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Purpose This study aims to determine whether radiologists who perform well in screening also perform well in interpreting diagnostic mammography. Materials and methods We evaluated the accuracy of 468 radiologists interpreting 2,234,947 screening and 196,164 diagnostic mammograms. Adjusting for site, radiologist, and patient characteristics, we identified radiologists with performance in the highest tertile and compared to those with lower performance. Results A moderate correlation was noted for radiologists' accuracy when interpreting screening versus their accuracy on diagnostic examinations: sensitivity (r spearman =0.51, 95% CI: 0.22, 0.80; P =.0006) and specificity (r spearman =0.40, 95% CI: 0.30, 0.49; P <.0001). Conclusion Different educational approaches to screening and diagnostic imaging should be considered. [ABSTRACT FROM AUTHOR]

Background Context: This is the first study to systematically evaluate the value of a longer treatment period for massage. We provide a framework of how to conceptualize an optimal dose in this challenging setting of nonpharmacologic treatments.Purpose: The aim was to determine the optimal dose of massage for neck pain.Study Design/setting: Two-phase randomized trial for persons with chronic nonspecific neck pain. Primary randomization to one of five groups receiving 4 weeks of massage (30 minutes 2x/or 3x/wk or 60 minutes 1x, 2x, or 3x/wk). Booster randomization of participants to receive an additional six massages, 60 minutes 1x/wk, or no additional massage.Patient Sample: A total of 179 participants from Group Health and the general population of Seattle, WA, USA recruited between June 2010 and August 2011 were included.Outcome Measures: Primary outcomes self-reported neck-related dysfunction (Neck Disability Index) and pain (0-10 scale) were assessed at baseline, 12, and 26 weeks. Clinically meaningful improvement was defined as greater than or equal to 5-point decrease in dysfunction and greater than or equal to 30% decrease in pain from baseline.Methods: Clinically meaningful improvement for each primary outcome with both follow-up times was analyzed using adjusted modified Poisson generalized estimating equations (GEEs). Secondary analyses for the continuous outcomes used linear GEEs.Results: There were no observed differences by primary treatment group at 12 or 26 weeks. Those receiving booster dose had improvements in both dysfunction and pain at 12 weeks (dysfunction: relative risk [RR]=1.56 [1.08-2.25], p=.018; pain: RR=1.25 [0.98-1.61], p=.077), but those were nonsignificant at 26 weeks (dysfunction: RR=1.22 [0.85-1.74]; pain: RR=1.09 [0.82-1.43]). Subgroup analysis by primary and booster treatments found the booster dose only effective among those initially randomized to one of the 60-minute massage groups.Conclusions: "Booster" doses for those initially receiving 60 minutes of massage should be incorporated into future trials of massage for chronic neck pain. [ABSTRACT FROM AUTHOR]

Rationale and Objectives: Mammography quality assurance programs have been in place for more than a decade. We studied radiologists' self-reported performance goals for accuracy in screening mammography and compared them to published recommendations.Materials and Methods: A mailed survey of radiologists at mammography registries in seven states within the Breast Cancer Surveillance Consortium (BCSC) assessed radiologists' performance goals for interpreting screening mammograms. Self-reported goals were compared to published American College of Radiology (ACR) recommended desirable ranges for recall rate, false-positive rate, positive predictive value of biopsy recommendation (PPV2), and cancer detection rate. Radiologists' goals for interpretive accuracy within desirable range were evaluated for associations with their demographic characteristics, clinical experience, and receipt of audit reports.Results: The survey response rate was 71% (257 of 364 radiologists). The percentage of radiologists reporting goals within desirable ranges was 79% for recall rate, 22% for false-positive rate, 39% for PPV2, and 61% for cancer detection rate. The range of reported goals was 0%-100% for false-positive rate and PPV2. Primary academic affiliation, receiving more hours of breast imaging continuing medical education, and receiving audit reports at least annually were associated with desirable PPV2 goals. Radiologists reporting desirable cancer detection rate goals were more likely to have interpreted mammograms for 10 or more years, and >1000 mammograms per year.Conclusion: Many radiologists report goals for their accuracy when interpreting screening mammograms that fall outside of published desirable benchmarks, particularly for false-positive rate and PPV2, indicating an opportunity for education. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To examine how use of clinical history affects radiologist’s interpretation of screening mammography. Study Design and Setting: Using a self-administered survey and actual interpretive performance, we examined associations between use of clinical history and sensitivity, false-positive rate, recall rate, and positive predictive value, after adjusting for relevant covariates using conditional logistic regression. Results: Of the 216 radiologists surveyed (63.4%), most radiologists reported usually or always using clinical history when interpreting screening mammography. Compared with radiologists who rarely use clinical history, radiologists who usually or always use it had a higher false-positive rate with younger women (10.7 vs. 9.7), denser breast tissue (10.1 for heterogeneously dense to 10.9 for extremely dense vs. 8.9 for fatty tissue), or longer screening intervals (> prior 5 years) (12.5 vs. 10.5). Effect of current hormone therapy (HT) use on false-positive rate was weaker among radiologists who use clinical history compared with those who did not (P =0.01), resulting in fewer false-positive examinations and a nonsignificant lower sensitivity (79.2 vs. 85.2) among HT users. Conclusion: Interpretive performance appears to be influenced by patient age, breast density, screening interval, and HT use. This influence does not always result in improved interpretive performance. [Copyright &y& Elsevier]

Background: Measures of neighborhood deprivation used in health research are typically based on conventional area-based SES. Purpose: The aim of this study is to examine new data and measures of SES for use in health research. Specifically, assessed property values are introduced as a new individual-level metric of wealth and tested for their ability to substitute for conventional area-based SES as measures of neighborhood deprivation. Methods: The analysis was conducted in 2010 using data from 1922 participants in the 2008–2009 survey of the Seattle Obesity Study (SOS). It compared the relative strength of the association between the individual-level neighborhood wealth metric (assessed property values) and area-level SES measures (including education, income, and percentage above poverty as single variables, and as the composite Singh index) on the binary outcome fair/poor general health status. Analyses were adjusted for gender, categoric age, race, employment status, home ownership, and household income. Results: The neighborhood wealth measure was more predictive of fair/poor health status than area-level SES measures, calculated either as single variables or as indices (lower DIC measures for all models). The odds of having a fair/poor health status decreased by 0.85 (95% CI=0.77, 0.93) per $50,000 increase in neighborhood property values after adjusting for individual-level SES measures. Conclusions: The proposed individual-level metric of neighborhood wealth, if replicated in other areas, could replace area-based SES measures, thus simplifying analyses of contextual effects on health. [ABSTRACT FROM AUTHOR]

Rationale and Objectives: To examine the feasibility of and satisfaction with a tailored web-based intervention designed to decrease radiologists' recommendation of inappropriate additional work-up after a screening mammogram.Materials and Methods: We developed a web-based educational intervention designed to reduce inappropriate recall. Radiologists were randomly assigned to participate in an early intervention group or a late (control) intervention group, the latter of which served as a control for a 9-month follow-up period, after which they were invited to participate in the intervention. Intervention content was derived from our prior research and included three modules: 1) an introduction to audit statistics for mammography performance; 2) a review of data showing radiologists' inflated perceptions of medical malpractice risks related to breast imaging, and 3) a review of data on breast cancer risk among women seen in their practices. Embedded within the intervention were individualized audit data for each participating radiologists obtained from the national Breast Cancer Surveillance Consortium.Results: Seventy-four radiologists (37.8%; 74/196) consented to the intervention, which was completed by 67.5% (27/40) of those randomized to the early intervention group and 41.2% (14/34) of those randomized to the late (control) group. Thus, a total of 41 (55%) completed the intervention. On average, three log-ins were used to complete the program (range 1-14), which took approximately 1 hour. Ninety-five percent found the program moderately to very helpful in understanding how to calculate basic performance measures. Ninety-three percent found viewing their own performance measures moderately to very helpful, and 83% reported it being moderately to very important to learn that the breast cancer risk in their screening population program was lower than perceived. The percentage of radiologists who reported that the risk of medical malpractice influences their recall rates dropped from 36.3% preintervention to 17.8% after intervention with a similar drop in perceived influence of malpractice risk on their recommendations for breast biopsy (36.4 to 17.3%). More than 75% of radiologists answered the postintervention knowledge questions correctly, and the percent of time spent in breast imaging did not appear to influence responses. The majority (>92%) of participants correctly responded that the target recall rate in the United States is 9%. The mean self-reported recall rates were 13.0 for radiologists spending <40% time in breast imaging and 14.9% for those spending >40% time spent in breast imaging, which was highly correlated with their actual recall rates (0.991; P < .001).Conclusions: Radiologists who begin an internet-based tailored intervention designed to help reduce unnecessary recall will likely complete it, although only 55% who consented to the study actually undertook the intervention. Participants found the program useful in helping them understand why their recall rates may be elevated. [ABSTRACT FROM AUTHOR]

Abstract: Evidence suggests variability in adult obesity risk at a small-scale geographic area is associated with differences in neighborhood socioeconomic status (SES). However, the extent to which geographic variability in child obesity is associated with neighborhood SES is unknown. The objective of this paper was to estimate risk of child obesity associated with multiple census tract SES measures and race within a large urban U.S. county. Height, weight, age, sex, medical insurance type and census tract residence were obtained for 6–18 year old children (n =8616) who received medical care at a health plan in King County, Washington, in 2006. Spatial analyses examined the individual risk of obesity (BMI≥95th percentile) with 2000 US census tract measures of median household income, home ownership, adult female education level, single parent households, and race as predictors. Conditional autoregressive regression models that incorporated adjacent census tracts (spatial autocorrelation) were applied to each census tract variable, adjusting for individual variables. We found that in adjusted spatial models, child obesity risk was significantly associated with each census tract variable in the expected direction: lower household income, lower home ownership, and for each 10% increase in less educated women, and single parent households, as well as non-white residents. In a spatial model including all variables, the SES/race variables explained approximately 24% of geographic variability in child obesity. Results indicated that living in census tracts with social disadvantage defined by multiple different measures was associated with child obesity among insured children in a large U.S. urban county. These results contribute new information on relationships between broader social and economic context and child obesity risk using robust spatial analyses. [Copyright &y& Elsevier]

Abstract: Objective: To assess the impact of women''s breast cancer risk factors (use of hormone therapy, family history of breast cancer, previous breast biopsy) on radiologists'' mammographic interpretive performance and whether the influence of risk factors varies according to radiologist characteristics. Study Design and Setting: Screening mammograms (n =638,947) performed from 1996 to 2005 by 134 radiologists from three Breast Cancer Surveillance Consortium registries was linked to cancer outcomes, radiologist surveys, and patient questionnaires. Interpretive performance measures were modeled using marginal and conditional logistic regression. Results: Having one or more clinical risk factors was associated with higher recall rates (1 vs. 0 risk factors: odds ratio [OR]=1.17, 95% confidence interval [CI]=1.15–1.19; ≥2 vs. 0: OR=1.43, 95% CI=1.40–1.47) and lower specificity (1 vs. 0: OR=0.86 [95% CI=0.84–0.88]; ≥2 vs. 0: OR=0.70 [95% CI=0.68–0.72]) without a corresponding improvement in sensitivity and only a small increase in positive predictive value (1 vs. 0: OR=1.08 [95% CI=0.99–1.19]; ≥2 vs. 0: OR=1.12 [95% CI=0.99–1.26]). There was no indication that influence of risk factors varied by radiologist characteristics. Conclusion: Women with clinical risk factors who undergo screening mammography are more likely recalled for false-positive evaluation without an associated increase in cancer detection. Radiologists and patients with risk factors should be aware of this increased risk of adverse screening events. [Copyright &y& Elsevier]

Study objective: Survival after out-of-hospital cardiac arrest depends on the links in the chain of survival. The Utstein elements are designed to assess these links and provide the basis for comparing outcomes within and across communities. We assess whether these measures sufficiently predict survival and explain outcome differences. Methods: We used an observational, prospective data collection, case-series of adult persons with nontraumatic out-of-hospital cardiac arrest from December 1, 2005, through March 1, 2007, from the multisite, population-based Resuscitation Outcomes Consortium Epistry–Cardiac Arrest. We used logistic regression, receiver operating curves, and measures of variance to estimate the extent to which the Utstein elements predicted survival to hospital discharge and explained outcome variability overall and between 7 Resuscitation Outcomes Consortium sites. Analyses were conducted for all emergency medical services–treated cardiac arrests and for the subset of bystander-witnessed patient arrests because of presumed cardiac cause presenting with ventricular fibrillation or ventricular tachycardia. Results: Survival was 7.8% overall (n=833/10,681) and varied from 4.6% to 14.7% across Resuscitation Outcomes Consortium sites. Among bystander-witnessed ventricular fibrillation or ventricular tachycardia, survival was 22.1% overall (n=323/1459) and varied from 12.5% to 41.0% across sites. The Utstein elements collectively predicted 72% of survival variability among all arrests and 40% of survival variability among bystander-witnessed ventricular fibrillation. The Utstein elements accounted for 43.6% of the between-site survival difference among all arrests and 22.3% of the between-site difference among the bystander-witnessed ventricular fibrillation subset. Conclusion: The Utstein elements predict survival but account for only a modest portion of outcome variability overall and between Resuscitation Outcomes Consortium sites. The results underscore the need for ongoing investigation to better understand characteristics that influence cardiac arrest survival. [Copyright &y& Elsevier]

Rationale and Objectives: Research on communication between radiologists and women undergoing screening and diagnostic mammography is limited. We describe community radiologists'' communication practices with patients regarding screening and diagnostic mammogram results and factors associated with frequency of communication. Materials and Methods: We received surveys from 257 radiologists (70% of those eligible) about the extent to which they talk to women as part of their health care visit for either screening or diagnostic mammograms, whether this occurs if the exam assessment is positive or negative, and how they use estimates of patient risk to convey information about an abnormal exam where the specific finding of cancer is not yet known. We also assessed characteristics of the radiologists to identify associations with more or less frequent communication at the time of the mammogram. Results: Two hundred and forty-three radiologists provided complete data (95%). Very few (<6%) reported routinely communicating with women when screening mammograms were either normal or abnormal. Fewer than half (47%) routinely communicated with women when their diagnostic mammograms were normal, whereas 77% often or always communicated with women when their diagnostic exams were abnormal. For positive diagnostic exams, female radiologists were more likely to be frequent communicators compared to males (87.1%–72.8%; P =.02) and those who spend 40%–79% of their time in breast imaging (94.6%) were more likely to be frequent communicators compared to those who spend less time (67.2%–78.9%; P =.02). Most radiologists convey risk information using general rather than numeric statements (57.7% vs. 28.5%). Conclusions: Radiologists are most likely to convey information about diagnostic mammographic findings when results are abnormal. Most radiologists convey risk information using general rather than numeric statements. [Copyright &y& Elsevier]

Study objective: In 1996, the Food and Drug Administration and the Department of Health and Human Services enacted rules allowing a narrow exception from informed consent for critically ill patients enrolled in emergency research. These include requirements for community consultation prior to trial implementation. Previous studies have noted difficulty in engaging the community. We seek to describe the experience with random dialing surveys as a tool for community consultation across 5 metropolitan regions in the United States. Methods: Random dialing surveys were used as part of the community consultation for an out-of-hospital clinical trial sponsored by the Resuscitation Outcomes Consortium. The survey method was designed to obtain a representative sample of the community according to population demographics and geography. Logistics of survey administration, role of the survey in community consultation, and survey results by population demographics are discussed. Results: Random dialing surveys were conducted in 5 of 8 US Resuscitation Outcomes Consortium sites. Overall, 70% to 79% of respondents indicated they would be willing to be enrolled in this study. Support for the inclusion of children (aged 15 to 18 years) ranged from 52% to 71%. Respondents aged 18 to 34 years were more willing to participate in the trial than older age groups. Women and racial minorities were less likely to favor the inclusion of minors. Conclusion: Random dialing surveys provide an additional tool to engage the community and obtain a sample of the opinion of the population about research conducted under the emergency exception from informed consent regulations. Similar results were obtained across 5 diverse communities in the United States. [Copyright &y& Elsevier]

Summary: Objective: Manual CPR improves the likelihood of neurologically intact survival following cardiac arrest. The mechanism of this benefit is not completely understood. We propose a mechanism whereby manual CPR simultaneously limits ischemia and specifically protects against reperfusion injury. We derive a conceptual framework that describes cell survival as it relates to the ischemic and reperfusion stages and CPR effects. Results: Based on a synthesis of basic science and clinical information, we propose that the benefit of the subnormal circulation produced by manual CPR is multifaceted and specifically includes attenuating reperfusion injury by providing graded blood flow to the heart and brain. Although manual CPR produces reperfusion pathophysiology, the low flow from CPR limits reperfusion injury specifically through mechanisms of post-ischemic conditioning which include attenuating peak levels of oxidative substrate and activating pathways that protect against oxidative stress. Conclusions: If such a hypothesis of post-ischemic conditioning is borne out, CPR may be considered a dose-sensitive therapy whereby certain physiologic states would be best served by different levels of circulation and hence distinct grades of CPR. [Copyright &y& Elsevier]

Background: Pharmacist- or nurse-led team care decreases patient blood pressure (BP) and cardiovascular disease (CVD) risk. Purpose: To evaluate whether a Web-based dietitian-led (WD) team care intervention was feasible and resulted in decreased BP, CVD risk, and weight compared to usual care (UC). Methods: Electronic health record (EHR) data identified patients aged 30−69 years with BMI >26, elevated BP, and 10%−25% 10-year Framingham CVD risk who were registered patient website users. Patients with uncontrolled BP at screening were randomized to UC or WD, which included a home BP monitor, scale, and dietitian team care. WD participants had a single in-person dietitian visit to obtain baseline information and create a plan to reduce CVD risk. Planned follow-up occurred via secure messaging to report BP, weight, and fruit and vegetable intake and receive ongoing feedback. If needed, dietitians encouraged patients and their physicians to intensify antihypertensive and lipid-lowering medications. Primary outcomes were change in systolic BP and weight loss ≥4 kg at 6 months. Feasibility outcomes included intervention utilization and satisfaction. Results: Between 2010 and 2011, a total of 90 of 101 participants completed 6-month follow-ups. The WD group had higher rates of secure messaging utilization and patient satisfaction. The WD group lost significantly more weight than the UC group (adjusted net difference=−3.2 kg, 95% CI=−5.0, −1.5, p<0.001) and was more likely to lose ≥4 kg (adjusted relative risk [RRadj]=2.96, 95% CI=1.16, 7.53). BP control and CVD risk reduction were greater in WD than UC, but differences were not statistically significant. Conclusions: WD intervention was feasible and resulted in decreased weight, BP, and CVD risk. A larger trial is justified. Trial Registration Number: Trial Registration Number: NCT01077388. [Copyright &y& Elsevier]

Abstract: Shopping at low-cost supermarkets has been associated with higher obesity rates. This study examined whether attitudes toward healthy eating are independently associated with diet quality among shoppers at low-cost, medium-cost, and high-cost supermarkets. Data on socioeconomic status (SES), attitudes toward healthy eating, and supermarket choice were collected using a telephone survey of a representative sample of adult residents of King County, WA. Dietary intake data were based on a food frequency questionnaire. Thirteen supermarket chains were stratified into three categories: low, medium, and high cost, based on a market basket of 100 commonly eaten foods. Diet-quality measures were energy density, mean adequacy ratio, and total servings of fruits and vegetables. The analytical sample consisted of 963 adults. Multivariable regressions with robust standard error examined relations between diet quality, supermarket type, attitudes, and SES. Shopping at higher-cost supermarkets was associated with higher-quality diets. These associations persisted after adjusting for SES, but were eliminated after taking attitudinal measures into account. Supermarket shoppers with positive attitudes toward healthy eating had equally higher-quality diets, even if they shopped at low-, medium-, or high-cost supermarkets, independent of SES and other covariates. These findings imply that shopping at low-cost supermarkets does not prevent consumers from having high-quality diets, as long as they attach importance to good nutrition. Promoting nutrition-education strategies among supermarkets, particularly those catering to low-income groups, can help to improve diet quality. [Copyright &y& Elsevier]

Background: Multivariable cardiovascular disease (CVD) risk calculators, such as the Framingham risk equations, can be used to identify populations most likely to benefit from treatments to decrease risk. Purpose: To determine the proportion of adults within an electronic health record (EHR) for whom Framingham CVD risk scores could be calculated using cholesterol (lab-based) and/or BMI (BMI-based) formulae. Methods: EHR data were used to identify patients aged 30–74 years with no CVD and at least 2 years continuous enrollment before April 1, 2010, and relevant data from the preceding 5-year time frame. Analyses were conducted between 2010 and 2011 to determine the proportion of patients with a lab- or BMI-based risk score, the data missing, and the concordance between scores. Results: Of 122,270 eligible patients, 59.7% (n=73,023) had sufficient data to calculate the lab-based risk score and 84.1% (102,795) the BMI-based risk score. Risk categories were concordant in 78.2% of patients. When risk categories differed, BMI-based risk was almost always in a higher category, with 20.3% having a higher and 1.4% a lower BMI- than lab-based risk score. Concordance between lab- and BMI-based risk was greatest among those at lower estimated risk, including people who were younger, female, without diabetes, not obese, and those not on blood pressure– or lipid-lowering medications. Conclusions: EHR data can be used to classify CVD risk for most adults aged 30–74 years. In the population for the current study, CVD risk scores based on BMI could be used to identify those at low risk for CVD and potentially reduce unnecessary laboratory cholesterol testing. Trial registration: This study is registered at clinicaltrials.gov NCT01077388. [Copyright &y& Elsevier]

Background: Trauma is the leading cause of death among North Americans between the ages of 1 and 44 years. Resuscitation with hypertonic saline (7.5%) solutions can reduce mortality in hypotensive and brain-injured patients.Study Design: Two multicenter, randomized, clinical trials were designed to compare hypertonic saline resuscitation with or without dextran with conventional isotonic resuscitation in patients with hypovolemic shock or traumatic brain injury. During a 3-year period, 5,848 patients will be randomized, with a primary end point of 28-day survival in the hypovolemic shock cohort and 6-month neurologic outcomes in the traumatic brain injury cohort.Results: This is a report of the study design and implementation of 2 large-scale prehospital intervention trials from the Resuscitation Outcomes Consortium that qualify for exception from informed consent required for emergency research outlined in FDA regulation 21CFR50.24 and the Canadian Tri-Council Agreement for research in emergency health situations (Article 2.8).Conclusions: We have successfully designed and implemented two prehospital intervention trials. The proc-ess has helped define the numerous challenges that must be overcome to pursue exception from informed consent resuscitation research in the prehospital setting. The results of these studies will hopefully advance and improve the early care of the severely injured patient. [ABSTRACT FROM AUTHOR]

To examine whether built environment and food metrics are associated with glycemic control in people with type 2 diabetes. Research Design and Methods: We included 14,985 patients with type 2 diabetes using electronic health records from Kaiser Permanente Washington. Patient addresses were geocoded with ArcGIS using King County and Esri reference data. Built environment exposures estimated from geocoded locations included residential unit density, transit threshold residential unit density, park access, and having supermarkets and fast food restaurants within 1600-m Euclidean buffers. Linear mixed effects models compared mean changes of HbA1c from baseline at 1, 3 (primary) and 5 years by each built environment variable. Patients (mean age = 59.4 SD = 13.2, 49.5% female, 16.6% Asian, 9.8% Black, 5.5% Latino/Hispanic, 57.1% White, 20% insulin dependent, mean BMI = 32.7±7.7) had an average of 6 HbA1c measures available. Participants in the 1st tertile of residential density (lowest) had a greater decline in HbA1c (−0.42, −0.43, and −0.44 in years 1, 3, and 5 respectively) than those in the 3rd tertile (HbA1c = −0.37 at 1- and 3-years and −0.36 at 5-years; all p-values <0.05). Having any supermarkets within 1600 m of home was associated with a greater decrease in HbA1c at 1-year and 3-years compared to having none (all p-values <0.05). Lower residential density and better proximity to supermarkets may benefit HbA1c control in people with people with type 2 diabetes. However, effects were small and indicate limited clinical significance. • Among people with type 2 diabetes, those in the lowest residential density areas had better glycemic control over 5-years. • People with type 2 diabetes who had a supermarket within 1600 m of home had better glycemic control over 3-years. • Associations were small indicating that other social environmental factors may have larger impacts on glycemic control [ABSTRACT FROM AUTHOR]

COVID-19 vaccination rates among long-term care center (LTCC) workers are among the lowest of all frontline health care workers. Current efforts to increase COVID-19 vaccine uptake generally focus on strategies that have proven effective for increasing influenza vaccine uptake among health care workers including educational and communication strategies. Experimental evidence is lacking on the comparative advantage of educational strategies to improve vaccine acceptance and uptake, especially in the context of COVID-19. Despite the lack of evidence, education and communication strategies are recommended to improve COVID-19 vaccination rates and decrease vaccine hesitancy (VH), especially strategies using tailored messaging for disproportionately affected populations. We describe a cluster-randomized comparative effectiveness trial with 40 LTCCs and approximately 4000 LTCC workers in 2 geographically, culturally, and ethnically distinct states. We compare the effectiveness of two strategies for increasing COVID-19 booster vaccination rates and willingness to promote COVID-19 booster vaccination: co-design processes for tailoring educational messages vs. an enhanced usual care comparator. Our study focuses on the language and/or cultural groups that are most disproportionately affected by VH and low COVID-19 vaccine uptake in these LTCCs. Finding effective methods to increase COVID-19 vaccine uptake and decrease VH among LTCC staff is critical. Beyond COVID-19, better approaches are needed to improve vaccine uptake and decrease VH for a variety of existing vaccines as well as vaccines created to address novel viruses as they emerge. [ABSTRACT FROM AUTHOR]

Abstract Background The US Preventive Services Task Force recommends out-of-office blood pressure (BPs) before making a new diagnosis of hypertension, using 24-h ambulatory (ABPM) or home BP monitoring (HBPM), however this is not common in routine clinical practice. Blood Pressure Checks and Diagnosing Hypertension (BP-CHECK) is a randomized controlled diagnostic study assessing the comparability and acceptability of clinic, home, and kiosk-based BP monitoring to ABPM for diagnosing hypertension. Stakeholders including patients, providers, policy makers, and researchers informed the study design and protocols. Methods Adults aged 18–85 without diagnosed hypertension and on no hypertension medication with elevated BPs in clinic and at the baseline research visit are randomized to one of 3 regimens for diagnosing hypertension: (1) clinic BPs, (2) home BPs, or (3) kiosk BPs; all participants subsequently complete ABPM. The primary outcomes are the comparability (with daytime ABPM mean systolic and diastolic BP as the reference standard) and acceptability (e.g., adherence to, patient-reported outcomes) of each method compared to ABPM. Longer-term outcomes are assessed at 6-months including: patient-reported outcomes, primary care providers' diagnosis of hypertension; and BP control. We report challenges experienced and our response to these. Results Enrollment began in May of 2017 with a target of randomizing 510 participants. BP thresholds for diagnosing hypertension in the US changed after the trial started. We discuss the stakeholder process used to assess and respond to these changes. Conclusion and public health impact BP-CHECK will inform which hypertension diagnostic methods are most accurate, acceptable, and feasible to implement in primary care. [ABSTRACT FROM AUTHOR]

In cluster randomized trials (CRTs), the hierarchical nesting of participants (level 1) within clusters (level 2) leads to two conceptual populations: clusters and participants. When cluster sizes vary and the goal is to generalize to a hypothetical population of clusters, the unit average treatment effect (UATE), which averages equally at the cluster level rather than equally at the participant level, is a common estimand of interest. From an analytic perspective, when a generalized estimating equations (GEE) framework is used to obtain averaged treatment effect estimates for CRTs with variable cluster sizes, it is natural to specify an inverse cluster size weighted analysis so that each cluster contributes equally and to adopt an exchangeable working correlation matrix to account for within-cluster correlation. However, such an approach essentially uses two distinct weights in the analysis (i.e. both cluster size weights and covariance weights) and, in this article, we caution that it will lead to biased and/or inefficient treatment effect estimates for the UATE estimand. That is, two weights "make a wrong" or lead to poor estimation characteristics. These findings are based on theoretical derivations, corroborated via a simulation study, and illustrated using data from a CRT of a colorectal cancer screening program. We show that, an analysis with both an independence working correlation matrix and weighting by inverse cluster size is the only approach that always provides valid results for estimation of the UATE in CRTs with variable cluster sizes. [ABSTRACT FROM AUTHOR]

Older adults with obesity spend the majority of their waking hours sedentary. Given substantial barriers to regular physical activity in this population, approaches to reduce sedentary time could be an effective health promotion strategy. We present the protocol of a randomized controlled trial to reduce sitting time in older adults with a body mass index of 30 kg/m2 or above. Participants (N = 284) will be randomized to receive a sitting reduction intervention (termed I-STAND) or a healthy living focused attention control condition. I-STAND includes 10 contacts with a health coach (10 sessions total) and participants receive a wrist-worn prompting device and portable standing desk. The healthy living condition includes 10 sessions with a health coach to set goals around various topics relating to healthy aging. Participants receive their assigned intervention for 6 months. After 6 months, those receiving the I-STAND condition are re-randomized to receive five booster health coaching sessions by 'phone or no further contact; healthy living participants receive no further contact and those in both conditions are followed for an additional 6 months. Measurements initially included wearing an activPAL device and completing several biometric tests (e.g., blood pressure, HbA1c), at baseline, 3 months, 6 months, and 12 months; however, during the COVID-19 pandemic we shifted to remote assessments and were unable to collect all of these measures. The primary outcomes remained activPAL-assessed sitting time and blood pressure. Recruitment is anticipated to be completed in 2022. [ABSTRACT FROM AUTHOR]

High-dose, long-term opioid therapy (LtOT) is associated with risk for serious harms. Rapid opioid discontinuation may lead to increased pain, psychological distress, and illicit opioid use, but gradual, supported opioid taper may reduce these risks. We previously demonstrated that an opioid taper support and pain coping skills training intervention reduced opioid dose more than usual care (43% vs 19% dose reduction from baseline), with no increase in pain intensity and a significant reduction in activity interference. We aim to adapt and test this intervention in the Kaiser Permanente Washington healthcare system with STRategies to Improve Pain and Enjoy life (STRIPE, NCT03743402), a pragmatic, randomized trial. Our goal was to randomize 215 participants on moderate-high dose (≥40 morphine milligram equivalent/day) LtOT to either cognitive-behavioral therapy-based pain coping skills training involving 18 telephone sessions over 52 weeks with optional opioid taper support or usual care. Data are collected from electronic health records, claims, and self-report. The primary outcomes are mean daily opioid dose and the pain intensity, interference with enjoyment of life, and interference with general activity (PEG) score at 12 months (primary time point) and 6 months (secondary time point). Secondary outcomes include having ≥30% opioid dose reduction from baseline, and patient-reported problem opioid use, opioid-related difficulties, pain self-efficacy, opioid craving, global impression of change, and anxiety and depressive symptoms at 6 and 12 months. If effective, this treatment could reduce opioid exposure and associated risks to patients, families, and communities while offering patients an alternative for managing pain. [ABSTRACT FROM AUTHOR]