Health economic evaluation of a nurse-assisted online eye screening in home healthcare to reduce avoidable vision impairment (iScreen): study protocol for a cluster randomized controlled trial.

BACKGROUND: Among older people undiagnosed and untreated vision impairment and blindness are common. The leading causes are uncorrected refractive errors and cataracts. Vision problems are associated with a lower quality of life, several health problems, and a higher chance of falling accidents and fractures. To eliminate avoidable vision impairment and blindness, targeted eye screening programs are recommended. Older patients, receiving home healthcare, have not yet been considered as a population at risk who could benefit from eye screening. METHODS: A cluster-randomized controlled trial will be conducted to investigate the cost-effectiveness and cost-utility of online nurse-assisted eye screening in home healthcare, compared to care as usual, in reducing avoidable vision impairment. A healthcare and societal perspective will be used. The study will be performed in collaboration with several home healthcare organizations in the Netherlands. The online eye screening consists of near and distance visual acuity, followed by an Amsler grading test. Measurements in both groups will take place at baseline and after 6 and 12 months of follow-up. A total of 240 participants will be recruited. Older men and women (65 +), who receive home-based nursing and are cognitively able to participate, will be included. The primary outcome will be the change of two lines or more on the Colenbrander-1 M visual acuity chart between baseline and 12-month follow-up. DISCUSSION: An eye screening for populations at risk contributes to the detection of undiagnosed and untreated vision impairment. This may reduce the health-related consequences of vision loss and the high economic burden associated with vision impairment. TRIAL REGISTRATION: ClinicalTrials.gov NCT06058637. Registered on 27 September 2023.

E-nergEYEze, a vision-specific eHealth intervention based on cognitive behavioral therapy and self-management to reduce fatigue in adults with visual impairment: study protocol for a randomized controlled trial.

BACKGROUND: More than half of the adults with visual impairment experience severe symptoms of fatigue, with a negative impact on daily life. Since there is no evidence-based treatment to reduce fatigue in adults with visual impairment, we developed E-nergEYEze, an eHealth intervention based on cognitive behavioral therapy and self-management tailored to the needs of visually impaired adults. The aim is to describe the study protocol of a randomized controlled trial testing E-nergEYEze. METHODS: A randomized controlled trial will be conducted to investigate the cost-effectiveness and cost-utility of E-nergEYEze to reduce fatigue severity compared to care as usual from a healthcare and societal perspective. A total of 172 severely fatigued adults with visual impairment will be recruited and randomized to either the E-nergEYEze intervention plus care as usual or to care as usual only (ratio 1:1). Inclusion criteria are having a visual impairment, experiencing severe fatigue (Checklist Individual Strength - subscale Fatigue Severity: CIS-FS > 35), being 18 years or older, understanding the Dutch language, and having access to the internet. The intervention consists of one face-to-face session and a computer training followed by internet-based modules with information and assignments on coping with fatigue. During this 5-month intervention, participants will be digitally supported by a social worker. All measurements will be administered at baseline, after 6 and 12 months, and additionally, those related to cost-effectiveness at 3 and 9 months. The primary outcome is fatigue severity (CIS-FS). DISCUSSION: Severe fatigue on top of visual impairment compromises quality of life and is associated with incremental societal costs that largely determine the economic burden of low vision or blindness. E-nergEYEze contributes to the evidence base of potentially feasible interventions to reduce the important health-related consequences of vision loss and could fulfill the gap in knowledge, skills and treatment options for low vision services. TRIAL REGISTRATION: Dutch Trial Register NTR7764 . Registered on 28 May 2019.

Quality of Life and Participation of Children With Visual Impairment: Comparison With Population Reference Scores.

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.

Improving the participation of adults with visual and severe or profound intellectual disabilities: a process evaluation of a new intervention.

BACKGROUND: While the participation of adults with visual and severe or profound intellectual disabilities (VSPID) in society and community life is important, evidence-based interventions to improve their participation are lacking. We conducted a process evaluation of the implementation of 'Care for Participation+' (CFP+), a new intervention targeting the attitudes of direct support professionals (DSPs) toward the participation of adults with VSPID, within a residential facility in the Netherlands. METHODS: CFP+ was inspired by the Boston Psychiatric Rehabilitation Approach and adapted by adopting a new definition and operationalization of the concept of participation for adults with VSPID. Following systematic training, 16 DSPs of adults with VSPID were able to apply key elements of CFP+ to explore diverse roles and activities for this population, facilitating their self-management, teaching them necessary skills for participation, and organizing support. Our process evaluation entailed an investigation of the delivered dose, reach, fidelity, and adaptation of CFP+ during and after the CFP+ intervention. We also evaluated the mechanisms of impact and context using questionnaires, assignments, documentation, interviews, and a logbook. RESULTS: The intended dose, reach, and fidelity relating to the implementation of CFP+ were not achieved. Despite this fact, an assessment of the mechanisms of impact indicated that assignments of CFP+ were well (75%) or reasonably well (17%) understood by DSPs. CFP+ was applied by DSPs to stimulate self-management (83% of DSPs), new activities (100%), enhanced involvement in existing activities (67%) and to explore new roles (50%) for adults with VSPID. A negative contextual factor mentioned by the trainer and manager was the DSPs' lack of commitment to the training program. Another negative contextual factor mentioned by DSPs was the lack of time for implementing CFP+. CONCLUSIONS: CFP+ provides new opportunities to improve the participation of adults with VSPID. Despite the non-optimal conditions for implementing CFP+ and the DSPs' general reluctance to apply the new intervention, some have actively used CFP+ within the residential facility. Future studies should focus on the outcomes of CFP+ regarding attitudinal changes among DSPs relating to the participation of adults with VSPID and their quality of life.

The Economic Burden of Visual Impairment and Comorbid Fatigue: A Cost-of-Illness Study (From a Societal Perspective).

Purpose: To investigate the burden of visual impairment and comorbid fatigue in terms of impact on daily life, by estimating societal costs (direct medical costs and indirect non-health care costs) accrued by these conditions. Methods: This cost-of-illness study was performed from a societal perspective. Cross-sectional data of visually impaired adults and normally sighted adults were collected through structured telephone interviews and online surveys, respectively. Primary outcomes were fatigue severity (FAS), impact of fatigue on daily life (MFIS), and total societal costs. Cost differences between participants with and without vision loss, and between participants with and without fatigue, were examined by (adjusted) multivariate regression analyses, including bootstrapped confidence intervals. Results: Severe fatigue (FAS ≥ 22) and high fatigue impact (MFIS ≥ 38) was present in 57% and 40% of participants with vision loss (n = 247), respectively, compared to 22% (adjusted odds ratio [OR] 4.6; 95% confidence interval [CI] [2.7, 7.6]) and 11% (adjusted OR 4.8; 95% CI [2.7, 8.7]) in those with normal sight (n = 233). A significant interaction was found between visual impairment and high fatigue impact for total societal costs (€449; 95% CI [33, 1017]). High fatigue impact was associated with significantly increased societal costs for participants with visual impairment (mean difference €461; 95% CI [126, 797]), but this effect was not observed for participants with normal sight (€12; 95% CI [-527, 550]). Conclusions: Visual impairment is associated with an increased prevalence of high fatigue impact that largely determines the economic burden of visual impairment. The substantial costs of visual impairment and comorbid fatigue emphasize the need for patient-centered interventions aimed at decreasing its impact.

Economic evaluation of an e-mental health intervention for patients with retinal exudative diseases who receive intraocular anti-VEGF injections (E-PsEYE): protocol for a randomised controlled trial.

INTRODUCTION: Because of the great potential of vascular endothelial growth factor inhibitors (anti-VEGF) for retinal exudative diseases, an increased number of patients receives this treatment. However, during this treatment, patients are subjected to frequent invasive intravitreal injections, and the effects on reversing the process of vision loss are uncertain, which may have negative consequences for patients' mental health. One in three patients experience at least mild symptoms of depression/anxiety. To support patients in dealing with these symptoms, an e-mental health intervention (called E-PsEYE) has been developed. E-PsEYE is based on cognitive-behavioural therapy (CBT) and contains nine modules. A stepped-care model with three steps will be used to deliver the intervention: (1) providing information and psychoeducation, (2) when symptoms of depression/anxiety persist, guided CBT is offered and supported by social workers from low vision rehabilitation services and (3) when symptoms still persist, patients are referred to their general practitioner. METHODS AND ANALYSIS: An economic evaluation from a healthcare and societal perspective will be conducted alongside a multicentre randomised controlled trial in two parallel groups to evaluate whether E-PsEYE is cost-effective in comparison with usual care. Participants (n=174) will be 50 years or older, have retinal exudative diseases, receive anti-VEGF treatment and have mild symptoms of depression/anxiety (assessed prior to randomisation). Main outcome measures are: depression (Patient Health Questionnaire-9), anxiety (Hospital Anxiety and Depression Scale-Anxiety) and quality-adjusted life-years (determined with the Health Utility Index-3 and the EuroQol-5 dimensions). Five measurements take place: at baseline and after 3, 6, 9 and 12 months. ETHICS AND DISSEMINATION: The study has been approved by the Medical Ethics Committee of the VU University Medical Centre Amsterdam. It will provide new and essential information on the cost-effectiveness of an innovative intervention for a vulnerable population. Outcomes will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION: http://www.trialregister.nl, identifier: NTR6337.

Economic evaluation of stepped-care versus usual care for depression and anxiety in older adults with vision impairment: randomized controlled trial.

BACKGROUND: A stepped-care program was found effective in preventing depressive and anxiety disorders in older adults with vision impairment. However, before a decision can be made about implementation, the cost-effectiveness of this program should be investigated. Therefore, we aimed to compare the cost-effectiveness of stepped-care versus usual care within low vision rehabilitation. METHODS: An economic evaluation from a societal perspective was performed alongside a multicenter randomized controlled trial. Data were collected by masked assessors during 24 months. Included were 265 older adults with vision impairment and subthreshold depression and/or anxiety. They were randomly assigned to stepped-care plus usual care (n = 131) or usual care alone (n = 134). Stepped-care comprised 1) watchful waiting, 2) guided self-help based on cognitive behavioral therapy, 3) problem solving treatment, and 4) referral to a general practitioner. Costs were based on direct healthcare costs and indirect non-healthcare costs. Main outcome measures were quality-adjusted life years (QALYs) and the cumulative incidence of major depressive, dysthymic and/or anxiety disorders. Secondary outcomes were symptoms of depression and anxiety. RESULTS: Based on intention-to-treat, significant differences were found in the incidence of depressive/anxiety disorders (mean difference 0.17; 95% CI 0.06 to 0.29) and symptoms of anxiety (mean difference 1.43, 95% CI 0.10 to 2.77) in favor of stepped-care versus usual care; no significant difference was found for QALYs and symptoms of depression. Societal costs were non-significantly lower in the stepped-care group compared with the usual care group (mean difference: -€877; 95% confidence interval (CI): -8039 to 5489). Cost-effectiveness acceptability curves showed that the probability of cost-effectiveness was 95% or more at a willingness-to-pay of €33,000 per disorder prevented. The probability that stepped-care was cost-effective compared to usual care was 59% or more for a ceiling ratio of 0 €/QALY and increased to 65% at 20000 €/QALY. CONCLUSIONS: This economic evaluation shows that stepped-care is dominant to usual care, with a probability of around 60%, due to its clinical superiority and its modest cost savings. However, it depends on the willingness-to-pay of decision makers whether or not stepped-care is considered cost-effective compared with usual care. TRIAL REGISTRATION: identifier: NTR3296 , date: 13-02-2012.

Investigating rehabilitation needs of visually impaired young adults according to the International Classification of Functioning, Disability and Health.

PURPOSE: To gain qualitative insight into the rehabilitation needs of visually impaired young adults (18-25 years) and how these needs relate to the International Classification of Functioning, Disability and Health (ICF) and patient characteristics. METHODS: Rehabilitation needs and patient characteristics of young adults (N = 392) who applied for multidisciplinary services in 2012 and 2013 were obtained from structured and semi-structured intake records. Linking rules were used to assess how the needs related to Environmental Factors, Body Functions, Body Structures, and Activity and Participation (A&P) ICF components. The relationship between the type of rehabilitation goal and patient characteristics was assessed using multivariate logistic regression analyses. RESULTS: Most rehabilitation needs (67.6%; N = 510) were found on the A&P component of the ICF. Most prevalent needs were related to 'major life areas' (e.g. finding internship or job), followed by the chapters: 'mobility' (e.g. self-reliance in travelling), 'communication' (e.g. using communication devices and techniques), 'general tasks and demands' (e.g. psychological aspects of vision loss) and 'domestic life' (e.g. household tasks). Patients in one of the multidisciplinary rehabilitation centres (odds ratio (OR) = 7.07; 95% confidence interval (CI) [2.97-16.83]) and patients with comorbidity (OR = 3.82; 95% CI [1.62-9.02]) were more likely to report rehabilitation needs related to chapter E3 'support and relationships'. CONCLUSION: 'Major life areas' prevail in the content of rehabilitation needs, but tend to overshadow topics regarding peer interaction and social, community and civic life. A suitable survey method for young adults with visual impairments is required that contains rehabilitation domains and goals relevant to their lives and development.

Watchful waiting for subthreshold depression and anxiety in visually impaired older adults.

PURPOSE: Immediate treatment of depression and anxiety may not always be necessary in resilient patients. This study aimed to determine remission rates of subthreshold depression and anxiety, incidence rates of major depressive and anxiety disorders, and predictors of these remission and incidence rates in visually impaired older adults after a three-month 'watchful waiting' period. METHODS: A pretest-posttest study in 265 visually impaired older adults (mean age 74 years), from outpatient low-vision rehabilitation services, with subthreshold depression and/or anxiety was performed as part of a randomised controlled trial on the cost-effectiveness of a stepped-care intervention. An ordinal logistic regression analysis was conducted. Main outcome measures were: (1) subthreshold depression and anxiety measured with the Centre for Epidemiologic Studies Depression Scale (CES-D) and the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A), and (2) depressive and anxiety disorders measured with the Mini International Neuropsychiatric Interview. RESULTS: After a three-month watchful waiting period, depression and anxiety decreased significantly by 3.8 (CES-D) and 1.4 points (HADS-A) (p < 0.001). Of all participants, 34 % recovered from subthreshold depression and/or anxiety and 18 % developed a depressive and/or anxiety disorder. Female gender [odds ratio (OR) 0.49, 95 % confidence interval (CI) 0.28-0.86], more problems with adjustment to vision loss at baseline (OR 1.02, 95 % CI 1.00-1.03), more symptoms of depression and anxiety at baseline (OR 1.06, 95 % CI 1.02-1.10), and a history of major depressive, dysthymic, and/or panic disorder (OR 2.28, 95 % CI 1.28-4.07) were associated with lower odds of remitting from subthreshold depression and/or anxiety and higher odds of developing a disorder after watchful waiting. CONCLUSIONS: Watchful waiting can be an appropriate step in managing depression and anxiety in visually impaired older adults. However, female gender, problems with adjustment to vision loss, higher depression and anxiety symptoms, and a history of a depressive or anxiety disorder confer a disadvantage. Screening tools may be used to identify patients with these characteristics, who may benefit more from higher intensity treatment or a shorter period of watchful waiting.

Why visually impaired older adults often do not receive mental health services: the patient's perspective.

PURPOSE: Older adults with a visual impairment are particularly vulnerable for increased depression and anxiety symptoms; however, they tend to underutilise mental health services. The present study aims to characterise the perceived need for and barriers to use mental health services in visually impaired older adults based on Andersen's behavioural model. METHODS: A cross-sectional study in 871 visually impaired older adults (mean age 73 years) from outpatient low vision rehabilitation services was conducted. A multinomial logistic regression analysis was performed to assess potential-related factors to perceived need for mental health services, measured with the Perceived Need for Care Questionnaire (PNCQ). RESULTS: About 35 % of the population had subthreshold depression and/or anxiety, and 13 % had a mood and/or anxiety disorder according to the DSM-IV. Almost 34 % of the participants with an actual disorder did not receive mental health services, even though 57 % perceived to be in need of these services. Participants who had more severe depression and/or anxiety, comorbid depression and anxiety, no history of major depressive disorder, a lower perceived health status and a younger age were more likely to be in need of mental health services. Barriers to receive these services were lack of knowledge and self-reliance. CONCLUSIONS: Findings support the implementation of counselling methods, instead of medication, and patient empowerment to reduce an unmet need of mental health services in visually impaired older adults, for which extensive research is warranted.

Stepped-care to prevent depression and anxiety in visually impaired older adults--design of a randomised controlled trial.

BACKGROUND: Subthreshold depression and anxiety are common in the growing population of visually impaired older adults and increase the risk of full-blown depressive or anxiety disorders. Adequate treatment may prevent the development of depression or anxiety in this high risk group. METHOD/DESIGN: A stepped-care programme was developed based on other effective interventions and focus groups with professionals and patient representatives of three low vision rehabilitation organisations in The Netherlands and Belgium. The final programme consists of four steps: 1) watchful waiting, 2) guided self-help, 3) problem solving treatment, 4) referral to general practitioner. The (cost-)effectiveness of this programme is evaluated in a randomised controlled trial. Patients (N = 230) are randomly assigned to either a treatment group (stepped-care) or a control group (usual care). The primary outcome is the incidence of depressive and anxiety disorders, measured with the Mini International Neuropsychiatric Interview (MINI). DISCUSSION: Preventive interventions for depression and anxiety have received little attention in the field of low vision. A stepped-care programme that focuses on both depression and anxiety has never been investigated in visually impaired older adults before. If the intervention is shown to be effective, this study will result in an evidence based treatment programme to prevent depression or anxiety in patients from low vision rehabilitation organisations. The pragmatic design of the study greatly enhances the generalisability of the results. However, a possible limitation is the difficulty to investigate the contribution of each individual step. TRIAL REGISTRATION: Identifier: NTR3296.

Assessment of night vision problems in patients with congenital stationary night blindness.

Congenital Stationary Night Blindness (CSNB) is a retinal disorder caused by a signal transmission defect between photoreceptors and bipolar cells. CSNB can be subdivided in CSNB2 (rod signal transmission reduced) and CSNB1 (rod signal transmission absent). The present study is the first in which night vision problems are assessed in CSNB patients in a systematic way, with the purpose of improving rehabilitation for these patients. We assessed the night vision problems of 13 CSNB2 patients and 9 CSNB1 patients by means of a questionnaire on low luminance situations. We furthermore investigated their dark adapted visual functions by the Goldmann Weekers dark adaptation curve, a dark adapted static visual field, and a two-dimensional version of the "Light Lab". In the latter test, a digital image of a living room with objects was projected on a screen. While increasing the luminance of the image, we asked the patients to report on detection and recognition of objects. The questionnaire showed that the CSNB2 patients hardly experienced any night vision problems, while all CSNB1 patients experienced some problems although they generally did not describe them as severe. The three scotopic tests showed minimally to moderately decreased dark adapted visual functions in the CSNB2 patients, with differences between patients. In contrast, the dark adapted visual functions of the CSNB1 patients were more severely affected, but showed almost no differences between patients. The results from the "2D Light Lab" showed that all CSNB1 patients were blind at low intensities (equal to starlight), but quickly regained vision at higher intensities (full moonlight). Just above their dark adapted thresholds both CSNB1 and CSNB2 patients had normal visual fields. From the results we conclude that night vision problems in CSNB, in contrast to what the name suggests, are not conspicuous and generally not disabling.

A multilevel item response theory model was investigated for longitudinal vision-related quality-of-life data.

OBJECTIVE: To investigate how a multilevel item response theory (IRT) model for longitudinal dependent data could provide average and individual quality-of-life outcomes of low-vision rehabilitation. STUDY DESIGN AND SETTING: In a nonrandomized longitudinal design, visually impaired older patients (n=296) were referred to multidisciplinary rehabilitation or to an optometric service. The five-dimensional Low Vision Quality of Life Questionnaire was administered at four time points. The IRT model was characterized by the graded response model for rating scales. Covariates were added to the model, mainly to correct for missing data. The invariance assumption across time points was investigated. RESULTS: Average and individual rehabilitation effects were estimated. For multidisciplinary rehabilitation, significant average deterioration was seen on three dimensions after 4.4 years. Many individuals in the optometric service group significantly improved on the "reading small print" dimension (18.5%); in both groups, many individuals significantly deteriorated on "visual (motor) skills" (22.2-30.0%). Invariance across time points could be assumed for all dimensions, except for "adjustment." Gender, education, visual acuity, and health status were significantly associated with the outcome. CONCLUSION: We present how a multilevel IRT model can be applied to describe longitudinal dependent vision-related quality-of-life data, while focusing on average and individual effects.