In her PhD research, epidemiologist and optometrist Petra Rausch has developed a PROM that can be administered computer adaptively (CAT) in ophthalmic clinical practice. Instead of a long questionnaire, an algorithm determines which questions are important to the patient. In this way, the burden to fill out the questionnaire for the patient remains low. The questionnaire is called the CAT-EyeQ and can be used as a monitoring tool for the assessment of vision-related quality of life in patients who are being treated with intra-ocular anti-VEGF injections. The new PROM has been validated among more than 700 patients with macular edema due to several exudative retinal diseases.
Why are we doing this study?
The significant impact of having a visual impairment on quality of life and psychosocial functioning is well known. Retinal exudative conditions such as ‘wet’ age-related macular degeneration and macular edema due to diabetic retinopathy are the leading causes of vision loss in the elderly. To date there is no cure, however, anti-VEGF (the medicines that reduce vascular leakage and inhibits neovascularization) is injected into the eyes of patients with macular edema according to an individually tailored interval pattern. The treatment effects vary between patients: for about 80% of the patients the treatment leads to a stabilization or a substantial improvement of vision, but for about 20% the treatment is less effective and vision will progressively reduce. It is estimated that by 2020 there will be about 65.000 people who receive anti-VEGF treatment several times a year. However, the collaboration between ophthalmic clinical practices where patients receive anti-VEGF treatment and the visual rehabilitation centers is not yet self-evident.
Patient Reported Outcome Measures (PROMs) have been developed to measure the impact of disability and are used for the evaluation of treatment effects and to improve patient-doctor. Nowadays, PROMs are important indicators of quality of care. In ophthalmic clinical practice the patient perspective is currently assessed anecdotally and not yet structured in a digital environment. However, the newly developed EyeQ can be used as a computer adaptive test (CAT), called the CAT-EyeQ, to structurally measure patient perspective on their disease. Implementation of the CAT-EyeQ, built into a digital tool, should lead to the optimization of treatment effects evaluation, shared decision-making, patient-doctor communication and to enhance the referral to visual rehabilitation and make this more self-evident.
What is the aim of this study?
The aim of this study is to ensure the use of both clinical and patient reported outcome measures implemented in a digital tool to optimize the evaluation of treatment effects, shared decision making, patient-doctor communication and enhance the referral to visual rehabilitation and make this more self-evident. Sub-goals are:
- Translate the Impact of Vision Impairment Profile (Vision-related quality of life questionnaire) and assess the content validity of the Dutch translated version of the IVI;
- Add the Dutch IVI with items that measures vision-related quality of life to broaden the items collection and calibrate this ‘item-bank’ in cross-sectional research and longitudinal research and subsequently develop the CAT algorithm;
- Perform simulations of the computer adaptive test of the EyeQ, to investigate which rules must be set to optimize the performance of the computer adaptive test of the EyeQ in clinical practice.
- Investigate success factors and barriers for the implementation of the CAT in qualitative research.
How do we conduct this study?
Qualitative, cross-sectional (baseline) and longitudinal data are used to achieve the study aims. Patients (N=700) receiving monocular or binocular anti-VEGF intra-ocular injections for exudative retinal diseases potentially causing severe visual impairment (such as macular degeneration, diabetic retinopathy and retinal vein occlusions) were invited to participate in this study. Based on COSMIN standards for research of psychometric aspects of instruments, we follow the following steps:
First, the translation of the Dutch IVI was done and to assess the content validity of the questionnaire patients (N=10) participated in a qualitative research. The purpose of study was to evaluate if patients understand the questions, the response options and the questionnaire instructions. We evaluates this using a “think out loud” method. The results of this study has been published.
Second, data was collected: Socio-demographic characteristics and clinical data were collected using a questionnaire and were searched in clinical patient records. The total EyeQ questionnaire was mainly digitally filled out using CASTOR where items were presented in random order. We calibrated the EyeQ itembank using a model based on Item Response Theory (IRT). The CAT algorithm has been developed. The results of this step has been published.
Post hoc simulations were performed to evaluate what the optimal stopping rules can be used for the CAT-EyeQ. We evaluated four different combinations of stopping rules. Real data (collected for the calibration of the EyeQ itembank) was used for this step. The results of this step has been published.
Also factors (clinical of demographic) that are predictive of a lower vision-related quality (over time) were investigated using linear mixed models. The results of this study has been published.
Prof.dr. Ger van Rens, Prof.dr. Ruth van Nispen, Dr. Frank Verbraak
Rausch–Koster, T. P., van der Ham, A. J., Terwee, C. B., Verbraak, F. D., van Rens, G. H. M. B., & van Nispen, R. M. A. (2021). Translation and content validity of the Dutch Impact of Vision Impairment questionnaire assessed by Three-Step Test-Interviewing. Journal of Patient-Reported Outcomes, 5(1), . https://doi.org/10.1186/s41687-020-00272-z
Rausch–Koster, T. P., Luijten, M.A.J., Verbraak, F. D., van Rens, G. H. M. B., & van Nispen, R. M. A. (2022). Calibration of the Dutch EyeQ to Measure Vision Related Quality of Life in Patients With Exudative Retinal Diseases | TVST | ARVO Journals
Rausch–Koster, T. P., Luijten, M.A.J., Verbraak, F. D., van Rens, G. H. M. B., & van Nispen, R. M. A. (2022). Optimizing Computer Adaptive Test Performance: A Hybrid Simulation Study to Customize the Administration Rules of the CAT-EyeQ in Macular Edema Patients | TVST | ARVO Journals
Rausch-Koster TP, Rennert KN, Heymans MW, Verbraak FD, van Rens GH, van Nispen RM. Predictors of vision-related quality of life in patients with macular oedema receiving intra-vitreal anti-VEGF treatment. Ophthalmic Physiol Opt2022;00:1– 9. https://doi.org/10.1111/opo.12984