Search

Objective: To estimate the health utility scores associated with type 2 diabetes, its treatments, complications, and comorbidities.Research Design and Methods: We analyzed health-related quality-of-life data, collected at baseline during Translating Research Into Action for Diabetes, a multicenter, prospective, observational study of diabetes care in managed care, for 7,327 individuals with type 2 diabetes. We measured quality-of-life using the EuroQol (EQ)-5D, a standardized instrument for which 1.00 indicates perfect health. We used multivariable regression to estimate the independent impact of demographic characteristics, diabetes treatments, complications, and comorbidities on health-related quality-of-life.Results: The mean EQ-5D-derived health utility score for those individuals with diabetes was 0.80. The modeled utility score for a nonobese, non-insulin-treated, non-Asian, non-Hispanic man with type 2 diabetes, with an annual household income of more than $40,000, and with no diabetes complications, risk factors for cardiovascular disease, or comorbidities, was 0.92. Being a woman, being obese, smoking, and having a lower household income were associated with lower utility scores. Arranging complications from least to most severe according to the reduction in health utility scores resulted in the following order: peripheral vascular disease, other heart diseases, transient ischemic attack, cerebral vascular accident, nonpainful diabetic neuropathy, congestive heart failure, dialysis, hemiplegia, painful neuropathy, and amputation.Conclusions: Major diabetes complications and comorbidities are associated with decreased health-related quality-of-life. Utility estimates from our study can be used to assess the impact of diabetes on quality-of-life and conduct cost-utility analyses. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To examine racial/ethnic and economic variation in cost-related medication underuse among insured adults with diabetes. RESEARCH DESIGN AND METHODS: We surveyed 5,086 participants from the multicenter Translating Research Into Action for Diabetes Study. Respondents reported whether they used less medication because of cost in the past 12 months. We examined unadjusted and adjusted rates of cost-related medication underuse, using hierarchical regression, to determine whether race/ethnicity differences still existed after accounting for economic, health, and other demographic variables. RESULTS: Participants were 48% white, 14% African American, 14% Latino, 15% Asian/Pacific Islander, and 8% other. Overall, 14% reported cost-related medication underuse. Unadjusted rates were highest for Latinos (23%) and African Americans (17%) compared with whites (13%), Asian/Pacific Islanders (11%), and others (15%). In multivariate analyses, race/ethnicity significantly predicted cost-related medication underuse (P = 0.048). However, adjusted rates were only slightly higher for Latinos (14%) than whites (10%) (P = 0.026) and were not significantly different for African Americans (11%), Asian/Pacific Islanders (7%), and others (11%). Income and out-of-pocket drug costs showed the greatest differences in adjusted rates of cost-related medication underuse (15 vs. 5% for participants with income $50,000 and 24 vs. 7% for participants with out-of-pocket costs >$150 per month vs.

OBJECTIVE: To estimate the cost-effectiveness of screening overweight and obese individuals for pre-diabetes and then modifying their lifestyle based on the Diabetes Prevention Program (DPP). RESEARCH DESIGN AND METHODS: A Markov simulation model was used to estimate disease progression, costs, and quality of life. Cost-effectiveness was evaluated from a health care system perspective. We considered two screening/treatment strategies for pre-diabetes. Strategy 1 included screening overweight subjects and giving them the lifestyle intervention included in the DPP if they were diagnosed with both impaired glucose tolerance (IGT) and impaired fasting glucose (IFG). Strategy 2 included screening followed by lifestyle intervention for subjects diagnosed with either IGT or IFG or both. Each strategy was compared with a program of no screening. RESULTS: Screening for pre-diabetes and treating those identified as having both IGT and IFG with the DPP lifestyle intervention had a cost-effectiveness ratio of $8,181 per quality-adjusted life-year (QALY) relative to no screening. If treatment was also provided to subjects with only IGT or only IFG (strategy 2), the cost-effectiveness ratio increased to $9,511 per QALY. Changes in screening-related parameters had small effects on the cost-effectiveness ratios; the results were more sensitive to changes in intervention-related parameters. CONCLUSIONS: Screening for pre-diabetes in the overweight and obese U.S. population followed by the DPP lifestyle intervention has a relatively attractive cost-effectiveness ratio. [ABSTRACT FROM AUTHOR]

OBJECTIVE: Simple process-of-care indicators are commonly recommended to assess and compare quality of diabetes care across health plans. We sought to determine whether variation in the number of simple diabetes processes of care across provider groups is associated with variation in other quality indicators, including cardiometabolic risk factor levels, patient satisfaction with care, or patient-rated quality of care. RESEARCH DESIGN AND METHODS: We used cross-sectional survey and chart audit data for 8,733 patients with diabetes who received care from 68 provider groups nested in 10 health plans that participated in the Translating Research Into Action for Diabetes study. Analyses using hierarchical regression models assessed associations of the mean number of seven simple process measures with each of the following: HbA(1c) (A1C), systolic blood pressure (SBP), HDL and LDL cholesterol levels, patient satisfaction with care, and patient-rated quality of care. RESULTS: After adjusting for case-mix differences across groups and plans, an average of one additional documented process of care for each patient in a group or plan was associated with significantly lower mean LDL cholesterol levels (-4.51 mg/dl [95% CI 1.46-7.58]) but not with A1C, SBP, or HDL cholesterol levels. The number of care processes documented was associated with patient satisfaction measures and self-rated quality of diabetes care. CONCLUSIONS: Variation in the number of simple process-of-care indicators across provider groups or health plans is associated with differences in patient-centered measures of quality, but assessment of the quality of cardiometabolic risk factor control will require more advanced clinical performance indicators. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to compare the ability of risk stratification models derived from administrative data to classify groups of patients for enrollment in a tailored chronic disease management program.Subjects: This study included 19,548 Medicaid patients with chronic heart failure or diabetes in the Indiana Medicaid data warehouse during 2001 and 2002.Measures: To predict costs (total claims paid) in FY 2002, we considered candidate predictor variables available in FY 2001, including patient characteristics, the number and type of prescription medications, laboratory tests, pharmacy charges, and utilization of primary, specialty, inpatient, emergency department, nursing home, and home health care.Methods: We built prospective models to identify patients with different levels of expenditure. Model fit was assessed using R statistics, whereas discrimination was assessed using the weighted kappa statistic, predictive ratios, and the area under the receiver operating characteristic curve.Results: We found a simple least-squares regression model in which logged total charges in FY 2002 were regressed on the log of total charges in FY 2001, the number of prescriptions filled in FY 2001, and the FY 2001 eligibility category, performed as well as more complex models. This simple 3-parameter model had an R of 0.30 and, in terms in classification efficiency, had a sensitivity of 0.57, a specificity of 0.90, an area under the receiver operator curve of 0.80, and a weighted kappa statistic of 0.51.Conclusion: This simple model based on readily available administrative data stratified Medicaid members according to predicted future utilization as well as more complicated models. [ABSTRACT FROM AUTHOR]

Objective: We evaluated whether participation in a community-based group diabetes prevention program might lead to relative changes in composite 10-year coronary heart disease (CHD) risk for overweight adults with abnormal glucose metabolism.Research Design and Methods: We used the UK Prospective Diabetes Study engine to estimate CHD risk for group-lifestyle and brief counseling (control) groups. Between-group risk changes after 4 and 12 months were compared using ANCOVA.Results: Baseline 10-year risk was similar between treatment groups (P = 0.667). At 4 and 12 months, the intervention group experienced significant decreases in 10-year risk from baseline (-3.28%, P < 0.001; and -2.23%, P = 0.037) compared with control subjects (-0.78%, P = 0.339; and +1.88%, P = 0.073). Between-group differences were statistically significant and increased from the 4- to 12-month visits.Conclusions: Community-based delivery of the Diabetes Prevention Program lifestyle intervention could be a promising strategy to prevent both CHD and type 2 diabetes in adults with pre-diabetes. [ABSTRACT FROM AUTHOR]

Background: Shared decision making (SDM) is the process by which patients and clinicians exchange information and preferences to come to joint healthcare decisions. Clinical dashboards can support SDM by collecting, distilling, and presenting critical information, such as patient-reported outcomes (PROs), to be shared at points of care and in between appointments. We describe the implementation strategies and outcomes of a multistakeholder collaborative process known as "co-design" to develop a PRO-informed clinical dashboard to support SDM for patients with advanced cancer or chronic kidney disease (CKD). Methods: Across 14 sessions, two multidisciplinary teams comprising patients, care partners, clinicians, and other stakeholders iteratively co-designed an SDM dashboard for either advanced cancer (N = 25) or CKD (N = 24). Eligible patients, care partners, and frontline clinicians were identified by six physician champions. The co-design process included four key steps: (1) define "the problem", (2) establish context of use, (3) build a consensus on design, and (4) define and test specifications. We also evaluated our success in implementing the co-design strategy using measures of fidelity, acceptability, adoption, feasibility, and effectiveness which were collected throughout the process. Results: Mean ( M ) scores across implementation measures of the co-design process were high, including observer-rated fidelity and adoption of co-design practices ( M = 19.1 on a 7-21 scale, N = 36 ratings across 9 sessions), as well as acceptability based on the perceived degree of SDM that occurred during the co-design process ( M = 10.4 on a 0 to 12 adapted collaboRATE scale). Capturing the feasibility and adoption of convening multistakeholder co-design teams, min-max normalized scores (ranging from 0 to 1) of stakeholder representation demonstrated that, on average, 95% of stakeholder types were represented for cancer sessions ( M = 0.95) and 85% for CKD sessions ( M = 0.85). The co-design process was rated as either "fully" or "partially" effective by 100% of respondents, in creating a dashboard that met its intended objective. Conclusions: A co-design process was successfully implemented to develop SDM clinical dashboards for advanced cancer and CKD care. We discuss key strategies and learnings from this process that may aid others in the development and uptake of patient-centered healthcare innovations.

Introduction: The rapid development of artificial intelligence (AI) in healthcare has exposed the unmet need for growing a multidisciplinary workforce that can collaborate effectively in the learning health systems. Maximizing the synergy among multiple teams is critical for Collaborative AI in Healthcare., Methods: We have developed a series of data, tools, and educational resources for cultivating the next generation of multidisciplinary workforce for Collaborative AI in Healthcare. We built bulk-natural language processing pipelines to extract structured information from clinical notes and stored them in common data models. We developed multimodal AI/machine learning (ML) tools and tutorials to enrich the toolbox of the multidisciplinary workforce to analyze multimodal healthcare data. We have created a fertile ground to cross-pollinate clinicians and AI scientists and train the next generation of AI health workforce to collaborate effectively., Results: Our work has democratized access to unstructured health information, AI/ML tools and resources for healthcare, and collaborative education resources. From 2017 to 2022, this has enabled studies in multiple clinical specialties resulting in 68 peer-reviewed publications. In 2022, our cross-discipline efforts converged and institutionalized into the Center for Collaborative AI in Healthcare., Conclusions: Our Collaborative AI in Healthcare initiatives has created valuable educational and practical resources. They have enabled more clinicians, scientists, and hospital administrators to successfully apply AI methods in their daily research and practice, develop closer collaborations, and advanced the institution-level learning health system., Competing Interests: This work was supported by the grants from the National Institutes of Health (NIH) Yuan Luo, Kristi Holmes, Luke Rasmussen, Andrew Naidech, Lazaro Sanchez‐Pinto, Richard Wunderink, Jennifer Pacheco, Matthew Carson, Susan Clare. Kristi Holmes is a member of Learning Health Systems Editorial Board. Donald Lloyd‐Jones serves as a board member of the American Heart Association. Michael Markl receives grant support by Siemens and Circle Cardiovascular Imaging; co‐founder and co‐owner of Third Coast Dynamics. Susanna McColley reports grants from the NIH National Center for Advancing Translational Science, the Centers for Disease Control and Prevention, the Cystic Fibrosis Foundation, and the Rosenau Family Research Foundation. She receives compensation as an advisor to Vertex Pharmaceuticals, Inc. Huiping Liu is the scientific co‐founder of ExoMira Medicine. Justin Starren reports grants from the NIH and Greenwall Foundation. Theresa Walunas receives research funding from Gilead Sciences. Kelly Michelson reports grants from the NIH, Greenwall Foundation, and the Patient‐Centered Outcomes Research Institute. Richard D’Aquila reports grants from the NIH, serving on external advisory boards for NIH‐funded projects, serving on the NIAID AIDS Research Advisory Council, and serving on the editorial board of the Journal of Clinical Investigation. Abel Kho is an advisor to Datavant. Sanjiv Shah is supported by grants from the NIH and AHA. Lee Cooper reports grants from the NIH and has invention disclosures registered at the Northwestern Office of Innovation and New Ventures, consults for Tempus, and advises Veracyte and Targeted Bioscience. Feng Yue is supported by grants from NIH and is a co‐founder of Sariant Therapeutics, Inc. Deyu Fang is co‐founder of ExoMira Medicine. Ronald Ackermann is supported by grants from the NIH, CDC, and the UnitedHealth Group., (© 2024 The Authors. Learning Health Systems published by Wiley Periodicals LLC on behalf of University of Michigan.)

Background: Liver cirrhosis is a chronic disease that is known as a "silent killer" and its true prevalence is difficult to describe. It is imperative to accurately characterize the prevalence of cirrhosis because of its increasing healthcare burden., Methods: In this retrospective cohort study, trends in cirrhosis prevalence were evaluated using administrative data from one of the largest national health insurance providers in the US. (2011-2018). Enrolled adult (≥18-years-old) patients with cirrhosis defined by ICD-9 and ICD-10 were included in the study. The primary outcome measured in the study was the prevalence of cirrhosis 2011-2018., Results: Among the 371,482 patients with cirrhosis, the mean age was 62.2 (±13.7) years; 53.3% had commercial insurance and 46.4% had Medicare Advantage. The most frequent cirrhosis etiologies were alcohol-related (26.0%), NASH (20.9%) and HCV (20.0%). Mean time of follow-up was 725 (±732.3) days. The observed cirrhosis prevalence was 0.71% in 2018, a 2-fold increase from 2012 (0.34%). The highest prevalence observed was among patients with Medicare Advantage insurance (1.67%) in 2018. Prevalence increased in each US. state, with Southern states having the most rapid rise (2.3-fold). The most significant increases were observed in patients with NASH (3.9-fold) and alcohol-related (2-fold) cirrhosis., Conclusion: Between 2012-2018, the prevalence of liver cirrhosis doubled among insured patients. Alcohol-related and NASH cirrhosis were the most significant contributors to this increase. Patients living in the South, and those insured by Medicare Advantage also have disproportionately higher prevalence of cirrhosis. Public health interventions are important to mitigate this concerning trajectory of strain to the health system., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Dr. Lisa VanWagner serves as an advisor for Numares, Novo-Nordisk and Gerson Lehrman Group, receives grant support from W.L. Gore & Associates and provides expert witness services outside the submitted work. Other authors have no competing interests to disclose. This does not alter our adherence to PLOS ONE policies on sharing data and materials, (Copyright: © 2024 Ladner et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objectives: To describe changes in antidiabetic medication (ADM) use and characteristics associated with changes in ADM use after initiation of noninsulin second-line therapy., Study Design: Retrospective cohort study., Methods: This study analyzed private health plan claims for adults with type 2 diabetes who initiated 1 of 5 index ADM classes: sulfonylureas, dipeptidyl peptidase 4 inhibitors (DPP4is), sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide-1 receptor agonists (GLP-1 RAs), or thiazolidinediones. Analyses evaluated 3 treatment modification outcomes-discontinuation, switching, and intensification-over 12-month follow-up., Results: Of 82,624 included adults, nearly two-thirds (63.6%) experienced any treatment modification. Discontinuation was the most common modification (38.6%), especially among patients prescribed GLP-1 RAs (50.3%). Switching occurred in 5.2% of patients and intensification in 19.8%. In adjusted analysis, compared with patients prescribed sulfonylureas, discontinuation risk was 7% higher (HR, 1.07; 95% CI, 1.04-1.10) among patients prescribed DPP4is and 28% higher (HR, 1.28; 95% CI, 1.23-1.33) among patients prescribed GLP-1 RAs. Compared with sulfonylureas, all other index ADM classes had higher risks of switching and lower risks of intensification. Younger age group and female sex were both associated with higher risks of all modifications. Compared with index ADM prescription by a family medicine or internal medicine physician, index prescription by an endocrinologist was associated with both lower discontinuation risk and higher intensification risk., Conclusions: Most patients experienced a treatment modification within 1 year. Results highlight the need for new prescribing approaches and patient supports that can maximize medication adherence and reduce health system waste.

Background: In 2021, the U.S. Preventive Services Task Force (USPSTF) recommended screening for prediabetes and diabetes among adults aged 35-70 years with overweight or obesity. Studying dysglycemia screening in federally qualified health centers (FQHCs) that serve vulnerable patient populations is needed to understand health equity implications of this recommendation., Objective: To investigate screening practices among FQHC patients who would be eligible according to the 2021 USPSTF recommendation., Design: Retrospective cohort study analyzing electronic health records from a national network of 282 FQHC sites., Participants: We included 183,329 patients without prior evidence of prediabetes or diabetes, who had ≥ 1 office visit from 2018-2020., Main Measures: Screening eligibility was based on age and measured body mass index (BMI). The primary outcome, screening completion, was ascertained using hemoglobin A1c or fasting plasma glucose results from 2018-2020., Key Results: Among 89,543 patients who would be eligible according to the 2021 USPSTF recommendation, 53,263 (59.5%) were screened. Those who completed screening had higher BMI values than patients who did not (33.0 ± 6.7 kg/m 2 vs. 31.9 ± 6.2 kg/m 2 , p < 0.001). Adults aged 50-64 years had greater odds of screening completion relative to younger patients (OR 1.13, 95% CI: 1.10-1.17). Patients from racial and ethnic minority groups, as well as those without health insurance, were more likely to complete screening than White patients and insured patients, respectively. Clinical risk factors for diabetes were also associated with dysglycemia screening. Among patients who completed screening, 23,588 (44.3%) had values consistent with prediabetes or diabetes., Conclusions: Over half of FQHC patients who would be eligible according to the 2021 USPSTF recommendation were screened. Screening completion was higher among middle-aged patients, those with greater BMI values, as well as vulnerable groups with a high risk of developing diabetes. Future research should examine adoption of the 2021 USPSTF screening recommendation and its impact on health equity., (© 2023. The Author(s), under exclusive licence to Society of General Internal Medicine.)

Introduction: The American Diabetes Association (ADA) recommends screening for prediabetes and diabetes (dysglycemia) starting at age 35, or younger than 35 years among adults with overweight or obesity and other risk factors. Diabetes risk differs by sex, race, and ethnicity, but performance of the recommendation in these sociodemographic subgroups is unknown., Methods: Nationally representative data from the National Health and Nutrition Examination Surveys (2015-March 2020) were analyzed from 5,287 nonpregnant US adults without diagnosed diabetes. Screening eligibility was based on age, measured body mass index, and the presence of diabetes risk factors. Dysglycemia was defined by fasting plasma glucose ≥100mg/dL (≥5.6 mmol/L) or haemoglobin A1c ≥5.7% (≥39mmol/mol). The sensitivity, specificity, and predictive values of the ADA screening criteria were examined by sex, race, and ethnicity., Results: An estimated 83.1% (95% CI=81.2-84.7) of US adults were eligible for screening according to the 2023 ADA recommendation. Overall, ADA's screening criteria exhibited high sensitivity [95.0% (95% CI=92.7-96.6)] and low specificity [27.1% (95% CI=24.5-29.9)], which did not differ by race or ethnicity. Sensitivity was higher among women [97.8% (95% CI=96.6-98.6)] than men [92.4% (95% CI=88.3-95.1)]. Racial and ethnic differences in sensitivity and specificity among men were statistically significant ( P =0.04 and P =0.02, respectively). Among women, guideline performance did not differ by race and ethnicity., Discussion: The ADA screening criteria exhibited high sensitivity for all groups and was marginally higher in women than men. Racial and ethnic differences in guideline performance among men were small and unlikely to have a significant impact on health equity. Future research could examine adoption of this recommendation in practice and examine its effects on treatment and clinical outcomes by sex, race, and ethnicity., Competing Interests: SB has received consultant fees from Lundbeck, Luto, Pfizer, and Sanofi. SB has received research support from Eli Lilly, Gordon and Betty Moore Foundation, Lundbeck, Merk, Pfizer, and Retirement Research Foundation for Aging. RA has received consultant fees from UnitedHealth Group. MA has received advisory panel support from Bayer AG and research support from Merk. All potential financial dualities of interest reported here were unrelated to the current study. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 O’Brien, Zhang, Bailey, Khan, Ackermann, Ali, Bowen, Benoit, Imperatore, Holliday and McKeever Bullard.)

Aims: There is limited research using real-world data to evaluate protective cardiovascular effects of glucagon-like peptide-1 (GLP-1) agonists among adults with type 2 diabetes (T2D) early in treatment., Materials and Methods: We conducted a retrospective, active comparator cohort study using 2011-2015 administrative claims data to compare cardiovascular disease (CVD) event rates following initiation of exenatide extended-release (E-ER), exenatide immediate-release (E-IR) or liraglutide in T2D adults who previously received no other antidiabetic medication (ADM) except metformin. The primary outcome was time to first major adverse CVD event (ischaemic heart disease, stroke, congestive heart failure or peripheral arterial disease) after starting GLP-1. Cox proportional hazards regression was used to model the association between index GLP-1 and CVD events, adjusting for baseline patient, prescriber and plan characteristics. Primary analyses included all patients with ≥2 prescription fills for the index GLP-1, regardless of subsequent refill adherence or initiation of other ADM after index date., Results: Compared with liraglutide, neither E-ER nor E-IR was associated with risk of composite major CVD events (hazard ratios [HRs] for E-ER and E-IR: 1.33 [95% C.I. 0.73-2.39] and 1.30 [0.81-2.09]). No associations were observed between event rates for individual CVD components. The HR for an ischaemic event with E-IR relative to liraglutide was 1.85 (95% C.I. 0.97-3.53). Adjusting for time-varying exposure to other ADM and CVD medications after index date produced similar results., Conclusions: Initiating either immediate or extended-release exenatide rather than liraglutide was not associated with significant differences in CVD risk in this observational real-world study., (© 2023 The Authors. Endocrinology, Diabetes & Metabolism published by John Wiley & Sons Ltd.)

Background: Multidisciplinary transitional care services reduce readmissions for high-risk patients, but it is unclear if health system costs to offer these intensive services are offset by avoidance of higher downstream expenditures., Objective: To evaluate net costs for a health system offering transitional care services DESIGN: One-year pragmatic, randomized trial PARTICIPANTS: Adults aged ≥ 18 without a usual source of follow-up care at the time of hospital discharge were enrolled through a high-volume, urban academic medical center in Chicago, IL, USA, from September 2015 through February 2016., Interventions: Eligible patients were silently randomized before discharge by an automated electronic health record algorithm allocating them in a 1:3 ratio to receive routine coordination of post-discharge care (RC) versus being offered intensive, multidisciplinary transitional care (TC) services., Main Measurements: Health system costs were collected from facility administrative systems and transformed to standardized costs using Medicare reference files. Multivariable generalized linear models estimated proportional differences in net costs over one year., Key Results: Study patients (489 TC; 164 RC) had a mean age of 44 years; 34% were uninsured, 55% had public insurance, and 49% self-identified as Black or Latinx. Over 90 days, cost differences between groups were not statistically significant. Over 180 days, the TC group had 41% lower ED/observation costs (adjusted cost ratio [aCR], 0.59; 95% CI, 0.36-0.97), 50% lower inpatient costs (aCR, 0.50; 95% CI, 0.27-0.95), and 41% lower total healthcare costs (aCR, 0.59; 95% CI, 0.36-0.99) than the RC group. Over 365 days, total cost differences remained of similar magnitude but no longer were statistically significant., Conclusions: Offering TC services for vulnerable adults at discharge reduced net health system expenditures over 180 days. The promising economic case for multidisciplinary transitional care interventions warrants further research., Trial Registration: National Clinical Trials Registry (NCT03066492)., (© 2022. The Author(s) under exclusive licence to Society of General Internal Medicine.)

Background: Patient-reported outcomes-symptoms, treatment side effects, and health-related quality of life-are important to consider in chronic illness care. The increasing availability of health IT to collect patient-reported outcomes and integrate results within the electronic health record provides an unprecedented opportunity to support patients' symptom monitoring, shared decision-making, and effective use of the health care system., Objective: The objectives of this study are to co-design a dashboard that displays patient-reported outcomes along with other clinical data (eg, laboratory tests, medications, and appointments) within an electronic health record and conduct a longitudinal demonstration trial to evaluate whether the dashboard is associated with improved shared decision-making and disease management outcomes., Methods: Co-design teams comprising study investigators, patients with advanced cancer or chronic kidney disease, their care partners, and their clinicians will collaborate to develop the dashboard. Investigators will work with clinic staff to implement the co-designed dashboard for clinical testing during a demonstration trial. The primary outcome of the demonstration trial is whether the quality of shared decision-making increases from baseline to the 3-month follow-up. Secondary outcomes include longitudinal changes in satisfaction with care, self-efficacy in managing treatments and symptoms, health-related quality of life, and use of costly and potentially avoidable health care services. Implementation outcomes (ie, fidelity, appropriateness, acceptability, feasibility, reach, adoption, and sustainability) during the co-design process and demonstration trial will also be collected and summarized., Results: The dashboard co-design process was completed in May 2020, and data collection for the demonstration trial is anticipated to be completed by the end of July 2022. The results will be disseminated in at least one manuscript per study objective., Conclusions: This protocol combines stakeholder engagement, health care coproduction frameworks, and health IT to develop a clinically feasible model of person-centered care delivery. The results will inform our current understanding of how best to integrate patient-reported outcome measures into clinical workflows to improve outcomes and reduce the burden of chronic disease on patients and health care systems., International Registered Report Identifier (irrid): DERR1-10.2196/38461., (©Laura M Perry, Victoria Morken, John D Peipert, Betina Yanez, Sofia F Garcia, Cynthia Barnard, Lisa R Hirschhorn, Jeffrey A Linder, Neil Jordan, Ronald T Ackermann, Alexandra Harris, Sheetal Kircher, Nisha Mohindra, Vikram Aggarwal, Rebecca Frazier, Ava Coughlin, Katy Bedjeti, Melissa Weitzel, Eugene C Nelson, Glyn Elwyn, Aricca D Van Citters, Mary O'Connor, David Cella. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 21.09.2022.)

Prediabetes impacts 88 million U.S. adults, yet uptake of evidence-based treatment with intensive lifestyle interventions and metformin remains exceedingly low. After incorporating feedback from 15 primary care providers collected during semi-structured interviews, we developed a novel Prediabetes Clinical Decision Support (PreDM CDS) from August 2019 to February 2020. This tool included order options enabling prediabetes management in a single location within the electronic health record. We conducted a retrospective observational study examining the feasibility of implementing this tool at Erie Family Health Centers, a large community health center, examining its use and related outcomes among patients for whom it was used vs not. Overall, 7,424 eligible patients were seen during the implementation period (February 2020 to August 2021), and the PreDM CDS was used for 108 (1.5 %). Using the PreDM CDS was associated with higher rates of hemoglobin A1c orders (70.4 % vs 22.2 %; p < 0.001), lifestyle counseling (38.0 % vs 7.8 %; p < 0.001), and metformin prescription orders (5.6 % vs 2.6 %; p = 0.06). Exploratory analyses revealed small, nonsignificant weight loss among patients for whom the PreDM CDS was used. This study demonstrates the feasibility of developing and implementing the PreDM CDS in primary care. Its low use was likely related to not imposing an interruptive 'pop-up' alert, as well as major changes in workflows and clinical priorities during the Covid-19 pandemic. Use of the tool was associated with improved process outcomes. Future efforts with the PreDM CDS should follow standard CDS implementation processes that were not possible due to the Covid-19 pandemic., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2022 The Author(s).)

Background: Antidiabetic medications (ADM), especially sulfonylureas (SFU) and basal insulin (BI), are associated with increased risk of hypoglycemia, which is especially concerning among older adults in poor health. The objective of this study was to investigate prescribing patterns of ADM in older adults according to their health status., Methods: This case control study analyzed administrative claims between 2013 and 2017 from a large national payer. The study population was derived from a nationwide database of 84,720 U.S. adults aged ≥65, who were enrolled in Medicare Advantage health insurance plans. Participants had type 2 diabetes on metformin monotherapy, and started a second-line ADM during the study period. The exposure was a binary variable for health status, with poor health defined by end-stage medical conditions, dementia, or residence in a long-term nursing facility. The outcome was a variable identifying which second-line ADM class was started, categorized as SFU, BI, or other (i.e. all other ADM classes combined)., Results: Over half of participants (54%) received SFU as initial second-line ADM, 14% received BI, and 32% received another ADM. In multivariable models, the odds of filling SFU or BI was higher for participants in poor health than those in good or intermediate health [OR 1.13 (95% CI 1.05-1.21) and OR 2.34 (95% CI 2.14-2.55), respectively]. SFU and BI were also more commonly filled by older adults with poor glycemic control., Conclusions: Despite clinical consensus to use caution prescribing SFU and BI among older adults in poor health, these medications remain frequently used in this particularly vulnerable population., (© 2022. The Author(s).)

Objectives: To examine differences in health care costs associated with choice of second-line antidiabetes medication (ADM) for commercially insured adults with type 2 diabetes., Study Design: Retrospective cohort study with multiple pretests and posttests., Methods: Included patients initiated second-line ADM therapy between 2011 and 2015, with variable follow-up through 2017. The 6 index medication classes were sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 receptor agonists (GLP-1 RAs), basal insulin, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, and thiazolidinediones (TZDs). Multivariable regression models compared between-class changes in adjusted quarterly costs after second-line ADM initiation., Results: The study cohort included 34,963 adults. Most were prescribed a sulfonylurea (46.0%) or DPP-4 inhibitor (30.4%). Adjusted quarterly index medication costs were significantly higher for all patients receiving nonsulfonylurea medications, ranging from $108 (95% CI, $99-$118) for TZDs to $742 (95% CI, $720-$765) for GLP-1 RAs. Changes in quarterly total health care costs were significantly higher for all nonsulfonylurea classes. Conversely, changes in quarterly nonpharmacy medical costs were significantly lower for patients receiving DPP-4 inhibitors (-$67; 95% CI, -$92 to -$43), GLP-1 RAs (-$43; 95% CI, -$85 to -$1), and SGLT-2 inhibitors (-$46; 95% CI, -$87 to -$6); changes in all other quarterly costs besides the index medication were significantly lower for patients receiving DPP-4 inhibitors (-$60; 95% CI, -$94 to -$26) and SGLT-2 inhibitors (-$113; 95% CI, -$169 to -$57)., Conclusions: The higher cost of nonsulfonylurea medications was the main driver of relative increases in total costs. Relative decreases in nonpharmacy medical costs among patients receiving newer ADM classes reflect these medications' potential value.

Objective: Lifestyle interventions slow development of type 2 diabetes by half, but the impact of health payer reimbursement for delivery of intervention programs is not well known. We evaluated net commercial health payer expenditures when offering reimbursement for access to YMCA's Diabetes Prevention Program (YDPP) in 42 states., Research Design and Methods: We used a nonequivalent comparison group design to evaluate net health care expenditures for adults with prediabetes who attended one or more YDPP visit between 1 July 2009 and 31 May 2013 ("YDPP users"). Rolling, 1:1 nearest neighbor propensity score (PS) matching was used to identify a comparison group of nonusers. Administrative data provided measures of YDPP attendance, body weight at YDPP visits, and health care expenditures. Random effects, difference-in-difference regression was used to estimate quarterly health care expenditures before and after participants' first visit to YDPP., Results: Worksite screening identified 9.7% of the target population; 39.1% of those identified (19,933 participants through June 2015) became YDPP users. Mean weight loss for YDPP users enrolled before June 2013 ( n = 1,725) was 7.5 lb (3.4%); 29% achieved ≥5% weight loss. Inclusive of added costs to offer YDPP, there were no statistically significant differences in mean per-person net health care expenditures between YDPP users and PS-matched nonusers over 2 years ($0.2 lower [95% CI $56 lower to $56 higher]). Mean reimbursement to the YMCA was $212 per YDPP user, with 92.8% of all expenditures made for those who attended at a high rate (≥9 completed YDPP visits)., Conclusions: Worksite screening was inefficient for identifying the population with prediabetes, but those identified achieved modest YDPP attendance and clinically meaningful weight loss. Over 2 years, added costs to offer the intervention were modest, with neutral effects on net health care costs., (© 2019 by the American Diabetes Association.)

Background: There is limited experimental evidence on transitional care interventions beyond 30 days post-discharge and in vulnerable populations., Objective: Evaluate effects of a transitional care practice (TC) that comprehensively addresses patients' medical and psychosocial needs following hospital discharge., Design: Pragmatic, randomized comparative effectiveness trial., Patients: Adults discharged from an initial emergency, observation, or inpatient hospital encounter with no trusted usual source of care., Interventions: TC intervention included a scheduled post-discharge appointment at the TC practice, where a multidisciplinary team comprehensively assessed patients' medical and psychosocial needs, addressed modifiable barriers, and subsequent linkage to a new primary care source. Routine Care involved assistance scheduling a post-discharge appointment with a primary care provider that often partnered with the hospital where the initial encounter occurred., Main Measures: The primary outcome was a binary indicator of death or additional hospital encounters within 90 days of initial discharge. Secondary outcomes included any additional hospital encounters, and counts of hospital encounters, over 180 days., Key Results: Four hundred ninety patients were randomized to TC intervention and 164 to Routine Care; 34.6% were uninsured, 49.7% had Medicaid, and 57.4% were homeless or lived in a high-poverty area. There was no significant difference between arms in the 90-day probability of death or additional hospital encounters (relative risk [RR] 0.89; 0.91; 95% confidence interval [CI] 0.74-1.13). However, TC patients had 37% and 35% lower probability of any inpatient admission over 90 days (RR 0.63; 95% CI 0.43-0.91) and 180 days (RR 0.65; 95% CI 0.47-0.89), respectively. Over 180 days, TC patients had 42% fewer inpatient admissions (incidence rate ratio 0.58; 95% CI 0.37-0.90)., Conclusions: Among patients randomized to a patient-centered transitional care intervention, there was no significant reduction in 90-day probability of death or additional hospital encounters. However, there were significant decreases in measures of inpatient admissions over 180 days., Trial Registration: clinicaltrials.gov identifier NCT03066492.

Importance: Understanding cardiovascular outcomes of initiating second-line antidiabetic medications (ADMs) may help inform treatment decisions after metformin alone is not sufficient or not tolerated. To date, no studies have compared the cardiovascular effects of all major second-line ADMs during this early decision point in the pharmacologic management of type 2 diabetes., Objective: To examine the association of second-line ADM classes with major adverse cardiovascular events., Design, Setting, and Participants: Retrospective cohort study among 132 737 insured adults with type 2 diabetes who started therapy with a second-line ADM after taking either metformin alone or no prior ADM. This study used 2011-2015 US nationwide administrative claims data. Data analysis was performed from January 2017 to October 2018., Exposures: Dipeptidyl peptidase 4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, sodium-glucose cotransporter 2 (SGLT-2) inhibitors, thiazolidinediones (TZDs), basal insulin, and sulfonylureas or meglitinides (both referred to as sulfonylureas hereafter). The DPP-4 inhibitors served as the comparison group in all analyses., Main Outcomes and Measures: The primary outcome was time to first cardiovascular event after starting the second-line ADM. This composite outcome was based on hospitalization for the following cardiovascular conditions: congestive heart failure, stroke, ischemic heart disease, or peripheral artery disease., Results: Among 132 737 insured adult patients with type 2 diabetes (men, 55%; aged 45-64 years, 58%; white, 63%), there were 3480 incident cardiovascular events during 169 384 person-years of follow-up. Patients were censored after the first cardiovascular event, discontinuation of insurance coverage, transition from International Classification of Diseases, Ninth Revision (ICD-9) to end of ICD-9 coding, or 2 years of follow-up. After adjusting for patient, prescriber, and health plan characteristics, the risk of composite cardiovascular events after starting GLP-1 receptor agonists was lower than DPP-4 inhibitors (hazard ratio [HR], 0.78; 95% CI, 0.63-0.96), but this finding was not significant in all sensitivity analyses. Cardiovascular event rates after starting treatment with SGLT-2 inhibitors (HR, 0.81; 95% CI, 0.57-1.53) and TZDs (HR, 0.92; 95% CI, 0.76-1.11) were not statistically different from DPP-4 inhibitors. The comparative risk of cardiovascular events was higher after starting treatment with sulfonylureas (HR, 1.36; 95% CI, 1.23-1.49) or basal insulin (HR, 2.03; 95% CI, 1.81-2.27) than DPP-4 inhibitors., Conclusions and Relevance: Among insured adult patients with type 2 diabetes initiating second-line ADM therapy, the short-term cardiovascular outcomes of GLP-1 receptor agonists, SGLT-2 inhibitors, and DPP-4 inhibitors were similar. Higher cardiovascular risk was associated with use of sulfonylureas or basal insulin compared with newer ADM classes. Clinicians may consider prescribing GLP-1 receptor agonists, SGLT-2 inhibitors, or DPP-4 inhibitors more routinely after metformin rather than sulfonylureas or basal insulin.

Background: In 2015, The US Preventive Services Task Force (USPSTF) recommended screening for prediabetes and undiagnosed diabetes (collectively called dysglycemia) among adults aged 40-70 years with overweight or obesity. The recommendation suggests that clinicians consider screening earlier in people who have other diabetes risk factors., Objective: To compare the performance of limited and expanded screening criteria recommended by the USPSTF for detecting dysglycemia among US adults., Design: Cross-sectional analysis of survey and laboratory data collected from nationally representative samples of the civilian, noninstitutionalized US adult population., Participants: A total of 3643 adults without diagnosed diabetes who underwent measurement of hemoglobin A1c (A1c), fasting plasma glucose (FPG), and 2-h plasma glucose (2-h PG)., Main Measures: Screening eligibility according to the limited criteria was based on age 40 to 70 years old and overweight/obesity. Screening eligibility according to the expanded criteria was determined by meeting the limited criteria or having ≥ 1 of the following risk factors: family history of diabetes, history of gestational diabetes or polycystic ovarian syndrome, and non-white race/ethnicity. Dysglycemia was defined by A1c ≥ 5.7%, FPG ≥ 100 mg/dL, and/or 2-h PG ≥ 140 mg/dL., Key Results: Among the US adult population without diagnosed diabetes, 49.7% had dysglycemia. Screening based on the limited criteria demonstrated a sensitivity of 47.3% (95% CI, 44.7-50.0%) and specificity of 71.4% (95% CI, 67.3-75.2%). The expanded criteria yielded higher sensitivity [76.8% (95% CI, 73.5-79.8%)] and lower specificity [33.8% (95% CI, 30.1-37.7%)]. Point estimates for the sensitivity of the limited criteria were lower in all minority groups and significantly different for Asians compared to non-Hispanic whites [29.9% (95% CI, 23.4-37.2%) vs. 49.8% (95% CI, 45.9-53.7%); P < .001]., Conclusions: Diabetes screening that follows the limited USPSTF criteria will identify approximately half of US adults with dysglycemia. Screening other high-risk subgroups defined in the USPSTF recommendation would improve detection of dysglycemia and may reduce associated racial/ethnic disparities.

Objective: Past research provides insufficient evidence to inform second-line diabetes medication prescribing when metformin is no longer sufficient. We evaluated patient, prescriber, and health plan characteristics associated with selection of second-line diabetes medications in the USA., Research Design and Methods: We used a multiple case-comparison study design to identify characteristics associated with the probability of starting each of six second-line diabetes medication alternatives within 77 744 adults enrolled in commercial or Medicare Advantage health plans from 2011 to 2015. National administrative data were provided by a large commercial health payer. Multinomial logistic regression models were used to identify characteristics independently associated with selecting each diabetes drug class., Results: From 2011 to 2015, sulfonylureas still represented 47% of all second-line drug starts, with proportionately higher use in patients ≥75 years of age (63% of drug starts). Basal insulin was more likely to be selected when a past A1c test result was >10% (13.0% vs 4.5% for those with A1c <8%; p<0.001). Initiation of a glucagon-like peptide-1 receptor agonist was associated with being female (10.1% vs 6.0% for male; p<0.001) and having a diagnosis code for obesity (10.8% vs 6.9% for no diagnosis; p<0.001). For all drug classes, the recent prescribing behavior of the provider was a strong correlate of subsequent second-line drug selection., Conclusions: Sulfonylureas continue to represent almost half of second-line diabetes medication starts in the USA. This could reflect overuse for some groups such as older adults, for whom some alternatives may be safer, although more costly and potentially less effective. Future research should compare outcomes of medication choices and conditions under which particular classes are most effective., Competing Interests: Competing interests: AW discloses that she has received research grant support from Eli Lilly and has done trial adjudication for Lexicon Therapeutics, both of which are unrelated to this work.

Objectives: Continuous subcutaneous insulin infusion (CSII), or "insulin pump" therapy, is an alternative to multiple daily insulin injections (MDII) for management of diabetes. This study evaluates patterns of healthcare utilization, costs, and blood glucose control for patients with diabetes who initiate CSII., Study Design: Pre-post with propensity-matched comparison design involving commercially insured US adults (aged 18-64 years) with insulin-requiring diabetes who transitioned from MDII to CSII between July 1, 2009, and June 30, 2012 ("CSII initiators"; n = 2539), or who continued using MDI (n = 2539)., Methods: Medical claims and laboratory results files obtained from a large US-wide health payer were used to construct direct medical expenditures, hospital use, healthcare encounters for hypoglycemia, and mean concentration of glycated hemoglobin (A1C). We fit difference-in-differences regression models to compare healthcare expenditures for 3 years following the switch to CSII. Stratified analyses were performed for prespecified patient subgroups., Results: Over 3 years, mean per-person total healthcare expenditures were $1714 (95% confidence interval [CI], $1184-$2244) higher per quarter for CSII initiators compared with matched MDII patients (total mean 3-year difference of $20,565). Compared with matched controls, mean A1C concentrations became lower for CSII initiators by 0.46% in year 2 (P = .0003) and by 0.32% in year 3 (P = .047). CSII initiators also had a higher rate of hypoglycemia encounters in year 1 (P = .002)., Conclusions: For adults with insulin-requiring diabetes, transitioning from MDII to CSII was associated with modest improvements in A1C but more hypoglycemia encounters and increased healthcare expenditures, without significant improvement in other potentially offsetting areas of healthcare consumption.

Healthcare systems are challenged by steady increases in the number of patients who are overweight and obese. Large-scale, evidence-based behavioral approaches for addressing overweight and obesity have been successfully implemented in systems such as the Veterans Health Administration (VHA). These population-based interventions target reduction in risk for obesity-associated conditions through lifestyle change and weight loss, and are associated with modest weight loss. Despite the fact that VHA has increased the overall reach of these behavioral interventions, the number of high-risk overweight and obese patients continues to rise. Recommendations for weight loss medications and bariatric surgery are included in clinical practice guidelines for the management of overweight and obesity, but these interventions are underutilized. During a recent state of the art conference on weight management held by VHA, subject matter experts identified challenges and gaps, as well as potential solutions and overarching policy recommendations, for implementing an integrated system-wide approach for improving population-based weight management.

Background: In 2015, the United States Preventive Services Task Force (USPSTF) recommended targeted screening for prediabetes and diabetes (dysglycemia) in adults who are aged 40 to 70 y old and overweight or obese. Given increasing prevalence of dysglycemia at younger ages and lower body weight, particularly among racial/ethnic minorities, we sought to determine whether the current screening criteria may fail to identify some high-risk population subgroups., Methods and Findings: We investigated the performance of the 2015 USPSTF screening recommendation in detecting dysglycemia among US community health center patients. A retrospective analysis of electronic health record (EHR) data from 50,515 adult primary care patients was conducted. Longitudinal EHR data were collected in six health centers in the Midwest and Southwest. Patients with a first office visit between 2008 and 2010 were identified and followed for up to 3 y through 2013. We excluded patients who had dysglycemia at baseline and those with fewer than two office visits during the follow-up period. The exposure of interest was eligibility for screening according to the 2015 USPSTF criteria. The primary outcome was development of dysglycemia during follow-up, determined by: (1) laboratory results (fasting/2-h postload/random glucose ≥ 100/140/200 mg/dL [5.55/7.77/11.10 mmol/L] or hemoglobin A1C ≥ 5.7% [39 mmol/mol]); (2) diagnosis codes for prediabetes or type 2 diabetes; or (3) antidiabetic medication order. At baseline, 18,846 (37.3%) participants were aged ≥40 y, 33,537 (66.4%) were overweight or obese, and 39,061 (77.3%) were racial/ethnic minorities (34.6% Black, 33.9% Hispanic/Latino, and 8.7% Other). Overall, 29,946 (59.3%) patients had a glycemic test within 3 y of follow-up, and 8,478 of them developed dysglycemia. Only 12,679 (25.1%) patients were eligible for screening according to the 2015 USPSTF criteria, which demonstrated the following sensitivity and specificity (95% CI): 45.0% (43.9%-46.1%) and 71.9% (71.3%-72.5%), respectively. Racial/ethnic minorities were significantly less likely to be eligible for screening yet had higher odds of developing dysglycemia than whites (odds ratio [95% CI]: Blacks 1.24 [1.09-1.40]; Hispanics 1.46 [1.30-1.64]; and Other 1.33 [1.16-1.54]). In addition, the screening criteria had lower sensitivity in all racial/ethnic minority groups compared to whites. Limitations of this study include the ascertainment of dysglycemia only among patients with available test results and findings that may not be generalizable at the population level., Conclusions: Targeted diabetes screening based on new USPSTF criteria may detect approximately half of adult community health center patients with undiagnosed dysglycemia and proportionately fewer racial/ethnic minorities than whites. Future research is needed to estimate the performance of these screening criteria in population-based samples.

Objectives: We evaluated the weight loss effectiveness of a YMCA model for the Diabetes Prevention Program (DPP) lifestyle intervention., Methods: Between July 2008 and November 2010, we individually randomized 509 overweight or obese, low-income, nondiabetic adults with elevated blood glucose in Indianapolis, Indiana, to receive standard care plus brief lifestyle counseling or be offered a group-based YMCA adaptation of the DPP (YDPP). Primary outcome was mean weight loss difference at 12 months. In our intention-to-treat analyses, we used longitudinal linear or logistic regression, multiply imputing missing observations. We used instrumental variables regression to estimate weight loss effectiveness among participants completing 9 or more intervention lessons., Results: In the YDPP arm, 161 (62.6%) participants attended ≥ 1 lesson and 103 (40.0%) completed 9 or more lessons. In intention-to-treat analysis, mean 12-month weight loss was 2.3 kilograms (95% confidence interval [CI] = 1.1, 3.4 kg) more for the YDPP arm than for standard care participants. In instrumental variable analyses, persons attending 9 or more lessons had a 5.3-kilogram (95% CI = 2.8, 7.9 kg) greater weight loss than did those with standard care alone., Conclusions: The YMCA model for DPP delivery achieves meaningful weight loss at 12 months among low-income adults.

Objective. Weight loss is the most effective approach to reducing diabetes risk. It is a research priority to identify factors that may enhance weight loss success, particularly among those at risk for diabetes. This analysis explored the relationships between self-efficacy, weight loss, and dietary fat intake among adults at risk for developing type 2 diabetes. Methods. This pilot, site-randomized trial was designed to compare group-based Diabetes Prevention Program lifestyle intervention delivery by YMCA staff to brief counseling alone (control) in 92 adults at risk for diabetes (BMI ≥ 24 kg/m(2), ≥ 2 diabetes risk factors, and a random capillary blood glucose of 110-199 mg/dl). Self-efficacy was measured using the Weight Efficacy Lifestyle questionnaire. Data were collected at baseline, 6 months, and 12 months. A paired t test was used to determine within-group changes in self-efficacy and weight at 6 and 12 months. Using a fitted model, we estimated how much of an increase in self-efficacy was related to a 5% weight reduction at 6 and 12 months. Results. Self-efficacy was associated with a 5% reduction in baseline weight at 6 and 12 months but was not related to fat intake. Conclusion. These findings suggest that it is important to assess the level of self-efficacy when counseling adults at high risk for diabetes about weight loss. Certain aspects of self-efficacy seem to play a greater role, depending on the stage of weight loss.

Objective: To evaluate the use and effectiveness of two "in-home" strategies for delivering diabetes prevention programming using cable television., Methods: An individually randomized, two-arm intervention trial including adults with diabetes risk factors living in two US cities. Interventions involved a 16-session lifestyle intervention delivered via "video-on-demand" cable television, offered alone versus in combination with web-based lifestyle support tools. Repeated measures longitudinal linear regression with imputation of missing observations was used to compare changes in body weight., Results: A total of 306 individuals were randomized and offered the interventions. After 5 months, 265 (87%) participants viewed at least 1, and 110 (36%) viewed ≥9 of the video episodes. A total of 262 (86%) participants completed a 5-month weight measurement. In intention-to-treat analysis with imputation of missing observations, mean weight loss at 5 months for both treatment groups combined was 3.3% (95% CI 0.7-5.0%), regardless of intervention participation (with no differences between randomized groups (P = 0.19)), and was 4.9% (95% CI 2.1-6.5%) for participants who viewed ≥9 episodes., Conclusions: In-home delivery of evidence-based diabetes prevention programming in a reality television format, offered with or without online behavioral support tools, can achieve modest weight losses consistent with past implementation studies of face-to-face programs using similar content., (© 2014 The Authors Obesity published by Wiley Periodicals, Inc. on behalf of The Obesity Society (TOS).)

Objectives: To estimate the direct medical costs associated with type 2 diabetes, its complications, and its comorbidities among U.S. managed care patients., Study Design: Data were from patient surveys, chart reviews, and health insurance claims for 7109 people with type 2 diabetes from 8 health plans participating in the Translating Research Into Action for Diabetes (TRIAD) study between 1999 and 2002., Methods: A generalized linear regression model was developed to estimate the association of patients' demographic characteristics, tobacco use status, treatments, related complications, and comorbidities with medical costs., Results: The mean annualized direct medical cost was $2465 for a white man with type 2 diabetes who had been diagnosed fewer than 15 years earlier, was treated with oral medication or diet alone, and had no complications or comorbidities. We found annualized medical costs to be 10% to 50% higher for women and for patients whose diabetes had been diagnosed 15 or more years earlier, who used tobacco, who were being treated with insulin, or who had several other complications. Coronary heart disease, congestive heart failure, hemiplegia, and amputation were each associated with 70% to 150% higher costs. Costs were approximately 300% higher for end-stage renal disease treated with dialysis and approximately 500% higher for end-stage renal disease with kidney transplantation., Conclusions: Most medical costs incurred by patients with type 2 diabetes are related to complications and comorbidities. Our cost estimates can help when determining the most cost-effective interventions to prevent complications and comorbidities.

Objectives: We report the 10-year effectiveness and within-trial cost-effectiveness of the Diabetes Prevention Program (DPP) and its Outcomes Study (DPPOS) interventions among participants who were adherent to the interventions., Study Design: DPP was a 3-year randomized clinical trial followed by 7 years of open-label modified intervention follow-up., Methods: Data on resource utilization, cost, and quality of life were collected prospectively. Economic analyses were performed from health system and societal perspectives. Lifestyle adherence was defined as achieving and maintaining a 5% reduction in initial body weight, and metformin adherence as taking metformin at 80% of study visits., Results: The relative risk reduction was 49.4% among adherent lifestyle participants and 20.8% among adherent metformin participants compared with placebo. Over 10 years, the cumulative, undiscounted, per capita direct medical costs of the interventions, as implemented during the DPP, were greater for adherent lifestyle participants ($4810) than adherent metformin participants ($2934) or placebo ($768). Over 10 years, the cumulative, per capita non-interventionrelated direct medical costs were $4250 greater for placebo participants compared with adherent lifestyle participants and $3251 greater compared with adherent metformin participants. The cumulative quality-adjusted life-years (QALYs) accrued over 10 years were greater for lifestyle (6.80) than metformin (6.74) or placebo (6.67). Without discounting, from a modified societal perspective (excluding participant time) and a full societal perspective (including participant time), lifestyle cost < $5000 per QALY-gained and metformin was cost saving compared with placebo., Conclusions: Over 10 years, lifestyle intervention and metformin were cost-effective or cost saving compared with placebo. These analyses confirm that lifestyle and metformin represent a good value for money.

To address the growing incidence of type 2 diabetes in the United States, UnitedHealth Group, the YMCA of the USA, and the Centers for Disease Control and Prevention have partnered to bring a group-based adaptation of the Diabetes Prevention Program lifestyle intervention to a national scale. Researchers at Northwestern and Indiana universities are collaborating with these partners to design a robust evaluation of the reach, effectiveness, and costs of this natural experiment. We will employ a quasi-experimental, cluster-randomized study design and combine administrative, clinical, and programmatic data from existing sources to derive reliable, timely, and policy-relevant estimates of the program's impact and potential for sustainability. In this context, evaluation results will provide information about the unique role of a health care-community partnership to prevent type 2 diabetes.

Background: Adults at high risk for diabetes may have reduced health-related quality of life (HRQoL)., Objective: To assess changes in HRQoL after interventions aimed at diabetes risk reduction., Design, Setting, and Participants: A randomized clinical trial, the Diabetes Prevention Program, was conducted in 27 centers in the United States, in 3,234 non-diabetic persons with elevated fasting and post-load plasma glucose, mean age 51 years, mean BMI 34 Kg/m(2); 68 % women, and 45 % members of minority groups., Interventions: Intensive lifestyle (ILS) program with the goals of at least 7 % weight loss and 150 min of physical activity per week, metformin (MET) 850 mg twice daily, or placebo (PLB)., Measurements: HRQoL using the 36-Item Short-Form (SF-36) health survey to evaluate health utility index (SF-6D), physical component summaries (PCS) and mental component summaries (MCS). A minimally important difference (MID) was met when the mean of HRQoL scores between groups differed by at least 3 %., Results: After a mean follow-up of 3.2 years, there were significant improvements in the SF-6D (+0.008, p=0.04) and PCS (+1.57, p<0.0001) scores in ILS but not in MET participants (+0.002 and +0.15, respectively, p=0.6) compared to the PLB group. ILS participants showed improvements in general health (+3.2, p<0.001), physical function (+3.6, p<0.001), bodily pain (+1.9, p=0.01), and vitality (+2.1, p=0.01) domain scores. Treatment effects remained significant after adjusting sequentially for baseline demographic factors, and for medical and psychological comorbidities. Increased physical activity and weight reduction mediated these ILS treatment effects. Participants who experienced weight gain had significant worsening on the same HRQoL specific domains when compared to those that had treatment-related (ILS or MET) weight loss. No benefits with ILS or MET were observed in the MCS score., Conclusion: Overweight/obese adults at high risk for diabetes show small improvement in most physical HRQoL and vitality scores through the weight loss and increased physical activity achieved with an ILS intervention.

Health utilities are measures of health-related quality of life (HRQL) used in cost-effectiveness research. We evaluated whether changes in body weight were associated with changes in health utilities in the Diabetes Prevention Program (DPP) and whether associations differed by treatment assignment (lifestyle intervention, metformin, placebo) or baseline obesity severity. We constructed physical (PCS-36) and mental component summary (MCS-36) subscales and short-form-6D (SF-6D) health utility index for all DPP participants completing a baseline 36-item short form (SF-36) HRQL assessment (N = 3,064). We used linear regression to test associations between changes in body weight and changes in HRQL indicators, while adjusting for other demographic and behavioral variables. Overall differences in HRQL between treatment groups were highly statistically significant but clinically small after 1 year. In multivariable models, weight change was independently associated with change in SF-6D score (increase of 0.007 for every 5 kg weight loss; P < 0.001), but treatment effects independent of weight loss were not. We found no significant interaction between baseline obesity severity and changes in SF-6D with changes in body weight. However, increases in physical function (PCS-36) with weight loss were greater in persons with higher baseline obesity severity. In summary, improvements in HRQL are associated with weight loss but not with other effects of obesity treatments that are unrelated to weight loss. Although improvements in the SF-6D did not exceed commonly reported thresholds for a minimally important difference (0.04), these changes, if causal, could still have a significant impact on clinical cost-effectiveness estimates if sustained over multiple years.

Background: The impact of open access (OA) scheduling on chronic disease care and outcomes has not been studied., Objective: To assess the effect of OA implementation at 1 year on: (1) diabetes care processes (testing for A1c, LDL, and urine microalbumin), (2) intermediate outcomes of diabetes care (SBP, A1c, and LDL level), and (3) health-care utilization (ED visits, hospitalization, and outpatient visits)., Methods: We used a retrospective cohort study design to compare process and outcomes for 4,060 continuously enrolled adult patients with diabetes from six OA clinics and six control clinics. Using a generalized linear model framework, data were modeled with linear regression for continuous, logistic regression for dichotomous, and Poisson regression for utilization outcomes., Results: Patients in the OA clinics were older, with a higher percentage being African American (51% vs 34%) and on insulin. In multivariate analyses, for A1c testing, the odds ratio for African-American patients in OA clinics was 0.47 (CI: 0.29-0.77), compared to non-African Americans [OR 0.27 (CI: 0.21-0.36)]. For urine microablumin, the odds ratio for non-African Americans in OA clinics was 0.37 (CI: 0.17-0.81). At 1 year, in adjusted analyses, patients in OA clinics had significantly higher SBP (mean 6.4 mmHg, 95% CI 5.4 - 7.5). There were no differences by clinic type in any of the three health-care utilization outcomes., Conclusion: OA scheduling was associated with worse processes of care and SBP at 1 year. OA clinic scheduling should be examined more critically in larger systems of care, multiple health-care settings, and/or in a randomized controlled trial.

Introduction: Our study was undertaken to determine the association between use of a health plan-sponsored health club benefit by older adults and total health care costs over 2 years., Methods: This retrospective cohort study used administrative and claims data from a Medicare Advantage plan. Participants (n = 4766) were enrolled in the plan for at least 1 year before participating in the plan-sponsored health club benefit (Silver Sneakers). Controls (n = 9035) were matched to participants by age and sex according to the index date of Silver Sneakers enrollment. Multivariate regression models were used to estimate health care use and costs and to make subgroup comparisons according to frequency of health club visits., Results: Compared with controls, Silver Sneakers participants were older and more likely to be male, used more preventive services, and had higher total health care costs at baseline. Adjusted total health care costs for Silver Sneakers participants and controls did not differ significantly in year 1. By year 2, compared with controls, Silver Sneakers participants had significantly fewer inpatient admissions (-2.3%, 95% confidence interval, -3.3% to -1.2%; P < .001) and lower total health care costs (-$500; 95% confidence interval, -$892 to -$106; P = .01]. Silver Sneakers participants who averaged at least two health club visits per week over 2 years incurred at least $1252 (95% confidence interval, -$1937 to -$567; P < .001) less in health care costs in year 2 than did those who visited on average less than once per week., Conclusion: Regular use of a health club benefit was associated with slower growth in total health care costs in the long term but not in the short term. These findings warrant additional prospective investigations to determine whether policies to offer health club benefits and promote physical activity among older adults can reduce increases in health care costs.

Objective: The purpose of this article was to determine the effects of a managed-Medicare physical activity benefit on health care utilization and costs among older adults with diabetes., Research Design and Methods: This retrospective cohort study used administrative and claims data for 527 patients from a diabetes registry of a staff model HMO. Participants (n = 163) were enrolled in the HMO for at least 1 year before joining the Enhanced Fitness Program (EFP), a community-based physical activity program for which the HMO pays for each EFP class attended. Control subjects were matched to participants according to the index date of EFP enrollment (n = 364). Multivariate regression models were used to determine 12-month postindex differences in health care use and costs between participants and control subjects while adjusting for age, sex, chronic disease burden, EFP attendance, prevention score, heart registry, and respective baseline use and costs., Results: Participants and control subjects were similar at baseline with respect to age (75 +/- 5.5 years), A1C levels (7.4 +/- 1.4%), chronic disease burden, prevention score, and health care use and costs. After exposure to the program, there was a trend toward lower hospital admissions in EFP participants compared with control subjects (13.5 vs. 20.9%, P = 0.08), whereas total health care costs were not different (P = 0.39). EFP participants who attended > or = 1 exercise session/week on average had approximately 41% less total health care costs compared with those attending <1 session/week (P = 0.03) and with control subjects (P = 0.02)., Conclusions: Although elective participation in a community-based physical activity benefit at any level was not associated with lower inpatient or total health care costs, greater participation in the program may lower health care costs. These findings warrant additional investigations to determine whether policies to offer and promote a community-based physical activity benefit in older adults with diabetes can reduce health care costs.