Trends in the use of biologic disease-modifying antirheumatic drugs in patients with rheumatoid arthritis and recently diagnosed colorectal, lung, or prostate cancer.

INTRODUCTION: Biologic disease-modifying antirheumatic drugs (bDMARD) are often discontinued when a patient with rheumatoid arthritis (RA) is diagnosed with cancer. Our aim was to determine trends in bDMARD utilization in patients with RA and recently diagnosed cancer. METHOD: We examined two national claims databases to identify adults with RA and recently diagnosed colorectal, lung, or prostate cancer (Optum's de-identified Clinformatics® Data Mart Database 2008-2022, and Surveillance, Epidemiology, and End Results Program (SEER) Medicare-linked 2008-2017). We determined time trends in bDMARD and tumor necrosis factor inhibitor (TNFi) prescriptions during the first 3 years after cancer with Cochram-Armitage tests and multivariable logistic regression. Cancer cohorts were analyzed separately. RESULTS: We included 3595 patients in all six cohorts (in Clinformatics® 503 with colorectal, 468 with lung, and 440 with prostate cancer; in SEER-Medicare 580 with colorectal, 1010 with lung, and 594 with prostate cancer). No significant increase was observed in bDMARD or TNFi utilization over time. Overall, use of bDMARD within the first 3 years of follow-up ranged from 16.7% (Clinformatics® lung cohort) to 29.7% (SEER-Medicare colorectal cohort). The major predictor of bDMARD utilization was prior use in the 3 months before cancer diagnosis (p < 0.001 for all cancers) and earlier cancer stage (p < 0.001 in colorectal and lung cancer and p = 0.05 in prostate cancer). CONCLUSIONS: Use of bDMARD in patients with RA and recently diagnosed common cancers has not increased since 2008. Additional evidence on the safety of bDMARD in patients with early cancer is needed to ensure appropriate management of their RA. Key Points • Use of bDMARD and TNFi in patients with RA and early colorectal, lung, or prostate cancer has been stable since 2008, with no significant increases over time. • The major determinant of receiving bDMARD after cancer diagnosis was prior treatment with bDMARD in the prior 3 months before cancer. • Patients with advanced cancer stage and distant metastases were less likely to receive bDMARD and TNFi than those at early stages of disease.

Survival in patients with rheumatoid arthritis and early breast cancer treated with tumor necrosis factor inhibitors.

BACKGROUND: There have been concerns about the use of tumor necrosis factor inhibitors (TNFi) for autoimmune disease in patients with recently diagnosed cancer. We assessed the survival of patients with rheumatoid arthritis (RA) and newly diagnosed early breast cancer (BC) treated with TNFi in the first two years after BC diagnosis. METHODS: We identified patients in two datasets: (1) Optum's de-identified Clinformatics® Data Mart Database (CDM), (2) Surveillance, Epidemiology, and End Results program (SEER) and Texas Cancer Registry (TCR) Medicare-linked cohort. We grouped patients according to whether they received TNFi, conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) only, or no DMARDs within 2 years after BC. Outcomes were overall survival (OS) and BC-specific survival (BCSS). We conducted landmark analyses at years 1 and 2, with multivariable Cox regressions using propensity scores for adjustment. RESULTS: In the first year after BC, 165/970 (17.0%) and 201/1246 (16.1%) patients received TNFi in CDM and SEER/TCR-Medicare respectively. In the 1 year landmark, no significant differences in OS were observed between patients treated with TNFi and patients treated with csDMARDs only in CDM (hazard ratio [HR] = 0.77, 95% confidence interval [CI] 0.42-1.40) or SEER/TCR-Medicare (HR = 0.84, 95% CI 0.54-1.31). BCSS (SEER/TCR-Medicare) was better in patients receiving TNFi than in those receiving csDMARDs only (HR = 0.28, 95% CI 0.08-0.98). In CDM, glucocorticoid therapy had worse OS than those without glucocorticoids (HR = 2.18, 95% CI 1.13-4.18). This was also observed in SEER/TCR-Medicare (not statistically significant). Similar results were observed for the 2 year landmark. CONCLUSIONS: TNFi treatment during the first two years after early BC was not associated with worse survival.

Medical Home Implementation and Follow-Up of Cancer-Related Abnormal Test Results in the Veterans Health Administration.

Importance: Lack of timely follow-up of cancer-related abnormal test results can lead to delayed or missed diagnoses, adverse cancer outcomes, and substantial cost burden for patients. Care delivery models, such as the Veterans Affairs' (VA) Patient-Aligned Care Team (PACT), which aim to improve patient-centered care coordination, could potentially also improve timely follow-up of abnormal test results. PACT was implemented nationally in the VA between 2010 and 2012. Objective: To evaluate the long-term association between PACT implementation and timely follow-up of abnormal test results related to the diagnosis of 5 different cancers. Design, Setting, and Participants: This multiyear retrospective cohort study used 14 years of VA data (2006-2019), which were analyzed using panel data-based random-effects linear regressions. The setting included all VA clinics and facilities. The participants were adult patients who underwent diagnostic testing related to 5 different cancers and had abnormal test results. Data extraction and statistical analyses were performed from September 2021 to December 2023. Exposure: Calendar years denoting preperiods and postperiods of PACT implementation, and the PACT Implementation Progress Index Score denoting the extent of implementation in each VA clinic and facility. Main Outcome and Measure: Percentage of potentially missed timely follow-ups of abnormal test results. Results: This study analyzed 6 data sets representing 5 different types of cancers. During the initial years of PACT implementation (2010 to 2013), percentage of potentially missed timely follow-ups decreased between 3 to 7 percentage points for urinalysis suggestive of bladder cancer, 12 to 14 percentage points for mammograms suggestive of breast cancer, 19 to 22 percentage points for fecal tests suggestive of colorectal cancer, and 6 to 13 percentage points for iron deficiency anemia laboratory tests suggestive of colorectal cancer, with no statistically significant changes for α-fetoprotien tests and lung cancer imaging. However, these beneficial reductions were not sustained over time. Better PACT implementation scores were associated with a decrease in potentially missed timely follow-up percentages for urinalysis (0.3-percentage point reduction [95% CI, -0.6 to -0.1] with 1-point increase in the score), and laboratory tests suggestive of iron deficiency anemia (0.5-percentage point reduction [95% CI,-0.8 to -0.2] with 1-point increase in the score). Conclusions and Relevance: This cohort study found that implementation of PACT in the VA was associated with a potential short-term improvement in the quality of follow-up for certain test results. Additional multifaceted sustained interventions to reduce missed test results are required to prevent care delays.

Utilization of Biologic Disease-Modifying Antirheumatic Therapy in Patients With Rheumatoid Arthritis and Recently Diagnosed Breast Cancer.

OBJECTIVE: Biologic disease-modifying antirheumatic drugs (bDMARDs) are immunosuppressants, and there have been concerns that they might impact tumor immunity in patients with cancer with rheumatoid arthritis (RA). The purpose of this study was to describe the utilization trends of bDMARD in patients with RA after breast cancer (BC) diagnosis. METHODS: We performed a retrospective cohort study of adults with RA and BC (2008 onward) from Optum's de-identified Clinformatics® Data Mart Database (CDM); the Surveillance, Epidemiology, and End Results Program (SEER) Medicare; and the Texas Cancer Registry (TCR) Medicare databases. We evaluated bDMARD utilization trends during the first three years after BC. We conducted multivariable logistic regression to evaluate the association of utilization with patient characteristics. RESULTS: A total 1,412 patients were identified in CDM and 1,439 patients in SEER/TCR-Medicare. During the three months before BC diagnosis, 28.2% (CDM) and 26.9% (SEER/TCR-Medicare) patients had received bDMARDs. Within the first three years after diagnosis, 24.1% (CDM) and 26.4% (SEER/TCR-Medicare) were receiving bDMARDs. About 70% of the patients in the two cohorts received glucocorticoids with no significant time trend increases. The largest predictor of bDMARD utilization was prior use before BC (CDM: odds ratio [OR] 27.15, 95% confidence interval [CI] 19.29-38.19; SEER/TCR: OR 18.98, 95% CI 13.72-26.26). Regional and distant BC compared to in situ or localized were also associated with lower bDMARDs utilization in SEER/TCR-Medicare (OR 0.54, 95% CI 0.36-0.82; OR 0.31, 95% CI 0.13-0.77, respectively). CONCLUSION: The utilization of tumor necrosis factor inhibitors and other bDMARDs in patients with RA and recent BC has not increased since 2008. Glucocorticoids utilization remained high. The largest predictor of bDMARD utilization was prior use before BC.

Strokes Averted by Intravenous Thrombolysis: A Secondary Analysis of a Prospective, Multicenter, Controlled Trial of Mobile Stroke Units.

OBJECTIVE: This study was undertaken to examine averted stroke in optimized stroke systems. METHODS: This secondary analysis of a multicenter trial from 2014 to 2020 compared patients treated by mobile stroke unit (MSU) versus standard management. The analytical cohort consisted of participants with suspected stroke treated with intravenous thrombolysis. The main outcome was a tissue-defined averted stroke, defined as a final diagnosis of stroke with resolution of presenting symptoms/signs by 24 hours attributed to thrombolysis and no acute infarction/hemorrhage on imaging. An additional outcome was stroke with early symptom resolution, defined as a final diagnosis of stroke with resolution of presenting symptoms/signs by 24 hours attributed to thrombolysis. RESULTS: Among 1,009 patients with a median last known well to thrombolysis time of 87 minutes, 159 (16%) had tissue-defined averted stroke and 276 (27%) had stroke with early symptom resolution. Compared with standard management, MSU care was associated with more tissue-defined averted stroke (18% vs 11%, adjusted odds ratio [aOR] = 1.82, 95% confidence interval [CI] = 1.13-2.98) and stroke with early symptom resolution (31% vs 21%, aOR = 1.74, 95% CI = 1.12-2.61). The relationships between thrombolysis treatment time and averted/early recovered stroke appeared nonlinear. Most models indicated increased odds for stroke with early symptom resolution but not tissue-defined averted stroke with earlier treatment. Additionally, younger age, female gender, hyperlipidemia, lower National Institutes of Health Stroke Scale, lower blood pressure, and no large vessel occlusion were associated with both tissue-defined averted stroke and stroke with early symptom resolution. INTERPRETATION: In optimized stroke systems, 1 in 4 patients treated with thrombolysis recovered within 24 hours and 1 in 6 had no demonstrable brain injury on imaging. ANN NEUROL 2024;95:347-361.

Association between psychosocial rehabilitation and recovery center service receipt and reported internalized stigma among veterans.

Internalized stigma, also known as self-stigma, is negatively associated with a person's willingness to seek mental health services and follow their treatment plan. This can hinder a person's recovery, exacerbate their mental health illnesses, and reduce their quality of life. A primary directive of the Veteran Affairs Psychosocial Rehabilitation and Recovery Center (PRRC) program is to help veterans overcome their internalized stigma. This study is the first to evaluate the association between receiving PRRC services over time and veteran reported levels of internalized stigma based on Internalized Stigma of Mental Illness-Brief-10 scores using longitudinal PRRC Forms Data. The analysis was performed using a random-effects ordered logistic regression adjusting for veteran sociodemographic and clinical characteristics. Our study cohort consisted of 2,774 veterans who received PRRC services between fiscal years 2018 and 2021 and who had an intake form at the start of the PRRC service and at least one follow-up form. Our study found that veterans had lower odds of having a higher level of internalized stigma at the first follow-up relative to their intake (OR: 0.80; 95% CI [0.70, 0.92]), and these odds continued to decrease with each subsequent follow-up. These results potentially indicate the effectiveness of the PRRC program in reducing levels of internalized stigma among the veterans. Our study also suggests the need for greater clinical attention and resources for subgroups such as older veterans, male veterans, and veterans with posttraumatic stress disorder, anxiety, or personality disorders, who reported higher levels of internalized stigma. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Comorbidity network analysis using graphical models for electronic health records.

Importance: The comorbidity network represents multiple diseases and their relationships in a graph. Understanding comorbidity networks among critical care unit (CCU) patients can help doctors diagnose patients faster, minimize missed diagnoses, and potentially decrease morbidity and mortality. Objective: The main objective of this study was to identify the comorbidity network among CCU patients using a novel application of a machine learning method (graphical modeling method). The second objective was to compare the machine learning method with a traditional pairwise method in simulation. Method: This cross-sectional study used CCU patients' data from Medical Information Mart for the Intensive Care-3 (MIMIC-3) dataset, an electronic health record (EHR) of patients with CCU hospitalizations within Beth Israel Deaconess Hospital from 2001 to 2012. A machine learning method (graphical modeling method) was applied to identify the comorbidity network of 654 diagnosis categories among 46,511 patients. Results: Out of the 654 diagnosis categories, the graphical modeling method identified a comorbidity network of 2,806 associations in 510 diagnosis categories. Two medical professionals reviewed the comorbidity network and confirmed that the associations were consistent with current medical understanding. Moreover, the strongest association in our network was between "poisoning by psychotropic agents" and "accidental poisoning by tranquilizers" (logOR 8.16), and the most connected diagnosis was "disorders of fluid, electrolyte, and acid-base balance" (63 associated diagnosis categories). Our method outperformed traditional pairwise comorbidity network methods in simulation studies. Some strongest associations between diagnosis categories were also identified, for example, "diagnoses of mitral and aortic valve" and "other rheumatic heart disease" (logOR: 5.15). Furthermore, our method identified diagnosis categories that were connected with most other diagnosis categories, for example, "disorders of fluid, electrolyte, and acid-base balance" was associated with 63 other diagnosis categories. Additionally, using a data-driven approach, our method partitioned the diagnosis categories into 14 modularity classes. Conclusion and relevance: Our graphical modeling method inferred a logical comorbidity network whose associations were consistent with current medical understanding and outperformed traditional network methods in simulation. Our comorbidity network method can potentially assist CCU doctors in diagnosing patients faster and minimizing missed diagnoses.

Quantifying the Implementation and Cost of a Multisite Antibiotic Stewardship Intervention for Asymptomatic Bacteriuria.

Objective: The intensity of an antibiotic stewardship intervention to achieve clinical impact is not known. We conducted a multisite dissemination project of an intervention to reduce treatment of asymptomatic bacteriuria (ASB) and studied: (1) the association between implementation metrics and clinical outcomes and (2) the cost of implementation. Design/Setting/Participants: A central site facilitated a multimodality intervention to decrease unnecessary urine cultures and antibiotic treatment in patients with ASB at 4 Veterans Affairs medical centers. Methods: The intervention consisted of a decision support aid algorithm and interactive teaching cases that provided in the moment audit and feedback on how to manage ASB. Implementation outcomes included minutes spent in intervention delivery, number of healthcare professionals reached, and number of sessions delivered. Clinical outcomes included days of antibiotic therapy (DOT), length of antibiotic therapy (LOT), and number of urine cultures ordered per 1000 bed days. Personnel reported weekly time logs. Results: Minutes spent in intervention delivery were inversely correlated with two clinical outcomes, DOT (R -0.3, P = .04) and LOT (R -0.3, P = .02). Number of healthcare professionals reached and number of sessions delivered were not correlated with clinical outcomes of DOT (R -0.003, P = .98, R = -0.059, P = .69) or LOT (R +0.073, P = .62, R -0.102, P = .49). Physician champions spent an average of 3.8% of effort on the intervention. The implementation cost was USD 22,299/year per site on average. Conclusions: The amount of time local teams spent in delivery of an antibiotic stewardship intervention was correlated with the desired decrease in antibiotic use. Implementing this successful antibiotic stewardship intervention required minimal time.

Outcomes of patients with pre-existing disability managed by mobile stroke units: A sub-analysis of the BEST-MSU study.

BACKGROUND: Few data exist on acute stroke treatment in patients with pre-existing disability (PD) since they are usually excluded from clinical trials. A recent trial of mobile stroke units (MSUs) demonstrated faster treatment and improved outcomes, and included PD patients. AIM: To determine outcomes with tissue plasminogen activator (tPA), and benefit of MSU versus management by emergency medical services (EMS), for PD patients. METHODS: Primary outcomes were utility-weighted modified Rankin Scale (uw-mRS). Linear and logistic regression models compared outcomes in patients with versus without PD, and PD patients treated by MSU versus standard management by EMS. Time metrics, safety, quality of life, and health-care utilization were compared. RESULTS: Of the 1047 tPA-eligible ischemic stroke patients, 254 were with PD (baseline mRS 2-5) and 793 were without PD (baseline mRS 0-1). Although PD patients had worse 90-day uw-mRS, higher mortality, more health-care utilization, and worse quality of life than non-disabled patients, 53% returned to at least their baseline mRS, those treated faster had better outcome, and there was no increased bleeding risk. Comparing PD patients treated by MSU versus EMS, 90-day uw-mRS was 0.42 versus 0.36 (p = 0.07) and 57% versus 46% returned to at least their baseline mRS. There was no interaction between disability status and MSU versus EMS group assignment (p = 0.67) for 90-day uw-mRS. CONCLUSION: PD did not prevent the benefit of faster treatment with tPA in the BEST-MSU study. Our data support inclusion of PD patients in the MSU management paradigm.

Geographic Variations and the Associated Factors in Adherence to and Persistence with Adjuvant Hormonal Therapy for the Privately Insured women Aged 18-64 with Breast Cancer in Texas.

The purpose of this study is to examine the geographical patterns of adjuvant hormonal therapy adherence and persistence and the associated factors in insured Texan women aged 18-64 with early breast cancer. A retrospective cohort study was conducted using 5-year claims data for the population insured by the Blue Cross Blue Shield of Texas (BCBSTX). Women diagnosed with early breast cancer who were taking tamoxifen or aromatase inhibitors (AIs) for adjuvant hormonal therapy with at least one prescription claim were identified. Adherence to adjuvant hormonal therapy and persistence with adjuvant hormonal therapy were calculated as outcome measures. Women without a gap between two consecutively dispensed prescriptions of at least 90 days were considered to be persistently taking the medications. Patient-level multivariate logistic regression models with repeated regional-level adjustments and a Cox proportional hazards model with mixed effects were used to determine the geographical variations and patient-, provider-, and area-level factors that were associated with adjuvant hormonal therapy adherence and persistence. Of the 938 women in the cohort, 627 (66.8%) initiated adjuvant hormonal therapy. Most of the smaller HRRs have significantly higher or lower rates of treatment adherence and persistence rates relative to the median regions. The use of AHT varies substantially from one geographical area to another, especially for adherence, with an approximately two-fold difference between the lowest and highest areas, and area-level factors were found to be significantly associated with the compliance of AHT. There are geographical variations in AHT adherence and persistence in Texas. Patient-level and area-level factors have significant associations explaining these patterns.

Bayesian regularization to predict neuropsychiatric adverse events in smoking cessation with pharmacotherapy.

BACKGROUND: Research on risk factors for neuropsychiatric adverse events (NAEs) in smoking cessation with pharmacotherapy is scarce. We aimed to identify predictors and develop a prediction model for risk of NAEs in smoking cessation with medications using Bayesian regularization. METHODS: Bayesian regularization was implemented by applying two shrinkage priors, Horseshoe and Laplace, to generalized linear mixed models on data from 1203 patients treated with nicotine patch, varenicline or placebo. Two predictor models were considered to separate summary scores and item scores in the psychosocial instruments. The summary score model had 19 predictors or 26 dummy variables and the item score model 51 predictors or 58 dummy variables. A total of 18 models were investigated. RESULTS: An item score model with Horseshoe prior and 7 degrees of freedom was selected as the final model upon model comparison and assessment. At baseline, smokers reporting more abnormal dreams or nightmares had 16% greater odds of experiencing NAEs during treatment (regularized odds ratio (rOR) = 1.16, 95% credible interval (CrI) = 0.95 - 1.56, posterior probability P(rOR > 1) = 0.90) while those with more severe sleep problems had 9% greater odds (rOR = 1.09, 95% CrI = 0.95 - 1.37, P(rOR > 1) = 0.85). The prouder a person felt one week before baseline resulted in 13% smaller odds of having NAEs (rOR = 0.87, 95% CrI = 0.71 - 1.02, P(rOR < 1) = 0.94). Odds of NAEs were comparable across treatment groups. The final model did not perform well in the test set. CONCLUSIONS: Worse sleep-related symptoms reported at baseline resulted in 85%-90% probability of being more likely to experience NAEs during smoking cessation with pharmacotherapy. Treatment for sleep disturbance should be incorporated in smoking cessation program for smokers with sleep disturbance at baseline. Bayesian regularization with Horseshoe prior permits including more predictors in a regression model when there is a low number of events per variable.

Golden Hour Treatment With tPA (Tissue-Type Plasminogen Activator) in the BEST-MSU Study.

BACKGROUND: Treatment of patients with acute ischemic stroke on mobile stroke units (MSUs) improves outcomes compared with management by standard emergency medical services ambulances and is associated with more patients treated with intravenous tPA (tissue-type plasminogen activator) in the first golden hour after last known normal. We explored the predictors and outcomes of first-hour treatment (FHT) compared with later treatment in an alternating-week cluster-controlled trial of MSUs. METHODS: We analyzed all patients treated with intravenous tPA in the BEST-MSU Study (Benefits of Stroke Treatment Delivered by a Mobile Stroke Unit Compared to Standard Management by Emergency Medical Services). After stratifying by treatment timeframe, we identified factors associated with FHT. We performed adjusted analyses of the association between FHT and clinical outcome and modeled the shape of the relationship between last known normal-to-treatment time and excellent outcome. RESULTS: Among 941 tPA-treated patients, 206 (21.8%) had lytic started within 60 minutes. Treatment on the MSU, older age, male sex, alert by 911, faster arrival on-scene and imaging, more severe stroke, atrial fibrillation, and absence of heart failure and pretreatment antihypertensive treatment were associated with FHT. Compared with later treatment, FHT was associated with higher adjusted odds ratio for 90-day modified Rankin Scale score of 0 to 1 (odds ratio, 1.87 [95% CI, 1.25-2.84]; P=0.003). Among FHT patients, 68% achieved a 90-day modified Rankin Scale of 0 or 1 or returned to their baseline status. FHT was not associated with higher risk of hemorrhage and was associated with reduced risk of treating neurovascular mimics. CONCLUSIONS: FHT almost doubles the odds of excellent clinical outcome without increased risk compared with later treatment, which supports the use of MSUs.

Implementation of an Evidence-Based Intervention with Safety Net Clinics to Improve Mammography Appointment Adherence Among Underserved Women.

The Peace of Mind Program is an evidence-based intervention to improve mammography appointment adherence in underserved women. The aim of this study was to assess effectiveness of the intervention and implementation of the intervention in safety net clinics. The intervention was implemented through a non-randomized stepped wedge cluster hybrid study design with 19 Federally Qualified Health Centers and charity care clinics within the Greater Houston area. A multivariable generalized estimating equation logistic regression was conducted to examine mammography appointment adherence. A survey assessing Consolidated Framework for Implementation Research constructs was also conducted with clinic staff prior to adoption and eight weeks post implementation. One-sided t-tests were conducted to analyze mean score changes between the surveys. A total of 4402 women (baseline period = 2078; intervention period = 2324) were included in the final regression analysis. Women in the intervention period were more likely to attend or reschedule their mammography appointment (OR = 1.30; p < 0.01) than those in the baseline period receiving usual care. Women who completed the intervention were more likely to attend or reschedule their mammography appointment than those who did not complete the intervention (OR = 1.62; p < 0.01). The mammography appointment no-show rates for those in the baseline period, in the intervention period, and who completed the intervention were, respectively, 22%, 19%, and 15%. A total of 15 clinics prior to adoption and eight clinics completed the survey at 8 weeks post implementation A statistically significant mean score decrease was observed in Inner Setting and in two Inner Setting CFIR constructs, Culture-Effort, and Implementation Climate. While the intervention improved mammography appointment adherence, there are opportunities to further integrate Consolidated Framework for Implementation Research constructs. Trial registration: Clinical trials registration number: NCT02296177.

Comparison of Collaborative Goal Setting With Enhanced Education for Managing Diabetes-Associated Distress and Hemoglobin A1c Levels: A Randomized Clinical Trial.

Importance: Type 2 diabetes is a prevalent and morbid condition. Poor engagement with self-management can contribute to diabetes-associated distress and hinder diabetes control. Objective: To evaluate the implementation and effectiveness of Empowering Patients in Chronic Care (EPICC), an evidence-based intervention to improve diabetes-associated distress and hemoglobin A1c (HbA1c) levels after the intervention and after 6-month maintenance. Design, Setting, and Participants: This hybrid (implementation-effectiveness) randomized clinical trial was performed in Veterans Affairs clinics across Illinois, Indiana, and Texas from July 1, 2015, to June 30, 2017. Participants included adults with uncontrolled type 2 diabetes (HbA1c level >8.0%) who received primary care during the prior year in participating clinics. Data collection was completed on November 30, 2018, and data analysis was completed on June 30, 2020. All analyses were based on intention to treat. Interventions: Participants in EPICC attended 6 group sessions based on a collaborative goal-setting theory led by health care professionals. Clinicians conducted individual motivational interviewing sessions after each group. Usual care was enhanced (EUC) with diabetes education. Main Outcomes and Measures: The primary outcome consisted of changes in HbA1c levels after the intervention and during maintenance. Secondary outcomes included the Diabetes Distress Scale (DDS), Morisky Medication Adherence Scale, and Lorig Self-efficacy Scale. Secondary implementation outcomes included reach, adoption, and implementation (number of sessions attended per patient). Results: A total of 280 participants with type 2 diabetes (mean [SD] age, 67.2 [8.4] years; 264 men [94.3]; 134 non-Hispanic White individuals [47.9%]) were equally randomized to EPICC or EUC. Participants receiving EPICC had significant postintervention improvements in HbA1c levels (F1, 252 = 9.12, Cohen d = 0.36 [95% CI, 0.12-0.59]; P = .003) and DDS (F1, 245 = 9.06, Cohen d = 0.37 [95% CI, 0.13-0.60]; P = .003) compared with EUC. During maintenance, differences between the EUC and EPICC groups remained significant for DDS score (F1, 245 = 8.94, Cohen d = 0.36 [95% CI, 0.12-0.59]; P = .003) but not for HbA1c levels (F1, 252 = 0.29, Cohen d = 0.06 [95% CI, -0.17 to 0.30]; P = .60). Improvements in DDS scores were modest. There were no differences between EPICC and EUC in improvements after intervention or maintenance for either adherence or self-efficacy. Among all 4002 eligible patients, 280 (7.0%) enrolled in the study (reach). Each clinic conducted all planned EPICC sessions and cohorts (100% adoption). The EPICC group participants attended a mean (SD) of 4.34 (1.98) sessions, with 54 (38.6%) receiving all 6 sessions. Conclusions and Relevance: A patient-empowerment approach using longitudinal collaborative goal setting and motivational interviewing is feasible in primary care. Improvements in HbA1c levels after the intervention were not sustained after maintenance. Modest improvements in diabetes-associated distress after the intervention were sustained after maintenance. Innovations to expand reach (eg, telemedicine-enabled shared appointments) and sustainability are needed. Trial Registration: ClinicalTrials.gov Identifier: NCT01876485.

Hemorrhage Enlargement Is More Frequent in the First 2 Hours: A Prehospital Mobile Stroke Unit Study.

BACKGROUND: Hematoma enlargement (HE) after intracerebral hemorrhage (ICH) is a therapeutic target for improving outcomes. Hemostatic therapies to prevent HE may be more effective the earlier they are attempted. An understanding of HE in first 1 to 2 hours specifically in the prehospital setting would help guide future treatment interventions in this time frame and setting. METHODS: Patients with spontaneous ICH within 4 hours of symptom onset were prospectively evaluated between May 2014 and April 2020 as a prespecified substudy within a multicenter trial of prehospital mobile stroke unit versus standard management. Baseline computed tomography scans obtained <1, 1 to 2, and 2 to 4 hours postsymptom onset on the mobile stroke unit in the prehospital setting were compared with computed tomography scans repeated 1 hour later and at 24 hours in the hospital. HE was defined as >6 mL if baseline ICH volume was <20 mL and 33% increase if baseline volume >20 mL. The association between time from symptom onset to baseline computed tomography (hours) and HE was investigated using Wilcoxon rank-sum test when time was treated as a continuous variable and using Fisher exact test when time was categorized. Kruskal-Wallis and Wilcoxon rank-sum tests evaluated differences in baseline volumes and HE. Univariable and multivariable logistic regression analyses were conducted to identify factors associated with HE and variable selection was performed using cross-validated L1-regularized (Lasso regression). This study adhered to STROBE guidelines (Strengthening the Reporting of Observational Studies in Epidemiology) for cohort studies. RESULTS: One hundred thirty-nine patients were included. There was no difference between baseline ICH volumes obtained <1 hour (n=43) versus 1 to 2 hour (n=51) versus >2 hours (n=45) from symptom onset (median [interquartile range], 13 mL [6-24] versus 14 mL [6-30] versus 12 mL [4-19]; P=0.65). However, within the same 3 time epochs, initial hematoma growth (volume/time from onset) was greater with earlier baseline scanning (median [interquartile range], 17 mL/hour [9-35] versus 9 mL/hour [5-23]) versus 4 mL/hour [2-7]; P<0.001). Forty-nine patients had repeat scans 1 hour after baseline imaging (median, 2.3 hours [interquartile range. 1.9-3.1] after symptom onset). Eight patients (16%) had HE during that 1-hour interval; all of these occurred in patients with baseline imaging within 2 hours of onset (5/18=28% with baseline imaging within 1 hour, 3/18=17% within 1-2 hour, 0/13=0% >2 hours; P=0.02). HE did not occur between the scans repeated at 1 hour and 24 hours. No association between baseline variables and HE was detected in multivariable analyses. CONCLUSIONS: HE in the next hour occurs in 28% of ICH patients with baseline imaging within the first hour after symptom onset, and in 17% of those with baseline imaging between 1 and 2 hours. These patients would be a target for ultraearly hemostatic intervention.

Assessment of US Preventive Services Task Force Guideline-Concordant Cervical Cancer Screening Rates and Reasons for Underscreening by Age, Race and Ethnicity, Sexual Orientation, Rurality, and Insurance, 2005 to 2019.

Importance: Cervical cancer screening rates are suboptimal in the US. Population-based assessment of reasons for not receiving screening is needed, particularly among women from historically underserved demographic groups. Objective: To estimate changes in US Preventive Service Task Force guideline-concordant cervical cancer screening over time and assess the reasons women do not receive up-to-date screening by sociodemographic factors. Design, Setting, and Participants: This pooled population-based cross-sectional study used data from the US National Health Interview Survey from 2005 and 2019. A total of 20 557 women (weighted, 113.1 million women) aged 21 to 65 years without previous hysterectomy were included. Analyses were conducted from March 30 to August 19, 2021. Exposures: Sociodemographic factors, including age, race and ethnicity, sexual orientation, rurality of residence, and health insurance type. Main Outcomes and Measures: Primary outcomes were US Preventive Services Task Force guideline-concordant cervical cancer screening rates and self-reported primary reasons for not receiving up-to-date screening. For 2005, up-to-date screening was defined as screening every 3 years for women aged 21 to 65 years. For 2019, up-to-date screening was defined as screening every 3 years with a Papanicolaou test alone for women aged 21 to 29 years and screening every 3 years with a Papanicolaou test alone or every 5 years with high-risk human papillomavirus testing or cotesting for women aged 30 to 65 years. Population estimation included sampling weights. Results: Among 20 557 women (weighted, 113.1 million women) included in the study, most were aged 30 to 65 years (16 219 women; weighted, 86.3 million women [76.3%]) and had private insurance (13 571 women; weighted, 75.8 million women [67.0%]). With regard to race and ethnicity, 997 women (weighted, 6.9 million women [6.1%]) were Asian, 3821 women (weighted, 19.5 million women [17.2%]) were Hispanic, 2862 women (weighted, 14.8 million women [13.1%]) were non-Hispanic Black, 12 423 women (weighted, 69.0 million women [61.0%]) were non-Hispanic White, and 453 women (weighted, 3.0 million women [2.7%]) were of other races and/or ethnicities (including Alaska Native and American Indian [weighted, 955 000 women (0.8%)] and other single and multiple races or ethnicities [weighted, 2.0 million women (1.8%)]). In 2019, women aged 21 to 29 years had a significantly higher rate of overdue screening (29.1%) vs women aged 30 to 65 years (21.1%; P < .001). In both age groups, the proportion of women without up-to-date screening increased significantly from 2005 to 2019 (from 14.4% to 23.0%; P < .001). Significantly higher rates of overdue screening were found among those of Asian vs non-Hispanic White race and ethnicity (31.4% vs 20.1%; P = .01), those identifying as LGBQ+ (gender identity was not assessed because of a small sample) vs heterosexual (32.0% vs 22.2%; P < .001), those living in rural vs urban areas (26.2% vs 22.6%; P = .04), and those without insurance vs those with private insurance (41.7% vs 18.1%; P < .001). The most common reason for not receiving timely screening across all groups was lack of knowledge, ranging from 47.2% of women identifying as LGBQ+ to 64.4% of women with Hispanic ethnicity. Previous receipt of a human papillomavirus vaccine was not a primary reason for not having up-to-date screening (<1% of responses). From 2005 to 2019, among women aged 30 to 65 years, lack of access decreased significantly as a primary reason for not receiving screening (from 21.8% to 9.7%), whereas lack of knowledge (from 45.2% to 54.8%) and not receiving recommendations from health care professionals (from 5.9% to 12.0%) increased significantly. Conclusions and Relevance: This cross-sectional study found that cervical cancer screening that was concordant with US Preventive Services Task Force guidelines decreased in the US between 2005 and 2019, with lack of knowledge reported as the biggest barrier to receiving timely screening. Campaigns addressing patient knowledge and provider communication may help to improve screening rates, and cultural adaptation of interventions is needed to reduce existing disparities.

Machine Learning Automated Detection of Large Vessel Occlusion From Mobile Stroke Unit Computed Tomography Angiography.

BACKGROUND: Prehospital automated large vessel occlusion (LVO) detection in Mobile Stroke Units (MSUs) could accelerate identification and treatment of patients with LVO acute ischemic stroke. Here, we evaluate the performance of a machine learning (ML) model on CT angiograms (CTAs) obtained from 2 MSUs to detect LVO. METHODS: Patients evaluated on MSUs in Houston and Los Angeles with out-of-hospital CTAs were identified. Anterior circulation LVO was defined as an occlusion of the intracranial internal carotid artery, middle cerebral artery (M1 or M2), or anterior cerebral artery vessels and determined by an expert human reader. A ML model to detect LVO was trained and tested on independent data sets consisting of in-hospital CTAs and then tested on MSU CTA images. Model performance was determined using area under the receiver-operator curve statistics. RESULTS: Among 68 patients with out-of-hospital MSU CTAs, 40% had an LVO. The most common occlusion location was the middle cerebral artery M1 segment (59%), followed by the internal carotid artery (30%), and middle cerebral artery M2 (11%). Median time from last known well to CTA imaging was 88.0 (interquartile range, 59.5-196.0) minutes. After training on 870 in-hospital CTAs, the ML model performed well in identifying LVO in a separate in-hospital data set of 441 images with area under receiver-operator curve of 0.84 (95% CI, 0.80-0.87). ML algorithm analysis time was under 1 minute. The performance of the ML model on the MSU CTA images was comparable with area under receiver-operator curve 0.80 (95% CI, 0.71-0.89). There was no significant difference in performance between the Houston and Los Angeles MSU CTA cohorts. CONCLUSIONS: In this study of patients evaluated on MSUs in 2 cities, a ML algorithm was able to accurately and rapidly detect LVO using prehospital CTA acquisitions.

Technology-Based Closed-Loop Tracking for Improving Communication and Follow-up of Pathology Results.

OBJECTIVE: Failure to follow-up on laboratory test results can lead to missed diagnoses, diagnostic delays, patient harm, and potential malpractice claims against providers. State-of-the-art tracking technologies such as the radio frequency identification (RFID) can potentially improve laboratory order processing and test result communication. We conducted a comparative evaluation of differences in completion rates for 5 testing process milestones and time to reach these process milestones, with and without RFID order tracking for skin biopsy orders. METHODS: This observational study analyzed 48,515 orders from 20 dermatology providers, sent to 8 pathology laboratories in 2016 to 2017. Descriptive t tests and multiple Cox proportional hazard regressions were used to examine the differences in completion rates and times to the 5 testing process milestones, namely, (1) provider receipt of results, (2) provider review of results, (3) patient notification, (4) follow-up scheduling, and (5) order case closure, for orders processed with and without RFID order tracking. RESULTS: Descriptive statistics illustrated that all 5 testing process milestone completion rates were statistically higher for RFID tracked orders compared with non-RFID tracked orders, and RFID tracked orders took 3 to 5 days lesser than non-RFID tracked orders to reach the 5 testing process milestones. Multiple cox proportional hazard regressions showed that the process milestones were achieved faster if orders were RFID tracked versus not (hazard ratios ranged from 1.3 to 4.9). CONCLUSIONS: The RFID tracking technology considerably improved test result communication timeliness and reliability. Such technologies can be beneficial for laboratory order processing, and their effectiveness should be explored in other practice settings.

Prospective association between receipt of the economic impact payment and mental health outcomes.

BACKGROUND: The Coronavirus Aid, Relief, and Economic Security Act of 2020 provided 'economic impact payments' (EIPs) of $1200 to US adults with annual personal income of $75 000 or less. This study examined the prospective association between EIP receipt and mental health outcomes. METHODS: A nationally representative sample of 3169 middle-income and low-income US adults completed a baseline assessment of their health and well-being in May-June 2020 and a 3-month follow-up assessment during the period of the COVID-19 pandemic when EIPs were distributed. RESULTS: Controlling for sociodemographic characteristics, EIP recipients had higher odds of reporting a positive COVID-19 test, endorsing a history of post-traumatic stress disorder and reporting any illicit drug use in the past month than participants who did not receive EIP. Participants who did not receive EIP were more likely to report a history of anxiety disorder or alcohol use disorder and recent suicidal ideation than EIP recipients. There was no association between EIP receipt and financial distress, although over one-third to over half of EIP recipients were not employed at baseline. Between baseline and 3-month follow-up, receipt of EIP was significantly associated with reduced medical conditions and alcohol use problems, but increased depression, suicidal ideation and COVID-19 era-related stress. CONCLUSION: The EIP provided a brief income stimulus to many adults in need but was not associated with improvements in financial distress or mental health among middle-income and low-income recipients. Long-term income security and employment may be more important to improving and sustaining positive mental health outcomes.

Retrospectively Collected EQ-5D-5L Data as Valid Proxies for Imputing Missing Information in Longitudinal Studies.

OBJECTIVES: Studies face challenges with missing 5-level EQ-5D (EQ-5D-5L) data, often because of the need for longitudinal EQ-5D-5L data collection. There is a dearth of validated methodologies for dealing with missing EQ-5D-5L data in the literature. This study, for the first time, examined the possibility of using retrospectively collected EQ-5D-5L data as proxies for the missing data. METHODS: Participants who had prospectively completed a 3rd month postdischarge EQ-5D-5L instrument (in-the-moment collection) were randomly interviewed to respond to a 2nd "retrospective collection" of their 3rd month EQ-5D-5L at 6th, 9th, or 12th month after hospital discharge. A longitudinal single imputation was also used to assess the relative performance of retrospective collection compared with the longitudinal single imputation. Concordances between the in-the-moment, retrospective, and imputed measures were assessed using intraclass correlation coefficients and weighted kappa statistics. RESULTS: Considerable agreement was observed on the basis of weighted kappa (range 0.72-0.95) between the mobility, self-care, and usual activities dimensions of EQ-5D-5L collected in-the-moment and retrospectively. Concordance based on intraclass correlation coefficients was good to excellent (range 0.79-0.81) for utility indices computed, and excellent (range 0.93-0.96) for quality-adjusted life-years computed using in-the-moment compared with retrospective EQ-5D-5L. The longitudinal single imputation did not perform as well as the retrospective collection method. CONCLUSIONS: This study demonstrates that retrospective collection of EQ-5D-5L has high concordance with "in-the-moment" EQ-5D-5L and could be a valid and attractive alternative for data imputation when longitudinally collected EQ-5D-5L data are missing. Future studies examining this method for other disease areas and populations are required to provide more generalizable evidence.