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Objective: 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., Results: 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)., Conclusions: 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., Competing Interests: Conflicts of interest AD is a scientific advisor to Nestlé, FrieslandCampina Institute and BEL, an invited member of the Carbohydrate Quality Panel supported by Potatoes USA, and is or has been consultant to National Pork Board, Ajinomoto, PepsiCo, FoodMinds, Nutrition Institute, Nutrition Impact, KraftHeinz, Samsung and to other commercial and nonprofit entities with an interest in diet quality and nutrient density of foods. The University of Washington receives research funding from public and private sectors. The remaining authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Background: 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., Methods: 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., Conclusion: 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., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

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., (Copyright © 2022. Published by Elsevier Inc.)

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/m 2 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., (Copyright © 2021 Elsevier Inc. All rights reserved.)

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., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objective: In-depth example of two new group sequential methods for postmarket safety monitoring of new medical products., Study Design and Setting: Existing trial-based group sequential approaches have been extended to adjust for confounders, accommodate rare events, and address privacy-related constraints on data sharing. Most adaptations have involved design-based confounder strategies, for example, self-controlled or exposure matching, while analysis-based approaches like regression and weighting have received less attention. We describe the methodology of two new group sequential approaches that use analysis-based confounder adjustment (GS GEE) and weighting (GS IPTW). Using data from the Food and Drug Administration's Sentinel network, we apply both methods in the context of a known positive association: the measles-mumps-rubella-varicella vaccine and seizure risk in infants., Results: Estimates from both new approaches were similar and comparable to prior studies using design-based methods to address confounding. The time to detection of a safety signal was considerably shorter for GS IPTW, which estimates a risk difference, compared to GS GEE, which provides relative estimates of excess risk., Conclusion: Future group sequential safety surveillance efforts should consider analysis-based confounder adjustment techniques that evaluate safety signals on the risk difference scale to achieve greater statistical power and more timely results., (Copyright © 2019 Elsevier Inc. All rights reserved.)

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., (Copyright © 2019. Published by Elsevier Inc.)

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., (Copyright © 2016 Elsevier Inc. All rights reserved.)

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 © 2014 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.)

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 © 2012 Elsevier Inc. All rights reserved.)

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; > or = 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]; > or = 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]; > or = 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 2010 Elsevier Inc. All rights reserved.)