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.

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.

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.

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.

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.

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.

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 Default Options in Advance Directives on Hospital-Free Days and Care Choices Among Seriously Ill Patients: A Randomized Clinical Trial.

Importance: There is limited evidence regarding how patients make choices in advance directives (ADs) or whether these choices influence subsequent care. Objective: To examine whether default options in ADs influence care choices and clinical outcomes. Design, Setting, and Participants: This randomized clinical trial included 515 patients who met criteria for having serious illness and agreed to participate. Patients were enrolled at 20 outpatient clinics affiliated with the University of Pennsylvania Health System and the University of Pittsburgh Medical Center from February 2014 to April 2016 and had a median follow-up of 18 months. Data analysis was conducted from November 2018 to April 2019. Interventions: Patients were randomly assigned to complete 1 of the 3 following ADs: (1) a comfort-promoting plan of care and nonreceipt of potentially life-sustaining therapies were selected by default (comfort AD), (2) a life-extending plan of care and receipt of potentially life-sustaining therapies were selected by default (life-extending AD), or (3) no choices were preselected (standard AD). Main Outcomes and Measures: This trial was powered to rule out a reduction in hospital-free days in the intervention groups. Secondary outcomes included choices in ADs for an overall comfort-oriented approach to care, choices to forgo 4 forms of life support, patients' quality of life, decision conflict, place of death, admissions to hospitals and intensive care units, and costs of inpatient care. Results: Among 515 patients randomized, 10 withdrew consent and 13 were later found to be ineligible, leaving 492 (95.5%) in the modified intention-to-treat (mITT) sample (median [interquartile range] age, 63 [56-70] years; 279 [56.7%] men; 122 [24.8%] black; 363 [73.8%] with cancer). Of these, 264 (53.7%) returned legally valid ADs and were debriefed about their assigned intervention. Among these, patients completing comfort ADs were more likely to choose comfort care (54 of 85 [63.5%]) than those returning standard ADs (45 of 91 [49.5%]) or life-extending ADs (33 of 88 [37.5%]) (P = .001). Among 492 patients in the mITT sample, 57 of 168 patients [33.9%] who completed the comfort AD, 47 of 165 patients [28.5%] who completed the standard AD, and 35 of 159 patients [22.0%] who completed the life-extending AD chose comfort care (P = .02), with patients not returning ADs coded as not selecting comfort care. In mITT analyses, median (interquartile range) hospital-free days among 168 patients assigned to comfort ADs and 159 patients assigned to life-extending default ADs were each noninferior to those among 165 patients assigned to standard ADs (standard AD: 486 [306-717] days; comfort AD: 554 [296-833] days; rate ratio, 1.05; 95% CI, 0.90-1.23; P < .001; life-extending AD: 550 [325-783] days; rate ratio, 1.03; 95% CI, 0.88-1.20; P < .001). There were no differences among groups in other secondary outcomes. Conclusions and Relevance: In this randomized clinical trial, default options in ADs altered the choices seriously ill patients made regarding their future care without changing clinical outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT02017548.

PaTH to partnership in stakeholder-engaged research: A framework for stakeholder engagement in the PaTH to Health Diabetes study.

Engaging a diverse stakeholder group, including patients, clinicians, policy makers, and leadership from national professional organizations as partners in research supports the pursuit of patient-centered outcomes. Utilizing the Patient-Centered Outcomes Research (PCOR) Engagement Principles and applying adult learning theories to training opportunities can enhance stakeholder-investigator collaborations. Regularly scheduled study meetings with stakeholders can help streamline communication, offer a platform for stakeholder voices to be shared, and increase study productivity. Ongoing engagement evaluations provide an important opportunity to assess engagement activities and improve processes moving forward. Benefits of a robust patient partner and stakeholder body extend beyond the study's objectives and translate into the creation of larger networks where resources are shared and patient-centeredness is enhanced.

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.

Accuracy of the Pediatric End-stage Liver Disease Score in Estimating Pretransplant Mortality Among Pediatric Liver Transplant Candidates.

Importance: Fair allocation of livers between pediatric and adult recipients is critically dependent on the accuracy of mortality estimates afforded by the Pediatric End-stage Liver Disease (PELD) and Model for End-stage Liver Disease, respectively. Widespread reliance on exceptions for pediatric recipients suggests that the 2 systems may not be comparable. Objective: To evaluate the accuracy of the PELD score in estimating 90-day pretransplant mortality among pediatric patients on the United Network for Organ Sharing (UNOS) waiting list. Design, Setting, and Participants: Patients who were listed from February 27, 2002, to March 31, 2014, for primary liver transplant were included in this retrospective analysis and were followed up for at least 2 years through June 17, 2016. The study analyzed 2 cohorts using the UNOS Standard Transplant Analysis and Research data files. The full cohort comprised 4298 patients (<18 years of age) who had chronic liver disease (excluding cancer). The reduced cohort (n = 2421) excluded patients receiving living donor transplantation or PELD exception points. Main Outcomes and Measures: Observed and expected 90-day pretransplant mortality rates evaluated at 10-point interval PELD levels. Results: Among the 4298 patients in the full cohort (mean [SD] age, 2.5 [4.2] years; 2251 [52.4%] female; 2201 [51.2%] white), PELD scores and mortality were concordant (C statistic, 0.8387 [95% CI, 0.8191-0.8584] for the full cohort and 0.8123 [95% CI, 0.7919-0.8327] for the reduced cohort). However, the estimated 90-day mortality using the PELD score underestimated the actual probability of death by as much as 17%. Conclusions and Relevance: With use of the PELD score, the ranking of risk among children was preserved, but direct comparisons between adult and pediatric candidates were not accurate. Children with chronic liver disease who are in need of transplant may be at a disadvantage compared with adults in a similar situation.

Using time-varying models to estimate post-transplant survival in pediatric liver transplant recipients.

PURPOSE: To distinguish clinical factors that have time-varying (as opposed to constant) impact upon patient and graft survival among pediatric liver transplant recipients. METHODS: Using national data from 2002 through 2013, we examined potential clinical and demographic covariates using Gray's piecewise constant time-varying coefficients (TVC) models. For both patient and graft survival, we estimated univariable and multivariable Gray's TVC, retaining significant covariates based on backward selection. We then estimated the same specification using traditional Cox proportional hazards (PH) models and compared our findings. RESULTS: For patient survival, covariates included recipient diagnosis, age, race/ethnicity, ventilator support, encephalopathy, creatinine levels, use of living donor, and donor age. Only the effects of recipient diagnosis and donor age were constant; effects of other covariates varied over time. We retained identical covariates in the graft survival model but found several differences in their impact. CONCLUSION: The flexibility afforded by Gray's TVC estimation methods identify several covariates that do not satisfy constant proportionality assumptions of the Cox PH model. Incorporating better survival estimates is critical for improving risk prediction tools used by the transplant community to inform organ allocation decisions.

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.

Diet and Physical Activity Behaviors in Primary Care Patients with Recent Intentional Weight Loss.

PURPOSE: Lifestyle habits of primary care patients with recent, intentional weight loss are unclear and need to be better understood to aid in translational health promotion efforts. We aimed to characterize diet and exercise habits in primary care patients with recent, intentional weight loss, comparing those with greater (≥10%) vs. lesser (5 to <10%) weight loss. METHODS: This was a cross-sectional analysis of baseline data from a randomized trial comparing weight loss maintenance interventions. The study included primary care patients, 18-75 years old, with ≥5% intentional weight loss via lifestyle change in the past 2 years. Participants (74% female, 87% white) had mean age 53 (12) years, body mass index 30.4 (5.9) kg/m2, and recent weight loss of 11 (8)%. Dietary habits were measured by the Diet Habits Survey. Physical activity and sedentary behavior were measured by self-report and objectively by pedometer. RESULTS: On average, participants reported high fruits and vegetables intake (5 servings/day), and low intake of fried foods (1 serving/week), desserts (1 serving/week) and sugar-sweetened beverages (0 servings/week). Those with greater vs. lesser weight loss had higher intake of fruits and vegetables (p=0.037) and low fat foods or recipes (p=0.019). Average self-reported moderate-vigorous physical activity was 319 (281) minutes/week, with significant differences between greater (374 (328) minutes/week) vs. lesser (276 (230) minutes/week) weight loss groups (p=0.017). By pedometer, 30% had ≥7,500 steps/day; the proportion was higher in greater (43%) vs. lesser (19%) weight loss groups (p=0.005). CONCLUSIONS: For weight loss, clinical patients typically employ simple strategies such as 5+ fruits and vegetables per day, fried foods and desserts ≤1 per week, elimination of sugary drinks, choosing low fat foods/recipes, and physical activity 45-60 min/day.

Promoting weight maintenance with electronic health record tools in a primary care setting: Baseline results from the MAINTAIN-pc trial.

Maintaining weight loss is a significant challenge in combating obesity. The goal of Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care (MAINTAIN-pc) is to evaluate the use of tools delivered through an electronic health record (EHR) and patient portal, with or without health coach support, to help primary care patients maintain weight loss. EHR tools include flowsheets, standardized surveys, and secure patient messaging. Inclusion criteria were age 18-75years, voluntary 5% weight loss in the past 2years with prior BMI≥25kg/m2, and no bariatric procedures in past 5years. Participants were randomized 1:1 to tailored online coaching with EHR tracking tools (CC) or EHR tracking tools alone (TO). We screened 721 individuals between October 2013 and February 2015; 194 participants enrolled (98 CC; 96 TO). The most common reasons for not enrolling included lack of interest (56%), not meeting age or weight loss criteria (17%), and no verified prior weight loss (10%). At baseline, participants were 53.4 (SD 12.2) years old, 74% female, and 88% White; 95% reported moderate physical activity. Average weight and BMI at baseline were 189.1 (SD 42.1) lbs and 30.4 (5.9) kg/m2, respectively. Pre-weight loss BMI was 34.4 (SD 6.5) kg/m2. Participants lost an average of 11.3% (SD 6.6) of their body weight before enrolling. Demographic and clinical characteristics did not differ by randomized group. The study successfully identified and recruited primary care patients with recent voluntary weight loss for participation in a weight maintenance program that uses EHR-based tools.

Protocol of the KTFT-TALK study to reduce racial disparities in kidney transplant evaluation and living donor kidney transplantation.

Living donor kidney transplantation (LDKT) is the optimal treatment for end-stage kidney disease (ESKD). The evaluation process for a kidney transplant is complex, time consuming, and burdensome to the ESKD patient. Also, race disparities exist in rates of transplant evaluation completion, transplantation, and LDKT. In December 2012 our transplant center implemented a streamlined, one-day evaluation process, dubbed Kidney Transplant Fast Track (KTFT). This paper describes the protocol of a two-part study to evaluate the effectiveness of KTFT at increasing transplant rates (compared to historical controls) and the TALK intervention (Talking About Live Kidney Donation) at increasing LDKT during KTFT. All participants will receive the KTFT evaluation as part of their usual care. Participants will be randomly assigned to TALK versus no-TALK conditions. Patients will undergo interviews at pre-transplant work-up and transplant evaluation. Transplant status will be tracked via medical records. Our aims are to: (1) test the efficacy and cost effectiveness of the KTFT in reducing time to complete kidney transplant evaluation, and increasing kidney transplant rates relative to standard evaluation practices; (2) test whether TALK increases rates of LDKT during KTFT; and (3) determine whether engaging in a streamlined and coordinated-care evaluation experience within the transplant center reduces negative perceptions of the healthcare system. The results of this two-pronged approach will help pave the way for other transplant centers to implement a fast-track system at their sites, improve quality of care by transplanting a larger number of vulnerable patients, and address stark race/ethnic disparities in rates of LDKT.

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.

Default options in advance directives: study protocol for a randomised clinical trial.

INTRODUCTION: Although most seriously ill Americans wish to avoid burdensome and aggressive care at the end of life, such care is often provided unless patients or family members specifically request otherwise. Advance directives (ADs) were created to provide opportunities to set limits on aggressive care near life's end. This study tests the hypothesis that redesigning ADs such that comfort-oriented care is provided as the default, rather than requiring patients to actively choose it, will promote better patient-centred outcomes. METHODS AND ANALYSIS: This multicentre trial randomises seriously ill adults to receive 1 of 3 different ADs: (1) a traditional AD that requires patients to actively choose their goals of care or preferences for specific interventions (eg, feeding tube insertion) or otherwise have their care guided by their surrogates and the prevailing societal default toward aggressive care; (2) an AD that defaults to life-extending care and receipt of life-sustaining interventions, enabling patients to opt out from such care; or (3) an AD that defaults to comfort care, enabling patients to opt into life-extending care. We seek to enrol 270 patients who return complete, legally valid ADs so as to generate sufficient power to detect differences in the primary outcome of hospital-free days (days alive and not in an acute care facility). Secondary outcomes include hospital and intensive care unit admissions, costs of care, hospice usage, decision conflict and satisfaction, quality of life, concordance of preferences with care received and bereavement outcomes for surrogates of patients who die. ETHICS AND DISSEMINATION: This study has been approved by the Institutional Review Boards at all trial centres, and is guided by a data safety and monitoring board and an ethics advisory board. Study results will be disseminated using methods that describe the results in ways that key stakeholders can best understand and implement. TRIAL REGISTRATION NUMBER: NCT02017548; Pre-results.

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.

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.