Objective To ascertain the reliability of applying the WHO Cardiovascular Risk Management Package by non-physician health-care workers (NPHWs) in typical primary health-care settings. Methods Based on an a priori 80% agreement level between the NPHWs and the "expert" physicians (gold standard), 649 paired (matched) applications of the protocol were obtained for analysis using Kappa statistic and multivariate logit regression. Findings Results indicate over 80% agreement between raters, from moderate to perfect levels of agreement in almost all of the sections in the package. The odds of obtaining a difference between raters and a benchmark are not statistically significant. Conclusion Applying the WHO Cardiovascular Risk Management Package, NPHWs can be retrained to reliably and effectively assess and manage cardiovascular risks in primary health-care settings where there are no attending physicians. The package could be a useful tool for scaling up the management of cardiovascular diseases in primary health care. IntroductionChronic noncommunicable diseases, especially cardiovascular diseases, are a major and increasing cause of death and disability worldwide, and may have retarding effects on the economies of affected individuals, households and countries. 1,2 The epidemiological and economic effects of cardiovascular diseases (specifically stroke and heart diseases) and diabetes, are especially pervasive in low-and middle-income countries 1-3 where health systems are less likely to adequately respond to the challenges of the increasing burden. Socioeconomic barriers and inequalities in access to treatment, suboptimal staffing of health-care facilities and limited capacity for ancillary investigations that complement cardiovascular risk profiling are some of the common problems limiting these countries' control of chronic diseases, especially at the primary healthcare level. 4 This situation is worsened by the brain-drain syndrome 5-9 resulting in shortages of skilled workers.Can non-physician health-care workers assess and manage cardiovascular risk in primary care? 29 However, such risk profiling protocols lack universal applicability 11,13,14,[29][30][31][32][33][34][35][36][37][38][39][40][41][42] and may be of limited applicability in developing countries, whose populations were not sampled for the Framingham 31,32 and other studies. Uncritical adoption of such protocols may result in negative clinical and economic consequences. 43 To address the absence of a CVD risk profiling tool for developing countries, WHO in 2000 developed a package for the assessment and management of cardiovascular risk in low-resource settings. 44 The package, developed through consultations with experts from all WHO regions, was designed as an adaptable, cost-effective tool for systematic case management at all health-care levels, and consequently for scaling up countries' health systems. The expert panel based the design of the package on the graded evidence available.The package includes three scenarios that reflect commonl...
BACKGROUND Guidelines recommend nonstatin lipid-lowering agents in patients at very high risk for major adverse cardiovascular events (MACE) if low-density lipoprotein cholesterol (LDL-C) remains ≥70 mg/dL on maximum tolerated statin treatment. It is uncertain if this approach benefits patients with LDL-C near 70 mg/dL. Lipoprotein(a) levels may influence residual risk. OBJECTIVES In a post hoc analysis of the ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial, the authors evaluated the benefit of adding the proprotein subtilisin/kexin type 9 inhibitor alirocumab to optimized statin treatment in patients with LDL-C levels near 70 mg/dL. Effects were evaluated according to concurrent lipoprotein(a) levels. METHODS ODYSSEY Outcomes compared alirocumab with placebo in 18,924 patients with recent acute coronary syndromes receiving optimized statin treatment. In 4,351 patients (23.0%), screening or randomization LDL-C was <70 mg/dL (median 69.4 mg/dL; interquartile range: 64.3–74.0 mg/dL); in 14,573 patients (77.0%), both determinations were ≥70 mg/dL (median 94.0 mg/dL; interquartile range: 83.2–111.0 mg/dL). RESULTS In the lower LDL-C subgroup, MACE rates were 4.2 and 3.1 per 100 patient-years among placebo-treated patients with baseline lipoprotein(a) greater than or less than or equal to the median (13.7 mg/dL). Corresponding adjusted treatment hazard ratios were 0.68 (95% confidence interval [Cl]: 0.52–0.90) and 1.11 (95% Cl: 0.83–1.49), with treatment-lipoprotein(a) interaction on MACE ( P interaction = 0.017). In the higher LDL-C subgroup, MACE rates were 4.7 and 3.8 per 100 patient-years among placebo-treated patients with lipoprotein(a) >13.7 mg/dL or ≤13.7 mg/dL; corresponding adjusted treatment hazard ratios were 0.82 (95% Cl: 0.72–0.92) and 0.89 (95% Cl: 0.75–1.06), with P interaction = 0.43. CONCLUSIONS In patients with recent acute coronary syndromes and LDL-C near 70 mg/dL on optimized statin therapy, proprotein subtilisin/kexin type 9 inhibition provides incremental clinical benefit only when lipoprotein(a) concentration is at least mildly elevated. (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; NCT01663402 )
Background The COVID-19 pandemic has imposed an enormous burden on health care systems around the world. In the past, the administration of convalescent plasma of patients having recovered from SARS and severe influenza to patients actively having the disease showed promising effects on mortality and appeared safe. Whether or not this also holds true for the novel SARS-CoV-2 virus is currently unknown. Methods DAWn-Plasma is a multicentre nation-wide, randomized, open-label, phase II proof-of-concept clinical trial, evaluating the clinical efficacy and safety of the addition of convalescent plasma to the standard of care in patients hospitalized with COVID-19 in Belgium. Patients hospitalized with a confirmed diagnosis of COVID-19 are eligible when they are symptomatic (i.e. clinical or radiological signs) and have been diagnosed with COVID-19 in the 72 h before study inclusion through a PCR (nasal/nasopharyngeal swab or bronchoalveolar lavage) or a chest-CT scan showing features compatible with COVID-19 in the absence of an alternative diagnosis. Patients are randomized in a 2:1 ratio to either standard of care and convalescent plasma (active treatment group) or standard of care only. The active treatment group receives 2 units of 200 to 250 mL of convalescent plasma within 12 h after randomization, with a second administration of 2 units 24 to 36 h after ending the first administration. The trial aims to include 483 patients and will recruit from 25 centres across Belgium. The primary endpoint is the proportion of patients that require mechanical ventilation or have died at day 15. The main secondary endpoints are clinical status on day 15 and day 30 after randomization, as defined by the WHO Progression 10-point ordinal scale, and safety of the administration of convalescent plasma. Discussion This trial will either provide support or discourage the use of convalescent plasma as an early intervention for the treatment of hospitalized patients with COVID-19 infection. Trial registration ClinicalTrials.govNCT04429854. Registered on 12 June 2020 - Retrospectively registered.
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