Cost-Effectiveness of Humidified High-Flow Therapy (HHFT) for COPD Patients on Long-Term Oxygen Therapy.

Purpose: Chronic obstructive pulmonary disease (COPD) is the third leading cause of mortality, and is associated with significant respiratory impairment, decreased quality of life, and high health care costs. Recent evidence indicates significant clinical benefit results from adding humidified high-flow therapy (HHFT) to standard long-term oxygen therapy (LTOT) as a home-based therapy in persons with severe COPD. The objective was to evaluate the cost-effectiveness of adding HHFT to standard treatment of COPD patients using LTOT with US healthcare cost estimates. Patients and Methods: A Markov state-transition model was developed using data from a prospective clinical trial of adding HHFT to standard therapy for persons with severe COPD using LTOT. The analysis was conducted from the US health care system perspective using a 5-year time horizon and 3% discount rate. QALYs and downstream healthcare costs were modeled. One-way and probabilistic sensitivity analyses were used to examine the impact of input parameters on the incremental net monetary benefit (NMB). Results: Incremental QALYs accrued were 0.058 (2.047 vs 1.989 QALYs for HHFT and standard therapy groups respectively). Incremental total costs were -$3939 ($47,516 vs $51,455 for HHFT and standard therapy groups respectively). Thus, HHFT was the dominant treatment in the analysis, resulting on both better health and lower total costs. Varying utility and cost inputs individually never resulted in NMB approaching 0. Probabilistic analyses indicate that HHFT is cost-effective in 84% of simulations. Conclusion: Our results indicate that the reductions in acute exacerbations of COPD (AECOPDs) that result from adding HHFT for persons with COPD on LTOT will produce both health benefit (QALYs) and cost savings. Cost savings occur because the HHFT device costs are more than offset by reductions in costly COPD exacerbations. Health care systems and payors can benefit from wider implementation of HHFT with existing treatments.

Cost-effectiveness of Yoga for Chronic Low Back Pain in Veterans.

BACKGROUND: Yoga interventions can improve function and reduce pain in persons with chronic low back pain (cLBP). OBJECTIVE: Using data from a recent trial of yoga for military veterans with cLBP, we analyzed the incremental cost-effectiveness of yoga compared with usual care. METHODS: Participants (n=150) were randomized to either 2× weekly, 60-minute yoga sessions for 12 weeks, or to delayed treatment (DT). Outcomes were measured at 12 weeks, and 6 months. Quality-adjusted life years (QALYs) were measured using the EQ-5D scale. A 30% improvement on the Roland-Morris Disability Questionnaire (primary outcome) served as an additional effectiveness measure. Intervention costs including personnel, materials, and transportation were tracked during the study. Health care costs were obtained from patient medical records. Health care organization and societal perspectives were examined with a 12-month horizon. RESULTS: Incremental QALYs gained by the yoga group over 12 months were 0.043. Intervention costs to deliver yoga were $307/participant. Negligible differences in health care costs were found between groups. From the health care organization perspective, the incremental cost-effectiveness ratio to provide yoga was $4488/QALY. From the societal perspective, yoga was "dominant" providing both health benefit and cost savings. Probabilistic sensitivity analysis indicates an 89% chance of yoga being cost-effective at a willingness-to-pay of $50,000. A scenario comparing the costs of yoga and physical therapy suggest that yoga may produce similar results at a much lower cost. DISCUSSION/CONCLUSIONS: Yoga is a cost-effective treatment for reducing pain and disability among military veterans with cLBP.

Cost-Effectiveness of a Pharmacogenetic Test to Guide Treatment for Major Depressive Disorder.

BACKGROUND: Recent clinical trials indicate that pharmacogenetic-guided treatment of major depressive disorder (MDD) results in higher treatment response rates by genetically matching patients to medications and avoiding a trial-and-error process. OBJECTIVE: To evaluate the cost-effectiveness of a pharmacogenetic test (IDGx) that has demonstrated effectiveness compared with standard of care (SOC) medication management among patients with varied MDD severity. METHODS: Data from a large prospective, randomized controlled trial of treatment-naive patients or patients with inadequately controlled MDD in general practice and psychiatric treatment settings were used to build a Markov state-transition probability model. Analyses were conducted from the societal perspective. Treatment response rates, mortality rates, direct and indirect medical costs, and utility inputs were derived from the reference study and published scientific literature. The cost of the pharmacogenetic test was $2,000. A 3% discount rate was used to discount costs and effects. Univariate one-way sensitivity analyses were performed to determine the effect of input parameters on net monetary benefit. RESULTS: For moderate to severe MDD, the model estimated a cumulative effect over 3 years of 2.07 quality-adjusted life-years (QALYs) for the pharmacogenetic-guided treatment group and 1.97 QALYs for the SOC group, including a lower probability of death from suicide (0.328% and 0.351%, respectively). Total costs over 3 years were $44,697 (IDGx) and $47,295 (SOC). This difference includes a savings of $2,918 in direct medical costs and $1,680 in indirect costs. Results were more pronounced when only severely depressed patients were evaluated. CONCLUSIONS: Pharmacogenetic testing among moderate to severe MDD patients improved QALYs and resulted in cost savings. Sensitivity analyses supported the robust nature of the current findings of the dominant IDGx test to guide treatment. DISCLOSURES: Funding for this analysis was provided by AltheaDx, which is the manufacturer of the IDgenetix test. AltheaDx personnel assisted in the study design, data collection, and review of the manuscript. Maciel and Garces are employed by AltheaDx. Groessl has received funding as a consultant from American Specialty Health.

Patient-Reported Spectacle Independence Questionnaire (PRSIQ): Development and Validation.

PURPOSE: To develop a questionnaire quantifying spectacle independence following cataract surgery. DESIGN: Questionnaire design and validation study. METHODS: A literature review, expert clinical interviews, and patient interviews were undertaken to develop a patient-reported questionnaire assessing spectacle independence. Draft items were assessed and revised in a series of cognitive interviews where the instructions, recall period, and response categories were evaluated for understandability and consistency. The final draft items were evaluated in 2 quantitative studies. Confirmatory factor analyses, including item response theory calibration, were performed; reliability estimates were obtained; and validity analyses of the resulting scores were carried out. RESULTS: Qualitative research demonstrated that patients often considered themselves spectacle independent yet, when probed, it was determined that the respondent actually wore correction for certain activities. Moreover, despite what the respondents claimed about needing to wear correction and their actual use of correction, there were various levels of function reported when carrying out activities at several different distances without the use of correction. Using the qualitative results, the Patient-Reported Spectacle Independence Questionnaire (PRSIQ) was developed to assess spectacle independence via items that assess what patients say and do, and how they function at various distances. All quantitative analyses (eg, discriminant and convergent validity correlations, known-groups analyses) conform to predictions and support the use of the PRSIQ as a measure of spectacle independence. CONCLUSIONS: The PRSIQ is a patient-reported measure assessing spectacle independence following cataract surgery. The analyses conducted provide evidence for the use of the PRSIQ total score as a measure of spectacle independence.

Gender differences in adapting driving behavior to accommodate visual health limitations.

This study investigated whether men and women are equally likely to adapt their driving behaviors in response to visual limitations. Participants were 376 (222 women and 154 men) pre-surgical cataract patients from the Shiley Eye Center in La Jolla, California. All participants completed the National Eye Institute Visual Functioning Questionnaire, which assesses self-reported visual symptoms, functional limitations, and behaviors including driving during the day, at night, or in difficult conditions. Visual acuity was assessed using the log of the minimal angle of resolution (LogMAR) scale. There were no significant differences in LogMAR visual acuity between men and women who reported either that they stopped driving at night because of visual impairment or reported having no difficulty driving at night. Of participants who reported having difficulty driving at night, mean weighted LogMAR scores indicated significantly better visual acuity for women than men. There were no significant differences in LogMAR visual acuity between women and men in any of the difficult driving condition categories. Significantly more women than men reported that they stopped driving in difficult conditions because of eyesight, despite the lack of gender differences in visual acuity for this sample. We found no evidence that cataract disease had different effects on the visual acuity of older adult men and women. However, there was a significant difference between genders in self-reported driving behavior. It is possible that some women are more cautious or have less need to drive. However, failing to adapt driving behaviors to accommodate visual limitations may represent a potential behavioral public health risk for men.

The impact of the San Diego wildfires on a general mental health population residing in evacuation areas.

San Diego County Mental Health system clients completed a questionnaire after the October 2007 wildfires. As compared to those not in an evacuation area, those residing in an evacuation area reported significantly more impact of the fires. Clients who evacuated were most affected, followed by those in an evacuation area who did not evacuate. Evacuation strongly impacted client-reported emotional effects of the fire, confusion about whether to evacuate, and ability to obtain medications. Gender and clinical diagnosis interacted with evacuation status for some fire impact variables. Loss of control and disruption of routine are discussed as possibly related factors.

A qualitative investigation of visual tasks with which to assess distance-specific visual function.

BACKGROUND: The ability to perform many daily tasks relies on good visual acuity at various distances. A review of existing measures of visual function revealed gaps in task content, particularly tasks that rely on intermediate vision. PURPOSE: This research sought to extend the content base and visual range coverage of tasks used to assess visual function. METHODS: Ophthalmology patients (n = 72) with myopia, hyperopia, presbyopia, astigmatism, cataracts, and/or glaucoma were involved in various qualitative sub-studies, including life event journaling, telephone interviews, and both on-line and face-to-face focus groups. The resulting journal entries and transcripts were thematically analyzed to identify visual tasks that rely on visual acuity in the near, intermediate, and distant visual ranges. RESULTS: A wide variety of distance-specific visual tasks were identified. Certain types of tasks relied on distance vision, such as; ambulation, driving, leisure and sports, and social functions. Other task groupings such as technology use and activities of daily living relied primarily on near and intermediate vision. Two new content areas were identified, technology use and safe task performance. CONCLUSIONS: This thematic analysis provides a rich body of information about tasks that affect daily life and are made more difficult by poor visual acuity at various distance ranges.

Development and validation of a mental health subscale from the Quality of Well-Being Self-Administered.

PURPOSE: The purpose of this study was to create and validate a mental health subscale for the Quality of Well-Being Self-Administered (QWB-SA). METHODS: The QWB-SA and other measures such as the Profile of Mood States (POMS), Medical Outcomes Study 36 Item Short Form (SF-36), EuroQOL 5D (EQ-5D), and Health Utilities Index Mark 2 (HUI) were administered to three samples: a general population (N = 3,844), a non-psychiatric medical population (N = 535), and a psychiatric population (N = 915). Independent expert ratings of which items represented the construct of mental health were used along with psychometric methods to develop and validate a 10-item QWB-SA mental health scale. RESULTS: The mental health scale demonstrated high internal consistency (Cronbach's alpha = 0.827-0.842) and strong correlations with other measures of mental health, such as the POMS (r = -0.77), mental health scale from the SF-36 (r = 0.72), EQ-5D mood item (r = 0.61), and HUI Emotion Scale (r = 0.59). It was not highly correlated with measures of physical health. Among the psychiatric population, the new mental health scale was moderately correlated with indicators of psychiatric problem severity. CONCLUSIONS: It is now possible to report outcomes and relationships with mental health in studies that use the QWB-SA. This new mental health subscale can also be used with the large volume of previously collected data using the QWB-SA to examine the impact of illnesses and interventions on mental health-related quality of life.

Measuring the impact of cataract surgery on generic and vision-specific quality of life.

PURPOSE: Cataracts are the leading cause of blindness worldwide and cause visual impairment for millions of adults in the United States. We compared the sensitivity of a vision-specific health-related quality of life (HRQOL) measure to that of multiple generic measures of HRQOL before and at 2 time points after cataract surgery. METHODS: Participants completed 1 vision-specific and 5 generic quality of life measures before cataract surgery, and again 1 and 6 months after surgery. Random effects modeling was used to measure changes over the three assessment points. RESULTS: The NEI-VFQ25 total score and all 11 subscales showed significant improvements during the first interval (baseline and 1 month). During the second interval (1-6 months post-surgery), significant improvements were observed on the total score and 5 of 11 NEI-VFQ25 subscales. There were significant increases in HRQOL during the first interval on some preference-based generic HRQOL measures, though changes during the second interval were mostly non-significant. None of the SF-36v2™ or SF6D scales changed significantly between any of the assessment periods. CONCLUSIONS: The NEI-VFQ25 was sensitive to changes in vision-specific domains of QOL. Some preference-based generic HRQOL measures were also sensitive to change and showed convergence with the NEI-VFQ25, but the effects were small. The SF-36v2™ and SF-6D did not change in a similar manner, possibly reflecting a lack of vision-related content. Studies seeking to document both the vision-specific and generic HRQOL improvements of cataract surgery should consider these results when selecting measures.

Evaluating a measure of social health derived from two mental health recovery measures: the California Quality of Life (CA-QOL) and Mental Health Statistics Improvement Program Consumer Survey (MHSIP).

Social health is important to measure when assessing outcomes in community mental health. Our objective was to validate social health scales using items from two broader commonly used measures that assess mental health outcomes. Participants were 609 adults receiving psychological treatment services. Items were identified from the California Quality of Life (CA-QOL) and Mental Health Statistics Improvement Program (MHSIP) outcome measures by their conceptual correspondence with social health and compared to the Social Functioning Questionnaire (SFQ) using correlational analyses. Pearson correlations for the identified CA-QOL and MSHIP items with the SFQ ranged from .42 to .62, and the identified scale scores produced Pearson correlation coefficients of .56, .70, and, .70 with the SFQ. Concurrent validity with social health was supported for the identified scales. The current inclusion of these assessment tools allows community mental health programs to include social health in their assessments.

Five preference-based indexes in cataract and heart failure patients were not equally responsive to change.

OBJECTIVE: To compare the responsiveness to clinical change of five widely used preference-based health-related quality-of-life indexes in two longitudinal cohorts. STUDY DESIGN AND SETTING: Five generic instruments were simultaneously administered to 376 adults undergoing cataract surgery and 160 adults in heart failure management programs. Patients were assessed at baseline and reevaluated after 1 and 6 months. The measures were the Short Form (SF)-6D (based on responses scored from SF-36v2), Self-Administered Quality of Well-being Scale (QWB-SA), the EuroQol-5D developed by the EuroQol Group, the Health Utilities Indexes Mark 2 (HUI2) and Mark 3 (HUI3). Cataract patients completed the National Eye Institute Visual Functioning Questionnaire-25, and heart failure patients completed the Minnesota Living with Heart Failure Questionnaire. Responsiveness was estimated by the standardized response mean. RESULTS: For cataract patients, mean changes between baseline and 1-month follow-up for the generic indices ranged from 0.00 (SF-6D) to 0.052 (HUI3) and were statistically significant for all indexes except the SF-6D. For heart failure patients, only the SF-6D showed significant change from baseline to 1 month, whereas only the QWB-SA change was significant between 1 and 6 months. CONCLUSIONS: Preference-based methods for measuring health outcomes are not equally responsive to change.

Evaluation of an internet-based disease trajectory decision tool for prostate cancer screening.

OBJECTIVE: To evaluate the application of a chronic disease model (CDM) for prostate cancer to visual analog scale (VAS) and time trade-off (TTO) decision tools. METHODS: A total of 138 men (mean age 58 years) viewed a CDM module for prostate cancer with and without prostate specific antigen (PSA) screening. Participants rated their hypothetical quality of life with potential prostate cancer treatment complications using a CDM-based VAS decision tool. They were then asked to estimate how many years they would be willing to trade to be free of treatment complications using a CDM-based TTO decision tool. The consistency between VAS and TTO scores and the relationship between scores and preferences for PSA screening test and hypothetical treatment choice for prostate cancer were then evaluated. RESULTS: There was a significant relationship between the VAS and TTO ratings (regression P < 0.001). The TTO tool was sensitive to age. Mean scores with standard deviations for those less than 58 years compared to those 58 years and more were 7.78 (1.75) and 8.41 (1.52), respectively (P = 0.04). Using the VAS tool, men who chose PSA screening had higher quality of life ratings compared to men who did not choose PSA screening: 7.73 (1.78) and 6.59 (2.39), respectively (P = 0.01). Similar results were found with the TTO decision tool: 8.33 (1.45) and 7.04 (2.00), respectively (P = 0.005). Men who would hypothetically prefer treatment for moderately differentiated prostate cancer also had higher TTO scores compared to men who preferred watchful waiting: 8.54 (1.39) and 7.85 (1.73), respectively (P = 0.04). CONCLUSION: CDM-based for prostate cancer, VAS and TTO ratings were consistent and were concordant with patient preferences for screening; TTO ratings were also concordant with treatment choice. The use of the CDM-based TTO ratings to adjust for quality of life in decision analytic modeling needs to be explored.

Internet patient decision support: a randomized controlled trial comparing alternative approaches for men considering prostate cancer screening.

BACKGROUND: We conducted a randomized controlled trial to evaluate the effects of patient decision support Web sites on decision quality for men considering prostate cancer screening. METHODS: Men older than 50 years (N = 611) were randomly assigned to 1 of 4 Internet conditions: traditional didactic decision aid providing information about prostate-specific antigen (PSA) screening options and outcomes; chronic disease trajectory model for prostate cancer followed by a time-trade-off exercise; both the didactic decision aid and the chronic disease trajectory model; or links to public prostate cancer-specific Web sites from credible sources (control condition). Participants completed questionnaires at baseline and after their physical examination. Primary outcome measures were PSA test choice, prostate cancer treatment preferences, knowledge and concern about prostate cancer, and decisional conflict. RESULTS: Participants assigned to view public Web sites were less likely to review information (116 participants [76.8%] reviewed) than those assigned to experimental groups (399 [86.7%] reviewed; P = .004). Greater reductions in PSA screening from pretest to posttest were observed among participants assigned to the traditional decision aid (-9.1%) or chronic disease trajectory model (-8.7%), compared with participants assigned to the combination (-5.3%) or control (-3.3%) groups (P = .047). Preferences for watchful waiting increased significantly in all 4 groups (baseline, 219 [35.8%]; follow-up, 303 [66.2%]; P < .001). Knowledge scores were lowest for those assigned to public Web sites (mean [SD] score, 7.49 [0.19] of questions correct) and highest for the traditional decision aid (8.65 [0.18] of questions correct; P = .005). CONCLUSION: Public Web sites about prostate cancer provide less effective decision support than a specially designed Internet decision aid.