Addendum. 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes-2022. Diabetes Care 2022;45(Suppl. 1):S144-S174.
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SUBMITTER: American Diabetes Association Professional Practice Committee
PROVIDER: S-EPMC9472485 | biostudies-literature | 2022 Sep
REPOSITORIES: biostudies-literature
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Addendum. 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes-2022. Diabetes Care 2022;45(Suppl. 1):S144-S174.
Diabetes care 20220901 9
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Project description:ObjectiveThe Diabetes Care Protocol (DCP), a multifaceted computerized decision support diabetes management intervention, reduces cardiovascular risk of type 2 diabetic patients. We performed a cost-effectiveness analysis of DCP from a Dutch health care perspective.Research design and methodsA cluster randomized trial provided data of DCP versus usual care. The 1-year follow-up patient data were extrapolated using a modified Dutch microsimulation diabetes model, computing individual lifetime health-related costs, and health effects. Incremental costs and effectiveness (quality-adjusted life-years [QALYs]) were estimated using multivariate generalized estimating equations to correct for practice-level clustering and confounding. Incremental cost-effectiveness ratios (ICERs) were calculated and cost-effectiveness acceptability curves were created. Stroke costs were calculated separately. Subgroup analyses examined patients with and without cardiovascular disease (CVD+ or CVD- patients, respectively).ResultsExcluding stroke, DCP patients lived longer (0.14 life-years, P = NS), experienced more QALYs (0.037, P = NS), and incurred higher total costs (euro 1,415, P = NS), resulting in an ICER of euro 38,243 per QALY gained. The likelihood of cost-effectiveness given a willingness-to-pay threshold of euro 20,000 per QALY gained is 30%. DCP had a more favorable effect on CVD+ patients (ICER = euro 14,814) than for CVD- patients (ICER = euro 121,285). Coronary heart disease costs were reduced (euro-587, P < 0.05).ConclusionsDCP reduces cardiovascular risk, resulting in only a slight improvement in QALYs, lower CVD costs, but higher total costs, with a high cost-effectiveness ratio. Cost-effective care can be achieved by focusing on cardiovascular risk factors in type 2 diabetic patients with a history of CVD.
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Project description:IntroductionHypertension and diabetes are leading causes of adult hospital admissions and mortality across health facilities in Ghana. Timely screening and diagnosis at primary health facilities are crucial to initiate treatment and avert complications. This study explored service availability and readiness of health systems for managing hypertension and diabetes in selected district hospitals in Ghana.MethodsWe adapted the World Health Organization (WHO) Service Availability and Readiness Assessment (SARA) tool to assess hypertension and diabetes management practices between June and July 2022 in four district hospitals in Ghana. Domain scores of service readiness were calculated based on the mean score of tracer item availability, transformed into percentages, and stratified by facility ownership. The mean readiness index was based on basic clinical logistics and equipment, diagnostic capacity, and first-line medications. Service availability was based on the core health workforce and specific service arrangements for the management of hypertension and diabetes. Facilities were considered 'ready' for services at a cut-off readiness score of 70%.ResultsAll facilities (n = 4, 100%) provided hypertension and diabetes services, with a median of 118 nurses (IQR 103-140) and 5 physicians (IQR 2-8). Only one facility (n = 1, 25%) had conducted cardiovascular disease training in the past year. All basic equipment (weighing scales, stethoscopes, glucometers, and blood pressure monitors) were available in all 4 facilities. Antihypertensives, including ACE inhibitors (n = 3; 75%), calcium channel blockers (n = 4; 100%), centrally acting agents (n = 4; 100%), and thiazides (n = 4; 100%), were available, as were antidiabetic medications like metformin (n = 4; 100%) and insulin (n = 2; 50%). Only two facilities (n = 2; 50%) could perform the required test (Hemoglobin A1c, full blood count, renal function, serum creatinine, blood urea, electrolytes, and blood lipid tests). Overall readiness score was 75.5%, essential medications (83.5%), basic equipment (78%), clinical guidelines for the management of cardiovascular disease management (75%), and diagnostic capacity (65.5%). Mission facilities had a higher readiness score (96%) and government facilities (55%).ConclusionFacilities demonstrated high readiness for basic hypertension and diabetes care, with higher availability of some essential medications and basic clinical logistics and equipment. Limited diagnostic capacity and cardiovascular disease training, highlight areas of improvement to strengthen hypertension and diabetes services in Ghana.
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Project description:BackgroundDrugs and high-risk medical devices are increasingly likely to receive Food and Drug Administration (FDA) approval through expedited pathways, which has implications for informed treatment consent (i.e., consent in clinical practice).ObjectiveTo obtain expert opinion about the clinical and ethical implications of the increasing availability of new drugs and devices approved through expedited development and regulatory review pathways.DesignQualitative study using individual semi-structured videoconference interviews.ParticipantsNational leaders in medicine, ethics, and law (n=12) with expertise in medical product regulation, payor policymaking, bioethics, physician practice, patient advocacy, public health expertise/advocacy, clinical trials, the pharmaceutical and device industry, institutional review board oversight, and real-world evidence.Main measuresPrincipal themes in 3 domains: expedited regulatory pathways, physician and patient understanding of and reliance on FDA approval, and informed treatment consent.Key resultsRespondents pointed out that more common use of expedited pathways translates to increased reliance on surrogate measures, some with uncertain clinical significance. While expedited development and review can have advantages, participants expressed worry that physicians were unaware when medical products were expedited and did not communicate about uncertainties in knowledge about new drug or device approvals effectively with patients. Many participants felt that informed treatment consent discussions about new drugs or devices should include some explanations of expedited pathways and use of surrogate measures.ConclusionsExperts identified advantages of expediting development and of FDA flexibility in applying its standards to new drugs and medical devices, but highlighted concerns that patients may not be adequately informed about the risks of shorter review times or about uncertainties in the evidence that result. There is a need to identify approaches to ensure effective clinical use of drugs and devices when approved through expedited pathways.
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