Skip to main content
Top
Published in: Health and Quality of Life Outcomes 1/2017

Open Access 01-12-2017 | Research

Development of a new Rasch-based scoring algorithm for the National Eye Institute Visual Functioning Questionnaire to improve its interpretability

Authors: Jennifer Petrillo, Neil M. Bressler, Ecosse Lamoureux, Alberto Ferreira, Stefan Cano

Published in: Health and Quality of Life Outcomes | Issue 1/2017

Login to get access

Abstract

Background

The NEI VFQ-25 has undergone psychometric evaluation in patients with varying ocular conditions and the general population. However, important limitations which may affect the interpretation of clinical trial results have been previously identified, such as concerns with reliability and validity. The purpose of this study was to evaluate the National Eye Institute Visual Functioning Questionnaire (NEI VFQ­25) and make recommendations for a revised scoring structure, with a view to improving its psychometric performance and interpretability.

Methods

Rasch Measurement Theory analyses were conducted in two stages using pooled baseline NEI VFQ­25 data for 2487 participants with retinal diseases enrolled in six clinical trials. In stage 1, we examined: scale-to-sample targeting; thresholds for item response options; item fit statistics; stability; local dependence; and reliability. In stage 2, a post-hoc revision of the scoring structure (VFQ-28R) was created and psychometrically re-evaluated.

Results

In stage 1, we found that the NEI VFQ­25 was mis-targeted to the sample, and had disordered response thresholds (15/25 items) and mis-fitting items (8/25 items). However, items appeared to be stable (differential item functioning for three items), have minimal item dependency (one pair of items) and good reliability (person-separation index, 0.93). In stage 2, the modified Rasch-scored NEI VFQ­28­R was assessed. It comprised two broad domains: Activity Limitation (19 items) and Socio-Emotional Functioning (nine items). The NEI VFQ­28­R demonstrated improved performance with fewer disordered response thresholds (no items), less item misfit (three items) and improved population targeting (reduced ceiling effect) compared with the NEI VFQ­25.

Conclusions

Compared with the original version, the proposed NEI VFQ­28­R, with Rasch-based scoring and a two-domain structure, appears to offer improved psychometric performance and interpretability of the vision-related quality of life scale for the population analysed.
Literature
1.
go back to reference Mangione CM, Berry S, Spritzer K, Janz NK, Klein R, Owsley C, Lee PP. 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;116:227–33.PubMed Mangione CM, Berry S, Spritzer K, Janz NK, Klein R, Owsley C, Lee PP. 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;116:227–33.PubMed
2.
go back to reference Mangione CM, Lee PP, Gutierrez PR, Spritzer K, Coleman AL. Development of the 25-item National Eye Institute visual function questionnaire. Arch Ophthalmol. 2001;119:1050–8.CrossRefPubMed Mangione CM, Lee PP, Gutierrez PR, Spritzer K, Coleman AL. Development of the 25-item National Eye Institute visual function questionnaire. Arch Ophthalmol. 2001;119:1050–8.CrossRefPubMed
3.
go back to reference Bressler N, Chang T, Fine J, Dolan C, Ward J. Improved vision-related function after ranibizumab vs photodynamic therapy: a randomized clinical trial. Arch Ophthalmol. 2009;127:13–21.CrossRefPubMed Bressler N, Chang T, Fine J, Dolan C, Ward J. Improved vision-related function after ranibizumab vs photodynamic therapy: a randomized clinical trial. Arch Ophthalmol. 2009;127:13–21.CrossRefPubMed
4.
go back to reference Chang T, Bressler N, Fine J, Dolan C, Ward J, Klesert T. Improved vision-related function after ranibizumab treatment of neovascular age-related macular degeneration: results of a randomized clinical trial. Arch Ophthalmol. 2007;125:1460–9.CrossRefPubMed Chang T, Bressler N, Fine J, Dolan C, Ward J, Klesert T. Improved vision-related function after ranibizumab treatment of neovascular age-related macular degeneration: results of a randomized clinical trial. Arch Ophthalmol. 2007;125:1460–9.CrossRefPubMed
5.
go back to reference Mitchell P, Bandello F, Schmidt-Erfurth U, Lang G, Massin P, Schlingemann R, Sutter F, Simader C, Burian G, Gerstner O, et al. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmol. 2011;118:615–25.CrossRef Mitchell P, Bandello F, Schmidt-Erfurth U, Lang G, Massin P, Schlingemann R, Sutter F, Simader C, Burian G, Gerstner O, et al. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmol. 2011;118:615–25.CrossRef
6.
go back to reference Mitchell P, Bressler N, Tolley K, Gallagher M, Petrillo J, Ferreira A, Wood R, Bandello F, Group RS. Patient-reported visual function outcomes improve after ranibizumab treatment in patients with vision impairment due to diabetic macular edema: randomized clinical trial. JAMA Ophthalmol. 2013;131:1339–47.CrossRefPubMed Mitchell P, Bressler N, Tolley K, Gallagher M, Petrillo J, Ferreira A, Wood R, Bandello F, Group RS. Patient-reported visual function outcomes improve after ranibizumab treatment in patients with vision impairment due to diabetic macular edema: randomized clinical trial. JAMA Ophthalmol. 2013;131:1339–47.CrossRefPubMed
7.
go back to reference Varma R, Bressler N, Suner I, Lee P, Dolan C, Ward J, Colman S, Rubio R, Groups BaCS. Improved vision-related function after ranibizumab for macular edema after retinal vein occlusion: results from the BRAVO and CRUISE trials. Ophthalmol. 2012;119:2108–18.CrossRef Varma R, Bressler N, Suner I, Lee P, Dolan C, Ward J, Colman S, Rubio R, Groups BaCS. Improved vision-related function after ranibizumab for macular edema after retinal vein occlusion: results from the BRAVO and CRUISE trials. Ophthalmol. 2012;119:2108–18.CrossRef
8.
go back to reference Ohno-Matsui K, Tan N, Wong T, Ishibashi T, Petrillo J, Bressler N, Leteneux C. Impact of ranibizumab on patient-reported visual functioning in Myopic Choroidal Neovascularization: 3- and 6-month results. Invest Ophthalmol Vis Sci. 2013;54(15):1245. Ohno-Matsui K, Tan N, Wong T, Ishibashi T, Petrillo J, Bressler N, Leteneux C. Impact of ranibizumab on patient-reported visual functioning in Myopic Choroidal Neovascularization: 3- and 6-month results. Invest Ophthalmol Vis Sci. 2013;54(15):1245.
11.
go back to reference Administration FaD: Qualification of clinical outcome assessments (COAs). 2013. Administration FaD: Qualification of clinical outcome assessments (COAs). 2013.
14.
go back to reference Varma R, Richman E, Ferris F, Bressler N, Varma R, Richman EA, Ferris FL 3rd, et al. Use of patient-reported outcomes in medical product development: a report from the 2009 NEI/FDA clinical trial endpoints symposium. Invest Ophthalmol Vis Sci. 2010(51):6095–103. Varma R, Richman E, Ferris F, Bressler N, Varma R, Richman EA, Ferris FL 3rd, et al. Use of patient-reported outcomes in medical product development: a report from the 2009 NEI/FDA clinical trial endpoints symposium. Invest Ophthalmol Vis Sci. 2010(51):6095–103.
15.
go back to reference Globe D, Varma R, Azen S, Paz S, Yu E, Preston-Martin S. Psychometric performance of the NEI VFQ-25 in visually normal Latinos: the Los Angeles Latino eye study. Invest Ophthalmol Vis Sci. 2003;44:1470–8.CrossRefPubMed Globe D, Varma R, Azen S, Paz S, Yu E, Preston-Martin S. Psychometric performance of the NEI VFQ-25 in visually normal Latinos: the Los Angeles Latino eye study. Invest Ophthalmol Vis Sci. 2003;44:1470–8.CrossRefPubMed
16.
go back to reference Suner IJKG, Yu E, Ward J, Dolan C, Bressler NM. Responsiveness of NEI VFQ-25 to changes in visual acuity in neovascular AMD: validation studies from two phase 3 clinical trials. IOVS. 2009;50:3629–35. Suner IJKG, Yu E, Ward J, Dolan C, Bressler NM. Responsiveness of NEI VFQ-25 to changes in visual acuity in neovascular AMD: validation studies from two phase 3 clinical trials. IOVS. 2009;50:3629–35.
17.
go back to reference Pesudovs K, Gothwal V, Wright T, Lamoureux E. Remediating serious flaws in the National Eye Institute Visual Function Questionnaire. J Cataract Refract Surg. 2010;36:718–32.CrossRefPubMed Pesudovs K, Gothwal V, Wright T, Lamoureux E. Remediating serious flaws in the National Eye Institute Visual Function Questionnaire. J Cataract Refract Surg. 2010;36:718–32.CrossRefPubMed
18.
go back to reference Marella M, Konrad Pesudovs K, Keeffe J, O’Connor P, Rees G, Lamoureux E. The psychometric validity of the NEI VFQ-25 for use in a low-vision population. Invest Ophthalmol Vis Sci. 2010;51:2878–84.CrossRefPubMed Marella M, Konrad Pesudovs K, Keeffe J, O’Connor P, Rees G, Lamoureux E. The psychometric validity of the NEI VFQ-25 for use in a low-vision population. Invest Ophthalmol Vis Sci. 2010;51:2878–84.CrossRefPubMed
19.
go back to reference Lloyd A, Loftus J, Turner M, Lai G, Pleil A. Psychometric validation of the Visual Function Questionnaire-25 in patients with diabetic macular edema. Health Qual Life Outcomes. 2013;11:10.CrossRefPubMedPubMedCentral Lloyd A, Loftus J, Turner M, Lai G, Pleil A. Psychometric validation of the Visual Function Questionnaire-25 in patients with diabetic macular edema. Health Qual Life Outcomes. 2013;11:10.CrossRefPubMedPubMedCentral
20.
go back to reference Naik RK, Gries KS, Rentz AM, Kowalski JW, Revicki DA. Psychometric evaluation of the National Eye Institute Visual Function Questionnaire and Visual Function Questionnaire Utility Index in patients with non-infectious intermediate and posterior uveitis. Qual Life Res. 2013;22:2801–8.CrossRefPubMed Naik RK, Gries KS, Rentz AM, Kowalski JW, Revicki DA. Psychometric evaluation of the National Eye Institute Visual Function Questionnaire and Visual Function Questionnaire Utility Index in patients with non-infectious intermediate and posterior uveitis. Qual Life Res. 2013;22:2801–8.CrossRefPubMed
21.
go back to reference DeMuro C, Clark M, Mordin M, Fehnel S, Copley-Merriman C, Gnanasakthy A. Reasons for rejection of patient-reported outcome label claims: a compilation based on a review of patient-reported outcome use among new molecular entities and biologic license applications, 2006–2010. Value Health. 2012;15:443–8.CrossRefPubMed DeMuro C, Clark M, Mordin M, Fehnel S, Copley-Merriman C, Gnanasakthy A. Reasons for rejection of patient-reported outcome label claims: a compilation based on a review of patient-reported outcome use among new molecular entities and biologic license applications, 2006–2010. Value Health. 2012;15:443–8.CrossRefPubMed
22.
go back to reference Hobart J, Cano S. Improving the evaluation of therapeutic intervention in MS: the role of new psychometric methods. Monograph for the UK Health Technology Assessment Programme. 2009;13:1–200. Hobart J, Cano S. Improving the evaluation of therapeutic intervention in MS: the role of new psychometric methods. Monograph for the UK Health Technology Assessment Programme. 2009;13:1–200.
23.
go back to reference Andrich D. Rating scales and Rasch measurement. Expert Rev Pharmacoeconomics Outcomes Res. 2011;11:571–85.CrossRef Andrich D. Rating scales and Rasch measurement. Expert Rev Pharmacoeconomics Outcomes Res. 2011;11:571–85.CrossRef
24.
go back to reference Petrillo J, Cano S, McLeod L, Coon C. Using classical test theory, item response theory, and Rasch measurement theory to evaluate patient-reported outcome (PRO) measures: a comparison of worked examples. Value Health. 2015;18:25–34.CrossRefPubMed Petrillo J, Cano S, McLeod L, Coon C. Using classical test theory, item response theory, and Rasch measurement theory to evaluate patient-reported outcome (PRO) measures: a comparison of worked examples. Value Health. 2015;18:25–34.CrossRefPubMed
25.
go back to reference Brown D, Kaiser P, Michels M, Soubrane G, Heier J, Kim R, Sy J, Schneider S, Group AS. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006;355:1432–44.CrossRefPubMed Brown D, Kaiser P, Michels M, Soubrane G, Heier J, Kim R, Sy J, Schneider S, Group AS. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006;355:1432–44.CrossRefPubMed
26.
go back to reference Rosenfeld P, Brown D, Heier J, Boyer D, Kaiser P, Chung C, Kim R, Group MS. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006;355:1419–31.CrossRefPubMed Rosenfeld P, Brown D, Heier J, Boyer D, Kaiser P, Chung C, Kim R, Group MS. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006;355:1419–31.CrossRefPubMed
27.
go back to reference Brown D, Campochiaro P, Singh R, Li Z, Gray S, Saroj N, Rundle A, Rubio R, Murahashi W, Investigators C. Ranibizumab for macular edema following central retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmol. 2010;117:1124–33.CrossRef Brown D, Campochiaro P, Singh R, Li Z, Gray S, Saroj N, Rundle A, Rubio R, Murahashi W, Investigators C. Ranibizumab for macular edema following central retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmol. 2010;117:1124–33.CrossRef
28.
go back to reference Campochiaro P, Heier J, Feiner L, Gray S, Saroj N, Rundle A, Murahashi W, Rubio R, Investigators B. Ranibizumab for macular edema following branch retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmol. 2010;117:1102–12.CrossRef Campochiaro P, Heier J, Feiner L, Gray S, Saroj N, Rundle A, Murahashi W, Rubio R, Investigators B. Ranibizumab for macular edema following branch retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmol. 2010;117:1102–12.CrossRef
29.
go back to reference Stevens S. Mathematics, measurement and psychophysics. In: Stevens S, editor. Handbook of experimental psychology. New York: Wiley; 1951. Stevens S. Mathematics, measurement and psychophysics. In: Stevens S, editor. Handbook of experimental psychology. New York: Wiley; 1951.
30.
go back to reference Rasch G. Probabilistic models for some intelligence and attainment tests. Copenhagen: Danish Institute for Education Research (Expanded edition (1980) with foreword and afterword by B.D. Wright, Chicago: The University of Chicago Press, 1980. Reprinted Chicago: MESA Press, 1993. Available from www.rasch.org/books.htm. Accessed 9 July 2015; 1960. Rasch G. Probabilistic models for some intelligence and attainment tests. Copenhagen: Danish Institute for Education Research (Expanded edition (1980) with foreword and afterword by B.D. Wright, Chicago: The University of Chicago Press, 1980. Reprinted Chicago: MESA Press, 1993. Available from www.​rasch.​org/​books.​htm. Accessed 9 July 2015; 1960.
31.
go back to reference Andrich D. Rasch models for measurement. Beverley Hills: Sage Publications; 1988.CrossRef Andrich D. Rasch models for measurement. Beverley Hills: Sage Publications; 1988.CrossRef
32.
go back to reference Cano S, Hobart J. The problem with health measurement. Patient Prefer Adher. 2011;5:279–90.CrossRef Cano S, Hobart J. The problem with health measurement. Patient Prefer Adher. 2011;5:279–90.CrossRef
33.
go back to reference Massof R. Understanding Rasch and item response theory models: applications to the estimation and validation of interval latent trait measures from responses to rating scale questionnaires. Ophthalmic Epidemiol. 2011;18:1–19.CrossRefPubMed Massof R. Understanding Rasch and item response theory models: applications to the estimation and validation of interval latent trait measures from responses to rating scale questionnaires. Ophthalmic Epidemiol. 2011;18:1–19.CrossRefPubMed
34.
go back to reference 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.CrossRefPubMed 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.CrossRefPubMed
35.
go back to reference Kowalski J, Rentz A, Walt J, Lloyd A, Lee J, Young T, Chen W, Bressler N, Lee P, Brazier J, et al. Rasch analysis in the development of a simplified version of the National Eye Institute Visual Function Questionnaire-25 for utility estimation. Qual Life Res. 2012;21:323–34.CrossRefPubMed Kowalski J, Rentz A, Walt J, Lloyd A, Lee J, Young T, Chen W, Bressler N, Lee P, Brazier J, et al. Rasch analysis in the development of a simplified version of the National Eye Institute Visual Function Questionnaire-25 for utility estimation. Qual Life Res. 2012;21:323–34.CrossRefPubMed
36.
go back to reference Mollazadegan K, Huang J, Khadka J, Wang Q, Yang F, Gao R, Pesudovs K. Cross-cultural validation of the National Eye Institute Visual Function Questionnaire. J Cataract Refract Surg. 2014;40:774–84.CrossRefPubMed Mollazadegan K, Huang J, Khadka J, Wang Q, Yang F, Gao R, Pesudovs K. Cross-cultural validation of the National Eye Institute Visual Function Questionnaire. J Cataract Refract Surg. 2014;40:774–84.CrossRefPubMed
37.
go back to reference Andrich D, Sheridan B: RUMM 2030. Perth: RUMM Laboratory Pty Ltd; 1997–2017. Andrich D, Sheridan B: RUMM 2030. Perth: RUMM Laboratory Pty Ltd; 1997–2017.
38.
go back to reference Smith E. Detecting and evaluating the impact of multidimensionality using item fit statistics and principal component analysis of residuals. J Appl Meas. 2002;3:205–31.PubMed Smith E. Detecting and evaluating the impact of multidimensionality using item fit statistics and principal component analysis of residuals. J Appl Meas. 2002;3:205–31.PubMed
40.
go back to reference Christensen K, Makransky G, Horton M. Critical values for Yen's Q 3. Appl Psychol Meas. 2017;41:178–94.CrossRef Christensen K, Makransky G, Horton M. Critical values for Yen's Q 3. Appl Psychol Meas. 2017;41:178–94.CrossRef
41.
go back to reference Andrich D, Luo G, Sheridan BE. Interpreting RUMM2030. RUMM laboratory: Perth; 2017. Andrich D, Luo G, Sheridan BE. Interpreting RUMM2030. RUMM laboratory: Perth; 2017.
42.
go back to reference Tennant A, Pallant J. Unidimensionality matters! (a tale of two Smiths?). Rasch Meas Trans 2006. 2006;20:1048–51. Tennant A, Pallant J. Unidimensionality matters! (a tale of two Smiths?). Rasch Meas Trans 2006. 2006;20:1048–51.
43.
go back to reference Cano S, Barrett L, Zajieck J, Hobart J. Dimensionality is a relative concept. Mult Scler. 2011;17:214–22.CrossRefPubMed Cano S, Barrett L, Zajieck J, Hobart J. Dimensionality is a relative concept. Mult Scler. 2011;17:214–22.CrossRefPubMed
44.
go back to reference Andrich D, de Jong JHAL, Sheridan BE. Diagnostic opportunities with the Rasch model for ordered response categories. In: Rost J, Langeheine R, editors. Applications of latent trait and latent class models in the social sciences. Munster: Waxmann Verlag GmbH; 1997. p. 59–70. Andrich D, de Jong JHAL, Sheridan BE. Diagnostic opportunities with the Rasch model for ordered response categories. In: Rost J, Langeheine R, editors. Applications of latent trait and latent class models in the social sciences. Munster: Waxmann Verlag GmbH; 1997. p. 59–70.
Metadata
Title
Development of a new Rasch-based scoring algorithm for the National Eye Institute Visual Functioning Questionnaire to improve its interpretability
Authors
Jennifer Petrillo
Neil M. Bressler
Ecosse Lamoureux
Alberto Ferreira
Stefan Cano
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Health and Quality of Life Outcomes / Issue 1/2017
Electronic ISSN: 1477-7525
DOI
https://doi.org/10.1186/s12955-017-0726-5

Other articles of this Issue 1/2017

Health and Quality of Life Outcomes 1/2017 Go to the issue