Cost-Effectiveness of Closed-Loop Automated Insulin Delivery Using the Cambridge Hybrid Algorithm in Children and Adolescents with Type 1 Diabetes: Results from a Multicenter 6-Month Randomized Trial.

BACKGROUND/OBJECTIVE: The main objective of this study is to evaluate the incremental cost-effectiveness (ICER) of the Cambridge hybrid closed-loop automated insulin delivery (AID) algorithm versus usual care for children and adolescents with type 1 diabetes (T1D). METHODS: This multicenter, binational, parallel-controlled trial randomized 133 insulin pump using participants aged 6 to 18 years to either AID (n = 65) or usual care (n = 68) for 6 months. Both within-trial and lifetime cost-effectiveness were analyzed. Analysis focused on the treatment subgroup (n = 21) who received the much more reliable CamAPS FX hardware iteration and their contemporaneous control group (n = 24). Lifetime complications and costs were simulated via an updated Sheffield T1D policy model. RESULTS: Within-trial, both groups had indistinguishable and statistically unchanged health-related quality of life, and statistically similar hypoglycemia, severe hypoglycemia, and diabetic ketoacidosis (DKA) event rates. Total health care utilization was higher in the treatment group. Both the overall treatment group and CamAPS FX subgroup exhibited improved HbA1C (-0.32%, 95% CI: -0.59 to -0.04; P = .02, and -1.05%, 95% CI: -1.43 to -0.67; P < .001, respectively). Modeling projected increased expected lifespan of 5.36 years and discounted quality-adjusted life years (QALYs) of 1.16 (U.K. tariffs) and 1.52 (U.S. tariffs) in the CamAPS FX subgroup. Estimated ICERs for the subgroup were £19 324/QALY (United Kingdom) and -$3917/QALY (United States). For subgroup patients already using continuous glucose monitors (CGM), ICERs were £10 096/QALY (United Kingdom) and -$33 616/QALY (United States). Probabilistic sensitivity analysis generated mean ICERs of £19 342/QALY (95% CI: £15 903/QALY to £22 929/QALY) (United Kingdom) and -$28 283/QALY (95% CI: -$59 607/QALY to $1858/QALY) (United States). CONCLUSIONS: For children and adolescents with T1D on insulin pump therapy, AID using the Cambridge algorithm appears cost-effective below a £20 000/QALY threshold (United Kingdom) and cost saving (United States).

Cost-effectiveness analysis of individual-level obesity treatment in paediatrics: A scoping review.

OBJECTIVES: This scoping review informs a health economics perspective on the treatment of paediatric obesity. The results detail recently published research findings on the cost-effectiveness of paediatric obesity treatments and identify key characteristics of cost-effective interventions. METHODS: A structured search was applied to six databases with no data restriction through March 2023: Medline, Embase, Cochrane CENTRAL, CINAHL, and PsycINFO. Studies that included a cost analysis of an individual level, weight management intervention (behavioural, pharmacotherapy, and surgical) in youth, with obesity, ages 2 to 21 years were eligible for inclusion. RESULTS: Of the 4371 records identified in the initial search, 353 underwent full-text review, 39 studies met the pre-specified inclusion criteria. The majority were published after 2010 (n = 36/39, 92%) and applied to high-income countries (n = 39/39, 100%). Thirty-five of the studies assessed the cost-effectiveness of lifestyle interventions (90%), and four studies assessed surgical outcomes (10%). No pharmacotherapy studies met eligibility criteria. Although the outcome measures differed across the studies, all four surgical interventions were reported to be cost-effective. Thirty of the 35 (85%) lifestyle modification studies were reported to be cost-effective compared to the study comparator examined. CONCLUSIONS: There is a small amount of evidence that individual-level paediatric obesity treatment interventions are cost-effective and, in some cases cost-saving, with most of this work conducted on behavioural interventions. The economic evaluation of paediatric obesity interventions poses various methodologic challenges, which should be addressed in future research to fully use the potential of economic evaluation as an aid to decision-making.

Virtual Peer Groups Reduce HbA1c and Increase Continuous Glucose Monitor Use in Adolescents and Young Adults with Type 1 Diabetes.

Background: Adolescents and young adults (AYA) from diverse and marginalized backgrounds with type 1 diabetes (T1D) generally have higher hemoglobin A1c (HbA1c) levels and less frequent continuous glucose monitor (CGM) use than AYA from more privileged backgrounds. Further, scant data address the impact of virtual peer groups (VPG) on health-related outcomes for ethnically and racially diverse AYA with T1D. Methods: CoYoT1 to California was a 15-month randomized controlled trial for AYA aged 16-25 years. In this study, AYA were randomized to receive standard care (n = 28), or CoYoT1 care (n = 40), which consisted of person-centered provider visits and bimonthly VPG. VPG were AYA-driven discussions. AYA completed the Diabetes Distress Scale (DDS), Center for Epidemiologic Studies Depression (CES-D), and Diabetes Empowerment Scale-Short Form (DES-SF) scales at baseline and all study visits. Results: Participants were 50% Latinx and 75% publicly insured. Among CoYoT1 care participants, 19 attended at least 1 VPG session (VPG attendees) and 21 did not attend any VPG sessions. VPG attendees participated in 4.1 VPG sessions on average. VPG attendees had a relative reduction in HbA1C (treatment effect -1.08%, effect sizes values [ES] = -0.49, P = 0.04) and increase in CGM use (treatment effect +47%, ES = 1.00, P = 0.02) compared to standard care. VPG participation was not associated with statistically significant changes in DDS, CES-D, and DES-SF scores. Conclusions: In a 15-month randomized controlled trial, AYA with T1D who participated in VPG reported significant improvements in HbA1c and CGM use. Peer interactions may support unmet needs of AYA with T1D from diverse and marginalized backgrounds. ClinicalTrials.gov Identifier: NCT03793673.

Greater Telehealth Use Results in Increased Visit Frequency and Lower Physician Related-Distress in Adolescents and Young Adults With Type 1 Diabetes.

BACKGROUND: Type one diabetes (T1D) management is challenging for adolescents and young adults (AYAs) due to physiological changes, psychosocial challenges, and increasing independence, resulting in increased diabetes distress and hemoglobin A1c (HbA1c). Alternative care models that engage AYAs and improve diabetes-related health outcomes are needed. METHODS: A 15-month study evaluated an adaptation of the Colorado Young Adults with T1D (CoYoT1) Care model. CoYoT1 Care includes person-centered care, virtual peer groups, and physician training delivered via telehealth. AYAs (aged 16-25 years) were partially randomized to CoYoT1 or standard care, delivered via telehealth or in-person. As the study was ending, the COVID-19 pandemic forced all AYAs to transition to primarily telehealth appointments. This secondary analysis compares changes in clinic attendance, T1D-related distress, HbA1c, and device use between those who attended more than 50% of diabetes clinic visits via telehealth and those who attended more sessions in-person throughout the course of the study. RESULTS: Out of 68 AYA participants, individuals (n = 39, 57%) who attended most (>50%) study visits by telehealth completed more diabetes care visits (3.3 visits) than those (n = 29, 43%) who primarily attended visits in-person (2.5 visits; P = .007). AYAs who primarily attended visits via telehealth maintained stable physician-related distress, while those who attended more in-person visits reported increases in physician-related distress (P = .03). CONCLUSIONS: Greater usage of telehealth improved AYA engagement with their care, resulting in increased clinic attendance and reduced physician-related diabetes distress. A person-centered care model delivered via telehealth effectively meets the needs of AYAs with T1D.

An addiction-based digital weight loss intervention: A multi-centre randomized controlled trial.

OBJECTIVE: This randomized clinical trial tested the effectiveness of an addiction-based digital weight-loss intervention, focusing on withdrawal/abstinence from self-identified problem foods, snacking and excessive amounts at meals, and discomfort displacement, with and without coaching, compared to an in-person, multi-disciplinary, care model among adolescents with obesity. We hypothesized that the digital intervention with coaching would yield greater weight loss and lower delivery burden than the standard clinical arm, and greater participant engagement than the digital arm without coaching. METHODS: Adolescents were randomized to app intervention, with or without coaching, or in-person multidisciplinary obesity intervention for 6 months. The primary outcome was change in %BMIp95 at weeks 12 and 24. A mixed-effects linear regression model was used to assess the association between change in %BMIp95 and intervention arm. We were also interested in assessing delivery burden, participant engagement and evaluating the relationships between weight change and demographic characteristics, mood, executive function and eating behaviours. RESULTS: All adolescents (n = 161; BMI ≥95th%, age 16 ± 2.5 year; 47% Hispanic, 65% female, 59% publicly insured) lost weight over 24-weeks (-1.29%, [-1.82, -0.76], p < 0.0001), with no significant weight loss difference between groups (p = 0.3). Girls lost more weight than boys, whereas binge eating behaviour at baseline was associated with increase in %BMIp95 when controlling for other covariates. There was no association between ethnicity, mood, timing of intervention in relation to the pandemic, or executive function and change in %BMIp95 . CONCLUSIONS: Contrary with our hypothesis, our results showed no difference in the change in BMI status between treatment arms. Since efficacy of this digital intervention was not inferior to in-person, multi-disciplinary care, this could offer a reasonable weight management option for clinicians, based on youth and family specific characteristics, such as accessibility, resources, and communication styles. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT035008353.

Lived experience of CamAPS FX closed loop system in youth with type 1 diabetes and their parents.

AIM: To examine changes in the lived experience of type 1 diabetes after use of hybrid closed loop (CL), including the CamAPS FX CL system. MATERIALS AND METHODS: The primary study was conducted as an open-label, single-period, randomized, parallel design contrasting CL versus insulin pump (with or without continuous glucose monitoring). Participants were asked to complete patient-reported outcomes before starting CL and 3 and 6 months later. Surveys assessed diabetes distress, hypoglycaemia concerns and quality of life. Qualitative focus group data were collected at the completion of the study. RESULTS: In this sample of 98 youth (age range 6-18, mean age 12.7 ± 2.8 years) and their parents, CL use was not associated with psychosocial benefits overall. However, the subgroup (n = 12) using the CamAPS FX system showed modest improvements in quality of life and parent distress, reinforced by both survey (p < .05) and focus group responses. There were no negative effects of CL use reported by study participants. CONCLUSIONS: Closed loop use via the CamAPS FX system was associated with modest improvements in aspects of the lived experience of managing type 1 diabetes in youth and their families. Further refinements of the system may optimize the user experience.

Cambridge hybrid closed-loop algorithm in children and adolescents with type 1 diabetes: a multicentre 6-month randomised controlled trial.

BACKGROUND: Closed-loop insulin delivery systems have the potential to address suboptimal glucose control in children and adolescents with type 1 diabetes. We compared safety and efficacy of the Cambridge hybrid closed-loop algorithm with usual care over 6 months in this population. METHODS: In a multicentre, multinational, parallel randomised controlled trial, participants aged 6-18 years using insulin pump therapy were recruited at seven UK and five US paediatric diabetes centres. Key inclusion criteria were diagnosis of type 1 diabetes for at least 12 months, insulin pump therapy for at least 3 months, and screening HbA1c levels between 53 and 86 mmol/mol (7·0-10·0%). Using block randomisation and central randomisation software, we randomly assigned participants to either closed-loop insulin delivery (closed-loop group) or to usual care with insulin pump therapy (control group) for 6 months. Randomisation was stratified at each centre by local baseline HbA1c. The Cambridge closed-loop algorithm running on a smartphone was used with either (1) a modified Medtronic 640G pump, Medtronic Guardian 3 sensor, and Medtronic prototype phone enclosure (FlorenceM configuration), or (2) a Sooil Dana RS pump and Dexcom G6 sensor (CamAPS FX configuration). The primary endpoint was change in HbA1c at 6 months combining data from both configurations. The primary analysis was done in all randomised patients (intention to treat). Trial registration ClinicalTrials.gov, NCT02925299. FINDINGS: Of 147 people initially screened, 133 participants (mean age 13·0 years [SD 2·8]; 57% female, 43% male) were randomly assigned to either the closed-loop group (n=65) or the control group (n=68). Mean baseline HbA1c was 8·2% (SD 0·7) in the closed-loop group and 8·3% (0·7) in the control group. At 6 months, HbA1c was lower in the closed-loop group than in the control group (between-group difference -3·5 mmol/mol (95% CI -6·5 to -0·5 [-0·32 percentage points, -0·59 to -0·04]; p=0·023). Closed-loop usage was low with FlorenceM due to failing phone enclosures (median 40% [IQR 26-53]), but consistently high with CamAPS FX (93% [88-96]), impacting efficacy. A total of 155 adverse events occurred after randomisation (67 in the closed-loop group, 88 in the control group), including seven severe hypoglycaemia events (four in the closed-loop group, three in the control group), two diabetic ketoacidosis events (both in the closed-loop group), and two non-treatment-related serious adverse events. There were 23 reportable hyperglycaemia events (11 in the closed-loop group, 12 in the control group), which did not meet criteria for diabetic ketoacidosis. INTERPRETATION: The Cambridge hybrid closed-loop algorithm had an acceptable safety profile, and improved glycaemic control in children and adolescents with type 1 diabetes. To ensure optimal efficacy of the closed-loop system, usage needs to be consistently high, as demonstrated with CamAPS FX. FUNDING: National Institute of Diabetes and Digestive and Kidney Diseases.

Can a Behavioral Weight-Loss Intervention Change Adolescents' Food Addiction Severity?

Objective: This study examines changes in the Yale Food Addiction Scale symptom count over a 24-week, weight-loss mobile Health (mHealth) intervention incorporating elements of addiction medicine. Methods: Adolescents (n = 117) with obesity (15.5 ± 1.3 years; 66% Hispanic) were randomized to the following: (1) mHealth intervention (AppAlone), (2) mHealth intervention+coaching (AppCoach), or (3) in-person intervention (Control). A multivariate mixed Poisson regression model was used to evaluate changes in symptom counts across intervention arms after adjusting for sex, age, depressive symptomatology, stress, and executive function. Results: After the intervention, 57% of adolescents showed a decrease in symptom count (median change: -0.3 [0 to -1.5]), with a significant change by intervention arm in the intention-to-treat analysis (p = 0.045). There was a positive linear relationship between change in symptom count and change in depressive symptomatology (p < 0.01) and stress (p < 0.01), with no association with change in weight (p = 0.3). Discussion: Both mHealth and in-person obesity interventions seemed to confer benefits in food addiction symptomatology associated with change in mood and stress. Clinical Trial Registration number: NCT035008353.

Use of continuous glucose monitoring in obesity research: A scoping review.

BACKGROUND: This scoping review provides a timely synthesis of the use of continuous glucose monitoring in obesity research with considerations to adherence to continuous glucose monitor devices and metrics most frequently reported. METHODS: This scoping review was conducted adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist. Eligible studies (n = 31) evaluated continuous glucose monitor use in research on participants, of all ages, with overweight or obesity. RESULTS: Reviewed studies varied in duration from one to 84 days (mean: 8.74 d, SD 15.2, range 1-84 d) with 889 participants total (range: 11-118 participants). Across all studies, the mean percent continuous glucose monitor wear time (actual/intended wear time in days) was 92% (numerator - mean: 266.1 d, SD: 452, range: 9-1596 d/denominator - mean: 271.6 d, SD: 451.5, range: 9-1596 d). Continuous glucose monitoring was utilized to provide biofeedback (n = 2, 6%), monitor dietary adherence (n = 2, 6%), and assess glycemic variability (n = 29, 93%). The most common variability metrics reported were standard deviation (n = 19, 62%), area under the curve (n = 12, 39%), and glycemic range (n = 12, 39%). CONCLUSIONS: Available evidence suggests that continuous glucose monitoring is a well-tolerated and versatile tool for obesity research in pediatric and adult patients. Future investigation is needed to substantiate the feasibility and utility of continuous glucose monitors in obesity research and maximize comparability across studies.

Executive Functioning, Depressive Symptoms, and Intervention Engagement in a Sample of Adolescents Enrolled in a Weight Management Program.

Purpose: This study examines how baseline demographics, psychosocial characteristics, and intervention delivery predict engagement among adolescents with overweight and obesity seeking treatment. Methods: Data originates from a multisite randomized control trial evaluating the efficacy of an app-based weight loss intervention, compared with standard in-clinic model in adolescents with overweight and obesity. Participants were randomized to one of the three arms: (1) AppCoach, (2) AppAlone, or (3) Control. Demographic, executive functioning (EF), and depression questionnaires were completed at baseline. Percent engagement was compared within and between groups defined by demographics and depressive symptoms. Quantile regression was used to evaluate the association between age and EF on percent engagement. Results: Baseline demographics were not associated with engagement within or between groups. Neither baseline self-reported depressive symptoms (p = 0.244) nor deficits in EF (p = 0.34) were predictors of engagement. Univariate analysis found that the control arm had the highest engagement (83%) compared with AppCoach (63.5%) and AppAlone (22.5%, p = 0.02). Hispanic ethnicity was predictive of higher engagement in the control arm (p = 0.02). On multivariate quartile regression no other baseline characteristics were significant predictors of engagement. Conclusion: Baseline demographics and individual psychosocial characteristics were not related to engagement in this cohort. The intervention arm that required parental involvement resulted in the greatest engagement suggesting that family involvement may overshadow individual behavioral phenotype and thus promote better engagement. Further investigation is needed to understand how program delivery can be leveraged to optimize treatment engagement and outcomes in adolescence. Clinical Trial Registration number: NCT03500835.

Team clinic: Expansion of a multidisciplinary care model for adolescents with type 1 diabetes.

BACKGROUND: Adolescent and young adults (AYA) with Type 1 Diabetes (T1D) experience more difficulty with glycemic control than patients in all other age groups. The shared medical appointment (SMA) model has been effective in multiple healthcare populations, but the feasibility and effectiveness of SMA in AYA patients with T1D is unclear. METHODS: This research leverages the team's multidisciplinary expertise to develop an engaging intervention toolkit and test the implementation of the Team Clinic care model for the treatment of T1D among middle school adolescents in a large urban children's hospital serving an economically, racially and ethnically diverse population. In Phase 1, the team will manualize the Team Clinic care model into an engaging, age-appropriate educational and intervention toolkit. In Phase 2, the team will conduct a randomized clinical trial to test the feasibility and usability of the toolkit from the provider perspective (team member satisfaction; clinical efficiency; compliance with American Diabetes Association, American Association of Diabetes Educators, and California Children's Services standards; and payor-level cost data) and the preliminary efficacy of the intervention toolkit on patient- and family-level outcomes (attendance, acceptability/satisfaction with care, patient-level cost data, diabetes outcomes, diabetes family conflict, diabetes distress, and depression). DISCUSSION: AYA patients with T1D often receive care in clinics and institutions with limited resources and time. This research tests the feasibility and efficacy of an innovative and potentially cost-effective SMA model to address the unique needs of underserved populations, while meeting national and state clinical standards. Trial registration The study is registered with ClinicalTrials.gov (Protocol Record: NCT04190368).

Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial.

Importance: Continuous glucose monitoring (CGM) provides real-time assessment of glucose levels and may be beneficial in reducing hypoglycemia in older adults with type 1 diabetes. Objective: To determine whether CGM is effective in reducing hypoglycemia compared with standard blood glucose monitoring (BGM) in older adults with type 1 diabetes. Design, Setting, and Participants: Randomized clinical trial conducted at 22 endocrinology practices in the United States among 203 adults at least 60 years of age with type 1 diabetes. Interventions: Participants were randomly assigned in a 1:1 ratio to use CGM (n = 103) or standard BGM (n = 100). Main Outcomes and Measures: The primary outcome was CGM-measured percentage of time that sensor glucose values were less than 70 mg/dL during 6 months of follow-up. There were 31 prespecified secondary outcomes, including additional CGM metrics for hypoglycemia, hyperglycemia, and glucose control; hemoglobin A1c (HbA1c); and cognition and patient-reported outcomes, with adjustment for multiple comparisons to control for false-discovery rate. Results: Of the 203 participants (median age, 68 [interquartile range {IQR}, 65-71] years; median type 1 diabetes duration, 36 [IQR, 25-48] years; 52% female; 53% insulin pump use; mean HbA1c, 7.5% [SD, 0.9%]), 83% used CGM at least 6 days per week during month 6. Median time with glucose levels less than 70 mg/dL was 5.1% (73 minutes per day) at baseline and 2.7% (39 minutes per day) during follow-up in the CGM group vs 4.7% (68 minutes per day) and 4.9% (70 minutes per day), respectively, in the standard BGM group (adjusted treatment difference, -1.9% (-27 minutes per day); 95% CI, -2.8% to -1.1% [-40 to -16 minutes per day]; P <.001). Of the 31 prespecified secondary end points, there were statistically significant differences for all 9 CGM metrics, 6 of 7 HbA1c outcomes, and none of the 15 cognitive and patient-reported outcomes. Mean HbA1c decreased in the CGM group compared with the standard BGM group (adjusted group difference, -0.3%; 95% CI, -0.4% to -0.1%; P <.001). The most commonly reported adverse events using CGM and standard BGM, respectively, were severe hypoglycemia (1 and 10), fractures (5 and 1), falls (4 and 3), and emergency department visits (6 and 8). Conclusions and Relevance: Among adults aged 60 years or older with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in hypoglycemia over 6 months. Further research is needed to understand the long-term clinical benefit. Trial Registration: ClinicalTrials.gov Identifier: NCT03240432.

Impact of early initiation of antihypertensive medications for patients with hypertension or elevated blood pressure.

OBJECTIVES: The 2017 American College of Cardiology/American Heart Association High Blood Pressure Guidelines lowered high blood pressure (BP) threshold, recommending earlier treatment to prevent cardiovascular disease. This study estimated the impact of initiating early antihypertensive medications on the risk of acute myocardial infarction (AMI), stroke, death, and on healthcare costs in patients potentially qualifying for antihypertensive treatment under the 2017 guidelines. METHODS: High-risk patients qualifying for antihypertensive medications under the 2017 guidelines were identified using Optum data. Patients with a diagnosis of elevated BP were also assumed eligible for hypertension treatment under the new guidelines. Patients were defined to have initiated early treatment if they initiated treatment before experiencing a cardiovascular event postdiagnosis. RESULTS: A total of 916 633 patients met eligibility requirements and all other study inclusion criteria. Of those, 66% initiated treatment during 2007-2016. Initiating early antihypertensive treatment decreased the likelihood of having AMI by 59%, stroke by 60% and death by 9%. Patients with only an 'elevated BP' diagnosis experienced reduced risk of stroke once they initiated medications. Treatment reduced the risk of AMI or stroke for patients with diabetes, chronic renal disease and obesity and also significantly lowered all-cause healthcare costs in the first postindex year. CONCLUSION: Initiating antihypertensive medications before experiencing a cardiovascular disease-related clinical event was associated with reduced risk of AMI, stroke and death for all hypertensive patients identified in the new guidelines. However, early treatment had a significantly smaller effect for patients with only 'elevated' BP, who experienced just a lower risk of stroke once treated.

Primary Prevention Using Cholesterol-Lowering Medications in Patients Meeting New Treatment Guidelines: A Retrospective Cohort Analysis.

BACKGROUND: The American College of Cardiology and American Heart Association (ACC/AHA) issued new cholesterol treatment guidelines in 2013. Two of the groups designated for primary prevention were analyzed: patients with a low-density lipoprotein cholesterol (LDL-C) level ≥ 190 mg per dL and diabetic patients aged 40-75 years. OBJECTIVE: To estimate the effects of primary prevention as specified in the 2013 guidelines on cardiovascular event risk and cost. METHODS: Primary prevention patients were identified using laboratory and diagnostic data for Humana members from 2007 to 2013. Potential study patients were classified into 3 risk groups: elevated LDL-C, diabetes, and elevated LDL-C and diabetes. Patients receiving cholesterol-lowering medications before their index date were excluded. Eligible patients were divided into 2 treatment groups: (1) primary prevention patients who initiated treatment before experiencing any cardiovascular disease (CVD)-related event, and (2) patients who either did not initiate treatment until after experiencing a CVD event or never initiated treatment. The associations between initiating cholesterol-lowering medications for primary prevention and the risk for acute myocardial infarction, stroke, coronary angioplasty, or coronary artery bypass graft surgery were estimated using Cox proportional hazards models. The effect of primary prevention on health care costs was estimated using generalized linear models. RESULTS: 91,066 patients met study selection criteria. Primary prevention rates were the lowest in diabetic patients (35%), who were newly designated for treatment in the 2013 guidelines. Primary prevention rates were higher for patients designated for treatment under earlier guidelines: 65% for patients with elevated LDL-C and 78% for the combined LDL-C and diabetes group. Primary prevention treatment was associated with significant reductions in cardiovascular event risk (up to 37%) and lower total all-cause costs (by $673) in the first post-index year. CONCLUSIONS: Initiating cholesterol-lowering medications for primary prevention, as specified in the ACC/AHA 2013 guidelines, for patients with high LDL-C and diabetes is associated with reduced CVD event risks and lower health care costs. DISCLOSURES: No outside funding supported this study. Han received fellowship support from the Pharmaceutical Research and Manufacturers Association Foundation (PhRMA) during the conduct of this study. Dougherty is employed by PhRMA. The authors have nothing to disclose.

Comparative treatment effectiveness of direct acting antiviral regimens for hepatitis C: Data from the Veterans administration.

BACKGROUND AND AIMS: Data addressing real world effectiveness of direct acting antiviral agents in hepatitis C infected patients are now emerging. This study compared the sustained virologic response rates achieved 12 weeks post-treatment in patients treated with three such agents by the Veterans Health Administration. METHODS: A retrospective cohort study was conducted using patients who terminated treatment by July 1, 2015. Data were retrieved from the Veterans Health Administration electronic medical records system. Patients were included if sufficient viral load laboratory data were available to determine sustained virologic response. Applying an intention to treat approach and logistic regression analysis, the sustained virologic response rates achieved were compared across drug regimens. RESULTS: A total of 11 464 patients met study selection criteria. Without controlling for other risk factors, sustained virologic response at least 12 weeks post treatment was achieved in 92% of ledipasvir/ sofosbuvir, 86% of ombitasvir/paritaprevir/ritonavir/dasabuvir, and 83% of simeprevir/sofosbuvir patients. After adjusting for patient characteristics, simeprevir/sofosbuvir (93.3%) and ledipasvir/sofosbuvir (96.2%) patients were statistically more likely than ombitasvir/paritaprevir/ritonavir/dasabuvir (91.8%) patients to demonstrate sustained virologic response. Human immunodeficiency virus, hepatitis B infection, diabetes, obesity, previous treatment history and augmentation therapy using ribavirin did not impact sustained virologic response rates. Sustained virologic response rates were lower for patients under age 65, with cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, indications of fibrosis, or a non-genotype 1 infection. Women and Caucasian patients were more likely to achieve a sustained virologic response. CONCLUSIONS: All three direct acting antiviral regimens appear highly effective in achieving sustained virologic response.

Measuring Care Continuity: A Comparison of Claims-based Methods.

BACKGROUND: Assessing care continuity is important in evaluating the impact of health care reform and changes to health care delivery. Multiple measures of care continuity have been developed for use with claims data. OBJECTIVE: This study examined whether alternative continuity measures provide distinct assessments of coordination within predefined episodes of care. RESEARCH DESIGN AND SUBJECTS: This was a retrospective cohort study using 2008-2009 claims files for a national 5% sample of beneficiaries with congestive heart failure, chronic obstructive pulmonary disease, and diabetes mellitus. MEASURES: Correlations among 4 measures of care continuity-the Bice-Boxerman Continuity of Care Index, Herfindahl Index, usual provider of care, and Sequential Continuity of Care Index-were derived at the provider- and practice-levels. RESULTS: Across the 3 conditions, results on 4 claims-based care coordination measures were highly correlated at the provider-level (Pearson correlation coefficient r=0.87-0.98) and practice-level (r=0.75-0.98). Correlation of the results was also high for the same measures between the provider- and practice-levels (r=0.65-0.92). CONCLUSIONS: Claims-based care continuity measures are all highly correlated with one another within episodes of care.

The Impact of Delayed Hepatitis C Viral Load Suppression on Patient Risk: Historical Evidence from the Veterans Administration.

BACKGROUND: The high cost of new hepatitis C (HCV) treatments has resulted in "watchful waiting" strategies being developed to safely delay treatment, which will in turn delay viral load suppression (VLS). OBJECTIVE: To document if delayed VLS adversely impacted patient risk for adverse events and death. METHODS: 187,860 patients were selected from the Veterans Administration's (VA) clinical registry (CCR), a longitudinal compilation of electronic medical records (EMR) data for 1999-2010. Inclusion criteria required at least 6 months of CCR/EMR data prior to their HCV diagnosis and sufficient data post-diagnosis to calculate one or more FIB-4 scores. Primary outcome measures were time-to-death and time-to-a composite of liver-related clinical events. Cox proportional hazards models were estimated separately using three critical FIB-4 levels to define early and late viral response. RESULTS: Achieving an undetectable viral load before the patient's FIB-4 level exceed pre-specified critical values (1.00, 1.45 and 3.25) effectively reduced the risk of an adverse clinical events by 33-35% and death by 21-26%. However, achieving VLS after FIB-4 exceeds 3.25 significantly reduced the benefit of viral response. CONCLUSIONS: Delaying VLS until FIB-4 >3.25 reduces the benefits of VLS in reducing patient risk.

Continuity and the costs of care for chronic disease.

IMPORTANCE: Better continuity of care is expected to improve patient outcomes and reduce health care costs, but patterns of use, costs, and clinical complications associated with the current patterns of care continuity have not been quantified. OBJECTIVE: To measure the association between care continuity, costs, and rates of hospitalizations, emergency department visits, and complications for Medicare beneficiaries with chronic disease. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study of insurance claims data for a 5% sample of Medicare beneficiaries experiencing a 12-month episode of care for congestive heart failure (CHF, n = 53,488), chronic obstructive pulmonary disease (COPD, n = 76,520), or type 2 diabetes mellitus (DM, n = 166,654) in 2008 and 2009. MAIN OUTCOMES AND MEASURES: Hospitalizations, emergency department visits, complications, and costs of care associated with the Bice-Boxerman continuity of care (COC) index, a measure of the outpatient COC related to conditions of interest. RESULTS: The mean (SD) COC index was 0.55 (0.31) for CHF, 0.60 (0.34) for COPD, and 0.50 (0.32) for DM. After multivariable adjustment, higher levels of continuity were associated with lower odds of inpatient hospitalization (odds ratios for a 0.1-unit increase in COC were 0.94 [95% CI, 0.93-0.95] for CHF, 0.95 [0.94-0.96] for COPD, and 0.95 [0.95-0.96] for DM), lower odds of emergency department visits (0.92 [0.91-0.92] for CHF, 0.93 [0.92-0.93] for COPD, and 0.94 [0.93-0.94] for DM), and lower odds of complications (odds ratio range, 0.92-0.96 across the 3 complication types and 3 conditions; all P < .001). For every 0.1-unit increase in the COC index, episode costs of care were 4.7% lower for CHF (95% CI, 4.4%-5.0%), 6.3% lower for COPD (6.0%-6.5%), and 5.1% lower for DM (5.0%-5.2%) in adjusted analyses. CONCLUSIONS AND RELEVANCE: Modest differences in care continuity for Medicare beneficiaries are associated with sizable differences in costs, use, and complications.

Systematic review of strategies to manage and allocate scarce resources during mass casualty events.

STUDY OBJECTIVE: Efficient management and allocation of scarce medical resources can improve outcomes for victims of mass casualty events. However, the effectiveness of specific strategies has never been systematically reviewed. We analyze published evidence on strategies to optimize the management and allocation of scarce resources across a wide range of mass casualty event contexts and study designs. METHODS: Our literature search included MEDLINE, Scopus, EMBASE, Cumulative Index to Nursing and Allied Health Literature, Global Health, Web of Science, and the Cochrane Database of Systematic Reviews, from 1990 through late 2011. We also searched the gray literature, using the New York Academy of Medicine's Grey Literature Report and key Web sites. We included both English- and foreign-language articles. We included studies that evaluated strategies used in actual mass casualty events or tested through drills, exercises, or computer simulations. We excluded studies that lacked a comparison group or did not report quantitative outcomes. Data extraction, quality assessment, and strength of evidence ratings were conducted by a single researcher and reviewed by a second; discrepancies were reconciled by the 2 reviewers. Because of heterogeneity in outcome measures, we qualitatively synthesized findings within categories of strategies. RESULTS: From 5,716 potentially relevant citations, 74 studies met inclusion criteria. Strategies included reducing demand for health care services (18 studies), optimizing use of existing resources (50), augmenting existing resources (5), implementing crisis standards of care (5), and multiple categories (4). The evidence was sufficient to form conclusions on 2 strategies, although the strength of evidence was rated as low. First, as a strategy to reduce demand for health care services, points of dispensing can be used to efficiently distribute biological countermeasures after a bioterrorism attack or influenza pandemic, and their organization influences speed of distribution. Second, as a strategy to optimize use of existing resources, commonly used field triage systems do not perform consistently during actual mass casualty events. The number of high-quality studies addressing other strategies was insufficient to support conclusions about their effectiveness because of differences in study context, comparison groups, and outcome measures. Our literature search may have missed key resource management and allocation strategies because of their extreme heterogeneity. Interrater reliability was not assessed for quality assessments or strength of evidence ratings. Publication bias is likely, given the large number of studies reporting positive findings. CONCLUSION: The current evidence base is inadequate to inform providers and policymakers about the most effective strategies for managing or allocating scarce resources during mass casualty events. Consensus on methodological standards that encompass a range of study designs is needed to guide future research and strengthen the evidence base. Evidentiary standards should be developed to promote consensus interpretations of the evidence supporting individual strategies.