Development and validation of the impact of dry eye on everyday life (IDEEL) questionnaire, a patient-reported outcomes (PRO) measure for the assessment of the burden of dry eye on patients.

OBJECTIVE: To develop and validate a comprehensive patient-reported outcomes instrument focusing on the impact of dry eye on everyday life (IDEEL). METHODS: Development and validation of the IDEEL occurred in four phases: 1) focus groups with 45 dry eye patients to develop a draft instrument, 2) item generation, 3) pilot study to assess content validity in 16 patients and 4) psychometric validation in 210 subjects: 130 with non-Sjögren's keratoconjunctivitis sicca, 32 with Sjögren's syndrome and 48 controls, and subsequent item reduction. RESULTS: Focus groups identified symptoms and the associated bother, the impact of dry eye on daily life and the patients' satisfaction with their treatment as the central concepts in patients' experience of dry eye. Qualitative analysis indicated that saturation was achieved for these concepts and yielded an initial 112-item draft instrument. Patients understood the questionnaire and found the items to be relevant indicating content validity. Patient input, item descriptive statistics and factor analysis identified 55 items that could be deleted. The final 57-item IDEEL assesses dry eye impact constituting 3 modules: dry eye symptom-bother, dry eye impact on daily life comprising impact on daily activities, emotional impact, impact on work, and dry eye treatment satisfaction comprising satisfaction with treatment effectiveness and treatment-related bother/inconvenience. The psychometric analysis results indicated that the IDEEL met the criteria for item discriminant validity, internal consistency reliability, test-retest reliability and floor/ceiling effects. As expected, the correlations between IDEEL and the Dry Eye Questionnaire (a habitual symptom questionnaire) were higher than between IDEEL and Short-Form-36 and EuroQoL-5D, indicating concurrent validity. CONCLUSION: The IDEEL is a reliable, valid and comprehensive questionnaire relevant to issues that are specific to dry eye patients, and meets current FDA patient-reported outcomes guidelines. The use of this questionnaire will provide assessment of the impact of dry eye on patient dry eye-related quality of life, impact of treatment on patient outcomes in clinical trials, and may aid in treatment effectiveness evaluation.

Quality of life and health economic assessments of age-related macular degeneration.

In this article, we review measures of patient-reported outcomes that can show whether a treatment for age-related macular degeneration also provides patient-perceived benefits. In addition, we look at health economic measurements currently being used to develop cost-effectiveness models for age-related macular degeneration.

The economic impact of blue-light filtering intraocular lenses on age-related macular degeneration associated with cataract surgery: a third-party payer's perspective.

OBJECTIVES: Epidemiological data support an association between age-related macular degeneration (AMD) and cataract surgery that may be attributed to post-operative blue light exposure. By limiting the retina's blue light exposure, new blue-light filtering intraocular lenses (BLF IOLs) have the potential to reduce the development of AMD following cataract surgery. In the current economic healthcare environment, there is increased interest in the cost impact of new medical technologies. The objective of this analysis was to evaluate the cost impact of a BLF IOL versus a non-BLF IOL in cataract surgery. METHODS: An economic model was developed to emulate three age-specific cohorts and to assess the clinical and economic outcomes over 5 years. Data from the published literature was supplemented with clinical expert opinion. Key literature inputs involved the risk of AMD after cataract surgery as well as laboratory and animal data on the effectiveness of the BLF IOL in reducing the risk of AMD. Clinical experts provided information on the management of AMD. Direct medical costs including the cost of the IOL, monitoring, and AMD prophylaxis and treatment were incorporated into the model. All costs were standardized to 2004 US dollars. Age-stratified sensitivity analyses were conducted. RESULTS: In the BLF IOL group, the 5-year age-stratified incidence of AMD ranged from 0.58 to 9.23 per 100 eyes, compared with 1.69 to 24.55 per 100 eyes in the non-BLF IOL group. The incremental cost of the BLF was offset by reduced costs associated with averted AMD treatment. Estimated savings with BLF IOLs per 100 eyes were $4275, $29 997, and $111 734 in the 55 to 64 year-old, 65 to 74 year-old, and >or= 75-year-old cohorts, respectively; these findings remained robust throughout the sensitivity analyses. CONCLUSION: Limitations of this analysis include the lack of prospective clinical trial data that definitively demonstrate the efficacy of a BLF IOL in preventing AMD. Moreover, the efficacy data used to populate the model were derived from laboratory and animal studies. Thus, based on preliminary data, this study suggests that the economic benefits of implanting BLF IOLs during cataract surgery are observed in all patients over a 5-year timeframe although cost savings are greatest in patients >or= 75 years.

Quality-of-life improvements in cataract patients with bilateral blue light-filtering intraocular lenses: clinical trial.

PURPOSE: To compare change in patient-reported vision-related and health-related functioning and quality of life (HRQOL) following bilateral implantation with a new blue light-filtering intraocular lens (IOL) with the results of a similar IOL that does not filter blue light. SETTING: Six clinical sites in the United States. METHODS: Patients were from 6 clinical sites in the United States that performed a high volume of cataract surgeries. The HRQOL assessments occurred via telephone while patients were at home. Patients requiring bilateral cataract extraction were randomly assigned to 1 of the 2 IOL groups for the first eye. The second eye was later implanted with the same type of IOL. Patients and HRQOL data collectors were treatment-masked, but investigators could not be. Health-related functioning and quality of life was measured with the 39-item National Eye Institute Visual Functioning Questionnaire (NEI VFQ-39) and 12-item Short Form Health Survey (SF-12). Assessments were at baseline before implantation in the first eye and 30 to 60 days and 120 to 180 days after implantation of the lens in the second eye. RESULTS: Both IOL types improved most aspects of patients' HRQOL including color vision and driving. The largest gains occurred on the VFQ composite, general vision, near activities, distance activities, driving, mental health, peripheral vision, and role difficulties scales. Significant gains also occurred on color vision and other vision-specific scales as well as the SF-12 physical component summary score. There were no significant differences in HRQOL gains between the IOLs. CONCLUSION: The blue light-filtering IOL improved color vision, driving, and other aspects of HRQOL in a manner similar to that of a lens that does not filter blue light.

ISPOR Code of Ethics for Researchers background article--report of the ISPOR Task Force on Code of Ethics for Researchers.

In 2001, ISPOR convened a Task Force on Code of Ethics for Researchers (The Task Force). This Task Force was to build on the previous work of ISPOR Health Science Policy Task Forces and develop a code of ethics that would be applicable to all ISPOR members and to ISPOR itself. The Task Force developed a code of ethics that was subsequently adopted by the ISPOR Board of Directors. The Code of Ethics is appended to this article and can be found on ISPOR's Web page at http://www.ispor.org/workpaper/code_ethic.htm. This article provides supportive information and justification for the ISPOR Code of Ethics for Researchers and includes a discussion of the stakeholders as well as ethical considerations for the researcher on research practices, research sponsorship, research publication and dissemination, and relationships with others. It also includes a discussion of the ethical considerations for the Society.