Medicine (RMH) - Research Publications
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ItemNo Preview AvailableImpact of prehospital opioid dose on angiographic and clinical outcomes in acute coronary syndromes(BMJ PUBLISHING GROUP, 2023-02)BACKGROUND: An adverse interaction whereby opioids impair and delay the gastrointestinal absorption of oral P2Y12 inhibitors has been established, however the clinical significance of this in acute coronary syndrome (ACS) is uncertain. We sought to characterise the relationship between prehospital opioid dose and clinical outcomes in patients with ACS. METHODS: Patients given opioid treatment by emergency medical services (EMS) with ACS who underwent percutaneous coronary intervention (PCI) between 1 January 2014 and 31 December 2018 were included in this retrospective cohort analysis using data linkage between the Ambulance Victoria, Victorian Cardiac Outcomes Registry and Melbourne Interventional Group databases. Patients with cardiogenic shock, out-of-hospital cardiac arrest and fibrinolysis were excluded. The primary end point was the risk-adjusted odds of 30-day major adverse cardiac events (MACE) between patients who received opioids and those that did not. RESULTS: 10 531 patients were included in the primary analysis. There was no significant difference in 30-day MACE between patients receiving opioids and those who did not after adjusting for key patient and clinical factors. Among patients with ST-elevation myocardial infarction (STEMI), there were significantly more patients with thrombolysis in myocardial infarction (TIMI) 0 or 1 flow pre-PCI in a subset of patients with high opioid dose versus no opioids (56% vs 25%, p<0.001). This remained significant after adjusting for known confounders with a higher predicted probability of TIMI 0/1 flow in the high versus no opioid groups (33% vs 11%, p<0.001). CONCLUSIONS: Opioid use was not associated with 30-day MACE. There were higher rates of TIMI 0/1 flow pre-PCI in patients with STEMI prescribed opioids. Future prospective research is required to verify these findings and investigate alternative analgesia for ischaemic chest pain.
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ItemProjecting the incidence and costs of major cardiovascular and kidney complications of type 2 diabetes with widespread SGLT2i and GLP-1 RA use: a cost-effectiveness analysis(SPRINGER, 2023-04)AIMS/HYPOTHESIS: Whether sodium-glucose co-transporter 2 inhibitors (SGLT2is) or glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are cost-effective based solely on their cardiovascular and kidney benefits is unknown. We projected the health and economic outcomes due to myocardial infarction (MI), stroke, heart failure (HF) and end-stage kidney disease (ESKD) among people with type 2 diabetes, with and without CVD, under scenarios of widespread use of these drugs. METHODS: We designed a microsimulation model using real-world data that captured CVD and ESKD morbidity and mortality from 2020 to 2040. The populations and transition probabilities were derived by linking the Australian Diabetes Registry (1.1 million people with type 2 diabetes) to hospital admissions databases, the National Death Index and the ESKD Registry using data from 2010 to 2019. We modelled four interventions: increase in use of SGLT2is or GLP-1 RAs to 75% of the total population with type 2 diabetes, and increase in use of SGLT2is or GLP-1 RAs to 75% of the secondary prevention population (i.e. people with type 2 diabetes and prior CVD). All interventions were compared with current use of SGLT2is (20% of the total population) and GLP-1 RAs (5% of the total population). Outcomes of interest included quality-adjusted life years (QALYs), total costs (from the Australian public healthcare perspective) and the incremental cost-effectiveness ratio (ICER). We applied 5% annual discounting for health economic outcomes. The willingness-to-pay threshold was set at AU$28,000 per QALY gained. RESULTS: The numbers of QALYs gained from 2020 to 2040 with increased SGLT2i and GLP-1 RA use in the total population (n=1.1 million in 2020; n=1.5 million in 2040) were 176,446 and 200,932, respectively, compared with current use. Net cost differences were AU$4.2 billion for SGLT2is and AU$20.2 billion for GLP-1 RAs, and the ICERs were AU$23,717 and AU$100,705 per QALY gained, respectively. In the secondary prevention population, the ICERs were AU$8878 for SGLT2is and AU$79,742 for GLP-1 RAs. CONCLUSIONS/INTERPRETATION: At current prices, use of SGLT2is, but not GLP-1 RAs, would be cost-effective when considering only their cardiovascular and kidney disease benefits for people with type 2 diabetes.
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ItemLong-Term Outcomes of Contemporary Percutaneous Coronary Intervention with the Xience Drug-Eluting Stent: Results from a Multicentre Australian Registry.(MDPI AG, 2022-12-29)Introduction: Several large registries have evaluated outcomes after percutaneous coronary intervention (PCI) in the USA, however there are no contemporary data regarding long-term outcomes after PCI, particularly comparing new generation drug-eluting stents (DES) with other stents in Australia. Additionally, approval of new-generation drug-eluting stents (DES) is almost exclusively based on non-inferiority trials comparing outcomes with early generation DES, and there are limited data comparing safety and efficacy outcomes of new-generation DES with bare metal stents (BMS). This study reports in-hospital and long-term outcomes after PCI with the Xience DES from a large national registry, the GenesisCare Outcomes Registry (GCOR). Methods: The first 1500 patients consecutively enrolled from January 2015 to January 2019 and treated exclusively with either Xience DES or BMS and eligible for 1-year follow-up were included. Baseline patient and procedural data, major adverse cardiovascular events (MACE) in-hospital, at 30 days and 1-year, and medications were reported and analysed with respect to Xience DES (n = 1000) or BMS (n = 500) use. Results: In this cohort the mean age was 68.4 ± 10.7 years, 76.9% were male, 24.6% had diabetes mellitus and 45.9% presented with acute coronary syndromes. Of the overall cohort of 4765 patients from this period including all DES types, and patients who received multiple DES or a combination of DES and BMS, DES were exclusively used in 3621 (76.0%) patients, and BMS were exclusively used in 596 (12.5%). In comparison to international cohorts, adverse clinical event rates were low at 30 days in terms of mortality (0.20%), target lesion revascularisation (TLR, 0.27%) and MACE (0.47%), and at 12 months for mortality (1.26%) TLR (1.16%) and MACE (1.78%). Conclusions: Clinical practice and long-term outcomes of PCI with the Xience DES in Australia are consistent with international series. Recent trends indicate DES use has increased in parallel with good outcomes despite an increasingly complex patient and lesion cohort.
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ItemNo Preview AvailableLong-Term Outcome of Multidisciplinary Versus Standard Gastroenterologist Care for Functional Gastrointestinal Disorders: A Randomized Trial(ELSEVIER SCIENCE INC, 2022-09)BACKGROUND & AIMS: Functional gastrointestinal disorders are common and costly to the healthcare system. In the Multidisciplinary Treatment of Functional Gastrointestinal Disorders study, we demonstrated that multidisciplinary care resulted in superior clinical and cost outcomes, when compared with standard gastroenterologist-only care at end of treatment. In this study we evaluate the longer-term outcomes. METHODS: In a single-center, pragmatic trial patients with Rome IV criteria-defined functional gastrointestinal disorders were randomized 1:2 to a gastroenterologist-only standard care vs a multidisciplinary clinic comprising gastroenterologists, dietitians, gut hypnotherapists, psychiatrists, and biofeedback physiotherapists. Outcomes in this study were assessed 12 months after the end of treatment. Global symptom improvement was assessed by using a 5-point Likert scale. Symptoms, specific disorder status, psychological state, quality of life, and cost were additional outcomes. A modified intention-to-treat analysis was performed. RESULTS: Of 188 randomized patients, 143 (46 standard care, 97 multidisciplinary) formed the longer-term modified intention-to-treat analysis. Sixty-two percent of multidisciplinary clinic patients saw allied clinicians. Sixty-five percent (30/46) standard care versus 76% (74/97) multidisciplinary clinic patients achieved global symptom improvement 12 months after end of treatment (P = .17), whereas 20% (9/46) versus 37% (36/97) rated their symptoms as "5/5 much better" (P = .04). A ≥50-point reduction in Irritable Bowel Syndrome Severity Scoring System occurred in 38% versus 66% (P = .02), respectively, for irritable bowel syndrome patients. Anxiety and depression were greater in the standard care than multidisciplinary clinic (12 vs 10, P = .19), and quality of life was lower in standard care than the multidisciplinary clinic (0.75 vs 0.77, P =·.03). An incremental cost-effectivness ratio found that for every additional 3555AUD spent in the multidisciplinary clinic, a further quality-adjusted life year was gained. CONCLUSIONS: Twelve months after the completion of treatment, integrated multidisciplinary clinical care achieved a greater proportion of patients with improvement of symptoms, psychological state, quality of life, and cost, compared with gastroenterologist-only care. CLINICAL TRIALS: gov: number NCT03078634.
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ItemIntegrating the Biology of Cardiovascular Disease into the Epidemiology of Economic Decision Modelling via Mendelian Randomisation(ADIS INT LTD, 2022-11)Health economic analyses are essential for health services research, providing decision-makers and payers with evidence about the value of interventions relative to their opportunity cost. However, many health economic approaches are still limited, especially regarding the primary prevention of cardiovascular disease (CVD). In this article, we discuss some limitations to current health economic models and then outline an approach to address these via the incorporation of genomics into the design of health economic models for CVD. We propose that when a randomised clinical trial is not possible or practical, health economic models for primary prevention of CVD can be based on Mendelian randomisation analyses, a technique to assess causality in observational data. We discuss the advantages of this approach, such as integrating well-known disease biology into health economic models and how this may overcome current statistical approaches to assessing the benefits of interventions. We argue that this approach may provide the economic argument for integrating genomics into clinical practice and the efficient targeting of newer therapeutics, transforming our approach to the primary prevention of CVD, thereby moving from reactive to preventive healthcare. We end by discussing some limitations and potential pitfalls of this approach.
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ItemAcademic health science centre models across the developing countries and lessons for implementation in Indonesia: a scoping review.(BMJ, 2022-09-06)OBJECTIVE: To describe models of academic health science centres (AHSCs) across developing countries, in order to inform AHSC development in Indonesia. DESIGN: Scoping review with systematic methods. DATA SOURCES: Ovid MEDLINE, ProQuest Central, Wiley online library, Scopus and Web of Sciences were searched for relevant publications from 1 January 2015 to 1 December 2020. 'Grey literature' was hand searched by targeted website searches, Google searches, as well as personal communication held with stakeholders in Indonesia specifically. Relevant articles regarding AHSCs in developing countries are included. The review would be synthesised to focus on the purpose, structure and core activities of AHSCs. Strategies for success were also considered. RESULTS: Twenty-six recognised AHSCs in developing countries were identified, located in Asia (n=13), Europe (n=1), South America (n=7) and Africa (n=5). Innovation, health system improvement and enhancement in academic capacity were the common visions. Most centres are functionally integrated and university-led. Most AHSCs include community health services to complement primary stakeholders such as academic institutions and hospitals. Limited information was identified regarding patient and public involvement and workforce capacity building. Five AHSCs have been piloted in Indonesia since 2018, integrating universities, academic hospitals and provincial health offices. However, information regarding their core activities and successes is limited. CONCLUSIONS: The review suggests that limited published data are available on AHSC models in developing countries, but they still provide important insight into AHSC development in Indonesia. Innovation and health systems strengthening are the common visions. Functional integration with university leadership is the most common model of governance. Other than universities and hospitals, community health centres, research centres and regional health offices are common partners. There is a little description of community engagement and workforce capacity building.
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ItemIncidence, predictors and clinical implications of new renal impairment following percutaneous coronary intervention(BMJ PUBLISHING GROUP, 2022-10)BACKGROUND: Renal impairment post-percutaneous coronary intervention (post-PCI) is a well-described adverse effect following the administration of contrast media. Within a large cohort of registry patients, we aimed to explore the incidence, predictors and clinical outcomes of renal impairment post-PCI. METHODS: The Victorian Cardiac Outcomes Registry is an Australian state-based clinical quality registry focusing on collecting data from all PCI capable centres. Data from 36 970 consecutive PCI cases performed between 2014 and 2018 were analysed. Patients were separated into three groups based on post-procedure creatinine levels (new renal impairment (NRI), defined as an absolute rise in serum creatinine>44.2 µmol/L or>25% of baseline creatinine; new renal impairment requiring dialysis (NDR), defined as worsening renal failure that necessitated a new requirement for renal dialysis; no NRI). Multivariate logistic regression analysis was performed to investigate the impact of NRI and NDR on clinical outcomes. RESULTS: 3.1% (n=1134) of patients developed NRI, with an additional 0.6% (n=225) requiring dialysis. 96.3% (n=35 611) of patients did not develop NRI. Those who developed renal impairment were more comorbid, with higher rates of diabetes (22% vs 38% vs 38%, p<0.001), peripheral vascular disease (3.4% vs 8.2% vs 11%, p<0.001), chronic kidney disease (19% vs 49.7% vs 54.2%) and severe left ventricular dysfunction (5% vs 22% vs 40%, p<0.001). Multivariable analysis found that when compared with the no NRI group, those in the combined NRI/NDR group were at a greater risk of 30-day mortality (OR 4.77; 95% CI 3.89 to 5.86, p<0.001) and 30-day major adverse cardiac events (OR 3.72; 95% CI 3.15 to 4.39, p<0.001). CONCLUSIONS: NRI post-PCI remains a common occurrence, especially among comorbid patients, and is associated with a significantly increased morbidity and mortality risk.
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ItemPrior Coronary Artery Bypass Graft Surgery Impacts 30-day Quality of Life after Percutaneous Coronary Intervention: Evidence from the Victorian Cardiac Outcomes Registry (VCOR): 30-day QoL after PCI in patients with prior CABG(Springer Science and Business Media LLC, 2022-12-01)Abstract Quality of life following percutaneous coronary intervention (PCI) in patients with coronary artery bypass graft surgery (CABG) has been reported as lower than non-CABG patients, however previous reports pre-date modern developments in PCI and cardiac surgery. This study aimed to examine the 30-day QoL after PCI between patients with and without prior CABG using a contemporary dataset. A retrospective analysis of the Victorian Cardiac Outcomes Registry was undertaken. This study included 36,799 patients who completed the EQ-5D questionnaire that was used to assess the 30-day QoL and was compared between groups with and without prior CABG at baseline. Most of the participants were older than 65 years, more than half were male and had PCI due to acute coronary symptoms (ACS) and nearly 90% of patients received drug eluting stents. Compared to the ‘no prior CABG’ group, the ‘CABG’ group had a significantly higher rate of reporting a health problem (OR 1.30, 95% CI 1.10–1.53), presence of a problem in mobility (OR 1.42, 95% CI 1.15–1.75), personal care (OR 1.49, 95%CI 1.13–1.97) and usual activities (OR 1.39, 95%CI 1.15–1.68), pain/discomfort (OR 1.31, 95%CI 1.11–1.54), and anxiety/depression (OR 1.20, 95%CI 1.02–1.42). Despite modern developments in both PCI and CABG, our study showed a consistent negative association between prior CABG status and 30-day QoL following PCI. There is a need for better targeted cardiac rehabilitation in patients with prior CABG to address their greater relative risk of experiencing poor health.
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ItemEstimating the economic impact of acute coronary syndrome in New Zealand over time (ANZACS-QI 64): a national registry-based cost burden study.(BMJ, 2022-08-01)OBJECTIVES: To estimate the changes in costs associated with acute coronary syndrome (ACS) admissions in New Zealand (NZ) public hospitals over a 12-year period. DESIGN: A cost-burden study of ACS in NZ was conducted from the NZ healthcare system perspective. SETTING: Hospital admission costs were estimated using relevant diagnosis-related groups and their costs for publicly funded casemix hospitalisations, and applied to 190 364 patients with ACS admitted to NZ public hospitals between 2007 and 2018 identified from routine national hospital datasets. Trends in the costs of index ACS hospitalisation, hospital admissions costs, coronary revascularisation and all-cause mortality up to 1 year were evaluated. All costs were presented as 2019 NZ dollars. PRIMARY OUTCOME MEASURES: Healthcare costs attributed to ACS admissions in NZ over time. RESULTS: Between 2007 and 2018, there was a 42% decrease in costs attributed to ACS (NZ$7.7 million (M) to NZ$4.4 M per 100 000 per year), representing a decrease of NZ$298 827 per 100 000 population per year. Mean admission costs associated with each admission declined from NZ$18 411 in 2007 to NZ$16 898 over this period (p<0.001) after adjustment for key clinical and procedural characteristics. These reductions were against a background of increased use of coronary revascularisation (23.1% (2007) to 38.1% (2018)), declining ACS admissions (366-252 per 100 000 population) and an improvement in 1-year survival post-ACS. Nevertheless, the total ACS cost burden remained considerable at NZ$237 M in 2018. CONCLUSIONS: The economic cost of hospitalisations for ACS in NZ decreased considerably over time. Further studies are warranted to explore the association between reductions in ACS cost burden and changes in the management of ACS.
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ItemPatient Perceived Financial Burden in Haematological Malignancies: A Systematic Review(MDPI, 2022-06)UNLABELLED: Advances in scientific understanding have led to novel therapies and improved supportive care for many patients with haematological malignancies. However, these new drugs are often costly, only available at centralised health care facilities, require regular specialist reviews and lengthy treatment regimens. This leads to a significant financial burden. Understanding the impact of financial burden on haematological patients is important to appreciate the urgency of alleviating this systemic issue. METHOD: Eligible studies were identified by systematically searching Medline, PsycINFO, CINAHL and Embase. Self-reported data reported in both quantitative and qualitative studies that described the financial burden for patients with haematological malignancies were included. Quality appraisal of the included studies was undertaken using the Joanna Briggs Institute tools. A narrative synthesis was employed. For quantitative studies, outcomes were extracted, tabulated and categorised to find similarities and differences between the studies. For qualitative studies, quotations, codes and themes were extracted and then clustered. An inductive approach derived qualitative themes. RESULTS: Twenty studies were identified for inclusion. Of the quantitative studies most (83%) employed un-validated researcher-generated measures to assess financial burden. Between 15-59% of patients experienced a financial burden. Out-of-pocket expenditure was frequent for clinical appointments, prescription and non-prescription medication, and travel. Financial burden was associated with a worsening quality of life and living in metropolitan areas, but there was no evidence for impact on survival. Patient-centred experiences from the qualitative inquiry complemented the quantitative findings and five themes were determined: familial or household impact; reliance on others; barriers to care due to cost; and barriers to accessing financial assistance and sources of out-of-pocket expenses. CONCLUSION: The impacts of financial burden are yet to be fully appreciated in haematological malignancies, exacerbated by the heterogeneous methods employed by researchers. Future work should focus on identifying the long-term ramifications of financial burden for patients and should trial interventions to reduce its prevalence and patient impacts.