Verteporfin Photodynamic Therapy Cohort Study: Report 2: Clinical Measures of Vision and Health-Related Quality of Life

doi:10.1016/j.ophtha.2009.10.031

Ophthalmology

Volume 116, Issue 12, December 2009, Pages 2463-2470

https://doi.org/10.1016/j.ophtha.2009.10.031 Get rights and content

Purpose

To quantify decreases in health-related quality of life (HRQoL) for given deterioration in clinical measures of vision; to describe the shape of these relationships; and to test whether the gradients of these relationships change with duration of visual loss.

Design

A prospective, longitudinal study of patients treated with verteporfin photodynamic therapy in the United Kingdom National Health Service.

Participants

Patients with neovascular age-related macular degeneration (AMD) treated in 18 ophthalmology departments in the United Kingdom with expertise in management of neovascular AMD.

Methods

Responses to HRQoL questionnaires (Short Form 36 [SF-36] and National Eye Institute Visual Functioning Questionnaire [NEIVFQ]) and clinical measures of vision were recorded at baseline and at follow-up visits. Mixed regression models were used to characterize the relationships of interest.

Main Outcome Measures

Measures of vision were best-corrected visual acuity (BCVA) and contrast sensitivity (CS). The SF-36 physical and mental component scores (PCS and MCS), SF-6D utility, and distance, near, and composite NEIVFQ scores were derived to characterize HRQoL.

Results

The SF-6D, PCS, and MCS were linearly associated with BCVA; predicted decreases for a 5-letter drop in BCVA in the better-seeing eye were 0.0058, 0.245, and 0.546, respectively (all P<0.0001). Gradients were not influenced by duration of follow-up. Models predicting distance, near, and composite NEIVFQ scores from BCVA were quadratic; predicted decreases for a 5-letter drop in BCVA in the better-seeing eye were 5.08, 5.48, and 3.90, respectively (all P<0.0001). The BCVA predicted HRQoL scores more strongly than CS.

Conclusions

Clinically significant deterioration in clinical measures of vision is associated with small decreases in generic and vision-specific HRQoL. Our findings are important for further research modeling the cost effectiveness of current and future interventions for neovascular AMD.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found after the references.

Section snippets

Methods

Details of the study have been described elsewhere.¹⁴ In brief, we collected functional and morphologic data longitudinally on all patients with neovascular age-related macular degeneration (AMD) who received treatment with VPDT between June 2004 and September 2007 in designated eye hospitals in the United Kingdom. The HRQoL data for the objectives of this paper were collected at 18 centers, chosen to represent the United Kingdom geographically. We assessed HRQoL using the NEIVFQ and the SF-36.4

Results

There were BCVA, CS, and HRQoL data for 3262 visits by 1829 patients (Table 1, Table 2). Most data were available for visits at 0, 6, and 12 months, as planned, but data for many patients were also available for 3 and 9 months; 53% of patients had data for ≥2 visits (1 visit, 47%; 2 visits, 33%; 3 visits, 16%; >3 visits [max 6], 4%).

Discussion

Our results show that BCVA and CS in the better-seeing eye are highly significant predictors of SF-6D utility, SF-36 component scores and NEIVFQ scores. There were 3 main features of the relationship between visual function and HRQoL:

•
HRQoL decreased with deteriorating visual function over a wide range of visual function.
•
It was not sigmoid but, when visual function was measured by CS or HRQoL was measured using the NEIVFQ, the relationship tended to a plateau at low levels of visual function.
•
The

Strengths and Weaknesses

The size and scope of this study is much larger than any previous study. Protocol-based BCVA and CS were measured at multiple time points. We investigated the relationships between clinical measures of vision and HRQoL as continuous scales (in contrast with many previous studies). The large sample gave us reasonable power to test our secondary objectives about the shape of the relationships and adaptation to vision loss over a 2-year period, even though the proportion of patients with data for

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Citation Excerpt :
Another study assessed the shape of the relationship of VA with health-related QoL in photodynamic therapy–treated patients. It was found that the relationship had a relatively shallow gradient at the lower extreme of the visual function continuum.7 The concept described bears clinical significance.
To determine whether there is a level of visual acuity (VA) in neovascular age-related macular degeneration (nAMD) above which the correlation of VA with disease-related quality of life (QoL) is significantly greater than below this level.
An observational, cross-sectional study.
A total of 184 patients with nAMD aged at least 50 years were included in the study.
In face-to-face interviews, we assessed QoL with the Macular Disease-Dependent Quality of Life (MacDQoL) questionnaire. We measured VA with standardized Radner reading charts. We used regression splines analysis with a single hinge point, with the MacDQoL score as the dependent variable and VA as the independent variable. The x-coordinate (VA) of the hinge point was varied and tested with each iteration. A second method of regression splines analysis was also performed, without a preset hinge point.
The primary outcome measure is the cutoff point at or below which VA is associated with significantly less change in QoL than above this cutoff. The linear coefficients below and above the cutoff are defined as change in MacDQoL score per logarithm of the minimum angle of resolution (logMAR) unit of change in VA.
With Snellen equivalent VA 0.05 (1.3 logMAR) or worse, the linear coefficient was 0.15. With VA better than 0.05, the linear coefficient was 2.40 (P value of the difference: 0.009).
When VA is above 0.05, there is a stronger and significant relation between VA and QoL. At or below this level, the relation between VA and QoL approaches zero. With better VA, a difference in VA implies a significant difference in QoL. With poorer VA, a difference in VA is unlikely to imply a difference in QoL. Therefore, in treating nAMD, the aim should be to keep Snellen VA above 0.05 to have an impact on QoL. If it is certain that the best-corrected VA below 0.05 is permanent, these findings imply there may be less, if any, benefit to continue further treatment. This is to be evaluated on a case-by-case basis.
Verteporfin Photodynamic Therapy Cohort Study. Report 3: Cost Effectiveness and Lessons for Future Evaluations
2009, Ophthalmology
Citation Excerpt :
The VPDT Cohort Study found that a 5-letter decline in BCVA was associated with a small mean reduction in Short Form 6D of 0.0058 (on a scale with anchors of 0 = death and 1 = perfect health).14 This association was combined with the differential decline in BCVA from baseline for the VPDT and placebo groups in TAP to derive differences in HRQoL between VPDT and BSC at 3-month intervals (see Fig 1, available at: available at http://aaojournal.org).12,14 The incremental QALYs for VPDT versus BSC were calculated as the average HRQoL difference for each 3-month time point multiplied by 0.25 years and summed over 1 or 2 years.
To report (1) the costs of verteporfin photodynamic therapy (VPDT) in routine treatment of neovascular age-related macular degeneration (nAMD), (2) the relationship between health and social service costs and best-corrected visual acuity (BCVA), (3) the cost-effectiveness of VPDT versus a best supportive care (BSC) group who were assumed to have no active treatment, and (4) lessons for future cost-effectiveness analyses (CEAs).
The CEA of VPDT versus BSC that uses health-related quality of life (HrQoL), resource use, and visual acuity data from the United Kingdom (UK) VPDT Cohort Study.
Data on VPDT use were collected from patients attending 45 ophthalmology provider units in the UK National Health Service, 15 units collected data on self-reported use of services.
Incremental costs of VPDT versus BSC were calculated from treatment costs, change in cost associated with declining BCVA, and difference in BCVA previously attributed to VPDT. Similarly, incremental quality-adjusted life years (QALYs) were calculated from change in HRQoL associated with declining BCVA, giving an incremental cost per QALY of VPDT versus BSC over 2 years.
Incremental costs (UK pounds [£]; United States dollars [$]); incremental QALYs; costs per QALY.
The treatment costs of VDPT were £3026 ($4544) in year 1 and £845 ($1269) in year 2. For patients who used services, a 5-letter decrease in BCVA was associated with an increase in annual costs of approximately £110 ($165; 95% confidence intervals, approximately £48 [$72] to £174 [$261]). The incremental costs and QALYs for VPDT were £3514 ($5276) and 0.021, respectively, giving incremental costs per QALY gained of £170 000 ($255 000).
Verteporfin photodynamic therapy is unlikely to be cost effective for patients with nAMD. This article provides realistic estimates of VPDT costs and the costs associated with declining vision. Future studies can follow this approach to assess accurately the cost effectiveness of new interventions for nAMD.
Proprietary or commercial disclosure may be found after the references.
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A systematic review on the quality, validity and usefulness of current cost-effectiveness studies for treatments of neovascular age-related macular degeneration
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: Manuscript no. 2009-936.

Financial Disclosure(s): The authors have made the following disclosures:

Simon P. Harding – consultant and lecturer, Novartis.

James Carpenter – consultant and lecturer, Novartis

Usha Chakravarthy – lecturer, Novartis

: Supported by The United Kingdom National Institute for Health Research, Health Technology Assessment Programme, Southampton, England. The views and opinions expressed are those of the authors and do not necessarily reflect those of the Department of Health.

^⁎

Group members listed online (available at http://aaojournal.org).

A listing of the VPDT Cohort Study Group appeared in Vereteporfin Photodynamic Therapy Cohort Study: Report 1: Effectiveness and Factors Influencing Outcomes. Ophthalmology 2009;116:e1–e8.

View full text

Original articleVerteporfin Photodynamic Therapy Cohort Study: Report 2: Clinical Measures of Vision and Health-Related Quality of Life

Purpose

Design

Participants

Methods

Main Outcome Measures

Results

Conclusions

Financial Disclosure(s)

Section snippets

Methods

Results

Discussion

Strengths and Weaknesses

Lancet

J Health Econ

Ophthalmology

The importance of patient-reported outcomes … it's all about the patients

FDA Consum

Publications policy and guidelinesGuidance on the routine collection of Patient Reported Outcome Measures (PROMs) (for the NHS in England in 2009/10

Development of the 25-item National Eye Institute Visual Function Questionnaire

Arch Ophthalmol

EuroQol—a new facility for the measurement of health-related quality of life

Health Policy

Measuring and Valuing Health Benefits for Economic Evaluation

Guide to the methods of technology appraisal

Quality of life of low-vision patients and outcomes of low-vision rehabilitation

Optom Vis Sci

Vision-specific instruments for the assessment of health-related quality of life and visual functioning: a literature review

Pharmacoeconomics

Utility values and age-related macular degeneration

Arch Ophthalmol

Ranibizumab and pegaptanib for the treatment of age-related macular degeneration: a systematic review and economic evaluation

Health Technol Assess

Verteporfin Photodynamic Therapy Cohort studyReport 3: Cost effectiveness and Lessons for Future Evaluations

Ophthalmology

The MOS 36-item short-form health survey (SF-36)I. Conceptual framework and item selection

Med Care

Original article
Verteporfin Photodynamic Therapy Cohort Study: Report 2: Clinical Measures of Vision and Health-Related Quality of Life