Effect of adjustable gastric banding on quality of life and weight loss in the Helping Evaluate Reduction in Obesity (HERO) registry study: 2 year analysis.

OBJECTIVE: This report from the Helping Evaluate Reduction in Obesity (HERO) Study investigated weight loss, health-related quality of life (HRQOL), and factors predictive of HRQOL improvement during a 2 year period following Lap-Band AP implantation (post-LBAP). RESEARCH DESIGN AND METHODS: This prospective, observational study included patients with 1 and 2 year follow-up data post-LBAP (N = 585). Changes in body mass index (BMI), percentage of weight loss (%WL), excess weight loss (%EWL) and HRQOL (Impact of Weight on Quality of Life [IWQOL]-Lite measure), and differences between <30% EWL and ≥30% EWL subgroups were assessed at 1 and 2 years post-LBAP. Multiple linear regression examined association of %EWL groups with IWQOL-Lite scores controlling for age, gender, region (US vs outside US), household income, employment status, and comorbidities. RESULTS: Most patients were female (80.2%) and from the US (64.8%); overall mean (SD) age was 43.6 (11.28) years and 65.8% of patients had ≥30% EWL at year 2. At 2 years post-LBAP, mean %EWL was 43.5%; %EWL was 12.4% in the <30% EWL group and 59.6% in ≥30% EWL group (P ≤ 0.0001). Changes in IWQOL total and subscores were significantly greater in ≥30% EWL versus <30% EWL patients (all P < 0.0005) at years 1 and 2; Self-Esteem and Physical subscores had the largest changes. Multiple regression analysis showed that patients with ≥30% EWL had clinically meaningful improvements in HRQOL compared with patients having <30% EWL (P ≤ 0.001). Similarly, US patients and females had a clinically significant change in IWQOL score versus their counterparts (P ≤ 0.001). Conversely, income, comorbidities and employment status were not significant predictors of change in IWQOL scores at year 2. CONCLUSIONS: These results support and extend findings regarding the effectiveness of LBAP for weight loss and illustrate the importance of ≥30% EWL as a significant factor in predicting clinically significant improvement in HRQOL 1 and 2 years post-LBAP. CLINICAL TRIAL REGISTRATION: NCT00953173.

Why should we care about quality of life in persons with haemophilia?

The very high cost of haemophilia care, including the increase in use of factor prophylaxis in both children and adults requires that funders of clotting factor concentrates require objective measures of health, such as joint status and quality of life (QOL). Many clinical trials, especially those for licensing of new products, are including QOL instruments in their protocols to evaluate the patients' perspective of wellbeing before and during therapy. This article gives a perspective on QOL the importance of QOL measurement in the field of haemophilia and its impact on patient outcome.

Disability outcomes and dose escalation with etanercept, adalimumab, and infliximab in rheumatoid arthritis patients: a US-based retrospective comparative effectiveness study.

INTRODUCTION: Rheumatoid arthritis (RA) is a chronic disease that if left untreated may substantially impair physical functioning. Etanercept, infliximab, and adalimumab are tumor necrosis factor (TNF) blockers whose FDA-approved indications in the US include moderate to severe RA. TNF-blocker dose escalation has been well documented in the literature; however, the comparative effectiveness of these agents remains uncertain. OBJECTIVE: To compare the effectiveness and dose escalation rates of etanercept, adalimumab, and infliximab in US community settings. We hypothesized that etanercept would be equivalent to infliximab and adalimumab in patient-reported disability 9-15 months after therapy initiation, and that fewer etanercept patients would experience dose escalation. METHODS: This is a retrospective analysis of the Arthritis, Rheumatism, and Aging Medical Information System (ARAMIS). Adult patients with no biologic use 6 months before TNF-blocker initiation (index) and with Health Assessment Questionnaire Disability Index (HAQ-DI) scores at index and 9-15 months after index were analyzed (218 etanercept, 93 infliximab, and 40 adalimumab). RESULTS: HAQ-DI change scores at 9-15 months did not differ by treatment (-0.12, -0.10, and -0.08 points for etanercept, infliximab, and adalimumab, respectively; p = 0.52). Dose increases were observed in 1.4% of etanercept, 10.8% of infliximab (p < 0.001), and 12.5% of adalimumab patients (p = 0.004). HAQ-DI change was associated with pre-index HAQ-DI score (p < 0.0001) and disease duration (p = 0.001). CONCLUSIONS: Fewer etanercept patients escalated dose than infliximab or adalimumab patients, but improvements in functional disability were similar. These differences may have been influenced by package labeling, mode of administration, or other factors. RA treatment with infliximab and adalimumab in community settings, characterized by dose escalation, did not yield greater disability improvements compared to etanercept, which remained at a relatively stable dose. Uncontrolled treatment selection in this observational design may have influenced outcomes, and prior methotrexate treatment may partly explain disability improvements smaller than typically observed in clinical trials.

Measuring patient-reported outcomes in haemophilia clinical research.

Patient-reported outcome (PRO) measures have been used to assess quality of life and health state preferences from the patient's perspective. However, they have not been fully utilized in haemophilia clinical practice and research. A series of meetings were convened to review and document the state of the art in PROs relevant to haemophilia. Experts developed a process for selection of measures and identified published measures of health-related quality of life (HRQoL) relevant to patients with haemophilia. These were synthesized and reviewed. Patient preference measures were also identified and reviewed. Although the majority of measures were developed for and validated in adults, several measures were identified for use in paediatric populations. This paper recommends an approach to the selection of PROs for application in haemophilia clinical research and practice and identifies several potential measures relevant for application in haemophilia clinical research and practice.

Comparing total health care costs and treatment patterns of HIV patients in a managed care setting.

The objective of this study was to investigate total health care costs and time to occurrence of hospitalization in HIV-infected patients treated according to the 1998 DHHS guidelines in a managed care setting. The study also investigated which patients do not receive guideline treatment. We used a retrospective cross-sectional study design using medical and pharmacy claims data. Data from 1,791 HIV-infected patients using antiretroviral agents between 1 February 1998 and 31 July 1999, including demographic characteristics, medication guideline use, medication adherence and cost of care, were examined. Factors associated with total health care costs and time-to-inpatient admission (as a proxy for patient outcomes) were assessed. Patients receiving guideline (HAART) therapy (55%) had higher prescription and total health care costs but lower medical costs. Patients not receiving treatment according to guidelines were more likely to be female, older, have comorbidities, lower medication adherence and no AIDS-defining illness. Treatment with HAART guidelines was associated with longer time-to-inpatient admission controlling for other factors. In a short-term cross-sectional analysis, patients treated with HAART guidelines had better outcomes based on time-to-inpatient admission but higher prescription and total health care costs. Some patients are at risk for not receiving care according to national treatment guidelines and may be targeted for intervention programmes.

Utilization of care in haemophilia: a resource-based method for cost analysis from the Haemophilia Utilization Group Study (HUGS).

The Haemophilia Utilization Group Study (HUGS) was created 10 years ago to examine the annual utilization and cost of haemophilia-related healthcare services. Retrospective chart reviews for 336 patients with haemophilia A receiving treatment in one of five comprehensive haemophilia treatment centres (HTCs) during 1995 were completed through interview of the provider. This method provided adequate collection of data from patient charts without the abstractor having direct access to patient health information. Utilization data were used to impute the costs of different components of care (e.g. physician visits, factor VIII concentrate, emergency room, hospitalization). The total annual cost of care was 139,102 dollars (SD $304,033). Factor VIII concentrate costs comprised the largest proportion of these costs; mean factor VIII concentrate use was 128,517 units per patient per year. Unbilled physician utilization accounted for 7.8% of the mean total physician costs per annum, while mean allied healthcare costs accounted for 33.5% of the total annual allied healthcare costs per patient. In the ordinary least-squares regression model, higher costs were associated with severe factor VIII deficiency, arthropathy, more comorbid conditions, an inhibitor to factor VIII concentrate, infusing through a port and prophylaxis. Although factor VIII concentrate is the most costly component, the treatment of haemophilia uses many healthcare resources. HUGS has demonstrated that patient clinical characteristics and physician practices predominantly drive the costs of haemophilia care. Specifically, patients with more severe arthropathy had greater healthcare costs. As future funding decisions are made, it is important to provide for all components of care.

The Hemophilia Utilization Group Study (HUGS): determinants of costs of care in persons with haemophilia A.

OBJECTIVE: The main objective of this study was to examine factors associated with utilization and costs for persons with haemophilia. STUDY DESIGN: Utilization data and patient characteristics were collected through medical record review of 336 patients receiving treatment for at least 90% of their haemophilia care at one of five comprehensive haemophilia treatment centres in California. PRINCIPAL FINDINGS: The range of factor VIII deficiency in our sample was similar to the distribution among haemophilic patients in the Western United States; 215 (64%) had severe FVIII deficiency. The mean age in our sample was 21.4 (SD = 16.2) years old and 114 (34%) were HIV-positive. In the multivariate model predicting the total cost of health care during 1995 (adjusted R2 = 0.40), total annual costs were significantly (P < 0.05) associated with being HIV-seropositive, infusing FVIII concentrate through a port vs. i.v. infusion, the number of comorbidities, moderate arthropathy (compared with no arthropathy), mild arthropathy, history of inhibitor to FVIII, and current prophylactic FVIII concentrate infusion. CONCLUSION: As expected, total health-care costs were correlated with comorbid medical conditions, such as HIV and sequelae of haemophilia such as arthropathy. Health policy should consider risk adjustment for the presence of complications such as arthropathy and HIV infection in the financing of haemophilia treatment to promote more equitable delivery of these services.

Haemophilia Utilization Group Study: assessment of functional health status in haemophilia.

The purpose of this study was to assess the relationship between health care and utilization of that health care, and to provide a base measurement of health status in patients with haemophilia. Provider interview and retrospective chart review of 336 patients with haemophilia treated during 1995 at one of five comprehensive haemophilia treatment centres was conducted to measure patient health status characteristics and utilization of health care. Two health status scales were included. The first, the Self-Care Measure, was a four-point single item scale measuring the patient's ability for basic self-care, which was scored by a chart review and an interview with the health-care provider. The second, the Haemophilia Utilization Group Study (HUGS) Functional Status Measure, is a four-item, 10-point scale developed specifically for patients with haemophilia. Our sample represents 27% of actively treated patients in region IX. The mean score on the HUGS Functional Status Measure was 8.7 (SD=2.4). The HUGS scale exhibited a ceiling effect across all four scales: attitude (n=269, 80.1%), overall wellbeing (n=263, 78.3%), working (n=254, 75.6%) and orthopaedic status (n=195, 58.0%). Both higher total health-care costs and factor VIII annual costs were significantly associated with lower scores on the HUGS Functional Status Measure. Health status is a critical component in the assessment of the utilization and outcomes of care. In the absence of the availability of a patient interview, the HUGS Functional Status Measure can be used as one characteristic that explains the variation in the utilization of health care by patients with haemophilia.

Posttraumatic stress, quality of life, and psychological distress in young adult survivors of childhood cancer.

PURPOSE/OBJECTIVES: To explore the relationship between posttraumatic stress disorder (PTSD) and quality of life (QOL)/psychological outcome in young adult survivors of childhood cancer. DESIGN: Cross-sectional, descriptive study. SETTING: A large comprehensive pediatric cancer center on the West Coast. SAMPLE: Fifty-one young adult survivors of childhood cancer, 18-37 years of age, disease free, and off treatment for an average of 11 years (range 2.8-26.7 years). METHODS: A structured clinical interview was used to establish a PTSD diagnosis. Self-report instruments were used to assess QOL (RAND SF-36) and psychological distress (Brief Symptom Inventory (BSI)). Survivors with and without PTSD were compared on the BSI and RAND SF-36. MAIN RESEARCH VARIABLES: PTSD status, QOL and psychological distress. FINDINGS: Eleven subjects (20%) met full criteria for PTSD. Significant group differences were found for 17 of the 18 outcome variables. Survivors with PTSD reported clinically significant levels of psychological distress, whereas symptom levels for those without PTSD fell well within population norms. On all domains, QOL scores were significantly lower for the PTSD group compared to the non-PTSD group. CONCLUSIONS: PTSD in survivors of childhood cancer is related to long-term outcome. PTSD is associated with a poorer QOL (physical and mental) and an increase in psychological distress. Data suggest that survivors with PTSD have significant functional limitations and psychological comorbidity. IMPLICATIONS FOR NURSING PRACTICE: Screening cancer survivors for PTSD will identify high-risk patients who need further evaluation and intervention.

Evaluating quality-adjusted life years: estimation of the health utility index (HUI2) from the SF-36.

UNLABELLED: Quality-adjusted life years (QALYs) are well recognized as a valid measure for outcomes in cost-effectiveness analyses. A summary health utility score is necessary to evaluate QALYs. The objective of this study was to predict a summary utility score (represented by the Health Utility Index [HUI2]) from scores on the SF-36. METHODS: A structural equation framework was applied to longitudinal data collected from 1992 to 1995 on a sample of patients insured by Southem California Kaiser Permanente (N = 6921). An ordinary least squares (OLS) method was used to estimate the HUI2. RESULTS: The OLS model on cross-sectional data predicted 50.5% of the observed variance in HUI2 scores. Parameter estimates of all SF-36 components showed statistical significance at the P < 0.05 level. CONCLUSIONS: Results of this study provide a quantitative link between two important measures of health status. The present model can be used to estimate health utility summary scores in studies that have collected SF-36 data.

Associations of clinical parameters with health-related quality of life in hospitalized persons with HIV disease.

To assess the associations of clinical parameters with health-related quality of life (HRQOL) in hospitalized patients with HIV a cross-sectional survey and medical record review was conducted. Medical record reviews for clinical data were completed for 217 hospitalized, HIV-positive individuals. HRQOL was measured in face-to-face interviews using a 44-item survey instrument that yielded 11 multi-item scales. Internal consistency reliability was adequate for the 11 HRQOL scales. HRQOL scores were significantly lower for our hospitalized sample compared to a previous sample of ambulatory clinical trial patients. As expected, individuals reporting more days spent in bed due to illness had significantly lower HRQOL than those reporting fewer days spent in bed due to illness. In addition, those with greater severity of illness had significantly lower HRQOL than persons with less severe illness. In multivariate models, severity of illness and the number of disability days due to illness were significantly associated with worse HRQOL, controlling for CD4 count, symptoms and other patient characteristics. Severity of illness and disability days due to illness are associated with poorer functioning and well-being in hospitalized persons with HIV disease. HRQOL measures are useful tools for assessing the effects of HIV disease on the day-to-day life of individuals with HIV disease.