Short Form-6D Scores Research Articles

Health care disparities and chronic rhinosinusitis: Does neighborhood disadvantage impact outcomes in sinonasal disease?

Socioeconomic status (SES) is linked to health outcomes but has not been well studied in patients with chronic rhinosinusitis (CRS). The area deprivation index (ADI) is a comprehensive measure of geographic SES that ranks neighborhood disadvantage. This investigation used ADI to understand the impact of neighborhood disadvantage on CRS treatment outcomes. A total of 642 study participants with CRS were prospectively enrolled and self-selected endoscopic sinus surgery (ESS) or continued appropriate medical therapy as treatment. The 22-item SinoNasal Outcome Test (SNOT-22) and Medical Outcomes Study Questionnaire Short-Form 6-D (SF-6D) health utility value scores were recorded pre- and post-treatment. Using residence zip codes, national ADI scores were retrospectively assigned to patients. Spearman's correlation coefficients (Rs) and Cramer's V effect size (φc) with 95% confidence interval (CI) were calculated. A history of ESS was associated with significantly worse ADI scores compared to no history of ESS (φc=0.18; 95% CI: 0.10, 0.25; p<0.001). Baseline total SNOT-22 (Rs=0.14; 95% CI: 0.06, 0.22; p<0.001) and SF-6D values (Rs=-0.20; 95% CI: -0.27, -0.12; p<0.001) were significantly negatively correlated with national ADI rank. No significant correlations between ADI and within-subject improvement, or achievement of>1 minimal clinically important difference, in SNOT-22 or SF-6D scores after treatment were found. Geographic socioeconomic deprivation was associated with worse baseline disease severity and history of prior surgical intervention. However, ADI did not correlate with improvement in disease-specific outcomes. The impact of socioeconomic deprivation on outcomes in CRS requires further investigation.

Does air pollutant exposure impact disease severity or outcomes in chronic rhinosinusitis?

Poor air quality increases the risk of developing chronic rhinosinusitis (CRS) and other airway diseases. However, there are limited data on air pollutants and CRS-specific disease severity. We assessed the impact of air pollutants on sinonasal-specific and general quality-of-life (QOL) measures in a multi-institutional cohort of patients with CRS. Participants with CRS were prospectively enrolled in a cross-sectional study and self-selected continued appropriate medical therapy or endoscopic sinus surgery (ESS). The 22-item SinoNasal Outcome Test (SNOT-22) and Medical Outcomes Study Questionnaire Short-Form 6-D (SF-6D) health utility value scores were recorded. Patient exposure to air pollutants was determined using residence zip codes. Unadjusted group differences were compared, and correlation coefficients were evaluated to identify the magnitude of bivariate association. A total of 486 patients were enrolled and followed for a mean of 6.9 (standard deviation [SD]±2.3) months. Pollutant exposure did not significantly correlate with baseline SNOT-22 or SF-6D scores. Revision ESS was associated with higher median fine particulate matter (PM2.5; Δ=0.12, [95% confidence interval {CI}: 0.003, 0.234]; p=0.006) compared with primary surgery. PM2.5, PM10, and nitrogen dioxide concentrations (μg/m3) did not correlate with change in total SNOT-22 or SF-6D scores after treatment. Nevertheless, sulfur dioxide (SNOT-22: ρ=-0.121 [95% CI: -0.210, -0.030]; p=0.007; SF-6D: ρ=0.095 [95% CI: 0.002, 0.186]; p=0.04) and carbon monoxide (SNOT-22: ρ=-0.141 [95% CI: -0.230, 0.050]; p=0.002) exposure did correlate with these outcome measures. Air pollutants may contribute, at least in part, to disease severity in CRS; future investigation is needed to further elucidate the nature of this relationship.

The Relationship Between Preoperative Oxford Hip and Knee Score and Change in Health-Related Quality of Life After Total Hip and Total Knee Arthroplasty: Can It Help Inform Rationing Decisions?

BackgroundIn countries with publicly funded health care, there is an increasing need for explicit rationing for total joint arthroplasty (TJA). The Oxford Hip and Knee Scores (OHS/OKS) have been used to set access thresholds for TJA despite not being developed for that purpose. The aim of this study was to determine whether preoperative OHS/OKS can aid rationing decisions by investigating the changes in general health-related quality of life after TJA.MethodsOHS/OKS, Short Form-12, and Short Form-6D (SF-6D) scores were collected preoperatively and at 1 year postoperatively in a cohort of patients undergoing total hip arthroplasty (THA; n = 713) and total knee arthroplasty (TKA; n = 520). The association between preoperative OHS/OKS and postoperative score and the change in OHS/OKS and SF-6D was investigated, adjusting for age and gender.ResultsThe mean Oxford scores improved from 13.9 to 40.7 (OHS) and 15.6 to 37.4 (OKS). The mean SF-6D improved after THA (0.53 to 0.80) and TKA (0.56 to 0.78) (all P < .0001). Poorer preoperative Oxford scores were associated with poorer postoperative OHS/OKS and SF-6D but larger improvements. For every 5 points lower preoperative OHS/OKS, the postoperative SF-6D score was worse by a margin of 0.019 (THA) and 0.023 (TKA).ConclusionsPreoperative OHS/OKS can help inform rationing decisions. A lower preoperative OHS/OKS will result in greater gains but a lower final outcome score in general health-related quality of life.

Degree of Self-Reported Facial Impairment Correlates with Social Impairment in Individuals with Facial Paralysis and Synkinesis.

Importance: Facial paralysis leads to both aesthetic and functional deficits placing patients at risk for sociopsychological sequelae and social impairment. Objective: To examine the effect of facial paralysis and synkinesis on social impairment and quality of life (QOL). Design, Setting, and Participants: This is a cross-sectional study at a tertiary care medical center. Adults with a history of facial palsy were broadly categorized by self-reported degree of facial paralysis and synkinesis. Main Outcomes and Measures: Clinical demographic information, self-reported degrees of facial paralysis and synkinesis, and facial palsy-specific QOL as measured by the Facial Clinimetric Evaluation (FaCE) Scale and the Synkinesis Assessment Questionnaire (SAQ) were collected. FaCE and SAQ scales were evaluated as predictors of social impairment outcomes, as measured by the Brief Fear of Negative Evaluation-II (BFNE-II), the Social Anxiety Questionnaire (SAQ-A30), and Social Avoidance and Distress (SAD) scales, in addition to health utility scores from the Short-Form 6D (SF-6D). Results: Fifty-six participants with facial palsy were included (30% male; average age: 56.4 [standard deviation (SD): 15] years). Sixty-three percent of participants reported history of Bell's palsy; 37% reported other etiologies. Forty-seven percent of participants reported moderate or severe facial impairment and 46% of participants reported involuntary facial movement. Participants with moderate or severe facial impairment exhibited increased BFNE-II (p = 0.03), SAQ-A30 (p = 0.04), and SAD (p < 0.01) scores and lower health valuation on SF-6D (p = 0.04). FaCE scores moderately correlated with lower health valuation (r = 0.39, p < 0.01), and moderately and inversely correlated with SAD (r = -0.33, p = 0.01) and BFNE-II (r = -0.35, p < 0.01) scores. Furthermore, worsening FaCE scores predicted worsening SAQ (p < 0.01), SAD (p = 0.01), BFNE-II (p < 0.01), and SF-6D (p < 0.01) scores. Worse degrees of synkinesis correlated with higher BFNE-II scores (r = 0.38, p < 0.01) and worsening SAQ scores predicted worsening FaCE (p < 0.01) and BFNE-II (p < 0.01) scores. Females demonstrated significantly worse BFNE-II scores (p = 0.04) when compared with men, and female gender significantly predicted worse FaCE scores (p < 0.01). Seventy-one percent of women with self-reported moderate or severe facial impairment met criteria for social anxiety, as did 67% of women with self-reported moderate or severe synkinesis. Conclusions and Relevance: Individuals with self-reported moderate or severe facial impairment exhibit a higher degree of social impairment and poorer health valuation than those with no or mild facial impairment. Facial palsy-specific QOL moderately and inversely correlated with social impairment and moderately correlated with health valuation. Our results indicate that FaCE scores may be used as a predictor of SAD, BFNE-II, and SF-6D scores and that facial palsy QOL and its relationship with social impairment should be considered when treating patients with a history of facial palsy.

Responsiveness and minimally important difference of SF-6D and EQ-5D utility scores for the treatment of pelvic organ prolapse

Utility preference scores are standardized, generic, health-related quality of life (HRQOL) measures that quantify disease severity and burden and summarize morbidity on a scale from 0 (death) to 1 (optimal health). Utility scores are widely used to measure HRQOL and in cost-effectiveness research. To determine the responsiveness, validity properties, and minimal important difference (MID) of utility scores, as measured by the Short Form 6D (SF-6D) and EuroQol (EQ-5D), in women undergoing surgery for pelvic organ prolapse (POP). This study combined data from 4 large, U.S., multicenter surgical trials enrolling 1321 women with pelvic organ prolapse. We collected condition-specific quality of life data using the Pelvic Floor Distress Inventory (PFDI) and Pelvic Floor Impact Questionnaire (PFIQ). A subset of women completed the SF6D; women in 2 trials also completed the EQ5D. Mean utility scores were compared from baseline to 12 months after surgery. Responsiveness was assessed using effect size (ES) and standardized response mean (SRM). Validity properties were assessed by (1) comparing changes in utility scores at 12 months between surgical successes and failures as defined in each study, and (2) correlating changes in utility scores with changes in the PFDI and PFIQ. MID was estimated using both anchor-based (SF-36 general health global rating scale "somewhat better" vs "no change") and distribution-based methods. The mean SF-6D score improved 0.050, from 0.705 ± 0.126 at baseline to 0.761 ± 0.131 at 12 months (P < .01). The mean EQ-5D score improved 0.060, from 0.810 ± 0.15 at baseline to 0.868 ± 0.15 at 12 months (P < .01). The ES (0.13-0.61) and SRM (0.13-0.57) were in the small-to-moderate range, demonstrating the responsiveness of the SF-6D and EQ-5D similar to other conditions. SF-6D and EQ-5D scores improved more for prolapse reconstructive surgical successes than for failures. The SF-6D and EQ-5D scores correlated with each other (r= 0.41; n= 645) and with condition-specific instruments. Correlations with the PFDI and PFIQ and their prolapse subscales were in the low to moderate range (r= 0.09-0.38), similar to other studies. Using the anchor-based method, the MID was 0.026 for SF-6D and 0.025 for EQ-5D, within the range of MIDs reported in other populations and for other conditions. These findings were supported by distribution-based estimates. The SF-6D and EQ-5D have good validity properties and are responsive, preference-based, utility and general HRQOL measures for women undergoing surgical treatment for prolapse. The MIDs for SF-6D and EQ-5D are similar and within the range found for other medical conditions.

Effect of gel seat cushion on chronic low back pain in occupational drivers: A double-blind randomized controlled trial.

Background:Low back pain (LBP) is an exceedingly common medical condition that results in significant medical and social burden. Sitting for a long period is a common aggravating factor for LBP. Although seat cushion is known to promote comfort, relieve pressure, and correct posture, its effect on chronic LBP has not yet been investigated. This study aimed to evaluate the clinical effect of gel seat cushion on chronic LBP in occupational drivers.Methods:Occupational drivers with chronic LBP lasting for >6 months were recruited. Subjects were double-blinded, randomly assigned to 2 groups (gel and foam cushion groups), and instructed to use the provided cushions while driving. Pain threshold and tissue hardness were measured at tender points using a digital algometer. Numeric pain intensity scale (NPIS), Roland–Morris Disability Questionnaire (RMDQ), and Oswestry Disability Index (ODI) were used to analyze the primary endpoint, whereas the Beck Depression Inventory and Short Form-6D were used for the secondary endpoint.Results:Of 80 enrolled subjects, 75 (gel cushion group, 40; foam cushion group, 35) were included for analysis. Both groups showed significant improvement in NPIS and ODI scores following cushion use. Results for Beck Depression Inventory and Short Form-6D scores indicated that gel cushion use was significantly helpful. Change in NPIS score was significantly greater in the gel cushion group than in the foam cushion group.Conclusion:Gel cushion use may be effective in relieving LBP in occupational drivers seated for a long period compared with foam cushion use.

PCV52 - Cost-Utility Analysis Of Valsartan Versus Valsartan Plus Hydrochlorothiazide In Patients With Hypertension In The US

To compare the cost-utility of Valsartan with the combination therapy Valsartan plus Hydrochlorothiazide used to treat adult patients with hypertension in the United States from the third-party payer’s perspective. The study used the Medical Expenditure Panel Survey (MEPS) 2012-2014 database. The study population included individuals diagnosed with essential hypertension who were 18 years old and older. Patients using the combination therapy of Valsartan plus Hydrochlorothiazide were matched with those using only valsartan in 1:1 ratio using propensity scores. Study included all direct medical costs in MEPS which combined total healthcare expenditure, payments by private insurance, Medicaid, Medicare and other sources. Utility scores from Short Form 6D (SF-6D) were used to calculate quality-adjusted life years (QALYs). SF-6D scores were calculated from Physical and Mental Health Composite Scores (PCS & MCS) derived from SF-12 questionnaire. Monte Carlo probabilistic simulation technique was used to determine the cost-effectiveness acceptability curve. Total 794 adults with hypertension were included in the study, of which 498 individuals were taking only Valsartan and 296 were on the combination therapy of Valsartan plus Hydrochlorothiazide. After matching, there were 296 patients in each cohort. The total mean annual cost was found to be $12981.58 for Valsartan and $9551.97 for Valsartan plus Hydrochlorothiazide treatment. The mean utility gain for valsartan was found to be 0.7144, whereas for Valsartan plus Hydrochlorothiazide treatment it was 0.7233. Probabilistic sensitivity analysis showed that at all willingness-to-pay (WTP) thresholds, the probability of Valsartan plus Hydrochlorothiazide treatment being cost-effective was greater than the probability of the Valsartan being cost-effective. The combination therapy of Valsartan plus Hydrochlorothiazide for hypertension was found to be more cost-effective than treatment using Valsartan only at all levels of willingness-to-pay for adults in the US.

Determining Health-Related Quality-of-Life Outcomes Using the SF-6D Following Total Hip Arthroplasty.

Following total hip arthroplasty, patients' perception of their postoperative improvement and health plays a large role in satisfaction with and success of the surgical procedure. The Short Form-6D (SF-6D) is a health-related quality-of-life measure that assigns numerical value to the perception of patients' own health. The purpose was to determine SF-6D values of patients after total hip arthroplasty, to determine whether score changes were clinically relevant, and to compare these with postoperative functional improvements. We evaluated 188 patients who underwent primary total hip arthroplasty at 7 institutions and who had a mean age of 69 years (range, 47 to 88 years) and a mean body mass index of 28.8 kg/m (range, 19.8 to 38.9 kg/m). The SF-6D values were obtained from patients' SF-36 scores, and clinical relevance of value changes was determined using effect size. Using previous research, effect sizes were considered small between 0.2 and 0.5, moderate between 0.6 to 0.8, and large at >0.8. Clinical correlation was assessed using the Lower-Extremity Activity Scale and Harris hip scores. Patients were assessed preoperatively and postoperatively at 6 months and 1, 2, 3, and 5 years. The SF-6D scores improved from preoperatively and achieved significance (p < 0.05) at all points. The effect size demonstrated good clinical relevance up to the latest follow-up: 1.27 at 6 months, 1.30 at 1 year, 1.07 at 2 years, 1.08 at 3 years, and 1.05 at 5 years. The Lower-Extremity Activity Scale improved at all follow-up points from preoperatively to 1.8 at 6 months, 2.0 at 1 year, 1.8 at 2 years, 1.5 at 3 years, and 1.6 points at 5 years. The Harris hip score improved to 38 points at 6 months, 40 points at 1 year, 38 points at 2 years, 39 points at 3 years, and 41 points at 5 years postoperatively. The improvements in the Lower-Extremity Activity Scale and the Harris hip score significantly positively correlated (p < 0.01) with the SF-6D scores at all time points. SF-6D scores after total hip arthroplasty correlate with functional outcomes and have clinical relevance, as demonstrated by their effect size. Incorporating this straightforward and easy-to-use measurement tool when evaluating patients following total hip arthroplasty will facilitate future cost-utility analyses. Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Chronic Conditions and Utility-Based Health-Related Quality of Life in Adult Childhood Cancer Survivors.

Health utility, a summary measure of quality of life, has not been previously used to compare outcomes among childhood cancer survivors and individuals without a cancer history. We estimated health utility (0, death; 1, perfect health) using the Short Form-6D (SF-6D) in survivors (n = 7105) and siblings of survivors (n = 372) (using the Childhood Cancer Survivor Study cohort) and the general population (n = 12 803) (using the Medical Expenditures Panel Survey). Survivors had statistically significantly lower SF-6D scores than the general population (mean = 0.769, 95% confidence interval [CI] = 0.766 to 0.771, vs mean = 0.809, 95% CI = 0.806 to 0.813, respectively, ITALIC! P< .001, two-sided). Young adult survivors (age 18-29 years) reported scores comparable with general population estimates for people age 40 to 49 years. Among survivors, SF-6D scores were largely determined by number and severity of chronic conditions. No clinically meaningful differences were identified between siblings and the general population (mean = 0.793, 95% CI = 0.782 to 0.805, vs mean = 0.809, 95% CI = 0.806 to 0.813, respectively). This analysis illustrates the importance of chronic conditions on long-term survivor quality of life and provides encouraging results on sibling well-being. Preference-based utilities are informative tools for outcomes research in cancer survivors.

Impact of intensive lifestyle intervention on preference-based quality of life in type 2 diabetes: Results from the Look AHEAD trial.

To assess the effect of an intensive lifestyle intervention (ILI) compared with standard diabetes support and education (DSE) on preference-based health-related quality of life (HRQOL) in persons with overweight or obesity and type 2 diabetes. Look AHEAD was a multisite, randomized trial of 5,145 participants assigned to ILI or DSE. Four instruments were administered during the trial: Feeling Thermometer (FT), Health Utilities Index Mark 2 (HUI2), Health Utilities Index Mark 3 (HUI3), and Short Form 6D (SF-6D). Linear mixed effect models were used to estimate the mean difference in preference scores by treatment group for 9 years. The ILI had higher mean FT (0.019, 95% CI, 0.015-0.024, P < 0.001) and SF-6D (0.011, 95% CI, 0.006-0.014, P < 0.001) scores than the DSE. No significant group differences were observed for the HUI2 (0.004, 95% CI, -0.003 to 0.010, P = 0.23) and HUI3 (0.004, -0.004 to 0.012, P = 0.36). In year 1, the ILI had higher mean preference scores for all instruments. Thereafter, the increases remained significant only for FT and SF-6D, and the effects also become smaller. ILI aimed at reducing body weight among persons with overweight or obesity and type 2 diabetes improves preference-based HRQOL in the short term, but its long-term effect is unclear.

Predicting SF-6D Utility Scores From the Neck Disability Index and Numeric Rating Scales for Neck and Arm Pain

Cross-sectional cohort. This study aims to provide an algorithm to estimate Short Form-6D (SF-6D) utilities using data from the Neck Disability Index (NDI), neck pain, and arm pain scores. Although cost-utility analysis is increasingly used to provide information about the relative value of alternative interventions, health state values or utilities are rarely available from clinical trial data. The Neck Disability Index (NDI) and numerical rating scales for neck and arm pain are widely used disease-specific measures in patients with cervical degenerative disorders. The purpose of this study is to provide an algorithm to allow estimation of SF-6D utilities using data from the NDI, and numerical rating scales for neck and arm pain. SF-36, NDI, neck and arm pain rating scale scores were prospectively collected before surgery, at 12 and 24 months after surgery in 2080 patients undergoing cervical fusion for degenerative disorders. SF-6D utilities were computed, and Spearman correlation coefficients were calculated for paired observations from multiple time points between NDI, neck and arm pain scores, and SF-6D utility scores. SF-6D scores were estimated from the NDI, neck and arm pain scores were estimated using a linear regression model. Using a separate, independent dataset of 396 patients in which NDI scores were available, SF-6D was estimated for each subject and compared to their actual SF-6D. The mean age for those in the development sample was 50.4 ± 11.0 years and 33% were male. In the validation sample, the mean age was 53.1 ± 9.9 years and 35% were male. Correlations between the SF-6D and the NDI, neck and arm pain scores were statistically significant (P < 0.0001) with correlation coefficients of 0.82, 0.62, and 0.50, respectively. The regression equation using NDI aloneto predict SF-6D had an R of 0.66 and a root mean square error of 0.056. In the validation analysis, there was no statistically significant difference (P 5 0.961) between actual mean SF-6D (0.49 6 0.08) and the estimated mean SF-6D score (0.49 6 0.08), using the NDI regression model. This regression-based algorithm may be a useful tool to predict SF-6D scores in studies of cervical degenerative disease that have collected NDI but not utility scores.

Improvements in quality of life and functional status in patients with psoriatic arthritis receiving anti–tumor necrosis factor therapies

ObjectiveTo evaluate the impact of anti–tumor necrosis factor (anti-TNF) therapies on quality of life (QOL) and functional status in psoriatic arthritis (PsA) patients and study potential predictors for QOL improvements.MethodsThe study was based on a cohort of 596 PsA patients receiving anti-TNF therapies. Changes in functional status and QOL were assessed using the Health Assessment Questionnaire (HAQ) and Short Form 36 (SF-36) questionnaire on a 6-month basis. The Short Form 6D (SF-6D) was calculated as a utility score. Univariate and multivariate linear regression models were developed to examine potential predictors of QOL improvements at 6 months, using a range of demographic, baseline disease-specific, and therapeutic variables.ResultsAt 6 months, significant improvements in all SF-36 subscale scores were found, with the greatest percentage improvement from baseline related to physical role (113.8%; 95% confidence interval [95% CI] 102.6, 125.0). The percent improvement for the physical component scale was 53.2% (95% CI 44.5, 61.9) at 6 months, whereas that for the mental component scale was 16.9% (95% CI 14.7, 19.2). The mean ± SD SF-6D score was 0.58 ± 0.07 at baseline, and this improved to 0.63 ± 0.06 at 6 months. The median HAQ score at baseline was 1.88 (interquartile range [IQR] 1.38–2.25) for the entire cohort, and this improved to 1.25 (IQR 0.63–1.88) at 6 months. Improvements in Disease Activity Score in 28 joints at 6 months were found to be significantly associated with QOL improvements at the same time point.ConclusionAnti-TNF therapy is associated with improvement in both physical and mental status in PsA patients. These improvements were most substantial in patients who also had improvements in their disease activity.

Exploring the validity of estimating EQ-5D and SF-6D utility values from the health assessment questionnaire in patients with inflammatory arthritis

BackgroundUtility scores are used to estimate Quality Adjusted Life Years (QALYs), applied in determining the cost-effectiveness of health care interventions. In studies where no preference based measures are collected, indirect methods have been developed to estimate utilities from clinical instruments. The aim of this study was to evaluate a published method of estimating the EuroQol-5D (EQ-5D) and Short Form-6D (SF-6D) (preference based) utility scores from the Health Assessment Questionnaire (HAQ) in patients with inflammatory arthritis.MethodsData were used from 3 cohorts of patients with: early inflammatory arthritis (<10 weeks duration); established (>5 years duration) stable rheumatoid arthritis (RA); and RA being treated with anti-TNF therapy. Patients completed the EQ-5D, SF-6D and HAQ at baseline and a follow-up assessment. EQ-5D and SF-6D scores were predicted from the HAQ using a published method. Differences between predicted and observed EQ-5D and SF-6D scores were assessed using the paired t-test and linear regression.ResultsPredicted utility scores were generally higher than observed scores (range of differences: EQ-5D 0.01 - 0.06; SF-6D 0.05 - 0.10). Change between predicted values of the EQ-5D and SF-6D corresponded well with observed change in patients with established RA. Change in predicted SF-6D scores was, however, less than half of that in observed values (p < 0.001) in patients with more active disease. Predicted EQ-5D scores underestimated change in cohorts of patients with more active disease.ConclusionPredicted utility scores overestimated baseline values but underestimated change. Predicting utility values from the HAQ will therefore likely underestimate the QALYs of interventions, particularly for patients with active disease. We recommend the inclusion of at least one preference based measure in future clinical studies.

Changes in Health State Utilities With Changes in Body Mass in the Diabetes Prevention Program

Health utilities are measures of health-related quality of life (HRQL) used in cost-effectiveness research. We evaluated whether changes in body weight were associated with changes in health utilities in the Diabetes Prevention Program (DPP) and whether associations differed by treatment assignment (lifestyle intervention, metformin, placebo) or baseline obesity severity. We constructed physical (PCS-36) and mental component summary (MCS-36) subscales and short-form-6D (SF-6D) health utility index for all DPP participants completing a baseline 36-item short form (SF-36) HRQL assessment (N = 3,064). We used linear regression to test associations between changes in body weight and changes in HRQL indicators, while adjusting for other demographic and behavioral variables. Overall differences in HRQL between treatment groups were highly statistically significant but clinically small after 1 year. In multivariable models, weight change was independently associated with change in SF-6D score (increase of 0.007 for every 5 kg weight loss; P < 0.001), but treatment effects independent of weight loss were not. We found no significant interaction between baseline obesity severity and changes in SF-6D with changes in body weight. However, increases in physical function (PCS-36) with weight loss were greater in persons with higher baseline obesity severity. In summary, improvements in HRQL are associated with weight loss but not with other effects of obesity treatments that are unrelated to weight loss. Although improvements in the SF-6D did not exceed commonly reported thresholds for a minimally important difference (0.04), these changes, if causal, could still have a significant impact on clinical cost-effectiveness estimates if sustained over multiple years.

Validating and Assessing the Sensitivity of the Health Assessment Questionnaire-Disability Index-derived Short Form-6D in Patients with Early Aggressive Rheumatoid Arthritis

New methodologies allow the scores for the Health Assessment Questionnaire-Disability Index (HAQ-DI) to be translated into preferences/utility scores. We evaluated the construct validity of the HAQ-DI-derived Short Form-6D (SF-6D) score and assessed its responsiveness to change over 6- and 12-month followup periods in patients with early aggressive rheumatoid arthritis (RA). Patients (n=277) participating in an RA observational study completed self-reported measures of symptoms and the HAQ-DI at baseline and at 6 and 12 months. Total Sharp scores, C-reactive protein, and erythrocyte sedimentation rate were assessed along with clinical data. Construct validity was assessed by examining the association between SF-6D score and patient-reported and clinical measures using Spearman correlation coefficients. The responsiveness of SF-6D to change was assessed using patient and physician assessments of the disease as clinical anchors. The magnitude of responsiveness was calculated using SF-6D effect size (ES). Mean SF-6D scores were 0.690, 0.720, and 0.723 at baseline and 6 and 12-month followup, respectively. Baseline patient-reported measures had moderate to high correlations with baseline SF-6D (r=0.43 to 0.52); whereas clinical measures had negligible to low correlations with SF-6D (r=0.001 to 0.32). ES was moderate for the groups that were deemed to have improved (ES 0.63-0.75) but negligible to small for those that did not (ES 0.13-0.46). Our data support the validity and responsiveness of the HAQ-DI derived SF-6D score in an early RA cohort. These results support the use of the HAQ-DI derived SF-6D in RA cohorts and clinical trials lacking preference-based measures.

Psychometric Properties of the EuroQol-5D and Short Form-6D in Patients with Systemic Lupus Erythematosus

Health related quality of life (HRQOL) is an important patient-reported outcome in systemic lupus erythematosus (SLE). We evaluated the psychometric properties of 2 widely used preference-based generic HRQOL measures, EuroQol-5D (EQ-5D) and Short Form-6D (SF-6D), among United States patients with SLE. Patients with SLE enrolled at an academic institution were assessed for self-reported generic HRQOL (EQ-5D, Medical Outcomes Study SF-36), disease activity, and disease damage SF-6D. Physical Component Score (PCS) and Mental Component Score (MCS) were calculated from SF-36. Criterion validity, convergent validity, and known-groups comparisons were evaluated for EQ-5D and SF-6D. Sensitivity to change (t tests, effect size) was evaluated in a subset of the cohort followed longitudinally. One hundred sixty-seven patients with SLE were enrolled. Related domains on the EQ-5D and SF-36 correlated strongly, e.g., mobility and physical functioning (r=0.60), whereas unrelated domains showed weak to moderate correlation. EQ-5D index, EQ-5D visual analog scale, and SF-6D score correlated strongly among each other as well as with most domains of SF-36. Both EQ-5D and SF-6D indices differentiated among patients of varied disease severity. EQ-5D and SF-6D were found to be sensitive to self-reported change in health but insensitive to change in disease activity longitudinally. Disease activity and damage showed weak correlation with HRQOL measures. The SF-6D and EQ-5D exhibited satisfactory psychometric properties for use among US patients with SLE. Measures of disease activity and damage were weakly correlated with HRQOL, suggesting that HRQOL is an important complementary source of information about patients with SLE.

Mapping Utility Scores from a Disease-Specific Quality-of-Life Measure in Bariatric Surgery Patients

Objectives To develop algorithms for a conversion of disease-specific quality-of-life into health state values for morbidly obese patients before or after bariatric surgery. Methods A total of 893 patients were enrolled in a prospective cross-sectional multicenter study. In addition to demographic and clinical data, health-related quality-of-life (HRQoL) data were collected using the disease-specific Moorehead-Ardelt II questionnaire (MA-II) and two generic questionnaires, the EuroQoL-5D (EQ-5D) and the Short Form-6D (SF-6D). Multiple regression models were constructed to predict EQ-5D- and SF-6D-based utility values from MA-II scores and additional demographic variables. Results The mean body mass index was 39.4, and 591 patients (66%) had already undergone surgery. The average EQ-5D and SF-6D scores were 0.830 and 0.699. The MA-IIwas correlated to both utility measures (Spearman's r = 0.677 and 0.741). Goodness-of-fit was highest ( R 2 = 0.55 in the validation sample) for the following item-based transformation algorithm: utility (MA-II-based) = 0.4293 + (0.0336 × MA1) + (0.0071 × MA2) + (0.0053 × MA3) + (0.0107 × MA4) + (0.0001 × MA5). This EQ-5D-based mapping algorithm outperformed a similar SF-6D-based algorithm in terms of mean absolute percentage error ( P = 0.045). Conclusions Because the mapping algorithm estimated utilities with only minor errors, it appears to be a valid method for calculating health state values in cost-utility analyses. The algorithm will help to define the role of bariatric surgery in morbid obesity.

Cost‐effectiveness of intensive exercise therapy directly following hospital discharge in patients with arthritis: Results of a randomized controlled clinical trial

To estimate the cost-utility and cost-effectiveness of a 3-week intensive exercise training (IET) program directly following hospital discharge in patients with rheumatic diseases. Patients with arthritis who were admitted to the hospital because of a disease activity flare or for elective hip or knee arthroplasty were randomly assigned to either the IET group or usual care (UC) group. Followup lasted 1 year. Quality-adjusted life years (QALYs) were derived from Short Form 6D scores and a visual analog scale (VAS) rating personal health. Function-related outcome was measured using the Health Assessment Questionnaire, the McMaster Toronto Arthritis (MACTAR) Patient Preference Disability Questionnaire, and the Escola Paulista de Medicina Range of Motion scale (EPMROM). Costs were reported from a societal perspective. Differences in costs and incremental cost-effectiveness ratios (ICERs) were estimated. Data from 85 patients (50 IET and 35 UC) could be used for health-economic analysis. VAS personal health-based QALYs were in favor of IET. Function-related outcome showed statistically significant improvements in favor of IET over the first 6 months, according to the MACTAR (P < 0.05) and the EPMROM (P < 0.01). At 1-year followup, IET was euro718 less per patient. The ICER showed a reduction in mean total costs per QALY. In 70% of cases the intervention was cost-saving. IET results in better quality of life at lower costs after 1 year. Thus, IET is the dominant strategy compared with UC. This highlights the need for implementation of IET after hospital discharge in patients with arthritis.

0071 PATIENTS AT HIGH RISK FOR PSYCHOSIS: LEVEL OF FUNCTIONING AND HANDICAPS OF THE TRANSITION AND NON-TRANSITION GROUP

To develop algorithms for a conversion of disease-specific quality-of-life into health state values for morbidly obese patients before or after bariatric surgery.A total of 893 patients were enrolled in a prospective cross-sectional multicenter study. In addition to demographic and clinical data, health-related quality-of-life (HRQoL) data were collected using the disease-specific Moorehead-Ardelt II questionnaire (MA-II) and two generic questionnaires, the EuroQoL-5D (EQ-5D) and the Short Form-6D (SF-6D). Multiple regression models were constructed to predict EQ-5D- and SF-6D-based utility values from MA-II scores and additional demographic variables.The mean body mass index was 39.4, and 591 patients (66%) had already undergone surgery. The average EQ-5D and SF-6D scores were 0.830 and 0.699. The MA-IIwas correlated to both utility measures (Spearman's r = 0.677 and 0.741). Goodness-of-fit was highest (R2 = 0.55 in the validation sample) for the following item-based transformation algorithm: utility (MA-II-based) = 0.4293 + (0.0336 × MA1) + (0.0071 × MA2) + (0.0053 × MA3) + (0.0107 × MA4) + (0.0001 × MA5). This EQ-5D-based mapping algorithm outperformed a similar SF-6D-based algorithm in terms of mean absolute percentage error (P = 0.045).Because the mapping algorithm estimated utilities with only minor errors, it appears to be a valid method for calculating health state values in cost-utility analyses. The algorithm will help to define the role of bariatric surgery in morbid obesity.