Health-Related Quality of Life Questionnaire for Corneal Anesthesia Patients: A Content Validity Assessment

Health-Related Quality of Life Questionnaire for Corneal Anesthesia Patients: A Content Validity Assessment | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article Health-Related Quality of Life Questionnaire for Corneal Anesthesia Patients: A Content Validity Assessment Helen Dimaras, Farheen Khan, Roxanne Noronha, Sara Williams, Anojan Satgunalingam, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3921346/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 01 Sep, 2025 Read the published version in Eye → Version 1 posted 8 You are reading this latest preprint version Abstract Background/Objectives: FACE-Q Craniofacial Module (FACE-Q) is a validated patient-reported outcome measure (PROM) for appearance. This study aimed to assess the content validity of FACE-Q for use in patients treated for corneal anesthesia. Subjects/Methods: This was a prospective observational and qualitative study. Cognitive debriefing interviews were conducted with patients ≥ 8 years old who had surgical treatment for corneal anesthesia at least six months before time of study. Interviews consisted of gathering feedback on the comprehensibility, comprehensiveness, and relevance of three eye scales and checklists and four health-related quality-of-life scales. Based on the input from participants and further discussion with ophthalmologists, scientists, and patient advocates, the scales and checklists were modified, then further refined with input from additional participants. Results Feedback on the FACE-Q scales and checklists was obtained from 10 participants. Instructions for the scales were modified to enhance comprehensibility. Eleven items were revised for enhanced comprehensibility and relevance. Twelve items were added to enhance comprehensiveness. Four items were removed due to their irrelevance to corneal anesthesia. Modifications to the eye and health-related quality-of-life scales were generally condition-specific and generic respectively. A comment section was added to the end of each scale and checklist. Conclusions FACE-Q may be a suitable PROM to adapt to measure appearance-based outcomes in corneal anesthesia patients. With lived expertise, clinical, and scientific input, the content validity of FACE-Q was improved for use in corneal anesthesia patients. The modified FACE-Q is now ready for psychometric evaluation and further validation. Health sciences/Health care/Quality of life Health sciences/Diseases/Eye diseases/Corneal diseases INTRODUCTION Corneal anesthesia (CA), or the absence of corneal sensation, is a rare condition that is a contributing factor to the development of neurotrophic keratopathy (NK).( 1 – 3 ) A procedure which can restore sensation in the cornea, facilitate epithelial healing and prevent vision loss, is corneal neurotization (CN) which can be performed by redirecting cutaneous innervation to the cornea via nerve grafts and nerve transfers.( 4 , 5 ) CN has proven to be clinically successful for restoration of epithelial integrity and prevention of persistent corneal epithelial defects and other consequences of NK( 6 ). However, patient-reported outcomes on other aspects of NK, such as impact of the procedure on appearance or daily life functioning, have not been evaluated. Patient-centred care is of great importance in contemporary healthcare as understanding patient perspectives on health status and health-related quality of life (HRQoL) is essential to enhance quality of care. Patient-reported outcome measures (PROMs) are tools that assess patient perceptions of health outcomes via standardized and validated questionnaires.( 7 ) Prior research has identified the need for PROMs to evaluate treatment outcomes for patients treated via CN.( 8 ) Patients were particularly concerned about appearance, daily functioning, and psychosocial outcomes. An existing PROM, the “FACE-Q Craniofacial Module (FACE-Q)”, may be a suitable instrument to adapt for this patient population, as it aims to assess facial appearance, HRQoL, and adverse effects in patients with conditions that affect the face.( 9 ) FACE-Q also includes independent scales and checklists related to the eye, though it was developed with input from patients with largely craniofacial conditions and not ocular conditions specifically.( 9 ) FACE-Q has been validated and tested in over 2 000 patients worldwide, aged 8 to 29 years old with conditions associated with visible and/or functional facial differences.( 9 ) Such facial differences are also present in CA patients due to symptoms such as corneal scarring.( 1 – 3 ) As such, adapting the FACE-Q for use in CA patients represents an exciting avenue for exploration. An important first step to adapt a PROM is to assess its content validity, or evaluate whether the items within the PROM are comprehensive and adequately reflect the perspective of the patient population of interest. ( 10 – 13 ) In this study, we aimed to assess the content validity of seven FACE-Q scales and checklists to evaluate the outcomes of individuals who were treated for CA by CN. METHODS Study Design This study was approved by the Hospital for Sick Children Research Ethics Board (REB#1000079009). All participants or their caregivers provided written informed consent or assent before enrolment in the study. This study is also part of a broader qualitative observational study which included individuals treated for CA, retinoblastoma, or strabismus. This manuscript focuses on the results from the CA cohort alone. Study Instrument - FACE-Q® | CRANIOFACIAL Seven FACE-Q scales and checklists were evaluated in this study, chosen for their potential relevance to CA patients. Three scales measured eye-related concepts and four scales evaluated HRQoL outcomes associated with appearance (Table 1 ). Table 1 FACE-Q Scales and Checklists Adapted for Corneal Anesthesia Patients Scale or Checklist Domain Title Number of Items Eye or HRQoL Scale Appearance Appearance of the Eyes 9 Eye Checklist Function Eye Function 7 Eye Checklist Adverse Effects Eye Adverse Effects 7 Eye Scale HRQoL a Appearance Distress 8 HRQoL Scale HRQoL a Psychological Function 10 HRQoL Scale HRQoL a School Function 10 HRQoL Scale HRQoL a Social Function 10 HRQoL Study Participants Eligibility Criteria Patients were eligible to participate in the study if they were diagnosed with CA, 8 years of age or older, and had CN surgery at least six months before enrolment in the study. Individuals were excluded if they were developmentally delayed, hard of hearing with no hearing aids, or unable to read, write, and communicate in English. Sample Size A convenience sample of a minimum target of seven participants was recruited for each round of the study to achieve the highest rating as per the “COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) Methodology for Assessing the Content Validity of PROMs User Manual Version 1.0”( 11 ) While we aimed for unique participants in each round, individuals were eligible to participate in both rounds due to the rarity of the condition and small available patient population. A maximum number of participants was not set as sampling continued until point of saturation. Saturation was defined as having occurred when no new, relevant information related to the study’s purpose was collected from participants in subsequent interviews. Study participant recruitment Eligible patients were identified and introduced to the research study team by a member of their circle of care. Interested patients (or their caregivers if deemed by clinician to not have the capacity to consent on their behalf ) then filled out a consent form virtually via Research Electronic Data Capture (REDCap)( 14 , 15 ) after completing an informed consent discussion during a telephone call with a member of the research study team. Data Collection Intake Survey All participants completed an intake survey administered electronically via REDCap.( 14 , 16 ) The survey collected information on personal sociodemographic characteristics (i.e., sex, gender identity, language spoken at home, population groups, religion, place of residence, highest level of education completed, employment status, marital status, annual household income, number of offspring) and CA history (i.e., perceived severity, laterality, date of diagnosis, treatment). Cognitive Debriefing Interviews Data was collected in two rounds of one-on-one cognitive debriefing interviews held over the course of one year. Interviews were facilitated by the first author (FK), following round-specific semi-structured interview guides (Supplementary File 1), and audio- and video-recorded with permission from the participants. In both rounds, participants were asked to answer each item in the original (Round 1) or working version of the (Round 2) seven FACE-Q scales and checklists and explain the reasoning for their chosen answers. Participants were also asked to provide insight into the ( 1 ) clarity of the instructions, ( 2 ) comprehensibility and relevance of each item, ( 3 ) comprehensiveness of each scale in capturing all relevant experiences, and ( 4 ) appropriateness of the response options. In Round 2, participants were also asked to provide feedback or additional clarification on ( 1 ) modifications applied to the working version of the FACE-Q; ( 2 ) unsettled suggestions from Round 1 participants; and ( 3 ) the relevance of new concepts suggested by participants in preceding interviews in Round 2. Data Analysis Quantitative data from the intake survey was analyzed using descriptive statistics. Qualitative data from the interviews was analysed iteratively and occurred concurrently with data collection in both rounds. A working version and pilot version of the FACE-Q were created after analysis of results from Rounds 1 and 2 respectively. As this study was part of a larger study including additional ophthalmologic patient groups, data obtained from non-CA participants were cross-referenced with CA participants to identify similarities in participants’ experiences with the scales and checklists, and their conditions and treatments. Results were summarized and shared with an interdisciplinary modification panel which consisted of an ophthalmologist (AA) specializing in CA who co-developed the CN procedure, a co-developer of the FACE-Q (KWR) who is also a plastic surgeon experienced in CN, a scientist (HD) in pediatric ophthalmology, and a patient advocate (AS) with lived experience of CN. Together, the panel provided clinical, methodological, and lived experience expertise to finalize decisions regarding modifications based on the feedback from study participants. During both Rounds 1 and 2, field notes about feedback regarding the comprehensibility, comprehensiveness, and relevance of items, response options, recall periods, and instructions were taken from the audio recordings of each interview on Microsoft Excel by FK. The frequency of each specific feedback was noted on an item-by-item or scale-by-scale basis. The content of FACE-Q had already been evaluated by 43 participants aged 8–29 during its development.( 17 ) As such, to address comprehensibility, as recommended by the literature, feedback mentioned by at least three participants was brought forward for discussion with the modification panel.( 18 ) For comprehensiveness, new concepts were organized by frequency and clinical and methodological relevance. Similar concepts were amalgamated to avoid redundancies. All relevant concepts, irrespective of their frequency, were discussed with the modification panel, leveraging on their experiences and knowledge given their potential broader relevance to the CA patient population. To address relevance, items deemed irrelevant by at least three participants in either round were brought forward for input from the modification panel. After discussion with the modification panel, the wording of new and revised items was assessed using a Flesch Kincaid calculator to ensure a maximum reading Grade Level of 3 was obtained.( 19 ) This wording was then finalized in collaboration with the patient advocate to incorporate a patient-centric perspective and further ensure that plain, accessible language was utilized. RESULTS Study Participants The FACE-Q was reviewed in two rounds by ten participants in total, seven participants per round (Table 2 ). Feedback on all seven scales and checklists was provided by 9/10 participants on an item-by-item basis. Due to time constraints, one participant in Round 1 provided feedback on five scales and checklists only. In Round 1, the School Function scale was evaluated by school-aged participants only (n = 2), while all Round 2 participants evaluated the School Function scale regardless of age. Table 2 Number of Participants per Scale or Checklist Appearance of the Eyes Eye Function Eye Adverse Effects Appearance Distress Psychological Function School Function Social Function Round 1 3 2 3 3 3 1 2 Round 2 3 3 3 3 3 6 3 Both 4 4 4 4 4 1 4 Total 10 9 10 10 10 8 9 The intake survey was completed by 9/10 participants (Table 3 ). The average age was 37.44 (median: 42, range: 14 to 65). Participants were predominantly male (56%), white (56%), and Christian (67%). All participants spoke English most often at home. In terms of their condition, all participants reported having bilateral CA, 56% perceived their condition to be moderately severe, 66% were diagnosed 11 + years ago, 67% were treated at SickKids, and 33% had CN ≤ 3 years before time of study. Table 3 Results from Intake Survey Characteristics of Participants (N = 9) a N % Age (Mean: 37.44 years; Median: 42 years) ≤ 20 2 22 21–40 2 22 41–60 4 44 ≥ 61 1 11 Treatment at SickKids Yes 6 67 No 3 33 Sex at Birth Male 5 56 Female 4 44 Gender Male 5 56 Female 4 44 Language Most Often Spoken at Home English 9 100 Population Group White 7 78 First Nation, Inuit and Metis 1 11 Filipino 1 11 Latin American 1 11 South Asian 1 11 West Indian 1 11 Religion Christian 6 67 Atheist 1 11 Prefer not to Answer 1 11 Roman Catholic 1 11 Geographic Location Small Population Centre 3 33 Large Urban Population Centre 2 22 Rural Area 2 22 Medium Population Centre 1 11 Prefer not to Answer 1 11 Education Some secondary education (high school) 3 33 Post-secondary certificate or diploma 2 22 Secondary school (high school) diploma or equivalent 2 22 Bachelor's degree 1 11 Grade 8 or equivalent or lower 1 11 Employment Status Employed 3 33 Student 3 33 Retired 1 11 Unable to work 1 11 Unemployed and looking for work 1 11 Marital Status Married 5 56 Single (never legally married or marriage never legally annulled) 4 44 Household Income Prefer not to Answer 4 44 $150,000 CAD and over 2 22 $100,000 - $149,999 CAD 1 11 $80,000 - $99,999 CAD 1 11 $60,000 - $79,999 CAD 1 11 Number of Children 0 5 56 3+ 3 33 1 1 11 Perceived Severity Moderate 5 56 Severe 4 44 Mild 0 0 Reported Laterality Bilateral 9 100 Unilateral 0 0 Date of Diagnosis (Prior to Time of Study) 0–5 years ago 1 11 6–10 years ago 2 22 11–15 years ago 3 33 15 + years ago 3 33 Time Since Treatment (Prior to Time of Study) 1–3 years ago 3 33 4–6 years ago 2 22 7–9 years ago 2 22 10 + years ago 2 22 Modifications to FACE-Q Items The seven original FACE-Q scales and checklists consisted of 61 items (Table 1 ). The data from this study resulted in the revision of 11 items, addition of 12 items, and removal of 4 items; the pilot versions of the FACE-Q scales and checklists now consist of 69 items in total (Table 4 ). Two types of modifications were implemented: condition-specific modifications were made exclusively to the scales and checklists that were intended for use in the CA population only, whereas generic modifications were made to scales and checklists that could be used across all the ophthalmologic populations of interest in the larger study. Condition-specific modifications were predominantly applied to the eye scales, while the generic modifications were predominantly applied to the HRQoL scales. Table 4 Quantitative Summary of Modifications Applied to FACE-Q Title of Scale or Checklist Scale or Checklist Modifications Total Modifications (n=27) Number of Items in Original FACE-Q Number of Items in Pilot FACE-Q Revision (n=11) Addition (n=12) Removal (n=4) Eye-Related Comprehension Inclusiveness Universality Consistency Appearance of the Eyes Scale 1 0 0 1 2 0 4 9 11 Eye Function Checklist 0 0 0 0 2 3 5 7 6 Eye Adverse Effects Checklist 1 0 0 0 2 1 4 7 8 HRQoL Appearance Distress Scale 1 1 1 0 2 0 5 8 10 Psychological Function Scale 0 0 0 0 0 0 0 10 10 School Function Scale 1 1 0 0 0 0 2 10 10 Social Function Scale 1 1 1 0 4 0 7 10 14 Total Number of Items 61 69 Revisions Revisions were made if they were thought to improve FACE-Q in the following ways: ( 1 ) comprehensibility, ( 2 ) inclusiveness of the experiences of visually impaired patients, ( 3 ) universality and applicability to a broader range of experiences, and ( 4 ) consistency among the wording of all items. Additions Participants elicited a total of 24 new concepts (Supplementary File 4) during the two rounds of cognitive debriefing interviews. As per discussions with the modification panel, 12/24 concepts were relevant to the FACE-Q’s conceptual framework, resulting in the addition of six items to the pilot versions of the eye scales and checklists, and six to the HRQoL scales (Table 4 ). All of the new items added to the HRQoL sales were generic, while 5/6 of the new items added to the eye scales were condition-specific. Of the new HRQoL items, 4/6 were added to the Social Function scale, while the remaining 2/6 were added to the Appearance Distress scale. The items added to the Appearance Distress scale were originally elicited by non-CA participants and cross-checked with CA participants in Rounds 1 and 2. The items added to the Social Function scale, however, were all originally elicited by Round 1 CA participants. Upon cross-referencing the relevance of the four new Social Function items with non-CA participants, it was discovered that they applied generically across all three ophthalmologic patient populations of the larger study. Removals Two items were removed from the Eye Function scale (“I have trouble seeing properly (even with glasses or contacts)” and “One of my eyes work better than the other eye”) because they covered concepts related to visual function that the modification panel deemed could be more comprehensively evaluated using functional vision PROMs. An additional two items were removed from the Eye Function and Eye Adverse Effects scale (“My eyelids close unexpectedly when I don’t want them to (like when I smile or talk)” and “My eyes are itchy”) because they were not clinically relevant to the CA population. Modifications to the PROM Components of FACE-Q During the think-aloud process of some interviews, participants discussed appearance-related concerns that were not condition-specific or eye-specific. Therefore, upon discussion with the modification panel, the qualifier, “With your eye condition in mind” was added to the instructions of all scales except the “Psychological Function” scale. Additional modifications were made to enhance the clarity of the instructions and their consistency for generic adaptation such as accounting for experiences with glasses, and clarifying that patients think of their appearance as it pertains to CA and CN. The recall period and response options were not changed for any scales or checklists. A comment section, however, was added to the end of each scale and checklist for respondents to elaborate on their answers as necessary. DISCUSSION Clinical outcomes for CA patients were revolutionized through the introduction of CN, a ground-breaking surgical technique developed to restore sensation to the cornea and preserve vision.( 6 ) To capture the efficacy of this procedure holistically, it is imperative to assess treatment outcomes from the patient perspective, using more than just objective clinical markers( 20 ). PROMs provide an added dimension to the evaluation of treatment- and health-related outcomes by doing so from the patient perspective.( 21 ) In ophthalmology in particular, there has been a shift from solely using traditional outcome metrics such as visual acuity, to also incorporating the patient voice to understand outcomes pertaining to, for instance, quality of life.( 22 ) With the growing recognition that incorporating the patient perspective is necessary to comprehensively understand the needs and values of patients and deliver high-quality patient-centred care,( 21 ) it is vital to develop a PROM to evaluate the outcomes of CN. PROM development is a long, iterative process.( 23 , 24 ) Our prior research identified several outcomes of interest important to CA patients, including daily functioning, physical signs and symptoms, and appearance.( 8 ) Due to the extensive research conducted to develop the FACE-Q – a well-validated, appearance-based PROM with eye-specific scales and checklists - we chose appearance-based outcomes as a starting point to develop a full set of PROMs that capture the full spectrum of experiences and perceptions of the CA patient population.( 9 ) By adapting the FACE-Q to render it more comprehensive and relevant to the experiences of CA patients undergoing the CN procedure, the modified FACE-Q with enhanced content validity represents the first comprehensible, comprehensive, and relevant PROM tailored to evaluate CN-specific outcomes from the patient perspective.( 11 , 23 ) This study also represents the first in which the content validity of the FACE-Q has been assessed in a non-craniofacial population.( 25 ) There are limited PROMs available which have been developed specifically for use in patients with corneal diseases.( 22 ) The Catquest-9SF, a 9-item visual disability instrument, was developed originally to evaluate the outcomes of patients who had cataract surgery but was later validated to evaluate the outcomes of patients who had corneal transplant surgery.( 26 ) The only other potentially relevant condition-specific PROM identified in the literature was the Neurotrophic Keratopathy Questionnaire (NKQ) which intends to evaluate symptoms and signs of NK (11 items) and the impacts of NK as they relate to eyesight (3 items).( 27 ) However, the NKQ is still in the process of being developed as it has not yet been psychometrically validated,( 27 ) and is not as comprehensive as the FACE-Q in evaluating patients’ HRQoL. Interestingly however, an overlap between concepts in the pilot FACE-Q and the symptoms-and-signs-related items in the NKQ concerning dry eye, redness, watery eye, reduced tear production, reduced sensation, and irregular blinking was observed.( 27 ) The remaining symptoms-and-signs-related items covered concepts that were also elicited in the cognitive debriefing interviews with CA patients (e.g., blurry vision) but did not capture appearance-based outcomes, further highlighting the need for additional non-appearance-based PROMs to holistically capture the CA and CN experience (see Supplementary file 4). The FACE-Q was originally developed with the input of patients with cleft and non-cleft craniofacial conditions, both congenital and acquired (e.g., microtia, facial paralysis, craniosynostosis, etc.) that affected the skeleton or eyelid function( 28 ). Patients with ocular conditions or affected globes or vision were not included, thus visual impairment was not something broadly considered in the development of the FACE-Q. In contrast, among the CA population, visual impairment is a common experience and therefore factored quite heavily in adapting FACE-Q. Typically in PROM adaptation, comprehensive inclusion of all experiences is addressed by adding items, whereas comprehension is addressed by changing language or phraseology, and relevance is addressed by removing irrelevant items. It was interesting to note that in our revision process, inclusion of the visual impairment experience required modification of original, rather than addition of new, FACE-Q items. Our research thereby recognizes the importance of enhancing the inclusivity of visually impaired patients and is reflective of our commitment to ensure that the pilot FACE-Q captures a diverse range of patient perspectives. However, further work is necessary to improve accessibility of this and other PROMs to patients with visual impairment (e.g., exploring Braille, large print, or assistive technologies).( 29 ) Patient input is essential to the development and adaptation of PROMs.( 23 ) Patients can best ascertain and speak to which health outcomes they value and desire, and assess whether or not PROMs capture these outcomes comprehensively and comprehensibly.( 30 ) Research suggests that over 50% of PROMs commonly used in ophthalmology have reading comprehension levels that are too difficult for most patients and higher than that recommended by the American Medical Association and National Institutes of Health (sixth-grade reading level) for patient material.( 31 ) To mitigate this in our study, we used the Flesch Kincaid calculator( 19 ) to assess the approximate reading grade level of all text (i.e., instructions and items) and consulted with a patient advocate for final revisions. This study had a few limitations. Due to the rarity of CA and novelty of CN, the eligible patient population for this study was limited, resulting in ( 1 ) not attaining the target sample size of seven participants for the revision of each scale and checklist in Round 1, ( 2 ) four participants interviewing in both rounds of the study, and ( 3 ) the inability to capture the experiences of young patients due to an overall older sample and insufficient eligible and interested parents to participate as parent-proxies. To overcome these limitations, the study team relied heavily on the lived experience expertise and input from the patient advocate, clinical input from the ophthalmologist, the Flesch-Kincaid calculator, and non-condition-specific input from young, non-CA participants in the larger study. The inclusion of participants in both rounds of the study provided explicit input from patients outside of the study team on whether the working versions of the FACE-Q scales and checklists were more comprehensive, comprehensible, and relevant to the CA experience compared to the original versions. In the future, as the number of eligible patients may increase, a study to develop a parent-proxy version of the FACE-Q scales and checklists with a sufficient sample of parents may be more feasible. In conclusion, the pilot versions of the seven FACE-Q scales and checklists now have enhanced comprehensibility, comprehensiveness, and relevance for the evaluation of appearance-related outcomes of CA patients who had CN. The next step of this study is to evaluate the psychometric properties of the pilot PROM via field testing and psychometric analysis to finalize which items will comprise the final, adapted scales and checklists. The final, adapted scales and checklists will then be ready for clinical implementation, while additional evaluations of their test-retest reliability and responsiveness are conducted. DECLARATIONS The authors declare no competing financial interests. ACKNOWLEDGEMENT/DISCLOSURE STATEMENT Author FK is supported by the Vision Science Research Program Award and the Ontario Graduate Scholarship. A special thanks to the Dimaras Lab members, Dr. Sarah Wheeler, and patient advocates Ava Beatty, Ivana Ristevski, and Michelle Prunier for their valuable insights throughout the study. FUNDING Author FK is supported by the Vision Science Research Program Award and the Ontario Graduate Scholarship. REFERENCES Mantelli F, Nardella C, Tiberi E, Sacchetti M, Bruscolini A, Lambiase A. Congenital Corneal Anesthesia and Neurotrophic Keratitis: Diagnosis and Management. BioMed Research International. 2015 Sep 16;2015:e805876. Jayarajan AP, Sharma A, Sharma R, Nirankari VS, Narayana S, Christy JS. 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Health Qual Life Outcomes. 2006 Oct 11;4:79. Prinsen CAC, Mokkink LB, Bouter LM, Alonso J, Patrick DL, de Vet HCW, et al. COSMIN guideline for systematic reviews of patient-reported outcome measures. Qual Life Res. 2018 May 1;27(5):1147–57. Tassi A, Tan J, Piplani B, Longmire N, Wong Riff KWY, Klassen AF. Establishing content validity of an orthodontic subset of the FACE-Q Craniofacial Module in children and young adults with malocclusion. Orthod Craniofac Res. 2021 Nov;24(4):553–60. Claesson M, Armitage WJ, Byström B, Montan P, Samolov B, Stenvi U, et al. Validation of Catquest-9SF-A Visual Disability Instrument to Evaluate Patient Function After Corneal Transplantation. Cornea. 2017 Sep;36(9):1083–8. Murray LT, McCormack J, Grobeiu I, Wiklund I, Kimel M, Van Nooten F. Development of the neurotrophic keratopathy questionnaire: qualitative research. Journal of Patient-Reported Outcomes. 2020 May 4;4(1):30. Longmire NM, Wong Riff KWY, O’Hara JL, Aggarwala S, Allen GC, Bulstrode NW, et al. Development of a New Module of the FACE-Q for Children and Young Adults with Diverse Conditions Associated with Visible and/or Functional Facial Differences. Facial Plast Surg. 2017 Oct;33(5):499–508. Iezzoni LI, Rao SR, Ressalam J, Bolcic-Jankovic D, Campbell EG. Incidence of Accommodations for Patients With Significant Vision Limitations in Physicians’ Offices in the US. JAMA Ophthalmol. 2022 Jan;140(1):79–84. Wiering B, de Boer D, Delnoij D. Patient involvement in the development of patient-reported outcome measures: a scoping review. Health Expect. 2017 Feb;20(1):11–23. Taylor DJ, Jones L, Edwards L, Crabb DP. Are commonly used patient-reported outcome measure (PROM) questionnaires easy to read? Investigative Ophthalmology & Visual Science. 2019 Jul 22;60(9):4462. Additional Declarations There is no conflict of interest Supplementary Files SupplementaryFile1.docx Interview Guide SupplementaryFile2.docx New Concepts Elicited Cite Share Download PDF Status: Published Journal Publication published 01 Sep, 2025 Read the published version in Eye → Version 1 posted Editorial decision: Reject after peer review 30 Sep, 2024 Review # 2 received at journal 06 Apr, 2024 Reviewer # 2 agreed at journal 03 Apr, 2024 Reviewer # 1 agreed at journal 24 Mar, 2024 Reviewers invited by journal 22 Mar, 2024 Editor assigned by journal 22 Mar, 2024 Submission checks completed at journal 07 Feb, 2024 First submitted to journal 02 Feb, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3921346","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":282660438,"identity":"79c5591c-797a-4b11-914f-0dde4ad3dd64","order_by":0,"name":"Helen Dimaras","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABEUlEQVRIiWNgGAWjYBACAwbmBiDFzAPhVjDwMPCwMRzgwauFEVnLGRK0QHiMbUACqIUBnxZz9sbGxwUM1jK67Wcffvw5r06Gv+dY4oE3fxjk+Ruwa7HsOdhsPIMhncfsTLqxNO+2wzwSZ9sOHJzbxmA44wAOh91IbJPmYTjMY3YgjUGacdsBHgN+9obDvA0MCQy4tNx/2P4brOX8M+afP+fUQbTw/GFIkMdpC2MbM1jLjTQ2Cd4GZh4D3rYDh4FBkGCAS8uZxGZpHgOgX248Y7PmOQb0y5ljCUC/SBhuxKXl+OGDn3kqrO3Nzqcx3/xRU2fP35Nm/OHNHxt5ORxaoBoxhSTwqR8Fo2AUjIJRQAAAABAWWLaqmpzCAAAAAElFTkSuQmCC","orcid":"","institution":"","correspondingAuthor":true,"prefix":"","firstName":"Helen","middleName":"","lastName":"Dimaras","suffix":""},{"id":282660439,"identity":"8b5564c9-9480-4934-b61f-4ee45013a44c","order_by":1,"name":"Farheen Khan","email":"","orcid":"https://orcid.org/0009-0001-8142-3405","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Farheen","middleName":"","lastName":"Khan","suffix":""},{"id":282660440,"identity":"d18e7308-2cff-4fdd-af35-e53ffa0fe563","order_by":2,"name":"Roxanne Noronha","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Roxanne","middleName":"","lastName":"Noronha","suffix":""},{"id":282660441,"identity":"24ead6b9-63ca-4766-aac7-c4014d77f251","order_by":3,"name":"Sara Williams","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Sara","middleName":"","lastName":"Williams","suffix":""},{"id":282660442,"identity":"ff069e85-e62e-48fb-9d11-3ffe3a40c535","order_by":4,"name":"Anojan Satgunalingam","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Anojan","middleName":"","lastName":"Satgunalingam","suffix":""},{"id":282660443,"identity":"be97768e-11e9-45be-92ce-d5bfa00ab405","order_by":5,"name":"Karen Wong-Riff","email":"","orcid":"","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Karen","middleName":"","lastName":"Wong-Riff","suffix":""},{"id":282660444,"identity":"c6932b35-2cb1-479d-a2b3-6df1f0bb579a","order_by":6,"name":"Asim Ali","email":"","orcid":"https://orcid.org/0000-0002-6896-8507","institution":"","correspondingAuthor":false,"prefix":"","firstName":"Asim","middleName":"","lastName":"Ali","suffix":""}],"badges":[],"createdAt":"2024-02-02 15:13:19","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3921346/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3921346/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1038/s41433-025-03969-x","type":"published","date":"2025-09-01T04:00:00+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":90384600,"identity":"c3b36ec2-a8a9-4e39-bb10-b30de59fb85f","added_by":"auto","created_at":"2025-09-02 07:10:22","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1100088,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3921346/v1/ba573ca4-eda1-4115-b715-252f5e4d4535.pdf"},{"id":53583975,"identity":"ed4756ae-f14b-48b4-92c1-52e222a4e897","added_by":"auto","created_at":"2024-03-27 17:53:45","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":45713,"visible":true,"origin":"","legend":"\u003cp\u003eInterview Guide\u003c/p\u003e","description":"","filename":"SupplementaryFile1.docx","url":"https://assets-eu.researchsquare.com/files/rs-3921346/v1/d2dd306216939d4009aeacc0.docx"},{"id":53583976,"identity":"9ebd136a-d8bb-40d3-af79-ee3831c5940b","added_by":"auto","created_at":"2024-03-27 17:53:45","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":21103,"visible":true,"origin":"","legend":"\u003cp\u003eNew Concepts Elicited\u003c/p\u003e","description":"","filename":"SupplementaryFile2.docx","url":"https://assets-eu.researchsquare.com/files/rs-3921346/v1/dc20db80d2833de483cecb7f.docx"}],"financialInterests":"There is no conflict of interest","formattedTitle":"Health-Related Quality of Life Questionnaire for Corneal Anesthesia Patients: A Content Validity Assessment","fulltext":[{"header":"INTRODUCTION","content":"\u003cp\u003eCorneal anesthesia (CA), or the absence of corneal sensation, is a rare condition that is a contributing factor to the development of neurotrophic keratopathy (NK).(\u003cspan additionalcitationids=\"CR2\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) A procedure which can restore sensation in the cornea, facilitate epithelial healing and prevent vision loss, is corneal neurotization (CN) which can be performed by redirecting cutaneous innervation to the cornea via nerve grafts and nerve transfers.(\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e) CN has proven to be clinically successful for restoration of epithelial integrity and prevention of persistent corneal epithelial defects and other consequences of NK(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e). However, patient-reported outcomes on other aspects of NK, such as impact of the procedure on appearance or daily life functioning, have not been evaluated.\u003c/p\u003e \u003cp\u003ePatient-centred care is of great importance in contemporary healthcare as understanding patient perspectives on health status and health-related quality of life (HRQoL) is essential to enhance quality of care. Patient-reported outcome measures (PROMs) are tools that assess patient perceptions of health outcomes via standardized and validated questionnaires.(\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e) Prior research has identified the need for PROMs to evaluate treatment outcomes for patients treated via CN.(\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) Patients were particularly concerned about appearance, daily functioning, and psychosocial outcomes.\u003c/p\u003e \u003cp\u003eAn existing PROM, the \u0026ldquo;FACE-Q Craniofacial Module (FACE-Q)\u0026rdquo;, may be a suitable instrument to adapt for this patient population, as it aims to assess facial appearance, HRQoL, and adverse effects in patients with conditions that affect the face.(\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e) FACE-Q also includes independent scales and checklists related to the eye, though it was developed with input from patients with largely craniofacial conditions and not ocular conditions specifically.(\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e) FACE-Q has been validated and tested in over 2 000 patients worldwide, aged 8 to 29 years old with conditions associated with visible and/or functional facial differences.(\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e) Such facial differences are also present in CA patients due to symptoms such as corneal scarring.(\u003cspan additionalcitationids=\"CR2\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) As such, adapting the FACE-Q for use in CA patients represents an exciting avenue for exploration. An important first step to adapt a PROM is to assess its content validity, or evaluate whether the items within the PROM are comprehensive and adequately reflect the perspective of the patient population of interest. (\u003cspan additionalcitationids=\"CR11 CR12\" citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e) In this study, we aimed to assess the content validity of seven FACE-Q scales and checklists to evaluate the outcomes of individuals who were treated for CA by CN.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Design\u003c/h2\u003e \u003cp\u003e This study was approved by the Hospital for Sick Children Research Ethics Board (REB#1000079009). All participants or their caregivers provided written informed consent or assent before enrolment in the study. This study is also part of a broader qualitative observational study which included individuals treated for CA, retinoblastoma, or strabismus. This manuscript focuses on the results from the CA cohort alone.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eStudy Instrument - FACE-Q\u0026reg; | CRANIOFACIAL\u003c/h2\u003e \u003cp\u003eSeven FACE-Q scales and checklists were evaluated in this study, chosen for their potential relevance to CA patients. Three scales measured eye-related concepts and four scales evaluated HRQoL outcomes associated with appearance (Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eFACE-Q Scales and Checklists Adapted for Corneal Anesthesia Patients\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eScale or Checklist\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDomain\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eTitle\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNumber of Items\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eEye or HRQoL\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eScale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAppearance\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAppearance of the Eyes\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eEye\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eChecklist\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eFunction\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eEye Function\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eEye\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eChecklist\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAdverse Effects\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eEye Adverse Effects\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eEye\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eScale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHRQoL\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAppearance Distress\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eHRQoL\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eScale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHRQoL\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePsychological Function\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eHRQoL\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eScale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHRQoL\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSchool Function\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eHRQoL\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eScale\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eHRQoL\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eSocial Function\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eHRQoL\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eStudy Participants\u003c/h2\u003e \u003cdiv id=\"Sec6\" class=\"Section3\"\u003e \u003ch2\u003eEligibility Criteria\u003c/h2\u003e \u003cp\u003ePatients were eligible to participate in the study if they were diagnosed with CA, 8 years of age or older, and had CN surgery at least six months before enrolment in the study. Individuals were excluded if they were developmentally delayed, hard of hearing with no hearing aids, or unable to read, write, and communicate in English.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eSample Size\u003c/h2\u003e \u003cp\u003eA convenience sample of a minimum target of seven participants was recruited for each round of the study to achieve the highest rating as per the \u0026ldquo;COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) Methodology for Assessing the Content Validity of PROMs User Manual Version 1.0\u0026rdquo;(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e) While we aimed for unique participants in each round, individuals were eligible to participate in both rounds due to the rarity of the condition and small available patient population. A maximum number of participants was not set as sampling continued until point of saturation. Saturation was defined as having occurred when no new, relevant information related to the study\u0026rsquo;s purpose was collected from participants in subsequent interviews.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eStudy participant recruitment\u003c/h2\u003e \u003cp\u003eEligible patients were identified and introduced to the research study team by a member of their circle of care. Interested patients (or their caregivers if deemed by clinician to not have the capacity to consent on their behalf ) then filled out a consent form virtually via Research Electronic Data Capture (REDCap)(\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e) after completing an informed consent discussion during a telephone call with a member of the research study team.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eData Collection\u003c/h2\u003e \u003cdiv id=\"Sec10\" class=\"Section3\"\u003e \u003ch2\u003eIntake Survey\u003c/h2\u003e \u003cp\u003eAll participants completed an intake survey administered electronically via REDCap.(\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e) The survey collected information on personal sociodemographic characteristics (i.e., sex, gender identity, language spoken at home, population groups, religion, place of residence, highest level of education completed, employment status, marital status, annual household income, number of offspring) and CA history (i.e., perceived severity, laterality, date of diagnosis, treatment).\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eCognitive Debriefing Interviews\u003c/h2\u003e \u003cp\u003eData was collected in two rounds of one-on-one cognitive debriefing interviews held over the course of one year. Interviews were facilitated by the first author (FK), following round-specific semi-structured interview guides (Supplementary File 1), and audio- and video-recorded with permission from the participants. In both rounds, participants were asked to answer each item in the original (Round 1) or working version of the (Round 2) seven FACE-Q scales and checklists and explain the reasoning for their chosen answers. Participants were also asked to provide insight into the (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) clarity of the instructions, (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) comprehensibility and relevance of each item, (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) comprehensiveness of each scale in capturing all relevant experiences, and (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e) appropriateness of the response options. In Round 2, participants were also asked to provide feedback or additional clarification on (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) modifications applied to the working version of the FACE-Q; (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) unsettled suggestions from Round 1 participants; and (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) the relevance of new concepts suggested by participants in preceding interviews in Round 2.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eData Analysis\u003c/h2\u003e \u003cp\u003eQuantitative data from the intake survey was analyzed using descriptive statistics. Qualitative data from the interviews was analysed iteratively and occurred concurrently with data collection in both rounds. A working version and pilot version of the FACE-Q were created after analysis of results from Rounds 1 and 2 respectively. As this study was part of a larger study including additional ophthalmologic patient groups, data obtained from non-CA participants were cross-referenced with CA participants to identify similarities in participants\u0026rsquo; experiences with the scales and checklists, and their conditions and treatments. Results were summarized and shared with an interdisciplinary modification panel which consisted of an ophthalmologist (AA) specializing in CA who co-developed the CN procedure, a co-developer of the FACE-Q (KWR) who is also a plastic surgeon experienced in CN, a scientist (HD) in pediatric ophthalmology, and a patient advocate (AS) with lived experience of CN. Together, the panel provided clinical, methodological, and lived experience expertise to finalize decisions regarding modifications based on the feedback from study participants.\u003c/p\u003e \u003cp\u003eDuring both Rounds 1 and 2, field notes about feedback regarding the comprehensibility, comprehensiveness, and relevance of items, response options, recall periods, and instructions were taken from the audio recordings of each interview on Microsoft Excel by FK. The frequency of each specific feedback was noted on an item-by-item or scale-by-scale basis.\u003c/p\u003e \u003cp\u003eThe content of FACE-Q had already been evaluated by 43 participants aged 8\u0026ndash;29 during its development.(\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e) As such, to address comprehensibility, as recommended by the literature, feedback mentioned by at least three participants was brought forward for discussion with the modification panel.(\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e) For comprehensiveness, new concepts were organized by frequency and clinical and methodological relevance. Similar concepts were amalgamated to avoid redundancies. All relevant concepts, irrespective of their frequency, were discussed with the modification panel, leveraging on their experiences and knowledge given their potential broader relevance to the CA patient population. To address relevance, items deemed irrelevant by at least three participants in either round were brought forward for input from the modification panel.\u003c/p\u003e \u003cp\u003eAfter discussion with the modification panel, the wording of new and revised items was assessed using a Flesch Kincaid calculator to ensure a maximum reading Grade Level of 3 was obtained.(\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e) This wording was then finalized in collaboration with the patient advocate to incorporate a patient-centric perspective and further ensure that plain, accessible language was utilized.\u003c/p\u003e \u003c/div\u003e"},{"header":"RESULTS","content":"\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\n\u003ch2\u003eStudy Participants\u003c/h2\u003e\n\u003cp\u003eThe FACE-Q was reviewed in two rounds by ten participants in total, seven participants per round (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e). Feedback on all seven scales and checklists was provided by 9/10 participants on an item-by-item basis. Due to time constraints, one participant in Round 1 provided feedback on five scales and checklists only. In Round 1, the School Function scale was evaluated by school-aged participants only (n\u0026thinsp;=\u0026thinsp;2), while all Round 2 participants evaluated the School Function scale regardless of age.\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003ctable id=\"Tab2\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003eNumber of Participants per Scale or Checklist\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eAppearance of the Eyes\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eEye Function\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eEye Adverse Effects\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eAppearance Distress\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003ePsychological Function\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eSchool Function\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eSocial Function\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eRound 1\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eRound 2\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eBoth\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eTotal\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e10\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e10\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e10\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e10\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e8\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"char\" char=\".\"\u003e\n\u003cp\u003e9\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003eThe intake survey was completed by 9/10 participants (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e). The average age was 37.44 (median: 42, range: 14 to 65). Participants were predominantly male (56%), white (56%), and Christian (67%). All participants spoke English most often at home. In terms of their condition, all participants reported having bilateral CA, 56% perceived their condition to be moderately severe, 66% were diagnosed 11\u0026thinsp;+\u0026thinsp;years ago, 67% were treated at SickKids, and 33% had CN\u0026thinsp;\u0026le;\u0026thinsp;3 years before time of study.\u003c/p\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003ctable id=\"Tab3\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003eResults from Intake Survey\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth colspan=\"3\" align=\"left\"\u003e\n\u003cp\u003eCharacteristics of Participants (N\u0026thinsp;=\u0026thinsp;9)\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eN\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e%\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"3\" align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eAge (Mean: 37.44 years; Median: 42 years)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026le;\u0026thinsp;20\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e22\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e21\u0026ndash;40\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e22\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e41\u0026ndash;60\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e44\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u0026ge;\u0026thinsp;61\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"3\" align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eTreatment at SickKids\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eYes\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e67\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNo\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e33\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"3\" align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eSex at Birth\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMale\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e56\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eFemale\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e44\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"3\" align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eGender\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMale\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e56\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eFemale\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e44\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"3\" align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eLanguage Most Often Spoken at Home\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eEnglish\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e100\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"3\" align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003ePopulation Group\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eWhite\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e78\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eFirst Nation, Inuit and Metis\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eFilipino\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eLatin American\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSouth Asian\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eWest Indian\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"3\" align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eReligion\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eChristian\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e67\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eAtheist\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePrefer not to Answer\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eRoman Catholic\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"3\" align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eGeographic Location\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSmall Population Centre\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e33\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eLarge Urban Population Centre\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e22\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eRural Area\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e22\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMedium Population Centre\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePrefer not to Answer\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"3\" align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eEducation\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSome secondary education (high school)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e33\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePost-secondary certificate or diploma\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e22\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSecondary school (high school) diploma or equivalent\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e22\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eBachelor's degree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eGrade 8 or equivalent or lower\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"3\" align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eEmployment Status\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eEmployed\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e33\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eStudent\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e33\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eRetired\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eUnable to work\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eUnemployed and looking for work\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"3\" align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eMarital Status\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMarried\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e56\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSingle (never legally married or marriage never legally annulled)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e44\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"3\" align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eHousehold Income\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePrefer not to Answer\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e44\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e$150,000 CAD and over\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e22\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e$100,000 - $149,999 CAD\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e$80,000 - $99,999 CAD\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e$60,000 - $79,999 CAD\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"3\" align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eNumber of Children\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e56\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3+\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e33\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"3\" align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003ePerceived Severity\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eModerate\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e56\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSevere\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e44\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMild\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"3\" align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eReported Laterality\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eBilateral\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e100\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eUnilateral\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"3\" align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eDate of Diagnosis (Prior to Time of Study)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0\u0026ndash;5 years ago\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6\u0026ndash;10 years ago\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e22\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11\u0026ndash;15 years ago\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e33\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e15\u0026thinsp;+\u0026thinsp;years ago\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e33\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"3\" align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eTime Since Treatment (Prior to Time of Study)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1\u0026ndash;3 years ago\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e33\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e4\u0026ndash;6 years ago\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e22\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e7\u0026ndash;9 years ago\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e22\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e10\u0026thinsp;+\u0026thinsp;years ago\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e22\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec15\" class=\"Section2\"\u003e\n\u003ch2\u003eModifications to FACE-Q Items\u003c/h2\u003e\n\u003cp\u003eThe seven original FACE-Q scales and checklists consisted of 61 items (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e). The data from this study resulted in the revision of 11 items, addition of 12 items, and removal of 4 items; the pilot versions of the FACE-Q scales and checklists now consist of 69 items in total (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e4\u003c/span\u003e). Two types of modifications were implemented: condition-specific modifications were made exclusively to the scales and checklists that were intended for use in the CA population only, whereas generic modifications were made to scales and checklists that could be used across all the ophthalmologic populations of interest in the larger study. Condition-specific modifications were predominantly applied to the eye scales, while the generic modifications were predominantly applied to the HRQoL scales.\u003c/p\u003e\n\u003ctable border=\"1\"\u003e\u003ccaption\u003e\n\u003cp\u003eTable 4\u003c/p\u003e\n\u003cp\u003eQuantitative Summary of Modifications Applied to FACE-Q\u003c/p\u003e\n\u003c/caption\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"2\" width=\"61\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd rowspan=\"3\" width=\"92\"\u003e\n\u003cp\u003e\u003cstrong\u003eTitle of Scale or Checklist\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd rowspan=\"3\" width=\"71\"\u003e\n\u003cp\u003e\u003cstrong\u003eScale or Checklist\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd colspan=\"6\" width=\"519\"\u003e\n\u003cp\u003e\u003cstrong\u003eModifications\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd rowspan=\"3\" width=\"97\"\u003e\n\u003cp\u003e\u003cstrong\u003eTotal Modifications (n=27)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd rowspan=\"3\" width=\"63\"\u003e\n\u003cp\u003e\u003cstrong\u003eNumber of Items in Original FACE-Q\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd rowspan=\"3\" width=\"63\"\u003e\n\u003cp\u003e\u003cstrong\u003eNumber of Items in Pilot FACE-Q\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"4\" width=\"385\"\u003e\n\u003cp\u003e\u003cstrong\u003eRevision (n=11)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd rowspan=\"2\" width=\"66\"\u003e\n\u003cp\u003e\u003cstrong\u003eAddition (n=12)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd rowspan=\"2\" width=\"68\"\u003e\n\u003cp\u003e\u003cstrong\u003eRemoval (n=4)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"4\" width=\"61\"\u003e\n\u003cp\u003e\u003cstrong\u003eEye-Related\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"110\"\u003e\n\u003cp\u003e\u003cstrong\u003eComprehension\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"97\"\u003e\n\u003cp\u003e\u003cstrong\u003eInclusiveness\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"86\"\u003e\n\u003cp\u003e\u003cstrong\u003eUniversality\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"90\"\u003e\n\u003cp\u003e\u003cstrong\u003eConsistency\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"92\"\u003e\n\u003cp\u003eAppearance of the Eyes\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"71\"\u003e\n\u003cp\u003eScale\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"110\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"97\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"86\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"90\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"68\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"97\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"63\"\u003e\n\u003cp\u003e9\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"63\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"92\"\u003e\n\u003cp\u003eEye Function\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"71\"\u003e\n\u003cp\u003eChecklist\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"110\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"97\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"86\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"90\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"68\"\u003e\n\u003cp\u003e3\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"97\"\u003e\n\u003cp\u003e5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"63\"\u003e\n\u003cp\u003e7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"63\"\u003e\n\u003cp\u003e6\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"92\"\u003e\n\u003cp\u003eEye Adverse Effects\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"71\"\u003e\n\u003cp\u003eChecklist\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"110\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"97\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"86\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"90\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"68\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"97\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"63\"\u003e\n\u003cp\u003e7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"63\"\u003e\n\u003cp\u003e8\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd rowspan=\"5\" width=\"61\"\u003e\n\u003cp\u003e\u003cstrong\u003eHRQoL\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"92\"\u003e\n\u003cp\u003eAppearance Distress\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"71\"\u003e\n\u003cp\u003eScale\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"110\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"97\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"86\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"90\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"68\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"97\"\u003e\n\u003cp\u003e5\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"63\"\u003e\n\u003cp\u003e8\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"63\"\u003e\n\u003cp\u003e10\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"92\"\u003e\n\u003cp\u003ePsychological Function\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"71\"\u003e\n\u003cp\u003eScale\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"110\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"97\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"86\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"90\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"68\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"97\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"63\"\u003e\n\u003cp\u003e10\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"63\"\u003e\n\u003cp\u003e10\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"92\"\u003e\n\u003cp\u003eSchool Function\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"71\"\u003e\n\u003cp\u003eScale\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"110\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"97\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"86\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"90\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"68\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"97\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"63\"\u003e\n\u003cp\u003e10\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"63\"\u003e\n\u003cp\u003e10\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"92\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"71\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"110\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"97\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"86\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"90\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"68\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"97\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"63\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"63\"\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"92\"\u003e\n\u003cp\u003eSocial Function\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"71\"\u003e\n\u003cp\u003eScale\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"110\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"97\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"86\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"90\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"66\"\u003e\n\u003cp\u003e4\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"68\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"97\"\u003e\n\u003cp\u003e7\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"63\"\u003e\n\u003cp\u003e10\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"63\"\u003e\n\u003cp\u003e14\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"10\" width=\"839\"\u003e\n\u003cp\u003e\u003cstrong\u003eTotal Number of Items\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"63\"\u003e\n\u003cp\u003e\u003cstrong\u003e61\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"63\"\u003e\n\u003cp\u003e\u003cstrong\u003e69\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec16\" class=\"Section2\"\u003e\n\u003ch2\u003eRevisions\u003c/h2\u003e\n\u003cp\u003eRevisions were made if they were thought to improve FACE-Q in the following ways: (\u003cspan class=\"CitationRef\"\u003e1\u003c/span\u003e) comprehensibility, (\u003cspan class=\"CitationRef\"\u003e2\u003c/span\u003e) inclusiveness of the experiences of visually impaired patients, (\u003cspan class=\"CitationRef\"\u003e3\u003c/span\u003e) universality and applicability to a broader range of experiences, and (\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e) consistency among the wording of all items.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec17\" class=\"Section2\"\u003e\n\u003ch2\u003eAdditions\u003c/h2\u003e\n\u003cp\u003eParticipants elicited a total of 24 new concepts (Supplementary File 4) during the two rounds of cognitive debriefing interviews. As per discussions with the modification panel, 12/24 concepts were relevant to the FACE-Q\u0026rsquo;s conceptual framework, resulting in the addition of six items to the pilot versions of the eye scales and checklists, and six to the HRQoL scales (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e4\u003c/span\u003e). All of the new items added to the HRQoL sales were generic, while 5/6 of the new items added to the eye scales were condition-specific.\u003c/p\u003e\n\u003cp\u003eOf the new HRQoL items, 4/6 were added to the Social Function scale, while the remaining 2/6 were added to the Appearance Distress scale. The items added to the Appearance Distress scale were originally elicited by non-CA participants and cross-checked with CA participants in Rounds 1 and 2. The items added to the Social Function scale, however, were all originally elicited by Round 1 CA participants.\u003c/p\u003e\n\u003cp\u003eUpon cross-referencing the relevance of the four new Social Function items with non-CA participants, it was discovered that they applied generically across all three ophthalmologic patient populations of the larger study.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec18\" class=\"Section2\"\u003e\n\u003ch2\u003eRemovals\u003c/h2\u003e\n\u003cp\u003eTwo items were removed from the Eye Function scale (\u0026ldquo;I have trouble \u003cspan class=\"Underline\"\u003eseeing\u003c/span\u003e properly (even with glasses or contacts)\u0026rdquo; and \u0026ldquo;One of my eyes work better than the other eye\u0026rdquo;) because they covered concepts related to visual function that the modification panel deemed could be more comprehensively evaluated using functional vision PROMs.\u003c/p\u003e\n\u003cp\u003eAn additional two items were removed from the Eye Function and Eye Adverse Effects scale (\u0026ldquo;My eyelids \u003cspan class=\"Underline\"\u003eclose unexpectedly\u003c/span\u003e when I don\u0026rsquo;t want them to (like when I smile or talk)\u0026rdquo; and \u0026ldquo;My eyes are itchy\u0026rdquo;) because they were not clinically relevant to the CA population.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec19\" class=\"Section2\"\u003e\n\u003ch2\u003eModifications to the PROM Components of FACE-Q\u003c/h2\u003e\n\u003cp\u003eDuring the think-aloud process of some interviews, participants discussed appearance-related concerns that were not condition-specific or eye-specific. Therefore, upon discussion with the modification panel, the qualifier, \u0026ldquo;With your eye condition in mind\u0026rdquo; was added to the instructions of all scales except the \u0026ldquo;Psychological Function\u0026rdquo; scale. Additional modifications were made to enhance the clarity of the instructions and their consistency for generic adaptation such as accounting for experiences with glasses, and clarifying that patients think of their appearance as it pertains to CA and CN. The recall period and response options were not changed for any scales or checklists. A comment section, however, was added to the end of each scale and checklist for respondents to elaborate on their answers as necessary.\u003c/p\u003e\n\u003c/div\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eClinical outcomes for CA patients were revolutionized through the introduction of CN, a ground-breaking surgical technique developed to restore sensation to the cornea and preserve vision.(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e) To capture the efficacy of this procedure holistically, it is imperative to assess treatment outcomes from the patient perspective, using more than just objective clinical markers(\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e). PROMs provide an added dimension to the evaluation of treatment- and health-related outcomes by doing so from the patient perspective.(\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e) In ophthalmology in particular, there has been a shift from solely using traditional outcome metrics such as visual acuity, to also incorporating the patient voice to understand outcomes pertaining to, for instance, quality of life.(\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e) With the growing recognition that incorporating the patient perspective is necessary to comprehensively understand the needs and values of patients and deliver high-quality patient-centred care,(\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e) it is vital to develop a PROM to evaluate the outcomes of CN.\u003c/p\u003e \u003cp\u003ePROM development is a long, iterative process.(\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e) Our prior research identified several outcomes of interest important to CA patients, including daily functioning, physical signs and symptoms, and appearance.(\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) Due to the extensive research conducted to develop the FACE-Q \u0026ndash; a well-validated, appearance-based PROM with eye-specific scales and checklists - we chose appearance-based outcomes as a starting point to develop a full set of PROMs that capture the full spectrum of experiences and perceptions of the CA patient population.(\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e) By adapting the FACE-Q to render it more comprehensive and relevant to the experiences of CA patients undergoing the CN procedure, the modified FACE-Q with enhanced content validity represents the first comprehensible, comprehensive, and relevant PROM tailored to evaluate CN-specific outcomes from the patient perspective.(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e) This study also represents the first in which the content validity of the FACE-Q has been assessed in a non-craniofacial population.(\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e)\u003c/p\u003e \u003cp\u003eThere are limited PROMs available which have been developed specifically for use in patients with corneal diseases.(\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e) The Catquest-9SF, a 9-item visual disability instrument, was developed originally to evaluate the outcomes of patients who had cataract surgery but was later validated to evaluate the outcomes of patients who had corneal transplant surgery.(\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e) The only other potentially relevant condition-specific PROM identified in the literature was the Neurotrophic Keratopathy Questionnaire (NKQ) which intends to evaluate symptoms and signs of NK (11 items) and the impacts of NK as they relate to eyesight (3 items).(\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e) However, the NKQ is still in the process of being developed as it has not yet been psychometrically validated,(\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e) and is not as comprehensive as the FACE-Q in evaluating patients\u0026rsquo; HRQoL. Interestingly however, an overlap between concepts in the pilot FACE-Q and the symptoms-and-signs-related items in the NKQ concerning dry eye, redness, watery eye, reduced tear production, reduced sensation, and irregular blinking was observed.(\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e) The remaining symptoms-and-signs-related items covered concepts that were also elicited in the cognitive debriefing interviews with CA patients (e.g., blurry vision) but did not capture appearance-based outcomes, further highlighting the need for additional non-appearance-based PROMs to holistically capture the CA and CN experience (see Supplementary file 4).\u003c/p\u003e \u003cp\u003eThe FACE-Q was originally developed with the input of patients with cleft and non-cleft craniofacial conditions, both congenital and acquired (e.g., microtia, facial paralysis, craniosynostosis, etc.) that affected the skeleton or eyelid function(\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e). Patients with ocular conditions or affected globes or vision were not included, thus visual impairment was not something broadly considered in the development of the FACE-Q. In contrast, among the CA population, visual impairment is a common experience and therefore factored quite heavily in adapting FACE-Q. Typically in PROM adaptation, comprehensive inclusion of all experiences is addressed by adding items, whereas comprehension is addressed by changing language or phraseology, and relevance is addressed by removing irrelevant items. It was interesting to note that in our revision process, inclusion of the visual impairment experience required modification of original, rather than addition of new, FACE-Q items. Our research thereby recognizes the importance of enhancing the inclusivity of visually impaired patients and is reflective of our commitment to ensure that the pilot FACE-Q captures a diverse range of patient perspectives. However, further work is necessary to improve accessibility of this and other PROMs to patients with visual impairment (e.g., exploring Braille, large print, or assistive technologies).(\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e)\u003c/p\u003e \u003cp\u003ePatient input is essential to the development and adaptation of PROMs.(\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e) Patients can best ascertain and speak to which health outcomes they value and desire, and assess whether or not PROMs capture these outcomes comprehensively and comprehensibly.(\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e) Research suggests that over 50% of PROMs commonly used in ophthalmology have reading comprehension levels that are too difficult for most patients and higher than that recommended by the American Medical Association and National Institutes of Health (sixth-grade reading level) for patient material.(\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e) To mitigate this in our study, we used the Flesch Kincaid calculator(\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e) to assess the approximate reading grade level of all text (i.e., instructions and items) and consulted with a patient advocate for final revisions.\u003c/p\u003e \u003cp\u003eThis study had a few limitations. Due to the rarity of CA and novelty of CN, the eligible patient population for this study was limited, resulting in (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) not attaining the target sample size of seven participants for the revision of each scale and checklist in Round 1, (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) four participants interviewing in both rounds of the study, and (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) the inability to capture the experiences of young patients due to an overall older sample and insufficient eligible and interested parents to participate as parent-proxies. To overcome these limitations, the study team relied heavily on the lived experience expertise and input from the patient advocate, clinical input from the ophthalmologist, the Flesch-Kincaid calculator, and non-condition-specific input from young, non-CA participants in the larger study. The inclusion of participants in both rounds of the study provided explicit input from patients outside of the study team on whether the working versions of the FACE-Q scales and checklists were more comprehensive, comprehensible, and relevant to the CA experience compared to the original versions. In the future, as the number of eligible patients may increase, a study to develop a parent-proxy version of the FACE-Q scales and checklists with a sufficient sample of parents may be more feasible.\u003c/p\u003e \u003cp\u003eIn conclusion, the pilot versions of the seven FACE-Q scales and checklists now have enhanced comprehensibility, comprehensiveness, and relevance for the evaluation of appearance-related outcomes of CA patients who had CN. The next step of this study is to evaluate the psychometric properties of the pilot PROM via field testing and psychometric analysis to finalize which items will comprise the final, adapted scales and checklists. The final, adapted scales and checklists will then be ready for clinical implementation, while additional evaluations of their test-retest reliability and responsiveness are conducted.\u003c/p\u003e "},{"header":"DECLARATIONS","content":"\u003cp\u003eThe authors declare no competing financial interests.\u003c/p\u003e\u003ch2\u003eACKNOWLEDGEMENT/DISCLOSURE STATEMENT\u003c/h2\u003e\n\u003cp\u003eAuthor FK is supported by the Vision Science Research Program Award and the Ontario Graduate Scholarship.\u003c/p\u003e\n\u003cp\u003eA special thanks to the Dimaras Lab members, Dr. Sarah Wheeler, and patient advocates Ava Beatty, Ivana Ristevski, and Michelle Prunier for their valuable insights throughout the study.\u003c/p\u003e\n\u003ch2\u003eFUNDING\u003c/h2\u003e\n\u003cp\u003eAuthor FK is supported by the Vision Science Research Program Award and the Ontario Graduate Scholarship.\u003c/p\u003e"},{"header":"REFERENCES","content":"\u003col\u003e\n\u003cli\u003eMantelli F, Nardella C, Tiberi E, Sacchetti M, Bruscolini A, Lambiase A. Congenital Corneal Anesthesia and Neurotrophic Keratitis: Diagnosis and Management. BioMed Research International. 2015 Sep 16;2015:e805876. \u003c/li\u003e\n\u003cli\u003eJayarajan AP, Sharma A, Sharma R, Nirankari VS, Narayana S, Christy JS. Congenital corneal anesthesia: A case series. Indian J Ophthalmol. 2022 Jul;70(7):2588\u0026ndash;91. \u003c/li\u003e\n\u003cli\u003eGelzinis A, Simonaviciute D, Krucaite A, Buzzonetti L, Dollfus H, Zemaitiene R. Neurotrophic Keratitis Due to Congenital Corneal Anesthesia with Deafness, Hypotonia, Intellectual Disability, Face Abnormality and Metabolic Disorder: A New Syndrome? Medicina. 2022 May;58(5):657. \u003c/li\u003e\n\u003cli\u003eElbaz U, Bains R, Zuker RM, Borschel GH, Ali A. Restoration of corneal sensation with regional nerve transfers and nerve grafts: a new approach to a difficult problem. JAMA Ophthalmol. 2014 Nov;132(11):1289\u0026ndash;95. \u003c/li\u003e\n\u003cli\u003eCatapano J, Fung SSM, Halliday W, Jobst C, Cheyne D, Ho ES, et al. Treatment of neurotrophic keratopathy with minimally invasive corneal neurotisation: long-term clinical outcomes and evidence of corneal reinnervation. British Journal of Ophthalmology. 2019 Dec 1;103(12):1724\u0026ndash;31. \u003c/li\u003e\n\u003cli\u003eDragnea DC, Krolo I, Koppen C, Faris C, Van den Bogerd B, N\u0026iacute; Dhubhghaill S. Corneal Neurotization\u0026mdash;Indications, Surgical Techniques and Outcomes. J Clin Med. 2023 Mar 13;12(6):2214. \u003c/li\u003e\n\u003cli\u003eKingsley C, Patel S. Patient-reported outcome measures and patient-reported experience measures. BJA Education. 2017 Apr 1;17(4):137\u0026ndash;44. \u003c/li\u003e\n\u003cli\u003eUnpublished. \u003c/li\u003e\n\u003cli\u003eFACE-Q | Craniofacial - Q-Portfolio MEASURING WHAT MATTERS TO PATIENTS [Internet]. 2021 [cited 2023 Jun 7]. Available from: https://qportfolio.org/face-q/craniofacial/\u003c/li\u003e\n\u003cli\u003eU.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. Health Qual Life Outcomes. 2006 Oct 11;4:79. \u003c/li\u003e\n\u003cli\u003eTerwee CB, Prinsen C a. C, Chiarotto A, Westerman MJ, Patrick DL, Alonso J, et al. COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study. Qual Life Res. 2018 May;27(5):1159\u0026ndash;70. \u003c/li\u003e\n\u003cli\u003ePatrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, et al. Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1--eliciting concepts for a new PRO instrument. Value Health. 2011 Dec;14(8):967\u0026ndash;77. \u003c/li\u003e\n\u003cli\u003ePatrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, et al. Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2--assessing respondent understanding. Value Health. 2011 Dec;14(8):978\u0026ndash;88. \u003c/li\u003e\n\u003cli\u003eHarris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O\u0026rsquo;Neal L, et al. The REDCap consortium: Building an international community of software platform partners. Journal of Biomedical Informatics. 2019 Jul 1;95:103208. \u003c/li\u003e\n\u003cli\u003eHarris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)\u0026mdash;A metadata-driven methodology and workflow process for providing translational research informatics support. Journal of Biomedical Informatics. 2009 Apr 1;42(2):377\u0026ndash;81. \u003c/li\u003e\n\u003cli\u003eHarris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)\u0026mdash;A metadata-driven methodology and workflow process for providing translational research informatics support. Journal of Biomedical Informatics. 2009 Apr 1;42(2):377\u0026ndash;81. \u003c/li\u003e\n\u003cli\u003eLongmire NM, Riff KWYW, O\u0026rsquo;Hara JL, Aggarwala S, Allen GC, Bulstrode NW, et al. Development of a New Module of the FACE-Q for Children and Young Adults with Diverse Conditions Associated with Visible and/or Functional Facial Differences. Facial Plast Surg. 2017 Oct;33(05):499\u0026ndash;508. \u003c/li\u003e\n\u003cli\u003eCheng KKF, Clark AM. Qualitative Methods and Patient-Reported Outcomes: Measures Development and Adaptation. International Journal of Qualitative Methods. 2017 Dec 1;16(1):1609406917702983. \u003c/li\u003e\n\u003cli\u003eFlesch Kincaid Calculator | Good Calculators [Internet]. [cited 2023 Jun 21]. Available from: https://goodcalculators.com/flesch-kincaid-calculator/\u003c/li\u003e\n\u003cli\u003eKluzek S, Dean B, Wartolowska KA. Patient-reported outcome measures (PROMs) as proof of treatment efficacy. BMJ Evidence-Based Medicine. 2022 Jun 1;27(3):153\u0026ndash;5. \u003c/li\u003e\n\u003cli\u003eDean S, Al Sayah F, Johnson JA. Measuring value in healthcare from a patients\u0026rsquo; perspective. J Patient Rep Outcomes. 2021 Oct 12;5(Suppl 2):88. \u003c/li\u003e\n\u003cli\u003eBraithwaite T, Calvert M, Gray A, Pesudovs K, Denniston AK. The use of patient-reported outcome research in modern ophthalmology: impact on clinical trials and routine clinical practice. Patient Related Outcome Measures. 2019;10:9. \u003c/li\u003e\n\u003cli\u003eGuidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes. 2006 Oct 11;4:79. \u003c/li\u003e\n\u003cli\u003ePrinsen CAC, Mokkink LB, Bouter LM, Alonso J, Patrick DL, de Vet HCW, et al. COSMIN guideline for systematic reviews of patient-reported outcome measures. Qual Life Res. 2018 May 1;27(5):1147\u0026ndash;57. \u003c/li\u003e\n\u003cli\u003eTassi A, Tan J, Piplani B, Longmire N, Wong Riff KWY, Klassen AF. Establishing content validity of an orthodontic subset of the FACE-Q Craniofacial Module in children and young adults with malocclusion. Orthod Craniofac Res. 2021 Nov;24(4):553\u0026ndash;60. \u003c/li\u003e\n\u003cli\u003eClaesson M, Armitage WJ, Bystr\u0026ouml;m B, Montan P, Samolov B, Stenvi U, et al. Validation of Catquest-9SF-A Visual Disability Instrument to Evaluate Patient Function After Corneal Transplantation. Cornea. 2017 Sep;36(9):1083\u0026ndash;8. \u003c/li\u003e\n\u003cli\u003eMurray LT, McCormack J, Grobeiu I, Wiklund I, Kimel M, Van Nooten F. Development of the neurotrophic keratopathy questionnaire: qualitative research. Journal of Patient-Reported Outcomes. 2020 May 4;4(1):30. \u003c/li\u003e\n\u003cli\u003eLongmire NM, Wong Riff KWY, O\u0026rsquo;Hara JL, Aggarwala S, Allen GC, Bulstrode NW, et al. Development of a New Module of the FACE-Q for Children and Young Adults with Diverse Conditions Associated with Visible and/or Functional Facial Differences. Facial Plast Surg. 2017 Oct;33(5):499\u0026ndash;508. \u003c/li\u003e\n\u003cli\u003eIezzoni LI, Rao SR, Ressalam J, Bolcic-Jankovic D, Campbell EG. Incidence of Accommodations for Patients With Significant Vision Limitations in Physicians\u0026rsquo; Offices in the US. JAMA Ophthalmol. 2022 Jan;140(1):79\u0026ndash;84. \u003c/li\u003e\n\u003cli\u003eWiering B, de Boer D, Delnoij D. Patient involvement in the development of patient-reported outcome measures: a scoping review. Health Expect. 2017 Feb;20(1):11\u0026ndash;23. \u003c/li\u003e\n\u003cli\u003eTaylor DJ, Jones L, Edwards L, Crabb DP. Are commonly used patient-reported outcome measure (PROM) questionnaires easy to read? Investigative Ophthalmology \u0026amp; Visual Science. 2019 Jul 22;60(9):4462. \u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"eye","isNatureJournal":false,"hasQc":false,"allowDirectSubmit":false,"externalIdentity":"eye","sideBox":"Learn more about [Eye](http://www.nature.com/eye/)","snPcode":"41433","submissionUrl":"https://mts-eye.nature.com/cgi-bin/main.plex","title":"Eye","twitterHandle":"@eye_journal","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"ejp","reportingPortfolio":"Nature AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-3921346/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3921346/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground/Objectives:\u003c/h2\u003e \u003cp\u003eFACE-Q Craniofacial Module (FACE-Q) is a validated patient-reported outcome measure (PROM) for appearance. This study aimed to assess the content validity of FACE-Q for use in patients treated for corneal anesthesia.\u003c/p\u003e\u003ch2\u003eSubjects/Methods:\u003c/h2\u003e \u003cp\u003eThis was a prospective observational and qualitative study. Cognitive debriefing interviews were conducted with patients\u0026thinsp;\u0026ge;\u0026thinsp;8 years old who had surgical treatment for corneal anesthesia at least six months before time of study. Interviews consisted of gathering feedback on the comprehensibility, comprehensiveness, and relevance of three eye scales and checklists and four health-related quality-of-life scales. Based on the input from participants and further discussion with ophthalmologists, scientists, and patient advocates, the scales and checklists were modified, then further refined with input from additional participants.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eFeedback on the FACE-Q scales and checklists was obtained from 10 participants. Instructions for the scales were modified to enhance comprehensibility. Eleven items were revised for enhanced comprehensibility and relevance. Twelve items were added to enhance comprehensiveness. Four items were removed due to their irrelevance to corneal anesthesia. Modifications to the eye and health-related quality-of-life scales were generally condition-specific and generic respectively. A comment section was added to the end of each scale and checklist.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eFACE-Q may be a suitable PROM to adapt to measure appearance-based outcomes in corneal anesthesia patients. With lived expertise, clinical, and scientific input, the content validity of FACE-Q was improved for use in corneal anesthesia patients. The modified FACE-Q is now ready for psychometric evaluation and further validation.\u003c/p\u003e","manuscriptTitle":"Health-Related Quality of Life Questionnaire for Corneal Anesthesia Patients: A Content Validity Assessment","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-03-27 17:53:40","doi":"10.21203/rs.3.rs-3921346/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Reject after peer review","date":"2024-09-30T07:55:13+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"This content is not available.","date":"2024-04-06T23:59:12+00:00","index":2,"fulltext":"This content is not available."},{"type":"reviewerAgreed","content":"This content is not available.","date":"2024-04-04T00:18:21+00:00","index":2,"fulltext":"This content is not available."},{"type":"reviewerAgreed","content":"This content is not available.","date":"2024-03-25T00:20:12+00:00","index":1,"fulltext":"This content is not available."},{"type":"reviewersInvited","content":"","date":"2024-03-22T13:21:45+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-03-22T11:19:06+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-02-07T15:08:35+00:00","index":"","fulltext":""},{"type":"submitted","content":"Eye","date":"2024-02-02T15:09:33+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"eye","isNatureJournal":false,"hasQc":false,"allowDirectSubmit":false,"externalIdentity":"eye","sideBox":"Learn more about [Eye](http://www.nature.com/eye/)","snPcode":"41433","submissionUrl":"https://mts-eye.nature.com/cgi-bin/main.plex","title":"Eye","twitterHandle":"@eye_journal","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"ejp","reportingPortfolio":"Nature AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"52163467-2ccf-4599-af32-0f3221c23a13","owner":[],"postedDate":"March 27th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[{"id":29761730,"name":"Health sciences/Health care/Quality of life"},{"id":29761731,"name":"Health sciences/Diseases/Eye diseases/Corneal diseases"}],"tags":[],"updatedAt":"2025-09-02T07:10:17+00:00","versionOfRecord":{"articleIdentity":"rs-3921346","link":"https://doi.org/10.1038/s41433-025-03969-x","journal":{"identity":"eye","isVorOnly":false,"title":"Eye"},"publishedOn":"2025-09-01 04:00:00","publishedOnDateReadable":"September 1st, 2025"},"versionCreatedAt":"2024-03-27 17:53:40","video":"","vorDoi":"10.1038/s41433-025-03969-x","vorDoiUrl":"https://doi.org/10.1038/s41433-025-03969-x","workflowStages":[]},"version":"v1","identity":"rs-3921346","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3921346","identity":"rs-3921346","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}