The EQ-5D-3L Valuation Study in Pakistan.

BACKGROUND: To utilize EQ-5D in economic evaluations, a societal-based value set is needed. To date, no value sets exist for any EQ-5D instrument in Pakistan. Previous EQ-5D studies conducted in Pakistan 'borrowed' health preferences developed in other countries. However, for a value set to be valid for Pakistani population, it should represent the preferences of the Pakistani population, and culture and living standards of Pakistan. OBJECTIVE: The aim of this study was to derive a Pakistani EQ-5D-3L value set. METHODS: A moderately representative sample aged 18 years and over was recruited from the Pakistani general population. A multi-stage stratified quota method with respect to ethnicity, gender, age and religion was utilized. Two elicitation techniques, the composite time trade-off (cTTO) and discrete choice experiments (DCE) were applied. Interviews were undertaken by trained interviewers using computer-assisted face-to-face interviews with the EuroQol Portable Valuation Technology (EQ-PVT) platform. To estimate the value set, a hybrid regression model combining cTTO and DCE data was used. RESULTS: A total of 289 respondents who completed the interviews were included for the analysis. The hybrid model correcting for heteroskedasticity without a constant was selected as the final model for the value set. It is shown that being unable to do usual activities (level 3) was assigned the largest weight, followed by mobility level 3, self-care level 3, pain/discomfort level 3 and anxiety/depression level 3. The worst health state was assigned the value - 0.171 in the final model. CONCLUSIONS: A Pakistani country-specific EQ-5D-3L value set is now available. The availability of this value set may help promote and facilitate health economic evaluations and health-related quality-of-life (HRQoL) research in Pakistan.

A cross-country comparison of health-related quality of life in the United States, Sweden, and Norway during the first year of the COVID-19 pandemic.

BACKGROUND: Limited studies have directly compared health-related quality of life (HRQoL) in different countries during the COVID-19 global pandemic. The objective of this study was to evaluate the HRQoL outcomes in the US, Sweden, and Norway during the first year under the pandemic. METHODS: In April 2020, during early phase of the pandemic, separately in the US, Sweden, and Norway, we surveyed 2,734, 1,003 and 1,020 respondents, then again in January 2021, we collected 2,252, 1,013 and 1,011 respondents. The survey was first developed in English and translated into Swedish and Norwegian. Selected variables were used for the current study. We collected respondents' HRQoL using the EQ-5D-5L. Respondents' background information included their sociodemographic data, medical history, and COVID-19 status. We reported the EQ-5D-5L utility, EQ-VAS, and the proportion of problems with each of the EQ-5D-5L health subdomains. Population quality-adjusted life year (QALY) changes based on EQ-5D-5L utility scores were also calculated. Outcomes were stratified by age. One-way ANOVA test was used to detect significant differences between countries and Student's t-tests were used to assess the differences between waves. RESULTS: Respectively for the US, Sweden, and Norway, mean EQ-5D-5L utilities were 0.822, 0.768, and 0.808 in April 2020 (p < 0.001); 0.823, 0.783, and 0.777 in January 2021 (p < 0.001); mean EQ-VAS scores were 0.746, 0.687, and 0.692 in April 2020 (p < 0.001), 0.764, 0.682, and 0.678 in January 2021 (p < 0.001). For both waves, EQ-5D-5L utilities and EQ-VAS scores in the US remained higher than both Sweden and Norway (p < 0.001). Norwegians reported considerably lowered HRQoL over time (p < 0.01). Self-reported problems with anxiety/depression were highest for the US and Sweden, while Norwegians reported most problems with pain/discomfort, followed by anxiety/depression. The population QALYs increased in the US and Sweden, but decreased in Norway. CONCLUSIONS: In the first year of the pandemic, a rebound in HRQoL was observed in the US, but not in Sweden or Norway. Mental health issues during the pandemic warrant a major public health concern across all 3 countries.

Measurement of Health-Related Quality of Life from Conception to Postpartum Using the EQ-5D-5L Among a National Sample of US Pregnant and Postpartum Adults.

BACKGROUND: During pregnancy, physiological changes occur from conception to birth. We assessed the health-related quality of life (HRQoL) throughout pregnancy and postpartum using the EQ-5D-5L. METHODS: Between May and July 2021 (wave 1) and December 2021 and April 2022 (wave 2), we conducted a series of cross-sectional, national online surveys of 5250 pregnant and postpartum United States (US) adults. The survey included the EQ-5D-5L, EQ visual analog scale (EQ VAS), items measuring respondents' sociodemographic and health information, last menstrual period, estimated date of delivery, and date of pregnancy end (if postpartum). We examined monthly EQ-5D-5L items, utility values, and EQ VAS scores during pregnancy and postpartum. We used quantile regression adjusted for calendar month of last menstrual period to estimate changes in HRQoL at different time points of pregnancy and postpartum. RESULTS: There was a steady increase in the frequency of respondents reporting health-related problems and a decline in EQ-5D-5L utility values from early pregnancy until the ninth month of pregnancy (ß = - 0.21; standard error [SE] 0.02; P < 0.001), followed by a 0.10 (SE 0.02; P < 0.001) unit increase in values during the first postpartum month and a stabilization during the remainder of the postpartum period (ß = 0.02; SE 0.02; P = 0.214). The median EQ-5D-5L utility value was lowest during the ninth month of pregnancy (median 0.78 [interquartile range 0.30]). CONCLUSIONS: HRQoL as measured by EQ-5D-5L varies across pregnancy, indicating progressive declines throughout pregnancy and a return to first trimester values during the first month postpartum. Studies involving HRQoL measurement in pregnant people should account for the stage of pregnancy in their estimates.

Modifying the Composite Time Trade-Off Method to Improve Its Discriminatory Power.

OBJECTIVES: In cost-effectiveness analysis of health technologies, health state utilities are needed. They are often elicited with a composite time trade-off (cTTO) method, particularly for the widely used EQ-5D-5L. Unfortunately, cTTO discriminatory power is hindered by (1) respondents' nontrading (NT) of time for quality, (2) censoring of utilities at -1, and (3) poor correlation of negative utilities with state severity. We investigated whether modifying cTTO can mitigate these effects. METHODS: We interviewed online 478 students (February to April, 2021) who each valued the same 10 EQ-5D-5L health states in 1 of 3 arms. Arm A used a standard cTTO, expanded with 2 questions to explore reasons for NT and censoring. Arms B and C used a time trade-off with modified alternatives offered to overcome loss aversion, to unify the tasks for positive and negative utilities, and to enable eliciting utilities < -1. RESULTS: In arms B and C, we observed less NT than in A (respectively, 4% and 4% vs 10%), more strictly negative utilities (38% and 40% vs 25%), and more utilities ≤ -1 (18% and 30% vs 10%). The average utility of state 55555 dropped to -2.15 and -2.52 from -0.53. Enabling finer trades in arm A reduced NT by 70%. Arms B and C yielded an intuitive association between negative utilities and state severity. These arms were considered more difficult and resulted in more inconsistencies. CONCLUSIONS: The discriminatory power of cTTO can be improved, but it may require increasing the difficulty of the task. The standard cTTO may overestimate the utilities, especially of severe states.

Findings from a Roundtable Discussion with US Stakeholders on Valuation of the EQ-5D-Y-3L.

OBJECTIVES: The International Valuation Protocol for the valuation of the EQ-5D-Y-3L provides baseline guidance, but country-specific context is also important. This study aimed to obtain US stakeholders' input on key considerations for youth valuation in the US. METHODS: A total of 14 stakeholders representing various backgrounds were identified via the investigators' networks. A 2-h online meeting was held to discuss (1) the need for a US value set for the EQ-5D-Y-3L; (2) willingness to pay more for quality-adjusted life-year (QALY) gains for children versus adults; (3) sampling strategies; (4) framing perspectives; and (5) other challenges. The session was recorded, transcribed, and summarized. RESULTS: Several stakeholders supported paying more for QALY gains for children in recognition of their potential future contributions to society, as well as to avoid potential undervaluation and promote access to innovative treatments. Concerns regarding possible double counting, lack of data to showcase long-term benefits, and dangers of paying more for certain subgroups were also expressed. Most of the stakeholders felt that adolescents could relate to a 10-year-old's perspective better than adults and were capable of self-completing valuation tasks, and thus should be directly included in the valuation study. There were concerns that adults would be inconsistent in their views about a 10-year-old, partly depending on their status as a parent. CONCLUSIONS: US stakeholders provided insights relevant to youth valuation in a US context and were open to continued dialogue with investigators. This study could be useful to investigators who are conducting youth valuation studies in different countries and seeking stakeholder input.

COVID-19 vaccine acceptance and coverage among pregnant persons in the United States.

Pregnant persons are at higher risk of severe COVID-19. Although vaccination is recommended, COVID-19 vaccination rates are lower among pregnant persons compared to the non-pregnant population. We aimed to evaluate acceptance of any dose of COVID-19 vaccine during pregnancy. A national online cross-sectional survey of US adults who were pregnant between December 2020 and July 2021 was used to measure COVID-19 vaccine behaviors, attitudes, and beliefs. Post-stratification weighting was used to ensure representativeness to the US population. Marginal log-binomial models were used to estimate adjusted prevalence ratios (aPR) of COVID-19 vaccine acceptance, accounting for sociodemographic factors. Of 5,660 who responded to survey advertisements, 2,213 met eligibility criteria and completed the survey; 55.4% of respondents received or planned to receive COVID-19 vaccine prior to or during pregnancy, 27.0% planned to vaccinate after pregnancy, 8.8% were unsure and 8.7% had no plans to vaccinate. Individuals were more likely to receive or plan to receive COVID-19 vaccine if they had group prenatal care (aPR 1.57; 95% CI 1.40, 1.75), were employed in a workplace with a policy recommending vaccination (aPR 1.15; 95% CI 1.06, 1.26), and believed COVID-19 vaccines are safe (aPR 2.86; 95% CI 2.49, 3.29). Pregnant persons who were recommended COVID-19 vaccination by their healthcare provider less commonly reported concerns about vaccine safety (35.5% vs 55.9%) and were more likely to accept COVID-19 vaccines (aPR 1.52; 95% CI 1.31, 1.76). COVID-19 vaccine acceptance during pregnancy is not universal and public health intervention will be needed to continue to increase vaccine coverage.

Predicting panel attrition in longitudinal HRQoL surveys during the COVID-19 pandemic in the US.

BACKGROUND: Online longitudinal surveys may be subject to potential biases due to sample attrition. This study was designed to identify potential predictors of attrition using a longitudinal panel survey collected during the COVID-19 pandemic. METHODS: Three waves of data were collected using Amazon Mechanical Turk (MTurk), an online crowd-sourced platform. For each wave, the study sample was collected by referencing a US national representative sample distribution of age, gender, and race, based on US census data. Variables included respondents' demographics, medical history, socioeconomic status, COVID-19 experience, changes of health behavior, productivity, and health-related quality of life (HRQoL). Results were compared to pre-pandemic US norms. Measures that predicted attrition at different times of the pandemic were identified via logistic regression with stepwise selection. RESULTS: 1467 of 2734 wave 1 respondents participated in wave 2 and, 964 of 2454 wave 2 respondents participated in wave 3. Younger age group, Hispanic origin (p ≤ 0.001) and higher self-rated survey difficulty (p ≤ 0.002) consistently predicted attrition in the following wave. COVID-19 experience, employment, productivity, and limited physical activities were commonly observed variables correlated with attrition with specific measures varying by time periods. From wave 1, mental health conditions, average daily hours worked (p = 0.004), and COVID-19 impact on work productivity (p < 0.001) were associated with a higher attrition rate at wave 2, additional to the aforementioned factors. From wave 2, support of social distancing (p = 0.032), being Republican (p < 0.001), and having just enough money to make ends meet (p = 0.003) were associated with predicted attrition at wave 3. CONCLUSIONS: Attrition in this longitudinal panel survey was not random. Besides commonly identified demographic factors that contribute to panel attrition, COVID-19 presented novel opportunities to address sample biases by correlating attrition with additional behavioral and HRQoL factors in a constantly evolving environment. While age, ethnicity, and survey difficulty consistently predicted attrition, other factors, such as COVID-19 experience, changes of employment, productivity, physical health, mental health, and financial situation impacted panel attrition during the pandemic at various degrees.

A Pilot Study of Valuation Methods of the EQ-5D and the Impact of Literacy, Cultural, and Religious Factors on Preferences.

OBJECTIVES: This study aimed to examine the feasibility of the 3-level-EQ-5D valuation methods and the impact of literacy, culture, and religion on the preferences of the Pakistani population. METHODS: Respondents aged 18 to 65 years were recruited using quota sampling. The EuroQol Portable Valuation Technology was used, and data collection was done in Urdu. Graphical presentations were used to elicit responses from illiterate respondents. All interviews were audio recorded and transcribed. Odds ratios associated with the choice impact were assessed. RESULTS: Usual activities showed highest impact on respondents' choice outcomes, followed by self-care and then anxiety/depression and mobility. Compared with "no problem," any problems in mobility had higher odds for a respondent to not to choose otherwise. The impact of health impairment on usual activities imposed the highest influences choices made. Most of the respondents reported that religion had no impact on their responses. Compared with literate respondents, illiterate respondents were more likely to be older, were unemployed, resided in rural, had lower self-reported health, had lower education/income, and had family members living in the same household with lower income. Although not significant, the number of nontraders was slightly higher in illiterate respondents. Literate respondents indicated cultural beliefs did not affects their responses whereas most of the illiterate respondents highlighted the impact of cultural norms on their responses, especially for self-care. CONCLUSIONS: Preference elicitation methods used in 3-level-EQ-5D valuation studies, namely, time trade-off and discrete choice experiments, are feasible in the Pakistani population. The use of graphical illustrations for illiterate respondents was successful.

A US Population Health Survey on the Impact of COVID-19 Using the EQ-5D-5L.

BACKGROUND: The COVID-19 pandemic has resulted in negative impacts on the economy, population health, and health-related quality-of-life (HRQoL). OBJECTIVE: To assess the impact of COVID-19 on US population HRQoL using the EQ-5D-5L. DESIGN: We surveyed respondents on physical and mental health, demographics, socioeconomics, brief medical history, current COVID-19 status, sleep, dietary, financial, and spending changes. Results were compared to online and face-to-face US population norms. Predictors of EQ-5D-5L utility were analyzed using both standard and post-lasso OLS regressions. Robustness of regression coefficients against unmeasured confounding was analyzed using the E-Value sensitivity analysis. SUBJECTS: Amazon MTurk workers (n=2776) in the USA. MAIN MEASURES: EQ-5D-5L utility and VAS scores by age group. KEY RESULTS: We received n=2746 responses. Subjects 18-24 years reported lower mean (SD) health utility (0.752 (0.281)) compared with both online (0.844 (0.184), p=0.001) and face-to-face norms (0.919 (0.127), p<0.001). Among ages 25-34, utility was worse compared to face-to-face norms only (0.825 (0.235) vs. 0.911 (0.111), p<0.001). For ages 35-64, utility was better during pandemic compared to online norms (0.845 (0.195) vs. 0.794 (0.247), p<0.001). At age 65+, utility values (0.827 (0.213)) were similar across all samples. VAS scores were worse for all age groups (p<0.005) except ages 45-54. Increasing age and income were correlated with increased utility, while being Asian, American Indian or Alaska Native, Hispanic, married, living alone, having history of chronic illness or self-reported depression, experiencing COVID-19-like symptoms, having a family member diagnosed with COVID-19, fear of COVID-19, being underweight, and living in California were associated with worse utility scores. Results were robust to unmeasured confounding. CONCLUSIONS: HRQoL decreased during the pandemic compared to US population norms, especially for ages 18-24. The mental health impact of COVID-19 is significant and falls primarily on younger adults whose health outcomes may have been overlooked based on policy initiatives to date.

Cost-effectiveness of percutaneous patent foramen ovale closure as secondary stroke prevention.

OBJECTIVE: Compared to medical therapy alone, percutaneous closure of patent foramen ovale (PFO) further reduces risk of recurrent ischemic strokes in carefully selected young to middle-aged patients with a recent cryptogenic ischemic stroke. The objective of this study was to evaluate the cost-effectiveness of this therapy in the context of the United Kingdom (UK) healthcare system. METHODS: A Markov cohort model consisting of four health states (Stable after index stroke, Post-Minor Recurrent Stroke, Post-Moderate Recurrent Stroke, and Death) was developed to simulate the economic outcomes of device-based PFO closure compared to medical therapy. Recurrent stroke event rates were extracted from a randomized clinical trial (RESPECT) with a median of 5.9-year follow-up. Health utilities and costs were obtained from published sources. One-way and probabilistic sensitivity analyses (PSA) were performed to assess robustness. The model was discounted at 3.5% and reported in 2016 Pounds Sterling. RESULTS: Compared with medical therapy alone and using a willingness-to-pay (WTP) threshold of £20,000, PFO closure reached cost-effectiveness at 4.2 years. Cost-effectiveness ratios (ICERs) at 4, 10, and 20 years were £20,951, £6,887, and £2,158, respectively. PFO closure was cost-effective for 89% of PSA iterations at year 10. Sensitivity analyses showed that the model was robust. CONCLUSIONS: Considering the UK healthcare system perspective, percutaneous PFO closure in cryptogenic ischemic stroke patients is a cost-effective stroke prevention strategy compared to medical therapy alone. Its cost-effectiveness was driven by substantial reduction in recurrent strokes and patients' improved health-related quality-of-life.

Complications and Health Care Costs Associated With Transvenous Cardiac Pacemakers in a Nationwide Assessment.

OBJECTIVES: The aim of this study was to retrospectively characterize transvenous pacemaker (TVP) complications and associated health care costs in a large-scale U.S. patient cohort. BACKGROUND: TVP complications have previously been shown to affect more than 1 in 10 patients but may be underestimated. Pacemakers are widely implanted across community and urban hospitals by operators of varying specialization and experience. METHODS: Truven Health MarketScan databases track U.S. health care claims and encounters of private or Medicare supplemental insurance. Patients implanted with de dual- and single-chamber TVPs between April 2010 and March 2014 and over 1 year of pre-implantation MarketScan enrollment were identified. International Classification of Diseases-Ninth Revision and Current Procedural Terminology codes were used to extract relevant comorbidities and complications. Incremental adjusted cost analysis was performed for acute complications, defined as those occurring within 30 days of implantation. RESULTS: Among 72,701 TVP implantations (mean age 75 ± 12 years, 55% men, 13% single chamber) with 1.5 ± 1.1 years of follow-up, acute complications (0 to 1 month) occurred in 7.7% of single- and 9.1% of dual-chamber TVPs and long-term complications (1 to 36 months) in 6.4% and 5.9% of single- and dual-chamber TVPs, respectively. The net 3-year event rates were approximately 15% and 16%. The incidence and incremental cost of complications are considerable. Most common acute complications include thoracic trauma (3.71%, $70,114), leads requiring revision (3.51%, $9,296), and infection (1.15%, $80,247). Long-term complications are attributed to leads (2.84%), infection (2.42%), and pocket (0.96%). CONCLUSIONS: Claims data suggest that TVP complications are more common than previously reported, affecting nearly 1 in 6 patients by 3 years and contributing to considerable incremental U.S. health care cost.

Relationship between local family physician supply and influenza vaccination after controlling for individual and neighborhood effects.

BACKGROUND: Family physicians (FPs) play an important role in influenza vaccination. We investigated how local FP supply is associated with influenza vaccination, controlling for both individual-level and county-level characteristics. METHODS: The 2008-2010 individual-level data from the Behavioral Risk Factor Surveillance System were merged with county-level data from the Area Resource File (n = 985,157). Multivariate logistic analyses were performed to predict influenza vaccination using the number of FPs per 1000 population as the key predictor, adjusting for individual-level demographic, socioeconomic, and health information, as well as county-level racial composition and income level. Additional analyses were performed across racial/ethnic and employment status categories. RESULTS: Increasing local FP supply was associated with higher odds (adjusted odds ratio [aOR], 1.58; 95% confidence interval [CI], 1.49-1.67) and varied across racial/ethnic groups (Hispanic: aOR, 2.05, 95% CI, 1.55-2.72; non-Hispanic white: aOR, 1.57, 95% CI, 1.48-1.66; non-Hispanic black: aOR, 1.49, 95% CI, 1.18-1.89), employment status categories, and county types. CONCLUSIONS: FP supply was significantly associated with influenza vaccination. The association was greatest among those who were Hispanic, residing in a rural area, or out of work. Our findings lend support to initiatives aimed at increasing the FP supply, particularly among disadvantaged populations.

Eliciting health state utilities for Dupuytren's contracture using a discrete choice experiment.

BACKGROUND AND PURPOSE: An internet-based discrete choice experiment (DCE) was conducted to elicit preferences for a wide range of Dupuytren's contracture (DC)-related health states. An algorithm was subsequently developed to convert these preferences into health state utilities that can be used to assess DC's impact on quality of life and the value of its treatments. METHODS: Health state preferences for varying levels of DC hand severity were elicited via an internet survey from a sample of the UK adult population. Severity levels were defined using a combination of contractures (0, 45, or 90 degrees) in 8 proximal interphalangeal and metacarpophalangeal joints of the index, middle, ring, and little fingers. Right-handed, left-handed, and ambidextrous respondents indicated which hand was preferable in each of the 10 randomly-selected hand-pairings comparing different DC severity levels. For consistency across comparisons, anatomically precise digital hand drawings were used. To anchor preferences onto the traditional 0-1 utility scale used in health economic evaluations, unaffected hands were assigned a utility of 1.0 whereas the utility for a maximally affected hand (i.e., all 8 joints set at 90 degrees of contracture) was derived by asking respondents to indicate what combination of attributes and levels of the EQ-5D-5L profile most accurately reflects the impact of living with such hand. Conditional logistic models were used to estimate indirect utilities, then rescaled to the anchor points on the EQ-5D-5L. RESULTS: Estimated utilities based on the responses of 1,745 qualified respondents were 0.49, 0.57, and 0.63 for completely affected dominant hands, non-dominant hands, or ambidextrous hands, respectively. Utility for a dominant hand with 90-degree contracture in t h e metacarpophalangeal joints of the ring and little fingers was estimated to be 0.89. Separately, reducing the contracture of metacarpophalangeal joint for a little finger from 50 to 12 degrees would improve utility by 0.02. INTERPRETATION: DC is associated with substantial utility decrements. The algorithms presented herein provide a robust and flexible framework to assess utility for varying degrees of DC severity.

A literature review of cost-effectiveness analyses of prostate-specific antigen test in prostate cancer screening.

Prostate cancer is the most common non-skin cancer in American men, and prostate-specific antigen (PSA) testing is its common screening procedure. In May 2012, the US Preventive Services Task Force recommended against PSA-based screening. These recommendations contradict the current recommendations of other organizations such as the American Urological Association. The authors conducted a systematic review of PubMed, EMBASE and Cochrane to examine the published literature reporting the cost-effectiveness of PSA-based screening. The authors found ten studies each for US and non-US jurisdiction population. All reviewed studies concluded PSA-based screening to be cost effective in younger men (≤60 years of age) and at higher PSA levels (≥3 ng/ml). Further cost-effectiveness analyses reflecting latest clinical practice and current perspectives regarding adverse outcomes of potentially unnecessary treatment are required, especially from the US government perspective.

Estimating preference-based EQ-5D health state utilities or item responses from neuropathic pain scores.

BACKGROUND: Preference-based health state utilities are required for many health economic evaluations. When the direct evidence of such is lacking and only condition-specific scores are available, establishing a 'mapping' relationship between instruments can be useful. OBJECTIVE: Our objective was to map the 11-point Pain Intensity Numerical Rating Scale (PI-NRS-11), a pain-specific instrument ranging from 0 ('no pain') to 10 ('pain as bad as you can imagine'), to the EQ-5D, a preference-based generic instrument. METHODS: We used web survey data collected from adult US respondents who (i) had ≥ 3 months of neuropathic pain (NP), either painful diabetic peripheral neuropathy (pDPN) or post-herpetic neuralgia (PHN); (ii) were receiving medications treating NP; and (iii) had completed the EQ-5D and PI-NRS-11. We explored indirect and direct mapping approaches. The indirect method took a probabilistic approach using ordered logistic models (OLMs) predicting response levels for each EQ-5D item via repeated Monte Carlo simulations before computing utilities. The direct approach simply predicted EQ-5D utilities directly using ordinary least squares (OLS). Categorical scores of PI-NRS-11 were used as the predictors. Patient age, gender, and pain duration were additionally controlled in the full model specification. Seventy percent of the data were used for estimation and 30% for prediction. Mean square errors (MSEs) and 95% confidence intervals (CIs) of prediction errors were reported. RESULTS: A total of 2719 respondents were included. Mean (SD) age was 55.48 (10.65) years and 56.23% were female. Average NP duration was 61 months and 58% gave scores ≥ 6 on the PI-NRS-11. The clinical pain scores were significantly associated with all EQ-5D items, especially with the 'pain/discomfort' item (p < 0.001). The observed mean (SD) EQ-5D index was 0.594 (0.22). Predicted utilities and responses showed good representation of the observed ones. The reduced model showed comparable results with the full model while imposing minimum data collection burden. From the reduced model, the predicted mean (SD) EQ-5D index was 0.594 (0.11) from direct estimation and 0.588 (0.19) from indirect estimation. All estimated utilities discriminated health gains/losses along the PI-NRS-11. Lower MSEs and prediction errors were found for EQ-5D >0.2. CONCLUSIONS: Findings suggest that EQ-5D utilities or item responses could be estimated on the basis of NP scores. Independent testing of the external validity of the mapping algorithms developed herein is encouraged.

Comparison of one and two-stage revision of total hip arthroplasty complicated by infection: a Markov expected-utility decision analysis.

BACKGROUND: Two-stage revisions of total hip arthroplasties complicated by chronic infection result in reinfection rates that are lower than those following single-stage revisions but may also result in increased surgical morbidity. Using a decision analysis, we compared single-stage and two-stage revisions to determine which treatment modality resulted in greater quality-adjusted life years (QALYs). METHODS: A review of the literature on the treatment of patients with an infection at the site of a total hip arthroplasty provided probabilities; utility values for common postoperative health states were determined in a previously published study. With these data, we conducted a Markov cohort simulation decision analysis. Sensitivity analysis validated the model, and comparisons were made in terms of QALYs. RESULTS: The twelve-month model favored direct-exchange revision over the two-stage approach, regardless of whether surgeon or patient-derived utilities were used (0.945 versus 0.896 and 0.897 versus 0.861 QALYs for the patient and surgeon models, respectively). Similar results were observed in a lifetime model with a ten-year life expectancy (7.853 versus 7.771, and 7.438 versus 7.362 QALYs, respectively). The findings were found to be robust in sensitivity analyses in which clinically relevant ranges of input variables were used. CONCLUSIONS: This analysis favored the direct-exchange arthroplasty over the two-stage approach. This study should be considered hypothesis-generating for future randomized controlled trials in which, ideally, health end points will be considered in addition to the eradication of infection.

Mapping of the Insomnia Severity Index and other sleep measures to EuroQol EQ-5D health state utilities.

BACKGROUND: This study sought to map the Insomnia Severity Index (ISI) and symptom variables onto the EQ-5D. METHODS: A cross-sectional survey was conducted among adult US residents with self-reported sleep problems. Respondents provided demographic, comorbidity, and sleep-related information and had completed the ISI and the EQ-5D profile. Respondents were classified into ISI categories indicating no, threshold, moderate, or severe insomnia. Generalized linear models (GLM) were used to map the ISI's 7 items (Model I), summary scores (Model II), clinical categories (Model III), and insomnia symptoms (Model IV), onto the EQ-5D. We used 50% of the sample for estimation and 50% for prediction. Prediction accuracy was assessed by mean squared errors (MSEs) and mean absolute errors (MAEs). RESULTS: Mean (standard deviation) sleep duration for respondents (N = 2,842) was 7.8 (1.9) hours, and mean ISI score was 14.1 (4.8). Mean predicted EQ-5D utility was 0.765 (0.08) from Models I-III, which overlapped with observed utilities 0.765 (0.18). Predicted utility using insomnia symptoms was higher (0.771(0.07)). Based on Model I, predicted utilities increased linearly with improving ISI (0.493 if ISI = 28 vs. 1.00 if ISI = 0, p < 0.01). From Model II, each unit decrease in ISI summary score was associated with a 0.022 (p < 0.001) increase in utility. Predicted utilities were 0.868, 0.809, 0.722, and 0.579, respectively, for the 4 clinical categories, suggesting that lower utility was related to greater insomnia severity. The symptom model (Model IV) indicated a concave sleep-duration function of the EQ-5D; thus, utilities diminished after an optimal amount of sleep. The MSEs/MAEs were substantially lower when predicting EQ-5D > 0.40, and results were comparable in all models. CONCLUSIONS: Findings suggest that mapping relationships between the EQ-5D and insomnia measures could be established. These relationships may be used to estimate insomnia-related treatment effects on health state utilities.

Comparison of methods for measuring dose escalation of the subcutaneous TNF antagonists for rheumatoid arthritis patients treated in routine clinical practice.

OBJECTIVES: Tumor necrosis factor (TNF) antagonists, most frequently prescribed biologics for moderate to severe rheumatoid arthritis (RA), are subject to dose escalation. Even though different methods have been employed to estimate the timing and magnitude of dose escalation, there is no consensus on which method is optimal. The purpose was to evaluate different methods for assessing dose escalation patterns for the subcutaneously delivered TNF antagonists, etanercept and adalimumab. METHODS: Five different methods to describe dose escalation patterns were compared using a large administrative claims database from US health plans. RA patients age 18 and above with >or=2 claims for etanercept or adalimumab were included. These methods included last dose versus index dose (the dose of a patient's first biologic prescription [adalimumab or etanercept]), average dose versus recommended dose, multiple (>or=2) instances of subsequent doses exceeding the index dose, subsequent doses exceeding a predetermined threshold above the index dose, and the time-trend method, comparing each subsequent dose throughout the course of therapy to the index dose. RESULTS: A total of 1369 etanercept and 461 adalimumab RA patients were evaluated for dose escalation. Estimates of dose escalation were highest for both drugs based on the average dose method (10.3% for etanercept, 33.6% for adalimumab). The time-trend method demonstrated the temporal trends in the percent of patients with dose escalation. Adalimumab patients had a higher rate of dose escalation than etanercept patients, regardless of method. The study is limited in that it could not assess the reason for or clinical outcomes associated with dose escalation. CONCLUSIONS: Different methods for evaluating dose escalation yield different numerical estimates but consistently give the same overall comparative result. The choice of method should depend on the specific research question. The average dose method may be the most useful for cost impact studies, whereas the time-trend method provides the most comprehensive information on dose patterns.

Association between insurance gaps and continued antihypertension medication usage in a US national representative population.

BACKGROUND: Medication persistence is important for adequate control of blood pressure. In this article, we assess the association between gaps in insurance coverage and continued antihypertensive medication using a US national representative sample. METHODS: We used three recent panels from the Medical Expenditure Panel Survey (MEPS). Our sample included hypertensive individuals 18-65 years of age. We identified four insurance categories: (i) continuous coverage by private insurance, (ii) continuous coverage by public insurance, (iii) single or multiple gaps in coverage, and (iv) continuously uninsured. Binary logit models were used to analyze the association between interruptions in medication and insurance after controlling for socioeconomic factors. Patients with continuous private insurance were used as the reference group. Results were weighted to adjust for oversampling and clustering in the survey. RESULTS: There was no statistically significant difference in the probability of medication persistence between individuals with continuous private insurance (the reference group) and individuals with continuous public insurance (adjusted odds ratio (AOR) 1.324, 95% confidence interval (CI) 0.774-2.266, P = 0.304). Compared to the reference group, individuals with insurance gaps had lower odds of continuing their medication (AOR 0.636, 95% CI 0.418-0.0.969, P = 0.035). Continuously uninsured individuals had even lower odds of medication persistence (AOR 0.462, 95% CI 0.282-0.757, P = 0.002). Age, marital status, body mass index (BMI) change, and years of education were also associated with continued medication usage. CONCLUSION: Studies focusing on current insurance status may underestimate the impact of health insurance gaps and the population at risk. Continuous insurance coverage is needed to increase continued antihypertensive medication usage.