HIV Immunocapture Reveals Particles Expressed in Semen under INSTI-based Therapy are Largely Myeloid Cell-Derived and Disparate from Circulating Provirus.

As use of HIV integrase strand transfer inhibitors (INSTI) increases and formulations are being developed for maintenance therapies and chemoprophylaxis, assessing virus suppression under INSTI-based regimens in prevention-relevant biologic compartments, such as the male genital tract, is timely. We used cell-source marker virion immunocapture to examine amplification of particle RNA then assessed the phylogenetic relatedness of seminal and blood viral sequences from men with HIV who were prescribed INSTI-based regimens. Seminal plasma immunocaptures yielded amplifiable virion RNA from 13/24 (54%) men, and the sequences were primarily associated with markers indicative of macrophage and resident dendritic cell sources. Genetic distances were greatest (>2%) between seminal virions and circulating proviruses, pointing to ongoing low-level expression from tissue-resident cells. While the low levels in semen predict an improbable likelihood of transmission, viruses with large genetic distances are expressed under potent INSTI therapy and have implications for determining epidemiologic linkages if adherence is suboptimal.

Reduced incidence of diabetes during the COVID-19 pandemic in Alberta: A time-segmented longitudinal study of Alberta's Tomorrow Project.

AIM: To characterize the impact of the COVID-19 pandemic on diabetes diagnosis using data from Alberta's Tomorrow Project (ATP), a population-based cohort study of chronic diseases in Alberta, Canada. MATERIALS AND METHODS: The ATP participants who were free of diabetes on 1 April 2018 were included in the study. A time-segmented regression model was used to compare incidence rates of diabetes before the COVID-19 pandemic, during the first two COVID-19 states of emergency, and in the period when the state of emergency was relaxed, after adjusting for seasonality, sociodemographic factors, socioeconomic status, and lifestyle behaviours. RESULTS: Among 43 705 ATP participants free of diabetes (65.5% females, age 60.4 ± 9.5 years in 2018), the rate of diabetes was 4.75 per 1000 person-year (PY) during the COVID-19 pandemic (up to 31 March 2021), which was 32% lower (95% confidence interval [CI] 21%, 42%; p < 0.001) than pre-pandemic (6.98 per 1000 PY for the period 1 April 2018 to 16 March 2020). In multivariable regression analysis, the first COVID-19 state of emergency (first wave) was associated with an 87.3% (95% CI -98.6%, 13.9%; p = 0.07) reduction in diabetes diagnosis; this decreasing trend was sustained to the second COVID-19 state of emergency and no substantial rebound (increase) was observed when the COVID-19 state of emergency was relaxed. CONCLUSIONS: The COVID-19 public health emergencies had a negative impact on diabetes diagnosis in Alberta. The reduction in diabetes diagnosis was likely due to province-wide health service disruptions during the COVID-19 pandemic. Systematic plans to close the post-COVID-19 diagnostic gap are required in diabetes to avoid substantial downstream sequelae of undiagnosed disease.

Preference-based measures of health-related quality of life in Indigenous people: a systematic review.

PURPOSE: In many countries, there are calls to address health inequalities experienced by Indigenous people. Preference-based measures (PBMs) provide a measurement of health-related quality of life and can support resource allocation decisions. This review aimed to identify, summarize, and appraise the literature reporting the use and performance of PBMs with Indigenous people. METHODS: Eleven major databases were searched from inception to August 31, 2022. Records in English that (1) assessed any measurement property of PBMs, (2) directly elicited health preferences, (3) reported the development or translation of PBMs for Indigenous people, or (4) measured health-related quality of life (HRQL) using PBMs were included. Ethically engaged research with Indigenous people was considered as an element of methodological quality. Data was synthesized descriptively (PROSPERO ID: CRD42020205239). RESULTS: Of 3139 records identified, 81 were eligible, describing psychometric evaluation (n = 4), preference elicitation (n = 4), development (n = 4), translation (n = 2), and HRQL measurement (n = 71). 31 reported ethically engaged research. Reports originated primarily from Australia (n = 38), New Zealand (n = 20), USA (n = 9) and Canada (n = 6). Nearly all (n = 73) reported indirect, multi-attribute PBMs, the most common of which was the EQ-5D (n = 50). CONCLUSION: A large number of recent publications from diverse disciplines report the use of PBMs with Indigenous people, despite little evidence on measurement properties in these populations. Understanding the measurement properties of PBMs with Indigenous people is important to better understand how these measures might, or might not, be used in policy and resource decisions affecting Indigenous people. (Funding: EuroQoL Research Foundation).

Exploring patient perspectives on EQ-5D-5L data visualization within an individualized decision aid for total knee arthroplasty (TKA) in Alberta, Canada.

BACKGROUND: Decision aids can help patients set realistic expectations. In this study, we explored alternative presentations to visualise patient-reported outcomes (EQ-5D-5L) data within an online, individualized patient decision aid for total knee arthroplasty (TKA) that, in part, generates individualized comparisons based on age, sex and body mass index, to enhance usability prior to implementation into routine clinical practice. METHODS: We used data visualization techniques to modify the presentation of EQ-5D-5L outcomes data within the decision aid. The EQ-5D-5L data was divided into two parts allowing patients to compare themselves to similar individuals (1) pre-surgery and (2) 1-year post-surgery. We created 2 versions for each part and sought patient feedback on comprehension, usefulness, and visual appeal. Patients from an urban orthopedic clinic were recruited and their ratings and comments were recorded using a researcher-administered checklist. Data were managed using Microsoft Excel, R version 3.6.1 and ATLAS.ti V8 and analyzed using descriptive statistics and directed content analysis. RESULTS: A total of 24 and 25 patients participated in Parts 1 and 2, respectively. Overall, there was a slight preference for Version 1 in Part 1 (58.3%) and Version 2 in Part 2 (64%). Most participants demonstrated adequate comprehension for all versions (range 50-72%) and commented that the instructions were clear. While 50-60% of participants rated the content as useful, including knowing the possible outcomes of surgery, some participants found the information interesting only, were unsure how to use the information, or did not find it useful because they had already decided on a treatment. Participants rated visual appeal for all versions favorably but suggested improvements for readability, mainly larger font and image sizes and enhanced contrast between elements. CONCLUSIONS: Based on the results, we will produce an enhanced presentation of EQ-5D-5L data within the decision aid. These improvements, along with further usability testing of the entire decision aid, will be made before implementation of the decision aid in routine clinical practice. Our results on patients' perspectives on the presentation of EQ-5D-5L data to support decision making for TKA treatments contributes to the knowledge on EQ-5D-5L applications within healthcare systems for clinical care.

Association between pulse width and health-related quality of life after electroconvulsive therapy in patients with unipolar or bipolar depression: an observational register-based study.

AIMS: To examine the association between pulse width and HRQoL measured within one week after electroconvulsive therapy (ECT) and at six-month follow-up in patients with unipolar or bipolar depression. METHODS: This was an observational register study using data from the Swedish National Quality Registry for ECT (2011-2019). Inclusion criteria were: age ≥18 years; index treatment for unipolar/bipolar depression; unilateral electrode placement; information on pulse width; EQ-5D measurements before and after ECT. Multiple linear regressions were performed to investigate the association between pulse width (<0.5 ms; 0.5 ms; >0.5 ms) and HRQoL (EQ-5D-3L index; EQ VAS) one week after ECT (primary outcome) and six months after ECT (secondary outcome). RESULTS: The sample included 5,046 patients with unipolar (82%) or bipolar (18%) depression. At first ECT session, 741 patients (14.7%) had pulse width <0.5 ms, 3,639 (72.1%) had 0.5 ms, and 666 (13.2%) had >0.5 ms. There were no statistically significant associations between pulse width and HRQoL one week after ECT. In the subsample of patients with an EQ-5D index recorded six months after ECT (n = 730), patients receiving 0.5 ms had significantly lower HRQoL (-0.089) compared to <0.5 ms, after adjusting for demographic and clinical characteristics (p = .011). The corresponding analysis for EQ VAS did not show any statistically significant associations. CONCLUSION: No robust associations were observed between pulse width and HRQoL after ECT. On average, significant improvements in HRQoL were observed one week and six months after ECT for patients with unipolar or bipolar disease, independent of the pulse width received.

The use of EQ-5D-5L as a patient-reported outcome measure in evaluating community rehabilitation services in Alberta, Canada.

BACKGROUND: The purpose of this study was to describe the characteristics and health-related quality of life (HRQL) of patients accessing community rehabilitation services in Alberta, Canada, using routinely collected EQ-5D-5L data, and explore factors associated with the impact of these services. METHODS: A retrospective, longitudinal, observational design was used. Patients completed the EQ-5D-5L and demographic questions at intake and end of rehabilitation care. Change in EQ-5D-5L dimensions from intake until end of rehabilitation was examined using the Pareto Classification of Health Change. Change scores were calculated for the EQ-5D-5L index, VAS, and total sum scores. Change groups in the EQ-5D-5L index and VAS scores, were defined by minimally important differences of 0.04 and 7.0, respectively. One level change was considered important for the total sum score. Effect size of the change in index, VAS, and total sum scores was also examined. Chi-squared tests were conducted to examine whether change in EQ-5D-5L varied by age, gender, region, and having anxiety/depression at intake. RESULTS: Three service programs were examined; pulmonary rehabilitation (n = 542), group-based community exercise (n = 463), and physiotherapy for bone and joint care (n = 391). At intake, HRQL in all programs was lower than that of the general Alberta population norms and improved by end of rehabilitation. The mean (SD) change in index, VAS, and total sum scores were 0.02 (0.13), 6.0 (18.3), and - 0.5 (2.4) in pulmonary rehabilitation, 0.06 (0.13), 6.6 (18.7), - 1.2 (2.4) in community exercise, and 0.13 (0.16), 1.2 (0.9), and - 2.8 (2.8) in physiotherapy, respectively. Based on change of the index score, 24% deteriorated, 38% improved, and 38% had no change in pulmonary rehabilitation; 17% deteriorated, 51% improved, and 32% had no change in community exercise; 5% deteriorated, 72% improved, and 23% had no change in physiotherapy. Similar trends were seen in the VAS and total sum scores. Older age, urban region, and having anxiety/depression at intake were associated with positive change in EQ-5D-5L. CONCLUSIONS: The results of this study are intended to inform program/service level decisions by describing the characteristics and HRQL of patients accessing community rehabilitation, as well as the predictors of change in health status, which will help direct future program growth and service changes.

Effectiveness of RADAR: An Innovative Model to Organize Diabetes Care in First Nations Communities.

Challenges exist for the management of diabetes care in First Nations populations. RADAR (Reorganizing the Approach to Diabetes through the Application of Registries) is a culturally appropriate, innovative care model that incorporates a disease registry and electronic health record for local care provision with remote coordination, tailored for First Nations people. This study assessed the effectiveness of RADAR on patient outcomes and diabetes care organization in participating communities in Alberta, Canada. It revealed significant improvements in outcomes after 2 years, with 91% of patients achieving a primary combined end point of a 10% improvement in or persistence at target for A1C, systolic blood pressure, and/or LDL cholesterol. Qualitative assessment showed that diabetes care organization also improved. These multimethod findings support tailored diabetes care practices in First Nations populations.

Transmitted Drug Resistance Among Human Immunodeficiency Virus (HIV)-1 Diagnoses in the United States, 2014-2018.

BACKGROUND: Transmitted human immunodeficiency virus (HIV) drug resistance can threaten the efficacy of antiretroviral therapy and pre-exposure prophylaxis (PrEP). Drug-resistance testing is recommended at entry to HIV care in the United States and provides valuable insight for clinical decision making and population-level monitoring. METHODS: We assessed transmitted drug-resistance-associated mutation (TDRM) prevalence and predicted susceptibility to common HIV drugs among US persons with HIV diagnosed during 2014-2018 who had a drug resistance test performed ≤3 months after HIV diagnosis and reported to the National HIV Surveillance System and who resided in 28 jurisdictions where ≥20% of HIV diagnoses had an eligible sequence during this period. RESULTS: Of 50 747 persons in the analysis, 9616 (18.9%) had ≥1 TDRM. TDRM prevalence was 0.8% for integrase strand transfer inhibitors (INSTIs), 4.2% for protease inhibitors, 6.9% for nucleoside reverse transcriptase inhibitors (NRTIs), and 12.0% for non-NRTIs. Most individual mutations had a prevalence <1.0% including M184V (0.9%) and K65R (0.1%); K103N was most prevalent (8.6%). TDRM prevalence did not increase or decrease significantly during 2014-2018 overall, for individual drug classes, or for key individual mutations except for M184V (12.9% increase per year; 95% confidence interval, 5.6-20.6%). CONCLUSIONS: TDRM prevalence overall and for individual drug classes remained stable during 2014-2018; transmitted INSTI resistance was uncommon. Continued population-level monitoring of INSTI and NRTI mutations, especially M184V and K65R, is warranted amidst expanding use of second-generation INSTIs and PrEP.

Mapping the Edmonton Symptom Assessment System-Revised: Renal to the EQ-5D-5L in patients with chronic kidney disease.

PURPOSE: The Edmonton Symptom Assessment System-Revised: Renal (ESAS-r: Renal) is a disease-specific patient-reported outcome measure (PROM) that assesses symptoms common in chronic kidney disease (CKD). There is no preference-based scoring system for the ESAS-r: Renal or a mapping algorithm to predict health utility values. We aimed to develop a mapping algorithm from the ESAS-r: Renal to the Canadian EQ-5D-5L index scores. METHODS: We used data from a multi-centre cluster randomized-controlled trial of the routine measurement and reporting of PROMs in hemodialysis units in Northern Alberta, Canada. In two arms of the trial, both the ESAS-r: Renal and the EQ-5D-5L were administered to CKD patients undergoing hemodialysis. We used data from one arm for model estimation, and data from the other for validation. We explored direct and indirect mapping models; model selection was based on statistical fit and predictive power. RESULTS: Complete data were available for 506 patient records in the estimation sample and 242 in the validation sample. All models tended to perform better in patients with good health, and worse in those with poor health. Generalized estimating equations (GEE) and generalized linear model (GLM) on selected ESAS-r: Renal items were selected as final models as they fitted the best in estimation and validation sample. CONCLUSION: When only ESAS-r: Renal data are available, one could use GEE and GLM to predict EQ-5D-5L index scores for use in economic evaluation. External validation on populations with different characteristics is warranted, especially where renal-specific symptoms are more prevalent.

The performance of the EQ-5D-3L in screening for anxiety and depressive symptoms in hospital and community settings.

BACKGROUND: To examine the performance of the EQ-5D-3L in screening for anxiety and depressive symptoms in hospital and community settings compared to other patient-reported screening tools. METHODS: Data from a prospective cohort of patients discharged from general internal medicine wards from two hospitals in Edmonton, Alberta were used in this study. Two waves of measurements (discharge and 90-days post-discharge) were analyzed. The performance of the EQ-5D-3L was compared to other self-report screening tools: Generalized Anxiety Disorder 2-item questionnaire was used to categorize anxiety symptoms into absent (< 3) and present (≥ 3), and the Patient Health Questionnaire 9-items was used to categorize depressive symptoms by two severity cut-points: no (< 10) vs. mild (≥ 10), and no (< 15) vs. moderate-severe (≥ 15). Performance of EQ-5D-3L in screening for anxiety and depressive symptoms was evaluated using receiver operating curve (ROC) analysis. RESULTS: Average age of participants (n = 493) was 62.9 years (SD 18.6); 51% were female. At discharge, 30.0% screened positive for mild and 12.8% for moderate-severe depressive symptoms, while 27.6% screened positive for anxiety symptoms. For co-morbid symptoms, 17.1% screened positive for anxiety and any depressive symptoms, while 10.8% for anxiety and moderate-severe depressive symptoms. While the EQ-5D-3L had limited screening ability in hospital, the anxiety/depression dimension performed well in the community setting (90-days post-discharge) in screening for anxiety (area under ROC 0.79), depressive symptoms (any: 0.78, moderate-severe: 0.84), and a combination of both (any: 0.86; moderate-severe: 0.91). CONCLUSIONS: The EQ-5D-3L anxiety/depression dimension could be a useful tool in screening for anxiety and depressive symptoms in community settings compared to other self-report screening tools. The usefulness of the EQ-5D-3L as a screening tool in other settings and populations is warranted.

The predictive ability of EQ-5D-3L compared to the LACE index and its association with 30-day post-hospitalization outcomes.

PURPOSE: To examine whether the EQ-5D-3L at the time of discharge from hospital provides additional prognostic information above the LACE index for 30-day post-discharge hospital readmission and to explore the association of EQ-5D-3L with readmissions, emergency department (ED) visits, and death within the same period. METHODS: Using data (n = 495; mean age 62.9 years (SD 18.6), 50.5% female) from a prospective cohort study of patients discharged from medical wards at two university hospitals, the prognostic ability of EQ-5D-3L was examined using C-statistic, Integrated Discrimination Improvement (IDI) Index, and Akaike's Information Criterion (AIC). The associations between EQ-5D-3L dimensions, total sum, index and VAS scores at the time of discharge and 30-day post-discharge ED visits, readmission, and readmission/death were examined using multivariate logistic regression. RESULTS: At the time of discharge, 58.6% of participants reported problems in mobility, 28.3% in self-care, 62.1% in usual activities, 62.7% in pain/discomfort, and 42.4% in anxiety/depression. Mean (SD) total sum score was 7.9 (2.0), index score was 0.69 (0.21), and VAS score was 63.7 (18.4). In adjusted analyses, mobility, self-care, usual activities, and the total sum score were significantly associated with 30-day readmission and readmission/death. Differences in C-statistic for LACE readmission prediction models with and without EQ-5D-3L were small. AIC analysis suggests that readmission prediction models containing EQ-5D-3L dimensions or scores were more often preferred to those with the LACE index only. IDI analysis indicates that the discrimination slope of readmission prediction models is significantly improved with the addition of mobility, self-care, or the total sum score of the EQ-5D-3L. CONCLUSION: The EQ-5D-3L, especially the mobility and self-care dimensions as well as the total sum score, improves 30-day readmission prediction of the LACE index and is associated with 30-day readmissions or readmissions/death.

Adopting and implementing an innovative model to organize diabetes care within First Nations communities: A qualitative assessment.

BACKGROUND: Diabetes care remains suboptimal in First Nations populations. Innovative and culturally relevant approaches are needed to promote systematic and proactive organization of diabetes care for people living with diabetes on-reserve in Canada. The RADAR model is one strategy to improve care: an integrated disease registry paired with an electronic health record for local community healthcare providers with remote care coordination. We qualitatively assessed adoption and implementation of RADAR in First Nations communities in Alberta to inform its potential spread in the province. METHODS: We used the RE-AIM framework to evaluate adoption and implementation of RADAR in 6 First Nations communities. Using purposeful sampling, we recruited local healthcare providers and remote care coordinators involved in delivering RADAR to participate in telephone or in-person interviews at 6- and 24-months post-implementation. Interviews were digitally recorded, transcribed, and verified for accuracy. Data was analyzed using content analysis and managed using ATLAS.ti 8. RESULTS: In total, we conducted 21 semi-structured interviews (6 at 6-months; 15 at 24-months) with 11 participants. Participants included 3 care coordinators and 8 local healthcare providers, including registered nurses, licensed practical nurses, and registered dietitians. We found that adoption of RADAR was influenced by leadership as well as appropriateness, acceptability, and perceived value of the model. In addition, we found that implementation of RADAR was variable across communities regardless of implementation supports and appropriate community-specific adaptations. CONCLUSIONS: The variable adoption and implementation of RADAR has implications for how likely it will achieve its anticipated outcomes. RADAR is well positioned for spread through continued appropriate community-based adaptations and by expanding the existing implementation supports, including dedicated human resources to support the delivery of RADAR and the provision of levels of RADAR based on existing or developed capacity among local HCPs. TRIAL REGISTRATION: Not applicable to this qualitative assessment.  ISRCTN14359671 .

Exploring the impact of pharmacist comprehensive annual care plans on perceived quality of chronic illness care by patients in Alberta, Canada.

BACKGROUND: In 2012, the Government of Alberta introduced a funding program to remunerate pharmacists to develop a comprehensive annual care plan (CACP) for patients with complex needs. The objective of this study is to explore patients' perceptions of the care they received through the pharmacist CACP program in Alberta. METHODS: We invited 3442 patients who received a pharmacist-billed CACP within the previous 3 months and 6888 matched controls across Alberta to complete an online questionnaire. The questionnaire consisted of the short version Patient Assessment of Chronic Illness Care (PACIC-11), with 3 additional pharmacy-specific assessment questions added. Additional questions related to health status and demographics were also included. RESULTS: Overall, most patients indicated a low level of chronic illness care by pharmacists, with few differences noted between CACP patients and non-CACP controls. Of note, controls reported higher quality of care for 5 domains within the adapted PACIC-like tool compared with CACP patients (p < 0.05 for all). Interestingly, only 79 (44%) of CACP patients reported that they had received a CACP, whereas only 192 (66%) of control patients reported that they did not receive a care plan. In a sensitivity analysis including only these respondents, individuals who received a CACP perceived a significantly higher quality of chronic illness care across all PACIC domains. CONCLUSION: Overall, chronic illness care incentivized by the pharmacist CACP program in Alberta is perceived to be moderate to low. When limited to respondents who explicitly recognized receiving the service or not, the perceptions of quality of care were more positive. This suggests that better implementation of CACP by pharmacists may be associated with improved quality of care and that some redesign is needed to engage patients more. Can Pharm J (Ott) 2021;154:xx-xx.

Angiogenin activates the astrocytic Nrf2/antioxidant-response element pathway and thereby protects murine neurons from oxidative stress.

The angiogenin (ANG) gene is mutated frequently in individuals with amyotrophic lateral sclerosis (ALS), a fatal neurodegenerative disease characterized by the progressive loss of motor neurons. Delivering human ANG to mice that display ALS-like symptoms extends their lifespan and improves motor function. ANG is a secretory vertebrate RNase that enters neuronal cells and cleaves a subset of tRNAs, leading to the inhibition of translation initiation and the assembly of stress granules. Here, using murine neuronal and astrocytic cell lines, we find that ANG triggers the activation of the Nrf2 (nuclear factor erythroid 2-related factor 2) pathway, which provides a critical cellular defense against oxidative stress. This activation, which occurred in astrocytes but not in neurons, promoted the survival of proximal neurons that had oxidative injury. These findings extend the role of ANG as a neuroprotective agent and underscore its potential utility in ALS management.

SARS-CoV-2 Infections and Serologic Responses from a Sample of U.S. Navy Service Members - USS Theodore Roosevelt, April 2020.

Compared with the volume of data on coronavirus disease 2019 (COVID-19) outbreaks among older adults, relatively few data are available concerning COVID-19 in younger, healthy persons in the United States (1,2). In late March 2020, the aircraft carrier USS Theodore Roosevelt arrived at port in Guam after numerous U.S. service members onboard developed COVID-19. In April, the U.S. Navy and CDC investigated this outbreak, and the demographic, epidemiologic, and laboratory findings among a convenience sample of 382 service members serving aboard the aircraft carrier are reported in this study. The outbreak was characterized by widespread transmission with relatively mild symptoms and asymptomatic infection among this sample of mostly young, healthy adults with close, congregate exposures. Service members who reported taking preventive measures had a lower infection rate than did those who did not report taking these measures (e.g., wearing a face covering, 55.8% versus 80.8%; avoiding common areas, 53.8% versus 67.5%; and observing social distancing, 54.7% versus 70.0%, respectively). The presence of neutralizing antibodies, which represent antibodies that inhibit SARS-CoV-2, among the majority (59.2%) of those with antibody responses is a promising indicator of at least short-term immunity. This report improves the understanding of COVID-19 in the U.S. military and among young adults in congregate settings and reinforces the importance of preventive measures to lower risk for infection in similar environments.

Estimated Community Seroprevalence of SARS-CoV-2 Antibodies - Two Georgia Counties, April 28-May 3, 2020.

Transmission of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), is ongoing in many communities throughout the United States. Although case-based and syndromic surveillance are critical for monitoring the pandemic, these systems rely on persons obtaining testing or reporting a COVID-19-like illness. Using serologic tests to detect the presence of SARS-CoV-2 antibodies is an adjunctive strategy that estimates the prevalence of past infection in a population. During April 28-May 3, 2020, coinciding with the end of a statewide shelter-in-place order, CDC and the Georgia Department of Public Health conducted a serologic survey in DeKalb and Fulton counties in metropolitan Atlanta to estimate SARS-CoV-2 seroprevalence in the population. A two-stage cluster sampling design was used to randomly select 30 census blocks in each county, with a target of seven participating households per census block. Weighted estimates were calculated to account for the probability of selection and adjusted for age group, sex, and race/ethnicity. A total of 394 households and 696 persons participated and had a serology result; 19 (2.7%) of 696 persons had SARS-CoV-2 antibodies detected. The estimated weighted seroprevalence across these two metropolitan Atlanta counties was 2.5% (95% confidence interval [CI] = 1.4-4.5). Non-Hispanic black participants more commonly had SARS-CoV-2 antibodies than did participants of other racial/ethnic groups (p<0.01). Among persons with SARS-CoV-2 antibodies, 13 (weighted % = 49.9; 95% CI = 24.4-75.5) reported a COVID-19-compatible illness,* six (weighted % = 28.2; 95% CI = 11.9-53.3) sought medical care for a COVID-19-compatible illness, and five (weighted % = 15.7; 95% CI = 5.1-39.4) had been tested for SARS-CoV-2 infection, demonstrating that many of these infections would not have been identified through case-based or syndromic surveillance. The relatively low seroprevalence estimate in this report indicates that most persons in the catchment area had not been infected with SARS-CoV-2 at the time of the survey. Continued preventive measures, including social distancing, consistent and correct use of face coverings, and hand hygiene, remain critical in controlling community spread of SARS-CoV-2.

3125 steps to perfect health: a nonparametric approach to developing the EQ-5D-5L value set.

PURPOSE: The EQ-5D-5L is a commonly used instrument for assessing the utility of different health states. Health state utility values are a key component of health technology evaluations. Such evaluations are used to support evidence-based decisions surrounding health resource allocations and therefore rely on the accuracy of the valuation set used. This paper takes an alternative approach to developing an EQ-5D-5L value set for Canada. The aim is to introduce a robust method that is likely to generate a value set with improved accuracy and that can be used to generate value sets for other populations without the need for modification. METHODS: The common approach to developing a valuation set for preference-based instruments is to ask a population sample to value a subset of the health states using an established preference elicitation technique. The relationship between the elicited health states and the preferences is used to inform a model to predict the utility values for the unsampled health states described by the instrument. The true relationship is unknown and the functional forms chosen in the modelling process vary across valuation studies. We use nonparametric local constant regression to estimate an EQ-5D-5L value set for Canada and propose this method as an alternative for value set development because it does not require the specification of a functional form at the outset. RESULTS: Compared to the existing valuation model for Canada, the nonparametric method improves in-sample fit, reducing the average squared prediction error by 94.46% and the mean absolute error by 79.37%. In four of five sets of out-of-sample studies, this new approach performs significantly better than 9 comparison models. Despite lacking any restriction on the functional form of the resulting valuations, the valuation set generated by this new approach is logically consistent. 100% of the pairs of health states in which one state is dominant have health state values which respect this ordering. The value set also appears to differ substantially from the comparators. CONCLUSIONS: Overall, the results suggest that nonparametric regression is a promising tool for the estimation of EQ-5D-5L valuation sets and may be a good option in a standardised methodology for value set development.

A cluster randomized controlled trial for the Evaluation of routinely Measured PATient reported outcomes in HemodialYsis care (EMPATHY): a study protocol.

BACKGROUND: Kidney failure requiring dialysis is associated with poor health outcomes and health-related quality of life (HRQL). Patient-reported outcome measures (PROMs) capture symptom burden, level of functioning and other outcomes from a patient perspective, and can support clinicians to monitor disease progression, address symptoms, and facilitate patient-centered care. While evidence suggests the use of PROMs in clinical practice can lead to improved patient experience in some settings, the impact on patients' health outcomes and experiences is not fully understood, and their cost-effectiveness in clinical settings is unknown. This study aims to fill these gaps by evaluating the effectiveness and cost-effectiveness of routinely measuring PROMs on patient-reported experience, clinical outcomes, HRQL, and healthcare utilization. METHODS: The EMPATHY trial is a pragmatic multi-centre cluster randomized controlled trial that will implement and evaluate the use of disease-specific and generic PROMs in three kidney care programs in Canada. In-centre hemodialysis units will be randomized into four groups, whereby patients: 1) complete a disease-specific PROM; 2) complete a generic PROM; 3) complete both types of PROMs; 4) receive usual care and do not complete any PROMs. While clinical care pathways are available to all hemodialysis units in the study, for the three active intervention groups, the results of the PROMs will be linked to treatment aids for clinicians and patients. The primary outcome of this study is patient-provider communication, assessed by the Communication Assessment Tool (CAT). Secondary outcomes include patient management and symptoms, use of healthcare services, and the costs of implementing this intervention will also be estimated. The present protocol fulfilled the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) checklist. DISCUSSION: While using PROMs in clinical practice is supported by theory and rationale, and may engage patients and enhance their role in decisions regarding their care and outcomes, the best approach of their use is still uncertain. It is important to rigorously evaluate such interventions and investments to ensure they provide value for patients and health systems. TRIAL REGISTRATION: Protocol version (1.0) and trial registration data are available on www.clinicaltrials.gov , identifier: NCT03535922 , registered May 24, 2018.

Evaluation of comprehensive annual care plans by pharmacists in Alberta for patients with complex conditions.

OBJECTIVES: To characterize the population of patients who received a pharmacist-billed comprehensive annual care plan (CACP) in Alberta and to evaluate any changes in health care use for such patients, including physician visits, hospitalizations, and emergency department (ED) visits. METHODS: We used administrative data from Alberta Health to identify all individuals in Alberta who received a pharmacist CACP between July 1, 2012, and March 31, 2015. Two control patients were identified for each CACP patient, matched on age, sex, provider, date of service, and qualifying conditions. Controlled interrupted time series analyses were used to evaluate changes in physician visits, all-cause and ambulatory care-sensitive condition (ACSC)-related hospitalizations, and ED visits in the 12 months before and after the CACP index date. RESULTS: Between July 1, 2012, and March 31, 2015, 188,640 pharmacy CACPs were billed in Alberta. Of these, 137,178 CACP patients were matched to 241,658 control patients. Those who received a CACP were associated with an overall decrease in all-cause hospitalizations, ACSC-related ED visits, and physician visits (181, 144, and 1206 events per 10,000 people, respectively, P < 0.05) compared with controls. However, among those who received a CACP, all-cause ED visits and ACSC-related hospitalizations increased by 40.1 and 8 visits per 10,000, respectively (P < 0.05), compared with controls. CONCLUSION: The uptake of the pharmacy CACP remuneration model has been substantial since 2012. Overall, the CACP philosophy of a single yearly assessment has demonstrated limited impact on major health care use.

Discriminative validity of the EQ-5D-5 L and SF-12 in older adults with arthritis.

BACKGROUND: The EQ-5D-5 L and the SF-12 are the most commonly used generic measures of health-related quality of life among people with arthritis. However, there is little evidence on the extent to which the individual dimensions and domains of these instruments perform among this population. The objective was to examine the discriminative validity of the EQ-5D-5 L and the SF-12 version 2 (and SF-6D) in capturing the burden of arthritis on health-related quality of life in older adults. METHODS: Cross-sectional data from the Alberta Retired Teachers Association survey were used. A known-groups approach, with a-priori hypotheses, was used to examine the discriminative validity of the domain and summary scores of the EQ-5D-5 L and the SF-12 version 2 (and SF-6D). Groups were defined based on self-reported of arthritis, chronic pain level, presence and number of comorbidities, and self-reported health status. RESULTS: Mean age of respondents (N = 2844) was 68.6 (standard deviation [SD] 5.9) years; 54.8% were female, with mean body mass index (BMI) of 27.2 kg/m2 (SD 4.8), and 36.6% reported having arthritis. The overall mean EQ-5D-5 L index score was 0.86 (SD 0.11) and that of SF-6D was 0.79 (SD 0.13). Participants with arthritis had lower EQ-5D-5 L index score (0.83, SD 0.13) and SF-6D index score (0.75, SD 0.13) compared to those without arthritis (0.88, SD 0.09 and 0.81, SD 0.12, respectively). EQ-5D-5 L and SF-6D index scores demonstrated moderate discriminative validity with a moderate effect size (0.5). Related dimensions and domains between the EQ-5D-5 L and SF-12 (e.g., mobility with physical functioning score, pain/discomfort with bodily pain and anxiety/depression with mental health) were moderately to strongly correlated (r = 0.6-0.7). Both instruments could not adequately discriminate between participants with moderate and severe chronic pain of 6-month duration. CONCLUSION: Overall, the EQ-5D-5 L pain/discomfort and mobility dimensions, and the SF-12 bodily pain scale had moderate discriminative ability among older adults with arthritis. However, both instruments had limited discriminative ability for chronic pain. The importance and nature of chronic pain assessment in a given application need to be considered when choosing any of these instruments for measuring health-related quality of life in this patient population.