The evaluation and management of patients with LDL-C ≥ 190 mg/dL in a large health care system.
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ABSTRACT: Objectives
Patients with severe hyperlipidemia (low-density lipoprotein-cholesterol (LDL-C) ≥190 mg/dL) have a significantly increased risk of cardiovascular disease (CVD) and are more likely to have familial hypercholesterolemia (FH). We sought to determine how often health care providers recognize the implications of and adjust therapy for an LDL-C ≥190 mg/dL.Methods
We conducted a retrospective review of patients with an LDL-C measurement in the medical record of a large health care system between November 2015 and June 2016. Patients were restricted to those with LDL-C ≥190 mg/dL and without secondary causes of dyslipidemia, with sensitivity analyses for those with LDL-C ≥220 mg/dL.Results
Of 27,963 patients, 227 had LDL-C ≥190 mg/dL. Only 21% were on a statin at the time of LDL-C measurement. More than 90% had a follow-up clinic visit, but 41% had no change in treatment. FH was only included in the differential for 14%. The presence/absence of a family history of dyslipidemia, myocardial infarction, and premature CVD were documented in 26%, 29%, and 31%. Only 20.7% and 22.1% had documentation of the presence or absence of tendinous xanthomas or corneal arcus, respectively. Among those without prior specialist care (cardiologist or endocrinologist), only 13% were referred. These measures were only slightly better for those with LDL-C ≥220 mg/dL.Conclusion
In a large health care system, the possibility of FH was rarely acknowledged in those with residual LDL-C ≥190 mg/dL, few were referred to specialists, and therapeutic adjustments were suboptimal. Additional efforts are required to understand barriers to improving the evaluation and management of patients with LDL-C ≥190 mg/dL.
SUBMITTER: Jackson CL
PROVIDER: S-EPMC8315478 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Even with statins and other lipid-lowering therapy (LLT), many patients with heterozygous familial hypercholesterolemia (heFH) continue to have elevated low-density lipoprotein cholesterol (LDL-C) levels. ODYSSEY HIGH FH (NCT01617655) assessed the efficacy and safety of alirocumab, a proprotein convertase subtilisin/kexin type 9 monoclonal antibody, versus placebo in patients with heFH and LDL-C ? 160 mg/dl despite maximally tolerated statin ± other LLT.Patients were randomized to subcutaneous alirocumab 150 mg or placebo every 2 weeks (Q2W) for 78 weeks. The primary endpoint was percent change in LDL-C from baseline to week 24.Mean baseline LDL-C levels were 196.3 mg/dl in the alirocumab (n = 71) and 201.0 mg/dl in the placebo groups (n = 35). Significant mean (standard error [SE]) reductions in LDL-C from baseline to week 24 were observed with alirocumab (-45.7 [3.5] %) versus placebo (-6.6 [4.9] %), a difference of -39.1 (6.0) % (P < 0.0001). Absolute mean (SE) LDL-C levels were reduced from baseline by 90.8 (6.7) mg/dl with alirocumab at week 24, with reductions maintained to week 78. Treatment-emergent adverse events were generally comparable between groups. Injection-site reactions were more frequent in the alirocumab group (8.3 %) versus placebo (5.7 %); most were mild in severity and did not result in study medication discontinuation.In patients with heFH and very high LDL-C baseline levels despite maximally tolerated statin ± other LLT, alirocumab 150 mg Q2W demonstrated significant reductions in LDL-C levels with 41 % of patients achieving predefined LDL-C goals. Alirocumab was generally well tolerated.
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Project description:Background: Studies of closed-loop control (CLC) in patients with type 1 diabetes (T1D) consistently demonstrate improvements in glycemic control as measured by increased time-in-range (TIR) 70-180 mg/dL. However, clinical predictors of TIR in users of CLC systems are needed. Materials and Methods: We analyzed data from 100 children aged 6-13 years with T1D using the Tandem Control-IQ CLC system during a randomized trial or subsequent extension phase. Continuous glucose monitor data were collected at baseline and during 12-16 weeks of CLC use. Participants were stratified into quartiles of TIR on CLC to compare clinical characteristics. Results: TIR for those in the first, second, third, and fourth quartiles was 54%, 65%, 71%, and 78%, respectively. Lower baseline TIR was associated with lower TIR on CLC (r = 0.69, P < 0.001). However, lower baseline TIR was also associated with greater improvement in TIR on CLC (r = -0.81, P < 0.001). During CLC, participants in the highest versus lowest TIR-quartile administered more user-initiated boluses daily (8.5 ± 2.8 vs. 5.8 ± 2.6, P < 0.001) and received fewer automated boluses (3.5 ± 1.0 vs. 6.0 ± 1.6, P < 0.001). Participants in the lowest (vs. the highest) TIR-quartile received more insulin per body weight (1.13 ± 0.27 vs. 0.87 ± 0.20 U/kg/d, P = 0.008). However, in a multivariate model adjusting for baseline TIR, user-initiated boluses and insulin-per-body-weight were no longer significant. Conclusions: Higher baseline TIR is the strongest predictor of TIR on CLC in children with T1D. However, lower baseline TIR is associated with the greatest improvement in TIR. As with open-loop systems, user engagement is important for optimal glycemic control.
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Project description:BACKGROUND:Patients with low-density lipoprotein cholesterol (LDL-C) ?190 mg/dL are at high risk of atherosclerotic cardiovascular disease events. Treatment guidelines recommend intensive treatment in these patients. Variation in the use of lipid-lowering therapies (LLTs) in these patients in a national sample of cardiology practices is not known. METHODS AND RESULTS:Using data from the American College of Cardiology National Cardiovascular Data Registry-Practice Innovation and Clinical Excellence registry, we assessed the proportion of patients with LDL-C ?190 mg/dL (n=49?447) receiving statin, high-intensity statin, LLT associated with ?50% LDL-C lowering, ezetimibe, or a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor between January 2013 and December 2016. We assessed practice-level rates and variation in LLT use using median rate ratio (MRR) adjusted for patient and practice characteristics. MRRs represent the likelihood that 2 random practices would differ in treatment of identical patients with LDL-C ?190 mg/dL. The proportion of patients receiving a statin, high-intensity statin, LLT associated with ?50% LDL-C reduction, ezetimibe, or PCSK9 inhibitor were 58.5%, 31.9%, 34.6%, 8.5%, and 1.5%, respectively. Median practice-level rates and adjusted MRR for statin (56% [interquartile range, 47.3%-64.8%]; MRR, 1.20 [95% confidence interval [CI], 1.17-1.23]), high-intensity statin (30.2% [interquartile range, 12.1%-41.1%]; MRR, 2.31 [95% CI, 2.12-2.51]), LLT with ?50% LDL-C lowering (31.8% [interquartile range, 15.3%-45.5%]; MRR, 2.12 [95% CI, 1.95-2.28]), ezetimibe (5.8% [interquartile range, 2.8%-9.8%]; MRR, 2.42 [95% CI, 2.21-2.63]), and PCSK9 inhibitors (0.16% [interquartile range, 0%-1.9%]; MRR, 2.38 [95% CI, 2.04-2.72]) indicated significant gaps and >200% variation in receipt of several of these medications for patients across practices. Among those without concomitant atherosclerotic cardiovascular disease, even larger treatment gaps were noted (proportion of patients on a statin, high-intensity statin, LLT with ?50% LDL-C reduction, ezetimibe, or PCSK9 inhibitor were 50.8%, 25.25%, 26.8%, 4.9%, and 0.74%, respectively). CONCLUSIONS:Evidence-based LLT use remains low among patients with elevated LDL-C with significant variation in care. System-level interventions are needed to address these gaps and reduce variation in care of these high-risk patients.
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Project description:Objective: We aimed to evaluate the fidelity and estimate the effectiveness of a novel health system employee weight-management program. Methods: Employees participating in a weight loss program consisting of self-monitoring, health coaching and meal replacements optionally enrolled in the 12-month study. Longitudinal, single-arm analyses were conducted evaluating change over time via survey, claims and programmatic data. Token participation incentives were offered for survey completion. Results: In total, 140 participants enrolled (51.2 ± 9.8 years; BMI = 33.2 ± 6.5 kg/m2; 89.3% female). During 1 year, participants attended 18.0 ± 12.2 coaching appointments and self-reported significant improvements in weight (-8.2 ± 10.5% body weight), BMI (-3.9 ± 6.5 kg/m2), fruit/vegetable intake, home food preparation, added sugar, sugar sweetened beverages and life satisfaction (all p < 0.05). No significant changes were reported in physical activity, weight-related social support, self-efficacy or healthcare utilization (all p > 0.05). Conclusions: The findings from this evaluation establish implementation fidelity. Clinically significant self-reported weight loss, coupled with improvements in many weight-related behaviors, suggest the program is an effective weight management tool when offered as an employee well-being program.
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Project description:ImportanceThere are few population-based studies addressing trends in neonatal intensive care unit (NICU) admission and NICU patient-days, especially in the subpopulation that, by gestational age (GA) and birth weight (BW), might otherwise be able to stay in the room with their mothers.ObjectiveTo describe population-based trends in NICU admissions, NICU patient-days, readmissions, and mortality in the birth population of a large integrated health care system.Design, setting, and participantsThis cohort study was conducted using data extracted from electronic medical records at Kaiser Permanente Southern California (KPSC) health care system. Participants included all women who gave birth at KPSC hospitals and their newborns from January 1, 2010, through December 31, 2018. Data extraction was limited to data entry fields whose contents were either numbers or fixed categorical choices. Rates of NICU admission, NICU patient-days, readmission rates, and mortality rates were measured in the total population, in newborns with GA 35 weeks or greater and BW 2000 g or more (high GA and BW group), and in the remaining newborns (low GA and BW group). Admissions to the NICU and NICU patient-days were risk adjusted with a machine learning model based on demographic and clinical characteristics before NICU admission. Changes in the trends were assessed with 2-sided correlated seasonal Mann-Kendall test. Data analysis was performed in August 2019.ExposuresAdmission to the NICU and NICU patient-days among the birth cohort.Main outcomes and measuresThe primary outcomes were NICU admission and NICU patient-days in the total neonatal population and GA and BW subgroups. The secondary outcomes were readmission and mortality rates.ResultsOver the study period there were 320 340 births (mean [SD] age of mothers, 30.1 [5.7] years; mean [SD] gestational age, 38.6 [1.97] weeks; mean [SD] birth weight, 3302 [573] g). The risk-adjusted NICU admission rate decreased from a mean of 14.5% (95% CI, 14.2%-14.7%) to 10.9% (95% CI, 10.7%-11.7%) (P for trend = .002); 92% of the change was associated with changes in the care of newborns in the high GA and BW group. The number of risk-adjusted NICU patient-days per birth decreased from a mean of 1.50 patient-days (95% CI, 1.43-1.54 patient-days) to 1.40 patient-days (95% CI, 1.36-1.48 patient-days) (P for trend = .03); 70% of the change was associated with newborns in the high GA and BW group. The unadjusted 30-day readmission rates and mortality rates did not change.Conclusions and relevanceAdmission rates to the NICU and numbers of NICU patient-days decreased over the study period without an increase in readmissions or mortality. The observed decrease was associated with the high GA and BW newborn population. How much of this decrease is attributable to intercurrent health care systemwide quality improvement initiatives would require further investigation. The remaining unexplained variation suggests that further changes are also possible.
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Project description:BackgroundHealth care practice relies on evidence-based decisions and needs the use of quality health care data. Health management information system (HMIS) is among the core elements of health system building blocks. In our study setting, there is a lack of adequate information on the quality of health information data. This study aimed at exploring the quality of health management information system data in terms of timeliness, completeness, and accuracy. The specific objectives were to evaluate the quality and use of the health management information system in Primary health care units of East Wollega zone, Ethiopia.MethodsA cross-sectional study was conducted from April to June 2016 on 316 health professionals/health information technicians. The sample was obtained by simple random sampling technique. Qualitative data were obtained from 16 purposefully selected key informants by Focus group discussion (FGD). We observed 50 selected health facilities using an observation checklist. We analyzed quantitative data by SPSS version 20 using descriptive and logistic regression analysis techniques. we applied a thematic analysis approach to analyze qualitative data.ResultsTimeliness of report, registration completeness, report completeness, and data accuracy level of the selected facilities were 70, 78.2, 86, and 48%, respectively. All results are below the expected national standards. Commonly reported reasons for the poor practice of data quality were; poor support of management, lack of accountability for the false report, poor supportive supervision, and lack of separate and responsible unit for health information management.ConclusionThe Health information management system is poorly coordinated at the primary health units. Accountability should be assured through continuous in-service training, supportive supervision, and concrete feedbacks. Electronic management of health information should be available in primary health care units.
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