Reaching cardiovascular prevention guideline targets with a polypill-based approach: a meta-analysis of randomised clinical trials.

OBJECTIVE: The aim of this study was to determine the effect of polypill-based care on the achievement of 2016 European Society of Cardiology (ESC) guideline targets for blood pressure (BP), low-density lipoprotein (LDL) cholesterol and antiplatelet therapy. METHODS: We conducted an individual participant data meta-analysis of three randomised clinical trials that compared a strategy using a polypill containing aspirin, statin and antihypertensive therapy with usual care in patients with a prior cardiovascular disease (CVD) event or who were at high risk of their first event. Overall, the trials included 3140 patients from Australia, England, India, Ireland, the Netherlands and New Zealand (75% male, mean age 62 years and 76% with a prior CVD event). The primary outcome for this study was the proportion of people achieving ESC guideline targets for BP, LDL and antiplatelet therapy. RESULTS: Those randomised to polypill-based care were more likely than those receiving usual care to achieve recommended targets for BP (62% vs 58%, risk ratio (RR) 1.08, 95% CI 1.02 to 1.15), LDL (39% vs 34%, RR 1.13, 95% CI 1.02 to 1.25) and all three targets for BP, LDL and adherence to antiplatelet therapy (the latter only applicable to those with a prior CVD event) simultaneously (24% vs 19%, RR 1.27, 95% CI 1.10 to 1.47) at 12 months. There was no difference between groups in antiplatelet adherence (96% vs 96%, RR 1.00, 95% CI 0.98 to 1.01). There was heterogeneity by baseline treatment intensity such that treatment effects increased with the fewer the number of treatments being taken at baseline: for patients taking 3, 2 and 0-1 treatment modalities the RRs for reaching all three guideline goals simultaneously were 1.10 (95% CI 0.94 to 1.30, 22% vs 20%), 1.62 (95% CI 1.09 to 2.42, 27% vs 17%) and 3.07 (95% CI 1.77 to 5.33, 35% vs 11%), respectively. CONCLUSIONS: Polypill-based therapy significantly improved the achievement of all three ESC targets for BP, LDL and antiplatelet therapy compared with usual care, particularly among those undertreated at baseline.

Safer Prescribing and Care for the Elderly (SPACE): a pilot study in general practice.

BACKGROUND: High-risk prescribing places patients at increased risk of adverse drug events (ADEs). High-risk prescribing and ADE hospitalisations are increasingly common as people are living longer and taking more medicines for multiple chronic conditions. The Safer Prescribing and Care for the Elderly (SPACE) intervention is designed to foster patient engagement in medicines management and prompt medicines review. AIM: To pilot the SPACE intervention in preparation for a larger cluster randomised controlled trial (RCT). DESIGN & SETTING: A pilot study in two general practices. Study participants were all patients at increased risk of an adverse drug reaction (ADE) from non-steroidal anti-inflammatory drugs (NSAIDs) and/or antiplatelet medicines. The primary outcome was the proportion of participants receiving high-risk prescribing at 6 months and 12 months compared with baseline. METHOD: The SPACE intervention comprised automated practice audit to identify and generate for each GP a list of patients with high-risk prescribing for these medicines; an outreach visit by clinical advisory pharmacist to deliver education and to go through with each GP their list of at-risk patients and indicate in a tick-box the intended action for each patient; and a mail-out from GPs to selected patients containing a medicines information brochure and a letter encouraging patients to discuss their medicines when they next see their GP. RESULTS: SPACE can be delivered within existing primary care infrastructure. The rate of high-risk prescribing was reduced at 6 months following the delivery of the intervention, but these improvements were not evident at 12 months. CONCLUSION: SPACE prompts medicines review and shows promising signs of supporting safer prescribing in general practice in the short term. A randomised trial of SPACE started in 2018.

International Validation of the Thrombolysis in Myocardial Infarction (TIMI) Risk Score for Secondary Prevention in Post-MI Patients: A Collaborative Analysis of the Chronic Kidney Disease Prognosis Consortium and the Risk Validation Scientific Committee.

BACKGROUND: The Thrombolysis in Myocardial Infarction (TIMI) Risk Score for Secondary Prevention (TRS2°P), a 0-to-9-point system based on the presence/absence of 9 clinical factors, was developed to classify the risk of major adverse cardiovascular events (MACE) (a composite of cardiovascular death, recurrent myocardial infarction, or ischemic stroke) among patients with a recent myocardial infarction. Its performance has not been examined internationally outside of a clinical trial setting. METHODS AND RESULTS: We evaluated the performance of TRS2°P for predicting MACE in 53 599 patients with recent myocardial infarction in 5 international cohorts from New Zealand, South Korea, Sweden, and the United States participating in the Chronic Kidney Disease Prognosis Consortium. Overall, there were 19 444 cases of MACE across 5 cohorts over a mean follow-up of 5 years, and the overall MACE rate ranged from 5.0 to 18.4 (per 100 person-years). The TRS2°P showed modest calibration (Brier score ranged from 0.144 to 0.173) and discrimination (C-statistics >0.61 in all studies except 1 from Korea with 0.55) across cohorts relative to its original Brier score of 0.098 and C-statistic of 0.67 in the derived data set. Although there was some heterogeneity across cohorts, the 9 predictors in the TRS2°P were generally associated with higher MACE risk, with strongest associations observed (meta-analyzed adjusted hazard ratio 1.6-1.7) for history of heart failure, age ≥75 years, and prior stroke, followed by peripheral artery disease, kidney dysfunction, diabetes mellitus, and hypertension (hazard ratio 1.3-1.4). Prior coronary bypass graft surgery and smoking did not reach statistical significance (hazard ratio ≈1.1). CONCLUSIONS: TRS2°P, a simple scoring system with 9 routine clinical factors, was modestly predictive of secondary events when applied in patients with recent myocardial infarction from diverse clinical and geographic settings.

Effectiveness of Chiropractic Care to Improve Sensorimotor Function Associated With Falls Risk in Older People: A Randomized Controlled Trial.

OBJECTIVE: This study assessed whether 12 weeks of chiropractic care was effective in improving sensorimotor function associated with fall risk, compared with no intervention, in community-dwelling older adults living in Auckland, New Zealand. METHODS: Sixty community-dwelling adults older than 65 years were enrolled in the study. Outcome measures were assessed at baseline, 4 weeks, and 12 weeks and included proprioception (ankle joint position sense), postural stability (static posturography), sensorimotor function (choice stepping reaction time), multisensory integration (sound-induced flash illusion), and health-related quality of life (SF-36). RESULTS: Over 12 weeks, the chiropractic group improved compared with the control group in choice stepping reaction time (119 milliseconds; 95% confidence interval [CI], 26-212 milliseconds; P = .01) and sound-induced flash illusion (13.5%; 95% CI, 2.9%-24.0%; P = .01). Ankle joint position sense improved across the 4- and 12-week assessments (0.20°; 95% CI, 0.01°-0.39°; P = .049). Improvements were also seen between weeks 4 and 12 in the SF-36 physical component of quality of life (2.4; 95% CI, 0.04-4.8; P = .04) compared with control. CONCLUSION: Sensorimotor function and multisensory integration associated with fall risk and the physical component of quality of life improved in older adults receiving chiropractic care compared with control. Future research is needed to investigate the mechanisms of action that contributed to the observed changes in this study and whether chiropractic care has an impact on actual falls risk in older adults.

A Peer-Support and Mindfulness Program to Improve the Mental Health of Medical Students.

PROBLEM: There is evidence that peer-support programs can improve mental health indices and help-seeking behavior among students in some secondary school and university settings and that mindfulness can improve mental health in medical students. Peer-led programs have not been formally assessed in a medical student population, where psychological issues exist and where it has been shown that students approach peers for help in preference to staff members or professional services. INTERVENTION: Medical students elected peer leaders who underwent training and then provided the intervention. The peer leaders provided support to students in the intervention group, as well as offering teaching in mindfulness meditation. CONTEXT: An exploratory study was conducted with 2nd- and 3rd-year medical students at 1 medical school in New Zealand randomized into 2 groups. In addition to existing mental health resources, intervention participants received a program including peer support and peer-taught mindfulness practice. Study participants not offered the intervention participants could use existing mental health resources. Primary measures included depression (PHQ-9) and anxiety (GAD-7) scores. Secondary measures were quality of life, resilience (15-item resilience scale), academic self-concept, and motivation to learn, assessed at baseline and 6 months. OUTCOME: Of the 402 students eligible, 275 (68%) participated and 232 (58%) completed the study. At baseline, 53% were female and mean age was 21 years (SD = 3)-PHQ-9 score (M = 5.2, SD = 3.7) and GAD-7 score (M = 4.5, SD = 3.4). Twelve peer leaders were elected. There was good participation in the intervention. One fourth of intervention students used the face-to-face peer support and more than 50% attended a peer social event and/or participated in the mindfulness program. Although improvements in mental health were seen in the intervention group, the difference between the intervention and nonintervention groups did not reach statistical significance. LESSONS LEARNED: Although evidence exists for effectiveness of peer support and mindfulness in other contexts, this exploratory study was not able to show a statistically significant effect. Future studies could consider using a longer training period for the peer leaders, as well as targeting the study population to those most likely to benefit such as those with poorer mental health, or using a more intensive intervention or larger sample size. A cluster randomized study design would also reduce the risk of contamination.

Exploring the maternal and infant continuum - ethnic disparities in infant hospital admissions for respiratory disease.

OBJECTIVE: To investigate maternal and birth-related risk factors associated with infant respiratory hospitalisations in New Zealand. METHODS: A Kaupapa Maori-framed retrospective cohort analysis of public hospital maternal data linked to infant data (54,980 births 1995-2009). Primary outcome was rate of hospitalisation for respiratory disease in the first year of life. Risk variables examined included socioeconomic status (SES), age, smoking, parity, gestation, time to hospital discharge, breastfeeding and maternal ethnicity as a potential marker of differential exposure to risk factors. RESULTS: Independent risk factors for hospitalisation included low maternal SES (rate ratio: 1.33 [95% CI 1.19-1.49]); smoking (1.3 [1.19-1.41]); parity (2.77 [2.37-3.24]); preterm birth (3.14 [2.58-3.83]; 30 compared with 40 weeks); but not breastfeeding (0.99 [0.87-1.11]). After adjustment for risk factors, respiratory hospitalisations remained highest among infants of young Maori women (rate ratio 1.93 [1.46-2.55] at age 22.5 years) and Pacific women across all maternal age groups (rate ratios 2.43 to 2.55), compared with infants of European women. CONCLUSIONS: Maternal and birth factors are strongly associated with ethnic disparities in infant hospital admissions for respiratory disease. IMPLICATIONS: Interventions that begin in pregnancy and address risk factors and social determinants of health are needed to address these disparities.

Multinational Assessment of Accuracy of Equations for Predicting Risk of Kidney Failure: A Meta-analysis.

IMPORTANCE: Identifying patients at risk of chronic kidney disease (CKD) progression may facilitate more optimal nephrology care. Kidney failure risk equations, including such factors as age, sex, estimated glomerular filtration rate, and calcium and phosphate concentrations, were previously developed and validated in 2 Canadian cohorts. Validation in other regions and in CKD populations not under the care of a nephrologist is needed. OBJECTIVE: To evaluate the accuracy of the risk equations across different geographic regions and patient populations through individual participant data meta-analysis. DATA SOURCES: Thirty-one cohorts, including 721,357 participants with CKD stages 3 to 5 in more than 30 countries spanning 4 continents, were studied. These cohorts collected data from 1982 through 2014. STUDY SELECTION: Cohorts participating in the CKD Prognosis Consortium with data on end-stage renal disease. DATA EXTRACTION AND SYNTHESIS: Data were obtained and statistical analyses were performed between July 2012 and June 2015. Using the risk factors from the original risk equations, cohort-specific hazard ratios were estimated and combined using random-effects meta-analysis to form new pooled kidney failure risk equations. Original and pooled kidney failure risk equation performance was compared, and the need for regional calibration factors was assessed. MAIN OUTCOMES AND MEASURES: Kidney failure (treatment by dialysis or kidney transplant). RESULTS: During a median follow-up of 4 years of 721,357 participants with CKD, 23,829 cases kidney failure were observed. The original risk equations achieved excellent discrimination (ability to differentiate those who developed kidney failure from those who did not) across all cohorts (overall C statistic, 0.90; 95% CI, 0.89-0.92 at 2 years; C statistic at 5 years, 0.88; 95% CI, 0.86-0.90); discrimination in subgroups by age, race, and diabetes status was similar. There was no improvement with the pooled equations. Calibration (the difference between observed and predicted risk) was adequate in North American cohorts, but the original risk equations overestimated risk in some non-North American cohorts. Addition of a calibration factor that lowered the baseline risk by 32.9% at 2 years and 16.5% at 5 years improved the calibration in 12 of 15 and 10 of 13 non-North American cohorts at 2 and 5 years, respectively (P = .04 and P = .02). CONCLUSIONS AND RELEVANCE: Kidney failure risk equations developed in a Canadian population showed high discrimination and adequate calibration when validated in 31 multinational cohorts. However, in some regions the addition of a calibration factor may be necessary.

Simplified sleep restriction for insomnia in general practice: a randomised controlled trial.

BACKGROUND: Insomnia is common in primary care. Cognitive behavioural therapy for insomnia (CBT-I) is effective but requires more time than is available in the general practice consultation. Sleep restriction is one behavioural component of CBT-I. AIM: To assess whether simplified sleep restriction (SSR) can be effective in improving sleep in primary insomnia. DESIGN AND SETTING: Randomised controlled trial of patients in urban general practice settings in Auckland, New Zealand. METHOD: Adults with persistent primary insomnia and no mental health or significant comorbidity were eligible. Intervention patients received SSR instructions and sleep hygiene advice. Control patients received sleep hygiene advice alone. Primary outcomes included change in sleep quality at 6 months measured by the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), and sleep efficiency (SE%). The proportion of participants reaching a predefined 'insomnia remission' treatment response was calculated. RESULTS: Ninety-seven patients were randomised and 94 (97%) completed the study. At 6-month follow-up, SSR participants had improved PSQI scores (6.2 versus 8.4, P<0.001), ISI scores (8.6 versus 11.1, P = 0.001), actigraphy-assessed SE% (difference 2.2%, P = 0.006), and reduced fatigue (difference -2.3 units, P = 0.04), compared with controls. SSR produced higher rates of treatment response (67% [28 out of 42] versus 41% [20 out of 49]); number needed to treat = 4 (95% CI = 2.0 to 19.0). Controlling for age, sex, and severity of insomnia, the adjusted odds ratio for insomnia remission was 2.7 (95% CI = 1.1 to 6.5). There were no significant differences in other outcomes or adverse effects. CONCLUSION: SSR is an effective brief intervention in adults with primary insomnia and no comorbidities, suitable for use in general practice.

A Meta-analysis of the Association of Estimated GFR, Albuminuria, Diabetes Mellitus, and Hypertension With Acute Kidney Injury.

BACKGROUND: Diabetes mellitus and hypertension are risk factors for acute kidney injury (AKI). Whether estimated glomerular filtration rate (eGFR) and urine albumin-creatinine ratio (ACR) remain risk factors for AKI in the presence and absence of these conditions is uncertain. STUDY DESIGN: Meta-analysis of cohort studies. SETTING & POPULATION: 8 general-population (1,285,045 participants) and 5 chronic kidney disease (CKD; 79,519 participants) cohorts. SELECTION CRITERIA FOR STUDIES: Cohorts participating in the CKD Prognosis Consortium. PREDICTORS: Diabetes and hypertension status, eGFR by the 2009 CKD Epidemiology Collaboration creatinine equation, urine ACR, and interactions. OUTCOME: Hospitalization with AKI, using Cox proportional hazards models to estimate HRs of AKI and random-effects meta-analysis to pool results. RESULTS: During a mean follow-up of 4 years, there were 16,480 episodes of AKI in the general-population and 2,087 episodes in the CKD cohorts. Low eGFRs and high ACRs were associated with higher risks of AKI in individuals with or without diabetes and with or without hypertension. When compared to a common reference of eGFR of 80mL/min/1.73m(2) in nondiabetic patients, HRs for AKI were generally higher in diabetic patients at any level of eGFR. The same was true for diabetic patients at all levels of ACR compared with nondiabetic patients. The risk gradient for AKI with lower eGFRs was greater in those without diabetes than with diabetes, but similar with higher ACRs in those without versus with diabetes. Those with hypertension had a higher risk of AKI at eGFRs>60mL/min/1.73m(2) than those without hypertension. However, risk gradients for AKI with both lower eGFRs and higher ACRs were greater for those without than with hypertension. LIMITATIONS: AKI identified by diagnostic code. CONCLUSIONS: Lower eGFRs and higher ACRs are associated with higher risks of AKI among individuals with or without either diabetes or hypertension.

Development and validation of a predictive risk model for all-cause mortality in type 2 diabetes.

AIMS: Type 2 diabetes is common and is associated with an approximate 80% increase in the rate of mortality. Management decisions may be assisted by an estimate of the patient's absolute risk of adverse outcomes, including death. This study aimed to derive a predictive risk model for all-cause mortality in type 2 diabetes. METHODS: We used primary care data from a large national multi-ethnic cohort of patients with type 2 diabetes in New Zealand and linked mortality records to develop a predictive risk model for 5-year risk of mortality. We then validated this model using information from a separate cohort of patients with type 2 diabetes. RESULTS: 26,864 people were included in the development cohort with a median follow up time of 9.1 years. We developed three models initially using demographic information and then progressively more clinical detail. The final model, which also included markers of renal disease, proved to give best prediction of all-cause mortality with a C-statistic of 0.80 in the development cohort and 0.79 in the validation cohort (7610 people) and was well calibrated. Ethnicity was a major factor with hazard ratios of 1.37 for indigenous Maori, 0.41 for East Asian and 0.55 for Indo Asian compared with European (P<0.001). CONCLUSIONS: We have developed a model using information usually available in primary care that provides good assessment of patient's risk of death. Results are similar to models previously published from smaller cohorts in other countries and apply to a wider range of patient ethnic groups.

Computer Assisted Learning for the Mind (CALM): the mental health of medical students and their use of a self-help website.

AIMS: The aim of this study was to develop an evidence-based self-help website, Computer Assisted Learning for the Mind (CALM) designed to improve mental health amongst medical students; and to assess the proportion, demographics and mental health of students who chose to use the site. METHODS: All 2nd and 3rd year medical students from one New Zealand university were invited to participate. Demographics and mental health scores of those accessing CALM were compared with those not accessing it. Outcome measures included depression (PHQ-9) and anxiety (GADS-7) scores recorded at baseline. Anonymous identifiers were used to track website use. RESULTS: Baseline questionnaires were completed by 279/321 (87%) of eligible students. CALM was accessed by 80/321 (25%) of the students over a 5 week period. Those who accessed CALM and could be linked by unique identifier (n=49) had significantly higher anxiety scores (p=0.01) but not higher depression scores (p=0.067) at baseline, than those who did not access CALM (n=230). Of those students with both PHQ-9 scores and GAD-7 scores =10 (at risk of significant depression and anxiety) at baseline, 41% went on to access CALM. CONCLUSIONS: The CALM website was used by 25% of medical students, particularly those with poorer anxiety scores. Self-selection to a web-based resource may provide assistance to those most in need, but further research would be needed to assess effectiveness.

Feasibility of an after-school group-based exercise and lifestyle programme to improve cardiorespiratory fitness and health in less-active Pacific and Maori adolescents.

INTRODUCTION: Obesity and low levels of physical activity are increasing among Pacific and Maori adolescents in New Zealand. AIM: To assess the feasibility of an after-school exercise and lifestyle programme to improve cardiorespiratory fitness, health and usual activity in less-active Pacific and Maori adolescents over six weeks. METHODS: Eighteen less-active secondary school students participated. The six-week programme included 3 x 1.5 hour exercise and healthy lifestyle sessions per week. Outcomes included estimated cardiorespiratory fitness (VO2max), insulin resistance (Homeostasis Model Assessment), physical activity, glycated haemoglobin (HbA1c), fasting plasma glucose, blood pressure, waist circumference and fasting lipids, measured at baseline and six weeks. Programme attendance and qualitative comments were also recorded. Student's t-tests were used. RESULTS: Of the 18 students enrolled, 16 (89%) completed six-week follow-up, 14 (78%) were female, 13 (72%) were Pacific ethnicity and 5 (28%) were Maori . At baseline, mean age was 16.3 (standard deviation [SD] 1.0) years, body mass index (BMI) 35.2 (SD 6.7) kg/m2, VO2max 31.5 (SD 4.3) mL/kg/min, systolic blood pressure 125.0 (SD 12.9) mm Hg, HbA1c 39.9 (SD 3.8) mmol/mol, fasting serum insulin 28.3 (SD 27.8) µU/mL. At follow-up, improvements had occurred in VO2max (3.2 mL/kg/min; p=0.02), systolic blood pressure (-10.6 mm Hg; p=0.003), HbA1c (-1.1 mmol/mol; p=0.03) and weekly vigorous (4 hours, p=0.002) and moderate (2 hours, p=0.006) physical activity, although waist circumference increased (p=0.005). Programme attendance was over 50%. Comments were mostly positive. DISCUSSION: The after-school exercise and lifestyle programme and study methods were feasible. Such programmes have the potential to improve health outcomes for Pacific and Maori adolescents.

Preventing diabetes in primary care: a feasibility cluster randomized trial.

OBJECTIVE: To determine the feasibility of implementing a large-scale primary care-based diabetes prevention trial. METHODS: A feasibility cluster randomized controlled trial was conducted in British Columbia, Canada, amongst adults with prediabetes using the Facilitated Lifestyle Intervention Prescription (FLIP) vs. usual care. FLIP included lifestyle advice, a pedometer, and telephone support from a lifestyle facilitator for 6 months. Indicators of feasibility included recruitment rates of family practices, participants and facilitators, as well as feasibility and retention rates in the FLIP program and study protocols. RESULTS: Six family practices participated; 59 patients were enrolled between October 2012 and March 2013. The trial protocol was acceptable to practices and participants and had a 95% participant retention rate over the 6 months (56/59). Adherence to the intervention was high (97%), with 34 of 35 patients continuing to receive telephone calls from the facilitator for 6 months. The mean cost of the intervention was C$144 per person. Compared with control, intervention participants significantly reduced weight by 3.2 kg (95% CI, 1.7 to 4.6); body mass index by 1.2 (95% CI, 0.7 to 1.7) and waist circumference by 3 cm (95% CI, 0.3 to 5.7). CONCLUSIONS: It is feasible to implement FLIP and to conduct a trial to assess effectiveness. A larger trial with longer follow up to assess progression to diabetes is warranted.

Effect of fixed dose combination treatment on adherence and risk factor control among patients at high risk of cardiovascular disease: randomised controlled trial in primary care.

OBJECTIVE: To evaluate whether provision of fixed dose combination treatment improves adherence and risk factor control compared with usual care of patients at high risk of cardiovascular disease in primary care. DESIGN: Open label randomised control trial: IMPACT (IMProving Adherence using Combination Therapy). SETTING: 54 general practices in the Auckland and Waikato regions of New Zealand, July 2010 to August 2013. PARTICIPANTS: 513 adults (including 257 indigenous Maori) at high risk of cardiovascular disease (established cardiovascular disease or five year risk ≥ 15%) who were recommended for treatment with antiplatelet, statin, and two or more blood pressure lowering drugs. 497 (97%) completed 12 months' follow-up. INTERVENTIONS: Participants were randomised to continued usual care or to fixed dose combination treatment (with two versions available: aspirin 75 mg, simvastatin 40 mg, and lisinopril 10 mg with either atenolol 50 mg or hydrochlorothiazide 12.5 mg). All drugs in both treatment arms were prescribed by their usual general practitioners and dispensed by local community pharmacists. MAIN OUTCOME MEASURES: Primary outcomes were self reported adherence to recommended drugs (antiplatelet, statin, and two or more blood pressure lowering agents) and mean change in blood pressure and low density lipoprotein cholesterol at 12 months. RESULTS: Adherence to all four recommended drugs was greater among fixed dose combination than usual care participants at 12 months (81% v 46%; relative risk 1.75, 95% confidence interval 1.52 to 2.03, P<0.001; number needed to treat 2.9, 95% confidence interval 2.3 to 3.7). Adherence for each drug type at 12 months was high in both groups but especially in the fixed dose combination group: for antiplatelet treatment it was 93% fixed dose combination v 83% usual care (P<0.001), for statin 94% v 89% (P=0.06), for combination blood pressure lowering 89% v 59% (P<0.001), and for any blood pressure lowering 96% v 91% (P=0.02). Self reported adherence was highly concordant with dispensing data (dispensing of all four recommended drugs 79% fixed dose combination v 47% usual care, relative risk 1.67, 95% confidence interval 1.44 to 1.93, P<0.001). There was no statistically significant improvement in risk factor control between the fixed dose combination and usual care groups over 12 months: the difference in systolic blood pressure was -2.2 mm Hg (-4.5 v -2.3, 95% confidence interval -5.6 to 1.2, P=0.21), in diastolic blood pressure -1.2 mm Hg (-2.1 v -0.9, -3.2 to 0.8, P=0.22) and in low density lipoprotein cholesterol -0.05 mmol/L (-0.20 v -0.15, -0.17 to 0.08, P=0.46). The number of participants with cardiovascular events or serious adverse events was similar in both treatment groups (fixed dose combination 16 v usual care 18 (P=0.73), 99 v 93 (P=0.56), respectively). Fixed dose combination treatment was discontinued in 94 participants (37%). The most commonly reported reason for discontinuation was a side effect (54/75, 72%). Overall, 89% (227/256) of fixed dose combination participants' general practitioners completed a post-trial survey, and the fixed dose combination strategy was rated as satisfactory or very satisfactory for starting treatment (206/227, 91%), blood pressure control (180/220, 82%), cholesterol control (170/218, 78%), tolerability (181/223, 81%), and prescribing according to local guidelines (185/219, 84%). When participants were asked at 12 months how easy they found taking their prescribed drugs, most responded very easy or easy (224/246, 91% fixed dose combination v 212/246, 86% usual care, P=0.09). At 12 months the change in other lipid fractions, difference in EuroQol-5D, and difference in barriers to adherence did not differ significantly between the treatment groups. CONCLUSIONS: Among this well treated primary care population, fixed dose combination treatment improved adherence to the combination of all recommended drugs but improvements in clinical risk factors were small and did not reach statistical significance. Acceptability was high for both general practitioners and patients, although the discontinuation rate was high. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry ACTRN12606000067572.

Standardised criteria improve accuracy of ECG interpretation in competitive athletes: a randomised controlled trial.

BACKGROUND: Screening to prevent sudden cardiac death remains a contentious topic in sport and exercise medicine. The aim of this study was to assess whether the use of a standardised criteria tool improves the accuracy of ECG interpretation by physicians screening athletes. METHODS: Design: Randomised control trial. Study Population: General practitioners with an interest in sports medicine, sports physicians, sports medicine registrars and cardiologists from Australia and New Zealand were eligible to participate. Outcome Measures: Accuracy, sensitivity, specificity and false-positive rates of screening ECG interpretation of athletes. Intervention: A two-page standardised ECG criteria tool was provided to intervention participants. Control participants undertook 'usual' interpretation. RESULTS: 62 physicians, with a mean duration of practice of 16 years, were randomised to intervention and control. 10 baseline and 30 postrandomisation athlete ECGs were interpreted by the participants. Intervention participants were more likely to be correct: OR 1.72 (95% CI 1.31 to 2.27, p<0.001). Correct ECG interpretation was higher in the intervention group, 88.4% (95% CI 85.7% to 91.2%), than in the control group, 82.2% (95% CI 78.8% to 85.5%; p=0.005). Sensitivity was 95% in the intervention group and 92% in the control group (p=0.4), with specificity of 86% and 78%, respectively (p=0.006). There were 36% fewer false positives in the intervention group (p=0.006). CONCLUSIONS: ECG interpretation in athletes can be improved by using a standardised ECG criteria tool. Use of the tool results in lower false-positive rates; this may have implications for screening recommendations. TRIAL REGISTRATION NUMBER: ACTRN12612000641897.

The association between church attendance and obesity-related lifestyle behaviours among New Zealand adolescents from different Pacific Island ethnic groups.

INTRODUCTION: Obesity is disproportionately prevalent among Pacific population groups in New Zealand. Lifestyle behaviours of excessive consumption of high energy, unhealthy foods and inadequate physical activity are risk factors for obesity that can be modified. AIM: To identify and describe the risk factors for and protective factors against obesity among Pacific Island (PI) adolescents who attend church and compare them with PI adolescents who do not attend church. METHODS: We investigated the lifestyle behaviours of 2495 PI adolescents at six secondary schools in Auckland, New Zealand (NZ), 77% of whom attend a church or other place of worship. The cross-sectional survey was undertaken in 2005. Structured individual interviews and anthropometric measurements were undertaken. RESULTS: Church attendees had a higher mean body mass index (BMI) compared with non-attendees (BMI 27.4 vs BMI 26.6), adjusted for age, gender and PI ethnicity (p=0.01). The weight status of attendees was associated with less healthy breakfast and lunch sources, lower levels of physical activity, and limited knowledge of the risk factors for obesity (p<0.05) DISCUSSION: Culturally appropriate and ethnic-specific weight management interventions, including monitoring and policy development programmes, are needed urgently to change pro-obesity lifestyle behaviours in PI adolescents and to avoid the burgeoning future obesity-related illnesses that would otherwise result. The church may be an important venue and change agent in the prevention of obesity for this population.

Prospective meta-analysis of trials comparing fixed dose combination based care with usual care in individuals at high cardiovascular risk: the SPACE Collaboration.

BACKGROUND: An international collaboration of investigators will assess the benefits and risks of fixed dose combination (FDC) based care compared with usual care in populations at high risk of cardiovascular disease (CVD). Several trials are being conducted, as the effectiveness and economic impact of a FDC-based strategy may vary substantially between countries, given the varying influence of the health-care system within which the intervention is delivered. METHODS: Individual patient data (IPD) will be provided by participating trials for combined IPD meta-analysis. RESULTS: Primary outcomes will include self-reported current use of antiplatelet, statin, and combination (≥ 2) blood pressure lowering therapies at 12 months, and change in systolic blood pressure (SBP) and LDL cholesterol from baseline to 12 months. Non-inferiority margins of 3 mm Hg for SBP and 0.3 mmol/L for LDL cholesterol have been pre-specified. Secondary outcomes will include change in cholesterol fractions, diastolic blood pressure and creatinine from baseline to 12 months, quality of life, new onset diabetes mellitus, mortality (cardiovascular, non-cardiovascular and all cause) and a composite outcome of cardiovascular events (including all coronary heart disease events, heart failure events leading to death or requiring hospital admission, cerebrovascular events and peripheral arterial events). CONCLUSION: The SPACE group of trials will assess, in a variety of healthcare settings, whether a FDC strategy for delivery of preventive medication has the potential to significantly improve prevention of cardiovascular disease in patients at high risk.

Maori experiences and perceptions of gout and its treatment: a kaupapa Maori qualitative study.

INTRODUCTION: The prevalence of gout among Maori is one of the highest in the world. This study explores the perceptions, understanding and treatment of gout among Maori. METHODS: A qualitative general inductive approach was used, guided by kaupapa Maori principles. Participants included 12 Maori aged 48-79 years with gout. Semi-structured interviews were undertaken, taped and transcribed. Themes were identified from transcripts. FINDINGS: Participants described overwhelming sufferance due to gout, which was sometimes considered inevitable. All participants believed or had been informed that gout is caused by food and/or drink. This led to feelings of self-blame and blame from partners and employers. Whanau (family) were a resource for information and a support when independence was limited. Rongoa (traditional medicine) played a role in the lives of rural but not urban participants. Many reported stoicism, putting up with pain and putting others before themselves, as the 'Maori way'. Medicines used for gout management were predominantly non-steroidal anti-inflammatory drugs, colchicine and prednisone, with allopurinol only playing a role late in the disease. Medications were often poorly understood and consequently improperly used. Relationships with health professionals were important, but cultural, financial and time barriers impaired access and understanding. Gout had a huge, negative impact on the lives of participants. CONCLUSION: The quality of lives of many people with gout could be improved by better understanding through educational campaigns for health professionals and the community. Culturally sensitive health care systems and a paradigm shift in gout management and early preventive treatment are needed.

Wahine hauora: linking local hospital and national health information datasets to explore maternal risk factors and obstetric outcomes of New Zealand Maori and non-Maori women in relation to infant respiratory admissions and timely immunisations.

BACKGROUND: Significant health inequities exist around maternal and infant health for Maori, the indigenous people of New Zealand. The infants of Maori are more likely to die in their first year of life and also have higher rates of hospital admission for respiratory illnesses, with the greatest burden of morbidity being due to bronchiolitis in those under one year of age. Timely immunisations can prevent some respiratory related hospitalisations, although for Maori, the proportion of infants with age appropriate immunisations are lower than for non-Maori. This paper describes the protocol for a retrospective cohort study that linked local hospital and national health information datasets to explore maternal risk factors and obstetric outcomes in relation to respiratory admissions and timely immunisations for infants of Maori and non-Maori women. METHODS/DESIGN: The study population included pregnant women who gave birth in hospital in one region of New Zealand between 1995 and 2009. Routinely collected local hospital data were linked via a unique identifier (National Health Index number) to national health information databases to assess rates of post-natal admissions and access to health services for Maori and non-Maori mothers and infants. The two primary outcomes for the study are: 1. The rates of respiratory hospitalisations of infants (≤ 1 yr of age) calculated for infants of both Maori and non-Maori women (for mothers under 20 years of age, and overall) accounting for relationship to parity, maternal age, socioeconomic deprivation index, maternal smoking status. 2. The proportion of infants with age appropriate immunisations at six and 12 months, calculated for both infants born to Maori women and infants born to non-Maori women, accounting for relationship to parity, maternal age, socioeconomic deprivation index, smoking status, and other risk factors. DISCUSSION: Analysis of a wide range of routinely collected health information in which maternal and infant data are linked will allow us to directly explore the relationship between key maternal factors and infant health, and provide a greater understanding of the causes of health inequalities that exist between the infants of Maori and non-Maori mothers.