOI:10.1007/s11136-012-0307-3.
	[19] Mollazadegan K, Huang J, Khadka J, et al. Cross-cultural validation of the National Eye Institute Visual Function Questionnaire[J]. J Cataract Refract Surg,2014,40(5):774-784. DOI:10.1016/j.jcrs.2013.10.040.
	[20] Ustün TB, Chatterji S, Bickenbach J, et al. The International Classification of Functioning, Disability and Health: a new tool for understanding disability and health[J]. Disabil Rehabil,2003, 25(11-12):565-571. DOI:10.1080/0963828031000137063.
	[21] Basch E, Spertus J, Dudley RA, et al. Methods for Developing Patient-Reported Outcome-Based Performance Measures (PRO-PMs)[J]. Value Health,2015,18(4):493-504. DOI:10.1016/j.jval.2015.02.018.
	[22] Skevington SM.Advancing cross-cultural research on quality of life: observations drawn from the WHOQOL development. World Health Organisation Quality of Life Assessment[J]. Qual Life Res,2002,11(2):135-144.
	[23] Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures[J]. Spine (Phila Pa 1976),2000,25(24):3186-3191.
	[24] Bullinger M, Alonso J, Apolone G, et al. Translating health status questionnaires and evaluating their quality: the IQOLA Project approach. International Quality of Life Assessment[J]. J Clin Epidemiol,1998,51(11):913-923.
	[25] 夏萍,李宁秀,吕玉波,等. 生命质量量表跨文化调适方法概述[J].中国心理卫生杂志,2007,21(4):230-232.
	[26] Coyne KS, Margolis MK, Kennedy-Martin T, et al. The impact of diabetic retinopathy: perspectives from patient focus groups[J]. Fam Pract,2004,21(4):447-453. DOI:10.1093/fampra/cmh417.
	[27] Gothwal VK, Wright TA, Lamoureux EL, et al. Multiplicative rating scales do not enable measurement of vision-related quality of life[J]. Clin Exp Optom,2011,94(1):52-62. DOI:10.1111/j.1444-0938.2010.00554.x.
	[28] Khadka J, Huang J, Mollazadegan K, et al. Translation, cultural adaptation, and Rasch analysis of the visual function (VF-14) questionnaire[J]. Invest Ophthalmol Vis Sci,2014,55(7):4413-4420. DOI:10.1167/iovs.14-14017.
	[29] Gothwal VK, Wright TA, Lamoureux EL, et al. Multiplicative rating scales do not enable measurement of vision-related quality of life[J]. Clin Exp Optom,2011,94(1):52-62. DOI:10.1111/j.1444-0938.2010.00554.x.