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Background: With many drug-related deaths driven by potent synthetic opioids tainting the illicit drug supply, drug checking services are becoming a key harm reduction strategy. Many drug checking technologies are available, ranging from fentanyl test strips to mass spectrometry. This study aimed to identify key considerations when implementing drug checking technologies and services to support harm reduction initiatives. Methods: Key informant interviews were conducted with harm reduction stakeholders throughout Illinois. Participants included members of existing drug checking services and recovery centers. Interviews were recorded, transcribed, and coded by two researchers using the framework method. Findings were contextualized according to micro (client)-, meso (organization)-, and macro (policy)-level themes. Results: Seven interviews were conducted with ten participants. Fourier transform infrared spectroscopy was consistently identified as a technology of choice given its accuracy, range of substance detection, portability, and usability. Recommendations included the use of confirmatory testing, which can help address the limitations of technologies and provide a mechanism to train technicians. Locations of drug checking services should maximize public health outreach and leverage existing harm reduction agencies and staff with lived experience, who are critical to developing trust and rapport with clients. Criminalization and loss of privacy were major concerns for clients using drug checking services. Additional issues included the need to raise awareness of the legitimacy of services through public support from governing bodies, and funding to ensure the sustainability of drug checking services. Conclusions: This research facilitated the identification of issues and recommendations from stakeholders around key considerations for the adoption of drug checking technologies, which not only included the cost and technical specifications of instrumentation, but also broader issues such as accessibility, privacy, and well-trained personnel trusted by clients of the service. Successful implementation of drug checking services requires knowledge of local needs and capacity and an in-depth understanding of the target population. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Parkinson's disease is a progressive neurodegenerative disease, which significantly impacts patients' quality of life and is associated with high treatment and direct healthcare costs. In England, levodopa/carbidopa intestinal gel (LCIG) is indicated for the treatment of levodopa-responsive advanced Parkinson's disease with troublesome motor fluctuations when available combinations of medicinal products are unsatisfactory.Objective: We aimed to determine the cost effectiveness of LCIG compared to the standard of care for patients with advanced Parkinson's disease in England, using real-world data.Methods: A Markov model was adapted from previous published studies, using the perspective of the English National Health System and Personal and Social Services to evaluate the cost effectiveness of LCIG compared to standard of care in patients with advanced Parkinson's disease over a 20-year time horizon. The model comprised 25 health states, defined by a combination of the Hoehn and Yahr scale, and waking time spent in OFF-time. The base case considered an initial cohort of patients with an Hoehn and Yahr score of ≥ 3, and > 4 h OFF-time. Standard of care comprised standard oral therapies, and a proportion of patients were assumed to be treated with subcutaneous apomorphine infusion or injection in addition to oral therapies. Efficacy inputs were based on LCIG clinical trials where possible. Resource use and utility values were based on results of a large-scale observational study, and costs were derived from the latest published UK data, valued at 2017 prices. The EuroQol five-dimensions-3-level (EQ-5D-3L) instrument was used to measure utilities. Costs and quality-adjusted life-years were discounted at 3.5%. Both deterministic and probabilistic sensitivity analyses were conducted.Results: Total costs and quality-adjusted life-years gained for LCIG vs standard of care were £586,832 vs £554,022, and 2.82 vs 1.43, respectively. The incremental cost-effectiveness ratio for LCIG compared to standard of care was £23,649/quality-adjusted life-year. Results were sensitive to the healthcare resource utilisation based on real-world data, and long-term efficacy of LCIG.Conclusions: The base-case incremental cost-effectiveness ratio was estimated to be within the acceptable thresholds for cost effectiveness considered for England. [ABSTRACT FROM AUTHOR]

Background: Concurrent opioid and benzodiazepine (BZD) use is a prevalent high‐risk prescribing behavior that increases the risk of opioid overdose. However, there is limited evidence on the relationship between timing of concurrent use and risk of opioid overdose. Objective: To evaluate the likelihood of opioid‐related overdose across levels of duration, recency, and daily dose of concurrent use. Design: A nested case‐control study was conducted using Truven MarketScan claims data (2009–2018). Participants: Commercially insured adults (age 18–64 years old) with a new opioid dispensing in 2010–2018. Main Measures: Cases of opioid‐related overdose were identified based on hospitalization diagnosis codes. Controls were matched to cases in a 10:1 ratio by age, sex, opioid start date, and cancer history. Concurrent use was classified based on duration, timing, and daily dose of overlapping opioids and BZDs during 90 days before the event. Conditional logistic regression models were used to evaluate the relationship between concurrent use and opioid‐related overdose. Key Results: Among 11,137,866 dispensed a new opioid, a total of 3388 patients experienced opioid‐related overdose and were matched to 33,893 controls. Cases and controls were 34 years old on average and 54% female. Patients with concurrent use were significantly more likely to have opioid‐related overdose compared to patients receiving opioids, BZDs, or neither (OR 9.28; 95% CI 7.87, 10.93). Longer concurrent use of 1–7, 8–30, and 31–90 days was associated with 4.6, 12.1, and 26.7‐fold higher likelihood of opioid‐related overdose (p < 0.01). Patients with overlapping prescriptions during previous 0–30, 31–60, and 61–90 days were 13.2, 6.0, and 3.2‐times more likely to experience an overdose (p < 0.01). Conclusions: Patients with an opioid‐related overdose were more likely to be prescribed concurrent opioid and BZD across all levels of duration, timing, and daily dose. Future policies and quality measures should be pursued to prevent concurrent use unless medically necessary. [ABSTRACT FROM AUTHOR]

Objective: To derive a US-based value set for the EQ-5D-5L questionnaire using an international, standardized protocol developed by the EuroQol Group.Methods: Respondents from the US adult population were quota-sampled on the basis of age, sex, ethnicity, and race. Trained interviewers guided participants in completing composite time trade-off (cTTO) and discrete choice experiment (DCE) tasks using the EuroQol Valuation Technology software and routine quality control measures. Data were modeled using a Tobit model for cTTO data, a mixed logit model for DCE data, and a hybrid model that combined cTTO and DCE data. Model performance was compared on the basis of logical ordering of coefficients, statistical significance, parsimony, and theoretical considerations.Results: Of 1134 respondents, 1062, 1099, and 1102 respondents provided useable cTTO, DCE, and cTTO or DCE responses, respectively, on the basis of quality control criteria and interviewer judgment. Respondent demographic characteristics and health status were similar to the 2015 US Census. The Tobit model was selected as the preferred model to generate the value set. Values ranged from -0.573 (55 555) to 1 (11 111), with 20% of all predicted health states scores less than 0 (ie, worse than dead).Conclusions: A societal value set for the EQ-5D-5L was developed that can be used for economic evaluations and decision making in US health systems. The internationally established, standardized protocol used to develop this US-based value set was recommended by the EuroQol Group and can facilitate cross-country comparisons. [ABSTRACT FROM AUTHOR]

Background: Strategies to improve public health may benefit from targeting specific lifestyles associated with poor health behaviors and outcomes. The aim of this study was to characterize and examine the relationship between health and lifestyle-related attitudes (HLAs) and self-rated health and life-satisfaction.Methods: Secondary analyses were conducted on data from a 2012 community wellness survey in Kirklees, UK. Using a validated HLA tool, respondents (n = 9130) were categorized into five segments: health conscious realists (33%), balanced compensators (14%), live-for-todays (18%), hedonistic immortals (10%), and unconfident fatalists (25%). Multivariate regression was used to examine whether HLAs could explain self-rated health using the EQ-5D visual analog scale (EQ-VAS) and life-satisfaction. Health conscious realists served as the reference group.Results: Self-rated health differed by HLA, with adjusted mean EQ-VAS scores being significantly higher (better) among balanced compensators (1.15, 95% CI 0.27, 2.03) and lower scores among unconfident fatalists (- 9.02, 95% CI - 9.85, - 8.21) and live-for-todays (- 1.96, 95% CI - 2.80, - 1.14). Balanced compensators were less likely to report low life-satisfaction (OR 0.75, 95% CI 0.62, 0.90), while unconfident fatalists were most likely to have low life-satisfaction (OR 3.51, 95% CI 2.92, 4.23).Significance: Segmentation by HLA explained differences in self-rated health and life-satisfaction, with unconfident fatalists being a distinct segment with significantly worse health perceptions and life-satisfaction. Health promotion efforts may benefit from considering the HLA segment that predominates a patient group, especially unconfident fatalists. [ABSTRACT FROM AUTHOR]

Purpose The objective of this study was to compare the health-related quality of life (HRQL) burden across different types of advanced cancer with the use of 2 widely used patient-reported outcome measures, the generic EQ-5D and the cancer-specific Functional Assessment of Cancer Therapy-General (FACT-G). Methods Patients with advanced cancer of the bladder, brain, breast, colon/rectum, head/neck, hepatobiliary tract/pancreas, kidney, lung, lymphoma, ovary, or prostate completed the EQ-5D and FACT-G. HRQL domains and summary scores were compared across types of cancer, using regression models to adjust for age and sex. Findings Approximately 50 patients with each type of cancer were recruited (total, 534 patients). According to EQ-5D dimensions, the highest proportion of problems was associated with prostate (mobility); prostate and kidney (self-care); head/neck, bladder, and lung (usual activities); breast, head/neck, and lung (pain/discomfort); and lymphoma and lung (anxiety/depression) cancers. EQ-5D visual analogue scale scores were lowest for breast and head/neck cancers; US index-based scores were lowest for breast and lung cancers and highest for brain cancer. For the FACT-G, physical well-being scores were lowest for head/neck, hepatobiliary, and kidney cancers; emotional well-being scores were lowest for hepatobiliary cancer, and functional well-being scores were lowest for head/neck, hepatobiliary, and bladder cancers. Implications The overall and dimension-specific HRQL burden of advanced cancer depended on the type of cancer. Such results may aid clinicians and patients in better understanding of how cancer site can affect HRQL and functioning in different ways. [ABSTRACT FROM AUTHOR]

Background The Patient Reported Outcomes Measurement Information System 43-item short form (PROMIS-43) and the five-level EQ-5D (EQ-5D-5 L) are recently developed measures of health-related quality of life (HRQL) that have potentially broad application in evaluating treatments and capturing burden of respiratory-related diseases. The aims of this study were: (1) to examine their psychometric properties in patients with chronic obstructive pulmonary disease (COPD), and (2) to identify dimensions of HRQL that differ and do not differ by lung function. Methods We conducted a multi-center, cross-sectional study ("COPD Outcomes-based Network for Clinical Effectiveness & Research Translation" [CONCERT]). We analyzed patients who met spirometric criteria for COPD, and completed EQ-5D-5 L and PROMIS questionnaires. Disease severity was graded based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification. Pulmonary function test, PROMIS-43, EQ-5D (index score and EQ-Visual Analog Scale [EQ-VAS]), six minute walk test (6MWT), and three dyspnea scales (mMRC, Borg, FACIT-Dyspnea) were administered. Validity and reliability of EQ- 5D-5 L and PROMIS-43 were examined, and differences in HRQL by GOLD grade were assessed. Results Data from 670 patients with COPD were analyzed (mean age 68.5 years; 58% male). More severe COPD was associated with more problems with mobility, self-care and usual activities (all p-values <0.01) according to EQ-5D-5 L. Related domains on EQ-5D-5 L, PROMIS and clinical measures were moderately (r = 0.30-0.49) to strongly (r = 0.50) correlated. A statistically significant trend of decreasing HRQL with more severe lung functions was observed for EQ-5D-5 L index scores, EQ-VAS scores, and PROMIS physical function and social roles. Conclusions Results supported the validity of EQ-5D-5 L and PROMIS-43 in COPD patients, and indicate that physical function and social activities decrease with level of lung function by GOLD grade, but not pain, mental health, sleep or fatigue as reported by patients. [ABSTRACT FROM AUTHOR]

Objectives: The EuroQol Group recently released youth (Y) and 5-level (5L) versions of its 3-level EQ-5D instrument (3L) that measures health-related quality of life. In this study, we (1) compare 3L, Y, and 5L responses among US adults and (2) assess construct validity. Study Design and Setting: Using a nationally representative sample of US adults (N 5 2,619), we collected 3L, Y, and 5L responses in random order and estimated their associations and their relationship with a 0 to 100 numerical visual analog scale. Results: The prevalence of US adults in the best possible EQ-5D state (i.e., 11111) was lower for the Y (38%) and 5L (35%) than for the 3L (44%), capturing more health problems. However, the prevalence of extreme responses in pain/discomfort and anxiety/depression decreased substantially between the 3L and 5L (from 44% to 17% and from 29% to 13%, respectively). Conclusion: Compared with the 3L, the Y and 5L versions describe population health as having more, yet milder, health problems. Although the 5L may have advantages in patient populations in which extreme problems are more prevalent, population studies or studies that follow patients from childhood may consider using the Y. [ABSTRACT FROM AUTHOR]

Abstract: Objective: Although utility-based algorithms have been developed for the Functional Assessment of Cancer Therapy (FACT), their properties are not well known compared with those of generic utility measures such as the EQ-5D. Our objective was to compare EQ-5D and FACT preference-based scores in cancer patients. Methods: A retrospective analysis was conducted on cross-sectional data collected from 472 cancer patients who completed both FACT-General and the EQ-5D. Preference-based scores were calculated by using published scoring functions for the EQ-5D (Dolan P. Modeling valuations for EuroQol health states. Med Care 1997;35:1095–108; Shaw JW, Johnson JA, Coons SJ. US valuation of the EQ-5D health states: development and testing of the D1 valuation model. Med Care 2005;43:203–20) and FACT (Dobrez D, Cella D, Pickard AS, et al. Estimation of patient preference-based utility weights from the Functional Assessment of Cancer Therapy-General. Value Health 2007;10:266–72; Kind P, Macran S. Eliciting social preference weights for Functional Assessment of Cancer Therapy-Lung health states. Pharmacoeconomics 2005;23:1143–53; Cheung YB, Thumboo J, Gao F, et al. Mapping the English and Chinese versions of the Functional Assessment of Cancer Therapy-General to the EQ-5D utility index. Value Health 2009;12:371–6). Scores were compared on the basis of clinical severity by using Eastern Cooperative Oncology Group performance status ratings by physicians and patients. Relative efficiency of each scoring function was examined by using ratios of F statistics. Results: Mean scores for the overall cohort were lowest when using Kind and Macran''s FACT UK societal algorithm (0.55, SD 0.09) and highest when using Dobrez et al.''s FACT US patient algorithm (0.83, SD 0.08). Mean difference scores associated with clinical severity, when extrapolated to quality-adjusted life-years (QALYs), had a range of 0.18 QALYs gained using FACT (Kind and Macran) to 0.45 QALYs gained using the EQ-5D (Dolan). However, relative efficiencies suggested that FACT (Kind and Macran) scores may provide greater statistical power to detect significant differences based on clinical severity. Conclusions: We found important differences in utilities scores estimated by each algorithm, with FACT-based algorithms tending to underestimate the QALY benefit compared with algorithms based on the EQ-5D. These differences highlight some of the challenges in using disease-specific preference-based measures for decision making despite potentially more relevant disease-specific content. [Copyright &y& Elsevier]

Background: The aims of this study were: (1) to compare the discriminative ability of a disease-specific instrument, the St. George's Respiratory Questionnaire (SGRQ) to generic instruments (i.e., EQ-5D and SF-36); and (2), to evaluate the strength of associations among clinical and health-related quality of life (HRQL) measures in chronic obstructive pulmonary disease (COPD).Methods: We analyzed data collected from 120 COPD patients in a Veterans Affairs hospital. Patients self-completed two generic HRQL measures (EQ-5D and SF-36) and the disease-specific SGRQ. The ability of the summary scores of these HRQL measures to discriminate COPD disease severity based on Global Obstructive Lung Disease (GOLD) stage was assessed using relative efficiency ratios (REs). Strength of correlation was used to further evaluate associations between clinical and HRQL measures.Results: Mean total scores for PCS-36, EQ-VAS and SGRQ were significantly lower for the more severe stages of COPD (p < 0.05). Using SGRQ total score as reference, the summary scores of the generic measures (PCS-36, MCS-36, EQ index, and EQ-VAS) all had REs of <1. SGRQ exhibited a stronger correlation with clinical measures than the generic summary scores. For instance, SGRQ was moderately correlated with FEV1 (r = 0.43), while generic summary scores had trivial levels of correlation with FEV1 (r < 0.2).Conclusions: The SGRQ demonstrated greater ability to discriminate among different levels of severity stages of COPD than generic measures of health, suggestive that SGRQ may provide COPD studies with greater statistical power than EQ-5D and SF-36 summary scores to capture meaningful differences in clinical severity. [ABSTRACT FROM AUTHOR]

Objective: The D1 model that was developed to predict US societal preferences for EQ-5D health states addressed several important conceptual and statistical issues. However, it has been criticized for being too complex, failing to account for the nonnormal distribution of health state values, and the transformation of preferences for worse-than-death health states before estimation. This research was conducted to develop an improved model for predicting median preferences for EQ-5D health states for the US population. Methods: Probability-weighted least absolute deviations regression was used to fit models to the time trade-off data collected in the US Valuation of the EQ-5D Health States study. No transformation was applied to the values for states considered worse than death. Several model specifications that differed with respect to explanatory variables were evaluated using two-sample cross-validation. Results: The best-fitting model included only fixed effects for moderate or severe problems in each of the 5 EQ-5D dimensions and excluded a constant. This specification yielded rank correlations between observed and predicted values and median observed and predicted values of 0.635 and 0.991, respectively, as well as a median absolute error of 0.026. The predicted median preferences ranged from 1.00 for full health, to –0.81 for the worst possible health state. Conclusions: Due to its simplicity and robustness, a median model is superior to other models for predicting US population preferences for EQ-5D health states. The predictions of this model are suggested for use in applications that require US societal health state values. [ABSTRACT FROM AUTHOR]

Background: The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) is a widely used quality-of-life measure in oncology. The ability to translate QLQ-C30 responses into utility scores would further expand its use in medical decision-making. The aims of this study were to: 1) map QLQ-C30 responses onto patient time trade-off utility scores; and 2) compare a multiattribute approach to a global evaluation approach to modeling utility scores. Methods: Two distinct approaches were applied to data from 1432 cancer patients. The multiattribute approach used psychometric analysis and expert input to select a subset of functioning and symptom scale items for modeling. The second approach focused on global health and quality-of-life items based on a conceptual model. Model selection criteria included parsimony, statistical significance and logical consistency of parameter estimates, predictive accuracy, number of states described, and scale range. Results: The optimal multiattribute model included nine variables for five items from different scales, described 144 unique states, predicted values ranging from 0.63 to 1.00, but it had poor predictive accuracy (cross-validation pseudo- R2 = 0.056). The best-fitting global approach-based model described 24 unique states using eight indicators for two items from one scale (plus a constant) and predicted values ranging from 0.17 to 1.00 (cross-validation pseudo- R2 = 0.127). Conclusions: Multiattribute models produced a greater number of unique predicted values, while global models exhibited more desirable statistical properties and a wider range of values. The recommended models will enable users to predict cancer patients’ utilities from existing and future QLQ-C30 data sets. [ABSTRACT FROM AUTHOR]

Purpose. An overview of the emerging field of comparative effectiveness research (CER) and its relevance to pharmacists and pharmacy-based decision-makers is provided. Summary. The U.S. government is investing over $1 billion on CER over the next two years. This investment is in part driven by the recognition that, despite having the highest per capita health care expenditures in the world, the United States does not always perform well on measures of health compared with other countries. There also is increased awareness of the limited information provided by results of traditional randomized clinical trials to inform decisions about therapeutic alternatives as applied in actual practice. Comparative effectiveness studies have two important principal components: (1) the comparison of two or more agents or interventions that are considered true therapeutic alternatives and (2) the examination of effects (outcomes) in actual practice. Comparative effectiveness studies differ from traditional efficacy studies in several ways, including the research question addressed, comparison groups, patient population, setting, outcomes measured, and validity. Studies that are within the scope of CER can be categorized as primary comparative effectiveness studies or secondary comparative effectiveness studies. CER also can be used to compare medical devices, procedures, health services, or any competing intervention. Conclusion. Comparative effectiveness is an emerging area of research relevant to many areas of health care, especially pharmacotherapy. The knowledge gained from CER is important to pharmacists when applying drug information and making decisions related to drug therapy. [ABSTRACT FROM AUTHOR]

The aims of this study were to characterize causes of death among veterans with COPD using multiple cause of death coding, and to examine whether causes of death differed according to timing of COPD diagnosis. Veterans with COPD who died during a five-year follow-up period were identified from national VA databases linked to National Death Index files. Primary, secondary, underlying, and all-coded causes of death were compared between recent and preexistent COPD cohorts using proportional mortality ratios (PMRs), which compares proportion dying from specific causes as opposed to absolute risk of death. Of 26,357 decedents, 7,729 were categorized preexistent and 18,628 were recent COPD cases. Unspecified COPD was listed as underlying cause of death in a significantly greater proportion of preexistent COPD cases compared to recent cases, 20% vs 10%, PMR = 2.0 (95% CI: 1.9-2.1). A relatively higher proportion of recently diagnosed cases died from lung/bronchus, prostate, and site-unspecified cancers. Respiratory failure (J969) was rarely coded as an underlying or primary cause (< 1%), but was a second-code cause of death in 9% of recent and 12% of preexistent cases. Differences in coded causes of death between patients with a recent diagnosis of COPD compared to a preexistent diagnosis of COPD suggests that there is either coded cause-related bias or true differences in cause of death related to length of time with diagnosis. Thus, methods used to identify cohorts of COPD patients, i.e., incidence versus prevalence-based approaches, and coded cause of death can affect estimates of cause-specific mortality. [ABSTRACT FROM AUTHOR]

Background: Concerns exist regarding increased risk for mortality associated with some chronic obstructive pulmonary disease (COPD) medications. Objective: To examine the association between various respiratory medications and risk for death in veterans with newly diagnosed COPD. Design: Nested case-control study in a cohort identified between 1 October 1999 and 30 September 2003 and followed through 30 September 2004 by using National Veterans Affairs inpatient, outpatient, pharmacy, and mortality databases; Centers for Medicare & Medicaid Services databases; and National Death Index Plus data. Cause of death was ascertained for a random sample of 40% of those who died during follow-up. Case patients were categorized on the basis of all-cause, respiratory, or cardiovascular death. Mortality risk associated with medications was assessed by using conditional logistic regression adjusted for comorbid conditions, health care use, and markers of COPD severity. Setting: U.S. Veterans Health Administration health care system. Participants: 32 130 case patients and 320 501 control participants in the all-cause mortality analysis. Of 11 897 patients with cause-of-death data, 2405 case patients had respiratory deaths and 3159 case patients had cardiovascular deaths. Measurements: All-cause mortality; respiratory and cardiovascular deaths; and exposure to COPD medications, inhaled corticosteroids, ipratropium, long-acting β-agonists, and theophylline in the 6 months preceding death. Results: Adjusted odds ratios (ORs) for all-cause mortality were 0.80 (95% CI, 0.78 to 0.83) for inhaled corticosteroids, 1.11 (CI, 1.08 to 1.15) for ipratropium, 0.92 (CI, 0.88 to 0.96) for long-acting β-agonists, and 1.05 (CI, 0.99 to 1.10) for theophylline. Ipratropium was associated with increased cardiovascular deaths (OR, 1.34 [CI, 1.22 to 1.47]), whereas inhaled corticosteroids were associated with reduced risk for cardiovascular death (OR, 0.80 [CI, 0.72 to 0.88]). Results were consistent across sensitivity analyses. Limitations: Current smoking status and lung function were not measured. Misclassification of cause-specific mortality is unknown. Conclusion: The possible association between ipratropium and elevated risk for all-cause and cardiovascular death needs further study. [ABSTRACT FROM AUTHOR]

Objective. To determine if clopidogrel use before coronary artery bypass grafting (CABG) is associated with an increase in major bleeding, hemorrhage-related complications, or transfusion requirements. Methods. A structured literature search of English-language articles was conducted by using MEDLINE, EMBASE, and the Cochrane Collaboration Database for the period of January 1, 1990-April 30, 2007. Studies were included if they met the following criteria: randomized controlled trials, prospective observational trials, or retrospective trials; characteristics and outcomes of patients who were exposed to clopidogrel within 7 days before CABG were analyzed; at least 20 patients were enrolled; and reported outcomes were related to transfusion requirements, resource utilization, clinical events, or hemorrhage-related reoperation rates. Patients were considered exposed to clopidogrel if they discontinued the drug within a specified time frame that was designated in each study. The rates of the outcomes were compared between those patients exposed and those not exposed to clopidogrel. Results. Twenty-three studies, with data on 3505 patients exposed to clopidogrel before CABG, met the selection criteria. Results suggested that clopidogrel exposure within 7 days before CABG increased the risk of major bleeding and related complications, such as reoperation and blood product transfusions. For other outcomes such as mortality, myocardial infarction, or stroke, the studies' designs lacked statistical power to detect significant differences. In five of the 23 studies, antifibrinolytic therapy with aprotinin was evaluated; in the other studies, aprotinin may have been administered, but it was not discussed in detail. In these studies, the clopidogrel-exposed patients typically had significantly higher chest tube output volumes, reoperation rates due to bleeding, and greater transfusion requirements. Although aprotinin appeared to mitigate hemorrhagic risk, the drug has been temporarily suspended from the market due to safety concerns. Conclusion. Clopidogrel exposure within 7 days before CABG is associated with an increase in major bleeding, hemorrhage-related complications, and transfusion requirements, and leads to potentially greater consumption of health care resources. The overall risks and benefits for each patient should be considered before using the drug. [ABSTRACT FROM AUTHOR]

Abstract: Objectives: Informal caregivers often serve as proxy raters of Health-Related Quality of Life (HRQL) when patients cannot report on their own behalf. Caregiver depression has been associated with bias in proxy ratings, but few studies have examined the role of caregiver pain. The aim of this study was to determine if caregiver depressive symptoms and/or pain systematically affected patient–proxy agreement on patient HRQL after stroke. Study Design and Settings: Secondary data analysis of 95 stroke patients and their caregivers (dyads) at 6 months poststroke. Caregiver depressive symptoms were measured by Center for Epidemiologic Studies Depression Rating Scale, and pain was measured using EQ-5D. Using multivariate regression, we examined the effect of caregiver depressive symptoms and pain on patient–proxy difference scores on Health Utilities Index 3 (HUI3) attributes and Short Form-36 domains of vitality and social functioning. Results: Caregiver depressive symptoms and pain were associated with significant differences in patient–proxy scores on HUI3 pain (P <0.05). Depressed caregivers underestimated pain experienced by patients, and caregivers with pain overestimated patient pain. Additionally, an interaction between caregiver depressive symptoms and pain was identified. Conclusion: Presence of pain and depressive symptoms in caregivers can significantly affect perceptions of pain in stroke patients. Results suggest that caregivers with pain and/or depression may provide more biased proxy assessments of pain. [Copyright &y& Elsevier]

Study Objective. To systematically review the efficacy of azelastine nasal spray for the treatment of allergic rhinitis. Design. Meta-analysis of published randomized controlled trials reported in English. Data Source. Published literature from the PubMed-MEDLINE database. Patients. Patients aged at least 12 (United States) or 16 years (Europe) with allergic rhinitis or nonallergic vasomotor rhinitis. Measurements and Main Results. A global assessment of efficacy was used to estimate the number needed to treat for azelastine nasal spray compared with placebo or active comparators. The total symptom score was used to compare the effect size between azelastine and placebo. In five comparisons of azelastine and placebo, azelastine was most efficacious, with a summary number needed to treat of 5.0 (95% confidence interval [CI] 3.3-10.0). In reviewing 11 studies of azelastine versus active comparators, we found no significant difference between azelastine and active comparators (number needed to treat 66.7, 95% CI 14.3 to ∞ to 25]). Azelastine was more efficacious than placebo in terms of total symptom score (effect size of 0.36, 95% CI 0.26-0.46). Conclusion. Azelastine nasal spray was more efficacious than placebo in the treatment of allergic rhinitis. No significant differences were observed between azelastine and active comparators for the treatment of allergic rhinitis; however, when azelastine was compared with oral antihistamines as monotherapy, the trend favored azelastine. Because azelastine appears to be as efficacious as oral antihistamines, the choice of treatment for seasonal allergic rhinitis should depend on the patient's preference regarding the route of administration, adverse effects, and the cost of the drug. [ABSTRACT FROM AUTHOR]

Purpose: Diseases are often described and studied in isolation, yet there is increasing recognition of the complex interrelatedness of diseases and treatments in patients with multiple chronic diseases. Our objective was to describe the impact of selected diseases involving chronic inflammation (chronic obstructive pulmonary disease [COPD], osteoarthritis, and rheumatoid arthritis) on mortality. Methods: We identified a cohort aged 55 to 64 years with one or more chronic conditions. Clusters of mutually exclusive disease combinations were created. Five-year all-cause mortality was determined and the relative risk (RR) of mortality was estimated when COPD, osteoarthritis, and rheumatoid arthritis were added to clusters. Results: In 741,847 persons the 5-year mortality rates were lowest among persons with one condition and increased with more chronic conditions. The presence of osteoarthritis in a cluster was an exception where the risk was lower compared with that cluster without osteoarthritis: COPD (RR = 0.73 [95% confidence interval (CI), 0.65, 0.81]); ischemic heart disease (0.63 [0.52, 0.76]); hypertension (0.77 [0.71, 0.83]); dementia (0.63 [0.42, 0.93]); depression (0.65 [0.50, 0.84]); hypertension plus diabetes (0.85 [0.77, 0.93]); and ischemic heart disease plus hypertension (0.83 [0.73, 0.94]). Conclusions: The association between osteoarthritis and lower rates of mortality is notable and replicating these findings to explore causal relationships is important. [Copyright &y& Elsevier]

Cancer is one of the most frequent disease-specific applications of the EQ-5D. The objective of this review was to summarise evidence to support the validity and reliability of the EQ-5D in cancer, and to provide a catalogue of utility scores based on the use of the EQ-5D in clinical trials and in studies of patients with cancer. A structured literature search was conducted in EMBASE and MEDLINE to identify papers using key words related to cancer and the EQ-5D. Original research studies of patients with cancer that reported EQ-5D psychometric properties, responses and/or summary scores were included. Of 57 identified articles, 34 were selected for inclusion, where 12 studies reported evidence of validity or reliability and 31 reported EQ-5D responses or summary scores. The majority of investigations using the EQ-5D concerned patients with prostate cancer (n = 4), breast cancer (n = 4), cancers of the digestive system (n = 7) and Hodgkin and/or non-Hodgkin lymphoma (n = 3). Mean index based scores ranged from 0.33 (SD 0.4) to 0.93 (SD 0.12) and visual analogue scale scores ranged from 43 (SD 13.3) to 84 (SD 12.0) across subtypes of cancer. A substantial and growing body of literature using the EQ-5D in cancer that supports the validity and reliability of EQ-5D in cancer has emerged. This review provides utility estimates for cancer patients across a wide range of cancer subtypes, treatment regimens and tumour stage(s) that may inform the modelling of outcomes in economic evaluations of cancer treatment. [ABSTRACT FROM AUTHOR]

Background: Understanding what constitutes an important difference on a HRQL measure is critical to its interpretation. The aim of this study was to provide a range of estimates of minimally important differences (MIDs) in EQ-5D scores in cancer and to determine if estimates are comparable in lung cancer. Methods: A retrospective analysis was conducted on cross-sectional data collected from 534 cancer patients, 50 of whom were lung cancer patients. A range of minimally important differences (MIDs) in EQ-5D index-based utility (UK and US) scores and VAS scores were estimated using both anchor-based and distribution-based (1/2 standard deviation and standard error of the measure) approaches. Groups were anchored using Eastern Cooperative Oncology Group performance status (PS) ratings and FACT-G total score-based quintiles. Results: For UK-utility scores, MID estimates based on PS ranged from 0.10 to 0.12 both for all cancers and for lung cancer subgroup. Using FACT-G quintiles, MIDs were 0.09 to 0.10 for all cancers, and 0.07 to 0.08 for lung cancer. For US-utility scores, MIDs ranged from 0.07 to 0.09 grouped by PS for all cancers and for lung cancer; when based on FACT-G quintiles, MIDs were 0.06 to 0.07 in all cancers and 0.05 to 0.06 in lung cancer. MIDs for VAS scores were similar for lung and all cancers, ranging from 8 to 12 (PS) and 7 to 10 (FACT-G quintiles). Discussion: Important differences in EQ-5D utility and VAS scores were similar for all cancers and lung cancer, with the lower end of the range of estimates closer to the MID, i.e. 0.08 for UK-index scores, 0.06 for US-index scores, and 0.07 for VAS scores. [ABSTRACT FROM AUTHOR]

Objectives: Clinical trials and community-based studies often include the Center for Epidemiologic Studies-Depression scale (CES-D) as a measure of depression outcome. We compared responses to symptom-related items on the CES-D by depressed stroke and primary-care patients for several purposes: 1) to illustrate the use of Item Response Theory (IRT)-based (Rasch) models for comparing scale functioning across different patient subgroups; and 2) to inform clinicians and outcome researchers about scale functioning and depressive symptomatology in stroke- compared with primary care-based depression. Methods: Two data sources were analyzed, including 32 depressed patients who were 3 months poststroke, and 366 depressed primary-care patients. Presence of depression was based on a CES-D score 16 or higher. Rasch models were used to assess item fit and compare item hierarchies between depressed primary-care and stroke patients. Results: Item hierarchies were similar for poststroke depression and primary care-based depression. Interpersonal disruption items were the most difficult to endorse for both groups. No items misfit the scale in primary-care depression. Items relating to restless sleep, unfriendliness, and crying slightly misfit the scale in stroke patients, that is, may measure a different trait. Differential item functioning (DIF) between the groups was identified for items relating to appetite, restless sleep, crying, and feeling disliked. Conclusions: Results generally supported the use of the CES-D as measure of depression outcome, particularly in primary care-based depression. DIF may imply that slightly different clusters of depressive symptoms are reported by depressed stroke patients compared with primary care, but this is conjectural given the small stroke sample size and the same items have been previously associated with bias in studies of large nonstroke samples. This study found Rasch models to be useful tools to investigate scale performance for different clinical applications. [ABSTRACT FROM AUTHOR]

In this paper, we examine how the management of prostate cancer lends itself to a disease state management (DSM)–based approach, and propose a framework that emphasizes the patient–provider–caregiver triad in managing the long-term implications of the condition. There is often no clearly superior approach to the management of patients with prostate cancer (eg, watchful waiting and hormonal therapy), and each option entails different trade-offs in quality of life. Ideally, the physician and patient discuss the options, issues, and patient preferences for treatment through the shared decision-making process. A family caregiver such as the spouse of the patient is often involved in the treatment decision and in the long-term management of the cancer experience. In order to develop a DSM program supporting both patient and caregiver, educational, psychosocial, and health care system support needs should be tailored to each phase of cancer treatment/management. To embrace the unique aspects of prostate cancer management, the proposed framework emphasizes communication among the patient–caregiver–provider triad, inclusion of family caregivers in the program, cancer phase–specific support, and psychosocial services as a basis for implementation and evaluation of a DSM program in prostate cancer. (Disease Management 2005;8:235–244) [ABSTRACT FROM AUTHOR]

Objective: To compare five preference-based generic measures of health-related quality of life (HRQOL) in terms of change scores, correlations among change scores, responsiveness, and quality adjusted life-years (QALYs) gained.Design: Observational longitudinal cohort study where clinical measures and self-assessed HRQOL measures were administered to stroke patients at baseline and at 6 months. Patients were categorized as 'stable', 'some improvement' and 'large improvement' using the Barthel Index, Modified Rankin Scale (MRS), and Center for Epidemiologic Studies Depression Scale (CES-D). For each group, paired t-tests and variants of effect size were used to compare the responsiveness of preference-based HRQOL summary scores, including the EQ-5D VAS and index-based score, SF-6D, and Health Utilities Index (HUI) Mark 2 (HUI2) and Mark 3 (HUI3) overall utility scores.Results: Ninety-eight of 124 (79%) patients completed the 6-month follow-up. Change scores of the EQ-Index, HUI2, and HUI3 were strongly correlated with changes in the Barthel Index and MRS, while the EQ-5D VAS had higher correlation with CES-D change scores than the other measures. The SF-6D, HUI3, and EQ-Index were generally more responsive than the HUI2 and EQ-5D Visual analogue scale (EQ-VAS). QALY estimates based on the EQ-5D index and HUI3 were twice as large as estimates based on the SF-6D and HUI2.Conclusions: The results of this study may assist in informing the selection of a preference-based generic HRQOL measure, although choice will also depend on study goals and context. We would caution against the generalization of the study results on responsiveness to conditions when more subtle change is expected. [ABSTRACT FROM AUTHOR]

Background: Cost utility analysis (CUA) using SF-36/SF-12 data has been facilitated by the development of several preference-based algorithms. The purpose of this study was to illustrate how decision-making could be affected by the choice of preference-based algorithms for the SF-36 and SF-12, and provide some guidance on selecting an appropriate algorithm. Methods: Two sets of data were used: (1) a clinical trial of adult asthma patients; and (2) a longitudinal study of post-stroke patients. Incremental costs were assumed to be $2000 per year over standard treatment, and QALY gains realized over a 1-year period. Ten published algorithms were identified, denoted by first author: Brazier (SF-36), Brazier (SF-12), Shmueli, Fryback, Lundberg, Nichol, Franks (3 algorithms), and Lawrence. Incremental cost-utility ratios (ICURs) for each algorithm, stated in dollars per quality-adjusted life year ($/QALY), were ranked and compared between datasets. Results: In the asthma patients, estimated ICURs ranged from Lawrence's SF-12 algorithm at $30,769/QALY (95% CI: 26,316 to 36,697) to Brazier's SF-36 algorithm at $63,492/QALY (95% CI: 48,780 to 83,333). ICURs for the stroke cohort varied slightly more dramatically. The MEPS-based algorithm by Franks et al. provided the lowest ICUR at $27,972/QALY (95% CI: 20,942 to 41,667). The Fryback and Shmueli algorithms provided ICURs that were greater than $50,000/QALY and did not have confidence intervals that overlapped with most of the other algorithms. The ICURbased ranking of algorithms was strongly correlated between the asthma and stroke datasets (r = 0.60). Conclusion: SF-36/SF-12 preference-based algorithms produced a wide range of ICURs that could potentially lead to different reimbursement decisions. Brazier's SF-36 and SF-12 algorithms have a strong methodological and theoretical basis and tended to generate relatively higher ICUR estimates, considerations that support a preference for these algorithms over the alternatives. The "second-generation" algorithms developed from scores mapped from other indirect preferencebased measures tended to generate lower ICURs that would promote greater adoption of new technology. There remains a need for an SF-36/SF-12 preference-based algorithm based on the US general population that has strong theoretical and methodological foundations. [ABSTRACT FROM AUTHOR]

Objectives. To characterize the services and activities performed by anticoagulation clinics (ACCs) across the United States, examine the anticipated impact that oral direct thrombin inhibitors (DTIs) will have on the clinical services of ACCs, and elicit possible management strategies to realign services provided by ACCs and opportunities for restructuring clinical services. Methods. A survey was developed in consultation with content experts in the field, pretested by several ACC providers, and subsequently refined. Surveys were mailed to 400 randomly selected ACC-based providers. Results. The final usable response rate was 34.5% (115 of 333 surveys). Respondents anticipated that the number of patient visits/month would decrease from a median of 336 (interquartile range [IQR] 151-775) to 150 (IQR 71-350, p<0.001) after the introduction of oral DTIs. In addition, time spent on many direct and indirect patient care activities currently performed by ACCs was expected to decline. Respondents indicated that ACCs may find new roles by providing guidance on individual suitability for therapy, managing the transition to oral DTIs, providing education for patients and health care providers on thrombotic disease state management, monitoring patients for recurrent thrombosis and risk of bleeding complications, monitoring patient compliance, and providing counseling and safety surveillance for patients receiving treatment with oral DTIs. Conclusion. The advent of oral DTIs is likely to have a significant impact on the structure and delivery of antithrombotic services. Clinics that are proactive and redesign their patient care services to consider emerging anticoagulant agents will be more likely to remain relevant and viable. [ABSTRACT FROM AUTHOR]

Alzheimer's disease is an irreversible neurodegenerative disease, which accounts for most dementia cases. Neuroinflammation is increasingly recognised for its roles in Alzheimer's disease pathogenesis which, in part, links amyloid-beta to neuronal death. Neuroinflammatory signalling can be exhibited by neurons themselves, potentially leading to widespread neuronal cell death, although neuroinflammation is commonly associated with glial cells. The presence of the inflammasomes such as nucleotide-binding leucine-rich repeat receptors protein 1 in neurons accelerates amyloid-beta -induced neuroinflammation and has been shown to trigger neuronal pyroptosis in murine Alzheimer's disease models. However, the pathways involved in amyloid-beta activation of inflammasomes have yet to be elucidated. In this study, a gene trap mutagenesis approach was utilised to resolve the genes functionally involved in inflammasome signalling within neurons, and the mechanism behind amyloid-beta-induced neuronal death. The results indicate that amyloid-beta significantly accelerated neuroinflammatory cell death in the presence of a primed inflammasome (the NLR family pyrin domain-containing 1). The mutagenesis screen discovered the atypical mitochondrial Ras homolog family member T1 as a significant contributor to amyloid-beta-induced inflammasome -mediated neuronal death. The mutagenesis screen also identified two genes involved in transforming growth factor beta signalling, namely Transforming Growth Factor Beta Receptor 1 and SNW domain containing 1. Additionally, a gene associated with cytoskeletal reorganisation, SLIT-ROBO Rho GTPase Activating Protein 3 was found to be neuroprotective. In conclusion, these genes could play important roles in inflammasome signalling in neurons, which makes them promising therapeutic targets for future drug development against neuroinflammation in Alzheimer's disease. [ABSTRACT FROM AUTHOR]

Rationale: The shift toward virtual academic detailing (AD) was accelerated by the COVID‐19 pandemic. Aims and Objectives: We aimed to examine the role of external, contextual, and intrinsic programme‐specific factors in virtual engagement of healthcare providers (HCPs) and delivery of AD. Methods: AD groups throughout North America were contacted to participate in semistructured interviews. An interview guide was constructed by adapting the Consolidated Framework for Implementation Research (CFIR). A point of emphasis included strategies AD groups employed for provider engagement while implementing virtual AD programmes. Independent coders conducted qualitative analysis using the framework method. Results: Fifteen AD groups from Canada (n = 3) and the United States (n = 12) participated. Technological issues and training detailers and HCPs were challenges during the transition to virtual AD visits. Restrictions on in‐person activities during the pandemic created difficulties engaging HCPs and fewer AD visits. Continuing education was one strategy to incentivize participation, but credits were often not claimed by HCPs. Groups with established networks and prior experience with virtual AD leveraged connections to mitigate disruptions and continue AD visits. Other facilitators included emphasizing contemporary topics, including opioid education beyond fundamental guidelines. Virtual AD had the additional benefit of expanding geographic reach and flexible scheduling with providers. Conclusions: AD groups across North America have shifted to virtual outreach and delivery strategies. This trend toward virtual AD may aid outreach to vulnerable rural communities, improving health equity. More research is needed on the effectiveness of virtual AD and its future implications. [ABSTRACT FROM AUTHOR]

Purpose: Caregiver burden (CB) is typically self-assessed by caregivers. However, an emerging concept is assessment of CB by the recipients of care, i.e., the patient. The specific objectives are (1) to assess the level of agreement between care recipients' and caregivers' view on CB, across financial, physical, emotional, and social domains; (2) to explore two care recipient perspectives: their self-perceived burden (CR-SPB), and their interpretation of the caregiver's view (Proxy-CB). Methods: Data were collected from 504 caregiver-care recipient dyads in the U.S. using an online Qualtrics panel. The survey assessed caregiver burden using CarerQol and newly developed items. The level of agreement between responses was quantified using weighted kappa (κ) coefficients for individual items and intraclass correlation coefficients (ICC) for index/summary scores. Results: The average age of caregivers was 49.2 years, and 62.7 years for care recipients. Dyads most commonly consisted of spouses/partners (34.5%); 68.3% lived together. Proxy-CB aligned more closely with caregiver's view, with moderate to substantial agreement across CB domains (from κ = 0.48 for emotional to κ = 0.66 for financial). In the same perspective, the CarerQol-7D Index showed moderate agreement (ICC = 0.58) and the summary score of CB items substantial agreement (ICC = 0.76). Care recipients generally overestimated CB in the Proxy-CB perspective, while they underestimated it in the CR-SPB perspective. Conclusion: Results demonstrate there is a difference between perspectives. Strong agreement in Proxy-CB perspective suggests that care recipients can potentially substitute for caregivers depending on the domain. CR-SPB agrees less with caregivers and may provide complementary information. [ABSTRACT FROM AUTHOR]

Background: Only one pilot value set (UK) is currently available for the EQ Health and Wellbeing Instrument short version (EQ-HWB-S). As an alternative to preference-weighted scoring, we examined whether a level summary score (LSS) is appropriate for the EQ-HWB-S using Mokken scaling analyses. Methods: Data from patients, carers and the general population collected during the developmental phase of the EQ-HWB-S in Australia, US and UK were used, noting 3 of 9 items have since undergone revision. EQ-HWB-S data fit was examined using R package Mokken scaling's monotone homogeneity model, utilizing the automated item selection procedure (AISP) as well as Loevinger's scaling coefficients for items and the scale (HS). Manifest monotonicity was assessed by examining whether the cumulative probability for responses at or above each response level did not decrease across the summary score. Results: EQ-HWB-S data were available for 3340 respondents: US = 903, Australia = 514 and UK = 1923. Mean age was 50 ± 18 and 1841 (55%) were female. AISP placed all 9 items of the EQ-HWB-S on a single scale when the lower bound was set to < 0.448. Strong scalability (HS = 0.561) was found for the EQ-HWB-S as a single scale. Stronger scales were formed by separating the psychosocial items (n = 6, HS = 0.683) and physical sensation items (n = 3, HS = 0.713). No violations of monotonicity were found except for the items mobility and daily activities for the subgroups with long-term conditions and UK subjects, respectively. Discussion: As EQ-HWB-S items formed a strong scale and subscales based on Mokken analysis, LSS is a promising weighting-free approach to scoring. [ABSTRACT FROM AUTHOR]

Objectives: The EQ Health and Wellbeing Short (EQ-HWB-S) is a new broad generic measure of health and wellbeing for use in economic evaluations of interventions across healthcare, social care, and public health. This measure conceptually overlaps with the 5-level version EQ-5D (EQ-5D-5L), while expanding on the coverage of health and social care related dimensions. This study aims to examine the extent to which the EQ-HWB-S and EQ-5D-5L overlap and are different.Methods: A sample of US-based respondents (n = 903; n = 400 cancer survivors and n = 503 general population) completed a survey administered via an online panel. The survey included the EQ-HWB item pool (62 items, including 11 items used in this analysis), EQ-5D-5L, and questions about sociodemographic and health characteristics. The analysis included (Spearman's) correlations, the comparison of patterns of response (distributions and ceiling effects), and the ability to discriminate between known groups.Results: Moderate to strong associations were found between conceptually overlapping dimensions of the EQ-5D-5L and the EQ-HWB-S (rs > 0.5, P < .001). Among respondents reporting full health on the EQ-5D-5L (n = 161, 18.23%), the EQ-HWB-S identified ceiling effects, particularly with the item "feeling exhausted." Most EQ-5D-5L and EQ-HWB-S items demonstrated discriminative ability among those with and without physical and mental conditions, yielding medium (> 0.5) to large effect sizes (> 0.8). Nevertheless, only EQ-HWB-S items distinguished between caregivers and noncaregivers and those with low and high caregiver burden, albeit with small effect sizes (0.2-0.5).Conclusions: Results indicate a convergence between the measures, especially between overlapping dimensions, lending support to the validity of the EQ-HWB-S. The EQ-HWB-S performed similarly or better than the EQ-5D-5L among patient groups and is better able to differentiate among caregivers and respondents closer to full health. [ABSTRACT FROM AUTHOR]

Background: The EQ-5D-5L is a well-established health questionnaire that estimates health utilities by applying preference-based weights. Limited work has been done to examine alternative scoring approaches when utility weights are unavailable or inapplicable. We examined whether the Mokken scaling approach can elucidate 1) if the level summary score is appropriate for the EQ-5D-5L and 2) an interpretation of such a score.Methods: The R package "mokken" was used to assess monotonicity (scaling coefficients H, automated item selection procedure) and manifest invariant item ordering (MIIO: paired item response functions [IRF], HT). We used a rich dataset (the Multiple Instrument Comparison, MIC) which includes EQ-5D-5L data from six Western countries.Results: While all EQ-5D-5L items demonstrated monotonicity, the anxiety/depression (AD) item had weak scalability (Hi = 0.377). Without AD, scalability improved from Hs = 0.559 to Hs = 0.714. MIIO revealed that the 5 items can be ordered, and the ordering is moderately accurate in the MIC data (HT = 0.463). Excluding AD, HT improves to 0.743. Results were largely consistent across disease and country subgroups.Discussion: The 5 items of the EQ-5D-5L form a moderate to strong Mokken scale, enabling persons to be ordered using the level summary score. Item ordering suggests that the lower range of the score represents mainly problems with pain and anxiety/depression, the mid-range indicates additional problems with mobility and usual activities, and middle to higher range of scores reveals additional limitations with self-care. Scalability and item ordering are even stronger when the anxiety/depression item is not included in the scale. [ABSTRACT FROM AUTHOR]

This study assessed the content validity of generic and condition-specific preference-based measures (PBMs) with patients treated for cancer, evaluated against 10 Consensus-Based Standards for the Selection of Health Measurement Instruments criteria for good content validity, to best inform measurement strategies regarding the use of PBMs in oncology development programs and real-world applications. Individual, semistructured interviews were conducted with patients who received drug treatment for cancer in the United Kingdom (n = 47) and the United States (n = 49). During the interview, patients completed 3 generic PBMs (EQ-5D-5L, EuroQol Health and Wellbeing measure–Short Form, Château Santé Base) and 2 condition-specific PBMs (Quality of Life Utility-Core 10 Dimension, Functional Assessment of Cancer Therapy Eight Dimension [FACT-8D]). Interviews were conducted via teleconference, audio recorded, and transcribed verbatim. Transcripts were coded using thematic and content analysis methods. Condition-specific measures were evaluated as having better relevancy than generic PBMs. Overall, the FACT-8D was evaluated as holding the best content validity in terms of relevancy, and the EuroQol Health and Wellbeing measure–Short Form received the most favorable evaluation of relevancy for generic PBMs. All measures demonstrated comparable comprehensiveness, with all suggested by patients to be missing concepts. The EQ-5D-5L was evaluated best in terms of comprehensibility. This was followed by the Quality of Life Utility-Core 10 Dimension and FACT-8D; both received similar evaluations. All measures were generally seen by patients as adequate in capturing appropriate aspects of health-related quality of life for measuring cancer outcomes, although together condition-specific measures were evaluated as having better relevancy than generic PBMs. Further health-related quality of life instrument development is encouraged, particularly with regard to the longer-term detrimental impacts of cancer and treatment side effects. Other developments could include new cancer-specific tools inclusive of conventional health items, treatment impacts, and psychological items. • Generic preference-based measures (PBMs) are recommended to assess patient-reported outcomes across interventions and to allow for comparative assessments across unrelated health conditions and interventions. Generic PBMs may exclude dimensions relevant to specific conditions, whereas condition-specific PBMs can contain items related to specific symptoms. Recent work has identified several concepts that are relevant to health-related quality of life and psychological wellbeing, which are not measured by existing outcome measures. • Patients who had received drug treatment for cancer in the United Kingdom and the United States evaluated 3 generic and 2 condition-specific PBMs during qualitative interviews. All measures demonstrated comparable comprehensiveness, missing concepts considered by patients as important to measure for their cancer and cancer treatment experiences. Language and format were frequently challenged, with patients suggesting changes to multiple items across all measures. Recall periods were frequently raised as problematic because of the substantial variation in cancer symptoms within a given day or week. • Given the burden of cancer symptoms and drug treatment effects, capturing all relevant outcomes of people with cancer is necessary to inform accurate decision making for cancer technologies. Modification of existing measures should be considered with regard to measurement gaps identified. New cancer-specific tools could be considered, inclusive of conventional health items, treatment impacts, and psychological items. These developments have a large potential for impact given the high proportions of oncology health technology assessment submissions. [ABSTRACT FROM AUTHOR]

Background: Carbidopa/levodopa enteral suspension (CLES) is indicated for the treatment of advanced Parkinson's disease (aPD) with severe motor fluctuations. Objective: To determine the cost, quality‐adjusted life years (QALY), and cost‐effectiveness of CLES compared to the standard‐of‐care (SoC) for aPD patients in the United States (US), using real‐world data. Methods: A published Markov model, comprising of 25 health states and a death state, (defined by a combination of the Hoehn and Yahr scale and waking time spent in OFF‐time) was adapted to estimate the benefits for CLES versus oral SoC over a patient's lifetime in the US healthcare setting. Clinical inputs were based on a clinical trial and a registry study; utility inputs were sourced from the Adelphi‐Disease Specific Programmes. Results: CLES compared to SoC was associated with incremental costs ($1,031,791 vs. $1,025,180) and QALY gain (4.61 vs. 3.76), resulting in an incremental cost‐effectiveness ratio of $7711/QALY. Conclusion: CLES is a cost‐effective treatment for aPD patients with medication resistant motor fluctuations. © 2023 AbbVie, Inc and The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society. [ABSTRACT FROM AUTHOR]

Background: The opioid epidemic continues to be a significant cause of morbidity and mortality in the US. In 2020, 83% of opioid-related overdose deaths were due to synthetic opioids, such as fentanyl. Drug checking services have been widely implemented as a harm reduction intervention to facilitate the identification of substances in a drug sample. There is a need to inform decision-making on drug checking technologies and service implementation. This research aims to outline contextual considerations for the implementation of a drug checking service. Methods: A scoping review was conducted using a structured search strategy in PubMed and EMBASE. Articles were independently screened by two reviewers, and included if they were primary literature and reported on an actionable consideration(s) for drug checking services. Data elements were extracted using a standardized form, and included study design, study population, drug checking technology utilized or discussed, and main findings. Results: Twenty-nine articles were selected for inclusion, and four primary areas of consideration were identified: drug checking technologies, venue of a drug checking service, legality, and privacy. Technological considerations include the need for highly accurate, quantitative results which appeal to both populations of people with drug use disorder and recreational users. Accessibility of services was identified as an important factor that may be impacted by the location, integration with other services, how the service is provided (mobile vs. fixed), and the hours of operation. Maintaining plausible deniability and building trust were seen as important facilitators to service use and engagement. Issues surrounding legality were the most frequently cited barrier by patrons, including fear of criminalization, policing, and surveillance. Patrons and stakeholders identified a need for supportive policies that offer protections. Maintaining anonymity for patrons is crucial to addressing privacy-related barriers. Conclusion: This review highlights the need to understand the local population and climate for drug checking to implement a drug checking service successfully. Common themes identified in the literature included considerations related to the choice of technology, the type of venue, and the impact of legality and privacy. We intend to utilize these considerations in future research to help guide discussions with US-based stakeholders. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to the article "Eliciting Social Preference Weights for Functional Assessment of Cancer Therapy-Lung Health States," P. Kind and S. Macran in the 2005; 23 issue.

A response by Elise Davis and Elizabeth Waters to a letter to the editor about their article "A Structured Review of Studies on Health-Related Quality of Life and Economic Evaluation in Pediatric Acute Lymphoblastic Leukemia," in the previous issue is presented.

The authors comment on the EQ-5D-3L instruments and its value set recommended by the National Institute for Health and Care Excellence (NICE) of Great Britain. They discuss the differences between the 3L and the 5L in regard to description of patient health via the health state classifier and the way they value health, as well as its impact on estimates of quality-adjusted life-years and cost effectiveness rations. They point out the impact of these differences on health technology assessment.

Objective: To assess if health-related quality of life (HRQOL) of children with chronic kidney disease (CKD) and different comorbid conditions can be identified based on the EQ-5D child-friendly version (EQ-5D-Y).Design: Prospective cross-sectional study.Setting: A tertiary care medical center in Taiwan.Study Participants: All CKD patients aged 7-18 years treated at the center between May 2014 and December 2016.Main Outcome Measures: HRQOL assessment was done using EQ-5D-Y. Spearman correlation tests were used for construct validity of the traditional Chinese version of EQ-5D-Y. Test-retest reliability was determined through Cohen's kappa values and intraclass correlation coefficients (ICC). Laboratory results and CKD-related morbid conditions were ascertained and assessed their associations with HRQOL score using multivariate linear regression.Results: Of 68 participants, 53 of them completed two HRQOL assessments of HRQOL at least 6-month. Cross-sectional analysis revealed fair to moderate correlations between EQ visual analogue score and patient characteristics. Older children at assessment (P < 0.01), girls (P = 0.03) and presence of mineral bone disorders had a significantly negative impact on HRQOL. Children self-reported EQ-5D-Y dimensions were found to be fairly to highly reliable (kappa = 0.2 to 0.8), except for 'pain/discomfort' and 'anxiety/depression'.Conclusions: The EQ-5D-Y discriminated among children with different level of CKD-related clinical burden, but the psychometric properties may be limited in some HRQOL dimensions. Further research will need to address factors that may threaten validity and reliability data provided by children and adolescents. [ABSTRACT FROM AUTHOR]

Background: The Patient Reported Outcomes Measurement Information System 43-item short form (PROMIS-43) and the five-level EQ-5D (EQ-5D-5L) are recently developed measures of health-related quality of life (HRQL) that have potentially broad application in evaluating treatments and capturing burden of respiratory-related diseases. The aims of this study were: (1) to examine their psychometric properties in patients with chronic obstructive pulmonary disease (COPD), and (2) to identify dimensions of HRQL that differ and do not differ by lung function.Methods: We conducted a multi-center, cross-sectional study ("COPD Outcomes-based Network for Clinical Effectiveness & Research Translation" [CONCERT]). We analyzed patients who met spirometric criteria for COPD, and completed EQ-5D-5L and PROMIS questionnaires. Disease severity was graded based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification. Pulmonary function test, PROMIS-43, EQ-5D (index score and EQ-Visual Analog Scale [EQ-VAS]), six minute walk test (6MWT), and three dyspnea scales (mMRC, Borg, FACIT-Dyspnea) were administered. Validity and reliability of EQ-5D-5L and PROMIS-43 were examined, and differences in HRQL by GOLD grade were assessed.Results: Data from 670 patients with COPD were analyzed (mean age 68.5 years; 58% male). More severe COPD was associated with more problems with mobility, self-care and usual activities (all p-values <0.01) according to EQ-5D-5L. Related domains on EQ-5D-5L, PROMIS and clinical measures were moderately (r = 0.30-0.49) to strongly (r ≥ 0.50) correlated. A statistically significant trend of decreasing HRQL with more severe lung functions was observed for EQ-5D-5L index scores, EQ-VAS scores, and PROMIS physical function and social roles.Conclusions: Results supported the validity of EQ-5D-5L and PROMIS-43 in COPD patients, and indicate that physical function and social activities decrease with level of lung function by GOLD grade, but not pain, mental health, sleep or fatigue as reported by patients. [ABSTRACT FROM AUTHOR]

Introduction: Minority-serving hospitals (MSHs) need evidence-based strategies tailored to the populations they serve to improve patient-centered outcomes after hospitalization.Methods: We conducted a pragmatic randomized clinical trial (RCT) from October 2014 to January 2017 at a MSH comparing the effectiveness of a stakeholder-supported Navigator intervention vs. Usual care on post-hospital patient experience, outcomes, and healthcare utilization. Community health workers and peer coaches delivered the intervention which included (1) in-hospital visits to assess barriers to health/healthcare and to develop a personalized Discharge Patient Education Tool (DPET); (2) a home visit to review the DPET; and (3) telephone-based peer coaching. The co-primary outcomes were between-group comparisons of 30-day changes in Patient-Reported Outcomes Measurement Information System (PROMIS) measures of anxiety and informational support (minimum important difference is 2 to 5 units change); a p-value <0.025 was considered significant using intention-to-treat analysis. Secondary outcomes included death, ED visits, or readmissions and measures of emotional, social, and physical health at 30 and 60 days.Results: We enrolled 1029 adults hospitalized with heart failure (28%), pneumonia (22%), MI (10%), COPD (11%), or sickle cell disease (29%). Over 80% were non-Hispanic Black. Overall, there were no significant between-group differences in the 30-day change in anxiety (adjusted difference: -1.6, 97.5% CI -3.3 to 0.1, p=0.03), informational support (adjusted difference: -0.01, 97.5% CI -2.0 to 1.9, p=0.99), or any secondary outcomes. Exploratory analyses suggested the Navigator intervention improved anxiety among participants with COPD, a primary care provider, a hospitalization in the past 12 months, or higher baseline anxiety; among participants without health insurance, the intervention improved informational support (all p-values <0.05).Conclusions: In this pragmatic RCT at a MSH, the Navigator intervention did not improve post-hospital anxiety, informational support, or other outcomes compared to Usual care. Benefits observed in participant subgroups should be confirmed in future studies.Trial Registration: Clinicaltrials.gov identifier: NCT02114515. [ABSTRACT FROM AUTHOR]

A correction to the article "Estimation of Minimally Important Differences in EQ-5D Utility and VAS Scores in Cancer" is presented.

Objective: The objective of this study was to compare the measurement properties of the US EQ-5D-3L, EQ-5D-5L, and -5L to -3L crosswalk value sets (3L; 5L; 5L > 3L) across the spectrum of health.Methods: The three scoring approaches were compared in terms of range of scale, percent of worse-than-dead health states, and mean single-level transitions. Discriminative ability was compared by leveraging two cross-sectional datasets. A novel method was used to visualize and compare the responsiveness of 3L and 5L scoring approaches across EQ VAS values.Results: The US 5L value set had the broadest range of scale at 1.573 (vs. 1.109 for 3L and crosswalk). The crosswalk had the smallest mean single-level transition of 0.061 (vs. 0.078 for 5L and 0.111 for 3L). The 5L value set tended to be more discriminative/greater statistical efficiency than the crosswalk (F-statistic ratio: 1.111, 95% CI 0.989-1.240) and 3L (F-statistic ratio: 1.102 95% CI 0.861-1.383) across levels of general health. The 5L was the most responsive value set between EQ VAS values of 25 and 75.Conclusion: These results imply greater sensitivity of the 5L to health changes and potentially lower incremental cost-utility ratios compared to the 3L. [ABSTRACT FROM AUTHOR]

This document is a correction notice for an article titled "Valuation of the EQ-5D-5L in Taiwan" published in the journal PLoS ONE. The correction addresses errors in the Funding statement and Competing Interests statement. The correct Funding statement acknowledges the sponsorship of various organizations, while clarifying that they had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The correct Competing Interests statement clarifies that two of the authors were executive directors of sponsoring agencies but declared no competing interests. The document also mentions that the Acknowledgement section was missing from the original article and provides the correct section, which includes gratitude to study participants, research assistants, interviewers, and others involved in the study. [Extracted from the article]

OFF Episodes occur in people with Parkinson's disease when their medication wears off, and motor and/or non-motor symptoms emerge. Existing measures used to assess OFF Episodes focus on the time spent in OFF Episodes through diaries or by identifying symptoms, but they are limited in their ability to capture the severity and functional impact of OFF episodes. The aim of this study was to develop and validate a new instrument, called "OFFELIA," that measures the impact of OFF episodes on the quality of life of individuals with Parkinson's disease. Participants completed a cross-sectional questionnaire, "Impact and Communication on OFF Periods," while enrolled in the online clinical study Fox Insights. The data collected was used to develop OFFELIA. Psychometric testing was performed on 18 candidate items using classical, exploratory factor analysis, and item response theory methods. 569 individuals with Parkinson's disease completed the questionnaire. All items were retained for the final measure, with 17 items aggregated into two multi-item scales (functioning and psychological well-being) and one item reported separately as it did not function well with the other items (employment). Known group comparisons based on average duration, frequency and unpredictability of OFF episodes indicated that OFFELIA subscales were more sensitive than existing generic and condition-specific measures. Initial evidence supports the validity of OFFELIA, a new instrument that assesses the impact of OFF periods on daily life. This instrument can be used in assessing clinical therapeutic strategies targeting OFF episodes in Parkinson's disease. • OFFELIA is a new patient-reported outcome measure for Parkinson's Disease. • OFFELIA assesses off episodes' impact on quality of life in people with Parkinson's. • Evidence supports validity and reliability of OFFELIA. • OFFELIA aids clinicians assessing treatment's effect on off episodes. • OFFELIA measures impact of interventions on off episodes in trials. [ABSTRACT FROM AUTHOR]

Introduction: Utility instruments are used to assess patients' health-related quality of life for cost-utility analysis (CUA). However, for cancer patients, the dimensions of generic utility instruments may not capture all the information relevant to the impact of cancer. Cancer-specific utilities provide a useful alternative. Under the auspices of the Multi-Attribute Utility in Cancer Consortium, a cancer-specific utility algorithm was derived from the FACT-G. The new FACT-8D contains eight dimensions: pain, fatigue, nausea, sleep, work, support from family/friends, sadness, and worry health will get worse. The aim of the study was to obtain a Canadian value set for the FACT-8D.Methods: A discrete choice experiment was administered to a Canadian general population online panel, quota sampled by age, sex, and province/territory of residence. Respondents provided responses to 16 choice sets. Each choice set consisted of two health states described by the FACT-8D dimensions plus an attribute representing survival duration. Sample weights were applied and the responses were analyzed using conditional logistic regression, parameterized to fit the quality-adjusted life year framework. The results were converted into utility weights by evaluating the marginal rate of substitution between each level of each FACT-8D dimension with respect to duration.Results: 2228 individuals were recruited. The analysis dataset included n = 1582 individuals, who completed at least one choice set; of which, n = 1501 completed all choice sets. After constraining to ensure monotonicity in the utility function, the largest decrements were for the highest levels of pain (- 0.38), nausea (- 0.30), and problems doing work (- 0.23). The decrements of the remaining dimensions ranged from - 0.08 to - 0.18 for their highest levels. The utility of the worst possible health state was defined as - 0.65, considerably worse than dead.Conclusions: The largest impacts on utility included three generic dimensions (i.e., pain, support, and work) and nausea, a symptom caused by cancer (e.g., brain tumours, gastrointestinal tumours, malignant bowel obstruction) and by common treatments (e.g., chemotherapy, radiotherapy, opioid analgesics). This may make the FACT-8D more informative for CUA evaluating in many cancer contexts, an assertion that must now be tested empirically in head-to-head comparisons with generic utility measures. [ABSTRACT FROM AUTHOR]