Ellen Bernadette Maria Elsman

Purpose: The Dutch Adult Strabismus-20 questionnaire (Dutch-AS-20) is a patient-reported outcome measure (PROM) developed to assess the strabismus-specific quality of life (QoL) in adult patients with strabismus in the Netherlands. This 18-item questionnaire comprises a psychosocial and visual function subscale. The aim of this prospective, multicenter, longitudinal study was to evaluate the responsiveness and determine the minimal important change (MIC) of the Dutch-AS-20 in patients undergoing strabismus surgery. Methods: Adult patients scheduled for strabismus surgery were enrolled. The Dutch-AS-20, EQ-5D-5L, Amblyopia and Strabismus Questionnaire (A&SQ), Diplopia Questionnaire (DQ) and two global rating of change (GRC) questions were administered pre- and/or postoperatively. We used a construct approach to assess the responsiveness, testing eight pre-specified hypotheses. We determined the MIC using adjusted anchor-based predictive modelling. Results: A total of 136 patients completed the questionnaires at baseline. All pre-specified hypotheses were met, indicating sufficient responsiveness of both subscales of the Dutch-AS-20. We estimated a MIC of 3.1 T-score points for the psychosocial subscale. We could not estimate the MIC for the visual function subscale due to a low correlation with the GRC question. Conclusion: Both subscales of the Dutch-AS-20 are sufficiently responsive to change in strabismus-specific QoL following strabismus surgery. These findings are an important step towards the use of the Dutch AS-20 in both research and clinical practice. Future research is needed to determine a more precise MIC and individual-level statistics for both subscales, in order to improve the interpretability of change scores for both clinical and research purposes.

Purpose: Systematic reviews of outcome measurement instruments (OMIs) are an important tool to guide the selection of OMIs for research and clinical practice. However, presenting the large amount of complex data pertaining both to the quality of each study (i.e., risk of bias) as well as the quality of the instrument (i.e., measurement properties), along with the underpinning certainty of evidence, is challenging. Here, we aim to provide guidance on optimizing data presentation in OMI systematic reviews, specifically focusing on patient-reported outcome measures (PROMs). Methods: A multidisciplinary team of experts in OMI systematic reviews, research reporting, and data visualization built on existing table templates from OMERACT and the COSMIN initiative, to align with reporting items in a recently developed reporting guideline for systematic reviews of OMIs: PRISMA-COSMIN for OMIs 2024. To enhance clarity and usability, we applied data visualization principles by reducing non-essential elements and improving interpretability through structured layouts and concise explanatory text. Results: We present eight templates for reporting PROM systematic review results: three pertain to PROM characteristics, two to studies’ characteristics, two to the evaluation of measurement properties, and one to the summary of findings. We also provide recommendations on whether to include these templates in the review’s main manuscript or in the supplementary materials. Word versions of these templates can be downloaded from www.prisma-cosmin.ca and www.cosmin.nl . Conclusion: Templates complementing the PRISMA-COSMIN for OMIs 2024 reporting guidance can be used to standardize and enhance the clarity and usefulness of OMI systematic reviews focusing on PROMs. They comprise a comprehensive set of tools to effectively report OMI systematic reviews, in service of end-users who are selecting OMIs.

Purpose: To evaluate the long‐term effect of corneal transplantation on health‐ and vision‐related quality of life, visual functioning, and societal participation, and to assess potential predictors. Methods: We conducted a multicenter prospective cohort study in 11 Dutch hospitals and eye clinics. Patients awaiting corneal transplantation ( n = 238) completed the Low Vision Quality of Life (LVQOL) questionnaire, Catquest‐9SF, Utrecht Scale for Evaluation of Rehabilitation‐Participation (USER‐P), and EuroQol‐5 Dimensions (EQ‐5D) at baseline and 3, 6, 12, and 24 months post‐transplantation. Potential predictors included sociodemographic and clinical characteristics. Linear mixed models analysed changes over time for most outcomes, and generalized estimating equations assessed EQ‐5D outcomes. Results: LVQOL subscale scores improved significantly from baseline to 24 months, with large effect sizes (Basic aspects: 44.5 vs. 24.7, p < 0.001; Mobility: 36.0 vs. 18.7, p < 0.001; Adjustment: 24.1 vs. 9.5, p < 0.001; Reading and Fine work: 28.0 vs. 12.2, p < 0.001), as did Catquest scores (57.6 vs. 79.8, p < 0.001). USER‐P Restrictions and Satisfaction improved (Restrictions: 83.6 vs. 88.0, p < 0.001; Satisfaction: 68.2 vs. 73.9, p < 0.001), while the Frequency subscale deteriorated (32.7 vs. 29.4, p < 0.001). Effect sizes were all small. The proportion with a perfect EQ‐5D score increased (47.7% vs. 56.5%, p = 0.04). Male sex, having work, and Fuchs' dystrophy predicted better outcomes, whereas visual impairment and (dry) eye complaints predicted worse outcomes. Conclusion: Health‐ and vision‐related quality of life, visual functioning, and societal participation are positively impacted by corneal transplantation, and important predictors were identified. The results of this study can be used by ophthalmologists to inform patients about realistic expectations of corneal transplantation.

Introduction: To evaluate the long‐term effect of corneal transplantation on mental health outcomes and to assess potential predictors of these outcomes. Methods: For this multicentre prospective cohort study, patients awaiting corneal transplantation were recruited from 11 (academic) hospitals and eye clinics in the Netherlands. Participants ( n = 238) completed the Centre for Epidemiological Studies Depression scale (CES‐D), the Hospital Anxiety and Depression Scale‐Anxiety subscale (HADS‐A) and the Dutch ICF Activity Inventory Emotional Health subscale (DAI‐EH) and Fatigue subscale (DAI‐F) 1 month prior and 3, 6, 12 and 24 months after corneal transplantation. Sociodemographic and clinical characteristics, as well as coping styles as measured with the Utrecht Coping List, were considered as potential predictors for mental health outcomes (depression, anxiety, emotional health problems and fatigue). Linear mixed models were used to analyse and predict symptoms of depression, anxiety, emotional health problems and fatigue over time. Results: Scores on the CES‐D and HADS‐A improved significantly from baseline to 24‐months (mean scores CES‐D: 8.6 vs. 7.7, p = 0.03; mean scores HADS‐A: 3.7 vs. 3.2, p = 0.002). Scores on the DAI‐EH and DAI‐F also improved significantly from baseline to 24‐months (mean scores DAI‐EH: 10.7 vs. 7.5, p < 0.001; mean scores DAI‐F: 17.4 vs. 11.3, p < 0.001). Male sex and Fuchs' dystrophy were important predictors of better mental health outcomes, whereas comorbidity, (dry) eye complaints and a passive reacting coping style were important predictors of worse mental health outcomes. Conclusion: Corneal transplantation had a positive impact on mental health outcomes and important predictors were identified. This study may improve the understanding of patients and eyecare practitioners about the effects of corneal transplantation, leading to realistic communication about corneal transplantation expectations.

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.