Assessing the Content Validity of Preference-Based Measures in Cancer.

OBJECTIVES: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Comparison of the EQ-HWB and EQ-HWB-S With Other Preference-Based Measures Among United States Informal Caregivers.

OBJECTIVES: Several measures have been used or developed to capture the health and well-being of caregivers, including the EQ Health and Well-being (EQ-HWB) and its short form, EQ-HWB-S. This study aimed to evaluate the psychometric properties and construct validity of the EQ-HWB/EQ-HWB-S in a US caregiver population. METHODS: A cross-sectional survey was conducted involving 504 caregivers. Eligible participants were 18+ years old, provided unpaid care to a relative/friend aged 18+ in the past 6 months, and spent on average of at least 1 hour per week caregiving. Survey included the following measures: EQ-HWB, Adult Social Care Outcomes Toolkit for Carers-Carer, CarerQol, and EQ-5D-5L. Psychometric properties were assessed using response distributions, floor/ceiling effects, Spearman's correlation for convergent validity, and effect sizes (ES) for known-group validity based on caregiving situations and intensity. RESULTS: The average age of caregivers was 49.2 (SD = 15.4), with 57.5% being female. More than half (54.4%) reported high caregiving intensity, and 68.3% lived with the care recipient. The EQ-HWB-S index showed a strong positive correlation with the EQ-5D-5L (rs = 0.72), Adult Social Care Outcomes Toolkit for Carers (rs = 0.54), and CarerQol (rs = 0.54) indices. Notably, the EQ-HWB-S index showed the largest ES among measures in differentiating caregiving scenarios with a large ES for caregiver's general health (d = 1.00) and small ES for caregiving intensity (d = 0.39). CONCLUSIONS: Results support construct validity of EQ-HWB and EQ-HWB-S as measures for assessing health and well-being of adult informal caregivers in comparison with other validated instruments. Differing levels of known-group validity across anchors emphasize the importance of selecting appropriate measures for caregivers, depending on research question and/or intervention aims.

The Measurement Properties of the EQ-HWB and the EQ-HWB-S in Italian Population: A Comparative Study With EQ-5D-5L.

OBJECTIVES: The EQ Health and Well-being, EQ-HWB (25-item) and the EQ-HWB-S (9-item), are new generic measures of health and well-being. The purpose of this study was to examine the measurement properties of the EQ-HWB and EQ-HWB-S measures in relation to the EQ-5D-5L among the Italian general population. METHODS: A cross-sectional survey was conducted from October 2020 to February 2021, followed by secondary analysis of collected data from Italian adults. This analysis included response pattern distributions, correlation strength, and known-group comparison. Known-group comparison was assessed using effect sizes (ES) across health conditions, caregiver status, and social care usage. The EQ-HWB-S index-based score was based on the UK pilot value set, whereas the Italian value set was used for scoring the EQ-5D-5L index. RESULTS: Out of the 1182 participants, 461 reported having a chronic condition, 185 identified as caregivers, and 42 were social care users. EQ-HWB items (7.5%) showed fewer ceiling effects than EQ-5D-5L items (34.7%). Strong correlations (rs > 0.5) were found between overlapping EQ-HWB and EQ-5D-5L items. EQ-HWB-S and EQ-5D-5L index scores demonstrated similar discrimination based on symptomatic chronic conditions (ES d = 0.68 vs d = 0.71), but EQ-HWB-S had slightly higher ES for social care users (ES d = 0.84 vs d = 0.74). CONCLUSIONS: Initial evidence supports the validity of EQ-HWB/EQ-HWB-S because outcome measures in the Italian population. EQ-HWB-S performed comparably to EQ-5D-5L among patients and was better in differentiating social care users. A slight decrease in discriminative properties for caregivers was observed when transitioning from EQ-HWB to EQ-HWB-S.

Scoring the EQ-HWB-S: can we do it without value sets? A non-parametric item response theory analysis.

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.

Understanding caregiver burden from multiple perspectives: dyadic agreement between caregiver and care recipient.

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.

Cost-Effectiveness of Carbidopa-Levodopa Enteral Suspension for Advanced Parkinson's Disease in the United States.

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.

Contextual factors affecting the implementation of drug checking for harm reduction: a scoping literature review from a North American perspective.

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.

A qualitative assessment of key considerations for drug checking service implementation.

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.

Pharmacists and Naloxone: Barriers to Dispensing and Effectiveness of an Educational Outreach Program.

BACKGROUND: The Illinois Naloxone Standing Order allows community pharmacists to dispense naloxone; however, this policy initiative may be underutilized. OBJECTIVE: Our study aims to characterize naloxone dispensing barriers, overall and by pharmacy type, make recommendations that can inform future policies to improve naloxone access, and evaluate outreach initiative effectiveness from academic detailers' perspectives. METHODS: We conducted a retrospective analysis of semistructured data collected as part of an educational outreach program targeting Illinois community pharmacists in 2021. Academic detailers conducted educational outreach visits across community pharmacy settings (i.e., primary pharmacy, grocery pharmacy, or independent pharmacy) to promote standing order use and discuss barriers pharmacists face when dispensing naloxone. Following each visit, detailers recorded visit characteristics, pharmacist-identified obstacles impacting naloxone dispensing, and visit effectiveness. RESULTS: Detailers performed in-person visits at 270 (78%) of 348 targeted sites. A lower proportion of independent pharmacies (61%) routinely stock naloxone than primary (95%, P < 0.001) or grocery (98%, P < 0.001) pharmacies. Among pharmacists at independent pharmacies, 43% indicated they were highly or extremely comfortable dispensing naloxone, a significantly lower proportion than pharmacists at grocery (79%, P < 0.001) or primary (68%, P < 0.001) pharmacies. The prevalence of salient barriers to naloxone dispensing was: cost/insurance issues (primary pharmacy = 38% vs. grocery pharmacy = 36% vs. independent pharmacy = 28%, P = 0.46), stigma (36% vs. 49% vs. 16%, P < 0.05), and lack of standing order enrollment (0% vs. 0% vs. 49%, P < 0.05). On average, detailers perceived visits as less useful to pharmacists working at independent pharmacies than those at primary or grocery pharmacies. CONCLUSIONS: Over 80% of pharmacists reported facing greater than one naloxone dispensing barrier. While cost/insurance issues appear ubiquitous, patient stigma-related factors were prevalent in primary and grocery pharmacies. Although many pharmacists are comfortable dispensing naloxone under the standing order, pharmacists at independent pharmacies are less comfortable, potentially secondary to lower standing order enrollment.

Pragmatic Clinical Trial to Improve Patient Experience Among Adults During Transitions from Hospital to Home: the PArTNER study.

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.

A Comparison of a Preliminary Version of the EQ-HWB Short and the 5-Level Version EQ-5D.

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.

Developing a New Generic Health and Wellbeing Measure: Psychometric Survey Results for the EQ-HWB.

OBJECTIVES: The development of measures such as the EQ-HWB (EQ Health and Wellbeing) requires selection of items. This study explored the psychometric performance of candidate items, testing their validity in patients, social carer users, and carers. METHODS: Article and online surveys that included candidate items (N = 64) were conducted in Argentina, Australia, China, Germany, United Kingdom, and the United States. Psychometric assessment on missing data, response distributions, and known group differences was undertaken. Dimensionality was explored using exploratory and confirmatory factor analysis. Poorly fitting items were identified using information functions, and the function of each response category was assessed using category characteristic curves from item response theory (IRT) models. Differential item functioning was tested across key subgroups. RESULTS: There were 4879 respondents (Argentina = 508, Australia = 514, China = 497, Germany = 502, United Kingdom = 1955, United States = 903). Where missing data were allowed, it was low (UK article survey 2.3%; US survey 0.6%). Most items had responses distributed across all levels. Most items could discriminate between groups with known health conditions with moderate to large effect sizes. Items were less able to discriminate across carers. Factor analysis found positive and negative measurement factors alongside the constructs of interest. For most of the countries apart from China, the confirmatory factor analysis model had good fit with some minor modifications. IRT indicated that most items had well-functioning response categories but there was some evidence of differential item functioning in many items. CONCLUSIONS: Items performed well in classical psychometric testing and IRT. This large 6-country collaboration provided evidence to inform item selection for the EQ-HWB measure.

The EQ-HWB: Overview of the Development of a Measure of Health and Wellbeing and Key Results.

OBJECTIVES: Existing measures for estimating quality-adjusted life-years are mostly limited to health-related quality of life. This article presents an overview of the development the EQ-HWB (EQ Health and Wellbeing), which is a measure that encompasses health and wellbeing. METHODS: Stages: (1) Establishing domains through reviews of the qualitative literature informed by a conceptual framework. (2) Generation and selection of items to cover the domains. (3) Face validation of these items through qualitative interviews with 168 patients, social care users, general population, and carers across 6 countries (Argentina, Australia, China, Germany, United Kingdom, United States). (4) Extensive psychometric testing of candidate items (using classical, factor analysis, and item response theory methods) on > 4000 respondents in the 6 countries. Stakeholders were consulted throughout. RESULTS: A total of 32 subdomains grouped into 7 high-level domains were identified from the qualitative literature and 97 items generated to cover them. Face validation eliminated 36 items, modified 14, and added 3. Psychometric testing of 64 items found little difference in missing data or problems with response distribution, the conceptual model was confirmed except in China, and most items performed well in the item response theory in all countries. Evidence was presented to stakeholders in 2 rounds of consultation to inform the final selection of items for the EQ-HWB (25-item) and the short version of EQ-HWB (9-items). CONCLUSIONS: EQ-HWB measures have been developed internationally for evaluating interventions in health, public health, and social care including the impact on patients, social care users, and carers.

EQ-5D-5L measurement properties are superior to EQ-5D-3L across the continuum of health using US value sets.

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.

The FACT-8D, a new cancer-specific utility algorithm based on the Functional Assessment of Cancer Therapies-General (FACT-G): a Canadian valuation study.

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.

Combining EQ-5D-5L items into a level summary score: demonstrating feasibility using non-parametric item response theory using an international dataset.

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.

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.

US population norms for the EQ-5D-5L and comparison of norms from face-to-face and online samples.

PURPOSE: Normative scores (norms) allow for comparisons between population(s) of interest and the general population, which is useful for burden of disease studies and cost-effectiveness analysis. The primary aim of this study was to estimate US visual analogue scale (EQ VAS) and utility-based norms for the EQ-5D-5L using the face-to-face sample. The secondary aim was to compare norms estimated in the face-to-face and online populations. METHODS: This study estimated population norms from two general population surveys: (a) face-to-face and (b) online. In these surveys, respondents provided their health state using the EQ-5D-5L health classifier and the EQ VAS. Descriptive statistics, including mean, standard deviation (SD), 95% confidence interval, and median for the 5L utility and EQ VAS were estimated for each sample and across relevant respondent characteristics to serve as the basis for US EQ-5D-5L norms RESULTS: Face-to-face sample respondents (n = 1134) were representative of the US adult general population. In this sample, mean (SD) utility decreased with increasing age until age 45 or greater (age 45-54: 0.816 (0.249) age 55-64: 0.815 (0.243) age 65-74: 0.824 (0.217) age 75 + : 0.811 (0.218)). With increasing age, more problems were reported on all dimensions except anxiety/depression; a smaller proportion of respondents age 65 and older reported problems with anxiety/depression (23.8%) as compared to the youngest respondents (42.1%). Online (n = 2018) mean utility and EQ VAS values were consistently lower than the face-to-face sample. CONCLUSIONS: The availability of US EQ-5D-5L norms facilitates interpretation and understanding of general population and patient health.

Comparison of online and face-to-face valuation of the EQ-5D-5L using composite time trade-off.

OBJECTIVE: The aim of this study was to compare online, unsupervised and face-to-face (F2F), supervised valuation of EQ-5D-5L health states using composite time trade-off (cTTO) tasks. METHODS: The official EuroQol experimental design and valuation protocol for the EQ-5D-5L of 86 health states were implemented in interviewer-assisted, F2F and unsupervised, online studies. Validity of preferences was assessed using prevalence of inconsistent valuations and expected patterns of TTO values. Respondent task engagement was measured using number of trade-offs and time per task. Trading patterns such as better-than-dead only was compared between modes. Value sets were generated using linear regression with a random intercept (RILR). Value set characteristics such as range of scale and dimension ranking were evaluated between modes. RESULTS: Five hundred one online and 1,134 F2F respondents completed the surveys. Mean elicited TTO values were higher online than F2F when compared by health state severity. Compared to F2F, a larger proportion of online respondents did not assign the poorest EQ-5D-5L health state (i.e., 55555) the lowest TTO value ([Online] 41.3% [F2F] 12.2%) (p < 0.001). A higher percentage of online cTTO tasks were completed in 3 trade-offs or fewer ([Online] 15.8% [F2F] 3.7%), (p < 0.001). When modeled using the RILR, the F2F range of scale was larger than online ([Online] 0.600 [F2F] 1.307) and the respective dimension rankings differed. CONCLUSIONS: Compared to F2F data, TTO tasks conducted online had more inconsistencies and decreased engagement, which contributed to compromised data quality. This study illustrates the challenges of conducting online valuation studies using the TTO approach.

Secondary effects of an opioid-focused academic detailing program on non-opioid controlled substance prescribing in primary care.

Background: Educational outreach programs that focus on safe opioid prescribing and awareness of state prescription monitoring programs may modify clinicians' prescribing behavior. The objective of this study was to evaluate the secondary effects of an opioid-focused academic detailing (AD) program on non-opioid controlled substance prescribing in primary care. Methods: A quasi-experimental pre-post study of primary care clinicians exposed and unexposed to the AD program was conducted using data from the Illinois Prescription Monitoring Program from December 2017 to February 2019. Outcomes were mean monthly prescriptions for benzodiazepines (BZD), non-BZD sedative-hypnotics, and carisoprodol, per clinician. A difference-in-differences (DID) approach utilizing repeated-measures mixed-effects linear regression models was used to compare changes in outcomes six-months before and after the program. Results: Mean monthly BZD prescriptions declined in both groups of clinicians (AD-exposed n = 151; controls n = 399) after implementation of the AD program. Although the mean monthly number of BZD prescriptions decreased in both groups after the AD program, BZD prescribing in the AD-exposed group declined at a slower rate following the AD program (DID = 0.73; 95% CI: 0.14, 1.31). The AD-exposed group had a 0.06 (95% CI: -0.11, -0.01) lower rate of mean monthly carisoprodol prescriptions compared to the control group following the AD program. There was no change in the rate of mean monthly non-BZD sedative-hypnotic prescriptions between the two groups. Conclusions: The higher relative rate of BZD prescribing in the AD-exposed group compared to the control group following the AD program may be reflective of an unintended consequence of opioid-focused AD programs as clinicians learn to be cautious about opioid prescribing. Our findings may suggest the need for incorporation of targeted education on appropriate BZD prescribing into opioid-focused AD programs as a featured component. These findings warrant further consideration and investigation before large-scale implementation of opioid-focused educational outreach programs.