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.

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.

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.

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.

Correction: A Patient-Centered PaTH to Address Diabetes: Protocol for a Study on the Impact of Obesity Counseling.

[This corrects the article DOI: 10.2196/12054.].

Understanding shared decision-making experience among vulnerable population: Focus group with food bank clients.

INTRODUCTION: Shared decision-making (SDM) is a critical component of delivering patient-centered care. Members of vulnerable populations may play a passive role in clinical decision-making; therefore, understanding their prior decision-making experiences is a key step to engaging them in SDM. OBJECTIVE: To understand the previous healthcare experiences and current expectations of vulnerable populations on clinical decision-making regarding therapeutic options. METHODS: Clients of a local food bank were recruited to participate in focus groups. Participants were asked to share prior health decision experiences, explain difficulties they faced when making a therapeutic decision, describe features of previous satisfactory decision-making processes, share factors under consideration when choosing between treatment options, and suggest tools that would help them to communicate with healthcare providers. We used the inductive content analysis to interpret data gathered from the focus groups. RESULTS: Twenty-six food bank clients participated in four focus groups. All participants lived in areas of socioeconomic disadvantage. Four themes emerged: prior negative clinical decision-making experience with providers, patients preparing to engage in SDM, challenges encountered during the decision-making process, and patients' expectations of decision aids. Participants also reported they were unable to discuss therapeutic options at the time of decision-making. They also expressed financial concerns and the need for sufficiently detailed information to evaluate risks. CONCLUSION: Our findings suggest the necessity of developing decision aids that would improve the engagement of vulnerable populations in the SDM process, including consideration of affordability, use of patient-friendly language, and incorporation of drug-drug and drug-food interactions information.

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.

A Patient-Centered PaTH to Address Diabetes: Protocol for a Study on the Impact of Obesity Counseling.

BACKGROUND: Overweight and obesity are America's number one health concern. The prevalence of obesity in the United States is greater than 36%, a rate that has doubled since 1970. As the second most preventable cause of death, obesity is a risk factor for diabetes, cardiovascular disease, stroke, and cancer, all major causes of death. Primary care clinics may be an ideal setting for weight control interventions to help manage and prevent diabetes. For this reason, the Centers for Medicare and Medicaid Services (CMS) implemented a health care procedure coding system code for intensive behavioral therapy (IBT) for obesity within primary care in 2012 to facilitate payment for addressing obesity, which was followed by broader coverage by most insurers for IBT for adults in 2013. However, the impact of this coverage on patient-centered outcomes is largely unknown. OBJECTIVE: The overarching goal of this study is to understand the comparative effectiveness of obesity counseling as covered by CMS and other insurers in improving weight loss for adults either with or at increased risk for type 2 diabetes. METHODS: This study leverages the novel infrastructure of the Patient-Centered Outcomes Research Institute-funded PaTH Clinical Data Research Network. The PaTH network is comprised of Geisinger Health System, Johns Hopkins University, Johns Hopkins Health System, Lewis Katz School of Medicine at Temple University, Temple Health System, Penn State College of Medicine, Penn State Milton S Hershey Medical Center, University of Pittsburgh, UPMC and UPMC Health Plan, and the University of Utah. Electronic health record (EHR) data will originate from the 6 PaTH health systems. Specifically, we will (1) evaluate the impact of broader preventive service coverage for obesity screening and counseling on weight loss, diabetes incidence, and diabetes outcomes in patients with diabetes or at increased risk for diabetes (defined by body mass index [BMI] ≥25). We will determine how the annual probability of receiving obesity and/or nutritional counseling changed pre- and postpolicy across all insurers in a cohort of patients with diabetes and at high risk for diabetes. We will (2) compare patient weight loss and diabetes-related outcomes among those who receive obesity screening and counseling with those who do not, following implementation of preventive service coverage. We will examine postpolicy impact of obesity screening and counseling in a cohort of patients with diabetes and at increased risk for diabetes. Specific outcomes to be examined include weight loss, diabetes incidence, and diabetes outcomes. Exploratory outcomes will include patient-reported outcomes. Furthermore, we will determine patient characteristics, including demographics, and practice characteristics, including provider type. RESULTS: Our PCORI-funded study is underway. To date, we have obtained our second data extraction from the PaTH CDRN and are performing data editing and cleaning. Next steps include analysis of early policy change. CONCLUSIONS: Given patients who are overweight are at highest risk for diabetes, improved weight management services could prevent diabetes and its negative health outcomes. Comparing weight and diabetes outcomes in 3 states using EHRs and claims data before and after this policy was implemented using the PaTH Network will allow important insight into policy effectiveness. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12054.

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.

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.

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.