Ling-Hsiang Chuang

South Korean time trade-off values for EQ-5D health states: modeling with observed values for 101 health states.

OBJECTIVES This study establishes the South Korean population-based preference weights for EQ-5D based on values elicited from a representative national sample using the time trade-off (TTO) method. METHODS The data for this paper came from a South Korean EQ-5D valuation study where 1307 representative respondents were invited to participate and a total of 101 health states defined by the EQ-5D descriptive system were directly valued. Both aggregate and individual level modeling were conducted to generate values for all 243 health states defined by EQ-5D. Various regression techniques and model specifications were also examined in order to produce the best fit model. Final model selection was based on minimizing the difference between the observed and estimated value for each health state. RESULTS The N3 model yielded the best fit for the observed TTO value at the aggregate level. It had a mean absolute error of 0.029 and only 15 predictions out of 101 had errors exceeding 0.05 in absolute magnitude. CONCLUSIONS The study successfully establishes South Korean population-based preference weights for the EQ-5D. The value set derived here is based on a representative population sample, limiting the interpolation space and possessing better model performance. Thus, this EQ-5D value set should be given preference for use with the South Korean population.

Yoga for chronic low back pain: A randomized trial

BACKGROUND Previous studies indicate that yoga may be an effective treatment for chronic or recurrent low back pain. OBJECTIVE To compare the effectiveness of yoga and usual care for chronic or recurrent low back pain. DESIGN Parallel-group, randomized, controlled trial using computer-generated randomization conducted from April 2007 to March 2010. Outcomes were assessed by postal questionnaire. (International Standard Randomised Controlled Trial Number Register: ISRCTN 81079604) SETTING 13 non-National Health Service premises in the United Kingdom. PATIENTS 313 adults with chronic or recurrent low back pain. INTERVENTION Yoga (n = 156) or usual care (n = 157). All participants received a back pain education booklet. The intervention group was offered a 12-class, gradually progressing yoga program delivered by 12 teachers over 3 months. MEASUREMENTS Scores on the Roland-Morris Disability Questionnaire (RMDQ) at 3 (primary outcome), 6, and 12 (secondary outcomes) months; pain, pain self-efficacy, and general health measures at 3, 6, and 12 months (secondary outcomes). RESULTS 93 (60%) patients offered yoga attended at least 3 of the first 6 sessions and at least 3 other sessions. The yoga group had better back function at 3, 6, and 12 months than the usual care group. The adjusted mean RMDQ score was 2.17 points (95% CI, 1.03 to 3.31 points) lower in the yoga group at 3 months, 1.48 points (CI, 0.33 to 2.62 points) lower at 6 months, and 1.57 points (CI, 0.42 to 2.71 points) lower at 12 months. The yoga and usual care groups had similar back pain and general health scores at 3, 6, and 12 months, and the yoga group had higher pain self-efficacy scores at 3 and 6 months but not at 12 months. Two of the 157 usual care participants and 12 of the 156 yoga participants reported adverse events, mostly increased pain. LIMITATION There were missing data for the primary outcome (yoga group, n = 21; usual care group, n = 18) and differential missing data (more in the yoga group) for secondary outcomes. CONCLUSION Offering a 12-week yoga program to adults with chronic or recurrent low back pain led to greater improvements in back function than did usual care. PRIMARY FUNDING SOURCE Arthritis Research UK.

Surgical vs Nonsurgical Treatment of Adults With Displaced Fractures of the Proximal Humerus: The PROFHER Randomized Clinical Trial

IMPORTANCE The need for surgery for the majority of patients with displaced proximal humeral fractures is unclear, but its use is increasing. OBJECTIVE To evaluate the clinical effectiveness of surgical vs nonsurgical treatment for adults with displaced fractures of the proximal humerus involving the surgical neck. DESIGN, SETTING, AND PARTICIPANTS A pragmatic, multicenter, parallel-group, randomized clinical trial, the Proximal Fracture of the Humerus Evaluation by Randomization (PROFHER) trial, recruited 250 patients aged 16 years or older (mean age, 66 years [range, 24-92 years]; 192 [77%] were female; and 249 [99.6%] were white) who presented at the orthopedic departments of 32 acute UK National Health Service hospitals between September 2008 and April 2011 within 3 weeks after sustaining a displaced fracture of the proximal humerus involving the surgical neck. Patients were followed up for 2 years (up to April 2013) and 215 had complete follow-up data. The data for 231 patients (114 in surgical group and 117 in nonsurgical group) were included in the primary analysis. INTERVENTIONS Fracture fixation or humeral head replacement were performed by surgeons experienced in these techniques. Nonsurgical treatment was sling immobilization. Standardized outpatient and community-based rehabilitation was provided to both groups. MAIN OUTCOMES AND MEASURES Primary outcome was the Oxford Shoulder Score (range, 0-48; higher scores indicate better outcomes) assessed during a 2-year period, with assessment and data collection at 6, 12, and 24 months. Sample size was based on a minimal clinically important difference of 5 points for the Oxford Shoulder Score. Secondary outcomes were the Short-Form 12 (SF-12), complications, subsequent therapy, and mortality. RESULTS There was no significant mean treatment group difference in the Oxford Shoulder Score averaged over 2 years (39.07 points for the surgical group vs 38.32 points for the nonsurgical group; difference of 0.75 points [95% CI, -1.33 to 2.84 points]; P = .48) or at individual time points. There were also no significant between-group differences over 2 years in the mean SF-12 physical component score (surgical group: 1.77 points higher [95% CI, -0.84 to 4.39 points]; P = .18); the mean SF-12 mental component score (surgical group: 1.28 points lower [95% CI, -3.80 to 1.23 points]; P = .32); complications related to surgery or shoulder fracture (30 patients in surgical group vs 23 patients in nonsurgical group; P = .28), requiring secondary surgery to the shoulder (11 patients in both groups), and increased or new shoulder-related therapy (7 patients vs 4 patients, respectively; P = .58); and mortality (9 patients vs 5 patients; P = .27). Ten medical complications (2 cardiovascular events, 2 respiratory events, 2 gastrointestinal events, and 4 others) occurred in the surgical group during the postoperative hospital stay. CONCLUSIONS AND RELEVANCE Among patients with displaced proximal humeral fractures involving the surgical neck, there was no significant difference between surgical treatment compared with nonsurgical treatment in patient-reported clinical outcomes over 2 years following fracture occurrence. These results do not support the trend of increased surgery for patients with displaced fractures of the proximal humerus. TRIAL REGISTRATION isrctn.com Identifier: ISRCTN50850043.

Use of weekly, low dose, high frequency ultrasound for hard to heal venous leg ulcers: the VenUS III randomised controlled trial

Objective To assess the clinical effectiveness of weekly delivery of low dose, high frequency therapeutic ultrasound in conjunction with standard care for hard to heal venous leg ulcers. Design Multicentre, pragmatic, two arm randomised controlled trial. Setting Community and district nurse led services, community leg ulcer clinics, and hospital outpatient leg ulcer clinics in 12 urban and rural settings (11 in the United Kingdom and one in the Republic of Ireland). Participants 337 patients with at least one venous leg ulcer of >6 months’ duration or >5 cm2 area and an ankle brachial pressure index of ≥0.8. Interventions Weekly administration of low dose, high frequency ultrasound therapy (0.5 W/cm2, 1 MHz, pulsed pattern of 1:4) for up to 12 weeks plus standard care compared with standard care alone. Main outcome measures Primary outcome was time to healing of the largest eligible leg ulcer. Secondary outcomes were proportion of patients healed by 12 months, percentage and absolute change in ulcer size, proportion of time participants were ulcer-free, health related quality of life, and adverse events. Results The two groups showed no significant difference in the time to healing of the reference leg ulcer (log rank test, P=0.61). After adjustment for baseline ulcer area, baseline ulcer duration, use of compression bandaging, and study centre, there was still no evidence of a difference in time to healing (hazard ratio 0.99 (95% confidence interval 0.70 to 1.40), P=0.97). The median time to healing of the reference leg ulcer was inestimable. There was no significant difference between groups in the proportion of participants with all ulcers healed by 12 months (72/168 in ultrasound group v 78/169 in standard care group, P=0.39 for Fisher’s exact test) nor in the change in ulcer size at four weeks by treatment group (model estimate 0.05 (95% CI –0.09 to 0.19)). There was no difference in time to complete healing of all ulcers (log rank test, P=0.61), with median time to healing of 328 days (95% CI 235 to inestimable) with standard care and 365 days (224 days to inestimable) with ultrasound. There was no evidence of a difference in rates of recurrence of healed ulcers (17/31 with ultrasound v 14/31 with standard care, P=0.68 for Fisher’s exact test). There was no difference between the two groups in health related quality of life, both for the physical component score (model estimate 0.69 (–1.79 to 3.08)) and the mental component score (model estimate –0.93 (–3.30 to 1.44)), but there were significantly more adverse events in the ultrasound group (model estimate 0.30 (0.01 to 0.60)). There was a significant relation between time to ulcer healing and baseline ulcer area (hazard ratio 0.64 (0.55 to 0.75)) and baseline ulcer duration (hazard ratio 0.59 (0.50 to 0.71)), with larger and older ulcers taking longer to heal. In addition, those centres with high recruitment rates had the highest healing rates. Conclusions Low dose, high frequency ultrasound administered weekly for 12 weeks during dressing changes in addition to standard care did not increase ulcer healing rates, affect quality of life, or reduce ulcer recurrence. Trial registration ISRCTN21175670 and National Research Register N0484162339

Hispanic Valuation of the EQ-5D Health States: A Social Value Set for Latin Americans

OBJECTIVES Cost-effectiveness analysis has been recommended by national health agencies worldwide. In the United Kingdom, the National Institute of Health and Clinical Excellence supports the use of generic health-related quality of life instruments such as EuroQol EQ-5D when quality-adjusted life-years are used to measure health benefits. Despite the urgent need for appropriate methodologies to improve the use of scarce resources in Latin American countries, little is known about how health is valued. METHODS A national population survey was conducted in the United States in 2002, based on a sample of 1603 non-Hispanic nonblacks and 1115 Hispanics. Participants provided time trade-off utilities for a subset of 42 EQ-5D health states. Hispanic respondents were grouped according to their language preferences (Spanish or English). Mean utilities were compared for each health state. A random-effects model was used to determine whether real population differences exist after adjusting for sociodemographic characteristics. A population value set for all 243 EQ-5D health states was developed using only the data from Spanish-speaking Hispanics. RESULTS Mean valuations differed slightly between non-Hispanic nonblacks and English-speaking Hispanics. Spanish-speaking Hispanics, however, tended to give higher valuations than non-Hispanic nonblacks (P < 0.05) corresponding to an average of 0.034 point. A regression model was developed for Spanish-speaking Hispanics with a mean absolute error of 0.031. Values estimated using this model show marked differences when compared with corresponding values estimated using the UK (N3) and US (D1) models. CONCLUSION The availability of a Hispanic model for EQ-5D valuations represents a significant new option for decision-makers, providing a set of social preference weights for use in Latin American countries that presently lack their own domestic value set.

Mapping for economic evaluation

INTRODUCTION/BACKGROUND Mapping provides a statistical algorithm that allows the estimation of utilities and consequently calculation of QALYs in clinical studies where preference-based measures are not implemented. SOURCES OF DATA Reviews of the mapping literature were utilized. AREAS OF AGREEMENT Mapping requires similar populations between the estimation and study data sets, with a high degree of overlap between the target and base measures being desirable. The National Institute for Health and Clinical Excellence recognizes mapping as a method to provide utility information. Areas of controversy Issues surrounding mapping include the descriptive system of the measure, the appropriate econometric method and model specification. GROWING POINTS There is a need for further research into the issue of over-prediction for severe health states and uncertainty around the estimated utility scores. AREAS TIMELY FOR DEVELOPING RESEARCH Mapping continues to be an important area of research for economic evaluation, in particular validation of mapping functions.

A pragmatic multicentered randomized controlled trial of yoga for chronic low back pain: economic evaluation.

Study Design. Multicentered randomized controlled trial with quality of life and resource use data collected. Objective. The objective of this study was to evaluate the cost-effectiveness of yoga intervention plus usual care compared with usual care alone for chronic or recurrent low back pain. Summary of Background Data. Yoga has been shown as an effective intervention for treating chronic or recurrent low back pain. However, there is little evidence on its cost-effectiveness. The data are extracted from a pragmatic, multicentered, randomized controlled trial that has been conducted to evaluate the effectiveness and cost-effectiveness of a 12-week progressive program of yoga plus usual care in patients with chronic or recurrent low back pain. Methods. With this trial data, a cost-effectiveness analysis during the time period of 12 months from both perspectives of the UK National Health Service and the societal is presented. Main outcome measure is an incremental cost per quality-adjusted life-year (QALY). Results. From the perspective of the UK National Health Service, yoga intervention yields an incremental cost-effectiveness ratio of £13,606 per QALY. Given a willingness to pay for an additional QALY of £20,000, the probability of yoga intervention being cost-effective is 72%. From the perspective of the society, yoga intervention is a dominant treatment compared with usual care alone. This result is surrounded by fewer uncertainties—the probability of yoga being cost-effective reaches 95% at a willingness to pay for an additional QALY of £20,000. Sensitive analyses suggest the same results that yoga intervention is likely to be cost-effective in both perspectives. Conclusion. On the basis of this trial, 12 weekly group classes of specialized yoga are likely to be a cost-effective intervention for treating patients with chronic or recurrent low back pain.

Converting the SF-12 into the EQ-5D An Empirical Comparison of Methodologies

AbstractBackground: For cost-utility analysis, analysts need a measure that summarizes health-status utilities in a single index of health-related quality of life (HR-QOL). It is common to find in clinical studies that only an HR-QOL profile measure such as the SF-36 is included, but not the summary HR-QOL index. Therefore, the economist’s usual practice is to reprocess the profile data into a single index format. Several ‘after-market’ tools are available to convert the SF-36 or SF-12 into a single form with or without utility-weighting metric property. However, there has been no consensus with regard to a regression method that should be recommended for such a mapping task. Objective: To report on the performance of different regression methods that have previously been applied to the conversion of SF-12 data in the analysis of a single common dataset. The mapping between the SF-12 and EQ-5D is the focus. Methods: The data were adopted from the Medical Expenditure Panel Survey 2003 where 19 678 adults completed both EQ-5D and SF-12 questionnaires. Four econometric techniques, namely ordinary least squares (OLS), censored least absolute deviation, multinomial logit model and two-part model regressions were investigated together with two main types of model specifications: item-based and summary score-based. The performance of each examined model was judged by various criteria, including its estimated mean, the size of mean absolute error and the number of errors. Results: Among four compared econometric techniques, OLS regression was the most accurate model in estimating the group mean. Models with item-based model specification performed better than those with summary scorebased regardless of the chosen econometric technique. Nevertheless, the accuracy of OLS deteriorates in older and less healthy subgroups. The results also suggested that the two-part model, which addresses the heterogeneity issue, performs better in these vulnerable subgroups. Conclusions: None of the mapping methods included in the current study are suitable for estimating at the individual level. The methodology exemplified here has wider applicability and might just as readily be applied to other members of the SF family or indeed to other profile measures of HR-QOL. However, it is recommended that a preference-based, single index measure of HR-QOL should be included in the clinical studies for the purpose of economic evaluation.

Validation of EQ-5D in patients with cervical cancer in Taiwan

PurposeThe survival rate of cervical cancer is increasing due to early diagnosis and timely treatment. As a result, the availability of a valid and reliable general HRQoL is important. The purpose of this study was to evaluate the psychometric properties of the EuroQol questionnaire (EQ-5D) in patients with cervical cancer in Taiwan.MethodOutpatients with cervical cancer were recruited from three medical centers across Taiwan. Test–retest reliability and ceiling effect were evaluated. Construct validity including convergent and discriminate validities were examined using the EORTC QLQ C-30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) and the clinical indicators of the functional performance assessment using the Karnofsky Performance Scale (KPS) and disease status.ResultsA total of 530 patients completed the questionnaire. The intraclass correlation coefficient for the EQ-5D index was 0.83, and the Cohens kappa values for the EQ-5D dimensions ranged from 0.54 to 0.73. The EQ-5D index and VAS scores were higher for patients with a higher KPS score and disease-free status. The EQ-5D index was strongly correlated with all EORTC QLQ-C30 functioning scales.ConclusionThe EQ-5D questionnaire is reliable and valid for the assessment of health-related quality of life in patients with cervical cancer in Taiwan.

The ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation) trial - a pragmatic multicentre randomised controlled trial evaluating the clinical effectiveness and cost-effectiveness of surgical compared with non-surgical treatment for proximal fracture of the humerus in adults.

BACKGROUND Proximal humeral fractures account for 5-6% of all fractures in adults. There is considerable variation in whether or not surgery is used in the management of displaced fractures involving the surgical neck. OBJECTIVE To evaluate the clinical effectiveness and cost-effectiveness of surgical compared with non-surgical treatment of the majority of displaced fractures of the proximal humerus involving the surgical neck in adults. DESIGN A pragmatic parallel-group multicentre randomised controlled trial with an economic evaluation. Follow-up was for 2 years. SETTING Recruitment was undertaken in the orthopaedic departments of 33 acute NHS hospitals in the UK. Patient care pathways included outpatient and community-based rehabilitation. PARTICIPANTS Adults (aged ≥ 16 years) presenting within 3 weeks of their injury with a displaced fracture of the proximal humerus involving the surgical neck. INTERVENTIONS The choice of surgical intervention was left to the treating surgeons, who used techniques with which they were experienced. Non-surgical treatment was initial sling immobilisation followed by active rehabilitation. Provision of rehabilitation was comparable in both groups. MAIN OUTCOME MEASURES The primary outcome was the Oxford Shoulder Score (OSS) assessed at 6, 12 and 24 months. Secondary outcomes were the 12-item Short Form health survey, surgical and other shoulder fracture-related complications, secondary surgery to the shoulder or increased/new shoulder-related therapy, medical complications during inpatient stay and mortality. European Quality of Life-5 Dimensions data and treatment costs were also collected. RESULTS The mean age of the 250 trial participants was 66 years and 192 (77%) were female. Independent assessment using the Neer classification identified 18 one-part fractures, 128 two-part fractures and 104 three- or four-part fractures. OSS data were available for 215 participants at 2 years. We found no statistically or clinically significant differences in OSS scores between the two treatment groups (scale 0-48, with a higher score indicating a better outcome) over the 2-year period [difference of 0.75 points in favour of the surgery group, 95% confidence interval (CI) -1.33 to 2.84; p = 0.479; data from 114 surgery and 117 non-surgery participants] or at individual time points. We found no statistically significant differences between surgical and non-surgical group participants in SF-12 physical or mental component summary scores; surgical or shoulder fracture-related complications (30 vs. 23 respectively); those undergoing further shoulder-related therapy, either surgery (11 vs. 11 respectively) or other therapy (seven vs. four respectively); or mortality (nine vs. five respectively). The base-case economic analysis showed that, at 2 years, the cost of surgical intervention was, on average, £1780.73 more per patient (95% CI £1152.71 to £2408.75) than the cost of non-surgical intervention. It was also slightly less beneficial in terms of utilities, although this difference was not statistically significant. The net monetary benefit associated with surgery is negative. There was only a 5% probability of surgery achieving the criterion of costing < £20,000 to gain a quality-adjusted life-year, which was confirmed by extensive sensitivity analyses. CONCLUSIONS Current surgical practice does not result in a better outcome for most patients with displaced fractures of the proximal humerus involving the surgical neck and is not cost-effective in the UK setting. Two areas for future work are the setting up of a national database of these fractures, including the collection of patient-reported outcomes, and research on the best ways of informing patients with these and other upper limb fractures about initial self-care. TRIAL REGISTRATION Current Controlled Trials ISRCTN50850043. FUNDING This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 24. See the NIHR Journals Library website for further project information.