Short Form 6D Research Articles

The Impact of Acute Peri-operative Particulate Matter Exposure on Endoscopic Sinus Surgery Outcomes: A Preliminary Multi-site Investigation.

Environmental exposures have been postulated to play an important role in the pathophysiology of chronic rhinosinusitis (CRS). Particulate matter (PM) is one of the most widely studied ambient air pollutants, but its peri-operative impact on CRS is unknown. To determine the effect of acute, peri-operative PM exposure on outcomes after endoscopic sinus surgery (ESS). Participants with CRS who self-selected ESS were prospectively enrolled. The 22-item SinoNasal Outcome Test (SNOT-22) and Medical Outcomes Study Questionnaire Short-Form 6-D (SF-6D) health utility values scores were recorded. Using residence zip codes, a secondary analysis of patient exposure to PM <2.5 μm and <10 μm (PM2.5 and PM10, respectively) was performed for the month of surgery utilizing data from Environmental Protection Agency air quality monitors. Spearman's correlation coefficients (ρ), 95% confidence intervals (CIs), and effect estimates (β) were used to determine the magnitudes of association. Simple, multivariate regression analysis was also completed. One hundred and seven patients from four geographically unique institutions across the US were enrolled with a follow-up of 6 months. Patients with higher peri-operative PM2.5 exposure had less improvement in their SNOT-22 scores after ESS compared to those with less exposure using both univariate analysis (ρ = 0.26, 95% CI: 0.08, 0.43; P = .01) and after covariate adjustment with multivariate analysis (B = 1.06, 95% CI: 0.001, 2.14, P = .05). Similar associations were not found with SF-6D outcomes or with PM10 as an exposure of interest. No significant correlations were found between peri-operative PM levels and Lund-Kennedy endoscopy scores post-operatively. Preliminary data from this pilot study reveal that PM exposure at the time of ESS may negatively associate with post-operative improvement in sinonasal quality-of-life. Larger, population-based studies with more standardized PM exposure windows are needed to confirm the clinical significance of the present findings.

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.

Early surgery compared to nonoperative management for mild degenerative cervical myelopathy: a cost-utility analysis

BACKGROUND CONTEXTDegenerative cervical myelopathy (DCM) is a form of acquired spinal cord compression and contributes to reduced quality of life secondary to neurological dysfunction and pain. There remains uncertainty regarding optimal management for individuals with mild myelopathy. Specifically, owing to lacking long-term natural history studies in this population, we do not know whether these individuals should be treated with initial surgery or observation. PURPOSEWe sought to perform a cost-utility analysis to examine early surgery for mild degenerative cervical myelopathy from the healthcare payer perspective. STUDY DESIGN/SETTINGWe utilized data from the prospective observational cohorts included in the Cervical Spondylotic Myelopathy AO Spine International and North America studies to determine health related quality of life estimates and clinical myelopathy outcomes. PATIENT SAMPLEWe recruited all patients that underwent surgery for DCM enrolled in the Cervical Spondylotic Myelopathy AO Spine International and North America studies between December 2005 and January 2011. OUTCOME MEASURESClinical assessment measures were obtained using the Modified Japanese Orthopedic Association scale and health-related quality of life measures were obtained using the Short Form-6D utility score at baseline (preoperative), 6 months, 12 months and 24 months postsurgery. Cost measures inflated to January 2015 values were obtained using pooled estimates from the hospital payer perspective for surgical patients. METHODSWe employed a Markov state transition model with Monte Carlo microsimulation using a lifetime horizon to obtain an incremental cost utility ratio associated with early surgery for mild myelopathy. Parameter uncertainty was assessed through deterministic means using one-way and two-way sensitivity analyses and probabilistically using parameter estimate distributions with microsimulation (10,000 trials). Costs and utilities were discounted at 3% per annum. RESULTSInitial surgery for mild degenerative cervical myelopathy was associated with an incremental lifetime increase of 1.26 quality-adjusted life years (QALY) compared to observation. The associated cost incurred to the healthcare payer over a lifetime horizon was $12,894.56, resulting in a lifetime incremental cost-utility ratio of $10,250.71/QALY. Utilizing a willingness to pay threshold in keeping with the World Health Organization definition of "very cost-effective" ($54,000 CDN), the probabilistic sensitivity analysis demonstrated that 100% of cases were cost-effective. CONCLUSIONSSurgery compared to initial observation for mild degenerative cervical myelopathy was cost-effective from the Canadian healthcare payer perspective and was associated with lifetime gains in health-related quality of life.

Validity and Reliability of the Fatigue Severity Scale in a Real-World Interstitial Lung Disease Cohort.

Rationale: Fatigue is a common and debilitating symptom for people living with interstitial lung disease (ILD). Studies on fatigue in ILD are limited, and little headway has been made toward developing interventions targeting the alleviation of fatigue. A barrier to progress is a lack of knowledge around the performance characteristics of a patient-reported outcome measure to assess fatigue in patients with ILD. Objectives: To assess the validity and reliability of the Fatigue Severity Scale (FSS) for measuring fatigue in a national cohort of patients with ILD. Methods: FSS scores and several anchors were measured in 1,881 patients from the Pulmonary Fibrosis Foundation Patient Registry. Anchors included the Short Form 6D Health Utility Index (SF-6D) score and a single vitality question from the SF-6D; the University of California, San Diego, Shortness of Breath Questionnaire; FVC; DlCO; and 6-minute-walk distance. Internal consistency reliability, concurrent validity, and known-groups validity were assessed. Structural validity was assessed using confirmatory factor analysis. Measurements and Main Results: The FSS demonstrated high internal consistency (Cronbach's α = 0.96). There were moderate to strong correlations between FSS score and patient-reported anchors (vitality question from the SF-6D [r = 0.55] and University of California, San Diego, Shortness of Breath Questionnaire total score [r = 0.70]) and weak correlations between FSS score and physiological measures (FVC [r = -0.24], percentage predicted DlCO [r = -0.23], and 6-minute-walk distance [r = -0.29]). Higher mean FSS scores, indicating greater fatigue, were observed among patients using supplemental oxygen, those prescribed steroids, and those with lower percentage predicted FVC and percentage predicted DlCO. The confirmatory factor analysis results suggest that the nine questions of the FSS reflect one dimension of fatigue. Conclusions: Fatigue is an important patient-centered outcome in ILD that is poorly correlated with physiological measures of disease severity, including lung function and walk distance. These findings further support the need for a reliable and valid measure of patient-reported fatigue in ILD. The FSS possesses acceptable performance characteristics for assessing fatigue and distinguishing different degrees of fatigue among patients with ILD.

The Associations between Insomnia Severity and Health Outcomes in the United States

Little is known about the associations between insomnia severity, insomnia symptoms, and key health outcomes. Using 2020 United States National Health and Wellness Survey (NHWS) data, we conducted a retrospective, cross-sectional analysis to determine the associations between insomnia severity and a number of health outcomes germane to patients (health-related quality of life (HRQoL), employers and government (workplace productivity), and healthcare payers (healthcare resource utilization (HCRU)). The Insomnia Severity Index (ISI) questionnaire was used to evaluate overall insomnia severity. HRQoL was assessed using the physical and mental component summary scores of the Short Form-36v2 (SF-36v2) questionnaire, and health utility status was measured using the Short Form-6D (SF-6D) and EuroQoL-5D (EQ-5D) questionnaires. Workplace productivity was measured using the Work Productivity and Activity Impairment (WPAI) questionnaire. After adjusting for confounders, greater insomnia severity was significantly associated with worsened quality of life, decreased productivity, and increased HCRU in an apparent linear fashion. These findings have important implications for future research, including the need for specific assessment of insomnia symptoms and their impact on key health outcomes.

Comparative evaluation of the health utilities index mark 3 and the short form 6D: evidence from an individual participant data meta-analysis of very preterm and very low birthweight adults

BackgroundThe most appropriate preference-based health-related quality of life (HRQoL) instruments for trials or research studies that ascertain the consequences of individuals born very preterm and/or low birthweight (VP/VLBW) are not known. Agreement between the HUI3 and SF-6D multi-attribute utility measures have not been previously investigated for VP/VLBW and normal birthweight or term-born controls. This study examined the agreement between the outputs of the HUI3 and SF-6D measures among adults born VP/VLBW and normal birthweight or term born controls.MethodsWe used two prospective cohorts of individuals born VP/VLBW and controls contributing to the ‘Research on European Children and Adults Born Preterm’ (RECAP) consortium which assessed HRQoL using two preference-based measures. The combined dataset of individual participant data (IPD) included 407 adult VP/VLBW survivors and 367 controls, ranging in age from 18 to 26 years. Bland–Altman plots, intra-class correlation coefficients, and generalized linear mixed models in a one-step approach were used to examine agreement between the measures.ResultsThere was significant discordance between the HUI3 and SF-6D multi-attribute utility measures in the VP/VLBW sample, controls, and in the combined samples. Agreement between the HUI3 and SF-6D multi-attribute utility measures was weaker in controls compared with VP/VLBW individuals.Conclusions and relevanceThe HUI3 and SF-6D each provide unique information on different aspects of health status across the groups. The HUI3 better captures preterm-related changes to HRQoL in adulthood compared to SF-6D. Studies focused on measuring physical or cognitive aspects of health will likely benefit from using the HUI3 instead of the SF-6D, regardless of gestational age at birth and birthweight status.

EE596 Comparative Evaluation of the Health Utilities Index Mark 3 and the Short Form-6D: Evidence From an Individual Participant Data Meta-Analysis of Very Preterm and Very Low Birthweight Adults

To investigate the extent of agreement of HUI3 and SF-6D measures by concurrent use of these instruments within a pooled harmonized dataset from two prospective longitudinal birth cohort studies conducted in Germany and Australia that followed-up individuals born very preterm or very low birth weight (VP/VLBW), and term-born or normal birthweight controls from birth into adulthood.

Diagnosis-Related Group–Based Payments for Adult Spine Deformity Surgery Significantly Vary across Centers: Results from a Multicenter Prospective Cohort Study

To investigate the variation in total episode-of-care (EOC) payment and quality-adjusted life-year (QALY) gain for complex adult spine deformity surgeries in the United States, adjusting for case type and surgeon preferences. Patients aged >18 years with adult spine deformity with Medicare Severity-Diagnosis-Related Groups (DRGs) 453-460 and a minimum of 2 years of follow-up from index surgery were included. Index and total payments were calculated using Medicare's Inpatient Prospective Payment System. All costs were adjusted for inflation to 2020 U.S. dollar values. QALYs gained were calculated using baseline, 1-year, and 2-year Short-Form 6D scores. Mixed-effect models were used to estimate the proportion of variation in total EOC payment and QALY gain. A total of 330/543 patients from 6 sites were included. Mean age was 62.4 ± 11.9 years, 79% were women, and 92% were white. The mean index and total EOC payment were $77,302 and $93,182, respectively. Patients gained on average 0.15 QALY (P < 0.0001) 2 years after surgery. In unadjusted analysis, 39% of the variation in total EOC payment across the 6 centers was attributable to relative weight of DRG and base rate. Adjusting for patient and procedural factors increased the proportion of variation in total EOC payments across the centers to 56%. Less than 2% of the variation in QALY gain was observed across the 6 centers. Medicare-based payments for complex spine deformity fusions are primarily driven by relative weight of the DRG and the hospital's base rate. Patient and procedural factors are unaccounted for in the DRG-based payments made to the providers.

Health-Related Quality-of-Life Outcomes of Very Preterm or Very Low Birth Weight Adults: Evidence From an Individual Participant Data Meta-Analysis.

Assessment of health-related quality of life for individuals born very preterm and/or low birthweight (VP/VLBW) offers valuable complementary information alongside biomedical assessments. However, the impact of VP/VLBW status on health-related quality of life in adulthood is inconclusive. The objective of this study was to examine associations between VP/VLBW status and preference-based health-related quality-of-life outcomes in early adulthood. Individual participant data were obtained from five prospective cohorts of individuals born VP/VLBW and controls contributing to the 'Research on European Children and Adults Born Preterm' Consortium. The combined dataset included over 2100 adult VP/VLBW survivors with an age range of 18-29 years. The main exposure was defined as birth before 32 weeks' gestation (VP) and/or birth weight below 1500 g (VLBW). Outcome measures included multi-attribute utility scores generated by the Health Utilities Index Mark 3 and the Short Form 6D. Data were analysed using generalised linear mixed models in a one-step approach using fixed-effects and random-effects models. VP/VLBW status was associated with a significant difference in the Health Utilities Index Mark 3 multi-attribute utility score of - 0.06 (95% confidence interval - 0.08, - 0.04) in comparison to birth at term or at normal birthweight; this was not replicated for the Short Form 6D. Impacted functional domains included vision, ambulation, dexterity and cognition. VP/VLBW status was not associated with poorer emotional or social functioning, or increased pain. VP/VLBW status is associated with lower overall health-related quality of life in early adulthood, particularly in terms of physical and cognitive functioning. Further studies that estimate the effects of VP/VLBW status on health-related quality-of-life outcomes in mid and late adulthood are needed.

Disparities in health utilities among hepatitis C patients receiving care in different settings.

BACKGROUND: Although chronic hepatitis C (CHC) disproportionately affects marginalized individuals, most health utility studies are conducted in hospital settings which are difficult for marginalized patients to access. We compared health utilities in CHC patients receiving care at hospital-based clinics and socio-economically marginalized CHC patients receiving care through a community-based program. METHODS: We recruited CHC patients from hospital-based clinics at the University Health Network and community-based sites of the Toronto Community Hep C Program, which provides treatment, support, and education to patients who have difficulty accessing mainstream health care. We elicited utilities using six standardized instruments (EuroQol-5D-3L [EQ-5D], Health Utilities Index Mark 2/Mark 3 [HUI2/HUI3], Short Form-6D [SF-6D], time trade-off [TTO], and Visual Analogue Scale [VAS]). Multivariable regression analysis was performed to examine factors associated with differences in health utility. RESULTS: Compared with patients recruited from the hospital setting (n = 190), patients recruited from the community setting (n = 101) had higher unemployment (87% versus 67%), history of injection drug use (88% versus 42%), and history of mental health issue(s) (79% versus 46%). Unadjusted health utilities were lower in community than hospital patients (e.g., EQ-5D: 0.722 [SD 0.209] versus 0.806 [SD 0.195]). Unemployment and a history of mental health issue(s) were significant predictors of low health utility. CONCLUSIONS: Socio-economically marginalized CHC patients have lower health utilities than patients typically represented in the CHC utility literature. Their utilities should be incorporated into future cost-utility analyses to better represent the population living with CHC in health policy decisions.

Changes in Health-Related Quality of Life and Physical Activity Among Older Adults in the First-Wave COVID-19 Outbreak: A Longitudinal Analysis.

The current study aimed to follow the effects of social/physical distancing strategies on health-related daily physical activity and quality of life among older adults during the COVID-19 pandemic. Seventy-two older adults who were enrolled in a University-Community program in March 2020 (age = 66.8 ± 4.82 years, ♀59) answered five phone-based surveys up to 120 days after the COVID-19 outbreak (from April to August 2020). The Short Form 6D and international physical activity (short version) questionnaires were applied. A significant reduction was observed in daily physical activity levels, metabolic equivalent of task, and health-related quality of life scores as well as an increase in sitting time during the week and on weekend days (all p < .01). The authors noted differences in lifestyle conditions at the beginning of the social/physical distancing in the community assessed (p < .01). Health vulnerabilities among older adults have been emphasized during the COVID-19 outbreak, impacting daily physical activity and health-related quality of life.

An online breathing and wellbeing programme (ENO Breathe) for people with persistent symptoms following COVID-19: a parallel-group, single-blind, randomised controlled trial

BackgroundThere are few evidence-based interventions for long COVID; however, holistic approaches supporting recovery are advocated. We assessed whether an online breathing and wellbeing programme improves health related quality-of-life (HRQoL) in people with persisting breathlessness following COVID-19.MethodsWe conducted a parallel-group, single-blind, randomised controlled trial in patients who had been referred from one of 51 UK-based collaborating long COVID clinics. Eligible participants were aged 18 years or older; were recovering from COVID-19 with ongoing breathlessness, with or without anxiety, at least 4 weeks after symptom onset; had internet access with an appropriate device; and were deemed clinically suitable for participation by one of the collaborating COVID-19 clinics. Following clinical assessment, potential participants were given a unique online portal code. Participants were randomly assigned (1:1) to either immediate participation in the English National Opera (ENO) Breathe programme or to usual care. Randomisation was done by the research team using computer-generated block randomisation lists, with block size 10. The researcher responsible for randomisation was masked to responses. Participants in the ENO Breathe group participated in a 6-week online breathing and wellbeing programme, developed for people with long COVID experiencing breathlessness, focusing on breathing retraining using singing techniques. Those in the deferred group received usual care until they exited the trial. The primary outcome, assessed in the intention-to-treat population, was change in HRQoL, assessed using the RAND 36-item short form survey instrument mental health composite (MHC) and physical health composite (PHC) scores. Secondary outcome measures were the chronic obstructive pulmonary disease assessment test score, visual analogue scales (VAS) for breathlessness, and scores on the dyspnoea-12, the generalised anxiety disorder 7-item scale, and the short form-6D. A thematic analysis exploring participant experience was also conducted using qualitative data from focus groups, survey responses, and email correspondence. This trial is registered with ClinicalTrials.gov, NCT04830033.FindingsBetween April 22 and May 25, 2021, 158 participants were recruited and randomly assigned. Of these, eight (5%) individuals were excluded and 150 participants were allocated to a treatment group (74 in the ENO Breathe group and 76 in the usual care group). Compared with usual care, ENO Breathe was associated with an improvement in MHC score (regression coefficient 2·42 [95% CI 0·03 to 4·80]; p=0·047), but not PHC score (0·60 [–1·33 to 2·52]; p=0·54). VAS for breathlessness (running) favoured ENO Breathe participation (−10·48 [–17·23 to –3·73]; p=0·0026). No other statistically significant between-group differences in secondary outcomes were observed. One minor self-limiting adverse event was reported by a participant in the ENO Breathe group who felt dizzy using a computer for extended periods. Thematic analysis of ENO Breathe participant experience identified three key themes: (1) improvements in symptoms; (2) feeling that the programme was complementary to standard care; and (3) the particular suitability of singing and music to address their needs.InterpretationOur findings suggest that an online breathing and wellbeing programme can improve the mental component of HRQoL and elements of breathlessness in people with persisting symptoms after COVID-19. Mind–body and music-based approaches, including practical, enjoyable, symptom-management techniques might have a role supporting recovery.FundingImperial College London.

Association of objectively measured daily physical activity and health utility to disease severity in chronic heart failure patients: A cross-sectional study

Background and aimsPhysical activity (PA) levels are related to mortality and morbidity in patients with chronic heart failure (CHF). Health utility (HU), a very important cost-effectiveness analysis for health care and health status, is measured by several preference-based utility measures. This study aimed to evaluate the relation between PA and HU and the effect of disease severity on PA and HU in patients with CHF. MethodsWe enrolled 226 consecutive outpatients with CHF (mean age, 57.5 years; males, 79.6%) in this retrospective cross-sectional study. Patients were divided into three groups by NYHA class for classification of disease severity. Patient characteristics, average step count in steps/day, PA energy expenditure (PAEE) in kcal/day for 7 days as assessed by accelerometer, and HU assessed by Short Form-6D were compared between the groups. ResultsAverage step count (r = 0.37, P < 0.01) and average PAEE (r = 0.36, P < 0.01) correlated positively with HU in all patients. Patients were classified into three groups by NYHA class: class I (n = 92), class II (n = 97), and class III (n = 37). Average step counts (7618.58, 6452.51, and 4225.63 steps/day, P < 0.001), average PAEE (244.65, 176.88, and 103.72 kcal/day, P < 0.001), and HU (0.68, 0.63, and 0.57, P < 0.001) respectively decreased with the increase in NYHA class (P < 0.001). ConclusionThis study showed a significant relationship of daily PA and HU to disease severity in patients with CHF. Although causation cannot be determined from this study, these results suggest that PA and HU may provide important information related to the severity of disease in patients with CHF.

Comparison of EuroQol-5D-3L and Short Form-6D Utility Scores in Family Caregivers of Colorectal Cancer Patients: A Cross-Sectional Survey in China.

Objective: To compare the EuroQol-5D-3L (EQ-5D-3L) and the Short Form-6D (SF-6D) utility scores in family caregivers (FCs) of colorectal cancer (CRC) patients.Method: This study was performed on FCs of CRC patients from three primary cancer centers in the capital city of the Heilongjiang province. The participants (FCs) who were enrolled, filled the EQ-5D-3L, along with the SF-6D questionnaire. Two tools were compared for their distribution, discriminant validity, agreement, and convergent validity along with known-groups validity.Result: Two hundred ninety-two FCs of CRC patients were enrolled. The score distribution of the SF-6D along with the EQ-5D-3L were not normal. A ceiling impact was seen in 31.8% of the FCs for EQ-5D-3L; however, none for the SF-6D. Good associations (Spearman’s rho = 0.622, p < 0.01) and intraclass correlation coefficient (ICC 0.637 and average ICC 0.778) between the two scores were observed. The EQ-5D-3L yielded higher utility scores in contrast with the SF-6D in the better health subclass. The SF-6D distinguished better between excellent and good health statuses, with better effect size and relative efficiency statistics. Both tools showed good known-groups validity.Conclusion: The utility scores of SF-6D were remarkably lower relative to that of the EQ-5D-3L, but the difference may be clinically insignificant. However, the SF-6D may be superior because of the lack of ceiling impact. SF-6D exhibited a better convergent validity along with discrimination validity of excellent health condition and improved known-groups validity efficiency.

Hepatic Fat Reduction Due to Resmetirom in Patients With Nonalcoholic Steatohepatitis Is Associated With Improvement of Quality of Life

Nonalcoholic steatohepatitis (NASH) is a chronic liver disease associated with adverse clinical outcomes and impaired health-related quality of life (HRQL). Patients with biopsy-proven non-cirrhotic NASH with hepatic fat fraction of ≥10% by magnetic resonance imaging-proton density fat fraction were enrolled in a phase 2, multicenter, double-blind, randomized, placebo-controlled study of resmetirom. HRQL was assessed using Short Form-36 throughout 36 weeks of treatment. One hundred twenty-five NASH patients were enrolled (50 ± 11 years old, 50% male, 94% white, body mass index 35 ± 6 kg/m2, 39% with diabetes mellitus). Of these, 84 patients received 80 mg of resmetirom daily, and 41 received placebo. At baseline, HRQL scores were not different from general population norms (Physical Component Summary [PCS] 47.9 ± 9.3 vs 50, Mental Component Summary 50.4 ± 10.0 vs 50; all P > .05). By treatment week 12, patients who received resmetirom experienced improvement of Bodily Pain and Short Form-6D utility scores (P < .05); no HRQL improvement was noted in placebo (all P > .05). Improvement in PCS continued up to week 36 of treatment with resmetirom, again with no improvement in placebo group (all P > .05). Adjusted for the baseline score and clinicodemographic confounders, meeting the endpoint of a decrease in proton density fat fraction of ≥30% by week 12 (met by 54 of 116 treatment completers; 47 of 54 on resmetirom) was independently associated with greater improvements in Physical Functioning and PCS scores at week 36 (P < .05). Patients with improvement in NASH and fibrosis on liver biopsy also showed improvement in components of HRQL. Patients with NASH treated who improved their hepatic fat fraction and/or Nonalcoholic Fatty Liver Disease Activity Score on serial liver biopsy experienced improvement of HRQL. Further studies are needed to confirm long-term sustainability of that improvement. gov #NCT02912260.

Cumulative comorbidity burden does not worsen outcomes in management of chronic rhinosinusitis.

The impact of multiple coexisting medical comorbidities on treatment outcomes in chronic rhinosinusitis (CRS) is unknown. In this study we sought to evaluate the effect of comorbidities on sinonasal quality of life (QOL) and general health utility values by utilizing the Functional Comorbidity Index (FCI) in CRS patients. Patients with CRS were prospectively enrolled in a cross-sectional study of medical and surgical therapies. The 22-item Sino-Nasal Outcome Test (SNOT-22) and Medical Outcomes Study Short-Form 6D (SF-6D) scores were recorded at enrollment and 6-month follow-up; Lund-Kennedy endoscopy and Lund-Mackay computed tomography scores were recorded at enrollment. The FCI was calculated using the electronic medical record. The impact of cumulative comorbidity burden on baseline and posttreatment outcomes was assessed using univariate and bivariate correlations. A total of 428 participants with CRS were included. The average (mean standard ± deviation) FCI score was 3.03 ± 2.28 (range, 0-12). Significant linear correlations were identified between increasing FCI score and baseline SNOT-22 and SF-6D scores (R=0.166, p=0.001 and R=-0.245, p<0.001, respectively). There was no correlation between FCI and change in SNOT-22 or SF-6D scores after CRS treatment (R=0.066, p=0.17 and R=-0.087, p=0.074, respectively). Achievement of a minimally clinically important difference was also independent of FCI. Although cumulative comorbidity burden, as measured by FCI, is associated with worse baseline SNOT-22 and SF-6D scores, it does not appear to limit posttreatment improvement in either outcome measure. On average, patients with high comorbidity burden report substantial improvement in both QOL and health utility after CRS treatment, similar to those with fewer comorbidities.

Mapping the Memorial Anxiety Scale for Prostate Cancer to the SF-6D.

To create a crosswalk that predicts Short Form 6D (SF-6D) utilities from Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scores. The data come from prostate cancer patients enrolled in the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS, N = 1016). Cross-sectional data from 12- to 24-month follow-up were used as estimation and validation datasets, respectively. Participants' SF-12 scores were used to generate SF-6D utilities in both datasets. Beta regression mixture models were used to evaluate SF-6D utilities as a function of MAX-PC scores, race, education, marital status, income, employment status, having health insurance, year of cancer diagnosis and clinically significant prostate cancer-related anxiety (PCRA) status in the estimation dataset. Models' predictive accuracies (using mean absolute error [MAE], root mean squared error [RMSE], Akaike information criterion [AIC] and Bayesian information criterion [BIC]) were examined in both datasets. The model with the highest prediction accuracy and the lowest prediction errors was selected as the crosswalk. The crosswalk had modest prediction accuracy (MAE = 0.092, RMSE = 0.114, AIC = -2708 and BIC = -2595.6), which are comparable to prediction accuracies of other SF-6D crosswalks in the literature. About 24% and 52% of predictions fell within ± 5% and ± 10% of observed SF-6D, respectively. The observed mean disutility associated with acquiring clinically significant PCRA is 0.168 (standard deviation = 0.179). This study provides a crosswalk that converts MAX-PC scores to SF-6D utilities for economic evaluation of clinically significant PCRA treatment options for prostate cancer survivors.

Estimating Long-Term Health Utility Scores and Expenditures for Cardiovascular Disease From the Medical Expenditure Panel Survey.

Long-term health utility scores and costs used in cost-effectiveness analyses of cardiovascular disease prevention and management can be inconsistent, outdated, or invalid for the diverse population of the United States. Our aim was to develop a user friendly, standardized, publicly available code and catalog to derive more valid long-term values for health utility and expenditures following cardiovascular disease events. Individual-level Short Form-12 version 2 health-related quality of life and expenditure data were obtained from the pooled 2011 to 2016 Medical Expenditure Panel Surveys. We developed code using the R programming language to estimate preference-weighted Short Form-6D utility scores from the Short Form-12 for quality-adjusted life year calculations and predict annual health care expenditures. Result predictors included cardiovascular disease diagnosis (myocardial infarction, ischemic stroke, heart failure, cardiac dysrhythmias, angina pectoris, and peripheral artery disease), sociodemographic factors, and comorbidity variables. The cardiovascular disease diagnoses with the lowest utility scores were heart failure (0.635 [95% CI, 0.615-0.655]), angina pectoris (0.649 [95% CI, 0.630-0.667]), and ischemic stroke (0.649 [95% CI, 0.635-0.663]). The highest annual expenditures were for heart failure ($20 764 [95% CI, $17 500-$24 027]), angina pectoris ($18 428 [95% CI, $16 102-$20 754]), and ischemic stroke ($16 925 [95% CI, $15 672-$20 616]). The developed code and catalog may improve the quality and comparability of cost-effectiveness analyses by providing standardized methods for extracting long-term health utility scores and expenditures from Medical Expenditure Panel Survey data, which are more current and representative of the US population than previous sources.

The efficacy, safety and cost-effectiveness of hydroxychloroquine, sulfasalazine, methotrexate triple therapy in preventing relapse among patients with rheumatoid arthritis achieving clinical remission or low disease activity: the study protocol of a randomized controlled clinical Trial (ESCoRT study)

BackgroundTumor necrosis factor α inhibitors (TNFi) is effective for rheumatoid arthritis (RA) patients who fail to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs). Because of high cost, the discontinuation is common but often lead to disease relapse. The study aims to investigate, if the combination therapy of csDMARDs is more effective in reducing disease relapse than methotrexate (MTX) monotherapy, and more cost-effective than continuing TNFi and MTX.MethodsIt will be a two-stage trial. In the first stage, all RA patients who failed to csDMARDs treatment [disease activity score 28 (DAS28)-CRP > 3.2] will receive MTX plus TNFi for no more than 12 weeks. Patients achieving DAS28-CRP < 3.2 during the first stage will be randomized into three groups at 1:1:1 ratio: (A) add hydroxychloroquine (HCQ) and sulfasalazine (SSZ) for the first 12 weeks and then remove TNFi but continue other treatments for the next 48 weeks; (B) maintain TNFi + MTX for 60 weeks; and (C) maintain TNFi + MTX for the first 12 weeks and then remove TNFi but continue MTX monotherapy for the next 48 weeks. The primary outcome will be disease relapse (DAS28-CRP increases by at least 0.6 and > 3.2). Secondary outcomes will include the incremental cost per reducing 1 case of relapse; patient reported intolerance to the treatment; adverse events; change of mean disease activity measured by DAS28, clinical disease activity index (CDAI) and simplified disease activity index (SDAI); the proportion of modified Sharp score increase < 0.3; ultrasound-detected remission in hands; Health Assessment Questionnaire Disability Index (HAQ-DI) and health related quality of life [the five-level EuroQol-5D (EQ-5D-5L) and short form-6D (SF-6D)].DiscussionThe aim of this trail will be to seek effective treatment options of preventing relapse of RA. The results of the current study may provide an instructive recommendation for more economical application of TNFi treatment in RA.Trial registration NCT, NCT02320630. Registered on 16 December 2014. https://register.clinicaltrials.gov/prs/app/action/LoginUser?ts=3&cx=-jg9qo2.