Cost-effectiveness of Choosing Wisely guidelines for axillary observation in women older than age 70 years with hormone receptor-positive, clinically node-negative, operable breast tumors.

BACKGROUND: The Society for Surgical Oncology's Choosing Wisely guidelines recommend against sentinel lymph node biopsy (SLNB) in favor of observation in this population. Recent analyses reveal that this has not been widely adopted. The purpose of this cost-effectiveness analysis is to compare the costs and benefits associated with observation or SLNB in women >70 years old with hormone receptor-positive, clinically node-negative, operable breast cancer. METHODS: A decision tree with Markov modeling was created to compare treatment strategies using long-term follow-up data from clinical trials in this population. Costs were estimated from published literature and publicly available databases. Breast cancer-specific health-state utilities were derived from the literature and expert opinion. One-way, 2-way, and probabilistic sensitivity analyses were conducted. A structural sensitivity analysis was performed to assess the effect of functional status and anxiety from nonevaluation of the axilla on cost-effectiveness. Costs and benefits, measured in life-years (LYs) and quality-adjusted life-years (QALYs), were tabulated across 10, 15, and 20 years and compared using incremental cost-effectiveness ratios (ICERs). RESULTS: SLNB is not cost-effective from the payer or societal perspectives with ICERs of $138,374/LY and $131,900/LY, respectively. When QALYs were considered, SLNB provided fewer QALYs (SLNB, 10.33 QALYs; observation, 10.53 QALYs) at a higher cost (SLNB, $15,845; observation, $4020). Structural sensitivity analysis revealed that SLNB was cost-effective in certain patients with significant anxiety related to axillary observation (ICER, $39,417/QALY). CONCLUSIONS: Routine SLNB in this population is not cost-effective. The cost-effectiveness of SLNB, however, is dependent on individual patient factors, including functional status as well as patient preference.

Lifestyle Habits Associated with Weight Regain After Intentional Loss in Primary Care Patients Participating in a Randomized Trial.

BACKGROUND: Though long-term weight loss maintenance is the treatment goal for obesity, weight regain is typical and few studies have evaluated lifestyle habits associated with weight regain. OBJECTIVE: To identify dietary and physical activity habits associated with 6- and 24-month weight regain among participants in a weight loss maintenance clinical trial. DESIGN: Secondary analysis of randomized clinical trial data. PARTICIPANTS: Adult primary care patients with recent, intentional weight loss of at least 5%. MAIN MEASURES: Lifestyle habits included consumption of low-fat foods, fish, desserts, sugary beverages, fruits, and vegetables and eating at restaurants from the Connor Diet Habit Survey; moderate-vigorous physical activity by self-report; steps recorded by a pedometer; and sedentary behavior by self-report. The outcome variable was weight change at 6 and 24 months. Linear regression models estimated adjusted associations between changes in weight and changes in dietary and physical activity habits. KEY RESULTS: Overall, participants (mean (SD): 53.4 (12.2) years old; 26% male; 88% white) maintained weight loss at 6 months (n = 178, mean (SD): - 0.02 (5.70)% change) but began to regain weight by 24 months (n = 157, mean (SD): 4.22 (9.15)% increase). When considered all together, more eating at restaurants, reduced fish consumption, and less physical activity were most consistently associated with weight regain in fully adjusted models at both 6 and 24 months of follow-up. In addition, more sedentary behavior was associated with weight regain at 6 months while reduced consumption of low-fat foods, and more desserts and sugary beverages were associated with weight regain at 24 months. CONCLUSIONS: Consuming less fish, fewer steps per day, and more frequent restaurant eating were most consistently associated with weight regain in primary care patients. Primary care providers may consider addressing specific lifestyle behaviors when counseling patients after successful weight loss. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01946191.

Effect of Electronic Health Record-Based Coaching on Weight Maintenance: A Randomized Trial.

Background: Weight regain after intentional loss is common. Most evidence-based weight management programs focus on short-term loss rather than long-term maintenance. Objective: To evaluate the benefit of coaching in an electronic health record (EHR)-based weight maintenance intervention. Design: Randomized controlled trial. (ClinicalTrials.gov: NCT01946191). Setting: Practices affiliated with an academic medical center. Participants: Adult outpatients with body mass index (BMI) of 25 kg/m2 or higher, intentional weight loss of at least 5% in the previous 2 years, and no bariatric procedures in the previous 5 years. Intervention: Participants were randomly assigned to EHR tools (tracking group) versus EHR tools plus coaching (coaching group). The EHR tools included weight, diet, and physical activity tracking flow sheets; standardized surveys; and reminders. The coaching group received 24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts. Measurements: The primary outcome was weight change at 24 months. Secondary outcomes included 5% weight loss maintenance and changes in BMI, waist circumference, number of steps per day, health-related quality of life, physical function, blood pressure, and satisfaction. Results: Among 194 randomly assigned participants (mean age, 53.4 years [SD, 12.2]; 143 [74%] women; 171 [88%] white), 157 (81%) completed the trial. Mean baseline weight and BMI were 85.8 kg (SD, 19.1) and 30.4 kg/m2 (SD, 5.9). At 24 months, mean weight regain (± SE) was 2.1 ± 0.62 kg and 4.9 ± 0.63 kg in the coaching and tracking groups, respectively. The between-group difference in weight change at 24 months was significant (-2.86 kg [95% CI, -4.60 to -1.11 kg]) in the linear mixed model. At 24 months, 65% of participants in the coaching group and 50% in the tracking group maintained weight loss of at least 5%. Limitation: Single-site trial, which limits generalizability. Conclusion: Among adults with intentional weight loss of at least 5%, use of EHR tools plus coaching resulted in less weight regain than EHR tools alone. Primary Funding Source: Agency for Healthcare Research and Quality and National Institutes of Health.

Cost-effectiveness analysis of biopsy strategies for endometrial cancer diagnosis in women with postmenopausal bleeding: Pipelle sampling curette versus dilatation & curettage.

BACKGROUND: Endometrial sampling is widely used for accurate diagnosis of endometrial cancer (EC), which is the most common gynecologic cancer in US women. The objective of this study was to explore the cost-effectiveness of two endometrial sampling procedures for diagnosing EC: (1) Pipelle endometrial sampling (Pipelle), and (2) dilatation & curettage (D&C), while accounting for sampling procedure failure rates and diagnostic accuracy in women with postmenopausal bleeding (PMB). METHOD: The decision analytic model was built to compare the cost-effectiveness of Pipelle and D&C strategies in a hypothetical cohort of PMB women. The analysis was performed from the perspective of a public healthcare payer (Medicare, US). We used 2017 Medicare reimbursement data for cost estimation. The effectiveness of these two diagnostic strategies was measured by analyzing the remaining life expectancy after EC diagnosis and subsequent treatment. RESULTS: The base case analysis suggested that Pipelle was not only equally effective (32.11 vs. 32.11 years of life), but also less costly ($1897.80 vs. $2999.11) based on Medicare reimbursement when compared to D&C. In one-way sensitivity analyses and Monte Carlo probabilistic sensitivity analysis, the Pipelle remained the more cost-effective sampling strategy even after accounting for sampling failure rate associated with each sampling strategy. CONCLUSION: The Pipelle is the more cost-effective sampling strategy compared to D&C for EC diagnosis in women with PMB. From the cost-effectiveness perspective, the higher sampling failure rate of Pipelle should not be regarded as a limitation in its clinical application.

Online Lifestyle Modification Intervention: Survey of Primary Care Providers' Attitudes and Views.

BACKGROUND: Online tools are a convenient and effective method of delivering lifestyle interventions to obese adult primary care patients. A referral model allows physicians to efficiently direct their patients to the intervention during a primary care visit. However, little is known of physicians' perspectives and utilization of the referral model for an online lifestyle modification intervention. OBJECTIVE: The aim was to evaluate the response of primary care providers (PCPs) to a referral model for implementing a year-long online intervention for weight loss to obese adult patients. METHODS: The PCPs at six primary care clinics were asked to refer adult obese patients to a year-long online lifestyle intervention providing self-management support for weight loss. Following the 1-year intervention, all providers at the participating practices were surveyed regarding their views of the program. Respondents completed survey items assessing their attitudes regarding the 1-year intensive weight loss intervention and identifying resources they would find helpful for assisting patients with weight loss. Referring physicians were asked about their level of satisfaction with implementing the counseling services using standard electronic health record referral processes. Attitudes toward obesity counseling among referring and nonreferring providers were compared. Impressions of how smoothly the referral model of obesity treatment integrated with the clinical workflow were also quantified. RESULTS: Of the 67 providers who completed the surveys, nonreferring providers (n=17) were more likely to prefer counseling themselves (P=.04) and to report having sufficient time to do so (P=.03) than referring providers (n=50) were. Nonreferring providers were more likely to report that their patients lacked computer skills (76%, 13/17 vs 34%, 17/50) or had less access to the Internet (65%, 11/17 vs 32%, 16/50). CONCLUSIONS: Understanding providers' views and barriers regarding the integration of online tools will facilitate widespread implementation of an online lifestyle modification intervention.

Cost-effectiveness of new antiviral regimens for treatment-naïve U.S. veterans with hepatitis C.

UNLABELLED: Recently approved, interferon-free medication regimens for treating hepatitis C are highly effective, but extremely costly. We aimed to identify cost-effective strategies for managing treatment-naïve U.S. veterans with new hepatitis C medication regimens. We developed a Markov model with 1-year cycle length for a cohort of 60-year-old veterans with untreated genotype 1 hepatitis C seeking treatment in a typical year. We compared using sofosbuvir/ledipasvir or ombitasvir/ritonavir/paritaprevir/dasabuvir to treat: (1) any patient seeking treatment; (2) only patients with advanced fibrosis or cirrhosis; or (3) patients with advanced disease first and healthier patients 1 year later. The previous standard of care, sofosbuvir/simeprevir or sofosbuvir/pegylated interferon/ribavirin, was included for comparison. Patients could develop progressive fibrosis, cirrhosis, or hepatocellular carcinoma, undergo transplantation, or die. Complications were less likely after sustained virological response. We calculated the incremental cost per quality-adjusted life year (QALY) and varied model inputs in one-way and probabilistic sensitivity analyses. We used the Veterans Health Administration perspective with a lifetime time horizon and 3% annual discounting. Treating any patient with ombitasvir-based therapy was the preferred strategy ($35,560; 14.0 QALYs). All other strategies were dominated (greater costs/QALY gained than more effective strategies). Varying treatment efficacy, price, and/or duration changed the preferred strategy. In probabilistic sensitivity analysis, treating any patient with ombitasvir-based therapy was cost-effective in 70% of iterations at a $50,000/QALY threshold and 65% of iterations at a $100,000/QALY threshold. CONCLUSION: Managing any treatment-naïve genotype 1 hepatitis C patient with ombitasvir-based therapy is the most economically efficient strategy, although price and efficacy can impact cost-effectiveness. It is economically unfavorable to restrict treatment to patients with advanced disease or use a staged treatment strategy. (Hepatology 2016;63:428-436).

Differences in Physician Referral Drive Disparities in Surgical Intervention for Hepatocellular Carcinoma: A Retrospective Cohort Study.

OBJECTIVE: To determine whether sociodemographic and geographic factors are associated with referral for surgery and receipt of recommended surgical intervention. BACKGROUND: Surgical interventions confer survival advantages compared with palliative therapies for hepatocellular carcinoma (HCC), but disparities exist in use of surgical intervention. Few have investigated referral for surgery as a potential barrier to surgical intervention, and little is known about the effects of patient geographic factors, including proximity to surgical centers. METHODS: Data were abstracted from the Pennsylvania Cancer Registry for patients with a diagnosis of HCC from 2006 to 2011. Using hospital procedure volume data from the Pennsylvania Health Care Cost Containment Council, we calculated proximity to a surgical center. We used multivariable logistic regression to determine whether geographic, racial, socioeconomic, and clinical factors were associated with referral for surgery and receipt of a recommended surgical intervention. RESULTS: Of 3576 patients with HCC, 41.0% were referred for surgery. Patients who lived closer to a surgical center were less likely to be referred for surgery (adjusted odds ratio = 0.79; 95% confidence interval, 0.68-0.92). Surgical referral was less likely among older, male patients with Medicaid insurance and advanced tumor stage at diagnosis. Of those referred, 1276 (87.0%) underwent surgical intervention. Proximity to a surgical center was not associated with receipt of surgical intervention (P = 0.27). Patients with distant tumor stage at diagnosis were less likely to receive recommended surgical intervention (adjusted odds ratio = 0.27; 95% confidence interval, 0.15-0.50). CONCLUSIONS: Geographic and sociodemographic disparities in referral for surgery may be major barriers to surgical intervention for patients with HCC.

Cost effectiveness of an internet-delivered lifestyle intervention in primary care patients with high cardiovascular risk.

OBJECTIVE: To assess the cost-effectiveness of an online adaptation of the diabetes prevention program (ODPP) lifestyle intervention. METHODS: ODPP was a before-after evaluation of a weight loss intervention comprising 16 weekly and 8 monthly lessons, incorporating behavioral tools and regular, brief, web-based individualized counseling in an overweight/obese cohort (mean age 52, 76% female, 92% white, 28% with diabetes). A Markov model was developed to estimate ODPP cost effectiveness compared with usual care (UC) to reduce metabolic risk over 10years. Intervention costs and weight change outcomes were obtained from the study; other model parameters were based on published reports. In the model, diabetes risk was a function of weight change with and without the intervention. RESULTS: Compared to UC, the ODPP in our cohort cost $14,351 and $29,331 per quality-adjusted life-year (QALY) gained from the health care system and societal perspectives, respectively. In a hypothetical cohort without diabetes, the ODPP cost $7777 and $18,263 per QALY gained, respectively. Results were robust in sensitivity analyses, but enrolling cohorts with lower annual risk of developing diabetes (≤1.8%), enrolling fewer participants (≤15), or increasing the hourly cost (≥$91.20) or annual per-participant time (≥1.45h) required for technical support could increase ODPP cost to >$20,000 per QALY gained. In probabilistic sensitivity analyses, ODPP was cost-effective in 20-58% of model iterations using an acceptability threshold of $20,000, 73-92% at $50,000, and 95-99% at $100,000 per QALY gained. CONCLUSIONS: The ODPP may offer an economical approach to combating overweight and obesity.

Economic and Public Health Impacts of Policies Restricting Access to Hepatitis C Treatment for Medicaid Patients.

BACKGROUND: Interferon-free hepatitis C treatment regimens are effective but very costly. The cost-effectiveness, budget, and public health impacts of current Medicaid treatment policies restricting treatment to patients with advanced disease remain unknown. OBJECTIVES: To evaluate the cost-effectiveness of current Medicaid policies restricting hepatitis C treatment to patients with advanced disease compared with a strategy providing unrestricted access to hepatitis C treatment, assess the budget and public health impact of each strategy, and estimate the feasibility and long-term effects of increased access to treatment for patients with hepatitis C. METHODS: Using a Markov model, we compared two strategies for 45- to 55-year-old Medicaid beneficiaries: 1) Current Practice-only advanced disease is treated before Medicare eligibility and 2) Full Access-both early-stage and advanced disease are treated before Medicare eligibility. Patients could develop progressive fibrosis, cirrhosis, or hepatocellular carcinoma, undergo transplantation, or die each year. Morbidity was reduced after successful treatment. We calculated the incremental cost-effectiveness ratio and compared the costs and public health effects of each strategy from the perspective of Medicare alone as well as the Centers for Medicare & Medicaid Services perspective. We varied model inputs in one-way and probabilistic sensitivity analyses. RESULTS: Full Access was less costly and more effective than Current Practice for all cohorts and perspectives, with differences in cost ranging from $5,369 to $11,960 and in effectiveness from 0.82 to 3.01 quality-adjusted life-years. In a probabilistic sensitivity analysis, Full Access was cost saving in 93% of model iterations. Compared with Current Practice, Full Access averted 5,994 hepatocellular carcinoma cases and 121 liver transplants per 100,000 patients. CONCLUSIONS: Current Medicaid policies restricting hepatitis C treatment to patients with advanced disease are more costly and less effective than unrestricted, full-access strategies. Collaboration between state and federal payers may be needed to realize the full public health impact of recent innovations in hepatitis C treatment.

Multiple listing for pediatric heart transplantation in the U.S.A.: analysis of OPTN registry data from 1995 through 2009.

Multiple listing is associated with shorter waitlist durations and increased likelihood of transplantation for renal candidates. Little is known about multiple listing in pediatric heart transplantation. We examined the prevalence and outcomes of multiple listing using OPTN data from 1995 through 2009. Characteristics and waitlist outcomes of propensity-score-matched single- and multiple-listed patients were compared. Multiple listing occurred in 23 of 6290 listings (0.4%). Median days between listings was 35 (0-1015) and median duration of multiple listings was 32 days (3-363). Among multiple-listed patients, there were trends toward less ECMO use (0% vs. 11%, p = 0.1) and more frequent requirement for a prospective cross-match (17% vs. 8%, p = 0.08). Multiple-listed patients more commonly had private insurance (78% vs. 56%; p = 0.03). Urgency status at listing was similar between groups (1/1A: 61% vs. 64%, 1B/2: 39 vs. 36%; p = 0.45) as were weight, age, diagnosis, ventilator/inotrope use, and median income (each p ≥ 0.17). There was a trend toward increased incidence of heart transplantation for multiple-listed patients at three, six, and 24 months (50%, 65%, 80%) vs. single-listed patients (40%, 54%, 64%; p = 0.11). Multiple listing for pediatric heart transplantation in the USA occurs infrequently and is more common in patients with private insurance.

Impact of electronic health record-coaching features in weight change: A secondary analysis from the MAINTAIN-pc randomized trial.

OBJECTIVE: This study aimed to evaluate whether coaching features were successfully transmitted via electronic health record (EHR) communication and to evaluate their relationship with weight change in a previously tested EHR-based coaching intervention. METHODS: A secondary analysis from the Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care (MAINTAIN-pc) study randomized clinical trial was conducted in nine primary care practices and one specialty practice (endocrinology) affiliated with the University of Pittsburgh Medical Center. Eligibility included age 18 to 75 years, intentional 5% weight loss in the previous 2 years, access to an internet-connected computer, and receipt of care from a University of Pittsburgh Medical Center primary care provider. Survey data were collected during the randomized clinical trial. RESULTS: Participants content with intervention delivery via the EHR and those who felt a strong connection to their coach had significantly less weight regain (p = 0.013 and p < 0.01, respectively). Participants who had needs unmet by the intervention (e.g., "in-person" support in a group setting or individual settings) regained more weight (p < 0.01). CONCLUSIONS: The data suggest heterogeneity in the patient population regarding preference for in-person versus EHR-based coaching formats. Such heterogeneity might result in the differential success of EHR-based interventions.

Lifestyle strategies after intentional weight loss: results from the MAINTAIN-pc randomized trial.

Introduction/Purpose: Weight maintenance following intentional weight loss is challenging and often unsuccessful. Physical activity and self-monitoring are strategies associated with successful weight loss maintenance. However, less is known about the type and number of lifestyle strategies used following intentional weight loss. The purpose of this study was to determine the types and amounts of strategies associated with successful long-term weight loss maintenance. Methods: Data from the 24-month Maintaining Activity and Nutrition Through Technology-Assisted Innovation in Primary Care (MAINTAIN-pc) trial were analyzed. MAINTAIN-pc recruited adults (n=194; 53.4±12.2 years of age, body mass index (BMI): 30.4±5.9 kg/m2, 74% female) with recent intentional weight loss of ≥5%, randomized to tracking tools plus coaching (i.e., coaching group) or tracking tools without coaching (i.e., tracking-only group). At baseline, 6, 12, and 24 months, participants reported lifestyle strategies used in the past 6 months, including self-monitoring, group support, behavioral skills, and professional support. General linear models evaluated changes in the number of strategies over time between groups and the consistency of strategies used over the 24-month intervention. Results: At baseline, 100% used behavioral skills, 73% used group support, 69% used self-monitoring, and 68% used professional support in the past 6 months; at 24 months, these rates were 98%, 60%, 75%, and 61%, respectively. While the number of participants utilizing individual strategies did not change significantly over time, the overall number of strategies participants reported decreased. More strategies were used at baseline and 6 months compared to 12- and 24-month follow-ups. The coaching group used more strategies at months 6 and 12 than the tracking-only group. Consistent use of professional support strategies over the 24-month study period was associated with less weight regain. Conclusion: Weight loss maintenance interventions that incorporate continued follow-up and support from healthcare professionals are likely to prevent weight regain after intentional weight loss.

Intensive behavioral Therapy for weight loss in patients with, or At-Risk of, type 2 Diabetes: Results from the PaTH to health diabetes study.

Intensive behavioral therapy (IBT) is an important component of obesity treatment and can reduce the risk of type 2 diabetes (T2DM). Objective was to compare the effectiveness of IBT to usual care in achieving weight loss in two study cohorts within PaTH Network: T2DM and At-Risk of T2DM. The TD2M cohort was defined as age 18 years and older with an indication of T2DM in the EHR based on a validated algorithm and at least 2 outpatient primary care visits. The At-Risk of T2DM cohort was defined by a BMI ≥ 25 kg/m2. The primary outcome was weight change within 1-year of index date. Mixed-effects models assessed the effectiveness of IBT by comparing the changes between study groups. Between 2009 and 2020, a total of 567,908 patients were identified in the T2DM cohort and2,054,256 patients in the At-Risk of T2DM cohort. Both IBT patients and matched non-IBT patients in the T2DM cohort had decreased mean weight (primary outcome) (-1.56 lbs, 95 %CI: -1.88, -1.24 vs -1.70 lbs, 95 %CI: -1.95, -1.44) in 1-year after index date. In the At-Risk of T2DM cohort, both IBT and non-IBT patients experienced weight gain and resultant increased BMI. Patients with more than one IBT visit gained less weight than those with only one visit (1.22 lbs, 95 %CI: 0.82, 1.62 vs 6.72 lbs, 95 %CI: 6.48, 6.97; p < 0.001). IBT was unlikely to result in clinically significant weight loss. Barriers to utilizing IBT require further research to ensure broader adoption of obesity management in primary care.

The impact of menopause on health-related quality of life: results from the STRIDE longitudinal study.

PURPOSE: We examine the impact of menopausal status, beyond menopausal symptoms, on health-related quality of life (HRQoL). METHODS: Seven hundred thirty-two women aged 40-65, regardless of health condition or menopausal status, were enrolled from single general internal medicine practice. Women completed annual questionnaires including HRQoL, and menopausal status and symptoms. RESULTS: The physical health composite of the RAND-36 is lower in late peri (45.6, P < .05), early post (45.4, P < .05), and late postmenopausal women (44.6, P < .01), and those who report a hysterectomy (44.2, P < .01) compared to premenopausal women (47.1), with effect sizes of Cohen's d = .12-.23. The mental health composite of the RAND-36 is lower in late peri (44.7, P < .01), early post (44.9, P < .01), and late postmenopausal women (45.0, P < .05) and those who report a hysterectomy (44.2, P < .01) compared to premenopausal women (46.8), with effect sizes of Cohen's d = .15-.20. Findings are comparable adjusted for menopausal symptom frequency and bother. CONCLUSIONS: Over a 5-year follow-up period, we found a negative impact of menopause on some domains of HRQoL, regardless of menopausal symptoms. Clinicians should be aware of this relationship and work to improve HRQoL, rather than expect it to improve spontaneously when menopausal symptoms resolve.

Hospitalization and mortality in patients with COVID-19 with or at risk of type 2 diabetes: data from five health systems in Pennsylvania and Maryland.

OBJECTIVE: To identify the demographic and clinical characteristics associated with adverse COVID-19 outcomes across a 12-month period in 2020 and 2021. RESEARCH DESIGN AND METHODS: We conducted a retrospective cohort study using electronic health records from five academic health systems in Pennsylvania and Maryland, including patients with COVID-19 with type 2 diabetes or at risk of type 2 diabetes. Patients were classified based on 30-day outcomes: (1) no hospitalization; (2) hospitalization only; or (3) a composite measure including admission to the intensive care unit (ICU), intubation, or death. Analyses were conducted in patients with type 2 diabetes and patients at risk of type 2 diabetes separately. RESULTS: We included 15 725 patients with COVID-19 diagnoses between March 2020 and February 2021. Older age and higher Charlson Comorbidity Index scores were associated with higher odds of adverse outcomes, while COVID-19 diagnoses later in the study period were associated with lower odds of severe outcomes. In patients with type 2 diabetes, individuals on insulin treatment had higher odds for ICU/intubation/death (OR=1.59, 95% CI 1.27 to 1.99), whereas those on metformin had lower odds (OR=0.56, 95% CI 0.45 to 0.71). Compared with non-Hispanic White patients, Hispanic patients had higher odds of hospitalization in patients with type 2 diabetes (OR=1.73, 95% CI 1.36 to 2.19) or at risk of type 2 diabetes (OR=1.77, 95% CI 1.43 to 2.18.) CONCLUSIONS: Adults who were older, in racial minority groups, had multiple chronic conditions or were on insulin treatment had higher risks for severe COVID-19 outcomes. This study reinforced the urgency of preventing COVID-19 and its complications in vulnerable populations. TRIAL REGISTRATION NUMBER: NCT02788903.

Protocol for the AKT-MP trial: Access to Kidney Transplantation in Minority Populations.

Background: Kidney transplant (KT) is the optimal treatment for kidney failure (KF), and although completion of KT evaluation is an essential step in gaining access to transplantation, the process is lengthy, time consuming, and burdensome. Furthermore, despite similar referral rates to non-Hispanic Whites, both Hispanic/Latinos and American Indians are less likely to be wait-listed or to undergo KT. Methods: The Access to Kidney Transplantation in Minority Populations (AKT-MP) Trial compares two patient-centered methods to facilitate KT evaluation: kidney transplant fast track (KTFT), a streamlined KT evaluation process; and peer navigators (PN), a peer-assisted evaluation program that incorporates motivational interviewing. This pragmatic randomized trial will use a comparative effectiveness approach to assess whether KTFT or PN can help patients overcome barriers to transplant listing. We will randomly assign patients to the two conditions. We will track participants' medical records and conduct surveys prior to their initial evaluation clinic visit and again after they complete or discontinue evaluation. Conclusion: Our aims are to (1) compare KTFT and PN to assess improvements in kidney transplant (KT) related outcomes and cost effectiveness; (2) examine how each approach effects changes in cultural/contextual factors, KT concerns, KT knowledge, and KT ambivalence; and (3) develop a framework for widespread implementation of either approach. The results of this trial will provide key information for facilitating the evaluation process, improving patient care, and decreasing disparities in KT.

A randomized trial of the effect of patient race on physicians' intensive care unit and life-sustaining treatment decisions for an acutely unstable elder with end-stage cancer.

OBJECTIVES: To test whether hospital-based physicians made different intensive care unit and life-sustaining treatment decisions for otherwise identical black and white patients with end-stage cancer and life-threatening hypoxia. DESIGN: We conducted a randomized trial of the relationship between patient race and physician treatment decisions using high-fidelity simulation. We counterbalanced the effects of race and case by randomly alternating their order using a table of random permutations. Physicians completed two simulation encounters with black and white patient simulator patients with prognostically identical end-stage gastric or pancreatic cancer and life-threatening hypoxia and hypotension, followed by a self-administered survey of beliefs regarding treatment preferences by race. We conducted within-subjects analysis of each physician's matched-pair simulation encounters, adjusting for order and case effects, and between-subjects analysis of physicians' first encounter, adjusting for case. SETTING: Peter M. Winter Institute for Simulation Education and Research at the University of Pittsburgh, Pennsylvania. SUBJECTS: Thirty-three hospital-based attending physicians, including 12 emergency physicians, eight hospitalists, and 13 intensivists from Allegheny County, Pennsylvania. INTERVENTION: Race of patient simulator. MEASUREMENTS AND MAIN RESULTS: Measurements included physician treatment decisions recorded during the simulation and documented in the chart and beliefs about treatment preference by race. When faced with a black vs. a white patient, physicians did not differ in their elicitation of intubation preferences (within-subject comparison, 28/32 [88%] vs. 28/32 [88%]; p = .589; between-subject comparison, 13/17 [87%] vs. 13/17 [76%]; p = .460), intensive care unit admission (within-subject comparison, 14/32 [44%] vs. 12/32 [38%]; p = .481; between-subject comparison, 8/15 (53%) vs. 7/17 (41%); p = .456), intubation (within-subject comparison, 5/32 [16%] vs. 4/32 [13%]; p = .567; between-subject comparison: 1/15 [7%] vs. 4/17 [24%]; p = .215), or initiation of comfort measures only (within-subject comparison: 16/32 [50%] vs. 19/32 [59%]; p = .681; between-subject comparison: 6/15 [40%] vs. 8/17 [47%]; p = .679). Physicians believed that a black patient with end-stage cancer was more likely than a similar white patient to prefer potentially life-prolonging chemotherapy over treatment focused on palliation (67% vs. 64%; z = -1.79; p = .07) and to want mechanical ventilation for 1 wk of life extension (43% vs. 34%; z = -2.93; p = .003), and less likely to want a do-not-resuscitate order if hospitalized (51% vs. 60%; z = 3.03; p = .003). CONCLUSIONS: In this exploratory study, hospital-based physicians did not make different treatment decisions for otherwise identical terminally ill black and white elders despite believing that black patients are more likely to prefer intensive life-sustaining treatment, and they grossly overestimated the preference for intensive treatment for both races.

Utilization of intensive behavioural treatment for obesity in patients with diabetes.

Obesity is a leading public health concern. The Centers for Medicare and Medicaid Services implemented a healthcare procedure code for intensive behavioural therapy (IBT) in 2012 to facilitate payment for addressing obesity in primary care settings, followed by universal coverage by insurers for all adults. Our objective was to understand utilization of IBT from 2009 to 2017 in patients with a diabetes diagnosis. Leveraging electronic health record data from the PaTH Clinical Data Research Network (CDRN), a partnership of six health systems, utilization of IBT was summarized at a yearly basis. The trend of IBT prevalence was examined for patients with diabetes by gender, race, age (>=65 vs <65) and rurality. A total of 205, 913 patients were included. While utilization of IBT is low (0.24% in 2017), use of IBT increased among patients with commercial insurance and Medicaid (codes S9449 and S9470) in 2011, and among patients with Medicare (code G0447) in 2012. IBT users tended to be less than 65 years of age, female, non-White (Black or Hispanic), and reside in urban areas. Overall, use of IBT in patients with diabetes remains low. Future work is necessary to understand the impact of IBT and, if effective, how to increase use within primary care.

Hospital utilization for hypoglycemia among patients with type 2 diabetes using pooled data from six health systems.

INTRODUCTION: Hypoglycemia is the most common serious adverse effect of diabetes treatment and a major cause of medication-related hospitalization. This study aimed to identify trends and predictors of hospital utilization for hypoglycemia among patients with type 2 diabetes using electronic health record data pooled from six academic health systems. RESEARCH DESIGN AND METHODS: This retrospective open cohort study included 549 041 adults with type 2 diabetes receiving regular care from the included health systems between 2009 and 2019. The primary outcome was the yearly event rate for hypoglycemia hospital utilization: emergency department visits, observation visits, or inpatient admissions for hypoglycemia identified using a validated International Classification of Diseases Ninth Revision (ICD-9) algorithm from 2009 to 2014. After the transition to ICD-10 in 2015, we used two ICD-10 code sets (limited and expanded) for hypoglycemia hospital utilization from prior studies. We identified independent predictors of hypoglycemia hospital utilization using multivariable logistic regression analysis with data from 2014. RESULTS: Yearly rates of hypoglycemia hospital utilization decreased from 2.7 to 1.6 events per 1000 patients from 2009 to 2014 (p-trend=0.023). From 2016 to 2019, yearly event rates were stable ranging from 5.6 to 6.6, or 6.3 to 7.3, using the limited and expanded ICD-10 code sets, respectively. In 2014, the strongest independent risk factors for hypoglycemia hospital utilization were chronic kidney disease (OR 2.86, 95% CI 2.33 to 3.57), ages 18-39 years (OR 2.43 vs age 40-64 years, 95% CI 1.78 to 3.31), and insulin use (OR 2.13 vs no diabetes medications, 95% CI 1.67 to 2.73). CONCLUSIONS: Rates of hypoglycemia hospital utilization decreased from 2009 to 2014 and varied considerably by clinical risk factors such that younger adults, insulin users, and those with chronic kidney disease were at especially high risk. There is a need to validate hypoglycemia ascertainment using ICD-10 codes, which detect a substantially higher number of events compared with ICD-9.