Performance of cardiovascular disease risk prediction equations in more than 14 000 survivors of cancer in New Zealand primary care: a validation study.

BACKGROUND: People with cancer have an increased risk of cardiovascular disease. Risk prediction equations developed in New Zealand accurately predict 5-year cardiovascular disease risk in a general primary care population in the country. We assessed the performance of these equations for survivors of cancer in New Zealand. METHODS: For this validation study, patients aged 30-74 years from the PREDICT open cohort study, which was used to develop the New Zealand cardiovascular disease risk prediction equations, were included in the analysis if they had a primary diagnosis of invasive cancer at least 2 years before the date of the first cardiovascular disease risk assessment. The risk prediction equations are sex-specific and include the following predictors: age, ethnicity, socioeconomic deprivation index, family history of cardiovascular disease, smoking status, history of atrial fibrillation and diabetes, systolic blood pressure, total cholesterol to HDL cholesterol ratio, and preventive pharmacotherapy (blood-pressure-lowering, lipid-lowering, and antithrombotic drugs). Calibration was assessed by comparing the mean predicted 5-year cardiovascular disease risk, estimated using the risk prediction equations, with the observed risk across deciles of risk, for men and women, and according to the three clinical 5-year cardiovascular disease risk groups in New Zealand guidelines (<5%, 5% to <15%, and ≥15%). Discrimination was assessed by Harrell's C statistic. FINDINGS: 14 263 patients were included in the study. The mean age was 61 years (SD 9) for men and 60 years (SD 8) for women, with a median follow-up of 5·8 years for men and 5·7 years for women. The observed cardiovascular disease risk was underpredicted by a maximum of 2·5% in male and 3·2% in female decile groups. When patients were grouped according to clinical risk groups, observed cardiovascular disease risk was underpredicted by less than 2% in the lower risk groups and overpredicted by 2·2% for men and 3·3% for women in the highest risk group. Harrell's C statistics were 0·67 (SE 0·01) for men and 0·73 (0·01) for women. INTERPRETATION: The New Zealand cardiovascular disease risk prediction equations reasonably predicted the observed 5-year cardiovascular disease risk in survivors of cancer in the country, in whom risk prediction was considered clinically appropriate. Prediction could be improved by adding cancer-specific variables and considering competing risks. Our findings suggest that the equations are reasonable clinical tools for use in survivors of cancer in New Zealand. FUNDING: Auckland Medical Research Foundation, Health Research Council of New Zealand.

Physicians' perspectives on clinical indicators: Systematic review and thematic synthesis.

BACKGROUND: Clinical indicators are increasingly used to improve the quality of care, particularly with the emergence of "big data", but physicians views regarding their utility in practice is unclear. We reviewed the published literature investigating physicians' perspectives, focusing on the following objectives in relation to quality improvement: 1) the role of clinical indicators, 2) what is needed to strengthen them, 3) their key attributes and 4) the best tool(s) for assessing their quality. METHODS: A systematic literature search (up to November 2022) was carried out using: Medline, EMBASE, Scopus, CINAHL, PsycInfo and Web of Science. Articles that met all of the following inclusion criteria were included: reported on physicians' perspectives on clinical indicators and/or tools for assessing the quality of clinical indicators, addressing at least one of the four review objectives; the clinical indicators related to care at least partially delivered by physicians; and published in a peer-reviewed journal. Data extracted from eligible studies were appraised using the Critical Appraisal Skills Programme (CASP) tool. A thematic synthesis of data was conducted using NVivo software. Descriptive themes were inductively derived from codes, which were grouped into analytical themes answering each objective. RESULTS: A total of 14 studies were included, with 17 analytical themes identified for objectives 1-3 and no data identified for objective 4. Results showed that indicators can play an important motivating role for physicians to improve the quality of care and show where changes need to be made. For indicators to be effective, physicians should be involved in indicator development, recording relevant data should be straightforward, indicator feedback must be meaningful to physicians, and clinical teams need to be adequately resourced to act on findings. Effective indicators need to focus on the most important areas for quality improvement, be consistent with good medical care, and measure aspects of care within the control of physicians. Studies cautioned against using indicators primarily as punitive measures, and there were concerns that an overreliance on indicators can lead to narrowed perspectives of quality of care. CONCLUSIONS: This review identifies facilitators and barriers to meaningfully engaging physicians in developing and using clinical indicators to improve the quality of health care.

Drivers of access to cardiovascular health care for rural Indigenous Peoples: a scoping review.

INTRODUCTION: Māori (the Indigenous Peoples of Aotearoa New Zealand) are disproportionately represented in cardiovascular disease (CVD) prevalence, morbidity and mortality rates, and are less likely to receive evidence-based CVD health care. Rural Māori experience additional barriers to treatment access, poorer health outcomes and a greater burden of CVD risk factors compared to Non-Māori and Māori living in urban areas. Importantly, these inequities are similarly experienced by Indigenous Peoples in other nations impacted by colonisation. Given the scarcity of available literature, a systematic scoping review was conducted on literature exploring barriers and facilitators in accessing CVD health care for rural Māori and other Indigenous Peoples in nations impacted by colonisation. METHODS: The review was underpinned by Kaupapa Māori Research methodology and was conducted utilising Arksey and O'Malley's (2005) methodological framework. A database search of MEDLINE (OVID), PubMed, Embase, SCOPUS, CINAHL Plus, Australia/New Zealand Reference Centre and NZResearch.org was used to explore empirical research literature. A grey literature search was also conducted. Literature based in any healthcare setting providing care to adults for CVD was included. Rural or remote Indigenous Peoples from New Zealand, Australia, Canada, and the US were included. Literature was included if it addressed cardiovascular conditions and reported barriers and facilitators to healthcare access in any care setting. RESULTS: A total of 363 articles were identified from the database search. An additional 19 reports were identified in the grey literature search. Following screening, 16 articles were included from the database search and 5 articles from the grey literature search. The literature was summarised using the Te Tiriti o Waitangi (Treaty of Waitangi) Framework principles: tino rangatiratanga (self-determination), partnership, active protection, equity and options. Themes elucidated from the literature were described as key drivers of CVD healthcare access for rural Indigenous Peoples. Key driver themes included input from rural Indigenous Peoples on healthcare service design and delivery, adequate resourcing and support of indigenous and rural healthcare services, addressing systemic racism and historical trauma, providing culturally appropriate health care, rural Indigenous Peoples' access to family and wellbeing support, rural Indigenous Peoples' differential access to the wider social determinants of health, effective interservice linkages and communication, and equity-driven and congruent data systems. CONCLUSION: The findings are consistent with other literature exploring access to health care for rural Indigenous Peoples. This review offers a novel approach to summarising literature by situating the themes within the context of equity and rights for Indigenous Peoples. This review also highlighted the need for further research in this area to be conducted in the context of Aotearoa New Zealand.

Cardiovascular risk prediction in type 2 diabetes before and after widespread screening: a derivation and validation study.

BACKGROUND: Until recently, most patients with diabetes worldwide have been diagnosed when symptomatic and have high cardiovascular risk, meaning most should be prescribed cardiovascular preventive medications. However, in New Zealand, a world-first national programme led to approximately 90% of eligible adults being screened for diabetes by 2016, up from 50% in 2012, identifying many asymptomatic patients with recent-onset diabetes. We hypothesised that cardiovascular risk prediction equations derived before widespread screening would now significantly overestimate risk in screen-detected patients. METHODS: New Zealanders aged 30-74 years with type 2 diabetes and without known cardiovascular disease, heart failure, or substantial renal impairment were identified from the 400 000-person PREDICT primary care cohort study between Oct 27, 2004, and Dec 30, 2016, covering the period before and after widespread screening. Sex-specific equations estimating 5-year risk of cardiovascular disease were developed using Cox regression models, with 18 prespecified predictors, including diabetes-related and renal function measures. Equation performance was compared with an equivalent equation derived in the New Zealand Diabetes Cohort Study (NZDCS), which recruited between 2000 and 2006, before widespread screening. FINDINGS: 46 652 participants were included in the PREDICT-1° Diabetes subcohort, of whom 4114 experienced first cardiovascular events during follow-up (median 5·2 years, IQR 3·3-7·4). 14 829 (31·8%) were not taking oral hypoglycaemic medications or insulin at baseline. Median 5-year cardiovascular risk estimated by the new equations was 4·0% (IQR 2·3-6·8) in women and 7·1% (4·5-11·2) in men. The older NZDCS equation overestimated median cardiovascular risk by three times in women (median 14·2% [9·7-20·0]) and two times in men (17·1% [4·5-20·0]). Model and discrimination performance measures for PREDICT-1° Diabetse equations were also significantly better than for the NZDCS equation (eg, for women: R2=32% [95% CI 29-34], Harrell's C=0·73 [0·72-0·74], Royston's D=1·410 [1·330-1·490] vs R2=24% [21-26], C=0·69 [0·67-0·70], and D=1·147 [1·107-1·187]). INTERPRETATION: International treatment guidelines still consider most people with diabetes to be at high cardiovascular risk; however, we show that recent widespread diabetes screening has radically changed the cardiovascular risk profile of people with diabetes in New Zealand. Many of these patients have normal renal function, are not dispensed glucose-lowering medications, and have low cardiovascular risk. These findings have clear international implications as increased diabetes screening is inevitable due to increasing obesity, simpler screening tests, and the introduction of new-generation glucose-lowering medications that prevent cardiovascular events. Cardiovascular risk prediction equations derived from contemporary diabetes populations, with multiple diabetes-related and renal function predictors, will be required to better differentiate between low-risk and high-risk patients in this increasingly heterogeneous population and to inform appropriate non-pharmacological management and cost-effective targeting of expensive new medications. FUNDING: Health Research Council of New Zealand, Heart Foundation of New Zealand, and Healthier Lives National Science Challenge.

Cardiovascular disease preventive medication dispensing for almost every New Zealander 65 years and over: a preventive treatment paradox?

OBJECTIVE: To describe the dispensing of cardiovascular disease (CVD) preventive medications among older New Zealanders with and without prior CVD or diabetes. METHODS: New Zealanders aged ≥65 years in 2013 were identified using anonymised linkage of national administrative health databases. Dispensing of blood pressure lowering (BPL), lipid lowering (LL) or antithrombotic (AT) medications, was documented, stratified by age and by history of CVD, diabetes, or neither. RESULTS: Of the 593,549 people identified, 32% had prior CVD, 14% had diabetes (of whom half also had prior CVD) and 61% had neither diagnosis. For those with prior CVD, between 79-87% were dispensed BPL and 73-79% were dispensed AT medications, across all age groups. In contrast, LL dispensing was lower than either BPL or AT in every age group, falling from 75% at age 65-69 years to 43% at 85+ years. For people with diabetes, BPL and LL dispensing was similar to those with prior CVD, but AT dispensing was approximately 20% lower. Among people without prior CVD or diabetes, both BPL and AT dispensing increased with age (from 39% and 17% at age 65-69 years to 56% and 35% at 85+ years respectively), whereas LL dispensing was 26-31% across the 65-84 year age groups, falling to 17% at 85+ years. CONCLUSION: The much higher dispensing of BPL and AT compared to LL medications with increasing age suggests a preventive treatment paradox for older people, with the medications most likely to cause adverse effects being dispensed most often.

Cardiovascular disease and its management among Pacific people: a systematic review by ethnicity and place of birth.

BACKGROUND: Pacific people experience a disproportionate burden of cardiovascular disease (CVD), whether they remain in their country of origin or migrate to higher-income countries, such as Australia, Aotearoa New Zealand or the United States of America. We sought to determine whether the CVD health needs of Pacific people vary according to their ethnicity or place of birth. METHODS: We conducted a systematic review of medical research databases and grey literature to identify relevant data published up to 2020. Texts were included if they contained original data stratified by Pacific-specific ethnicity or place of birth on the burden or management of CVD, and were assessed as having good quality using a National Heart, Lung, and Blood Institute quality assessment tool. The protocol for this review was registered with the Open Science Forum ( https://doi.org/10.17605/OSF.IO/X7NR6 ). RESULTS: Of 3679 texts identified, 310 full texts were reviewed and the quality of 23 of these assessed, using the pre-defined search strategy. Six items (four reports, one article, one webpage) of good quality met the review eligibility criteria. All included texts provided data on epidemiology but only one reported on the management of CVD. Four texts were of Pacific populations in Pacific Island countries and two were of Pacific diaspora in other countries. Data from the Global Burden of Disease study, which provided estimates for the greatest number of Pacific countries, showed substantial differences in mortality rates between Pacific countries for every CVD type. For example, the mortality rate per 100,000 for ischemic heart disease (IHD) ranged from 103.41 in the Cook Islands to 430.35 in the Solomon Islands. A New Zealand-based report showed differences in CVD rates by Pacific ethnicity (e.g. the age-standardised prevalence of IHD per 1,000 population in Auckland ranged from 107.8 (Niuean) to 138 among Cook Islands Maori (p < 0.001)). CONCLUSIONS: This review of published studies reveals that the epidemiology of CVD among Pacific people varies by specific ethnic groups, place of birth, and country of residence. There is a critical need for high-quality contemporary ethnic-specific Pacific data to respond to the diverse CVD health needs in these underrepresented groups.

Risk of major bleeding by ethnicity and socioeconomic deprivation among 488,107 people in primary care: a cohort study.

BACKGROUND: Antithrombotic medications (antiplatelets and anticoagulants) reduce the risk of cardiovascular disease (CVD), but with the disadvantage of increasing bleeding risk. Ethnicity and socioeconomic deprivation are independent predictors of major bleeds among patients without CVD, but it is unclear whether they are also predictors of major bleeds among patients with CVD or atrial fibrillation (AF) after adjustment for clinical variables. METHODS: Prospective cohort study of 488,107 people in New Zealand Primary Care (including 64,420 Maori, the indigenous people of New Zealand) aged 30-79 years who had their CVD risk assessed between 2007 and 2016. Participants were divided into three mutually exclusive subgroups: (1) AF with or without CVD (n = 15,212), (2) CVD and no AF (n = 43,790), (3) no CVD or AF (n = 429,105). Adjusted hazards ratios (adjHRs) were estimated from Cox proportional hazards models predicting major bleeding risk for each of the three subgroups to determine whether ethnicity and socioeconomic deprivation are independent predictors of major bleeds in different cardiovascular risk groups. RESULTS: In all three subgroups (AF, CVD, no CVD/AF), Maori (adjHR 1.63 [1.39-1.91], 1.24 [1.09-1.42], 1.57 [95% CI 1.45-1.70], respectively), Pacific people (adjHR 1.90 [1.58-2.28], 1.30 [1.12-1.51], 1.62 [95% CI 1.49-1.75], respectively) and Chinese people (adjHR 1.53 [1.08-2.16], 1.15 [0.90-1.47], 1.13 [95% CI 1.01-1.26], respectively) were at increased risk of a major bleed compared to Europeans, although for Chinese people the effect did not reach statistical significance in the CVD subgroup. Compared to Europeans, Maori and Pacific peoples were generally at increased risk of all bleed types (gastrointestinal, intracranial and other bleeds). An increased risk of intracranial bleeds was observed among Chinese and Other Asian people and, in the CVD and no CVD/AF subgroups, among Indian people. Increasing socioeconomic deprivation was also associated with increased risk of a major bleed in all three subgroups (adjHR 1.07 [1.02-1.12], 1.07 [1.03-1.10], 1.10 [95% CI 1.08-1.12], respectively, for each increase in socioeconomic deprivation quintile). CONCLUSION: Ethnicity and socioeconomic status should be considered in bleeding risk assessments to guide the use of antithrombotic medication for the management of AF and CVD.

Factors influencing the negotiation of ethnic identity among 1.5 and second-generation Asian migrants: A mixed methods systematic review.

INTRODUCTION: Whilst positive ethnic identity is associated with higher self-esteem, prosocial tendencies and peer acceptance, it is inversely associated with depressive symptoms and drug use among ethnic minority individuals. Negotiating ethnic identity is particularly challenging for 1.5-and second-generation migrant populations, finding themselves positioned between host culture and culture of origin. To inform positive youth development policies and practices, this systematic literature review aimed to identify factors influencing the negotiation of ethnic identity for 1.5-and second-generation Asian migrants living in high-income countries. METHODS: A mixed-methods systematic review was conducted of peer-reviewed literature in four databases: MEDLINE, EMBASE, PsychInfo and Scopus. Articles were screened by title, abstract and full text to ascertain whether they met the inclusion criteria. Quality of studies were assessed using MMAT Version 2011. Mixed-method thematic analysis was used to synthesis the data according to Bronfenbrenner's Ecological Model. RESULTS: Forty-seven studies met the inclusion criteria. The review findings confirm a wide range of factors influencing the negotiation of ethnic identity from three systems in Bronfenbrenner's Ecological Model, most commonly from the macrosystem (e.g stereotyping), followed by microsystem (e.g family) and individual factors (e.g heritage language use). CONCLUSIONS: Results indicate negotiating ethnic identity can be challenging and difficult, where the culture/norms of country of origin and host country play a significant role. Positive youth development policies and practices need to reflect these wide range of factors. More research is needed in countries where data is not available to facilitate greater response to needs of this increasing population group.

Predicting Bleeding Risk to Guide Aspirin Use for the Primary Prevention of Cardiovascular Disease: A Cohort Study.

Background: Many prognostic models for cardiovascular risk can be used to estimate aspirin's absolute benefits, but few bleeding risk models are available to estimate its likely harms. Objective: To develop prognostic bleeding risk models among persons in whom aspirin might be considered for the primary prevention of cardiovascular disease (CVD). Design: Prospective cohort study. Setting: New Zealand primary care. Participants: The study cohort comprised 385 191 persons aged 30 to 79 years whose CVD risk was assessed between 2007 and 2016. Those with indications for or contraindications to aspirin and those who were already receiving antiplatelet or anticoagulant therapy were excluded. Measurements: For each sex, Cox proportional hazards models were developed to predict major bleeding risk; participants were censored at the earliest of the date on which they first met an exclusion criterion, date of death, or study end date (30 June 2017). The main models included the following predictors: demographic characteristics (age, ethnicity, and socioeconomic deprivation), clinical measurements (systolic blood pressure and ratio of total-high-density lipoprotein cholesterol), family history of premature CVD, medical history (smoking, diabetes, bleeding, peptic ulcer disease, cancer, chronic liver disease, chronic pancreatitis, or alcohol-related conditions), and medication use (nonsteroidal anti-inflammatory agents, corticosteroids, and selective serotonin reuptake inhibitors). Results: During 1 619 846 person-years of follow-up, 4442 persons had major bleeding events (of which 313 [7%] were fatal). The main models predicted a median 5-year bleeding risk of 1.0% (interquartile range, 0.8% to 1.5%) in women and 1.1% (interquartile range, 0.7% to 1.6%) in men. Plots of predicted-against-observed event rates showed good calibration throughout the risk range. Limitation: Hemoglobin level, platelet count, and body mass index were excluded from the main models because of high numbers of missing values, and the models were not externally validated in non-New Zealand populations. Conclusion: Prognostic bleeding risk models were developed that can be used to estimate the absolute bleeding harms of aspirin among persons in whom aspirin is being considered for the primary prevention of CVD. Primary Funding Source: The Health Research Council of New Zealand.

Personalized Prediction of Cardiovascular Benefits and Bleeding Harms From Aspirin for Primary Prevention: A Benefit-Harm Analysis.

Background: Whether the benefits of aspirin for the primary prevention of cardiovascular disease (CVD) outweigh its bleeding harms in some patients is unclear. Objective: To identify persons without CVD for whom aspirin would probably result in a net benefit. Design: Individualized benefit-harm analysis based on sex-specific risk scores and estimates of the proportional effect of aspirin on CVD and major bleeding from a 2019 meta-analysis. Setting: New Zealand primary care. Participants: 245 028 persons (43.6% women) aged 30 to 79 years without established CVD who had their CVD risk assessed between 2012 and 2016. Measurements: The net effect of aspirin was calculated for each participant by subtracting the number of CVD events likely to be prevented (CVD risk score × proportional effect of aspirin on CVD risk) from the number of major bleeds likely to be caused (major bleed risk score × proportional effect of aspirin on major bleeding risk) over 5 years. Results: 2.5% of women and 12.1% of men were likely to have a net benefit from aspirin treatment for 5 years if 1 CVD event was assumed to be equivalent in severity to 1 major bleed, increasing to 21.4% of women and 40.7% of men if 1 CVD event was assumed to be equivalent to 2 major bleeds. Net benefit subgroups had higher baseline CVD risk, higher levels of most established CVD risk factors, and lower levels of bleeding-specific risk factors than net harm subgroups. Limitations: Risk scores and effect estimates were uncertain. Effects of aspirin on cancer outcomes were not considered. Applicability to non-New Zealand populations was not assessed. Conclusion: For some persons without CVD, aspirin is likely to result in net benefit. Primary Funding Source: Health Research Council of New Zealand.

What is the Optimal Rate of Invasive Coronary Angiography After Acute Coronary Syndrome? (ANZACS-QI 22).

BACKGROUND: Invasive coronary angiography plays a pivotal role in the management of acute coronary syndromes (ACS). Wide variability in its use has been previously documented. Our aim was to investigate whether coronary angiography is being used appropriately prior to discharge after ACS, taking into account relative contraindications of the procedure. METHODS: Patients presenting with ACS in 2015 to two large, demographically distinct New Zealand (NZ) District Health Boards (DHBs)-Counties Manukau (CMDHB) and Waitemata (WDHB)-were identified from the NZ Ministry of Health National Dataset using ICD-10-AM codes. Patients' clinical data were obtained from the electronic and paper clinical records. Pre-defined relative contraindications to coronary angiography were identified. RESULTS: Of the 3,809 patient admissions coded with ACS, 600 patient admissions (300 from each DHB) were reviewed. Sixty-one (61) (10%) did not meet diagnostic criteria for ACS on review of clinical data and were excluded. Of the patients reviewed, 55% received coronary angiography, with a higher rate in WDHB than CMDHB (61% and 49%, respectively) and 37.5% had relative contraindications documented. The overall rate of angiography was appropriately high in those without a relative contraindication (90.3%) and low in those with one (7.4%). There were fewer patients with relative contraindications in WDHB than CMDHB (36.7% and 48.5%) but the rate of angiography in those with (6.9% and 7.8%) and without (92.5% and 87.5%) contraindications in the two DHBs was similar. CONCLUSIONS: The decision to offer coronary angiography after ACS appears to be appropriately influenced by the presence or absence of relative contraindications. Approximately 60% of patients had no documented relative contraindication suggesting that this may be an appropriate angiography rate in New Zealand practice. However, differences between the two DHBs of around 10% appear to be clinically appropriate due to variation in contraindication rates.

Annual Risk of Major Bleeding Among Persons Without Cardiovascular Disease Not Receiving Antiplatelet Therapy.

Importance: A decision to initiate aspirin therapy for primary prevention of cardiovascular disease (CVD) requires consideration of both treatment benefits and harms. The most significant harm associated with aspirin is major bleeding, yet there is a paucity of data on bleeding risk in suitable community populations. Objective: To determine the risk of major bleeding among people without CVD who are not receiving antiplatelet therapy. Design, Setting, and Participants: Prospective cohort study of 359 166 individuals aged 30 to 79 years receiving primary care in New Zealand who had CVD risk assessment between 2002 and 2015. Participants were censored at the earliest date on which they had a first major bleeding event, died, or met any baseline cohort exclusion criteria or the study end date of December 31, 2015. Analyses were repeated after excluding people with medical conditions associated with increased bleeding risk (non-high-risk cohort; n=305 057) and after further excluding people receiving other medications associated with increased bleeding risk (nonmedication cohort; n=240 254). Exposures: Sex and age group in 10-year bands from 30 to 79 years. Main Outcomes and Measures: Risk of a major bleeding event (hospitalization or death associated with bleeding); nonfatal gastrointestinal tract bleeding; and gastrointestinal tract bleeding-related case fatality. Results: Mean participant age was 54 years (SD, 10 years), 44% were women, and 57% were European. Among the 359 166 individuals in the baseline cohort, 3976 had a major bleeding event during 1 281 896 person-years of follow-up. Most had gastrointestinal (GI) bleeding (n=2910 [73%]). There were 274 fatal bleeding events (7%), of which 153 were intracerebral. The risk of a nonfatal GI bleeding event per 1000 person-years was 2.19 (95% CI, 2.11-2.27), 1.77 (95% CI, 1.69-1.85) and 1.61 (95% CI, 1.52-1.69), in the baseline, non-high-risk, and nonmedication cohorts, respectively. Case fatality associated with GI bleeding was 3.4% (95% CI, 2.2%-4.1%), 4.0% (95% CI, 3.2%-5.1%), and 4.6% (95% CI, 3.6%-6.0%) in the baseline, non-high-risk, and nonmedication cohorts, respectively. Conclusions and Relevance: In a population not receiving antiplatelet therapy, the annual risk of major bleeding events and nonfatal major bleeding was estimated. These findings could inform population-level guidelines for primary prevention of CVD.

Fixed Low-Dose Triple Combination Antihypertensive Medication vs Usual Care for Blood Pressure Control in Patients With Mild to Moderate Hypertension in Sri Lanka: A Randomized Clinical Trial.

Importance: Poorly controlled hypertension is a leading global public health problem requiring new treatment strategies. Objective: To assess whether a low-dose triple combination antihypertensive medication would achieve better blood pressure (BP) control vs usual care. Design, Setting, and Participants: Randomized, open-label trial of a low-dose triple BP therapy vs usual care for adults with hypertension (systolic BP >140 mm Hg and/or diastolic BP >90 mm Hg; or in patients with diabetes or chronic kidney disease: >130 mm Hg and/or >80 mm Hg) requiring initiation (untreated patients) or escalation (patients receiving monotherapy) of antihypertensive therapy. Patients were enrolled from 11 urban hospital clinics in Sri Lanka from February 2016 to May 2017; follow-up ended in October 2017. Interventions: A once-daily fixed-dose triple combination pill (20 mg of telmisartan, 2.5 mg of amlodipine, and 12.5 mg of chlorthalidone) therapy (n = 349) or usual care (n = 351). Main Outcomes and Measures: The primary outcome was the proportion achieving target systolic/diastolic BP (<140/90 mm Hg or <130/80 mm Hg in patients with diabetes or chronic kidney disease) at 6 months. Secondary outcomes included mean systolic/diastolic BP difference during follow-up and withdrawal of BP medications due to an adverse event. Results: Among 700 randomized patients (mean age, 56 years; 58% women; 29% had diabetes; mean baseline systolic/diastolic BP, 154/90 mm Hg), 675 (96%) completed the trial. The triple combination pill increased the proportion achieving target BP vs usual care at 6 months (70% vs 55%, respectively; risk difference, 12.7% [95% CI, 3.2% to 22.0%]; P < .001). Mean systolic/diastolic BP at 6 months was 125/76 mm Hg for the triple combination pill vs 134/81 mm Hg for usual care (adjusted difference in postrandomization BP over the entire follow-up: systolic BP, -9.8 [95% CI, -7.9 to -11.6] mm Hg; diastolic BP, -5.0 [95% CI, -3.9 to -6.1] mm Hg; P < .001 for both comparisons). Overall, 419 adverse events were reported in 255 patients (38.1% for triple combination pill vs 34.8% for usual care) with the most common being musculoskeletal pain (6.0% and 8.0%, respectively) and dizziness, presyncope, or syncope (5.2% and 2.8%). There were no significant between-group differences in the proportion of patient withdrawal from BP-lowering therapy due to adverse events (6.6% for triple combination pill vs 6.8% for usual care). Conclusions and Relevance: Among patients with mild to moderate hypertension, treatment with a pill containing low doses of 3 antihypertensive drugs led to an increased proportion of patients achieving their target BP goal vs usual care. Use of such medication as initial therapy or to replace monotherapy may be an effective way to improve BP control. Trial Registration: anzctr.org.au Identifier: ACTRN12612001120864; slctr.lk Identifier: SLCTR/2015/020.

TRIple pill vs Usual care Management for Patients with mild-to-moderate Hypertension (TRIUMPH): Study protocol.

BACKGROUND: Hypertension management strategies have traditionally focused on "tailored therapy" and "stepped-care" approaches. These tend to be costly and time consuming and often fail to achieve adequate blood pressure (BP) control. The TRIUMPH study aims to investigate the effectiveness, cost-effectiveness, and acceptability of early use of a 3-in-1 BP-lowering pill ("Triple Pill") compared with usual care for the management of hypertension. METHODS: The prospective, open, randomized controlled clinical trial (n = 700) will compare Triple Pill-based strategy to usual care among individuals with persistent mild-to-moderate hypertension (systolic BP >140 mm Hg and/or diastolic BP >90 mm Hg, or systolic BP >130 mm Hg and/or diastolic BP >80 mm Hg in patients with diabetes or chronic kidney disease) on no or minimal drug therapy. The study will be conducted within approximately 20 hospital-based clinics in India. Participants will be randomized to the Triple Pill (initially strength 1-telmisartan 20 mg, amlodipine 2.5 mg, hydrochlorothiazide 6.25 mg, with the option of subsequent titration to strength 2-telmisartan 40 mg, amlodipine 5 mg, hydrochlorothiazide 12.5 mg) or continued usual care. Participants will be followed up for 6 months. The primary outcome is the proportion of participants achieving target BP at the end follow-up. CONCLUSION: This study will determine whether early use of a low-dose triple combination therapy has the potential to address some of the challenges in hypertension control through earlier achievement of BP control, better adherence, and fewer adverse effects, in the context of less intensive clinical follow-up.

Maori and Pacific families' experiences and perspectives of cardiovascular care; A qualitative study.

OBJECTIVE: This study aimed to understand the reasons behind evidence-practice gaps and inequities in cardiovascular care for Maori and Pacific people, as evidenced by the experiences and perspectives of patients and their families. METHODS: The research was guided by Maori and Pacific worldviews, incorporating Kaupapa Maori Theory and Pacific conceptual frameworks and research methodologies. Template analysis was used to analyse interview data from 61 Maori and Pacific people who had experienced a cardiovascular disease (CVD) risk assessment, acute coronary syndrome, and/or heart failure. RESULTS: The range of experiences relating to participants' heart health journeys are presented in five main themes: Context, Mana (maintaining control and dignity), Condition, People and Journey. CONCLUSIONS: Maori and Pacific people want to take charge of their heart health but face challenges. Participants described important obligations to family, community and tikanga (the culturally correct way of doing things). Participants described times when health care undermined existing responsibilities, their dignity and/or their mana, and they felt excluded from treatment as a result. IMPLICATIONS FOR PUBLIC HEALTH: Good reciprocal communication, stemming from a high-quality relationship is essential for successful outcomes. A workforce that is representative of the population it serves and is culturally safe lays the foundation for excellence in care.

Development and validation of cardiovascular risk prediction equations in 76 000 people with known cardiovascular disease.

AIMS: Multiple health administrative databases can be individually linked in Aotearoa New Zealand, using encrypted identifiers. These databases were used to develop cardiovascular risk prediction equations for patients with known cardiovascular disease (CVD). METHODS AND RESULTS: Administrative health databases were linked to identify all people aged 18-84 years with known CVD, living in Auckland and Northland, Aotearoa New Zealand, on 1 January 2014. The cohort was followed until study outcome, death, or 5 years. The study outcome was death or hospitalization due to ischaemic heart disease, stroke, heart failure, or peripheral vascular disease. Sex-specific 5-year CVD risk prediction equations were developed using multivariable Fine and Gray models. A total of 43 862 men {median age: 67 years [interquartile range (IQR): 59-75]} and 32 724 women [median age: 70 years (IQR: 60-77)] had 14 252 and 9551 cardiovascular events, respectively. Equations were well calibrated with good discrimination. Increasing age and deprivation, recent cardiovascular hospitalization, Mori ethnicity, smoking history, heart failure, diabetes, chronic renal disease, atrial fibrillation, use of blood pressure lowering and anti-thrombotic drugs, haemoglobin A1c, total cholesterol/HDL cholesterol, and creatinine were statistically significant independent predictors of the study outcome. Fourteen per cent of men and 23% of women had predicted 5-year cardiovascular risk <15%, while 28 and 24% had ≥40% risk. CONCLUSION: Robust cardiovascular risk prediction equations were developed from linked routine health databases, a currently underutilized resource worldwide. The marked heterogeneity demonstrated in predicted risk suggests that preventive therapy in people with known CVD would be better informed by risk stratification beyond a one-size-fits-all high-risk categorization.

Using regionwide New Zealand health databases, methods of predicting hospitalization risk in patients with existing heart disease were developed. Using only data from health databases, it was possible to predict the risk accurately.Among patients with existing heart disease, the predicted risk varied markedly which could help improve preventive strategies.

Recruiting equal numbers of indigenous and non-indigenous participants to a 'polypill' randomized trial.

INTRODUCTION: Maori are disproportionately affected by cardiovascular disease (CVD), which is the main reason for the eight year difference in life expectancy between Maori and non-Maori. The primary care-based IMPACT (IMProving Adherence using Combination Therapy) trial evaluates whether fixed dose combination therapy (a "polypill") improves adherence to guideline-based therapy compared with current care among people at high risk of CVD. Interventions shown in trials to be effective do not necessarily reduce ethnic disparities, and may in fact widen them. Indigenous populations with poorer health outcomes are often under-represented in trials so the effect of interventions cannot be assessed for them, specifically. Therefore, the IMPACT trial aimed to recruit as many Maori as non-Maori to assess the consistency of the effect of the polypill. This paper describes the methods and results of the recruitment strategy used to achieve this. METHODS: Experienced Maori researchers were involved in trial governance throughout trial development and conduct. The trial Steering Committee included leading Maori researchers and was committed to equal recruitment of Maori and non-Maori. Additional funding and Maori research nurses were sought to allow home-based assessment, establishment of the relationship between research nurse and participant, more family involvement prior to enrollment, continuity of the research nurse-participant relationship, and acknowledgement of other Maori culturally important procedures, interactions, language and manners. Primary care practices with high enrollment of Maori were targeted, with over-sampling of potentially eligible Maori patients, lower thresholds for screening of Maori and 6 months continued Maori recruitment after non-Maori recruitment had finished. RESULTS: A total of 257 Maori and 256 non-Maori participants were randomized. Four Maori and eight non-Maori participants were randomized per research nurse per month. Potentially eligible Maori were more likely than non-Maori to proceed to subsequent stages of recruitment. Differences between randomized Maori and non-Maori were evident (e.g. Maori were less likely to have established coronary artery disease). CONCLUSIONS: Recruitment of equal numbers of indigenous and non-indigenous participants is possible if it is prioritised, adequately resourced and self-determination is supported. TRIAL REGISTRATION: The trial is registered with the Australian New Zealand Clinical Trial Registry ACTRN12606000067572.

Pacific patients' reasons for attending the emergency department of Counties Manukau for non-urgent conditions.

AIM: To determine Pacific patients' reasons for Emergency Department (ED) use for non-urgent conditions by Pacific people at Counties Manukau Health. METHODS: Patients who self-presented to Counties Manukau ED with a non-urgent condition in June 2019 were surveyed. Responses to open-ended questions were analysed using a general inductive approach, in discussion with key stakeholders. RESULTS: Of 353 participants with ethnicity reported, 139 (39%) were Pacific, 66 (19%) Maori and 148 (42%) were non-Maori non-Pacific, nMnP. A total of 58 (42%) of Pacific participants had been to their general practitioner prior to presenting to the ED; this proportion was similar for Maori (19 [30%]) and nMnP (59 [40%]) (p=0.215). The most common reasons for ED attendance among Pacific (as well as other) participants were 1) advice by a health professional (41%, 95% CI 33-50%), 2) usual care unavailable (28%, 20-36%), 3) symptoms not improving (21%, 14-28%), and 4) symptoms too severe to be managed elsewhere (19%, 12-26%). CONCLUSIONS: Multiple reasons underlie non-urgent use of EDs by Pacific and other ethnic groups. These reasons need to be considered simultaneously in the design, implementation, and evaluation of multi-dimensional initiatives that discourage non-urgent use of EDs to ensure that such initiatives are effective, equitable, and unintended consequences are avoided.

The risk of subsequent invasive melanoma after a primary in situ or invasive melanoma in a high incidence country (New Zealand).

Background: Patients with invasive melanoma are at increased risk of developing subsequent invasive melanoma, but the risks for those with primary in situ melanoma are unclear. Objectives: To assess and compare the cumulative risk of subsequent invasive melanoma after primary invasive or in situ melanoma. To estimate the standardized incidence ratio (SIR) of subsequent invasive melanoma compared to population incidence in both cohorts. Methods: Patients with a first diagnosis of melanoma (invasive or in situ) between 2001 and 2017 were identified from the New Zealand national cancer registry, and any subsequent invasive melanoma during follow-up to the end of 2017 identified. Cumulative risk of subsequent invasive melanoma was estimated by Kaplan-Meier analysis separately for primary invasive and in situ cohorts. Risk of subsequent invasive melanoma was assessed using Cox proportional hazard models. SIR was assessed, allowing for age, sex, ethnicity, year of diagnosis and follow up time. Results: Among 33 284 primary invasive and 27 978 primary in situ melanoma patients, median follow up time was 5.5 and 5.7 years, respectively. A subsequent invasive melanoma developed in 1777 (5%) of the invasive and 1469 (5%) of the in situ cohort, with the same median interval (2.5 years) from initial to first subsequent lesion in both cohorts. The cumulative incidence of subsequent invasive melanoma at 5 years was similar in the two cohorts (invasive 4.2%, in situ 3.8%); the cumulative incidence increased linearly over time in both cohorts. The risk of subsequent invasive melanoma was marginally higher for primary invasive compared to in situ melanoma after adjustment for age, sex, ethnicity and body site of the initial lesion (hazard ratio 1.11, 95% CI 1.02-1.21). Compared to population incidence, the SIR of invasive melanoma was 4.6 (95% CI 4.3-4.9) for the primary invasive and 4 (95% CI 3.7-4.2) for the primary in situ melanoma cohorts. Conclusions: The risk of subsequent invasive melanoma is similar whether patients present with in situ or invasive melanoma. Thus follow-up surveillance for new lesions should be similar, although patients with invasive melanoma require more surveillance for recurrence.

Who are Pacific peoples in terms of ethnicity and country of birth? A cross sectional study of 2,238,039 adults in Aotearoa New Zealand's Integrated Data Infrastructure.

Background: The aggregation of Indigenous peoples from Pacific Island nations as 'Pacific peoples' in literature may mask diversity in the health needs of these different groups. The aim of this study was to examine the heterogeneity of Pacific groups according to ethnicity and country of birth. Methods: Anonymised individual-level linkage of administrative data identified all NZ residents aged 30-74 years on 31 March 2013 with known ethnicity and country of birth. All participants were described according to ethnicity and country of birth. Pacific participants were also described according to the number of ethnicities they identified. Findings: A total of 2,238,039 NZ residents were included, of whom 117,957 (5·0%) were Pacific. Nearly two-thirds of Pacific peoples (65·7%) were born overseas, ranging from 45·3% (Cook Islands Maori) to 82·7% (Fijian) (Maori 2·3%, non-Maori non-Pacific 28·9%). Among NZ-born Pacific peoples, 46·9% (Samoan) to 81·9% (Fijian) were multi-ethnic; the proportion was much lower for overseas-born Pacific peoples (ranging from 3·7% [Tongan] to 23·9% [Tokelauan]). Interpretation: There is substantial heterogeneity among Pacific peoples in their country of birth and identification with sole or multiple ethnicities. Assumptions regarding homogeneity in the needs of Pacific peoples are not appropriate and government statistics should therefore disaggregate Pacific peoples whenever possible. Funding: Supported by the Health Research Council of New Zealand and a part of Manawataki Fatu Fatu, a programme of research funded by the National Heart Foundation of New Zealand and Healthier Lives - He Oranga Hauora - National Science Challenge of New Zealand.