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Srijana Adhikari,1 Ruth Marie Antoinette van Nispen,2 Ellen Bernadette Maria Elsman,2 Fleur van Rens,3 Ger van Rens2 1Department of Pediatric Ophthalmology and Strabismus, Tilganga Institute of Ophthalmology, Kathmandu, Nepal; 2Department of Ophthalmology, VU University Medical Centre and the Amsterdam Public Health Research Institute, Amsterdam, the Netherlands; 3Discipline of Exercise Science, Murdoch University, Murdoch, WA, AustraliaCorrespondence: Srijana Adhikari, Tilganga Institute of Ophthalmology, Gaushala, PO Box 561, Kathmandu, Nepal, Tel +977-9849287387, Email srij_a@yahoo.comPurpose: To study the causes of moderate and severe visual impairment (VI) and blindness and its changing trends in Nepalese children.Patients and Methods: A cross-sectional descriptive study was conducted. Participants, aged 7 to 17 years were recruited from integrated schools for the blind and the outpatient department of a tertiary eye hospital in Kathmandu. VI and blindness were categorized according to World Health Organization (WHO) categories and its protocol for eye examination of children with blindness and VI was followed. Findings were compared to former studies from Nepal.Results: A total of 200 children were included, of whom 45% had moderate VI, 5% had severe VI, and 50% were blind. Mean age of children with VI and blindness was 11.1 (SD = 3.3) and 12.9 (SD = 3) years, respectively. Forty percent of children with VI and 38% of blind children were female. In our study, retina (39%) and whole globe (32%) were the most common anatomical site of involvement in children with VI and blindness, respectively, while cornea was the most common anatomical site of involvement in former studies. Heredity (43%) was the most common etiological factor although in 24.5% of all children, etiology was unknown. In 43.5% of children, blindness and VI was due to avoidable causes.Conclusion: In relatively many children, the etiology of VI and blindness could be either prevented or treated. Compared to former studies from Nepal, there is a changing trend in the etiology of severe VI and blindness.Keywords: childhood blindness, Nepal, visual impairment, pediatric

Purpose: Systematic reviews of patient-reported outcome measures (PROMs) are important tools to select the most suitable PROM for a study or clinical application. Conducting these reviews is challenging, and the quality of these reviews needs to be improved. We updated the COSMIN guideline for systematic reviews of PROMs, including the COSMIN Risk of Bias checklist, and the COSMIN criteria for good measurement properties., Methods: Adaptations to the methodology were based on our experience with applying the COSMIN guideline, through discussions among the authors, and results from two related Delphi studies., Results: The updated guideline places more emphasis on key aspects that are often missing or sub optimally conducted in published systematic reviews of PROMs, such as formulating a well-defined research question and developing a comprehensive search strategy, assessing risk of bias, applying criteria for good measurement properties, summarizing results, and grading the quality of the evidence. We also stress the importance of evaluating the measurement properties of each subscale of a PROM separately and evaluating content validity of all included PROMs., Conclusion: The quality of systematic reviews of PROMs can be improved by using this updated version of the COSMIN guideline for systematic reviews of PROMs. Improved quality will lead to better PROM selection and increased standardization of PROM use., (© 2024. The Author(s).)

Purpose: Systematic reviews evaluating and comparing the measurement properties of outcome measurement instruments (OMIs) play an important role in OMI selection. Earlier overviews of review quality (2007, 2014) evidenced substantial concerns with regards to alignment to scientific standards. This overview aimed to investigate whether the quality of recent systematic reviews of OMIs lives up to the current scientific standards., Methods: One hundred systematic reviews of OMIs published from June 1, 2021 onwards were randomly selected through a systematic literature search performed on March 17, 2022 in MEDLINE and EMBASE. The quality of systematic reviews was appraised by two independent reviewers. An updated data extraction form was informed by the earlier studies, and results were compared to these earlier studies' findings., Results: A quarter of the reviews had an unclear research question or aim, and in 22% of the reviews the search strategy did not match the aim. Half of the reviews had an incomprehensive search strategy, because relevant search terms were not included. In 63% of the reviews (compared to 41% in 2014 and 30% in 2007) a risk of bias assessment was conducted. In 73% of the reviews (some) measurement properties were evaluated (58% in 2014 and 55% in 2007). In 60% of the reviews the data were (partly) synthesized (42% in 2014 and 7% in 2007); evaluation of measurement properties and data syntheses was not conducted separately for subscales in the majority. Certainty assessments of the quality of the total body of evidence were conducted in only 33% of reviews (not assessed in 2014 and 2007). The majority (58%) did not make any recommendations on which OMI (not) to use., Conclusion: Despite clear improvements in risk of bias assessments, measurement property evaluation and data synthesis, specifying the research question, conducting the search strategy and performing a certainty assessment remain poor. To ensure that systematic reviews of OMIs meet current scientific standards, more consistent conduct and reporting of systematic reviews of OMIs is needed., (© 2024. The Author(s).)

Background and Objective: Although comprehensive and widespread guidelines on how to conduct systematic reviews of outcome measurement instruments (OMIs) exist, for example from the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) initiative, key information is often missing in published reports. This article describes the development of an extension of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 guideline: PRISMA-COSMIN for OMIs 2024., Methods: The development process followed the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines and included a literature search, expert consultations, a Delphi study, a hybrid workgroup meeting, pilot testing, and an end-of-project meeting, with integrated patient/public involvement., Results: From the literature and expert consultation, 49 potentially relevant reporting items were identified. Round 1 of the Delphi study was completed by 103 panelists, whereas round 2 and 3 were completed by 78 panelists. After 3 rounds, agreement (≥67%) on inclusion and wording was reached for 44 items. Eleven items without consensus for inclusion and/or wording were discussed at a workgroup meeting attended by 24 participants. Agreement was reached for the inclusion and wording of 10 items, and the deletion of 1 item. Pilot testing with 65 authors of OMI systematic reviews further improved the guideline through minor changes in wording and structure, finalized during the end-of-project meeting. The final checklist to facilitate the reporting of full systematic review reports contains 54 (sub)items addressing the review's title, abstract, plain language summary, open science, introduction, methods, results, and discussion. Thirteen items pertaining to the title and abstract are also included in a separate abstract checklist, guiding authors in reporting for example conference abstracts., Conclusion: PRISMA-COSMIN for OMIs 2024 consists of two checklists (full reports; abstracts), their corresponding explanation and elaboration documents detailing the rationale and examples for each item, and a data flow diagram. PRISMA-COSMIN for OMIs 2024 can improve the reporting of systematic reviews of OMIs, fostering their reproducibility and allowing end-users to appraise the quality of OMIs and select the most appropriate OMI for a specific application. NOTE: This paper was jointly developed by Journal of Clinical Epidemiology, Quality of Life Research, Journal of Patient Reported Outcomes, Health and Quality of Life Outcomes and jointly published by Elsevier Inc, Springer Nature Switzerland AG, and BioMed Central Ltd., part of Springer Nature. The articles are identical except for minor stylistic and spelling differences in keeping with each journal's style. Either citation can be used when citing this article., Competing Interests: Declaration of competing interest Drs Terwee and Mokkink are the founders of COSMIN; Dr Moher is a member of the PRISMA executive; Dr Tricco is the co-editor in chief of the Journal of Clinical Epidemiology. The other authors have no conflicts of interest., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Objective: To systematically evaluate the measurement properties of 12 patient-reported outcome measures (PROMs) used to measure depression symptom severity in adolescents with depression. Depression symptom severity was chosen as the outcome of focus given its importance as an outcome to measure in adolescents with depression across clinical trials and/or care., Method: MEDLINE, PsycInfo, Embase, Scopus, CINAHL, and Cochrane were searched from year of inception up to December 7, 2023. Study appraisal (ie, risk of bias), evaluation of measurement properties, and evidence synthesis followed the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines. Included studies evaluated at least 1 of 9 measurement properties as detailed in the COSMIN taxonomy within a reported sample or subgroup of youth ages 12 to 24 years, with at least 40% meeting criteria for any depressive disorder., Results: Of the 15,560 records identified, 31 studies for 7 PROMs were included in the COSMIN appraisal. Although several PROMs have the potential to accurately measure depression symptom severity in adolescents with depression, at this time none of the PROMs can be recommended for use without further evaluative work. High-quality evidence was generally lacking, largely due to few or inconsistent findings, small sample sizes, and other methodological concerns., Conclusion: This systematic review of the measurement properties of 12 PROMs used to measure depression symptom severity in adolescents with depression found that none of the PROMs can be recommended for use until further evaluative work is conducted. Clinicians and researchers should proceed with caution when using these PROMs., Diversity and Inclusion Statement: One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented racial and/or ethnic groups in science. One or more of the authors of this paper self-identifies as a member of one or more historically underrepresented sexual and/or gender groups in science. We actively worked to promote sex and gender balance in our author group. We actively worked to promote inclusion of historically underrepresented racial and/or ethnic groups in science in our author group. The author list of this paper includes contributors from the location and/or community where the research was conducted who participated in the data collection, design, analysis, and/or interpretation of the work., (Copyright © 2024 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.)

To identify priority areas to improve the design, conduct, and reporting of pediatric clinical trials, the international expert network, Standards for Research (StaR) in Child Health, was assembled and published the first 6 Standards in Pediatrics in 2012. After a recent review summarizing the 247 publications by StaR Child Health authors that highlight research practices that add value and reduce research "waste," the current review assesses the progress in key child health trial methods areas: consent and recruitment, containing risk of bias, roles of data monitoring committees, appropriate sample size calculations, outcome selection and measurement, and age groups for pediatric trials. Although meaningful change has occurred within the child health research ecosystem, measurable progress is still disappointingly slow. In this context, we identify and review emerging trends that will advance the agenda of increased clinical usefulness of pediatric trials, including patient and public engagement, Bayesian statistical approaches, adaptive designs, and platform trials. We explore how implementation science approaches could be applied to effect measurable improvements in the design, conducted, and reporting of child health research., (Copyright © 2024 by the American Academy of Pediatrics.)

Purpose: To compare objective physical activity (PA) levels of children with visual impairment (VI) and children with normal sight., Methods: One hundred children with VI and 100 age- and gender-matched normal-sighted peers 7 to 17 years of age wore an ActiGraph for 1 week. Activity count per minute (cpm) was modeled using a series of generalized linear mixed-effects models including vision, age, sex, time of day, and vision by time of day interaction. PA outcomes included mean counts per minute and proportion of time spent on sedentary, light, moderate, and vigorous intensity PA., Results: Data of 83 children with VI and 77 normal-sighted peers were included. Mean counts per minute were lower in children with VI (P < 0.001), especially during and after school. Children with VI were less sedentary (55%; 95% confidence interval [CI], 53-57) than children with normal sight before school (62%; 95% CI, 60-64) and over weekends: children with VI, 41% (95% CI, 39-43); children with normal sight, 45% (95% CI, 43-47). Yet, children with VI were more sedentary during school (36%; 95% CI, 34-37) compared with children with normal sight (30%; 95% CI, 29-32). They also spent more time performing light PA and less time performing moderate PA at school and vigorous PA across all periods of day (P < 0.001)., Conclusions: Children with VI participated in light and moderate PA but did not perform as much vigorous PA as children with normal sight, especially during school hours., Translational Relevance: There is a need to promote more intense PA programs in schools tailored for children with VI.

Purpose: Studies showing problematic sleep patterns in blind and visually impaired children are often based on (parent) self-report. The purpose was to compare sleep patterns of blind children to normally sighted peers using objective measures., Methods: In this cross-sectional study, 100 blind (best-corrected visual acuity <3/60) and 100 age- and gender-matched normally sighted children aged 7 to 17 years wore a digital activity monitoring device for 1 week. Sleep quantity (i.e., total sleep time and total time in bed) and sleep quality (number of awakenings, latency, efficiency, wake after sleep onset [WASO], and sleep fragmentation index) were measured. Adjusted linear regression analyses were used to model group differences in sleep parameters., Results: Data of 163 children were included. Blind children spent significantly less total time in bed in minutes (β, -31; 95% confidence interval, -56 to -6) and had a lower total sleep time (-41; -66 to -17), smaller number of awakenings (-2.8; -4.5 to -1.0), a lower WASO (-10; -16 to -5), and a more efficient sleep pattern (1.5; 0.1 to 2.8) compared to normally sighted children., Conclusions: Although sleep quantity and recommended hours of sleep per night were lower among blind children than normally sighted children, their sleep quality was better. This contradicts findings of self-report studies and warrants further studies to measure sleep objectively. Further, the discrepancy between previous findings and our findings regarding sleep quality may be explained by the house rules of the boarding schools attended by blind children, which may facilitate improved sleep hygiene.

Context: Recently a standard set for overall pediatric health outcomes in routine care was developed, which includes patient (or proxy) reported outcome measures (PROMs) for global health, cognitive functioning, and self-efficacy., Objectives: To determine whether the following PROMs have sufficient measurement properties to be used in pediatric routine care: PROMIS Pediatric and Parent Proxy Scale - Global Health 7+2, PROMIS Parent Proxy Short Form - Cognitive Function 7a, and NIH Toolbox Self-Efficacy CAT Ages 13 to 17., Data Sources: Embase, Psych INFO, and Web of Science were searched from year of inception of each PROM to May 25, 2020; Medline to October 24, 2022., Study Selection: English, full-text peer-reviewed articles that evaluated measurement properties of included PROMs were eligible., Data Extraction: The COSMIN guideline for systematic reviews was used to appraise eligible studies and synthesize the overall evidence., Results: Screening >4000 titles yielded 4 to 6 eligible empirical studies for each PROM. The PROMIS instruments had sufficient content validity with low-quality evidence and at least low-quality evidence for sufficient structural validity and internal consistency. The NIH Toolbox lacked essential evidence for content validity., Limitations: Assessments of measurement properties were based on information reported in the included studies; underreporting might have led to less favorable ratings., Conclusions: The PROMIS instruments assessed in this review measure their intended construct for their targeted age group; clinicians can use these PROMs in pediatric routine care. Additional studies evaluating measurement properties, including content validity, are needed for the NIH Toolbox before it should be recommended for use in clinical practice., (Copyright © 2023 by the American Academy of Pediatrics.)

Purpose: To investigate the agreement between an online nurse-assisted eye-screening tool and reference tests in older adults receiving home healthcare and to collect user experiences., Methods: Older adults (65+) receiving home healthcare were included. Home healthcare nurses assisted in administering the eye-screening tool at participants' homes. Approximately 2 weeks later, a researcher administered reference tests at participants' homes. Experiences from participants and home healthcare nurses were collected. Agreement in outcomes (distance and near visual acuity, with the latter being measured using two different optotypes, and macular problems) between the eye-screening tool and reference clinical testing was compared. A difference of less than ±0.15 logMAR was considered acceptable., Results: A total of 40 participants were included. Here, we describe the results for the right eye; results for the left eye were similar. The mean difference between the eye-screening tool and reference tests for distance visual acuity was 0.02 logMAR. The mean difference between the eye-screening tool and reference tests using two different optotypes for near visual acuity was 0.06 and 0.03 logMAR, respectively. The majority of the individual data points were within the ±0.15 logMAR threshold (75%, 51% and 58%, respectively). The agreement between tests for macular problems was 75%. Participants and home healthcare nurses were generally satisfied with the eye-screening tool, although remarks for further improvements were made., Conclusions: The eye-screening tool is promising for nurse-assisted eye screening in older adults receiving home healthcare, with the mostly satisfactory agreement. After implementing the eye-screening tool in practice, cost-effectiveness needs to be investigated., (© 2023 The Authors. Ophthalmic and Physiological Optics published by John Wiley & Sons Ltd on behalf of College of Optometrists.)

Psychometric properties of the v1.0 Patient-Reported Outcomes Measurement Information System (PROMIS®) sleep disturbance (27 items) and sleep-related impairment (SRI; 16 items) item banks, short forms derived from the item bank, and simulated computerised adaptive test (CAT), were assessed in a representative sample of 1,006 adults from the Dutch general population. For sleep disturbance all items fitted the item response theory model. Four items showed differential item functioning (i.e., lack of measurement invariance) for age and two for language but the impact on scores (expressed as T-scores) was small. Reliable scores (r > 0.90) were found for 92.2%-96.3% of respondents with the full bank, short forms with six and eight items, and CAT, but for only 25.6% with the four-item short form. For SRI two items did not fit the item response theory model. Four items showed differential item functioning for language but the impact on T-scores was small. Reliable scores were found for 82.1% with the full bank, for 47.8%-69.5% with short forms and CAT. T-scores of 49.7 and 49.3 represent the average score of the Dutch general population for sleep disturbance and SRI, respectively. In conclusion, sufficient structural validity, reliability, and cross-cultural validity was found for the full banks but short forms of four items are not reliable enough for clinical practice. For SRI we recommend the full item bank if this is the primary outcome., (© 2022 The Authors. Journal of Sleep Research published by John Wiley & Sons Ltd on behalf of European Sleep Research Society.)

Purpose: To investigate the structural validity, internal consistency, measurement invariance, and construct validity of the Dutch PROMIS-29 v2.1 profile, including seven physical (e.g., pain, physical function), mental (e.g., depression, anxiety), and social (e.g., role functioning) domains of health, in a Dutch general population sample including subsamples with and without chronic diseases., Methods: The PROMIS-29 was completed by 63,602 participants from the Lifelines cohort study. Structural validity of the PROMIS-29, including unidimensionality of each domain and the physical and mental health summary scores, was evaluated using factor analyses (criteria: CFI ≥ 0.95, TLI ≥ 0.95, RMSEA ≤ 0.06, SRMR ≤ 0.08). Internal consistency, measurement invariance (no differential item functioning (DIF) for age, gender, administration mode, educational level, ethnicity, chronic diseases), and construct validity (hypotheses on known-groups validity and correlations between domains) were assessed per domain., Results: The factor structure of the seven domains was supported (CFI = 0.994, TLI = 0.993, RMSEA = 0.046, SRMR = 0.031) as was unidimensionality of each domain, both in the entire sample and the subsamples. Model fit of the physical and mental health summary scores reached the criteria, and scoring coefficients were obtained. Cronbach's alpha for the seven PROMIS-29 domains ranged from 0.75 to 0.96 in the complete sample. No DIF was detected. Of the predefined hypotheses, 78% could be confirmed., Conclusion: Sufficient structural validity, internal consistency and measurement invariance were found, both in the entire sample and in subsamples with and without chronic diseases. Requirements for sufficient evidence for construct validity were (almost) met for most subscales. Future studies should investigate test-retest reliability, measurement error, and responsiveness of the PROMIS-29., (© 2022. The Author(s).)

Purpose of Review: We aimed to systematically evaluate the content validity of patient-reported outcome measures (PROMs) specifically developed to measure (aspects of) health-related quality of life (HRQOL) in people with type 2 diabetes. A systematic review was performed in PubMed and Embase of PROMs measuring perceived symptoms, physical function, mental function, social function/participation, and general health perceptions, and that were validated to at least some extent. Content validity (relevance, comprehensiveness, and comprehensibility) was evaluated using COSMIN methodology., Recent Findings: We identified 54 (different versions of) PROMs, containing 150 subscales. We found evidence for sufficient content validity for only 41/150 (27%) (subscales of) PROMs. The quality of evidence was generally very low. We found 66 out of 150 (44%) (subscales of) PROMs with evidence for either insufficient relevance, insufficient comprehensiveness, or insufficient comprehensibility. For measuring diabetes-specific symptoms, physical function, mental function, social function/participation, and general health perceptions, we identified one to 11 (subscales of) PROMs with sufficient content validity, although quality of the evidence was generally low. For measuring depressive symptoms, no PROM with sufficient content validity was identified. For each aspect of HRQL, we found at least one PROM with sufficient content validity, except for depressive symptoms. The quality of the evidence was mostly very low., (© 2022. The Author(s).)

Introduction: The outcomes anxiety and depression are measured frequently by healthcare providers to assess the impact of a disease, but with numerous instruments. PROMIS item banks provide an opportunity for standardized measurement. Cross-cultural validity of measures and the availability of reference values are prerequisites for standardized measurement., Methods: PROMIS Anxiety and Depression item banks were completed by 1002 representative Dutch persons. To evaluate cross-cultural validity, data from US participants in PROMIS wave 1 were used and differential item functioning (DIF) was investigated, using an iterative hybrid of logistic regression and item response theory. McFadden's pseudo R2-change of 2% was the critical threshold. The impact of any DIF on full item banks and short forms was investigated. To obtain Dutch reference values, T-scores for anxiety and depression were calculated for the complete Dutch sample, and age-group and gender subpopulations. Thresholds corresponding to normal limits, mild, moderate and severe symptoms were computed., Results: In both item banks, two items had DIF but with minimal impact on population level T-scores for full item banks and short forms. The Dutch general population had a T-score of 49.9 for anxiety and 49.6 for depression, similar to the T-scores of 50.0 of the US general population. T-scores for age-group and gender subpopulations were also similar to T-scores of the US general population. Thresholds for mild, moderate and severe anxiety and depression were set to 55, 60 and 70, identical to US thresholds., Conclusions: The limited number of items with DIF and its minimal impact, enables the use of standard (US) item parameters and comparisons of scores between Dutch and US populations. The Dutch reference values provide an important tool for healthcare professionals and researchers to evaluate and interpret symptoms of anxiety and depression, stimulating the uptake of PROMIS measures, and contributing to standardized outcome measurement., Competing Interests: CB Terwee and LD Roorda are members of the PROMIS Health Organization and the Dutch-Flemish PROMIS National Center, which aim to improve health outcomes by developing, maintaining, improving, and encouraging the application of PROMIS in research and clinical practice. This does not alter our adherence to PLOS ONE policies on sharing data and materials. The other authors have no conflict of interest.

Background: Systematic reviews of outcome measurement instruments are important tools in the evidence-based selection of these instruments. COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) has developed a comprehensive and widespread guideline to conduct systematic reviews of outcome measurement instruments, but key information is often missing in published reviews. This hinders the appraisal of the quality of outcome measurement instruments, impacts the decisions of knowledge users regarding their appropriateness, and compromises reproducibility and interpretability of the reviews' findings. To facilitate sufficient, transparent, and consistent reporting of systematic reviews of outcome measurement instruments, an extension of the PRISMA (Preferred Reporting of Items for Systematic reviews and Meta-Analyses) 2020 guideline will be developed: the PRISMA-COSMIN guideline., Methods: The PRISMA-COSMIN guideline will be developed in accordance with recommendations for reporting guideline development from the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network. First, a candidate reporting item list will be created through an environmental literature scan and expert consultations. Second, an international Delphi study will be conducted with systematic review authors, biostatisticians, epidemiologists, psychometricians/clinimetricians, reporting guideline developers, journal editors as well as patients, caregivers, and members of the public. Delphi panelists will rate candidate items for inclusion on a 5-point scale, suggest additional candidate items, and give feedback on item wording and comprehensibility. Third, the draft PRISMA-COSMIN guideline and user manual will be iteratively piloted by applying it to systematic reviews in several disease areas to assess its relevance, comprehensiveness, and comprehensibility, along with usability and user satisfaction. Fourth, a consensus meeting will be held to finalize the PRISMA-COSMIN guideline through roundtable discussions and voting. Last, a user manual will be developed and the final PRISMA-COSMIN guideline will be disseminated through publications, conferences, newsletters, and relevant websites. Additionally, relevant journals and organizations will be invited to endorse and implement PRISMA-COSMIN. Throughout the project, evaluations will take place to identify barriers and facilitators of involving patient/public partners and employing a virtual process., Discussion: The PRISMA-COSMIN guideline will ensure that the reports of systematic reviews of outcome measurement instruments are complete and informative, enhancing their reproducibility, ease of use, and uptake., (© 2022. The Author(s).)

We aimed to systematically assess the measurement properties of diabetes-specific patient-reported outcome measures (PROMs) for measuring physical functioning, one of the core outcomes, in adults with type 2 diabetes.We performed a systematic literature search for PROMs or subscales measuring physical function that were validated to at least some extent in EMBASE and MEDLINE. Measurement properties were evaluated according to the COSMIN guideline for systematic reviews of PROMs.In total 21 articles were included, describing 12 versions of 7 unique diabetes-specific PROMs or subscales measuring physical functioning. In general, there were few high-quality studies on measurement properties of PROMs measuring physical functioning in adults with type 2 diabetes. The Dependence/Daily Life subscale of the Diabetic Foot Ulcer Scale-Short Form (DFS-SF) and the Impact of Weight on Activities of Daily Living Questionnaire (IWADL) were most extensively evaluated. Both had sufficient ratings for aspects of content validity, although with mostly very low-quality evidence. Sufficient ratings for structural validity, internal consistency, and reliability were also found for both instruments, but responsiveness was rated inconsistent for both instruments. The other PROMs or subscales often had insufficient aspects of content validity, or their unidimensionality could not be confirmed.This systematic review showed that the Dependence/Daily Life subscale of the DFS-SF and the IWADL could be used to measure physical functioning in people with type 2 diabetes in research or clinical practice, while keeping the limitations of these instruments in mind. The measurement properties that have not been evaluated extensively for these PROMs should be evaluated in future studies.The study protocol was registered in the PROSPERO database, number CRD42021234890., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: To describe the process of implementing a screening questionnaire for depression and anxiety, the Patient Health Questionnaire-4 (PHQ-4), in low-vision service (LVS) organizations., Methods: This study consisted of three parts: (1) a usability study combined with semistructured interviews, in which clients (n = 10) of LVS organizations expressed their preference for using the PHQ-4; (2) a feasibility study, in which the PHQ-4 was implemented on a small scale and its use was evaluated, involving health care providers (n = 6) and clients (n = 9); and (3) semistructured interviews to identify barriers and facilitators for implementing the PHQ-4 according to health care providers (n = 6) and managers (n = 4) of LVS organizations. Results were integrated into themes and linked to constructs of the Consolidated Framework for Implementation Research (CFIR)., Results: Six themes were derived from the substudies: (1) quality of the intervention, (2) applicability for clients of LVS organizations, (3) attitude and needs of clients, (4) attitude of health care providers, (5) support within LVS organizations, and (6) embedment in current practice. Results could be linked to 12 CFIR constructs. The constructs "relative advantage," "patient needs and resources," and "available resources" emerged most prominently in our themes as either barrier or facilitator., Conclusions: The PHQ-4 seems an appropriate screening instrument for use in LVS organizations because of its quality and adaptable use. It might provide opportunities to timely detect depression and anxiety, but challenges in implementing the PHQ-4 should be considered., Translational Relevance: Barriers and facilitators for implementing the PHQ-4 may also apply to implementing other questionnaires in LVS organizations.

Background: Visual impairment is an important cause of disability in children. There is a lack of information on rehabilitation needs and low vision support services for children with visual impairment in Nepal. This is a pilot study designed to translate, culturally adapt and pre-test the Dutch version of the Participation and Activity Inventory for Children and Youth (PAI-CY) with visual impairment aged 7-17 years to develop a Nepali version. Questionnaires (PAI-CY versions for 7-12 and 13-17 years) were translated using standardized methods and were culturally adapted by a panel of experts. They were pretested to evaluate comprehensibility and relevance among six children with visual impairment and blindness. Finally, participants completed a questionnaire evaluation form., Results: The translation and cultural adaptation process resulted in the adaptation of nine items to make them suitable for Nepali culture. Most children had comprehensibility problems with some specific items because of vocabulary, sentence structure and the composition of items. Most of the children were satisfied with the questionnaires., Conclusion: The study resulted in the development of a Nepali version of the PAI-CY. We worked with a small group of content experts and a small but representative sample of children which allowed us to use rigorous translation procedures to address language and cultural differences. A population based study has been planned to investigate the psychometric properties of these questionnaires., (© 2021. The Author(s).)

Purpose: The purpose of this study was to investigate quality of life and participation in children aged 3 to 17 years with visual impairment (VI) compared to reference groups and between subgroups with increasing severity levels of VI., Methods: Parents of children aged 3 to 17 years (n = 500) and children aged 13 to 17 years (n = 75) completed the Child and Adolescent Scale of Participation (CASP). Children aged 7 to 17 years (n = 263) and their parents (n = 255) completed the KIDSCREEN-27 questionnaire to assess quality of life. Scores were compared to age and/or gender-appropriate population-based samples. For the CASP, a comparison was also made with children with chronic conditions or disabilities. The association between severity of VI and quality of life or participation was analyzed with linear regression models., Results: Children reported significantly worse on Physical Wellbeing and Social Support & Peers, but better on the School Environment KIDSCREEN-27 subscales compared to reference groups. Parents additionally reported worse on Autonomy & Parent Relation. Children's participation was significantly worse compared to a population-based sample, but significantly better compared to children with chronic conditions and disabilities. Having moderate or severe VI/blindness was significantly associated with worse participation, as reported by parents relative to those with no VI., Conclusions: Quality of life of children with VI is affected especially regarding Physical Wellbeing and Social Support & Peers compared to a reference population, and their participation is considerably worse. Participation was more affected in children with more severe VI. These results contribute to the understanding of the impact of VI. Interventions targeting physical health, social skills, and participation are warranted.

Background: To add context to the impact of medical conditions, it is important to interpret and compare health outcomes across studies and populations. We aimed to determine Dutch reference values for the Patient-Reported Outcomes Measurement Information System Scale v1.2 - Global Health (PROMIS-GH)., Methods: The PROMIS-GH, also referred to as PROMIS-10, was completed by 4370 Dutch persons, representative for the 2016 Dutch population. T-scores for the mental health (GMH) and physical health (GPH) subscales, and their shorter two-item subscales, were calculated for the entire population, age groups and gender. T-scores for GMH and GPH were compared to the US reference population, representative for the 2000 US general population. Interpretability thresholds for poor, fair, good, very good and excellent GPH and GMH were calculated based on T-scores of participants, which were categorized into five groups based on their response to item Global01. For each group the mean GPH and GMH T-score was calculated and the midpoint between two adjacent means was identified, resulting in thresholds. Thresholds based on the Dutch data were compared to US thresholds., Results: The Dutch population had a GMH T-score of 44.7 and a GPH T-score of 45.2, both substantially worse than the US reference population T-score of 50. Lower T-scores were also found for age-range and gender subpopulations. Dutch GMH and GPH interpretability thresholds were mostly not substantially different compared to the US thresholds, although the Dutch threshold between fair and poor mental health was considerably higher (29 vs. 38)., Conclusions: This study reports reference values for the PROMIS-GH scale for the Dutch general population, including age-range and gender subpopulations. These reference values provide an important tool for healthcare professionals and researchers to better evaluate and interpret patient-reported mental health and physical health. Scores are notably worse than the US reference values. The exact reason for this remains subject for further research, although possibilities for the differences are discussed, including the presence of differential item functioning and the representativeness and recentness of the data.

Purpose: To investigate the effect and potential predictors of corneal transplantation on patient-reported outcomes such as quality of life, visual functioning, and mental health by systematically reviewing the literature., Methods: Studies with 1 preoperative and at least 1 postoperative measurement were searched for in relevant literature databases. Methodological quality was assessed using the Quality Assessment Tool for Quantitative Studies, and effect sizes were calculated., Results: Of 1445 unique publications, 14 studies, including 15 study designs, were described in 16 publications. Four randomized controlled trials, 1 controlled clinical trial, 1 cohort study, and 1 before-after study (BA) were of good quality; 6 BAs were of moderate quality; and 2 BAs were of weak quality. Patients generally improved 12 months after transplantation on health-related quality of life (effect size between 0.08 and -3.06), vision-related quality of life (-0.67 and -6.65), visual functioning (-0.55 and -0.63), and subjective visual symptoms (-0.31 and -0.86). Patient satisfaction was high (-0.95). Patients improved on depression (-0.31) but remained stable on anxiety (-0.05) 4 months after transplantation. Predictors of positive outcomes were lower preoperative visual acuity and visual functioning, better postoperative visual factors, younger age, and male sex., Conclusions: Corneal transplantation showed overall beneficial effects on patient-reported outcomes. Knowledge of these effects and predictors might result in better treatment, more patient-centered care, and more realistic expectations on the part of patients and ophthalmologists. Future studies should focus on not only health- and vision-related quality of life but also mental health and labor participation using longitudinal study designs.

Background: To assess participation of children with visual impairment, the Participation and Activity Inventory for Children and Youth (PAI-CY) was recently developed. This study assessed some initial psychometric properties of the PAI-CY 13-17 years version, and investigated its feasibility., Methods: Adolescents with visual impairment and their parents (n = 72 dyads) completed the self-report and proxy-report version of the 58-item PAI-CY, an evaluation form and several questionnaires measuring related constructs. Item deletion was informed by item responses, inter-item correlations, test-retest reliability, adolescent-parent agreement and participants' feedback. Known-group validity and concurrent validity with related questionnaires were investigated for the final item-set., Results: Twelve items had > 20% missing values, whereas 39 items showed floor effects. Eight item pairs showed high inter-item correlations. Test-retest reliability was acceptable for most items (kappa ≥0.4). Evaluation forms showed that over 90% of respondents was neutral to very positive regarding several feasibility aspects such as administration time and comprehensiveness. Adolescent-parent agreement was mostly low. These results informed the deletion of three items. Known-group validity seemed adequate since PAI-CY scores were significantly worse for participants with comorbidity compared to those without. A trend towards worse scores for participants with more severe visual impairment was also observed. Correlations between the PAI-CY and related questionnaires confirmed concurrent validity., Conclusions: Initial psychometric properties of the PAI-CY 13-17 were acceptable, although more work is needed to assess other psychometric properties, such as the underlying construct. Following implementation in low vision care to assess participation needs, enabling larger samples, acceptability of the PAI-CY 13-17 to end-users should be carefully monitored, especially if alterations are made based on the current study.

Purpose: Children with visual impairment often experience more difficulties regarding participation compared to sighted peers. The Participation and Activity Inventory for Children and Youth (PAI-CY) has recently been developed to assess their participation needs. A novel application in the field of questionnaires is the use of network analysis to explore interrelations between items in order to capture their complex interactions as a reflection of the overall construct of measurement. This study aimed to apply network modeling for the PAI-CY 7-12 from the perspectives of children and their parents., Methods: Children and their parents ( n = 195) completed the 55-item PAI-CY via face-to-face interviews and a web-based survey, respectively. Internal consistency, test-retest reliability, and concordance between children and parents were investigated. Two networks were created, along with visualizations of shared and differential connections between children and parents., Results: Eight items were deleted. Network structures were dissimilar; for children, connections evolved around social contacts and school items, whereas for parents, mobility, leisure time, acceptance, self-reliance, and communication items prevailed. In the children's network, playing imaginary games, inviting a friend to play at home, and estimating the distance from others were most connected to other items., Conclusions: This study uniquely identifies connections between items of the PAI-CY 7-12, highlighting the different perspectives parents and children have on what defines participation, possibly implying that they perceive the relevance of various rehabilitation programs differently., Translational Relevance: Rehabilitation programs aimed at improving the most connected items might positively affect other items in the network, possibly improving children's participation., Competing Interests: Disclosure: E.B.M. Elsman, None; C.F.W. Peeters, None; R.M.A. van Nispen, None; G.H.M.B. van Rens, None, (Copyright 2020 The Authors.)

Purpose: To identify and monitor the developmental and participation needs of visually impaired (VI) children, the Participation and Activity Inventory for Children and Youth (PAI-CY) has recently been developed involving end-users as stakeholders. The aim was to investigate psychometric properties of the PAI-CY for children between 0 and 2 years., Methods: Responses from 115 parents were included in item analyses, after which a combination of classical test theory and item response theory (IRT) was used. Internal consistency, known-group validity, and test-retest reliability at item and scale level were investigated., Results: After deleting four items, the PAI-CY met IRT assumptions, i.e., unidimensionality, local independence, and monotonicity, and satisfactory model fit was obtained. Participants with more severe VI and comorbidity scored significantly worse than those with less severe VI and without comorbidity, supporting known-group validity. Satisfactory internal consistency and test-retest reliability were obtained (Cronbach's alpha 0.95, kappa 0.60-0.91, ICC 0.920)., Conclusions: The PAI-CY 0-2 years has acceptable psychometric properties and can be used to systematically assess and monitor developmental and participation needs of very young children with VI from parents' perspectives in low vision practice and research. Confirmation of psychometric properties is necessary, possibly facilitating further item reduction, increased precision, and improved user-friendliness.

Background: To assess cross-cultural validity between Dutch and English versions of the FVQ&#95;CYP, a patient-reported outcome measure developed in the United Kingdom (UK) for children and adolescents with (severe) visual impairment or blindness (VI for brevity) to measure functional vision., Methods: The 36-item FVQ&#95;CYP was translated and adapted into Dutch using standard guidelines. The questionnaire was administered to Dutch children and adolescents aged 7-17 years (N = 253) with impaired vision (no restrictions regarding acuity). Data were compared to existing UK data of children and adolescents aged 10-15 years (N = 91) with VI (acuity LogMar worse than 0.48). As with the original UK FVQ&#95;CYP validation, a rating scale model (RSM) was applied to the Dutch data., Results: Minor adaptations were needed in translation-rounds. Significant differences in item responses were found between the Dutch and UK data. Item response theory assumptions were met, but fit to the RSM was unsatisfactory. Therefore, psychometric properties of the Dutch FVQ&#95;CYP were analysed irrespective of the original model and criteria used. A graded response model led to the removal of 12 items due to missing data, low information, overlapping content and limited relevance to Dutch children. Fit indices for the remaining 24 items were adequate., Conclusions: Differences in population characteristics, distribution of responses, non-invariance at the model level and small sample sizes challenged the cross-cultural validation process. However, the Dutch adapted FVQ&#95;CYP showed high measurement precision and broad coverage of items measuring children's functional vision. The underlying reasons for differences between countries in instrument performance are discussed with implications for future studies.

Purpose: The aim was to compare fatigue levels between patients with visual impairment and controls with normal sight and to examine the association between fatigue and vision loss severity., Methods: A systematic literature search was performed using databases of PubMed, Embase, PsycINFO and Cochrane to identify observational studies with outcomes related to fatigue (e.g. vitality subscale of the Short-Form 36, Fatigue Assessment Scale). A meta-analysis was performed using standardised mean differences (SMDs) and odds ratios (OR) to quantitatively summarise the association between visual impairment and fatigue. Sources of heterogeneity were explored by subgroup and sensitivity analyses. Study quality was assessed with the Newcastle-Ottawa scale., Results: After reviewing 4477 studies, 22 studies with a total of 40 004 participants were included, of which 18 contributed to meta-analysis. Among these, eight were assessed as moderate quality studies and 10 as high quality studies. Pooled analysis involving 2500 patients and 8395 controls showed higher fatigue severity levels (S.M.D. = -0.36, 95% CI -0.50 to -0.22, 14 studies) among visually impaired patients compared to normally sighted controls. This effect size was small and persisted in sensitivity analyses that involved study quality, fatigue assessment tools and visual acuity data. Furthermore, pooled analysis of four studies including 2615 patients and 5438 controls showed a significant association between visual impairment and fatigue (OR = 2.61, 95% CI 1.69 to 4.04). Secondary meta-analysis of four studies showed no significant difference in fatigue severity (S.M.D. = 0.01, 95% CI -0.37 to 0.39) between patients with moderate visual impairment and patients with severe visual impairment or blindness., Conclusions: Current moderate to high quality evidence suggest that patients with visual impairment experience more severe fatigue symptoms than persons with normal sight. However, a limited number of available studies indicates that fatigue is not associated with severity of vision loss. Future studies are required to determine which factors and underlying mechanisms may explain the association between visual impairment and fatigue. Discussing fatigue at an early stage and developing intervention options for vision-related fatigue should be considered within the field of low vision rehabilitation., (© 2019 The Authors. Ophthalmic and Physiological Optics published by John Wiley & Sons Ltd on behalf of College of Optometrists.)

Purpose: The Participation and Activity Inventory for Children and Youth 3-6 years (PAI-CY 3-6) was recently developed to assess the participation needs of children with visual impairment (VI) by means of parent-proxy report. This study reports on its psychometric properties., Methods: Parents of children aged 3-6 years registered at two low vision rehabilitation centers in the Netherlands were invited to participate and completed the 52-item PAI-CY. Satisfaction with the PAI-CY 3-6 was determined using an evaluation form. Basic item analyses was conducted, after which an item response theory (IRT) model (i.e. the graded response model, GRM) was fitted. Deletion of items was informed by results of item analyses, fulfillment of IRT assumptions, differential item functioning, fit to the GRM and item information content. Face and content validity were considered; professionals from low vision rehabilitation centers were asked for their opinion in the item deletion process. After obtaining a satisfactory set of items, known-group validity, concurrent validity and test-retest reliability were also investigated., Results: Data of 237 parents were included in the analyses. Various aspects of the PAI-CY 3-6 were perceived as neutral to positive by over 85% of the respondents. After removing 17 items, the remaining 35 items reflected satisfactory fit to the GRM. Known-group validity was supported, since participants with more severe VI and comorbidity scored significantly worse than those with less severe VI and without comorbidity after correcting for potential confounders. Test-retest reliability was adequate, and the PAI-CY showed to have good concurrent validity. Feedback from professionals motivated the maintenance of 3 of the 17 deleted items, although not included in the scoring. Furthermore, two new items were added, resulting in a 40-item instrument., Conclusions: The PAI-CY 3-6 has sound psychometric properties and can now be used to assess the participation needs of children aged 3-6 years with VI by means of proxy. Implementation in routine low vision rehabilitation care enables further optimization and investigation of its acceptability and feasibility., (© 2019 The Authors. Ophthalmic and Physiological Optics published by John Wiley & Sons Ltd on behalf of College of Optometrists.)

Visual impairment in childhood often has life-long implications. To aim for the highest levels of functioning, participation, and quality of life and to ensure children's well-being, children should be entitled to the most effective rehabilitation programs. We review evidence for the effectiveness of rehabilitation interventions for children with visual impairment to improve skills and behavior, thereby improving participation and quality of life as an ultimate goal. Of the 441 potentially relevant articles identified, 66 studies met our inclusion criteria (i.e., 28 randomized controlled trials, 18 nonrandomized controlled trials, and 20 before-after comparisons). The results suggest that sports camps, prescription and training in the use of low vision devices, and oral hygiene programs might be effective in improving functioning and elements of participation and quality of life in children with visual impairment. Other interventions showed mixed or negative results. The results should be interpreted with caution because of moderate to high risk of bias and suboptimal reporting. Heterogeneity of results and the use of over 50 different outcome measures prevented a meta-analysis. Future studies should focus on promising interventions for which effectiveness is still unclear (e.g., mobility, social skills), with adequately designed methodology., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Purpose: To compare health-related quality of life and participation of visually impaired young adults with normative groups, and to explore severity of vision loss and its association with participation and quality of life., Methods: Young adults aged 18-25 years (n = 172) registered at two Dutch low vision rehabilitation organizations completed the Short Form Health Survey (SF-36), EuroQol-5 Dimensions (EQ-5D), Impact on Participation and Autonomy (IPA) and Low Vision Quality of Life questionnaire (LVQOL). EQ-5D and SF-36 scores were compared to age-specific norms. IPA scores were compared to norms of a population having three chronic diseases simultaneously. Linear regression was used to assess the association between severity of vision loss (mild VI, moderate VI and severe VI/blindness), and quality of life and participation., Results: Participants scored significantly worse on almost all (sub)scales compared with relevant norms. Effect sizes for the EQ-5D and SF-36 (sub)scales were mostly small; moderate and large effect sizes were found for the IPA. Compared to young adults with mild VI, corrected models showed a significant association between having moderate VI and the physical component score of the SF-36, and between severe VI/blindness and the LVQOL., Conclusion: VI has a moderate impact on some aspects of quality of life and a large impact on participation of young adults when compared with relevant normative populations. Severity of vision loss is associated with worse physical functioning and vision-related quality of life. The results contribute to a better understanding of the impact of VI and might lead to improved low vision services., (© 2018 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.)

Background: To be able to identify and monitor personal needs and goals of visually impaired young adults before and during rehabilitation trajectories, the Participation and Activity for Young Adults (PAI-YA) was developed involving young adults (18-25 years) and professionals as stakeholders. The psychometric properties of this new patient-reported outcome measure were investigated in order to develop an improved version., Methods: Young adults registered at two low vision rehabilitation centers in the Netherlands were invited to complete the 141-item PAI-YA (n = 186) in a test-retest design. To select the best items for the PAI-YA, response frequencies were assessed and a graded response model (GRM) was fitted. Item reduction was informed by response frequencies, insufficient item information, and participants' comments. Fit indices, item and person (theta) parameters were computed, after which known-group validity, concurrent validity, test-retest reliability and feasibility were studied., Results: Response frequencies, violation of assumptions and item information informed the elimination of 81 items, resulting in a unidimensional PAI-YA showing satisfactory fit to the GRM. Known-group validity showed significant differences for visual impairment, financial situation, sex, educational situation and employment situation. Concurrent validity with (scales of) other questionnaires showed moderate to strong expected correlations. Test-retest reliability was satisfactory for all items (kappa 0.47-0.87), as was agreement (63.1-92.0%). Four items and one response option were added to increase feasibility., Conclusions: This study contributes to the development and assessment of psychometric properties of the PAI-YA, which resulted in an improved 64-item version. Evidence was provided for construct validity, known-group validity, concurrent validity and test-retest reliability. These results are an important step in the development of a feasible instrument to investigate and monitor rehabilitation needs of visually impaired young adults, to structure the intake procedure at low vision rehabilitation services and to evaluate the effectiveness of rehabilitation., Competing Interests: The authors have declared that no competing interests exist.

Purpose: While the impact of visual impairments on specific aspects of young adults' lives is well recognised, a systematic understanding of its impact on all life aspects is lacking. This study aims to provide an overview of life aspects affected by visual impairment in young adults (aged 18-25 years) using a concept-mapping approach., Method: Visually impaired young adults (n = 22) and rehabilitation professionals (n = 16) participated in online concept-mapping workshops (brainstorm procedure), to explore how having a visual impairment influences the lives of young adults. Statements were categorised based on similarity and importance. Using multidimensional scaling, concept maps were produced and interpreted., Results: A total of 59 and 260 statements were generated by young adults and professionals, respectively, resulting in 99 individual statements after checking and deduplication. The combined concept map revealed 11 clusters: work, study, information and regulations, social skills, living independently, computer, social relationships, sport and activities, mobility, leisure time, and hobby., Conclusions: The concept maps provided useful insight into activities influenced by visual impairments in young adults, which can be used by rehabilitation centres to improve their services. This might help in goal setting, rehabilitation referral and successful transition to adult life, ultimately increasing participation and quality of life. Implications for rehabilitation Having a visual impairment affects various life-aspects related to participation, including activities related to work, study, social skills and relationships, activities of daily living, leisure time and mobility. Concept-mapping helped to identify the life aspects affected by low vision, and quantify these aspects in terms of importance according to young adults and low vision rehabilitation professionals. Low vision rehabilitation centres should focus on all life aspects found in this study when identifying the needs of young adults, as this might aid goal setting and rehabilitation referral, ultimately leading to more successful transitions, better participation and quality of life.

Background: Having a visual impairment affects quality of life, daily functioning and participation. To assess rehabilitation needs of visually impaired children and young adults, the Participation and Activity Inventory for Children and Youth (PAI-CY) and Young Adults (PAI-YA) were developed. The PAI-CY comprises four questionnaires for different age categories: 0-2 years, 3-6 years, 7-12 years and 13-17 years. This pilot study assesses the feasibility and acceptability of the PAI-CY and PAI-YA, and the relevance of the content of the questionnaires., Methods: In addition to the regular admission procedure, the PAI-CY and PAI-YA were completed by 30 participants (six per questionnaire). For the PAI-CY, parents completed the questionnaire online prior to admission. From age 7 years onwards, children completed the questionnaire face-to-face with a rehabilitation professional during the admission procedure. Young adults completed the PAI-YA online. Subsequently, participants and professionals administered an evaluation form., Results: Overall, 85% of the parents rated all aspects of the PAI-CY neutral to positive, whereas 100% of all children and young adults were neutral to positive on all aspects, except for the duration to complete. The main criticism of professionals was that they were unable to identify actual rehabilitation needs using the questionnaires. Minor adjustments were recommended for the content of questions., Conclusions: Parents, children and young adults were mostly satisfied with the questionnaires, however, professionals suggested some changes. The adaptations made should improve satisfaction with content, clarification of questions, and satisfaction with the questionnaires in compiling a rehabilitation plan. Although face and content validity has been optimized, a larger field study is taking place to further develop and evaluate the questionnaires.

Purpose: To develop a comprehensive, conceptual model detailing the aspects of a child's life (<18 years) that are affected by low vision., Methods: Three stakeholders were involved in the developmental process of the conceptual model: children and adolescents with a visual impairment (n = 40), parents of children with a visual impairment (n = 25) and professionals of multidisciplinary rehabilitation centres and specialised schools (n = 25). Qualitative methods including focus groups, online and face-to-face brainstorming sessions and concept mapping were used to investigate the impact of visual impairment on the lives of children and adolescents and to create the conceptual model. To aid interpretation of the large age range, four age-bands were formed., Results: For each age-band (0-2, 3-6, 7-12 and 13-17 years), a total of 153, 200, 297 and 306 statements were generated by all stakeholders, respectively. The conceptual models show that low vision affects the sensorial development as well as the physical, psychological and social well-being of children and adolescents. In addition, identified external factors (i.e. education/employment and parental influence) can either facilitate or hinder participation., Conclusions: The developed model shows which life aspects of children are affected by low vision. The needs identified by children and adolescents correspond not entirely to the perspective of parents and low vision professionals. Future research should focus on developing and validating a new questionnaire based on the conceptual model. This will aid goal setting, rehabilitation referral and the accomplishment of developmental milestones and life transitions of children and adolescents with a visual impairment, ultimately improving their participation and quality of life., Competing Interests: A grant for this study was provided by Royal Dutch Visio. The authors declare that they have no conflict of interest.