Decision Support and Behavioral Health for Reducing High-Dose Opioids in Comorbid Chronic Pain, Depression and Anxiety: Stepped-Wedge Cluster Randomized Trial.

BACKGROUND: High prevalence of depression or anxiety with opioid use for chronic pain complicates co-management and may influence prescribing behaviors. OBJECTIVE: Compare clinical effectiveness of electronic medical record clinical decision support (EMR-CDS) versus additional behavioral health (BH) care management for reducing rates of high-dose opioid prescriptions. DESIGN: Type 2 effectiveness-implementation hybrid stepped-wedge cluster randomized trial in 35 primary care clinics within a health system in LA, USA. PARTICIPANTS: Patients aged 18+ receiving chronic opioid therapy for non-cancer pain with depression or anxiety and matched controls. INTERVENTION: EMR-CDS included opioid risk mitigation procedures. BH care included cognitive behavioral therapy; depression or anxiety medication adjustments; and case management. MAIN MEASURES: Outcomes of interest included difference-in-difference (DID) estimate of changes in probability for prescribing high-dose morphine equivalent daily dose (MEDD ≥50 mg/day and MEDD ≥90), average MEDD, and rates of hospitalization, emergency department use, and opioid risk mitigation. KEY RESULTS: Most participants were female with 3+ pain syndromes. Data analysis included 632 patients. Absolute risk differences for MEDD≥50 and ≥90 decreased post-index compared to pre-index (DID of absolute risk difference [95%CI]: -0.036 [-0.089, 0.016] and -0.029 [-0.060, 0.002], respectively). However, these differences were not statistically significant. The average MEDD decreased at a higher rate for the BH group compared to EMR-CDS only (DID rate ratio [95%CI]: 0.85 [0.77, 0.93]). There were no changes in hospitalization and emergency department utilization. The BH group had higher probabilities of new specialty referrals and prescriptions for naloxone and antidepressants. CONCLUSIONS: Incorporation of a multidisciplinary behavioral health care team into primary care did not decrease high-dose prescribing; however, it improved adherence to clinical guideline recommendations for managing chronic opioid therapy for non-cancer pain. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT03889418.

Maternal Health Legislation Enacted in Three Southeastern States in the United States Between 2018-2023: Policy Surveillance.

Background: Maternal mortality and morbidity rates in the Southeastern states of the US are among the highest in the nation. Arkansas, Mississippi, and Louisiana are ranked first, second and fifth, respectively, in maternal mortality. This retrospective policy surveillance systematically documents legislation enacted to address maternal health disparities and ameliorate maternal health. Methods: The Maternal and Child Health Legislative Database of the National Conference of State Legislators was searched for all legislation relating to maternal health in Arkansas, Louisiana, and Mississippi between 2018-2023. Two reviewers independently identified the laws passed by year and state and cross-checked to verify results. The legislative screening process is documented on a modified PRISMA flow diagram. Data extracted included the specific maternal health population targeted, the general health area addressed by the bill, and the directive of the bill. Results: 126 pieces of legislation were identified using the database (41 AR, 12 MS, and 73 LA). There were no duplicates identified; 2 laws were identified outside of the database (1 AR, 1 MS). All 128 legislation titles and summaries were screened and laws pertaining to issues other than maternal health were excluded (28 AR, 9 MS, and 48 LA). 43 full text bills were retrieved and reviewed in their entirety to assess eligibility for inclusion. 40 pieces of legislation were included (11 AR, 4 MS, and 25 LA) in this policy surveillance. Discussion: Louisiana enacted the most laws targeting and addressing maternal health, while Mississippi enacted the least. The legislation enacted addresses a broad range of health aspects, such as maternal mental health, incarcerated pregnant population reproductive health, and postpartum Medicaid coverage extension. Together with the task forces, committees, and study commissions created, the legislation enacted has the potential to address current inequities and improve maternal health outcomes in this vulnerable population by increasing access to and/or utilization of care, extending duration and/or type of evidence-based care available, and decreasing racial disparities in maternal health with the eventual goal of rooting out preventable morbidity and mortality.

Cost-effectiveness analysis of a digital diabetes-prevention programme versus an in-person diabetes-prevention programme in people with prediabetes in the United States.

AIM: To assess the cost-effectiveness of a digital diabetes prevention programme (d-DPP) compared with a diabetes prevention programme (DPP) for preventing type 2 diabetes (T2D) in individuals with prediabetes in the United States. METHODS: A Markov cohort model was constructed, simulating a 10-year period starting at the age of 45 years, with a societal and healthcare sector perspective. The effectiveness of the d-DPP intervention was evaluated using a meta-analysis, with that of the DPP as the comparator. The initial cycle represented the treatment period, and transition probabilities for the post-treatment period were derived from a long-term lifestyle intervention meta-analysis. The onset of T2D complications was estimated using microsimulation. Quality-adjusted life years (QALYs) were calculated based on health utility measured by short form (SF)-12 scores, and a willingness-to-pay threshold of $100 000 per QALY gained was applied. RESULTS: The d-DPP intervention resulted in cost savings of $3,672 from a societal perspective and $2,990 from a healthcare sector perspective and a gain of 0.08 QALYs compared with the DPP. The dropout rate was identified as a significant factor influencing the results. Probabilistic sensitivity analysis showed that the d-DPP intervention was preferred in 85.8% in the societal perspective and 85.2% in the healthcare sector perspective. CONCLUSIONS: The d-DPP is a cost-effective alternative to in-person lifestyle interventions for preventing the development of T2D among individuals with prediabetes in the United States.

Renal function as an effect modifier of intensive glucose control in delaying cognitive function decline among individuals with type 2 diabetes: A revisit to the ACCORD MIND trial.

AIM: Dysglycaemia accelerates cognitive decline. Intensive glucose control may help delay or prevent cognitive function decline (CFD). We aimed to determine how patient characteristics influence the effect of intensive glucose control [glycated haemoglobin (HbA1c) <6.0%] on delaying CFD in people with type 2 diabetes. RESEARCH DESIGN AND METHODS: In this post-hoc analysis of 2977 type 2 diabetes participants from the ACCORD MIND trial, we applied the causal forest and causal tree algorithms to identify the effect modifier of intensive glucose control in delaying CFD from 68 variables (demographics, disease history, medications, vitals and baseline biomarkers). The exposure was intensive versus standard glucose control (HbA1c <6.0% vs. 7.0%-7.9%). The main outcome was cognitive function changes from baseline to the 40th month follow-up, which were evaluated using the digit symbol substitution test, Rey auditory verbal learning test, mini-mental state examination and Stroop test. We used Cohen's d, a measure of standardized difference, to quantify the effect size of intensive glucose control on delaying CFD. RESULTS: Among all the baseline characteristics, renal function was the most significant effect modifier. Participants with urinary albumin levels <0.4 mg/dl [absolute function change (AFC): 0.51 in mini-mental state examination, 95% confidence interval (CI): 0.04, 0.98, Cohen's d: 0.25] had slower CFD with intensive glucose control. Patients with preserved renal function (estimated glomerular filtration rate between 60 and 90 ml/min/1.73 m2) were associated with small benefits (AFC: 1.28 in Stroop, 95% CI: 0.28, 2.27, Cohen's d: 0.12) when undergoing intensive glucose control. Conversely, participants with an estimated glomerular filtration rate <60 ml/min/1.73 m2 (AFC: -0.57 in the Rey auditory verbal learning test, 95% CI: -1.09, -0.05, Cohen's d: -0.30) exhibited faster CFD when undergoing intensive glucose control. Participants who were <60 years old showed a significant benefit from intensive glucose control in delaying CFD (AFC: 1.08 in the digit symbol substitution test, 95% CI: 0.06, 2.10, Cohen's d: 0.13). All p < .05. CONCLUSIONS: Our findings linked renal function with the benefits of intensive glucose control in delaying CFD, informing personalized HbA1c goals for those with diabetes and at risk of CFD.

Glucagon-Like Peptide-1 Receptor Agonists and Risk for Suicidal Ideation and Behaviors in U.S. Older Adults With Type 2 Diabetes : A Target Trial Emulation Study.

BACKGROUND: A major concern has recently emerged about a potential link between glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and increased risk for suicidal ideation and behaviors based on International Classification of Diseases codes. OBJECTIVE: To investigate the association between GLP-1 RAs, compared with sodium-glucose cotransporter-2 inhibitors (SGLT2is) or dipeptidyl peptidase-4 inhibitors (DPP4is), and risk for suicidal ideation and behaviors in older adults with type 2 diabetes (T2D). DESIGN: Two target trial emulation studies comparing propensity score (PS)-matched cohorts for GLP-1 RAs versus SGLT2is and GLP-1 RAs versus DPP4is. SETTING: U.S. national Medicare administrative data from January 2017 to December 2020. PATIENTS: Older adults (≥66 years) with T2D; no record of suicidal ideation or behaviors; and a first prescription for a GLP-1 RA, SGLT2i, or DPP4i. MEASUREMENTS: The primary end point was a composite of suicidal ideation and behaviors. New GLP-1 RA users were matched 1:1 on PS to new users of an SGLT2i or DPP4i in each pairwise comparison. A Cox proportional hazards regression was used to estimate the hazard ratio (HR) and 95% CIs within matched groups. RESULTS: This study included 21 807 pairs of patients treated with a GLP-1 RA versus an SGLT2i and 21 402 pairs of patients treated with a GLP-1 RA versus a DPP4i. The HR of suicidal ideation and behaviors associated with GLP-1 RAs relative to SGLT2is was 1.07 (95% CI, 0.80 to 1.45; rate difference, 0.16 [CI, -0.53 to 0.86] per 1000 person-years); the HR relative to DPP4is was 0.94 (CI, 0.71 to 1.24; rate difference, -0.18 [CI, -0.92 to 0.57] per 1000 person-years). LIMITATIONS: Low event rate; imprecise estimates; unmeasured confounders, such as body mass index; and potential misclassification of outcomes. CONCLUSION: Among Medicare beneficiaries with T2D, this study found no clear increased risk for suicidal ideation and behaviors with GLP-1 RAs, although estimates were imprecise and a modest adverse risk could not be ruled out. PRIMARY FUNDING SOURCE: American Foundation for Pharmaceutical Education, Pharmaceutical Research and Manufacturers of America Foundation, National Institute on Aging, and National Institute of Diabetes and Digestive and Kidney Diseases.

An exploratory analysis of the cost-effectiveness of insulin glargine 300 units/mL versus insulin glargine 100 units/mL over a lifetime horizon using the BRAVO diabetes model.

BACKGROUND: This analysis assessed the cost-effectiveness of insulin glargine 300 units/mL (Gla-300) versus insulin glargine 100 units/mL (Gla-100) in insulin-naïve adults with type 2 diabetes (T2D) inadequately controlled with oral antidiabetic drugs (OADs). METHODS: Costs and outcomes for Gla-300 versus Gla-100 from a US healthcare payer perspective were assessed using the BRAVO diabetes model. Baseline clinical data were derived from EDITION-3, a 12-month randomized controlled trial comparing Gla-300 with Gla-100 in insulin-naïve adults with inadequately controlled T2D on OADs. Treatment costs were calculated based on doses observed in EDITION-3 and 2020 US net prices, while costs for complications were based on published literature. Lifetime costs ($US) and quality-adjusted life-years (QALYs) were predicted and used to calculate incremental cost-effectiveness ratio (ICER) estimates; extensive scenario and sensitivity analyses were conducted. RESULTS: Lifetime medical costs were estimated to be $353,441 and $352,858 for individuals receiving Gla-300 and Gla-100 respectively; insulin costs were $52,613 and $50,818. Gla-300 was associated with a gain of 8.97 QALYs and 21.12 life-years, while Gla-100 was associated with a gain of 8.89 QALYs and 21.07 life-years. This resulted in an ICER of $7522/QALY gained for Gla-300 versus Gla-100. Thus, Gla-300 was cost-effective versus Gla-100 based on a willingness-to-pay threshold of $50,000/QALY. Compared with Gla-100, Gla-300 provided a net monetary benefit of $3290. Scenario and sensitivity analyses confirmed the robustness of the base case. CONCLUSION: Gla-300 may be a cost-effective treatment option versus Gla-100 over a lifetime horizon for insulin-naïve people in the United States with T2D inadequately controlled on OADs.

Some patients with type 2 diabetes may benefit from intensive glycaemic and blood pressure control: A post-hoc machine learning analysis of ACCORD trial data.

AIM: The action to control cardiovascular risk in diabetes (ACCORD) trial showed a neutral average treatment effect of intensive blood glucose and blood pressure (BP) controls in preventing major adverse cardiovascular events (MACE) in individuals with type 2 diabetes. Yet, treatment effects across patient subgroups have not been well understood. We aimed to identify patient subgroups that might benefit from intensive glucose or BP controls for preventing MACE. MATERIALS AND METHODS: As a post-hoc analysis of the ACCORD trial, we included 10 251 individuals with type 2 diabetes. We applied causal forest and causal tree models to identify participant characteristics that modify the efficacy of intensive glucose or BP controls from 68 candidate variables (demographics, comorbidities, medications and biomarkers) at the baseline. The exposure was (a) intensive versus standard glucose control [glycated haemoglobin (HbA1c) <6.0% vs. 7.0%-7.9%], and (b) intensive versus standard BP control (systolic BP <120 vs. <140 mmHg). The primary outcome was MACE. RESULTS: Compared with standard glucose control, intensive one reduced MACE in those with baseline HbA1c <8.5% [relative risk (RR): 0.79, 95% confidence interval (CI): 0.67-0.93] and those with estimated glomerular filtration rate ≥106 ml/min/1.73 m2 (RR: 0.74, 95% CI: 0.55-0.99). Intensive BP control reduced MACE in those with normal high-density lipoprotein levels (women >55 mg/dl, men >45 mg/dl; RR: 0.51, 95% CI: 0.34-0.74). Risk reductions were not significant in other patient subgroups. CONCLUSIONS: Our findings suggest heterogeneous treatment effects of intensive glucose and BP control and could provide biomarkers for future clinical trials to identify more precise HbA1c and BP treatment goals for individualized medicine.

Effects of Non-Face-to-Face Chronic Care Management on Service Utilization and Outcomes Among US Medicare Beneficiaries with Diabetes.

BACKGROUND: Type 2 diabetes mellitus (T2DM) results in heavy economic and disease burdens in Louisiana. The Centers for Medicare and Medicaid Services has reimbursed non-face-to-face chronic care management (NFFCCM) for patients with two or more chronic conditions since 2015. OBJECTIVE: To assess the impacts of NFFCCM on healthcare utilization and health outcomes. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study included Medicare fee-for-service beneficiaries with T2DM and at least one additional chronic disease between 2014 and 2018. EXPOSURES: At least one record of NFFCCM Current Procedural Terminology codes. MAIN MEASURES: The health outcomes in the study included major adverse cardiovascular events (MACE), all-cause mortality, and heart failure. The monthly service utilization and continuity of care index for primary care were also included. The propensity score method was used to balance the baseline differences between the two groups. Weighted multivariate regression models were developed using propensity score weights to assess the impacts of NFFCCM on outcomes. KEY RESULTS: During the 5 years of study period, 8415 patients among the 118,643 Medicare beneficiaries received at least one NFFCCM. Patients receiving any NFFCCM had reduced healthcare utilization compared with patients not receiving NFFCCM, including 0.012 (95% CI - 0.014 to - 0.011; p < 0.001) fewer monthly hospital admissions, 0.017 (95% CI - 0.019 to - 0.016; p < 0.001) fewer monthly ED visits, and 0.399 (95% CI 0.375 to 0.423; p < 0.001) more monthly outpatient encounters. Patients receiving NFFCCM services had lower MACE event rates of 7.4% (95% CI 7.1 to 7.8%; p < 0.001), all-cause mortality rate of 7.8% (95% CI 7.4 to 8.1%; p < 0.001), and heart failure rate of 0.3% (95% CI 0.2 to 0.5%; p < 0.001), respectively. CONCLUSIONS AND RELEVANCE: These findings suggest that reimbursement for NFFCCM was associated with the shifting high-cost utilization to lower-cost primary health care settings among patients with diabetes in Louisiana.

5-Year simulation of diabetes-related complications in people treated with tirzepatide or semaglutide versus insulin glargine.

AIM: This study compared the 5-year incidence rate of macrovascular and microvascular complications for tirzepatide, semaglutide and insulin glargine in individuals with type 2 diabetes, using the Building, Relating, Assessing, and Validating Outcomes (BRAVO) diabetes simulation model. RESEARCH DESIGN AND METHODS: This study was a 5-year SURPASS-2 trial extrapolation, with an insulin glargine arm added as an additional comparator. The 1-year treatment effects of tirzepatide (5, 10 or 15 mg), semaglutide (1 mg) and insulin glargine on glycated haemoglobin, systolic blood pressure, low-density lipoprotein and body weights were obtained from the SUSTAIN-4 and SURPASS-2 trials. We used the BRAVO model to predict 5-year complications for each study arm under two scenarios: the 1-year treatment effects persisted (optimistic) or diminished to none in 5 years (conservative). RESULTS: When compared with insulin glargine, we projected a 5-year risk reduction in cardiovascular adverse events [rate ratio (RR) 0.64, 95% confidence interval (CI) 0.61-0.67] and microvascular composite (RR 0.67, 95% CI 0.64-0.70) with 15 mg tirzepatide, and 5-year risk reduction in cardiovascular adverse events (RR 0.75, 95% CI 0.72-0.79) and microvascular composite (RR 0.79, 95% CI 0.76-0.82) with semaglutide (1 mg) under an optimistic scenario. Lower doses of tirzepatide also had similar, albeit smaller benefits. Treatment effects for tirzepatide and semaglutide were smaller but still significantly higher than insulin glargine under a conservative scenario. The 5-year risk reduction in diabetes-related complication events and mortality for the 15 mg tirzepatide compared with insulin glargine ranged from 49% to 10% under an optimistic scenario, which was reduced by 17%-33% when a conservative scenario was assumed. CONCLUSION: With the use of the BRAVO diabetes model, tirzepatide and semaglutide exhibited potential to reduce the risk of macrovascular and microvascular complications among individuals with type 2 diabetes, compared with insulin glargine in a 5-year window. Based on the current modelling assumptions, tirzepatide (15 mg) may potentially outperform semaglutide (1 mg). While the BRAVO model offered insights, the long-term cardiovascular benefit of tirzepatide should be further validated in a prospective clinical trial.

Telehealth Use and Healthcare Utilization Among Individuals with Type 2 Diabetes During the COVID-19 Pandemic: Evidence From Louisiana Medicaid Claims.

INTRODUCTION: The impact of telehealth use on healthcare utilization is limited, especially among Medicaid beneficiaries with type 2 diabetes. Considering the rapid adoption of telehealth during the COVID-19 pandemic, this study examined associations between telehealth use and healthcare utilization among Medicaid beneficiaries with type 2 diabetes. METHODS: Using Louisiana Medicaid claims data from March 2019 to August 2021, the associations were examined using a difference-in-difference model with propensity score weighting. Demographic characteristics, baseline comorbidities and healthcare utilization, and zip code level environmental factors were included in the analysis. The monthly frequency of healthcare services, including in-person outpatient visits, inpatient visits, emergency department (ED) visits and hemoglobin A1C (HbA1C) tests, were measured as outcomes. Several sensitivity analyses were conducted across different subgroups. RESULTS: We included 48,992 beneficiaries with type 2 diabetes in the study of 27,340 beneficiaries in the telehealth group and 21,652 beneficiaries in the non-telehealth group. Of 1000 beneficiaries per month, the telehealth group had significantly more utilization compared to the non-telehealth group, with an increase of 195.049 in-person outpatient visits (95% CI: 166.169 to 223.929, p < 0.001), 3.816 inpatient visits (95% CI: 2.539 to 5.093, p < 0.001), 10.499 ED visits (95% CI: 7.287 to 13.712, p < 0.001) and 14.153 HbA1c tests (95% CI: 11.431 to 16.875, p < 0.001, respectively. Excluding beneficiaries who had ED or inpatient visits in the 30 days prior to receiving telehealth visits, overall ED visits significantly decreased for the telehealth group versus the non-telehealth group over time, by 9.456 visits (95% CI: - 12.356 to - 6.557, p < 0.001) per 1000 beneficiaries per month on average. CONCLUSION: The study found that telehealth was associated with a significant increase in healthcare utilization in general but has the potential to decrease ED and inpatient utilization for some groups among low-income populations with diabetes.

Optimizing Telehealth for Diabetes Management in the Deep South of the United States: Qualitative Study of Barriers and Facilitators on the Patient and Clinician Journey.

BACKGROUND: The Deep South of the United States, and Louisiana in particular, bears a greater burden of obesity, diabetes, and heart disease compared with other regions in the United States. Throughout the COVID-19 pandemic, there has been a substantial increase in telehealth visits for diabetes management to protect the safety of patients. Although there have been significant advancements in telehealth and chronic disease management, little is known about patient and provider perspectives on the challenges and benefits of telehealth visits among people living with diabetes and providers who care for patients with diabetes in Louisiana. OBJECTIVE: This study aimed to explore barriers, facilitators, challenges, and benefits to telehealth for patients with diabetes and health care providers as they transitioned from in-person to remote care during the early COVID-19 pandemic to understand potential optimization. METHODS: A total of 24 semistructured qualitative interviews were conducted with 18 patients living with diabetes and 6 clinicians who served patients with diabetes to explore their experiences and perceptions of telehealth services for diabetes care. Approximately half of the participants identified as Black or African American, half as White, and 75% as female. Interviews were recorded, transcribed, and coded by experienced qualitative researchers using inductive and deductive techniques. A narrative, descriptive approach to the patient and clinician journey framed the study, including the development of internal journey maps, and reflexive thematic analysis was applied to the transcripts, with special attention to barriers and facilitators. RESULTS: In total, 5 themes illustrated barriers and facilitators for participants: convenience, safety, and comfort are the benefits of telehealth for patients and clinicians; yet telehealth and in-person visits are valued differently; the convenience of telehealth may have a downside; technology acts as a double-edged sword; and managing expectations and efficiency of the visit experience was an important factor. Individual experiences varied in relation to several factors, including comfort level and access to technology, health system protocols for providing telemedicine, and level of diabetes control among patients. CONCLUSIONS: Recommendations for optimization include providing support to help guide and inform patients about what to expect and how to prepare for telehealth visits as well as allowing clinicians to schedule telehealth and in-person visits during discrete blocks of time to improve efficiency. Further research should address how hybrid models of telehealth and in-person care may differentially impact health outcomes for patients with diabetes, particularly for people with multiple chronic conditions in settings where access to technology and connectivity is not optimal.

Predictors of Telehealth Utilization and Subsequent Inpatient Stays and Emergency Visits During the COVID-19 Pandemic Among Patients with Type 2 Diabetes: Evidence from Louisiana.

Objective: To understand which types of Medicare patients with diabetes disproportionately used telehealth during the coronavirus disease 2019 pandemic and how their characteristics mediated their inpatient and emergency department (ED) utilization. Methods: Logistic regression analyses were used to measure the associations between patient characteristics and telehealth utilization using electronic health records among Medicare patients with diabetes (n = 31,654). Propensity score matching was used to examine the relative impact of telehealth use in conjunction with race, ethnicity, and age on inpatient and ED outcomes. Results: Telehealth was associated with age (75-84 vs. 65-74; odds ratio [OR] = 0.810, p < 0.01), gender (female: OR = 1.148, p < 0.01), and chronic diseases (e.g., lung disease: OR = 1.142; p < 0.01). Black patients using telehealth were less likely to visit the ED (estimate = -0.018; p = 0.08), whereas younger beneficiaries using telehealth were less likely to experience an inpatient stay (estimate = -0.017; p = 0.06). Conclusions: Telehealth expansion particularly benefited the clinically vulnerable but saw uneven use and uneven benefit along sociodemographic lines. Clinical Trial Registration Number: NCT03136471.

Telehealth use and its impact on clinical outcomes in patients with type 2 diabetes during the COVID-19 pandemic.

AIM: To evaluate the impact of telehealth use during the COVID-19 pandemic on glycaemic control and other clinical outcomes among patients with type 2 diabetes. METHODS: We used electronic health records from the Research Action for Health Network (REACHnet) database for patients with type 2 diabetes who had telehealth visits and those who only received in-person care during the pandemic. A quasi-experimental method of difference-in-difference with propensity-score weighting was implemented to mitigate selection bias and to control for observed factors related to telehealth use. Outcomes included glycated haemoglobin (HbA1c) and other clinical measures (low-density lipoprotein [LDL] cholesterol, blood pressure [BP], and body mass index [BMI]). RESULTS: Patients using telehealth had better HbA1c control compared to those receiving in-person care only during the pandemic. The telehealth group saw a significant average decrease of 0.146% (95% confidence interval [CI] -0.178% to -0.1145%; P < 0.001) in HbA1c levels over time. The proportion of patients with average HbA1c levels >7% decreased by 0.023 (95% CI -0.034, -0.011; P < 0.001) in the treatment group relative to the comparison group. Modest benefits in the control of LDL cholesterol levels, diastolic BP, and BMI were found in association with telehealth use. CONCLUSIONS: Our findings suggest that telehealth services contributed to better glycaemic control and management of other clinical outcomes in patients with type 2 diabetes during the pandemic. Factors unmeasured in this study would need to be further explored to better understand the impact of telehealth.

Mortality among US veterans with a physician-documented diagnosis of pyruvate kinase deficiency.

Real-world studies of pyruvate kinase (PK) deficiency and estimates of mortality are lacking. This retrospective observational study aimed to identify patients with PK deficiency and compare their overall survival (OS) to that of a matched cohort without PK deficiency. Patients with ≥1 diagnosis code related to PK deficiency were selected from the US Veterans Health Administration (VHA) database (01/1995-07/2019); patients with a physician-documented diagnosis were included (PK deficiency cohort; index: date of first diagnosis code related to PK deficiency). Patients in the PK deficiency cohort were matched 1:5 to patients from the general VHA population (non-PK deficiency cohort; index: random visit date during match's index year). OS from index was compared between the two cohorts. Eighteen patients in the PK deficiency cohort were matched to 90 individuals in the non-PK deficiency cohort (both cohorts: mean age 57 years, 94% males; median follow-up 6.0 and 8.0 years, respectively). At follow-up, patients in the non-PK deficiency cohort had significantly longer OS than the PK deficiency cohort (median OS: 17.1 vs. 10.9 years; hazard ratio: 2.3; p = 0.0306). During their first-year post-index, 75% and 40% of the PK deficiency cohort had laboratory-confirmed anemia and iron overload, respectively. Among patients who died, cause of death was highly heterogeneous. These results highlight the increased risk of mortality and substantial clinical burden among patients with PK deficiency. While the intrinsic characteristics of the VHA database may limit the generalizability of the results, this is the first real-world study to characterize mortality in patients with PK deficiency.

Economic burden of adult patients with ß-thalassaemia major in mainland China.

BACKGROUND: ß-thalassaemia major poses a substantial economic burden, especially in adults. We aimed to estimate the economic burden of adult patients with ß-thalassaemia major from a societal perspective using the real-world data. According to the clinical guideline, we also estimated the annual medical costs for patients with the same body weight and calculated the lifetime medical costs over 50 years in mainland China. METHODS: This was a retrospective cross-sectional study. An online survey with snowball sampling covering seven provinces was conducted. We extracted patient demographics, caregiver demographics, disease and therapy information, caring burden, and costs for adult patients diagnosed with ß-thalassaemia major and their primary caregivers. In the real world, we estimated the annual direct medical cost, direct nonmedical cost, and indirect cost. In addition, we calculated the annual direct medical cost and lifetime direct medical cost by weight with discounted and undiscounted rates according to the clinical guideline. RESULTS: Direct medical costs was the main driver of total cost, with blood transfusion and iron chelation therapy as the most expensive components of direct medical cost. In addition, adult patients with ß-thalassaemia major weighing 56 kg were associated with an increase of $2,764 in the annual direct medical cost using the real-world data. The undiscounted and discounted (5% discount rate) total lifetime treatment costs were $518,871 and $163,441, respectively. CONCLUSIONS: Patients with ß-thalassaemia major often encounter a substantial economic burden in mainland China. Efforts must be made to help policymakers develop effective strategies to reduce the burden and pevalence of thalassaemia.

Non-face-to-face care management and service utilization in patients with diabetes.

OBJECTIVES: In 2015, CMS implemented reimbursement for non-face-to-face chronic care management (NFFCCM) for beneficiaries with multiple chronic conditions, including diabetes. This analysis estimated the association between NFFCCM and utilization of inpatient, outpatient, and emergency services. STUDY DESIGN: We implemented a doubly robust estimator using propensity score matching in a regression context to compare eligible patients who used NFFCCM (n = 282) with eligible patients who did not use NFFCCM (n = 26,759). METHODS: We tested 4 definitions of treatment: having any NFFCCM encounters and having 1 NFFCCM encounter per month, per 2 months, and per 3 months. Two-tailed statistical inference testing was conducted at the 5% level. We examined the utilization differences among patients with diabetes 65 years and older using merged electronic health records for 4 health systems in Louisiana from the Research Action for Health Network database in 2013 through 2018. RESULTS: We found NFFCCM was associated with increased utilization of care in the outpatient setting by 0.056 visits per month (95% CI, 0.027-0.086) and with lower utilization in the inpatient setting (-0.024 visits per month; 95% CI, -0.038 to -0.010) and in the emergency department setting (-0.017 visits per month; 95% CI, -0.031 to -0.003). Alternative specifications of treatment showed similar associations. CONCLUSIONS: CMS implementation of reimbursement codes for NFFCCM, and subsequent utilization of that reimbursement by health systems, was associated with a shift in patient utilization from high-cost settings (inpatient and emergency department) to a lower-cost setting (outpatient office).

Valuing Chinese medicine quality of life-11 dimensions (CQ-11D) health states using a discrete choice experiment with survival duration (DCETTO).

OBJECTIVE: To explore generating a health utility value set for the Chinese medicine Quality of life-11 Dimensions (CQ-11D), a utility instrument designed to assess patients' health status while receiving TCM treatment, among the Chinese population. METHODS: The study was designed to recruit at least 2400 respondents across mainland China to complete one-to-one, face-to-face interviews. Respondents completed ten discrete choice experiment with survival duration (DCETTO) tasks during interviews. The conditional logit models were used to generate the health utility value set for the CQ-11D using the DCETTO data. RESULTS: A total of 2,586 respondents were invited to participate in the survey and 2498 valid interviews were completed (a completion rate of 96.60%). The modified conditional logit model with combing logically inconsistent levels was ultimately selected to construct the health utility value set for the CQ-11D instrument. The range of the measurable health utility value was -0.868 ~ 1. CONCLUSION: The study provides the first utility value set for the CQ-11D among the Chinese population. The CQ-11D and corresponding utility value set can be used to measure the health utility values of patients undergoing traditional Chinese medicine interventions, and further facilitate relevant cost-utility analyses. The application of the CQ-11D can support TCM resource allocation in China.

Successes and challenges of China's health care reform: a four-decade perspective spanning 1985-2023.

Chinese health system remains the crucial one for understanding the wider healthcare landscape across the Global South and in particular the leading Emerging Markets. Purpose of our observation was to understand the inner dynamics of mainland Chinese health reforms adopting a lengthy time horizon. We have analysed the public reports and seminal evidence on Chinese of multiple waves of national health reforms taking place since 1980s in terms of medical care and pharmaceuticals provision and financing. Chinese international trade with ASEAN nations and wider South-East Asia is accelerating its growth after the recovery of trade routes. In terms of health sector this means that global demand and supply of medical goods, services and pharmaceuticals remains largely driven by Chinese domestic developments. Furthermore, Chinese domestic manufacturing and sales of decent quality medical devices and services have grown exponentially. Some temporary pitfalls and increasing in rural-urban inequalities in equity of access and affordability of medical care and pharmaceuticals did take place. Despite these difficulties to generate a balanced development strategy for the largest global market, this is a clear path upwards. Further upcoming improvements expanding health insurance coverage are in strong demand for certain layers of the society. Domestic bottleneck weaknesses yet remain manufacturing, import and market penetration of cutting-edge pharmaceuticals such as monoclonal antibodies and targeted oncology agents. Yet some of these obstacles are likely to be overcome in foreseeable future with the adoption of responsible strategies by governmental agencies in health care arena.

External Validation of the BRAVO Diabetes Model Using the EXSCEL Clinical Trial Data.

INTRODUCTION: We have developed the Building, Relating, Assessing, and Validating Outcomes (BRAVO) diabetes model, an individual-level, discrete-time microsimulation model specifically designed for type 2 diabetes (T2D) management. This study aims to validate the model's performance when populated exclusively with a fully de-identified dataset to ensure its applicability in secure settings. METHODS: Patient-level data from the Exenatide Study of Cardiovascular Event Lowering (EXSCEL) trial were fully de-identified by removing all identifiable information and masking numerical values (e.g., age, body mass index) within ranges to minimize the risk of re-identification. To populate the simulation, we imputed the masked numerical values using data from the National Health and Nutrition Examination Survey (NHANES). We applied the BRAVO model to the baseline data to predict 7-year study outcomes for the EXSCEL trial and assessed its discrimination power and calibration using C-statistics and Brier scores. RESULTS: The model demonstrated acceptable discrimination and calibration in predicting the first occurrence of non-fatal myocardial infarction, non-fatal stroke, heart failure, revascularization, and all-cause mortality. Even with the fully deidentified data from the EXSCEL trial primarily presented in ranges rather than specific values, the BRAVO model exhibited robust prediction performance for diabetes complications and mortality. CONCLUSIONS: This study demonstrates the feasibility of using the BRAVO model in settings where only fully de-identified patient-level data are available.

A prediction model on incident chronic kidney disease among individuals with type 2 diabetes in the United States.

AIM: Early identification of incident chronic kidney disease (CKD) in individuals with diabetes may help improve patients' clinical outcomes. This study aimed to develop a prediction equation for incident CKD among people with type 2 diabetes (T2D). MATERIALS AND METHODS: A time-varying Cox model was applied to data from the ACCORD trial to predict the risk of incident CKD. A list of candidate variables was chosen based on literature reviews and experts' consultations, including demographic characteristics, vitals, laboratory results, medical history, drug use and health care utilization. Model performance was evaluated. Decomposition analysis was conducted, and external validation was performed. RESULTS: In total, 6006 patients with diabetes free of CKD were included, with a median follow-up of 3 years and 2257 events. The risk model included age at T2D diagnosed, smoking status, body mass index, high-density lipoprotein, very-low-density lipoprotein, alanine aminotransferase, estimated glomerular filtration rate, urine albumin-creatinine ratio, hypoglycaemia, retinopathy, congestive heart failure, coronary heart disease history, antihyperlipidaemic drug use, antihypertensive drug use and hospitalization. The urine albumin-creatinine ratio, estimated glomerular filtration rate and congestive heart failure were the top three factors that contributed most to the incident CKD prediction. The model showed acceptable discrimination [C-statistic: 0.772 (95% CI 0.767-0.805)] and calibration [Brier Score: 0.0504 (95% CI 0.0477-0.0531)] in the Harmony Outcomes Trial. CONCLUSION: Incident CKD prediction among individuals with T2D was developed and validated for use in decision support of CKD prevention.