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Post-licensure medical product safety surveillance is important for detecting adverse events potentially not identified pre-licensure. Historically, post-licensure safety monitoring has been accomplished using passive reporting systems and by conducting formal Phase IV randomized trials or large epidemiological studies, also known as safety surveillance or pharmacovigilance studies. However, crucial gaps in the safety evidence base provided by these approaches have led to high profile product withdrawals and growing public concern about unknown health risks associated with licensed products. To address the limitations of existing surveillance systems and to facilitate more accurate and rapid detection of safety problems, new systems involving active surveillance of large, population-based cohorts using observational health care databases are being developed. In this article, we review common statistical methods that have been employed previously for post-licensure safety monitoring, including data mining and sequential hypothesis testing, and assess which methods may be promising for potential use within this newly proposed prospective observational cohort monitoring framework. We discuss gaps in existing approaches and identify areas where methodological development is needed to improve the success of safety surveillance efforts in this setting. [ABSTRACT FROM AUTHOR]

Sequential methods are well established for randomized clinical trials (RCTs), and their use in observational settings has increased with the development of national vaccine and drug safety surveillance systems that monitor large healthcare databases. Observational safety monitoring requires that sequential testing methods be better equipped to incorporate confounder adjustment and accommodate rare adverse events. New methods designed specifically for observational surveillance include a group sequential likelihood ratio test that uses exposure matching and generalized estimating equations approach that involves regression adjustment. However, little is known about the statistical performance of these methods or how they compare to RCT methods in both observational and rare outcome settings. We conducted a simulation study to determine the type I error, power and time-to-surveillance-end of group sequential likelihood ratio test, generalized estimating equations and RCT methods that construct group sequential Lan-DeMets boundaries using data from a matched (group sequential Lan-DeMets-matching) or unmatched regression (group sequential Lan-DeMets-regression) setting. We also compared the methods using data from a multisite vaccine safety study. All methods had acceptable type I error, but regression methods were more powerful, faster at detecting true safety signals and less prone to implementation difficulties with rare events than exposure matching methods. Method performance also depended on the distribution of information and extent of confounding by site. Our results suggest that choice of sequential method, especially the confounder control strategy, is critical in rare event observational settings. These findings provide guidance for choosing methods in this context and, in particular, suggest caution when conducting exposure matching. Copyright © 2014 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

PURPOSE This trial was designed to evaluate the optimal dose of massage for individuals with chronic neck pain. METHODS We recruited 228 individuals with chronic nonspecific neck pain from an integrated health care system and the general population, and randomized them to 5 groups receiving various doses of massage (a 4-week course consisting of 30-minute visits 2 or 3 times weekly or 60-minute visits 1, 2, or 3 times weekly) or to a single control group (a 4-week period on a wait list). We assessed neck-related dysfunction with the Neck Disability Index (range, 0-50 points) and pain intensity with a numerical rating scale (range, 0-10 points) at baseline and 5 weeks. We used log-linear regression to assess the likelihood of clinically meaningful improvement in neck-related dysfunction (⩾5 points on Neck Disability Index) or pain intensity (⩾30% improvement) by treatment group. RESULTS After adjustment for baseline age, outcome measures, and imbalanced covariates, 30-minute treatments were not significantly better than the wait list control condition in terms of achieving a clinically meaningful improvement in neck dysfunction or pain, regardless of the frequency of treatments. In contrast, 60-minute treatments 2 and 3 times weekly significantly increased the likelihood of such improvement compared with the control condition in terms of both neck dysfunction (relative risk = 3.41 and 4.98, P = .04 and .005, respectively) and pain intensity (relative risk = 2.30 and 2.73; P = .007 and .001, respectively). CONCLUSIONS After 4 weeks of treatment, we found multiple 60-minute massages per week more effective than fewer or shorter sessions for individuals with chronic neck pain. Clinicians recommending massage and researchers studying this therapy should ensure that patients receive a likely effective dose of treatment. [ABSTRACT FROM AUTHOR]

In research assessing the effect of an intervention or exposure, a key secondary objective often involves assessing differential effects of this intervention or exposure in subgroups of interest; this is often referred to as assessing effect modification or heterogeneity of treatment effects (HTE). Observed HTE can have important implications for policy, including intervention strategies (e.g., will some patients benefit more from intervention than others?) and prioritizing resources (e.g., to reduce observed health disparities). Analysis of HTE is well understood in studies where the independent unit is an individual. In contrast, in studies where the independent unit is a cluster (e.g., a hospital or school) and a cluster-level outcome is used in the analysis, it is less well understood how to proceed if the HTE analysis of interest involves an individual-level characteristic (e.g., self-reported race) that must be aggregated at the cluster level. Through simulations, we show that only individual-level models have power to detect HTE by individual-level variables; if outcomes must be defined at the cluster level, then there is often low power to detect HTE by the corresponding aggregated variables. We illustrate the challenges inherent to this type of analysis in a study assessing the effect of an intervention on increasing COVID-19 booster vaccination rates at long-term care centers. [ABSTRACT FROM AUTHOR]

Background: The US Preventive Services Task Force recommends blood pressure (BP) measurements using 24-h ambulatory monitoring (ABPM) or home BP monitoring before making a new hypertension diagnosis. Objective: Compare clinic-, home-, and kiosk-based BP measurement to ABPM for diagnosing hypertension. Design, Setting, and Participants: Diagnostic study in 12 Washington State primary care centers, with participants aged 18–85 years without diagnosed hypertension or prescribed antihypertensive medications, with elevated BP in clinic. Interventions: Randomization into one of three diagnostic regimens: (1) clinic (usual care follow-up BPs); (2) home (duplicate BPs twice daily for 5 days); or (3) kiosk (triplicate BPs on 3 days). All participants completed ABPM at 3 weeks. Main Measures: Primary outcome was difference between ABPM daytime and clinic, home, and kiosk mean systolic BP. Differences in diastolic BP, sensitivity, and specificity were secondary outcomes. Key Results: Five hundred ten participants (mean age 58.7 years, 80.2% white) with 434 (85.1%) included in primary analyses. Compared to daytime ABPM, adjusted mean differences in systolic BP were clinic (−4.7mmHg [95% confidence interval −7.3, −2.2]; P<.001); home (−0.1mmHg [−1.6, 1.5];P=.92); and kiosk (9.5mmHg [7.5, 11.6];P<.001). Differences for diastolic BP were clinic (−7.2mmHg [−8.8, −5.5]; P<.001); home (−0.4mmHg [−1.4, 0.7];P=.52); and kiosk (5.0mmHg [3.8, 6.2]; P<.001). Sensitivities for clinic, home, and kiosk compared to ABPM were 31.1% (95% confidence interval, 22.9, 40.6), 82.2% (73.8, 88.4), and 96.0% (90.0, 98.5), and specificities 79.5% (64.0, 89.4), 53.3% (38.9, 67.2), and 28.2% (16.4, 44.1), respectively. Limitations: Single health care organization and limited race/ethnicity representation. Conclusions: Compared to ABPM, mean BP was significantly lower for clinic, significantly higher for kiosk, and without significant differences for home. Clinic BP measurements had low sensitivity for detecting hypertension. Findings support utility of home BP monitoring for making a new diagnosis of hypertension. Trial Registration: ClinicalTrials.gov NCT03130257 https://clinicaltrials.gov/ct2/show/NCT03130257 [ABSTRACT FROM AUTHOR]

Background: Screening over many years is required to optimize colorectal cancer (CRC) outcomes. Objective: To evaluate the effect of a CRC screening intervention on adherence to CRC screening over 9 years. Design: Randomized trial. Setting: Integrated health care system in Washington state. Participants: Between August 2008 and November 2009, 4653 adults in a Washington state integrated health care system aged 50–74 due for CRC screening were randomized to usual care (UC; N =1163) or UC plus study interventions (interventions: N = 3490). Interventions: Years 1 and 2: (arm 1) UC or this plus study interventions; (arm 2) mailed fecal tests or information on scheduling colonoscopy; (arm 3) mailings plus brief telephone assistance; or (arm 4) mailings and assistance plus nurse navigation. In year 3, stepped-intensity participants (arms 2, 3, and 4 combined) still eligible for screening were randomized to either stopped or continued interventions in years 3 and 5–9. Main Measures: Time in adherence to CRC testing over 9 years (covered time, primary outcome), and percent with no CRC testing in participants assigned to any intervention compared to UC only. Poisson regression models estimated incidence rate ratios for covered time, adjusting for patient characteristics and accounting for variable follow-up time. Key Results: Compared to UC, intervention participants had 21% more covered time over 9 years (57.5% vs. 69.1%; adjusted incidence rate ratio 1.21, 95% confidence interval 1.16–1.25, P<0.001). Fecal testing accounted for almost all additional covered time among intervention patients. Compared to UC, intervention participants were also more likely to have completed at least one CRC screening test over 9 years or until censorship (88.6% vs. 80.6%, P<0.001). Conclusions: An outreach program that included mailed fecal tests and phone follow-up led to increased adherence to CRC testing and fewer age-eligible individuals without any CRC testing over 9 years. Trial Registration: Systems of Support (SOS) to Increase Colon Cancer Screening and Follow-up (SOS), NCT00697047, clinicaltrials.gov/ct2/show/NCT00697047 [ABSTRACT FROM AUTHOR]

We consider the critical problem of pharmacosurveillance for adverse events once a drug or medical product is incorporated into routine clinical care. When making inference on comparative safety using large-scale electronic health records, we often encounter an extremely rare binary adverse outcome with a large number of potential confounders. In this context, it is challenging to offer flexible methods to adjust for high-dimensional confounders, whereas use of the propensity score (PS) can help address this challenge by providing both confounding control and dimension reduction. Among PS methods, regression adjustment using the PS as a covariate in an outcome model has been incompletely studied and potentially misused. Previous studies have suggested that simple linear adjustment may not provide sufficient control of confounding. Moreover, no formal representation of the statistical procedure and associated inference has been detailed. In this paper, we characterize a three-step procedure, which performs flexible regression adjustment of the estimated PS followed by standardization to estimate the causal effect in a select population. We also propose a simple variance estimation method for performing inference. Through a realistic simulation mimicking data from the Food and Drugs Administration's Sentinel Initiative comparing the effect of angiotensin-converting enzyme inhibitors and beta blockers on incidence of angioedema, we show that flexible regression on the PS resulted in less bias without loss of efficiency, and can outperform other methods when the PS model is correctly specified. In addition, the direct variance estimation method is a computationally fast and reliable approach for inference. [ABSTRACT FROM AUTHOR]

Background: Although bariatric procedures are commonly performed in clinical practice, long-term data on the comparative effectiveness and safety of different procedures on sustained weight loss, comorbidities, and adverse effects are limited, especially in important patient subgroups (eg, individuals with diabetes, older patients, adolescents, and minority patients). Objective: The objective of this study was to create a population-based cohort of patients who underwent 3 commonly performed bariatric procedures—adjustable gastric band (AGB), Roux-en-Y gastric bypass (RYGB), and sleeve gastrectomy (SG)—to examine the long-term comparative effectiveness and safety of these procedures in both adults and adolescents. Methods: We identified adults (20 to 79 years old) and adolescents (12 to 19 years old) who underwent a primary (first observed) AGB, RYGB, or SG procedure between January 1, 2005 and September 30, 2015 from 42 health systems participating in the Clinical Data Research Networks within the National Patient-Centered Clinical Research Network (PCORnet). We extracted information on patient demographics, encounters with healthcare providers, diagnoses recorded and procedures performed during these encounters, vital signs, and laboratory test results from patients' electronic health records (EHRs). The outcomes of interest included weight change, incidence of major surgery-related adverse events, and diabetes remission and relapse, collected for up to 10 years after the initial bariatric procedure. Results: A total of 65,093 adults and 777 adolescents met the eligibility criteria of the study. The adult subcohort had a mean age of 45 years and was predominantly female (79.30%, 51,619/65,093). Among adult patients with non-missing race or ethnicity information, 72.08% (41,248/57,227) were White, 21.13% (12,094/57,227) were Black, and 20.58% (13,094/63,637) were Hispanic. The average highest body mass index (BMI) recorded in the year prior to surgery was 49 kg/m2. RYGB was the most common bariatric procedure among adults (49.48%, 32,208/65,093), followed by SG (45.62%, 29,693/65,093) and AGB (4.90%, 3192/65,093). The mean age of the adolescent subcohort was 17 years and 77.5% (602/777) were female. Among adolescent patients with known race or ethnicity information, 67.3% (473/703) were White, 22.6% (159/703) were Black, and 18.0% (124/689) were Hispanic. The average highest recorded BMI in the year preceding surgery was 53 kg/m2. The majority of the adolescent patients received SG (60.4%, 469/777), followed by RYGB (30.8%, 239/777) and AGB (8.9%, 69/777). A BMI measurement (proxy for follow-up) was available in 84.31% (44,978/53,351), 68.09% (20,783/30,521), and 68.56% (7159/10,442) of the eligible adult patients at 1, 3, and 5 years of follow-up, respectively. The corresponding proportion was 82.0% (524/639), 49.9% (174/349), and 38.8% (47/121) in the adolescent subcohort. Conclusions: Our study cohort is one of the largest cohorts of patients with bariatric procedures in the United States. Patients are geographically and demographically diverse, which improves the generalizability of the research findings and allows examination of treatment effect heterogeneity. Ongoing and planned investigations will provide real-world evidence on the long-term benefits and risks of these most commonly used bariatric procedures in current clinical practice. [ABSTRACT FROM AUTHOR]

Background: Central nervous system (CNS) active medications have been consistently linked to falls in older people. However, few randomized trials have evaluated whether CNS-active medication reduction reduces falls and fall-related injuries. The objective of the Reducing CNS-active Medications to Prevent Falls and Injuries in Older Adults (STOP-FALLS) trial is to test the effectiveness of a health-system-embedded deprescribing intervention focused on CNS-active medications on the incidence of medically treated falls among community-dwelling older adults. Methods: We will conduct a pragmatic, cluster-randomized, parallel-group, controlled clinical trial within Kaiser Permanente Washington to test the effectiveness of a 12-month deprescribing intervention consisting of (1) an educational brochure and self-care handouts mailed to older adults prescribed one or more CNS-active medications (aged 60 + : opioids, benzodiazepines and Z-drugs; aged 65 + : skeletal muscle relaxants, tricyclic antidepressants, and antihistamines) and (2) decision support for their primary health care providers. Outcomes are examined over 18–26 months post-intervention. The primary outcome is first incident (post-baseline) medically treated fall as determined from health plan data. Our sample size calculations ensure at least 80% power to detect a 20% reduction in the rate of medically treated falls for participants receiving care within the intervention (n = 9) versus usual care clinics (n = 9) assuming 18 months of follow-up. Secondary outcomes include medication discontinuation or dose reduction of any target medications. Safety outcomes include serious adverse drug withdrawal events, unintentional overdose, and death. We will also examine medication signetur fields for attempts to decrease medications. We will report factors affecting implementation of the intervention. Discussion: The STOP-FALLS trial will provide new information about whether a health-system-embedded deprescribing intervention that targets older participants and their primary care providers reduces medically treated falls and CNS-active medication use. Insights into factors affecting implementation will inform future research and healthcare organizations that may be interested in replicating the intervention. Trial registration: ClinicalTrial.gov NCT05689554. Registered on 18 January 2023, retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: Patient-shared electronic health records provide opportunities for care outside of office visits. However, those who might benefit may be unable to or choose not to use these resources, while others might not need them. Objective: Electronic Communications and Home Blood Pressure Monitoring (e-BP) was a randomized trial that demonstrated that Web-based pharmacist care led to improved blood pressure (BP) control. During recruitment we attempted to contact all patients with hypertension from 10 clinics to determine whether they were eligible and willing to participate. We wanted to know whether particular subgroups, particularly those from vulnerable populations, were less willing to participate or unable to because they lacked computer access. Methods: From 2005 to 2006, we sent invitation letters to and attempted to recruit 9298 patients with hypertension. Eligibility to participate in the trial included access to a computer and the Internet, an email address, and uncontrolled BP (BP = 140/90 mmHg). Generalized linear models within a modified Poisson regression framework were used to estimate the relative risk (RR) of ineligibility due to lack of computer access and of having uncontrolled BP. Results: We were able to contact 95.1% (8840/9298) of patients. Those refusing participation (3032/8840, 34.3%) were significantly more likely (P < .05) to be female, be nonwhite, have lower levels of education, and have Medicaid insurance. Among patients who answered survey questions, 22.8% (1673/7354) did not have computer access. Older age, minority race, and lower levels of education were risk factors for lack of computer access, with education as the strongest predictor (RR 2.63, 95% CI 2.30-3.01 for those with a high school degree compared to a college education). Among hypertensive patients with computer access who were willing to participate, African American race (RR 1.22, 95% CI 1.06-1.40), male sex (RR 1.28, 95% CI 1.18-1.38), and obesity (RR 1.53, 95% CI 1.31-1.79) were risk factors for uncontrolled BP. Conclusion: Older age, lower socioeconomic status, and lower levels of education were associated with decreased access to and willingness to participate in a Web-based intervention to improve hypertension control. Failure to ameliorate this may worsen health care disparities. [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]

Background: The US Preventive Services Task Force recommends measuring blood pressure (BP) outside of clinic/office settings. While various options are available, including home devices, BP kiosks, and 24-h ambulatory BP monitoring (ABPM), understanding patient acceptability and adherence is a critical factor for implementation., Objective: To compare the acceptability and adherence of clinic, home, kiosk, and ABPM measurement., Design: Comparative diagnostic accuracy study which randomized adults to one of three BP measurement arms: clinic, home, and kiosk. ABPM was conducted on all participants., Participants: Adults (18-85 years) receiving care at 12 Kaiser Permanente Washington primary care clinics (Washington State, USA) with a high BP (≥ 138 mmHg systolic or ≥ 88 mmHg diastolic) in the electronic health record with no hypertension diagnosis and on no hypertensive medications and with high BP at a research screening visit., Measures: Patient acceptability was measured using a validated survey which was used to calculate an overall acceptability score (range 1-7) at baseline, after completing their assigned BP measurement intervention, and after completing ABPM. Adherence was defined based on the pre-specified number of BP measurements completed., Key Results: Five hundred ten participants were randomized (mean age 59 years), with mean BP of 150/88. Overall acceptability score was highest (i.e. most acceptable) for Home BP (mean 6.2, SD 0.7) and lowest (least acceptable) for ABPM (mean 5.0, SD 1.0); scores were intermediate for Clinic (5.5, SD 1.1) and Kiosk (5.4, SD 1.0). Adherence was higher for Home (154/170, 90.6%) and Clinic (150/172, 87.2%) than for Kiosk (114/168, 67.9%)). The majority of participants (467/510, 91.6%) were adherent to ABPM., Conclusions: Participants found home BP measurement most acceptable followed by clinic, BP kiosks, and ABPM. Our findings, coupled with recent evidence regarding the accuracy of home BP measurement, further support the routine use of home-based BP measurement in primary care practice in the US., Trial Registration: ClinicalTrials.gov NCT03130257 https://clinicaltrials.gov/ct2/show/NCT03130257., (© 2023. The Author(s), under exclusive licence to Society of General Internal Medicine.)

Objective: To examine whether depression status before metabolic and bariatric surgery (MBS) influenced 5-year weight loss, diabetes, and safety/utilization outcomes in the PCORnet Bariatric Study., Summary of Background Data: Research on the impact of depression on MBS outcomes is inconsistent with few large, long-term studies., Methods: Data were extracted from 23 health systems on 36,871 patients who underwent sleeve gastrectomy (SG; n=16,158) or gastric bypass (RYGB; n=20,713) from 2005-2015. Patients with and without a depression diagnosis in the year before MBS were evaluated for % total weight loss (%TWL), diabetes outcomes, and postsurgical safety/utilization (reoperations, revisions, endoscopy, hospitalizations, mortality) at 1, 3, and 5 years after MBS., Results: 27.1% of SG and 33.0% of RYGB patients had preoperative depression, and they had more medical and psychiatric comorbidities than those without depression. At 5 years of follow-up, those with depression, versus those without depression, had slightly less %TWL after RYGB, but not after SG (between group difference = 0.42%TWL, P = 0.04). However, patients with depression had slightly larger HbA1c improvements after RYGB but not after SG (between group difference = - 0.19, P = 0.04). Baseline depression did not moderate diabetes remission or relapse, reoperations, revision, or mortality across operations; however, baseline depression did moderate the risk of endoscopy and repeat hospitalization across RYGB versus SG., Conclusions: Patients with depression undergoing RYGB and SG had similar weight loss, diabetes, and safety/utilization outcomes to those without depression. The effects of depression were clinically small compared to the choice of operation., Competing Interests: The other authors report no conflicts of interest., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: Cognitive behavioral therapy for chronic pain (CBT-CP) is an effective but underused treatment for high-impact chronic pain. Increased access to CBT-CP services for pain is of critical public health importance, particularly for rural and medically underserved populations who have limited access due to these services being concentrated in urban and high income areas. Making CBT-CP widely available and more affordable could reduce barriers to CBT-CP use., Methods: As part of the National Institutes of Health Helping to End Addiction Long-term® (NIH HEAL) initiative, we designed and implemented a comparative effectiveness, 3-arm randomized control trial comparing remotely delivered telephonic/video and online CBT-CP-based services to usual care for patients with high-impact chronic pain. The RESOLVE trial is being conducted in 4 large integrated healthcare systems located in Minnesota, Georgia, Oregon, and Washington state and includes demographically diverse populations residing in urban and rural areas. The trial compares (1) an 8-session, one-on-one, professionally delivered telephonic/video CBT-CP program; and (2) a previously developed and tested 8-session online CBT-CP-based program (painTRAINER) to (3) usual care augmented by a written guide for chronic pain management. Participants are followed for 1 year post-allocation and are assessed at baseline, and 3, 6, and 12 months post-allocation. The primary outcome is minimal clinically important difference (MCID; ≥ 30% reduction) in pain severity (composite of pain intensity and pain-related interference) assessed by a modified 11-item version of the Brief Pain Inventory-Short Form at 3 months. Secondary outcomes include pain severity, pain intensity, and pain-related interference scores, quality of life measures, and patient global impression of change at 3, 6, and 12 months. Cost-effectiveness is assessed by incremental cost per additional patient with MCID in primary outcome and by cost per quality-adjusted life year achieved. Outcome assessment is blinded to group assignment., Discussion: This large-scale trial provides a unique opportunity to rigorously evaluate and compare the clinical and cost-effectiveness of 2 relatively low-cost and scalable modalities for providing CBT-CP-based treatments to persons with high-impact chronic pain, including those residing in rural and other medically underserved areas with limited access to these services., Trial Registration: ClinicalTrials.gov NCT04523714. This trial was registered on 24 August 2020., (© 2023. The Author(s).)

Both mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy (CBT) are effective for chronic low back pain (CLBP), but little is known regarding who might benefit more from one than the other. Using data from a randomized trial comparing MBSR, CBT, and usual care (UC) for adults aged 20 to 70 years with CLBP (N = 297), we examined baseline characteristics that moderated treatment effects or were associated with improvement regardless of treatment. Outcomes included 8-week function (modified Roland Disability Questionnaire), pain bothersomeness (0-10 numerical rating scale), and depression (Patient Health Questionnaire-8). There were differences in the effects of CBT versus MBSR on pain based on participant gender (P = .03) and baseline depressive symptoms (P = .01), but the only statistically significant moderator after Bonferroni correction was the nonjudging dimension of mindfulness. Scores on this measure moderated the effects of CBT versus MBSR on both function (P = .001) and pain (P = .04). Pain control beliefs (P <.001) and lower anxiety (P < .001) predicted improvement regardless of treatment. Replication of these findings is needed to guide treatment decision-making for CLBP. TRIAL REGISTRATION: The trial and analysis plan were preregistered in ClinicalTrials.gov (Identifier: NCT01467843). PERSPECTIVE: Although few potential moderators and nonspecific predictors of benefits from CBT or MBSR for CLBP were statistically significant after adjustment for multiple comparisons, these findings suggest potentially fruitful directions for confirmatory research while providing reassurance that patients could reasonably expect to benefit from either treatment., (Published by Elsevier Inc.)

Objective: To examine associations between neighborhood built environment (BE) variables, residential property values, and longitudinal 1- and 2-year changes in body mass index (BMI)., Methods: The Seattle Obesity Study III was a prospective cohort study of adults with geocoded residential addresses, conducted in King, Pierce, and Yakima Counties in Washington State. Measured heights and weights were obtained at baseline (n = 879), year 1 (n = 727), and year 2 (n = 679). Tax parcel residential property values served as proxies for individual socioeconomic status. Residential unit and road intersection density were captured using Euclidean-based SmartMaps at 800 m buffers. Counts of supermarket (0 versus. 1+) and fast-food restaurant availability (0, 1-3, 4+) were measured using network based SmartMaps at 1600 m buffers. Density measures and residential property values were categorized into tertiles. Linear mixed-effects models tested whether baseline BE variables and property values were associated with differential changes in BMI at year 1 or year 2, adjusting for age, gender, race/ethnicity, education, home ownership, and county of residence. These associations were then tested for potential disparities by age group, gender, race/ethnicity, and education., Results: Road intersection density, access to food sources, and residential property values were inversely associated with BMI at baseline. At year 1, participants in the 3rd tertile of density metrics and with 4+ fast-food restaurants nearby showed less BMI gain compared to those in the 1st tertile or with 0 restaurants. At year 2, higher residential property values were predictive of lower BMI gain. There was evidence of differential associations by age group, gender, and education but not race/ethnicity., Conclusion: Inverse associations between BE metrics and residential property values at baseline demonstrated mixed associations with 1- and 2-year BMI change. More work is needed to understand how individual-level sociodemographic factors moderate associations between the BE, property values, and BMI change., Competing Interests: Adam Drewnowski has received grants, honoraria, and consulting fees from numerous food, beverage, and ingredient companies and from other commercial and nonprofit entities with an interest in diet quality and nutrient density of foods. All other authors have no conflicts of interest to declare., (© 2022 The Authors.)

Background: Studies assessing the impact of built environments on body weight are often limited by modest power to detect residential effects that are small for individuals but may nonetheless comprise large attributable risks., Objective: We used data extracted from electronic health records to construct a large retrospective cohort of patients. This cohort will be used to explore both the impact of moving between environments and the long-term impact of changing neighborhood environments., Methods: We identified members with at least 12 months of Kaiser Permanente Washington (KPWA) membership and at least one weight measurement in their records during a period between January 2005 and April 2017 in which they lived in King County, Washington. Information on member demographics, address history, diagnoses, and clinical visits data (including weight) was extracted. This paper describes the characteristics of the adult (aged 18-89 years) cohort constructed from these data., Results: We identified 229,755 adults representing nearly 1.2 million person-years of follow-up. The mean age at baseline was 45 years, and 58.0% (133,326/229,755) were female. Nearly one-fourth of people (55,150/229,755) moved within King County at least once during the follow-up, representing 84,698 total moves. Members tended to move to new neighborhoods matching their origin neighborhoods on residential density and property values., Conclusions: Data were available in the KPWA database to construct a very large cohort based in King County, Washington. Future analyses will directly examine associations between neighborhood conditions and longitudinal changes in body weight and diabetes as well as other health conditions., International Registered Report Identifier (irrid): DERR1-10.2196/16787., (©Stephen J Mooney, Jennifer F Bobb, Philip M Hurvitz, Jane Anau, Mary Kay Theis, Adam Drewnowski, Anju Aggarwal, Shilpi Gupta, Dori E Rosenberg, Andrea J Cook, Xiao Shi, Paula Lozano, Anne Vernez Moudon, David Arterburn. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 19.05.2020.)

Background: Although bariatric procedures are commonly performed in clinical practice, long-term data on the comparative effectiveness and safety of different procedures on sustained weight loss, comorbidities, and adverse effects are limited, especially in important patient subgroups (eg, individuals with diabetes, older patients, adolescents, and minority patients)., Objective: The objective of this study was to create a population-based cohort of patients who underwent 3 commonly performed bariatric procedures-adjustable gastric band (AGB), Roux-en-Y gastric bypass (RYGB), and sleeve gastrectomy (SG)-to examine the long-term comparative effectiveness and safety of these procedures in both adults and adolescents., Methods: We identified adults (20 to 79 years old) and adolescents (12 to 19 years old) who underwent a primary (first observed) AGB, RYGB, or SG procedure between January 1, 2005 and September 30, 2015 from 42 health systems participating in the Clinical Data Research Networks within the National Patient-Centered Clinical Research Network (PCORnet). We extracted information on patient demographics, encounters with healthcare providers, diagnoses recorded and procedures performed during these encounters, vital signs, and laboratory test results from patients' electronic health records (EHRs). The outcomes of interest included weight change, incidence of major surgery-related adverse events, and diabetes remission and relapse, collected for up to 10 years after the initial bariatric procedure., Results: A total of 65,093 adults and 777 adolescents met the eligibility criteria of the study. The adult subcohort had a mean age of 45 years and was predominantly female (79.30%, 51,619/65,093). Among adult patients with non-missing race or ethnicity information, 72.08% (41,248/57,227) were White, 21.13% (12,094/57,227) were Black, and 20.58% (13,094/63,637) were Hispanic. The average highest body mass index (BMI) recorded in the year prior to surgery was 49 kg/m 2 . RYGB was the most common bariatric procedure among adults (49.48%, 32,208/65,093), followed by SG (45.62%, 29,693/65,093) and AGB (4.90%, 3192/65,093). The mean age of the adolescent subcohort was 17 years and 77.5% (602/777) were female. Among adolescent patients with known race or ethnicity information, 67.3% (473/703) were White, 22.6% (159/703) were Black, and 18.0% (124/689) were Hispanic. The average highest recorded BMI in the year preceding surgery was 53 kg/m 2 . The majority of the adolescent patients received SG (60.4%, 469/777), followed by RYGB (30.8%, 239/777) and AGB (8.9%, 69/777). A BMI measurement (proxy for follow-up) was available in 84.31% (44,978/53,351), 68.09% (20,783/30,521), and 68.56% (7159/10,442) of the eligible adult patients at 1, 3, and 5 years of follow-up, respectively. The corresponding proportion was 82.0% (524/639), 49.9% (174/349), and 38.8% (47/121) in the adolescent subcohort., Conclusions: Our study cohort is one of the largest cohorts of patients with bariatric procedures in the United States. Patients are geographically and demographically diverse, which improves the generalizability of the research findings and allows examination of treatment effect heterogeneity. Ongoing and planned investigations will provide real-world evidence on the long-term benefits and risks of these most commonly used bariatric procedures in current clinical practice., (©Sengwee Toh, Laura J Rasmussen-Torvik, Emily E Harmata, Roy Pardee, Rosalinde Saizan, Elisha Malanga, Jessica L Sturtevant, Casie E Horgan, Jane Anau, Cheri D Janning, Robert D Wellman, R Yates Coley, Andrea J Cook, Anita P Courcoulas, Karen J Coleman, Neely A Williams, Kathleen M McTigue, David Arterburn, James McClay, PCORnet Bariatric Surgery Collaborative. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 05.12.2017.)

This manuscript proposes a new spatial cluster detection method for longitudinal outcomes that detects neighborhoods and regions with elevated rates of disease while controlling for individual level confounders. The proposed method, CumResPerm, utilizes cumulative geographic residuals through a permutation test to detect potential clusters which are are defined as sets of administrative regions, such as a town, or group of administrative regions. Previous cluster detection methods are not able to incorporate individual level data including covariate adjustment, while still being able to define potential clusters using informative neighborhood or town boundaries. Often it is of interest to detect such spatial clusters because individuals residing in a town may have similar environmental exposures or socioeconomic backgrounds due to administrative reasons, such as zoning laws. Therefore these boundaries can be very informative and more relevant than arbitrary clusters such as the standard circle or square. Application of the CumResPerm method will be illustrated by the Home Allergens and Asthma prospective cohort study analyzing the relationship between area or neighborhood residence and repeated measured outcome, occurrence of wheeze in the last 6 months, while taking into account mobile locations.

Objective: The purposes of this study were to determine whether U.S. radiologists accurately estimate their own interpretive performance of screening mammography and to assess how they compare their performance with that of their peers., Subjects and Methods: Between 2005 and 2006, 174 radiologists from six Breast Cancer Surveillance Consortium registries completed a mailed survey. The radiologists' estimated and actual recall, false-positive, and cancer detection rates and positive predictive value of biopsy recommendation (PPV(2)) for screening mammography were compared. Radiologists' ratings of their performance as lower than, similar to, or higher than that of their peers were compared with their actual performance. Associations with radiologist characteristics were estimated with weighted generalized linear models., Results: Although most radiologists accurately estimated their cancer detection and recall rates (74% and 78% of radiologists), fewer accurately estimated their false-positive rate (19%) and PPV(2) (26%). Radiologists reported having recall rates similar to (43%) or lower than (31%) and false-positive rates similar to (52%) or lower than (33%) those of their peers and similar (72%) or higher (23%) cancer detection rates and similar (72%) or higher (38%) PPV(2). Estimation accuracy did not differ by radiologist characteristics except that radiologists who interpreted 1000 or fewer mammograms annually were less accurate at estimating their recall rates., Conclusion: Radiologists perceive their performance to be better than it actually is and at least as good as that of their peers. Radiologists have particular difficulty estimating their false-positive rates and PPV(2).

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., (Copyright © 2011 American Journal of Preventive Medicine. All rights reserved.)

Summary. This short note evaluates the assumptions required for a permutation test to approximate the null distribution of the spatial scan statistic for censored outcomes proposed in Cook et al. (2007). In particular, we study the exchangeability conditions required for such a test under survival models. A simulation study is further performed to assess the impact on the type I error when the global exchangeability assumption is violated and to determine whether the permutation test still well approximates the null distribution.