Web-based versus Paper Administration of Common Ophthalmic Questionnaires Comparison of Subscale Scores Janine Austin Clayton, MD, 1,2 Malvina Eydelman, MD, 3 Susan Vitale, PhD, 2 Zorayr Manukyan, PhD, 4 Robert Kramm, MD, MSE, 3 Manuel Datiles III, MD, 2 Alana Temple, BS, 2 Elizabeth Murphy, PhD, 2 Jonghyeon Kim, PhD, 4 Gene Hilmantel, OD, 3 Eva Rorer, MD, 3 Keri Hammel, MS, 4 Frederick Ferris III, MD 2 Objective: To compare participants’ responses to Web-based and paper-and-pencil versions of an ophthalmic, patient-reported outcome (PRO) questionnaire. Design: Questionnaire development. Participants: Matched subjects with ocular surface disease (OSD) (n ¼ 68) and without OSD (controls, n ¼ 50). Methods: Subjects completed a standard, paper-and-pencil and a Web-based version of the same ques- tionnaire in randomized order. The administered questionnaire included several ophthalmic PRO subscales: the National Eye Institute’s (NEI’s) Refractive Error Quality of Life Instrument’s Clarity of Vision, Near Vision, Far Vision, Glare, Symptoms, Worry, and Satisfaction with Correction subscales; the Ocular Surface Disease Index’s (OSDI’s) Symptoms subscale; and the NEI’s Visual Function Questionnaire’s Driving subscale. Possible scores for each subscale ranged from 0 (no difficulty) to 100 (most difficulty). Agreement of subscale scores between modes of administration was assessed using the BlandeAltman approach and multivariable logistic regression. Main Outcome Measures: Subscale scores and an unweighted average total score for each mode of administration. Results: Mean differences in scores between modes of administration ranged from 2.1 to þ2.3 units. Although no differences were found to be statistically significant, the Worry and Satisfaction with Correction subscales approached statistical significance (P ¼ 0.07 and 0.08, respectively). Although most subscale mean differences in score did not differ significantly by gender, age (40 vs. <40 years), disease status (OSD vs. control), order of administration, or time between completion of the questionnaires, women had slightly greater score differences than men for the Driving (P ¼ 0.04) and Clarity of Vision (P ¼ 0.03) subscales; those with OSD had greater score differences for Clarity of Vision than did controls (P ¼ 0.0006); and those aged 40 years had slightly greater differences in OSDI Symptoms subscale than those aged <40 years (P ¼ 0.04). Conclusions: To our knowledge, this Food and Drug Administration and NEI collaboration is the first study to evaluate the equivalence of Web-based and paper versions of ophthalmic PRO questionnaires. We found no evidence of clinically significant differences between scores obtained by the 2 modes for any of the examined subscales. A Web-based instrument should yield scores equivalent to those obtained by standard methods, providing a useful tool that may facilitate ophthalmic innovation. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article. Ophthalmology 2013;120:2151-2159 ª 2013 by the American Academy of Ophthalmology. A patient-reported outcome (PRO) is a measurement of any aspect of a patient’s health status that comes directly from the patient without being interpreted by another individual (e.g., a health care provider or caregiver). There has been a growing interest in PROs in many fields of medicine, especially in the context of clinical trials, where health- related quality of life (HRQoL) assessments are increas- ingly used in the overall evaluation of diseases and inter- ventions. Patient-reported outcomes are used in clinical studies of new medical products regulated by the Food and Drug Administration (FDA), for example, as part of the assessment of safety before and after entering the US market and to support specific medical claims related to effectiveness. The increased use of computers coupled with broader Internet accessibility suggests that PROs might be gathered in a cost-effective, efficient way in future ophthalmic clinical trials and studies. Efficient collection of PROs, in such a manner, could lessen the burden on research subjects and provide useful data for the marketing of innovative ophthalmic products. In clinical studies, PROs are usually assessed by an interviewer-administered or self-administered paper question- naire. It may be more efficient (time- and resource-wise) to administer questionnaires using a computerized, online, Web- based system, because the Internet is increasingly being used to access information on health care issues. Widespread 2151 Ó 2013 by the American Academy of Ophthalmology ISSN 0161-6420/13/$ - see front matter Published by Elsevier Inc. http://dx.doi.org/10.1016/j.ophtha.2013.03.019