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Structured Abstract
Objectives:
To identify and evaluate the psychometric properties of tools used to measure health-related quality of life (HRQL) in patients receiving treatment for diabetic retinopathy (DR), and to assess the effectiveness of interventions for DR to improve HRQL.
Data sources:
We conducted a systematic and comprehensive search in six electronic databases and hand searched reference lists of reviews and included studies.
Review methods:
Study selection, quality assessment, and data extraction were completed by reviewers independently and in duplicate. We included articles that presented data on HRQL outcomes following an intervention for DR (including diabetic macular edmema (DME). Mean differences and 95 percent confidence intervals were calculated for continuous outcomes. We did not conduct any meta-analyses due to heterogeneity.
Results:
We identified four validated HRQL measures: 36–Item Short Form Health Survey (SF–36), National Eye Institute Visual Functioning Questionnaire (VFQ–25 and –51), Visual Function Index (VF–14), and Diabetes Treatment Satisfaction Questionnaire (DTSQ). We also identified two tools that are currently undergoing evaluation: the Retinopathy Treatment Satisfaction Questionnaire (RetTSQ) and the Retinopathy Dependent Quality of Life (RetDQoL).
Two randomized controlled trials (RCTs) reported on HRQL outcomes following anti-vascular endothelial growth factor (anti-VEGF) treatment for DME. Seven observational studies reported on HRQL outcomes following: laser photocoagulation (two), vitrectomy (two), panretinal photocoagulation versus vitrectomy (one), and phacoemulsification cataract surgery (two).
The RCT comparing pegaptanib sodium versus sham reported a statistically significant improvement from baseline for the composite score of the VFQ–25 at 2 years (but not at 1 year). The three-arm RCT comparing ranibizumab monotherapy versus ranibizumab plus laser versus laser showed a statisitically significant difference for the composite score of the VFQ–25 for both anti-VEGF arms versus laser at 1 year. The strength of evidence for anti-VEGF was assessed as low.
For the remaining interventions, the studies were at high risk of bias due to weak study designs (before-after and cohort studies) and poor implementation. There is insufficient evidence to determine whether one of these treatments for DR is more effective than another in improving HRQL in this patient population.
Conclusions:
We identified few HRQL measurement instruments that have been used to assess the impact of treatment in patients with DR or DME; however, the tools that have been used have been adequately evaluated. Two tools developed specifically for patients with DR are currently undergoing evaluation. In general, HRQL was improved following interventions for DR. Further research on HRQL following anti-VEGF treatment for DME is needed to confirm the results of two RCTs. The current research on the impact of other interventions for DR on HRQL is insufficient to draw conclusions about the relative effect of one intervention versus another. RCTs that assess the impact of treatments for DR should include HRQL as an outcome.
Contents
- Acknowledgments
- Peer Reviewers
- Executive Summary
- Introduction
- Methods
- Results
- Literature Review and Screening
- Key Question 1a What HRQL measures have been used in studies of treatments for diabetic retinopathy?
- Key Question 1b What are the psychometric properties of the HRQL measures used in the studies?
- Key Questions 2 and 3 What is the evidence that HRQL is improved by any intervention; and what is the relationship between HRQL and any relevant variables?
- Discussion
- References
- Abbreviations and Acronyms
- Appendix A Search Strategies
- Appendix B Inclusion/Exclusion Form
- Appendix C Excluded Studies
- Appendix D Characteristics of the health-related quality of life assessment tools used in studies of the treatment of diabetic retinopathy
- Appendix E Sample HRQL assessment tools
- Appendix F Extended study characteristics and outcomes for studies reporting the impact of interventions for diabetic retinopathy on HRQL
This report is based on research conducted by the University of Alberta Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. HHSA 290 2007 10021 I). The findings and conclusions in this document are those of the author(s) who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. No statement in this article should be construed as an official position of the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human Services.
The information in this report is intended to help health care decision-makers; patients and clinicians, health system leaders, and policymakers, make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.
This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.
Andrea Milne, Jeffery A, Johnson and Donna M. Dryden have no affiliations or financial involvement related to the material presented in this report. Drs. Matthew Tennant and Christopher Rudnisky are directors of and have financial interests in Secure Diagnostic Imaging Inc., a company that developed and manages teleophthalmology software for the diagnosis and followup of diabetic retinopathy. There is no treatment performed via the software. Therefore, there is no conflict with their role in the development of, or the material presented in this report. Drs. Tennant and Rudnisky provided clinical expertise to the University of Alberta research team, feedback on draft reports, and assisted in writing background material on diabetic retinopathy.
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