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  •   Berry S, Mangione CM, Lindblad AS, McDonnell PJ
    Development of the National Eye Institute refractive error correction quality of life questionnaire: focus groups. Ophthalmology. 2003;110:2285-2291 // Bland JM & Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res 1999; 8: 135-160 // Bottomley A, Jones D, Claassens L. Patient-reported outcomes: assessment and current perspectives of the guidelines of the Food and Drug Administration and the reflection paper of the European Medicines Agency. Eur J Cancer. 2009;45:347-53 // Bourque LB, Cosand BB, Drews C, Waring GO 3rd, Lynn M, Cartwright C. Reported satisfaction, fluctuation of vision, and glare among patients one year after surgery in the Prospective Evaluation of Radial Keratotomy (PERK) Study. Arch Ophthalmol. 1986;104:356-363 // Brunette I, Gresset J, Boivin J-F, Boisjoly H, Makni H. Function¬al outcome and satisfaction after photorefractive keratectomy: Part 1. Development and validation of a survey questionnaire. Ophthalmology. 2000;107:1783-1789 // Buckhurst PJ, Wolffsohn JS, Gupta N, Naroo SA, Davies LN, Shah S. Development of a questionnaire to assess the relative subjective benefits of presbyopia correction. J Cataract Refract Surg. 2012;38:74-79 // DeWalt DA, Rothrock N, Yount S, Stone AA; PROMIS Cooperative Group. Evaluation of item candidates: the PROMIS qualitative item review. Med Care. 2007;45:12-21 // Erickson DB, Stapleton F, Erickson P, du Toit R, Giannako¬poulos E, Holden B. Development and validation of a multi¬dimensional quality-of-life scale for myopia. Optom Vis Sci. 2004;81:70-81 // Finger RP, Fenwick E, Owsley C, Holz FG, Lamoureux EL. Visual functioning and quality of life under low luminance: evaluation of the German Low Luminance Questionnaire. Invest Ophthalmol Vis Sci. 2011;52:8241-9 // Fraenkel G, Comaish lF, Lawless MA, Kelly MR, Dunn SM, Byth K, Webber SK, Sutton GL, Rogers CM. Development of a questionnaire to assess subjective vision score in myopes seeking refractive surgery. J Refract Surg. 2004;20:10-9 // Gothwal VK, Reddy SP, Bharani S, Bagga DK, Sumalini R, Garudadri CS, Rao HL, Senthil S, Pathak-Ray V, Mandal AK. Impact of glaucoma on visual functioning in Indians. Invest Ophthalmol Vis Sci. 2012;53:6081-92 // Hays RD, Mangione CM, Ellwein L, Lindblad AS, Spritzer KL, McDonnell PJ. Psychometric properties of the National Eye Institute-Refractive Error Quality of Life instrument. Ophthalmology. 2003;110:2292-301 // Johnson ME, Murphy PJ. Measurement of ocular surface irritation on a linear interval scale with the ocular comfort index (OCI). Invest Ophth Vis Sci 2007;48:4451-8 // Kandel H, Khadka J, Lundström M, Goggin M, Pesudovs K. Questionnaires for Measuring Refractive Surgery Outcomes. J Refract Surg. 2017;33:416-424 // Khadka J, McAlinden C, Pesudovs K. Quality assessment of ophthalmic questionnaires: review and recommendations. Optometry and Vision Science 2013; 90: 720-744 // Lee J, Lee J, Park K, Cho W, Kim JY, Kang HY. Assessing the value of laser in situ keratomileusis by patient-reported outcomes using quality of life assessment. J Refract Surg. 2005;21:59-71 // Lévy P, Elies D, Dithmer O, Gil-Campos I, Benmedjahed K, Berdeaux, Arnould B. Development of a new subjective questionnaire: the Freedom from Glasses Value Scale (FGVS). J Refract Surg. 2010;26:438-46 // Lundström M, Pesudovs K. Catquest-9SF: patient outcomes questionnaire - nine-item short-form Rasch-scaled revision of the Catquest questionnaire. J Cat Refract Surg 2009;35:504-13 //
  •   Lundström M, Pesudovs K
    Questionnaires for measuring cataract surgery outcomes. J Cataract Refract Surg. 2011;37:945-59 // McAlinden C, Pesudovs K, Moore JE. The development of an in¬strument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010;51:5537-5545 // Mokkink LB, Terwee CB, Knol DL, Stratford PW, Alonso J, Patrick DL, Bouter LM, de Vet HC. The COSMIN checklist for evaluating the methodological quality of studies on measurement properties: a clarification of its content. BMC Med Res Methodol 2010;10:22 // Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, Bouter LM, de Vet HC. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res. 2010;19:539-49 // Mullin PA, Lohr KN, Bresnahan BW, McNulty P. Applying cognitive design principles to formatting HRQOL instruments. Qual Life Res. 2000;9:13-27 // Pesudovs K, Garamendi E, Keeves JP, Elliott DB. The Activities of Daily Vision Scale for cataract surgery outcomes: re-evaluating validity with Rasch analysis. Invest Ophthalmol Vis Sci 2003;44: 2892-9 // Pesudovs K, Garamendi E, Elliott DB. The Quality of Life Impact of Refractive Correction (QIRC) Questionnaire: develop¬ment and validation. Optom Vis Sci. 2004;81:769-777 // Pesudovs K, Burr JM, Harley C, Elliott DB. The development, assessment, and selection of questionnaires. Optom Vis Sci. 2007;84:663-74 // Pesudovs K, Ratcliffe J, Lamoureux EL, Lundström M, Massof RW, Rubin GS. Measuring the patient's perspective. Optom Vis Sci. 2013;90:717-9 // 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. Lancet. 2007;369:540-2 // Schein OD. The measurement of patient-reported outcomes of refractive surgery: the refractive status and vision profile. Trans Am Ophthalmol Soc. 2000;98:439-469 // Sukhawarn R, Wiratchai N, Tatsanavivat P, Pitiyanuwat S, Kanato M, Srivannaboon S, Guyatt GH. Development of a refractive error quality of life scale for Thai adults (the REQ-Thai). J Med Assoc Thai. 2011;94:978-84 // Vandenbroeck S, De Geest S, Zeyen T, Stalmans I, Dobbels F. Patient-reported outcomes (PRO's) in glaucoma: a systematic review. Eye (Lond). 2011;25:555-77 // Vitale S, Schein OD, Meinert CL, Steinberg EP. The refractive status and vision profile: a questionnaire to measure vision-related quality of life in persons with refractive error. Ophthalmology. 2000;107:1529-1539

Development of a New Patient Reported Outcome (PRO) Measure for Refractive Surgery Patients as Part of the National Dataset in Refractive Surgery

Details for clinical trial NCT03655743