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Purpose: The Patient-Reported Outcomes Measurement Information System (PROMIS®) initiative was developed to advance the methodology of PROs applicable to chronic diseases. Chronic obstructive pulmonary disease (COPD) is a progressive chronic disease associated with poor health. This study was designed to examine the correlation of PROMIS health-related quality of life (HRQOL) scales and clinical measures among COPD patients. Methods: A cross-sectional analysis was conducted comparing patients who were stable (n = 100) with those currently experiencing a COPD exacerbation (n = 85). All PROMIS measures for adults available at the time of the study (2008), disease-targeted and other HRQOL instruments, health literacy, percent predicted FEV1, and a 6-min walk distance were assessed when patients were considered clinically stable. Results: Stable COPD patients reported significantly (p ≤ 0.05) better health-related quality of life on PROMIS domains than patients experiencing an exacerbation. PROMIS domain scores were significantly (p ≤ 0.01) correlated with each of legacy measures. Six-min walk scores were most highly correlated with the PROMIS physical function domain scores (r = 0.53) followed by the fatigue (r = −0.26), social (r = 0.24) and to a lesser extent depression (r = −0.23), and anxiety (r = −0.22) domain scores. Percent predicted FEV1 score was significantly associated with PROMIS physical function scores (r = 0.27). Conclusion: This study provides support for the validity of the PROMIS measures in COPD patients.

ObjectiveTo develop and test the psychometric properties of a 25-item version of the National Eye Institute Visual Function Questionnaire (NEI VFQ-25).DesignProspective observational cohort study of persons with 1 of 5 chronic eye diseases or low vision who were scheduled for nonurgent visits in ophthalmology practices and a reference sample of persons without eye disease.SettingEleven university-based ophthalmology practices and the NEI Clinical Center.PatientsEligible participants had to have 1 of the following eye conditions: age-related cataracts, age-related macular degeneration, diabetic retinopathy, primary open-angle glaucoma, cytomegalovirus retinitis, or low vision from any cause. Seven of the 12 sites also enrolled persons in a reference sample. Reference sample participants had no evidence of underlying eye disease but were scheduled for either screening eye examinations or correction of refractive error. All eligible persons had to be 21 years or older, English speaking, and cognitively able to give informed consent and participate in a health status interview.Measurements and main resultsTo provide the data needed to create the NEI VFQ-25, all subjects completed an interview that included the 51-item NEI VFQ. Estimates of internal consistency indicate that the subscales of the NEI VFQ-25 are reliable. The validity of the NEI VFQ-25 is supported by high correlations between the short- and long-form versions of the measure, observed between-group differences in scores for persons with different eye diseases of varying severity, and the moderate-to-high correlations between the NEI VFQ-25 subscales that have the most to do with central vision and measured visual acuity.ConclusionsThe reliability and validity of the NEI VFQ-25 are comparable to those of the 51-item NEI VFQ field test version of the survey. This shorter version will be more feasible in settings such as clinical trials where interview length is a critical consideration. In addition, preliminary analyses indicate that the psychometric properties of the NEI VFQ-25 are robust for the eye conditions studied; this suggests that the measure will provide reproducible and valid data when used across multiple conditions of varying severity.

ObjectiveTo develop and test the psychometric properties of a 25-item version of the National Eye Institute Visual Function Questionnaire (NEI VFQ-25).DesignProspective observational cohort study of persons with 1 of 5 chronic eye diseases or low vision who were scheduled for nonurgent visits in ophthalmology practices and a reference sample of persons without eye disease.SettingEleven university-based ophthalmology practices and the NEI Clinical Center.PatientsEligible participants had to have 1 of the following eye conditions: age-related cataracts, age-related macular degeneration, diabetic retinopathy, primary open-angle glaucoma, cytomegalovirus retinitis, or low vision from any cause. Seven of the 12 sites also enrolled persons in a reference sample. Reference sample participants had no evidence of underlying eye disease but were scheduled for either screening eye examinations or correction of refractive error. All eligible persons had to be 21 years or older, English speaking, and cognitively able to give informed consent and participate in a health status interview.Measurements and main resultsTo provide the data needed to create the NEI VFQ-25, all subjects completed an interview that included the 51-item NEI VFQ. Estimates of internal consistency indicate that the subscales of the NEI VFQ-25 are reliable. The validity of the NEI VFQ-25 is supported by high correlations between the short- and long-form versions of the measure, observed between-group differences in scores for persons with different eye diseases of varying severity, and the moderate-to-high correlations between the NEI VFQ-25 subscales that have the most to do with central vision and measured visual acuity.ConclusionsThe reliability and validity of the NEI VFQ-25 are comparable to those of the 51-item NEI VFQ field test version of the survey. This shorter version will be more feasible in settings such as clinical trials where interview length is a critical consideration. In addition, preliminary analyses indicate that the psychometric properties of the NEI VFQ-25 are robust for the eye conditions studied; this suggests that the measure will provide reproducible and valid data when used across multiple conditions of varying severity.

ObjectiveTo identify the content area for a questionnaire designed to measure vision-targeted health-related quality of life and to determine whether problems with vision-related functioning are qualitatively similar across different common eye diseases.DesignTwenty-six condition-specific focus groups were conducted with 246 patients from 5 geographic regions to identify the content area for a questionnaire for use among persons with diabetic retinopathy, glaucoma, macular degeneration, cytomegalovirus retinitis, and cataract. A standard protocol was used to structure each focus group discussion. Sessions were audiotaped, transcribed, and coded in preparation for a content analysis.SettingsFive university-based ophthalmology practices and 1 nonprofit eye care foundation.ParticipantsEligible participants had to have 1 of the following eye conditions: age-related cataracts, age-related macular degeneration, diabetic retinopathy, primary open angle glaucoma, cytomegalovirus retinitis, or low vision from any cause. All eligible persons were older than 21 years, spoke English, and had sufficient cognitive function to provide informed consent.ResultsAmong the 246 participants, 2623 problems with vision-related functioning were mentioned. The mean number of problems per person ranged from 13.5 for those with diabetic retinopathy to 7.9 for persons with glaucoma. For the sample overall, reading problems were mentioned most frequently, followed by driving, general problems with seeing clearly, and mental health complaints caused by vision. Although the proportion of persons who reported each problem varied by condition, at least some persons with each eye disease reported each problem. The 3 most common descriptors associated with each problem were difficulty or ease of performance (13%), psychological distress associated with performance of the activity (11%), and complete inability to participate in a visual activity (11%).ConclusionAn item-generation strategy for a new questionnaire using a standardized focus group method identified content areas and aspects of visual disability that are not included in currently available vision-specific instruments that assess the impact of common eye diseases on visual functioning in every-day life. Although participants mentioned problems that were unique to their disease, across conditions the problems mentioned were similar. These findings provide empirical evidence of content validity for a vision-targeted, health-related quality-of-life survey designed for use across conditions.

ObjectiveTo identify the content area for a questionnaire designed to measure vision-targeted health-related quality of life and to determine whether problems with vision-related functioning are qualitatively similar across different common eye diseases.DesignTwenty-six condition-specific focus groups were conducted with 246 patients from 5 geographic regions to identify the content area for a questionnaire for use among persons with diabetic retinopathy, glaucoma, macular degeneration, cytomegalovirus retinitis, and cataract. A standard protocol was used to structure each focus group discussion. Sessions were audiotaped, transcribed, and coded in preparation for a content analysis.SettingsFive university-based ophthalmology practices and 1 nonprofit eye care foundation.ParticipantsEligible participants had to have 1 of the following eye conditions: age-related cataracts, age-related macular degeneration, diabetic retinopathy, primary open angle glaucoma, cytomegalovirus retinitis, or low vision from any cause. All eligible persons were older than 21 years, spoke English, and had sufficient cognitive function to provide informed consent.ResultsAmong the 246 participants, 2623 problems with vision-related functioning were mentioned. The mean number of problems per person ranged from 13.5 for those with diabetic retinopathy to 7.9 for persons with glaucoma. For the sample overall, reading problems were mentioned most frequently, followed by driving, general problems with seeing clearly, and mental health complaints caused by vision. Although the proportion of persons who reported each problem varied by condition, at least some persons with each eye disease reported each problem. The 3 most common descriptors associated with each problem were difficulty or ease of performance (13%), psychological distress associated with performance of the activity (11%), and complete inability to participate in a visual activity (11%).ConclusionAn item-generation strategy for a new questionnaire using a standardized focus group method identified content areas and aspects of visual disability that are not included in currently available vision-specific instruments that assess the impact of common eye diseases on visual functioning in every-day life. Although participants mentioned problems that were unique to their disease, across conditions the problems mentioned were similar. These findings provide empirical evidence of content validity for a vision-targeted, health-related quality-of-life survey designed for use across conditions.