The impact of drug palatability on prescribing and dispensing of antibiotic formulations for paediatric patients: a cross-sectional survey of general practitioners and pharmacists.

BACKGROUND: Palatability is a key element of paediatric acceptability for medicines. Many patient and drug factors are considered when choosing an antibiotic for a child. Pharmacists report that they receive questions about the palatability of oral liquid antibiotics for children. This study aimed to explore the experiences of GPs and pharmacists concerning palatability of oral liquid antibiotics for children. METHODS: A questionnaire about the impact of palatability on the choice of antibiotic formulation for children was emailed to all community pharmacists in Ireland and to GPs and trainee GPs in the Cork region and posted on social media. Survey items were not compulsory; therefore, percentage responses were calculated based on the number of responses to that item. GP and pharmacist responses were analysed independently. RESULTS: Responses were received from 244 participants (59 GPs, 185 pharmacists). Clinical guidelines and availability of supply were the most important factors considered when choosing an oral liquid antibiotic formulation for children by GP (79.7%) and pharmacist (66.5%) respondents respectively. Forty GP respondents (76.9%) reported ensuring adherence was the most common palatability-related reason leading to deviation from guidelines. Pharmacist respondents (52%) reported advising a parent/caregiver to manipulate the required antibiotic dose to improve acceptability. The least palatable oral liquid antibiotics reported were flucloxacillin (16% GPs, 18% pharmacists) and clarithromycin (17% of each profession). CONCLUSION: This study identified palatability issues associated with oral liquid antibiotics for children reported by GPs and pharmacists. Pharmaceutical approaches to adapting oral liquid antibiotic formulations must be developed to improve palatability and thus paediatric acceptability.

Stakeholders' knowledge, attitudes and practices to pharmacovigilance and adverse drug reaction reporting in clinical trials: a mixed methods study.

PURPOSE: The purpose of this study was to explore the knowledge, attitudes and practices of health professionals working in clinical trials, to pharmacovigilance and adverse drug reaction (ADR) reporting. METHODS: A mixed methods study comprising an online questionnaire disseminated from September to November 2018, three semi-structured interviews and four focus groups. The qualitative components were conducted with a random sample of questionnaire participants who had provided their contact details (n = 24). The qualitative interviews were conducted at a location convenient to the participant's place of work between October and December 2018. RESULTS: One hundred forty-eight participants completed the questionnaire. Study coordinators/project managers represented the largest group of participants ( 28.6%, n = 38). Poor knowledge or understanding of ADR reporting was the most frequently cited barrier to ADR reporting (75%, n = 93). The most common enabler to reporting was having a clear understanding of an ADR definition (85.7%, n = 108). Focus group and interview participants described having limited staff as a barrier to reporting an ADR. They welcomed the prospect of pharmacovigilance training and indicated that face-to-face training would be preferred to provision of online training. CONCLUSION: This study highlights key factors that influence the reporting of ADRs in clinical trials. Although the findings are specifically related to the clinical trial environment in Ireland, they may provide a useful platform for optimising the future conduct of trials. This research suggests that ADR reporting may be improved through provision of enhanced pharmacovigilance training to clinical trial staff.

A tool for assessment of heart failure prescribing quality: A systematic review and meta-analysis.

INTRODUCTION: Heart failure (HF) guidelines aim to standardise patient care. Internationally, prescribing practice in HF may deviate from guidelines and so a standardised tool is required to assess prescribing quality. A systematic review and meta-analysis were performed to identify a quantitative tool for measuring adherence to HF guidelines and its clinical implications. METHODS: Eleven electronic databases were searched to include studies reporting a comprehensive tool for measuring adherence to prescribing guidelines in HF patients aged ≥18 years. Qualitative studies or studies measuring prescription rates alone were excluded. Study quality was assessed using the Good ReseArch for Comparative Effectiveness Checklist. RESULTS: In total, 2455 studies were identified. Sixteen eligible full-text articles were included (n = 14 354 patients, mean age 69 ± 8 y). The Guideline Adherence Index (GAI), and its modified versions, was the most frequently cited tool (n = 13). Other tools identified were the Individualised Reconciled Evidence Recommendations, the Composite Heart Failure Performance, and the Heart Failure Scale. The meta-analysis included the GAI studies of good to high quality. The average GAI-3 was 62%. Compared to low GAI, high GAI patients had lower mortality rate (7.6% vs 33.9%) and lower rehospitalisation rates (23.5% vs 24.5%); both P ≤ .05. High GAI was associated with reduced risk of mortality (hazard ratio = 0.29, 95% confidence interval, 0.06-0.51) and rehospitalisation (hazard ratio = 0.64, 95% confidence interval, 0.41-1.00). No tool was used to improve prescribing quality. CONCLUSION: The GAI is the most frequently used tool to assess guideline adherence in HF. High GAI is associated with improved HF outcomes.

Assessing awareness and attitudes of healthcare professionals on the use of biosimilar medicines: A survey of physicians and pharmacists in Ireland.

Increasing numbers of biosimilar medicines are becoming available. The objective of this survey was to assess awareness of and attitudes to biosimilars amongst physicians (medical specialists and General Practitioners (GPs)) and community pharmacists in Ireland. Physicians were invited to complete an online questionnaire during April and May 2016. Community pharmacists received a postal questionnaire in August 2015. Responses from 102 medical specialists, 253 GPs and 125 community pharmacists were analysed. The majority of medical specialists (85%) and pharmacists (77%) claimed to be either very familiar or familiar with the term biosimilar, whereas many GPs (60%) were unable to define or had never heard of the term. One in five (21%) healthcare professionals responded that biosimilars were the same as generic medicines. The majority of medical specialists opposed pharmacist-led substitution of biological medicines but some thought it could be appropriate if agreed with the clinician in advance. Medical specialists who prescribe biosimilars (n = 43) were more likely to do so on treatment initiation (67%), than switch a patient from an originator medicine to a biosimilar (28%). The findings will aid the design of educational initiatives for healthcare professionals and highlight attitudes of healthcare professionals to biosimilars, so informing regulators, policy makers and industry.

Health care utilization and the associated costs attributable to cardiovascular disease in Ireland: a cross-sectional study.

BACKGROUND: Cardiovascular disease (CVD) is the leading cause of mortality and disability globally. We examined healthcare service utilization and costs attributable to CVD in Ireland in the period before the introduction of a major healthcare reform in 2016. METHODS: Secondary analysis of data from 8 113 participants of the first wave of The Irish Longitudinal Study on Ageing. CVD was defined as having a self-reported doctor's diagnosis of myocardial infarction, angina, heart failure, stroke, atrial fibrillation or transient ischaemic attack. Participants self-reported the utilization of healthcare services in the year preceding the interview. Negative binomial regression with average marginal effects (AME) was used to estimate the incremental number of general practitioner (GP) and outpatient department (OPD) visits, accident and emergency department attendances and hospitalisations in population with CVD relative to population without CVD. We calculated the corresponding costs at individual and population levels, by gender and age groups. RESULTS: The prevalence of CVD was 18.2% (95% CI: 17.3, 19.0) Participants with CVD reported higher utilization of all healthcare services. In adjusted models, having CVD was associated with incremental 1.19 (95% CI: 0.99, 1.39) GP and 0.79 (95% CI: 0.65, 0.93) OPD visits. There were twice as many incremental hospitalisations in males with CVD compared to females with CVD (AME (95% CI): 0.20 (0.16, 0.23) vs 0.10 (0.07, 0.14)). The incremental cost of healthcare service use in population with CVD was an estimated €352.2 million (95% CI: €272.8, €431.7), 93% of which was due to use of secondary care services. CONCLUSION: We identified substantially increased use of healthcare services attributable to CVD in Ireland. Continued efforts aimed at CVD primary prevention and management are required.

Natriuretic peptide-based screening and collaborative care for heart failure: the STOP-HF randomized trial.

IMPORTANCE: Prevention strategies for heart failure are needed. OBJECTIVE: To determine the efficacy of a screening program using brain-type natriuretic peptide (BNP) and collaborative care in an at-risk population in reducing newly diagnosed heart failure and prevalence of significant left ventricular (LV) systolic and/or diastolic dysfunction. DESIGN, SETTING, AND PARTICIPANTS: The St Vincent's Screening to Prevent Heart Failure Study, a parallel-group randomized trial involving 1374 participants with cardiovascular risk factors (mean age, 64.8 [SD, 10.2] years) recruited from 39 primary care practices in Ireland between January 2005 and December 2009 and followed up until December 2011 (mean follow-up, 4.2 [SD, 1.2] years). INTERVENTION: Patients were randomly assigned to receive usual primary care (control condition; n=677) or screening with BNP testing (n=697). Intervention-group participants with BNP levels of 50 pg/mL or higher underwent echocardiography and collaborative care between their primary care physician and specialist cardiovascular service. MAIN OUTCOMES AND MEASURES: The primary end point was prevalence of asymptomatic LV dysfunction with or without newly diagnosed heart failure. Secondary end points included emergency hospitalization for arrhythmia, transient ischemic attack, stroke, myocardial infarction, peripheral or pulmonary thrombosis/embolus, or heart failure. RESULTS: A total of 263 patients (41.6%) in the intervention group had at least 1 BNP reading of 50 pg/mL or higher. The intervention group underwent more cardiovascular investigations (control, 496 per 1000 patient-years vs intervention, 850 per 1000 patient-years; incidence rate ratio, 1.71; 95% CI, 1.61-1.83; P<.001) and received more renin-angiotensin-aldosterone system-based therapy at follow-up (control, 49.6%; intervention, 56.5%; P=.01). The primary end point of LV dysfunction with or without heart failure was met in 59 (8.7%) of 677 in the control group and 37 (5.3%) of 697 in the intervention group (odds ratio [OR], 0.55; 95% CI, 0.37-0.82; P = .003). Asymptomatic LV dysfunction was found in 45 (6.6%) of 677 control-group patients and 30 (4.3%) of 697 intervention-group patients (OR, 0.57; 95% CI, 0.37-0.88; P = .01). Heart failure occurred in 14 (2.1%) of 677 control-group patients and 7 (1.0%) of 697 intervention-group patients (OR, 0.48; 95% CI, 0.20-1.20; P = .12). The incidence rates of emergency hospitalization for major cardiovascular events were 40.4 per 1000 patient-years in the control group vs 22.3 per 1000 patient-years in the intervention group (incidence rate ratio, 0.60; 95% CI, 0.45-0.81; P = .002). CONCLUSION AND RELEVANCE: Among patients at risk of heart failure, BNP-based screening and collaborative care reduced the combined rates of LV systolic dysfunction, diastolic dysfunction, and heart failure. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00921960.

Enhancing the clinical pharmacy service of a large teaching hospital: Development of a new clinical prioritisation tool.

Background: The number and complexity of patients being admitted to hospitals is rising and some patients may not receive a full clinical pharmacy review or be reviewed as regularly as needed during their inpatient stay. This is a risk factor for medication errors. Clinical prioritisation identifies patients who are high-risk and most in need of a pharmacist review, targeting finite pharmacy resources to patients who will benefit the most. Objectives: Assess and enhance clinical prioritisation within a hospital pharmacy department. Methods: The study was conducted in a large urban academic teaching hospital. A cross-sectional survey of clinical pharmacists in the hospital was conducted to establish the patient clinical criteria they prioritise in their work. A clinical prioritisation tool was developed based on survey findings and was integrated into an existing electronic pharmacy care interface. A pre- and post-intervention study was conducted, consisting of data collection for five days pre- and five days post-implementation of the tool. Quantitative data were analysed using descriptive and inferential statistics. Qualitative data were analysed by thematic analysis. Results: Of 39 eligible pharmacists, 37 (95%) responded to the survey. The top-rated prioritisation criteria, including medicines reconciliation tasks and high-risk medicines, helped to inform the content of the clinical prioritisation tool. Post-intervention, there were more Level 1 complex patients reviewed by pharmacists and fewer Level 3 stable patients compared to pre-intervention. Tool sensitivity ranged from 51 to 88%, depending on the experience of the pharmacist using the tool. High levels of satisfaction with clinical prioritisation were reported by those using the tool. Conclusion: This newly developed clinical prioritisation tool has the potential to support pharmacists in identifying and reviewing patients in a more targeted manner than practice prior to tool development. Continued development and validation of the tool is essential, with a focus on developing a fully automated tool.

Pharmacy students' experience of technology-enhanced learning during the COVID-19 pandemic.

Background: With the advent of the COVID-19 pandemic, pharmacy students and educators experienced an abrupt shift as programmes that were previously taught exclusively in-person were then predominantly taught online. This sudden change provided little time for students to prepare for the new learning environment. Objectives: The study objective was to explore pharmacy students' experiences of technology-enhanced learning during the COVID-19 pandemic. Methods: A cross-sectional survey was developed and distributed by email to all 3rd year (N = 76) and 4th year (N = 68) pharmacy students undertaking an MPharm programme in an Irish university. Results: A total of 32 responses were collected, including 20 third year and 12 fourth year pharmacy students (response rates of 26.3% and 17.6%, respectively). The majority of respondents reported good or very good internet speed (71%) and stability (59%). Almost all were confident or very confident using Canvas (97%) prior to the onset of online learning. Respondents preferred engaging with other students in-person rather than online for coursework (68.8%) and learning new material (56.3%). Students favoured face-to-face delivery, with a recording of the session available online afterwards, for lectures (68.8%), workshops (50%) and tutorials (56.3%). Analysis of free-text comments indicates that respondents used recorded content to support exam revision and that a key drawback of online learning was social isolation. Implications: Pharmacy students favoured a blended learning approach, with in-person learning being recorded to support study and revision. Students' experience of TEL during the pandemic should be considered in the development and ongoing review of pharmacy programmes.

Healthcare professional perspectives on medication challenges in the post-stroke patient.

Background: Medications play an essential role in the management of patients who have experienced a stroke. Despite the recognised importance and widespread availability of secondary prevention guidelines, Irish research has shown a continuous failure to meet secondary prevention targets upon discharge. While complex interventions involving healthcare professionals (HCPs) such as Speech and Language Therapists (SLT), Occupational Therapists (OTs) and Pharmacists have been effective in combatting medication non-adherence, community multidisciplinary teams (MDTs) are not as well defined as in the acute setting, leading to wide variation in patient care. Therefore, this study aims to investigate the knowledge, attitudes, beliefs, and challenges faced by HCPs in the continuity of care post-discharge from a hospital stroke ward, and its impact on medication adherence. Methods: Semi-structured interviews and one focus group with HCPs were conducted, and data were analysed using Braun & Clarke's reflexive Thematic Analysis. Results: Fourteen HCPs (6 Pharmacy, 4 SLT, 4 OTs) participated in this study. Participants discussed their views under two main themes 1) continuity of care and 2) medication adherence. Sub-themes observed regarding continuity of care include management and organisation, interpersonal continuity, and informational continuity. Themes generated which impact medication adherence post-discharge include condition-related factors, medication-related factors, systemic and HCP factors, and patient-related factors. Discussion: Additional resources are required to bring community healthcare in line with the standard of acute care. Increased channels of communication must be established across contexts and disciplines, and may be achieved using interprofessional training through continuous professional development or third-level education, a more clearly defined community team structure, and discharge summaries completed to relevant quality standards. While suboptimal continuity of care was reported as contributing to medication non-adherence, HCPs also acknowledged the complexities of medication management post-stroke.

Community Pharmacists' Attitude, Practice and Confidence in Supporting People with Diabetes in Japan and Ireland: A Cross-sectional Survey.

Diabetes is a chronic disease requiring long-term management. Poorly controlled diabetes is associated with reduced quality of life and micro- and macro-vascular complications. Community pharmacists have a role in supporting people with diabetes to better address their condition and reduce their risk of diabetes-related illness. The purpose of this study was to examine and compare the attitudes, practices, and confidence of community pharmacists in Japan and Ireland on the care of people with diabetes. A cross-sectional survey of community pharmacists in Ireland (388 respondents) and Japan (144 respondents) was conducted to assess their attitudes, practices, confidence, and other characteristics linked to diabetes management. A Likert scale was utilized, with a range of strongly agree to strongly disagree. The study reported that Japanese pharmacists have lower levels of practice (p<0.004), confidence, trust by patients, job satisfaction, concern with patients, and knowledge (all p<0.001) regarding diabetes management than Irish pharmacists. Although there was no significant difference in the attitude of pharmacists in both countries, the results show almost similar attitudes toward diabetes management, indicating their willingness to support people with diabetes. These results demonstrated less confidence in diabetes management and less practice of diabetes management care among Japanese pharmacists than Irish pharmacists. The results can be used to identify pharmacist education needs and develop training programs in diabetes management for pharmacists in Japan and Ireland.

The views and experiences of people with type 2 diabetes being cared for by their community pharmacist: a cross-sectional patient survey.

Purpose: Community pharmacists are highly accessible healthcare providers and studies in several countries have demonstrated a role for community pharmacists in delivering enhanced care to people with type 2 diabetes. The aim of this study is to evaluate the views and experiences of people with type 2 diabetes attending community pharmacies in Ireland. Methods: A 13-item questionnaire, anchored on a 5-point Likert scale, was used. The study took place in seven pharmacies in the Munster region of Ireland. Participants were people attending a participating pharmacy who had type 2 diabetes and were aged ≥ 18 years. Results: The questionnaire was answered by 125 people with type 2 diabetes. Mean age of participants was 65.7 ± 12.4 years and 59.2% were male. The statement "I am totally satisfied with my visit to this pharmacist", was the item that participants most frequently agreed with (agree/strongly agree = 99.2%, mean score 4.9 ± 0.4). Over 80% of participants agreed or strongly agreed with the statement "It is easier to get to see the pharmacist than the doctor", (mean score 4.3 ± 1.1). Conclusion: In this population, people with type 2 diabetes were highly satisfied with the care provided to them by their community pharmacist. These data support the implementation of enhanced community pharmacy services for people with type 2 diabetes in Ireland.

Guideline-led prescribing to ambulatory heart failure patients in a cardiology outpatient service.

Background Guidelines recommend heart failure (HF) patients be treated with multiple medications at doses proven to improve clinical outcomes. Objective To study guideline-led prescribing in an Irish outpatient HF population. Setting Cardiology Outpatient Clinic, Mercy University Hospital, Cork, Ireland. Methods Guideline-led prescribing was assessed using the Guideline Adherence Index (GAI-3), that considered the prescribing of ACE inhibitors and angiotensin receptor blockers; beta-blockers and mineralocorticoid receptor antagonists. The GAI-based target dose was calculated based on the prescription of ≥ 50% of the guideline-recommended target dose of each of the three GAI medications to HF patients with ejection fraction ≤ 40%. High-GAI was achieved by prescription of ≥ 2 GAI medicines. Potentially inappropriate prescribing was assessed using a HF-specific tool. Main outcome measure Heart failure guideline-led prescribing assessed using the GAI-3. Results A total of 127 HF patients, mean age 71.7 ± 13.1 years, were identified in the study. Seventy-one patients had ejection fraction ≤ 40%. Population mean GAI-3 was 65.8%. When contraindications to therapy are considered, the adjusted GAI-3 increased to 72.9%. The target dose GAI was 18.5%. High-GAI management was prescribed to 54 patients (76.1%). A potentially inappropriate medicine in HF was prescribed to 14 (19.7%) patients. Conclusion Most HF patients with ejection fraction ≤ 40% in this setting received optimal guideline-led prescribing however the proportion of patients achieving the target doses of these agents was suboptimal.

Heart Failure Prescribing Quality at Discharge from a Critical Care Unit in Egypt: The Impact of Multidisciplinary Care.

Discharge prescriptions for heart failure (HF) patients may not adhere to the clinical practice guidelines. This study aimed to assess the impact of the clinical pharmacist as a member of a multidisciplinary team on the quality of prescribing to HF patients at discharge from a Critical Care Unit (CCU) in Egypt. This was a retrospective cohort study of HF patients discharged from the CCU between January 2013 and December 2017. Guideline Adherence Index (GAI-3) was used to assess guideline-directed prescribing at discharge. Multidisciplinary care was introduced to the CCU on 1 January 2016. The study included 284 HF patients, mean (±SD) age 66.7 ± 11.5 years, 53.2% male. Heart failure with reduced ejection fraction affected 100 patients (35.2%). At discharge, loop diuretics were prescribed to 85.2% of patients; mineralocorticoid receptor antagonists to 54.9%; angiotensin-converting enzyme inhibitors/angiotensin receptor blockers to 51.4%; and ß-blockers to 29.9%. Population Guideline Adherence Index (GAI-3) was 45.5%. High-GAI was prescribed to 136 patients (47.9%). Patients with High-GAI were younger; less affected by chronic kidney disease and had fewer comorbidities than those without High-GAI. Prescription of ß-blocker increased (24.1% vs. 38.6%, p < 0.001) and digoxin utilization decreased (34.7% vs. 23.7%, p < 0.049) after the introduction of the multidisciplinary care. The inclusion of a clinical pharmacist in the multidisciplinary care team may have a role in optimizing the prescribing of HF guideline-directed therapies at discharge from this setting.

Knowledge of Adverse Drug Reaction Reporting and the Pharmacovigilance of Biological Medicines: A Survey of Healthcare Professionals in Ireland.

BACKGROUND: In Europe, changes to pharmacovigilance legislation, which include additional monitoring of medicines, aim to optimise adverse drug reaction (ADR) reporting systems. The legislation also makes provisions related to the traceability of biological medicines. OBJECTIVE: The objective of this study was to assess (i) knowledge and general experience of ADR reporting, (ii) knowledge, behaviours, and attitudes related to the pharmacovigilance of biologicals, and (iii) awareness of additional monitoring among healthcare professionals (HCPs) in Ireland. METHODS: Hospital doctors (n = 88), general practitioners (GPs) (n = 197), nurses (n = 104) and pharmacists (n = 309) completed an online questionnaire. RESULTS: There were differences in mean knowledge scores relating to ADR reporting and the pharmacovigilance of biologicals among the HCP groups. The majority of HCPs who use biological medicines in their practice generally record biologicals by brand name but practice behaviours relating to batch number recording differed between some professions. HCPs consider batch number recording to be valuable but also regard it as being more difficult than brand name recording. Most respondents were aware of the concept of additional monitoring but awareness rates differed between some groups. Among those who knew about additional monitoring, there was higher awareness of the inverted black triangle symbol among pharmacists (> 86.4%) compared with hospital doctors (35.1%), GPs (35.6%), and nurses (14.9%). Hospital pharmacists had more experience and knowledge of ADR reporting than other practising HCPs. CONCLUSION: This study highlights the important role hospital pharmacists play in post-marketing surveillance. There is a need to increase pharmacovigilance awareness of biological medicines and improve systems to support their batch traceability.

Intrauterine insemination-No more Mr. N.I.C.E. guy?

OBJECTIVE: To determine the per cycle chance of a live birth and to identify factors that may support a more individualised application of IUI in view of National Institute for Health and Care Excellence (NICE) updated guideline on fertility 2013. STUDY DESIGN: A retrospective, cohort study of 851 couples (1688 cycles) with unexplained, mild endometriosis, one patent Fallopian tube (with ovulation occurring in the corresponding ovary), mild male factor or ovulatory dysfunction, who initiated their first cycle of IUI/COH during the study period 2009-2013 and completed up to 3 cycles. Exclusion criteria included donor sperm and diminished ovarian reserve. Success factors and probabilities were determined based on live birth rates. RESULTS: Mean age was 33.8±3.3years and mean duration of subfertility was 2.28±1.47years. Independent associates of successful outcome factors were lower age (AOR 0.93; 95%CI 0.89-0.98, p=0.007) and multiparity (AOR 1.72; 95%CI 1.17-2.52). Live-birth rates declined independently of other factors from 15.3% (n=130/851) in cycle 1-7.0% (n=19/273) in cycle 3 (AOR 0.76; 95%CI, 0.62-0.93, p=0.008). Per cycle probabilities of live birth ranged from 21.4% to 5.1% dependent on age, cycle number and previous parity. The unadjusted cumulative pregnancy rate for live birth per cycle started, over three cycles, was 34.9% with a multiple live birth rate per cycle started of 5.4%. The associates of live birth amongst those with unexplained sub-fertility only (n=632, first cycle attempt) were also analysed, yielding similar results. CONCLUSIONS: IUI/COH is a simple treatment that produces good live birth rates, especially in younger patients and/or those with previous parity. More than 90% of total live births with IUI/COH is achieved during the first two cycles. As a retrospective, observational study, there is no comparator group and therefore we cannot comment on the relative efficacy of up to three IUI cycles over expectant management in a similar cohort. Our study suggests that probabilities of success can be used to individualise treatment decisions and that there is merit in continuing to offer IUI before resorting to IVF for certain patients.

Cost-effectiveness of natriuretic peptide-based screening and collaborative care: a report from the STOP-HF (St Vincent's Screening TO Prevent Heart Failure) study.

AIMS: Prevention of cardiovascular disease and heart failure (HF) in a cost-effective manner is a public health goal. This work aims to assess the cost-effectiveness of the St Vincent's Screening TO Prevent Heart Failure (STOP-HF) intervention. METHODS AND RESULTS: This is a substudy of 1054 participants with cardiovascular risk factors [median age 65.8 years, interquartile range (IQR) 57.8:72.4, with 4.3 years, IQR 3.4:5.2, follow-up]. Annual natriuretic peptide-based screening was performed, with collaborative cardiovascular care between specialist physicians and general practitioners provided to patients with BNP levels >50 pg/mL. Analysis of cost per case prevented and cost-effectiveness per quality-adjusted life year (QALY) gained was performed. The primary clinical endpoint of LV dysfunction (LVD) with or without HF was reduced in intervention patients [odds ratio (OR) 0.60; 95% confidence interval (CI) 0.38-0.94; P = 0.026]. There were 157 deaths and/or emergency hospitalizations for major adverse cardiac events (MACE) in the control group vs. 102 in the intervention group (OR 0.68; 95% CI 0.49-0.93; P = 0.01). The cost per case of LVD/HF prevented was €9683 (sensitivity range -€843 to €20 210), whereas the cost per MACE prevented was €3471 (sensitivity range -€302 to €7245). Cardiovascular hospitalization savings offset increased outpatient and primary care costs. The cost per QALY gain was €1104 and the intervention has an 88% probability of being cost-effective at a willingness to pay threshold of €30 000. CONCLUSION: Among patients with cardiovascular risk factors, natriuretic peptide-based screening and collaborative care reduced LVD, HF, and MACE, and has a high probability of being cost-effective. TRIAL REGISTRATION: NCT00921960.

Hypertriglyceridemic waist as a screening tool for CVD risk in indigenous Australian women.

Research has demonstrated that the simultaneous determination of waist circumference and fasting plasma triglyceride (TG) concentrations can identify men characterized by a metabolic triad of unconventional risk variables: increased levels of fasting insulin, apolipoprotein (apo) B, and a predominance of small, dense, low density lipoprotein (LDL) particles. The aim of this study was to assess the efficacy of using "hypertriglyceridemic waist" to identify individuals at high risk of CVD in a sample of indigenous Australian women, for whom 2 of the 3 non-traditional risk factors were measured (apo B and insulin). Subjects (N=80) were divided into subgroups on the basis of waist girth and TG levels. The TG/HDL ratio increased in women with both elevated waist (above 95 cm) and TG levels (above 2.0 mmol/L), who were also characterized by lower HDL and elevated LDL concentrations. Although there was no trend toward an increase in apo B with increasing waist girth and TG levels, apo B concentration was highest among subgroups with elevated waist and TG levels. Fasting insulin levels were higher with increasing waist girth, but not with increasing TG levels. Utilizing hypertriglyceridemic waist as a marker of high plasma insulin and apo B can be an important factor in assessing cardiovascular risk in indigenous Australian women, despite an unexpected apo B distribution.

Aspirin use in heart failure: is low-dose therapy associated with mortality and morbidity benefits in a large community population?

Background- Aspirin use in heart failure (HF) is controversial. The drug has proven benefit in comorbidities associated with HF; however, retrospective analysis of angiotensin-converting enzyme inhibitor trials and prospective comparisons with warfarin have shown increased risk of morbidity with aspirin use. This study aims to evaluate the association of low-dose aspirin with mortality and morbidity risk in a large community-based cohort. Methods and Results- This was a retrospective cohort study of patients attending an HF disease management program. Aspirin use at baseline and its association with mortality and HF hospitalization in the population was examined. Of 1476 patients (mean age, 70.4±12.4 years; 63% men), 892 (60.4%) were prescribed aspirin. Low-dose aspirin (75 mg/d) was prescribed to 828 (92.8%) patients. Median follow-up time was 2.6 (0.8-4.5) years. During the follow-up period, 464 (31.4%) patients died. In adjusted analysis, low-dose aspirin use was associated with reduced mortality risk compared with nonaspirin use (hazard ratio=0.58; 95% confidence interval, 0.46-0.74), and this was confirmed by a propensity-matched subgroup analysis. Low-dose aspirin use was associated with reduced risk of HF hospitalization compared with nonaspirin use in the total population (adjusted hazard ratio=0.70; 95% confidence interval, 0.54-0.90). In adjusted analysis, there was no difference in mortality or HF hospitalization between high-dose aspirin users (>75 mg/d) and nonaspirin users. Conclusions- In this study, low-dose aspirin therapy was associated with a significant reduction in mortality and morbidity risk during long-term follow-up. These results suggest that low-dose aspirin may have a continuing role in secondary prevention in HF and underline the need for more trials of low-dose aspirin use in HF.

The St Vincent's potentially inappropriate medicines study: development of a disease-specific consensus list and its evaluation in ambulatory heart failure care.

AIMS: Heart failure (HF) patients may be at risk of prescription of potentially inappropriate medicines (PIMs) yet no disease-specific list is available to assess PIM use in this population. A Consensus Potentially Inappropriate Medicines in Heart Failure (PIMHF) list was developed, assessed, and compared with an established, general tool in an ambulatory HF population. METHODS AND RESULTS: The Consensus PIMHF list was compiled using modified Delphi methodology with a multidisciplinary team. The list consisted of 11 items. The medication profile of 350 patients was assessed. The association of a Consensus PIMHF item use over a median follow-up period of 1.8 (interquartile range 1.3-2.1) years with the primary endpoint of death, acute hospitalization, or unscheduled outpatient visit was examined. Fifty-one patients (14.6%) were prescribed ≥1 Consensus PIMHF item. In univariable analysis, patients prescribed ≥1 Consensus PIMHF item were 58% more likely to experience the primary endpoint than those with none [95% confidence interval (CI) 1.02-2.45]. When adjusted for age, sex, and HF severity, this difference remained [hazard ratio (HR) 1.88, 95% CI 1.16-3.06] and these associations were in contrast to the use of a more general tool (HR 1.24, 95% CI 0.83-1.84). However, when further adjusted to include co-morbidity score and polypharmacy, there was no association with outcome using either tool (HR 1.40, 95% CI 0.83-2.38; HR 1.05, 95% CI 0.69-1.60, respectively). CONCLUSION: The Consensus PIMHF list provides the first HF-specific medicines review tool. These results provide some support for more disease-specific tools with limited lists of PIMs to rationalize medicines management in HF. However, more prospective work on the application of these tools in practice is needed.