Vision-related quality of life in adults with severe peripheral vision loss: a qualitative interview study.

BACKGROUND: Existing patient-reported outcome (PRO) measures may not be relevant to the full range of functional and vision-related quality of life (VR-QOL) concerns of individuals with vision impairment due to severe peripheral field loss (PFL). Measurement of VR-QOL in severe PFL is important in order to determine the effectiveness of vision rehabilitation interventions for this population. The purpose of this study was to characterize the impact of severe PFL due to retinitis pigmentosa (RP) and glaucoma on VR-QOL as the initial phase in the development of a novel PRO measure. METHODS: Individuals with severe PFL due to RP or glaucoma were recruited from the Kellogg Eye Center and the Association for the Blind and Visually Impaired. Participants completed semi-structured qualitative interviews, the Impact of Vision Impairment (IVI) questionnaire and the RAND 36-Item Health Survey. Interviews were analyzed by two coders using thematic analysis. A matrix analysis was conducted to compare VR-QOL by cause of severe PFL. Sample size was determined by thematic saturation. RESULTS: The study included 37 participants (19 RP, 18 glaucoma). Median best-corrected visual acuity for those with RP and glaucoma was 20/40 and 20/27.5, while Pelli-Robson contrast sensitivity was 1.2 log contrast sensitivity (logCS) and 1.1 logCS, respectively. Median domain scores on the IVI (reading, mobility, well-being) ranged from a low of - 0.2 to a high of 0.7 logits in those with RP and from 0.5 to 1.2 logits in those with glaucoma. Qualitative interviews identified six VR-QOL themes relevant across participants with both RP and glaucoma, including activity limitations, driving, emotional well-being, reading, mobility, and social function. VR-QOL concerns were largely consistent among those with severe PFL due to RP and glaucoma. These overarching themes contained content relevant to specific challenges related to severe PFL. CONCLUSIONS: There are commonly occurring VR-QOL concerns among individuals with severe PFL due to RP and glaucoma. The outlined themes will serve as the basis for development of the Low Vision Severely Constricted Peripheral Eyesight (LV-SCOPE) Questionnaire.

The Michigan Retinal Degeneration Questionnaire: A Patient-Reported Outcome Instrument for Inherited Retinal Degenerations.

PURPOSE: To create a psychometrically validated patient-reported outcome measure for inherited retinal degenerations. DESIGN: Qualitative and quantitative patient-reported outcome (PROs) questionnaire development using item response theory validation. METHODS: One hundred twenty-eight patients with a diagnosis of an inherited retinal degeneration at the Kellogg Eye Center (University of Michigan) were recruited and administered a 166-item questionnaire comprising 7 expert-defined domains. The questionnaire was re-administered 4-16 days later to a subset of 25 participants to assess test-retest variability. Graded response models were fit by Cai's Metropolis-Hastings Robbins-Monro algorithm using the R (version 3.6.3) package mirt. Model data were fit to assess questionnaire dimensionality, to estimate item information, and to score participants. Poorly functioning items were removed, and the model was refit to create the final questionnaire. RESULTS: The psychometrically validated PROs measure was reduced to a 59-item questionnaire measuring 7 unidimesnional domains: central vision, color vision, contrast sensitivity, scotopic function, photopic peripheral vision, mesopic peripheral vision, and photosensitivity. A total of 39 items were removed because of poor factor loading, low item information, poor person-ability differentiation, or high item-level interdependence. This novel questionnaire produces a reliable domain score for person ability that does not show significant test-retest variability across repeated administration. CONCLUSIONS: The final PRO questionnaire, known as the Michigan Retinal Degeneration Questionnaire, is psychometrically validated and available for use in the evaluation of patients with inherited retinal degenerations.

The Michigan Vision-Related Anxiety Questionnaire: A Psychosocial Outcomes Measure for Inherited Retinal Degenerations.

OBJECTIVE: We sought to construct and validate a patient-reported outcome measure for screening and monitoring vision-related anxiety in patients with inherited retinal degenerations. DESIGN: Item-response theory and graded response modeling to quantitatively validate questionnaire items generated from qualitative interviews and patient feedback. METHODS: Patients at the Kellogg Eye Center (University of Michigan, Ann Arbor, Michigan, USA) with a clinical diagnosis of an inherited retinal degeneration (n = 128) participated in an interviewer-administered questionnaire. The questionnaire consisted of 166 items, 26 of which pertained to concepts of "worry" and "anxiety." The subset of vision-related anxiety questions was analyzed by a graded response model using the Cai Metropolis-Hastings Robbins-Monro algorithm in the R software mirt package. Item reduction was performed based on item fit, item information, and item discriminability. To assess test-retest variability, 25 participants completed the questionnaire a second time 4 to 16 days later. RESULTS: The final questionnaire consisted of 14 items divided into 2 unidimensional domains: rod function anxiety and cone function anxiety. The questionnaire exhibited convergent validity with the Patient Health Questionnaire for symptoms of depression and anxiety. This vision-related anxiety questionnaire has high marginal reliability (0.81 for rod-function anxiety, 0.83 for cone-function anxiety) and exhibits minimal test-retest variability (ρ = 0.81 [0.64-0.91] for rod-function anxiety and ρ = 0.83 [0.68-0.92] for cone-function anxiety). CONCLUSIONS: The Michigan Vision-Related Anxiety Questionnaire is a psychometrically validated 14-item patient-reported outcome measure to be used as a psychosocial screening and monitoring tool for patients with inherited retinal degenerations. It can be used in therapeutic clinical trials for measuring the benefit of an investigational therapy on a patient's vision-related anxiety.

Cognitive Impairment among Veterans in Outpatient Vision Rehabilitation.

SIGNIFICANCE: Outpatient vision rehabilitation improves function in veterans with vision impairment, but the prevalence of cognitive impairment and the degree to which it may affect rehabilitation outcomes in the Veterans Affairs system are unknown. PURPOSE: The purpose of this study was to determine the prevalence of cognitive impairment among veterans receiving outpatient vision rehabilitation in the Veterans Affairs system and compare the benefits of rehabilitation in veterans with and without cognitive impairment. METHODS: We conducted cognitive assessments and a nested longitudinal cohort study in veterans with eye disorders at two outpatient rehabilitation sites. Cognition was assessed with the Modified Telephone Interview for Cognitive Status administered in person. Eligible veterans and their companions in the longitudinal study responded to questions about the veteran's function at baseline and 90 days later. Visual function was measured with the 48-item Low Vision Visual Function Questionnaire (LV-VFQ-48) and items from the Activity Inventory. RESULTS: Of 291 veterans assessed (mean ± standard deviation age, 78.2 ± 12 years), 136 (46.7%) were cognitively intact (Modified Telephone Interview for Cognitive Status scores, ≥33), whereas 58 (19.9%) had borderline scores of 30 to 32, 82 (28.2%) had scores suggesting mild/moderate cognitive impairment (scores of 20 to 29), and 15 (5.2%) had scores suggesting severe cognitive impairment (score of <20). After 90 days, mean LV-VFQ-48 reading scores tended to improve in veterans with (n = 21) and without (n = 28) cognitive impairment. The magnitude of self-reported improvement in LV-VFQ-48 scores was greater among cognitively intact, compared with cognitively impaired, veterans (effect size, 0.56 for reading; 0.71 for visual motor). Veterans and companions reported similar 90-day reduction in difficulty with the veterans' top 3 Activity Inventory goals, regardless of cognitive status. CONCLUSIONS: Approximately one in three veterans referred to outpatient vision rehabilitation has detectable cognitive impairment, yet many still experience functional improvements. Future research should determine best practices to accommodate challenges associated with cognitive impairment in vision rehabilitation and to track clinically meaningful outcomes.

Veterans Affairs Low-vision Intervention Trial II: One-year Follow-up.

SIGNIFICANCE: One-year follow-up is recommended for patients with macular diseases to assess functional changes associated with disease progression and to modify low-vision (LV) treatment plans, if indicated. PURPOSE: The purpose of this study was to observe 255 patients with macular diseases who received LV rehabilitation (rehabilitation with a therapist) or basic LV services (LV devices dispensed without therapy) during Veterans Affairs Low-vision Intervention Trial II after the trial ended at 4 months until 1-year follow-up. METHODS: The primary outcome measure was visual ability measured with the 48-item Veterans Affairs Low-vision Visual Functioning Questionnaire. Mean visual ability scores for the treatment groups were compared from baseline to 4 months, 4 months to 1 year, and baseline to 1 year. Changes from baseline to 1 year were compared between the two groups. Predictors of changes in visual ability from 4 months to 1 year were assessed using linear regression. RESULTS: Both groups experienced significant improvement in all measures of visual ability from baseline to 1 year but lost visual reading ability during the observation period (LV rehabilitation group, -0.64 [1.2] logit; 95% confidence interval [CI], -0.84 to -0.44 logit; basic LV group, -0.63 [1.4] logit; 95% CI, -0.88 to -0.38 logit), and overall visual ability was lost in the LV rehabilitation group (-0.20 [0.8] logit; 95% CI, -0.34 to -0.06 logit). Loss of visual reading ability in both groups from 4 months to 1 year was predicted by reading ability scores at 4 months, loss of near visual acuity from 4 months to 1 year, and lower EuroQol-5D utility index scores; loss of overall visual ability in the LV rehabilitation group during the same time period was predicted by lower overall ability scores at 4 months. CONCLUSIONS: Visual ability significantly improved in all groups from baseline to 1 year. However, the loss of visual reading ability experienced by both groups from 4 months to 1 year reduced the benefit of the services provided.

Economic Evaluation of Low-Vision Rehabilitation for Veterans With Macular Diseases in the US Department of Veterans Affairs.

Importance: Examining costs and consequences of different low-vision (LV) programs provides important information about resources needed to expand treatment options efficiently. Objective: To examine the costs and consequences of LV rehabilitation or basic LV services. Design, Setting, and Participants: The US Department of Veterans Affairs (VA) Low Vision Intervention Trial (LOVIT) II was conducted from September 27, 2010, to July 31, 2014, at 9 VA facilities and included 323 veterans with macular diseases and a best-corrected distance visual acuity of 20/50 to 20/200. Veterans were randomized to receive basic LV services that provided LV devices without therapy, or LV rehabilitation that added a therapist to LV services who provided instruction and homework on using LV devices, eccentric viewing, and environmental modification. We compared costs and consequences between these groups. Interventions: Low-vision devices without therapy and LV devices with therapy. Main Outcomes and Measures: Costs of providing basic LV services or LV rehabilitation were assessed. We measured consequences as changes in functional visual ability from baseline to follow-up 4 months after randomization using the VA Low Vision Visual Functioning Questionnaire. Visual ability was measured in dimensionless log odds units (logits). Results: Of 323 randomized patients, the mean (SD) age was 80 (10.5) years, 314 (97.2%) were men, and 292 (90.4%) were white. One hundred sixty (49.5%) received basic LV services and 163 (50.1%) received LV rehabilitation. The mean (SD) total direct health care costs per patient were similar between patients who were randomized to receive basic LV services ($1662 [$671]) or LV rehabilitation ($1788 [$864]) (basic LV services, $126 lower; 95% CI, $299 lower to $35 higher; P = .15). However, basic LV services required less time and had lower transportation costs. Patients receiving LV rehabilitation had greater improvements in overall visual ability, reading ability, visual information processing, and visual motor skill scores.

Outcomes of the Veterans Affairs Low Vision Intervention Trial II (LOVIT II): A Randomized Clinical Trial.

IMPORTANCE: Randomized clinical trials are needed to compare effectiveness and cost-effectiveness of different low-vision (LV) programs. OBJECTIVE: To determine the value of adding LV rehabilitation with a therapist compared with LV services without intervention. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial was conducted from September 27, 2010, to July 31, 2014, of 323 veterans with macular diseases and best-corrected distance visual acuity (BCDVAbetter-eye) of 20/50 to 20/200. Masked interviewers administered questionnaires by telephone before and after LV treatment. Using an intention-to-treat design, participants were randomized to receive LV devices with no therapy or LV devices with a rehabilitation therapist providing instruction and homework on the use of LV devices, eccentric viewing, and environmental modification. Visual ability was measured in dimensionless log odds units (logits) (0.14-logit change in visual ability corresponds to ability change expected from a 1-line change in visual acuity). INTERVENTIONS: Low-vision devices without therapy and LV devices with therapy. MAIN OUTCOMES AND MEASURES: Comparison of changes (baseline to 4 months) in overall visual ability and in 4 functional domains (reading, visual information, visual motor, and mobility) estimated from responses to the Veterans Affairs Low Vision Visual Functioning Questionnaire (higher scores indicates more ability or less difficulty in performing activities), and comparison of MNREAD changes (baseline to end of treatment) in maximum reading speed, critical print size, and reading acuity (higher number indicates lower visual acuity). RESULTS: Of the 323 participants, 314 were male (97.2%); mean (SD) age, 80 (10.5) years. Basic LV was effective in improving visual ability. However, the LV rehabilitation group improved more in all visual function domains except mobility. Differences were 0.34-logit reading (95% CI, 0.0005 to 0.69; P = .05), 0.27-logit visual information (95% CI, 0.01 to 0.53; P = .04), 0.37-logit visual motor (95% CI, 0.08 to 0.66; P = .01), and 0.27-logit overall (95% CI, 0.06 to 0.49; P = .01). For MNREAD measures, there was more improvement in reading acuity (difference, -0.11 logMAR, 95% CI, -0.15 to -0.07; P < .001) and maximum reading speed (mean increase of 21.0 words/min; 95% CI, 6.4 to 35.5; P = .005), but not critical print size for the LV rehabilitation group (-0.06 logMAR; 95% CI, -0.12 to 0.002; P = .06). In stratified analyses, the LV rehabilitation group with BCDVAbetter-eye worse than 20/63 to 20/200 improved more in visual ability (reading, visual motor, and overall). Differences were 0.56-logit reading ability (95% CI, 0.08-1.04; P = .02), 0.40-logit visual motor (95% CI, 0.03-0.78; P = .04), 0.34-logit overall (95% CI, 0.06-0.62; P = .02). There was no significant difference between treatment groups for those with BCDVAbetter-eye of 20/50 to 20/63. CONCLUSIONS AND RELEVANCE: Both basic LV alone and combined with LV rehabilitation were effective, but the added LV rehabilitation increased the effect only for patients with BCDVAbetter-eye worse than 20/63 to 20/200. Basic LV services may be sufficient for most LV patients with mild visual impairment. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00958360.

Interpretation of low-vision rehabilitation outcome measures.

PURPOSE: This article presents a theoretical interpretation of patient-reported outcomes of low-vision rehabilitation (LVR) using rating scale questionnaires and uses previously published results of LVR outcome studies to illustrate theoretical points and validate assumptions. THEORY: Patients' judgments of the difficulty they have performing tasks are interpreted as magnitude estimates of their functional reserve for each task, which is the difference between their visual ability and the visual ability demanded by the task. We assume that improvements in functional reserve can occur by increasing the patient's visual ability with medical, surgical, or refractive interventions or decreasing the visual ability demanded by the item with activity-specific vision assistive equipment, adaptations, and environmental modifications. Activity-specific interventions cause differential item functioning (intervention-related DIF). Intervention-related DIF makes the measured size of the treatment effect dependent on the item content and the mix of responsive and unresponsive items to intervention. CONCLUSIONS: Because intervention-related DIF depends on the choice of items, the outcome measure selected should be appropriate to the aims of the intervention and the impairment level of the sample to demonstrate the full effects of an intervention. Items that are given extreme positive ratings at preintervention baseline (e.g., "not difficult") have no room for improvement. These items must also be filtered out because they will dilute the measured effect of the activity-specific interventions of LVR.

VA LOVIT II: a protocol to compare low vision rehabilitation and basic low vision.

PURPOSE: To compare the effectiveness of low vision rehabilitation (LVR) and basic low vision (LV) in a single masked multicentre randomised controlled trial (RCT). METHODS: Three hundred and thirty patients eligible for US. Veterans Affairs (VA) healthcare services with primary eye diagnosis (better-seeing eye) of macular disease and best-corrected distance visual acuity of 0.40-1.00 logMAR (6/15 to 6/60 or 20/50 to 20/200 Snellen) are being enrolled at seven VA facilities. All participants receive an optometric LV examination; and they are eligible to receive the same LV devices that are provided without charge. In LVR, a LV therapist dispenses devices and provides 2 or 3 (1½ to 2½ h) therapy sessions with assigned homework to teach effective use of remaining vision and LV devices. Contact time with the therapist depends upon the devices prescribed and the patient's progress in learning the skills that are taught. In basic LV, devices are dispensed by the optometrist without LV therapy. Contact time for dispensing is one hour or less depending on LV devices prescribed. The primary outcome measure is a comparison of the changes in visual reading ability (estimated from patients' difficulty ratings of reading items on the VA LV VFQ-48 questionnaire) between the treatment and control arms from pre-intervention baseline to 4 months (2 months after completion of treatment). Secondary outcome measures are changes in overall visual ability, visual ability domain scores calculated from subsets of items (mobility, visual information processing and visual motor skills), Short Form-36, and Minnesota Low Vision Reading Test scores. Cost-effectiveness analysis will be conducted using VA LV VFQ-48 scores and QALYS computed from EuroQol scores. RESULTS: A total of 137 patients representing 41.5% of the study target of 330 patients were randomised from October 2010 to March 2012. Among those 137 patients, mean age was 80.2 (S.D. ± 9.9) years at enrollment; 97.1% of the patients were males; 94.2% were white. Mean best corrected VA was 0.65 (S.D. ± 0.3) logMAR (approximately Snellen 6/27 or 20/90) at baseline. CONCLUSIONS: LOVIT II is the first multicentre RCT comparing the effectiveness and cost-effectiveness of LVR and basic LV for patients with macular diseases and near normal or moderate levels of visual impairment.

The effectiveness of low-vision rehabilitation in 2 cohorts derived from the veterans affairs Low-Vision Intervention Trial.

OBJECTIVE: To evaluate the effectiveness of low-vision rehabilitation in 2 cohorts derived from the Veterans Affairs Low-Vision Intervention Trial. METHODS: In a prospective study, we observed 44 participants randomly assigned to outpatient low-vision rehabilitation who did not receive additional treatment after the trial ended at 4-month follow-up and 56 participants randomly assigned to the waiting-list control group and thereafter to standard therapy. The outcome measures included visual ability domains (reading, mobility, visual information processing, and visual motor skills) and overall visual ability estimated from difficulty ratings using the 48-item Veterans Affairs Low-Vision Visual Functioning Questionnaire. Mean visual ability scores for the treatment and control groups were compared at baseline, 4 months, and 1 year. A mixed-effects model was used to test treatment effects between groups over time. Differences in visual ability mean scores from baseline to 1 year were compared between the 2 groups. Within-group changes in visual ability were compared from baseline to 1 year, from baseline to 4 months, and from 4 months to 1 year. RESULTS: At baseline, there were no significant differences in mean visual ability scores between groups. From baseline to 4 months, the treatment effects for all visual ability domains and overall visual ability increased to a maximum in the treatment group (P< .001), whereas the mean scores (except visual motor skills) decreased in the control group (P< .01). From 4 months to 1 year, the differences became smaller. There was a loss of visual ability in reading and visual information processing (but not in visual motor skills, mobility, or overall visual ability) in the treatment group and a gain in all visual ability measures in the control group. Interactions of treatment and follow-up time in the mixed models showed the trend of treatment effects significantly changed over time from baseline to 1 year (P< .001) for all visual ability domains and overall visual ability. Both groups demonstrated improvement in visual ability from baseline to 1 year (P< .001) (except for mobility in the control group). Overall visual ability (but not other visual ability domains) improved more in the treatment group than in the control group (P= .01). CONCLUSIONS: Visual ability improved significantly in both groups from baseline to 1 year. The Low-Vision Intervention Trial treatment effect is robust and well maintained for patients with macular diseases.

Visual function in patients followed at a Veterans Affairs polytrauma network site: an electronic medical record review.

BACKGROUND: This observational study describes the "Polytrauma System of Care" used by the Veterans Health Administration to guide medical care and rehabilitation of injured military personnel serving in Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) and reports the visual function of patients with polytrauma and/or traumatic brain injury (TBI) at the Hines, Illinois, Polytrauma Network Site (PNS). METHODS: A retrospective medical record review was performed for 103 patients with polytrauma seen at the Hines PNS from October 2005 through March 2008 and 88 patients with TBI seen in the Hines TBI Clinic from December 2007 through March 2008. RESULTS: Visual symptoms were self-reported by 76% of patients with polytrauma and 75% of the patients with TBI. Problems with reading (polytrauma 60% and TBI 50%) and accommodation (polytrauma 30% and TBI 47%) were frequently found on eye examinations. Spectacles were the treatment most frequently prescribed (polytrauma 62% and TBI 78%). CONCLUSIONS: It is important for optometrists to be aware of the high rates of self-reported symptoms and visual problems in military personnel returning from deployment to the wars in Iraq and Afghanistan. Post-traumatic stress disorder and depression may complicate optometric evaluation and management.

Outcomes of the Veterans Affairs Low Vision Intervention Trial (LOVIT).

OBJECTIVE: To evaluate the effectiveness of a low-vision rehabilitation program. METHODS: A multicenter randomized clinical trial was conducted from November 2004 to November 2006 with a 4-month follow-up. A total of 126 patients were included, 98% of whom were white and male. The patients were referred from eye or low-vision clinics and blind rehabilitation centers with a visual acuity in the better-seeing eye worse than 20/100 and better than 20/500 and were eligible for Veterans Affairs (VA) services. Telephone interviews of patients were conducted in their homes before and after participation in an outpatient low-vision program at a VA medical care facility or a (waiting list) control group. The interviewer administering questionnaires by telephone was masked to patients' assignments. Interventions included low-vision examination, counseling, and prescription and provision of low-vision devices and 6 weekly sessions provided by a low-vision therapist to teach use of assistive devices and adaptive strategies to perform daily living tasks independently. MAIN OUTCOME MEASURE: Change in patients' visual reading ability estimated from participant responses to the Veterans Affairs Low-Vision Visual Functioning Questionnaire (LV VFQ-48) reading items completed at baseline compared with 4 months after enrollment for the treatment and control groups. The secondary outcomes were changes in other visual ability domains (mobility, visual information processing, visual motor skills) and overall visual ability from baseline to 4 months estimated from VA LV VFQ-48 difficulty ratings for subsets of items. RESULTS: The treatment group demonstrated significant improvement in all aspects of visual function compared with the control group. The difference in mean changes was 2.43 logits (95% confidence interval [CI], 2.07-2.77; P < .001; effect size, 2.51) for visual reading ability; 0.84 logit (95% CI, 0.58-1.10; P < .001; effect size, 1.14) for mobility; 1.38 logits (95% CI, 1.15-1.62; P < .001; effect size, 2.03) for visual information processing; 1.51 logits (95% CI, 1.22-1.80; P < .001; effect size, 1.82) for visual motor skills; and 1.63 logits (95% CI, 1.40-1.86; P < .001; effect size, 2.51) for overall visual function. CONCLUSION: The program effectively provided low-vision rehabilitation for patients with macular diseases. APPLICATIONS TO CLINICAL PRACTICE: At least 10 hours of low-vision therapy, including a home visit and assigned homework to encourage practice, is justified for patients with moderate and severe vision loss from macular diseases. Because the waiting-list control patients demonstrated a decline in functional ability, low-vision services should be offered as early as possible. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00223756.

Economic evaluation of blind rehabilitation for veterans with macular diseases in the Department of Veterans Affairs.

PURPOSE: The Department of Veterans Affairs (VA) Low Vision Intervention Trial (LOVIT) developed an outpatient low-vision programme for patients with macular diseases providing low-vision rehabilitation comparable to VA inpatient blind rehabilitation centres (BRCs). This programme targets veterans who do not need or chose not to participate in a comprehensive inpatient blind rehabilitation programme. We examined costs and consequences using veterans in LOVIT and comparable veterans in an inpatient BRC. METHODS: We compared costs and consequences between treatment patients who participated in LOVIT, a two-site randomized clinical trial, and a sample of comparable patients who received treatment at a VA inpatient BRC. We measured consequences as the change in functional visual ability from baseline to follow-up (LOVIT: 4 months after randomization; BRC: 3 months after discharge) using the VA Low Vision Visual Functioning Questionnaire (VA LV VFQ-48). RESULTS: There were 55 LOVIT and 121 BRC patients for our analyses. Average costs were $38,627.3 higher for BRC patients ($5,054.4 +/- $404.7 SD for LOVIT vs. $43,681.7 +/- $8,853.6 SD for BRC, p < 0.0001). Thus, the BRC cost $38,627.3 per patient more than the LOVIT programme (95% CI: $17,414 to $273,482). There was a greater improvement in overall visual ability, mobility, and visual motor skill scores for BRC patients; however, there was no significant difference in improvement in reading ability or visual information processing scores. CONCLUSIONS: As VA increases outpatient blind rehabilitation services, LOVIT provides a model for expanding outpatient low-vision rehabilitation services for veterans at substantially lower costs than current inpatient BRC services.

The Veterans Affairs Low Vision Intervention Trial (LOVIT): design and methodology.

BACKGROUND: Visual impairment is a major public health problem. Vision rehabilitation programs have the potential to restore independence and improve quality of life for persons with permanent vision loss, and few have been evaluated in randomized controlled trials. PURPOSE: The Veterans Affairs (VA) Low Vision Intervention Trial is a multicenter randomized clinical trial to evaluate the effectiveness of a new outpatient low vision rehabilitation program. METHODS: 126 patients with moderate and severe vision loss due to macular diseases are randomized to low vision treatment in an outpatient setting or a usual care control group at two VA facilities in Hines, Illinois, and Salisbury, North Carolina. The primary outcome is the change in visual reading ability from baseline to four months measured with the Veterans Affairs Low Vision Visual Functioning Questionnaire-48 (VA LV VFQ-48). Secondary outcomes compare the mean change in visual ability measured with the VA LV VFQ-48 (overall ability, mobility, visual information processing, visual motor skills) for the treatment and control groups. Costs and cost effectiveness of outpatient treatment are evaluated. RESULTS: The low vision rehabilitation setting, use of a waiting list control group to address ethical issues, development of the treatment protocol, development of a vision function questionnaire for patients to self-report the difficulty they experience performing daily activities, and the use of Rasch analysis to develop and estimate this outcome measure are described. LIMITATIONS: If the new low vision rehabilitation program is proven effective, studies will be needed to determine which of the multiple aspects of the intervention are necessary and sufficient. CONCLUSIONS: The challenges of conducting clinical trials in a rehabilitation setting and use of a waiting list (deferred treatment) control group extend beyond LOVIT. The design and methods of LOVIT may be applicable to other trials of rehabilitation services and to outcomes for which reliable and valid measurement tools must be developed.

Computer use, symptoms, and quality of life.

PURPOSE: To model the effects of computer use on reported visual and physical symptoms and to measure the effects upon quality of life measures. METHODS: A survey of 1000 university employees (70.5% adjusted response rate) assessed visual and physical symptoms, job, physical and mental demands, ability to control/influence work, amount of work at a computer, computer work environment, relations with others at work, life and job satisfaction, and quality of life. Data were analyzed to determine whether self-reported eye symptoms are associated with perceived quality of life. The study also explored the factors that are associated with eye symptoms. Structural equation modeling and multiple regression analyses were used to assess the hypotheses. RESULTS: Seventy percent of the employees used some form of vision correction during computer use, 2.9% used glasses specifically prescribed for computer use, and 8% had had refractive surgery. Employees spent an average of 6 h per day at the computer. In a multiple regression framework, the latent variable eye symptoms was significantly associated with a composite quality of life variable (p = 0.02) after adjusting for job quality, job satisfaction, supervisor relations, co-worker relations, mental and physical load of the job, and job demand. Age and gender were not significantly associated with symptoms. After adjusting for age, gender, ergonomics, hours at the computer, and exercise, eye symptoms were significantly associated with physical symptoms (p < 0.001) accounting for 48% of the variance. CONCLUSIONS: Environmental variability at work was associated with eye symptoms and eye symptoms demonstrated a significant impact on quality of life and physical symptoms.

Using the VA LV VFQ-48 and LV VFQ-20 in low vision rehabilitation.

PURPOSE: This study was conducted to demonstrate use of a simple scoring algorithm for the 48-item Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ-48) that approximates the measure of persons' visual ability that would be calculated with Rasch analysis and to provide a short form version of the questionnaire for clinical practice and outcomes research. METHODS: Items were eliminated from the VA LV VFQ-48 to reduce redundancy and shorten the instrument. The approximation of persons' visual ability calculated with the scoring algorithm for vision function questionnaires developed by Massof was compared with the person measure estimated from Rasch analysis for a sample of 126 subjects entering a low vision rehabilitation program. RESULTS: The approximation captures 98% of the variability in the Rasch measure estimate of persons' visual ability and 97% of the variability in the change score estimate. The relationship does not hold in circumstances where patients with high visual ability find most items to be easy. A 20-item short form of the instrument was constructed for use in low vision service delivery. CONCLUSIONS: The scoring algorithm can be used with the VA LV VFQ-48 or short form versions of the questionnaire. Clinicians can use the algorithm to score the VA LV VFQ from examination of individual patients or as an outcome measure for their low vision rehabilitation programs. Research investigators can use the scoring algorithm with small samples when Rasch analysis is not reliable or in studies where Rasch analysis is not practical. Rasch analysis is still recommended for research studies that require more accurate assessments.

Short- and long-term effects of an intensive inpatient vision rehabilitation program.

OBJECTIVE: To assess the effects of a visual rehabilitation program on visually impaired subjects' visual ability and ability to perform activities. DESIGN: Prospective observational study. SETTING: Telephone interviews of respondents in their homes the week before admission to the rehabilitation center and 3 months and 1 year after discharge from the rehabilitation center. PARTICIPANTS: A total of 178 consecutive patients from the Hines Blind Rehabilitation Center participated in development of the 48-item Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ-48). Data were analyzed for 95 who participated in all 3 administrations of the questionnaire. INTERVENTION: Comprehensive blind rehabilitation program (mean hospital admission, 40 d). MAIN OUTCOME MEASURE: The self-report ratings of patients' difficulty performing 48 activities on the VA LV VFQ-48. RESULTS: The increase in visual ability +/- standard deviation of .981+/-.482 logits (equivalent to an 8-line improvement in visual acuity on an Early Treatment of Diabetic Retinopathy Study chart) at 3 months postrehabilitation decreased to .682+/-.485 logits (equivalent to a loss of 2.5 lines of visual acuity on the same chart) 1 year postrehabilitation. The effect sizes measured at 3 months (2.035) and 1 year (1.495) indicate large treatment effects corresponding to statistically significant differences for the increase in visual ability at 3 months and 1 year postrehabilitation (paired 2-tailed t tests, P<.001) relative to pretreatment measures. The difference in visual abilities measured at 3 months and 1 year posttreatment also is statistically significant (P<.001). CONCLUSIONS: Treatment effects decreased over the 12-month follow-up period. However, the group of patients whose data were analyzed was still statistically and clinically significantly better at their 1-year follow-up than before beginning treatment.

Measuring outcomes of vision rehabilitation with the Veterans Affairs Low Vision Visual Functioning Questionnaire.

PURPOSE: To evaluate the sensitivity to change, in patients who undergo vision rehabilitation, of the Veteran Affairs (VA) Low Vision Visual Functioning Questionnaire (LV VFQ-48), which was designed to measure the difficulty visually impaired persons have in performing daily activities and to evaluate vision rehabilitation outcomes. METHODS: Before and after rehabilitation, the VA LV VFQ-48 was administered by telephone interview to subjects from five sites in the VA and private sector. Visual acuity of these subjects ranged from near normal to total blindness. RESULTS: The VA LV VFQ exhibited significant differential item functioning (DIF) for 7 of 48 items (two mobility tasks, four reading tasks, and one distance-vision task). However, the DIF was small relative to baseline changes in item difficulty for all items. Therefore, the data were reanalyzed with the constraint that item difficulties do not change with rehabilitation, which assigns all changes to the person measure. Subjects in the inpatient Blind Rehabilitation Center (BRC) program showed the largest changes in person measures after vision rehabilitation (effect size = 1.9; t-test P < 0.0001). The subjects in the outpatient programs exhibited smaller changes in person measures after rehabilitation (effect size = 0.29; t-test P < 0.01). There was no significant change in person measures for the control group (test-retest before rehabilitation). CONCLUSIONS: In addition to being a valid and reliable measure of visual ability, the VA LV VFQ-48 is a sensitive measure of changes that occur in visual ability as a result of vision rehabilitation. Patients' self-reports of the difficulty they experience performing daily activities measured with this instrument can be used to compute a single number, the person measure that can serve as an outcome measure in clinical studies. The VA LV VFQ-48 can be used to compare programs that offer different levels of intervention and serve patients across the continuum of vision loss.

Timing and directions for administration of questionnaires affect outcomes measurement.

We used data from two pilot studies to compare the change in patients' self-reported health-related quality of life after participation in two nearly identical Department of Veterans Affairs (VA) Blind Rehabilitation Center (BRC) programs, the Southwestern BRC in Tucson, Arizona, and the BRC at the VA hospital in Hines, Illinois. Researchers at the Southwestern BRC administered the National Eye Institute Visual Functioning Questionnaire as directed by the developer. Researchers at the Hines BRC modified the directions to consider use of low-vision devices. Interval person-ability and item-difficulty measures estimated from patient responses pre- and postrehabilitation were compared with these same measures obtained at follow-up. At the Southwestern BRC, no change was reported in either person or item measures 3 months after rehabilitation. At the Hines BRC, improvement was seen in both the person and item measures when measurements were made immediately following rehabilitation. Because a temporary halo effect may explain the higher ratings at discharge, veterans from the Hines cohort were contacted by telephone and administered the same instrument 3 years later. For these subjects, the improvement noted in the person measure disappeared at follow-up, while the improvement in the item measure was maintained.

Is there a standard of care for eccentric viewing training?

A study was conducted to determine the current Department of Veterans Affairs (VA) standard of practice for eccentric viewing (EV) training. EV training is the process of teaching patients to realign the visual image away from a diseased foveal/macular region onto healthier retina. Optometrists and Visual Skills Instructors at all VA blind rehabilitation centers (BRCs) and VICTORS (vision impairment centers to optimize remaining sight) programs were asked to rate preference for EV prescription criteria, evaluation, and training techniques. Responses were received from 70% of BRCs and 67% of VICTORS. The respondents reported that all programs include EV training. The average minutes of training per patient varied from 20 minutes to nearly 24 hours, with instructors within a single center varying by as much as two orders of magnitude. Routinely, 82% of optometrists prescribe EV training, yet no consensus was found among these practitioners as to the criteria for selecting the best EV area. The results of this survey reveal an inconsistent standard of practice across VA centers and demonstrate the need for prospective studies of the efficacy, effectiveness, and cost-effectiveness of EV training.