Skip to main content
NCBI home page
Transactions of the American Ophthalmological Society logoLink to Transactions of the American Ophthalmological Society
. 2000;98:439–469.

The measurement of patient-reported outcomes of refractive surgery: the refractive status and vision profile.

O D Schein 1
PMCID: PMC1298237  PMID: 11190036

Abstract

PURPOSE: To develop a questionnaire, the Refractive Status and Vision Profile (RSVP), to assess health-related quality of life associated with refractive error and its correction. METHODS: The published literature on patient report of visual and overall function was reviewed, and the RSVP was self-administered by 550 participants with refractive error. Cross-sectional validation was performed using standard psychometric techniques. The responsiveness of the RSVP to surgical intervention was assessed prospectively in a subset of 176 patients. The principal outcomes measures were scores on the overall RSVP scale (S) and on 8 RSVP subscales (functioning, driving, concern, expectations, symptoms, glare, optical problems, problems with corrective lenses). RESULTS: The RSVP (S) and its subscales demonstrated very good internal consistency (Cronbach's alpha, 0.70-0.93). S and several subscale scores were independently associated with satisfaction with vision and were more correlated with satisfaction with vision than with either visual acuity or refractive error. Higher refractive error was associated with lower scores on S and on 5 subscales. In the prospective surgical cohort, 15% of patients had some worsening in their total RSVP score; however, substantial variation was seen in the individual subscales where worsening ranged from 7% (problems with corrective lenses) to 41% (driving). The effect size (measure of responsiveness) of the RSVP and most of its subscales was very high. Approximately 14% of patients had significant worsening in 3 or more subscales, and this outcome was found to be independently associated with being dissatisfied with vision following surgery (OR, 5.84; 95% CI, 1.88, 8.13). CONCLUSIONS: The RSVP has been validated as a questionnaire that measures patient-reported quality of life related to refractive error and its correction. It is responsive to surgical intervention and provides important information regarding patient outcomes not available from standard clinical measurements.

Full text

PDF
439

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. Alonso J., Espallargues M., Andersen T. F., Cassard S. D., Dunn E., Bernth-Petersen P., Norregaard J. C., Black C., Steinberg E. P., Anderson G. F. International applicability of the VF-14. An index of visual function in patients with cataracts. Ophthalmology. 1997 May;104(5):799–807. doi: 10.1016/s0161-6420(97)30230-9. [DOI] [PubMed] [Google Scholar]
  2. Bass E. B., Steinberg E. P., Pitt H. A., Griffiths R. I., Lillemoe K. D., Saba G. P., Johns C. Comparison of the rating scale and the standard gamble in measuring patient preferences for outcomes of gallstone disease. Med Decis Making. 1994 Oct-Dec;14(4):307–314. doi: 10.1177/0272989X9401400401. [DOI] [PubMed] [Google Scholar]
  3. Bernth-Petersen P. Outcome of cataract surgery I. A prospective, observational study. Acta Ophthalmol (Copenh) 1982 Apr;60(2):235–242. doi: 10.1111/j.1755-3768.1982.tb08377.x. [DOI] [PubMed] [Google Scholar]
  4. Bernth-Petersen P. Outcome of cataract surgery. II. Visual functioning in aphakic patients. Acta Ophthalmol (Copenh) 1982 Apr;60(2):243–252. [PubMed] [Google Scholar]
  5. Bernth-Petersen P. Outcome of cataract surgery. IV. Socio-economic aspects. Acta Ophthalmol (Copenh) 1982 Jun;60(3):461–468. doi: 10.1111/j.1755-3768.1982.tb03039.x. [DOI] [PubMed] [Google Scholar]
  6. Bernth-Petersen P. Visual functioning in cataract patients. Methods of measuring and results. Acta Ophthalmol (Copenh) 1981 Apr;59(2):198–205. doi: 10.1111/j.1755-3768.1981.tb02979.x. [DOI] [PubMed] [Google Scholar]
  7. Boisjoly H., Gresset J., Fontaine N., Charest M., Brunette I., LeFrançois M., Deschênes J., Bazin R., Laughrea P. A., Dubé I. The VF-14 index of functional visual impairment in candidates for a corneal graft. Am J Ophthalmol. 1999 Jul;128(1):38–44. doi: 10.1016/s0002-9394(99)00071-9. [DOI] [PubMed] [Google Scholar]
  8. Bourque L. B., Cosand B. B., Drews C., Waring G. O., 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 Mar;104(3):356–363. doi: 10.1001/archopht.1986.01050150056026. [DOI] [PubMed] [Google Scholar]
  9. Bourque L. B., Lynn M. J., Waring G. O., 3rd, Cartwright C. Spectacle and contact lens wearing six years after radial keratotomy in the Prospective Evaluation of Radial Keratotomy Study. Ophthalmology. 1994 Mar;101(3):421–431. doi: 10.1016/s0161-6420(94)31315-7. [DOI] [PubMed] [Google Scholar]
  10. Bourque L. B., Rubenstein R., Cosand B., Waring G. O., 3rd, Moffitt S., Gelender H., Laibson P. R., Lindstrom R. L., McDonald M., Myers W. D. Psychosocial characteristics of candidates for the prospective evaluation of radial keratotomy (PERK) study. Arch Ophthalmol. 1984 Aug;102(8):1187–1192. doi: 10.1001/archopht.1984.01040030965027. [DOI] [PubMed] [Google Scholar]
  11. Brenner M. H., Curbow B., Javitt J. C., Legro M. W., Sommer A. Vision change and quality of life in the elderly. Response to cataract surgery and treatment of other chronic ocular conditions. Arch Ophthalmol. 1993 May;111(5):680–685. doi: 10.1001/archopht.1993.01090050114040. [DOI] [PubMed] [Google Scholar]
  12. Cowden J. W., Bores L. D. A clinical investigation of the surgical correction of myopia by the method of Fyodorov. Ophthalmology. 1981 Aug;88(8):737–741. doi: 10.1016/s0161-6420(81)34948-3. [DOI] [PubMed] [Google Scholar]
  13. Deyo R. A., Diehr P., Patrick D. L. Reproducibility and responsiveness of health status measures. Statistics and strategies for evaluation. Control Clin Trials. 1991 Aug;12(4 Suppl):142S–158S. doi: 10.1016/s0197-2456(05)80019-4. [DOI] [PubMed] [Google Scholar]
  14. Dutt S., Steinert R. F., Raizman M. B., Puliafito C. A. One-year results of excimer laser photorefractive keratectomy for low to moderate myopia. Arch Ophthalmol. 1994 Nov;112(11):1427–1436. doi: 10.1001/archopht.1994.01090230041018. [DOI] [PubMed] [Google Scholar]
  15. Fichte C. M., Bell A. M. Ongoing results of excimer laser photorefractive keratectomy for myopia: subjective patient impressions. J Cataract Refract Surg. 1994 Mar;20 (Suppl):268–270. doi: 10.1016/s0886-3350(13)80766-3. [DOI] [PubMed] [Google Scholar]
  16. Fletcher A. E., Ellwein L. B., Selvaraj S., Vijaykumar V., Rahmathullah R., Thulasiraj R. D. Measurements of vision function and quality of life in patients with cataracts in southern India. Report of instrument development. Arch Ophthalmol. 1997 Jun;115(6):767–774. doi: 10.1001/archopht.1997.01100150769013. [DOI] [PubMed] [Google Scholar]
  17. Fletcher A., Vijaykumar V., Selvaraj S., Thulasiraj R. D., Ellwein L. B. The Madurai Intraocular Lens Study. III: Visual functioning and quality of life outcomes. Am J Ophthalmol. 1998 Jan;125(1):26–35. doi: 10.1016/s0002-9394(99)80231-1. [DOI] [PubMed] [Google Scholar]
  18. Freitas C., Oliveiros B. M., Marques E., Leite E. B. Effect of photorefractive keratectomy on visual functioning and quality of life. J Refract Surg. 1995 May-Jun;11(3 Suppl):S327–S334. doi: 10.3928/1081-597X-19950502-29. [DOI] [PubMed] [Google Scholar]
  19. Froberg D. G., Kane R. L. Methodology for measuring health-state preferences--II: Scaling methods. J Clin Epidemiol. 1989;42(5):459–471. doi: 10.1016/0895-4356(89)90136-4. [DOI] [PubMed] [Google Scholar]
  20. Gartry D. S., Kerr Muir M. G., Marshall J. Excimer laser photorefractive keratectomy. 18-month follow-up. Ophthalmology. 1992 Aug;99(8):1209–1219. doi: 10.1016/s0161-6420(92)31821-4. [DOI] [PubMed] [Google Scholar]
  21. Gimbel H. V., Van Westenbrugge J. A., Johnson W. H., Willerscheidt A. B., Sun R., Ferensowicz M. Visual, refractive, and patient satisfaction results following bilateral photorefractive keratectomy for myopia. Refract Corneal Surg. 1993 Mar-Apr;9(2 Suppl):S5–10. [PubMed] [Google Scholar]
  22. Gresset J., Boisjoly H., Nguyen T. Q., Boutin J., Charest M. Validation of French-language versions of the Visual Functioning Index (VF-14) and the Cataract Symptom Score. Can J Ophthalmol. 1997 Feb;32(1):31–37. [PubMed] [Google Scholar]
  23. Guyatt G., Walter S., Norman G. Measuring change over time: assessing the usefulness of evaluative instruments. J Chronic Dis. 1987;40(2):171–178. doi: 10.1016/0021-9681(87)90069-5. [DOI] [PubMed] [Google Scholar]
  24. Halliday B. L. Refractive and visual results and patient satisfaction after excimer laser photorefractive keratectomy for myopia. Br J Ophthalmol. 1995 Oct;79(10):881–887. doi: 10.1136/bjo.79.10.881. [DOI] [PMC free article] [PubMed] [Google Scholar]
  25. Hersh P. S., Brint S. F., Maloney R. K., Durrie D. S., Gordon M., Michelson M. A., Thompson V. M., Berkeley R. B., Schein O. D., Steinert R. F. Photorefractive keratectomy versus laser in situ keratomileusis for moderate to high myopia. A randomized prospective study. Ophthalmology. 1998 Aug;105(8):1512-22, discussion 1522-3. doi: 10.1016/S0161-6420(98)98038-1. [DOI] [PubMed] [Google Scholar]
  26. Hersh P. S., Schein O. D., Steinert R. Characteristics influencing outcomes of excimer laser photorefractive keratectomy. Summit Photorefractive Keratectomy Phase III Study Group. Ophthalmology. 1996 Nov;103(11):1962–1969. doi: 10.1016/s0161-6420(96)30401-6. [DOI] [PubMed] [Google Scholar]
  27. Hersh P. S., Schwartz-Goldstein B. H. Corneal topography of phase III excimer laser photorefractive keratectomy. Characterization and clinical effects. Summit Photorefractive Keratectomy Topography Study Group. Ophthalmology. 1995 Jun;102(6):963–978. doi: 10.1016/s0161-6420(95)30927-x. [DOI] [PubMed] [Google Scholar]
  28. Hersh P. S., Shah S. I., Geiger D., Holladay J. T. Corneal optical irregularity after excimer laser photorefractive keratectomy. The Summit Photorefractive Keratectomy Topography Study Group. J Cataract Refract Surg. 1996 Mar;22(2):197–204. doi: 10.1016/s0886-3350(96)80219-7. [DOI] [PubMed] [Google Scholar]
  29. Hersh P. S., Shah S. I., Holladay J. T. Corneal asphericity following excimer laser photorefractive keratectomy. Summit PRK Topography Study Group. Ophthalmic Surg Lasers. 1996 May;27(5 Suppl):S421–S428. [PubMed] [Google Scholar]
  30. Javitt J. C., Steinberg E. P., Sharkey P., Schein O. D., Tielsch J. M., Diener M., Legro M., Sommer A. Cataract surgery in one eye or both. A billion dollar per year issue. Ophthalmology. 1995 Nov;102(11):1583–1593. doi: 10.1016/s0161-6420(95)30824-x. [DOI] [PubMed] [Google Scholar]
  31. Kahle G., Seiler T., Wollensak J. Report on psychosocial findings and satisfaction among patients 1 year after excimer laser photorefractive keratectomy. Refract Corneal Surg. 1992 Jul-Aug;8(4):286–289. [PubMed] [Google Scholar]
  32. Kazis L. E., Anderson J. J., Meenan R. F. Effect sizes for interpreting changes in health status. Med Care. 1989 Mar;27(3 Suppl):S178–S189. doi: 10.1097/00005650-198903001-00015. [DOI] [PubMed] [Google Scholar]
  33. Linder M., Chang T. S., Scott I. U., Hay D., Chambers K., Sibley L. M., Weis E. Validity of the visual function index (VF-14) in patients with retinal disease. Arch Ophthalmol. 1999 Dec;117(12):1611–1616. doi: 10.1001/archopht.117.12.1611. [DOI] [PubMed] [Google Scholar]
  34. Lundström M., Roos P., Jensen S., Fregell G. Catquest questionnaire for use in cataract surgery care: description, validity, and reliability. J Cataract Refract Surg. 1997 Oct;23(8):1226–1236. doi: 10.1016/s0886-3350(97)80321-5. [DOI] [PubMed] [Google Scholar]
  35. Mangione C. M., Berry S., Spritzer K., Janz N. K., Klein R., Owsley C., Lee P. P. Identifying the content area for the 51-item National Eye Institute Visual Function Questionnaire: results from focus groups with visually impaired persons. Arch Ophthalmol. 1998 Feb;116(2):227–233. doi: 10.1001/archopht.116.2.227. [DOI] [PubMed] [Google Scholar]
  36. Mangione C. M., Gutierrez P. R., Lowe G., Orav E. J., Seddon J. M. Influence of age-related maculopathy on visual functioning and health-related quality of life. Am J Ophthalmol. 1999 Jul;128(1):45–53. doi: 10.1016/s0002-9394(99)00169-5. [DOI] [PubMed] [Google Scholar]
  37. Mangione C. M., Orav E. J., Lawrence M. G., Phillips R. S., Seddon J. M., Goldman L. Prediction of visual function after cataract surgery. A prospectively validated model. Arch Ophthalmol. 1995 Oct;113(10):1305–1311. doi: 10.1001/archopht.1995.01100100093037. [DOI] [PubMed] [Google Scholar]
  38. Mangione C. M., Phillips R. S., Lawrence M. G., Seddon J. M., Orav E. J., Goldman L. Improved visual function and attenuation of declines in health-related quality of life after cataract extraction. Arch Ophthalmol. 1994 Nov;112(11):1419–1425. doi: 10.1001/archopht.1994.01090230033017. [DOI] [PubMed] [Google Scholar]
  39. Mangione C. M., Phillips R. S., Seddon J. M., Lawrence M. G., Cook E. F., Dailey R., Goldman L. Development of the 'Activities of Daily Vision Scale'. A measure of visual functional status. Med Care. 1992 Dec;30(12):1111–1126. doi: 10.1097/00005650-199212000-00004. [DOI] [PubMed] [Google Scholar]
  40. Martin T. P., Reed J. W., Legault C., Oberfeld S. M., Jacoby B. G., Yu D. D., Dickens A., Johnson H. P. Cataract formation and cataract extraction after penetrating keratoplasty. Ophthalmology. 1994 Jan;101(1):113–119. doi: 10.1016/s0161-6420(13)31252-4. [DOI] [PubMed] [Google Scholar]
  41. McGhee C. N., Orr D., Kidd B., Stark C., Bryce I. G., Anastas C. N. Psychological aspects of excimer laser surgery for myopia: reasons for seeking treatment and patient satisfaction. Br J Ophthalmol. 1996 Oct;80(10):874–879. doi: 10.1136/bjo.80.10.874. [DOI] [PMC free article] [PubMed] [Google Scholar]
  42. McHorney C. A., Ware J. E., Jr, Raczek A. E. The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care. 1993 Mar;31(3):247–263. doi: 10.1097/00005650-199303000-00006. [DOI] [PubMed] [Google Scholar]
  43. Musch D. C., Farjo A. A., Meyer R. F., Waldo M. N., Janz N. K. Assessment of health-related quality of life after corneal transplantation. Am J Ophthalmol. 1997 Jul;124(1):1–8. doi: 10.1016/s0002-9394(14)71636-8. [DOI] [PubMed] [Google Scholar]
  44. Natchiar G. N., Thulasiraj R. D., Negrel A. D., Bangdiwala S., Rahmathallah R., Prajna N. V., Ellwein L. B., Kupfer C. The Madurai Intraocular Lens Study. I: A randomized clinical trial comparing complications and vision outcomes of intracapsular cataract extraction and extracapsular cataract extraction with posterior chamber intraocular lens. Am J Ophthalmol. 1998 Jan;125(1):1–13. doi: 10.1016/s0002-9394(99)80229-3. [DOI] [PubMed] [Google Scholar]
  45. Neumann A. C., Osher R. H., Fenzl R. E. Radial keratotomy: a comprehensive evaluation. Doc Ophthalmol. 1984 Jan 30;56(3):275–301. doi: 10.1007/BF00159078. [DOI] [PubMed] [Google Scholar]
  46. Pallikaris I., McDonald M. B., Siganos D., Klonos G., Detorakis S., Frey R., Downes R., Gauthier C. A. Tracker-assisted photorefractive keratectomy for myopia of -1 to -6 diopters. J Refract Surg. 1996 Feb;12(2):240–247. doi: 10.3928/1081-597X-19960201-05. [DOI] [PubMed] [Google Scholar]
  47. Patrick D. L., Deyo R. A. Generic and disease-specific measures in assessing health status and quality of life. Med Care. 1989 Mar;27(3 Suppl):S217–S232. doi: 10.1097/00005650-198903001-00018. [DOI] [PubMed] [Google Scholar]
  48. Powers M. K., Meyerowitz B. E., Arrowsmith P. N., Marks R. G. Psychosocial findings in radial keratotomy patients two years after surgery. Ophthalmology. 1984 Oct;91(10):1193–1198. doi: 10.1016/s0161-6420(84)34164-1. [DOI] [PubMed] [Google Scholar]
  49. Prajna N. V., Chandrakanth K. S., Kim R., Narendran V., Selvakumar S., Rohini G., Manoharan N., Bangdiwala S. I., Ellwein L. B., Kupfer C. The Madurai Intraocular Lens Study. II: Clinical outcomes. Am J Ophthalmol. 1998 Jan;125(1):14–25. doi: 10.1016/s0002-9394(99)80230-x. [DOI] [PubMed] [Google Scholar]
  50. Rushood A. A., Nassim H. M., Azeemuddin T. Patient satisfaction after photorefractive keratectomy for low myopia using the visual analogue scale. J Refract Surg. 1997 Aug;13(5 Suppl):S438–S440. doi: 10.3928/1081-597X-19970801-11. [DOI] [PubMed] [Google Scholar]
  51. Schein O. D., Steinberg E. P., Cassard S. D., Tielsch J. M., Javitt J. C., Sommer A. Predictors of outcome in patients who underwent cataract surgery. Ophthalmology. 1995 May;102(5):817–823. doi: 10.1016/s0161-6420(95)30952-9. [DOI] [PubMed] [Google Scholar]
  52. Schwartz-Goldstein B. H., Hersh P. S. Corneal topography of phase III excimer laser photorefractive keratectomy. Optical zone centration analysis. Summit Photorefractive Keratectomy Topography Study Group. Ophthalmology. 1995 Jun;102(6):951–962. doi: 10.1016/s0161-6420(95)30928-1. [DOI] [PubMed] [Google Scholar]
  53. Shah S. I., Hersh P. S. Photorefractive keratectomy for myopia with a 6-mm beam diameter. J Refract Surg. 1996 Mar-Apr;12(3):341–346. doi: 10.3928/1081-597X-19960301-07. [DOI] [PubMed] [Google Scholar]
  54. Steinberg E. P., Tielsch J. M., Schein O. D., Javitt J. C., Sharkey P., Cassard S. D., Legro M. W., Diener-West M., Bass E. B., Damiano A. M. The VF-14. An index of functional impairment in patients with cataract. Arch Ophthalmol. 1994 May;112(5):630–638. doi: 10.1001/archopht.1994.01090170074026. [DOI] [PubMed] [Google Scholar]
  55. Stulting R. D., Carr J. D., Thompson K. P., Waring G. O., 3rd, Wiley W. M., Walker J. G. Complications of laser in situ keratomileusis for the correction of myopia. Ophthalmology. 1999 Jan;106(1):13–20. doi: 10.1016/S0161-6420(99)90000-3. [DOI] [PubMed] [Google Scholar]
  56. Torrance G. W., Feeny D. Utilities and quality-adjusted life years. Int J Technol Assess Health Care. 1989;5(4):559–575. doi: 10.1017/s0266462300008461. [DOI] [PubMed] [Google Scholar]
  57. Uusitalo R. J., Brans T., Pessi T., Tarkkanen A. Evaluating cataract surgery gains by assessing patients' quality of life using the VF-7. J Cataract Refract Surg. 1999 Jul;25(7):989–994. doi: 10.1016/s0886-3350(99)00082-6. [DOI] [PubMed] [Google Scholar]
  58. Waring G. O., 3rd, Carr J. D., Stulting R. D., Thompson K. P., Wiley W. Prospective randomized comparison of simultaneous and sequential bilateral laser in situ keratomileusis for the correction of myopia. Ophthalmology. 1999 Apr;106(4):732–738. doi: 10.1016/S0161-6420(99)90158-6. [DOI] [PubMed] [Google Scholar]
  59. Waring G. O., 3rd, Casebeer J. C., Dru R. M. One-year results of a prospective multicenter study of the Casebeer system of refractive keratotomy. Casebeer Chiron Study Group. Ophthalmology. 1996 Sep;103(9):1337–1347. doi: 10.1016/s0161-6420(96)30498-3. [DOI] [PubMed] [Google Scholar]
  60. Werblin T. P., Krider D. W., Stafford G. M. Casebeer System for refractive keratotomy: patient satisfaction. J Cataract Refract Surg. 1997 Apr;23(3):407–412. doi: 10.1016/s0886-3350(97)80185-x. [DOI] [PubMed] [Google Scholar]

Articles from Transactions of the American Ophthalmological Society are provided here courtesy of American Ophthalmological Society

RESOURCES