Clinical trials update from the European Society of Cardiology meeting 2005: CARE-HF extension study, ESSENTIAL, CIBIS-III, S-ICD, ISSUE-2, STRIDE-2, SOFA, IMAGINE, PREAMI, SIRIUS-II and ACTIVE

This article provides information and a commentary on trials presented at the European Society of Cardiology meeting held in September 2005, relevant to the pathophysiology, prevention and treatment of heart failure. All reports should be considered as preliminary data, as analyses may change in the final publication. In the CARE-HF extension study, the benefits of cardiac resynchronisation therapy (CRT) observed in the original study were maintained over an increased follow-up period. A study of oral enoximone (25-50 mg t.i.d.) in advanced heart failure (ESSENTIAL) showed limited benefit compared to placebo. The CIBIS-III study showed that heart failure therapy could be safely initiated with bisoprolol followed by the addition of enalapril. A subcutaneous ICD system (S-ICD) showed potential as an alternative to a transvenous ICD. In the ISSUE-2 study, an implantable loop recorder was used to guide therapy in patients with recurrent syncope. The selective endothelin antagonist sitaxsentan improved 6-MWT and functional class in patients with pulmonary arterial hypertension in the STRIDE-2 study. In SOFA, fish oil had no beneficial effect on the incidence of life-threatening arrhythmias in patients with an ICD. In IMAGINE, quinapril showed no benefit when administered to patients following CABG. Perindopril reduced cardiac remodelling in post-MI patients with normal LV function in PREAMI. SIRIUS-II showed encouraging results for the use of intravenous ularitide in symptomatic decompensated chronic heart failure. The ACTIVE W study of warfarin versus aspirin plus clopidogrel in atrial fibrillation has been stopped due to superiority of warfarin.     

Health-Related Quality of Life

Abstract

Background: Motor neurone disease (MND) remains universally fatal despite the introduction of disease-modifying therapy in the form of the glutamate inhibitor, riluzole. Caring for people with MND presents enormous challenges, many of which are particular to the disease complex. An understanding of the carer burden is required in order to inform the delivery of palliative care to MND patients and their carers.

Aim: To explore the experiences and perceptions of carers and former carers of people with MND with emphasis on the later stages of the disease.

Participants and Methods: Focus groups were conducted with two groups of former carers and one group of current carers recruited through the Motor Neurone Disease Association of NSW. Recruitment continued until no new themes emerged. The discussions were taped, transcribed verbatim and content analysed.

Results: There was a clear thematic trajectory from diagnosis through to death and bereavement with ramifications evident for the delivery of palliative care. Unmet emotional needs and the unremitting and all-encompassing nature of care were emphasised, as was the importance of love in sustaining the carer.

Conclusions: The experience of caring for a person with MND has a lasting psychological impact which may outweigh the physical and financial costs of care. This relatively unexplored area of enquiry lacks adequate models on which to base quantitative investigation. This qualitative study provides a starting point for future research.     

Protocol for the development of consensus-based clinical case reporting guideline extension: CARE for acupuncture

BackgroundHealth research reporting guidelines for case reports (CARE - CAse REport) published in 2013 and 2017 have become a generally accepted standard for publishing case reports. The CARE guidelines represent an architectural framework for writing an evidence-based case report that can be customized as need for a specialty (or disease) if needed. We aim to develop a CARE guideline extension for acupuncture following the EQUATOR Network (Enhancing the QUAlity and Transparency Of health Research) and the 2010″Guidance for Developers of Health Research Reporting". We have established a group of international experts including; clinicians, researchers and methodologists. We performed a needs assessment based on a review of acupuncture case reports published in the indexed medical literature. The needs assessment will be followed by (1) a series of expert interviews to establish a draft, (2) a modified Delphi process, and (3) a consensus meeting. Following the consensus meeting we will pilot test the CARE draft before publishing the CARE extension for acupuncture.MethodsWe will develop the CARE extensions for acupuncture following recommendations of the EQUATOR Network and the 2010 "Guidance for Developers of Health Research Reporting". We will establish an international multidisciplinary group including clinical practitioners, acupuncturists, researchers of reporting guidelines on acupuncture, clinical epidemiologists and statisticians.We performed a needs assessment, reviewing published case reports using acupuncture as a therapeutic intervention from indexed medical journals (PubMed-PMC and Medline, Scopus, Embase, the Allied and Complementary Medicine Database (AMED), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Wan Fang database, Chinese BioMedicine database (CBM), China National Knowledge Infrastructure (CNKI), and VIP). In consultations with advisors we will develop a draft of potential items to be included in the CARE extension for acupuncture. Then we will conduct a modified Delphi process of at least three rounds, hold a face-to-face consensus meeting, pilot test and submit the CARE extension for acupuncture for publication.ConclusionThe development of a widely accepted CARE extension for acupuncture for case reports published in indexed medical journals. These guidelines will follow the EQUATOR Network recommendations and the 2010 "Guidance for Developers of Health Research Reporting".     

A Summary and Critical Assessment of the 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Disease Risk in Adults: Filling the Gaps

The American College of Cardiology/American Heart Association (ACC/AHA) Task Force on Practice Guidelines has recently released the new cholesterol treatment guideline. This update was based on a systematic review of the evidence and replaces the previous guidelines from 2002 that were widely accepted and implemented in clinical practice. The new cholesterol treatment guideline emphasizes matching the intensity of statin treatment to the level of atherosclerotic cardiovascular disease (ASCVD) risk and replaces the old paradigm of pursuing low-density lipoprotein cholesterol targets. The new guideline also emphasizes the primacy of the evidence base for statin therapy for ASCVD risk reduction and lists several patient groups that will not benefit from statin treatment despite their high cardiovascular risk, such as those with heart failure (New York Heart Association class II-IV) and patients undergoing hemodialysis. The guideline has been received with mixed reviews and significant controversy. Because of the evidence-based nature of the guideline, there is room for several questions and uncertainties on when and how to use lipid-lowering therapy in clinical practice. The goal of the Mayo Clinic Task Force in the assessment, interpretation, and expansion of the ACC/AHA cholesterol treatment guideline is to address gaps in information and some of the controversial aspects of the newly released cholesterol management guideline using additional sources of evidence and expert opinion as needed to guide clinicians on key aspects of ASCVD risk reduction.     

Flash双源CT智能最佳管电压技术在小儿中耳胆脂瘤面神经管裸露中的应用

目的 评价高分辨率CT(HRCT)智能最佳管电压技术(CARE kV技术)在中耳炎患儿颞骨检查中对降低辐射剂量和显示面神经管裸露的应用价值。方法 收集中耳炎患儿(2~4岁)176例;按就诊先后顺序分为A组88例,采用CARE kV技术行颞骨HRCT扫描,B组88例,常规颞骨HRCT扫描。比较两组中耳胆脂瘤、面神经管裸露、HRCT图像质量及辐射剂量情况,并进行统计学分析。结果 A、B两组中耳胆脂瘤发生率[59.09%(52/88)vs 64.77%(57/88)]差异无统计学意义(χ²=0.020,P=0.887)。术前HRCT诊断中耳胆脂瘤的准确率两组间差异无统计学意义[96.15%(50/52) vs 96.49%(55/57),χ²=0.199,P=0.639]。A、B两组术前HRCT诊断面神经管裸露发生率分别为29.54%(26/88)和31.82%(28/88),术中观察面神经管裸露发生率分别为27.27%(24/88)和28.41%(25/88),两组间术前HRCT诊断及术中观察面神经管裸露发生率差异均无统计学意义(χ²=0.978、χ²=0.440,P均>0.05)。鼓室段面神经管裸露发生率最高(25/49,51.02%),迷路段最低(5/49,10.20%)。两组中,前膝段面神经管裸露长度术前HRCT与术中测量值差异有统计学意义(P均<0.05),其余各段差异均无统计学意义(P均>0.05)。两组间CT平均值、噪声(SD)、SNR、CNR差异无统计学意义(P均>0.05)。两组间剂量长度乘积(DLP)、有效剂量(ED)差异均有统计学意义(P=0.039、0.028)。结论 小儿颞骨HRCT智能最佳管电压技术能准确诊断面神经裸露,同时保证图像质量并有效降低辐射剂量。     

Cost effectiveness of cardiac resynchronization therapy in the Nordic region: an analysis based on the CARE-HF trial

BACKGROUND: The aim of this study was to investigate the cost-effectiveness of cardiac resynchronization therapy (CRT) in Denmark, Finland and Sweden. The analysis was based on the CARE-HF trial, a randomised clinical trial investigating the efficacy of adding CRT (n=409) to optimal pharmacological treatment (n=404) in patients with moderate to severe heart failure with markers of cardiac dyssynchrony. The average follow-up time was 29.4 months. METHODS: The health effects were measured in terms of quality-adjusted life years (QALYs) gained. Data on health care resource consumption from CARE-HF was combined with costs for CRT implantation and hospitalisation from university hospitals in Denmark, Finland and Sweden. Calculations were based on patients' expected life time. The expected device lifetime (6 years) was used for CRT, and no additional gains in clinical effects were assumed after the 6 years. RESULTS: The cost-effectiveness ratio per QALY gained was euro 4800 in Denmark, euro 3600 in Finland and euro 6700 in Sweden. The 95% confidence intervals for the cost per QALY gained varied between a lower limit of euro 1169 in Finland to an upper limit of euro 17,482 in Sweden. These values were all below the threshold for being cost-effective in Denmark, Finland and Sweden. CONCLUSIONS: The study indicates that CRT is a cost-effective treatment in Scandinavian health care settings compared to traditional pharmacological therapy and can therefore be recommended for routine use in patients with moderate to severe heart failure and markers of dyssynchrony.     

Preliminary investigation of adherence to antiretroviral therapy among children in Aminu Kano Teaching Hospital,Nigeria

Treatment of HIV with highly active antiretroviral therapy (HAART) has resulted in declining morbidity and mortality rates from HIV-associated diseases, but concerns regarding access and adherence are growing. To determine the adherence level and the reasons for non-adhering to antiretroviral therapy (ART) among children attending the clinic for infectious diseases at Aminu Kano Teaching Hospital in Nigeria, a cross-sectional study using the selfreport tool was carried out among 40 children with HIV infection who had been on ART for at least six months. Thirty-two patients (80%) were 95% or more adherent to their medications. The most common reasons for nonadherence were running out of medicines and the inability to purchase more due to financial constraints; other barriers were non-availability and inaccessibility to medications. Eighty-five percent of the paediatric patients took their medications at the same time everyday, and scheduled appointments were kept by 87.5%. The social class of the patients did not significantly affect adherence level. The level of adherence to ART was comparable to levels reported from other developing and developed countries. The cost of ART, and availability and accessibility to medications were the most significant barriers to adherence. Expanded access to subsidised antiretroviral drugs should improve adherence — and consequently treatment outcomes — for patients receiving this treatment in resource-poor settings.     

High-sensitivity C-reactive protein and atherosclerotic disease: From improved risk prediction to risk-guided therapy

There is compelling experimental and clinical evidence suggesting a crucial role for inflammation in the initiation and also the progression of atherosclerosis. Numerous biomarkers involved at various levels of the inflammation cascade have been shown to be associated with adverse cardiovascular outcomes. Yet, to date, it is not clear whether inflammation simply accompanies the atherosclerotic process or represents a major driver. Among all blood biomarkers, C-reactive protein (CRP), the classical acute phase reactant that can be measured with high-sensitivity (hs) assays seems to be the most promising candidate. It has already found its way into the guidelines in primary prevention. Hs-CRP can also be used to identify a high-risk group for recurrent events in patients with manifest atherosclerosis. Several post hoc analyses of large-scale randomized clinical trials testing various statins have indicated that, besides low density lipoprotein (LDL) cholesterol, hs-CRP levels might also further aid in tailoring statin treatment. The large JUPITER trial has prospectively confirmed these findings in primary prevention in patients with elevated hs-CRP but normal LDL cholesterol levels. Still, statin therapy is not a specific anti-inflammatory regime acting on the inflammation cascade. Thus, to directly test the inflammation hypothesis, a novel, more proximally located cytokine-based approach is needed. Canakinumab, a fully human monoclonal antibody against interleukin-1β, might represent a promising compound in this regard and provide a proof of concept. If successful, this may become a novel strategy to treat high-risk patients with stable atherosclerotic disease to prevent recurrent events on top of standard medical care.     

A Chinese version of the Caring Assessment Report Evaluation Q-sort scale for measuring patients' perception on nurses' caring behaviours: Reliability and validity assessment

A reliable and valid instrument for understanding patients' perceptions of nurses' caring behaviour as well as assessing the quality of nursing care is necessary. The purpose of this study was to assess the reliability and validity of a Chinese version of the Caring Assessment Report Evaluation Q-sort (CARE-Q) Scale for the measurement of patients' perceptions of nurses' caring behaviours. The study sample comprised 250 patients from a medical centre in central Taiwan. Content validity, construct validity, internal consistency and stability reliability were assessed. The Content Validity Index of the Chinese version of CARE-Q was 0.90. Cronbach's alpha indicated good internal consistency reliability. Stability reliabilities for the six subscales ranged from 0.83 to 0.92. The results reveal that the Chinese version of the CARE-Q scale for the measurement of patients' perceptions on nurses' caring behaviours indicates high reliability (internal consistency and stability) and good content validity.