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Venous insufficiency is the most common cause of leg ulceration, but the impact of venous leg ulceration on health‐related quality of life has not been adequately assessed. This study compared data from randomized controlled trials to population norms obtained from a large national population survey. We combined the baseline Short Form‐36 (SF‐36) version 1 data from two New Zealand randomized controlled trials that recruited participants with VLU and compared the pooled data to the population scores obtained from the New Zealand Health Survey using general linear regression to adjust for age, sex, and ethnicity differences between the cohorts. Baseline SF‐36 scores obtained from 618 trial participants were compared to the SF‐36 scores obtained from the 12,529 participants in the New Zealand Health Survey. Participants with VLU had significantly lower crude SF‐36 scores across all eight SF‐36 domains, but there was interaction between age and group. Adjusted mean differences for participants aged 65 years or younger were −25.8, −32.1, −21.2, −9.6, −7.6, −23.9, −21.5, and −9.3, respectively, for Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health whereas the adjusted mean differences for older participants were −15.7, −23.8, −13.8, −0.3 (nonsignificant), −4.6, −15.3, −21.2, and −6.6. This study is the first to compare a VLU population to norms from a general population survey and the first to show VLU interacts with age creating stronger impact in younger patients compared their age cohort. Younger patients may have need of more pastoral care as a consequence. [ABSTRACT FROM AUTHOR]

Objectives: To assess the effect of a point of care (POC) device for testing lipids and HbA1c in addition to testing by community laboratory facilities (usual practice) on the completion of cardiovascular disease (CVD) risk assessments in general practice. Methods: We conducted a pragmatic, cluster randomised controlled trial in 20 New Zealand general practices stratified by size and rurality and randomised to POC device plus usual practice or usual practice alone (controls). Patients aged 35–79 years were eligible if they met national guideline criteria for CVD risk assessment. Data on CVD risk assessments were aggregated using a web-based decision support programme common to each practice. Data entered into the on-line CVD risk assessment form could be saved pending blood test results. The primary outcome was the proportion of completed CVD risk assessments. Qualitative data on practice processes for CVD risk assessment and feasibility of POC testing were collected at the end of the study by interviews and questionnaire. The POC testing was supported by a comprehensive quality assurance programme. Results: A CVD risk assessment entry was recorded for 7421 patients in 10 POC practices and 6217 patients in 10 control practices; 99.5% of CVD risk assessments had complete data in both groups (adjusted odds ratio 1.02 [95%CI 0.61–1.69]). There were major external influences that affected the trial: including a national performance target for CVD risk assessment and changes to CVD guidelines. All practices had invested in systems and dedicated staff time to identify and follow up patients to completion. However, the POC device was viewed by most as an additional tool rather than as an opportunity to review practice work flow and leverage the immediate test results for patient education and CVD risk management discussions. Shortly after commencement, the trial was halted due to a change in the HbA1c test assay performance. The trial restarted after the manufacturing issue was rectified but this affected the end use of the device. Conclusions: Performance incentives and external influences were more powerful modifiers of practice behaviours than the POC device in relation to CVD risk assessment completion. The promise of combining risk assessment, communication and management within one consultation was not realised. With shifts in policy focus, the utility of POC devices for patient engagement in CVD preventive care may be demonstrated if fully integrated into the clinical setting. Trial registration: Australian New Zealand Clinical Trials Registry [ABSTRACT FROM AUTHOR]

Aim The aim of this study was to determine the effect of low-dose aspirin on venous leg ulcer healing when used in addition to compression. Background The mainstay of treatment for venous leg ulcers is compression therapy and there are few adjuvant treatments to accelerate healing. Design Pragmatic, community-based, double-blind, randomized trial. Methods Participants with venous leg ulcers will receive either 150 mg aspirin or placebo daily for up to 24 weeks. Participants will receive background treatment with compression therapy (system of choice guided by participant and/or clinical preference) delivered through district nursing services. The primary outcome will be time-to-healing. Secondary outcomes will include proportion healed at 24 weeks, change in ulcer area, change in health-related quality of life, adherence, efficacy of blinding and adverse events. The trial was funded in June 2014. Discussion The trial commenced in March 2015 and is successfully recruiting. The trial is one of three trials that will contribute to an individual participant data meta-analysis to be undertaken at the York Trials Centre. Trial registration Registered 5 June 2014 ClinicalTrials.gov NCT02158806. Protocol version 1·1, 14 April 2015. [ABSTRACT FROM AUTHOR]

Background: Parents play an important role in the lives of adolescents and efforts aimed at strengthening parenting skills and increasing knowledge on adolescent development hold much promise to prevent and mitigate adolescent mental health problems. Innovative interventions that make use of technology-based platforms might be an effective and efficient way to deliver such support to parents. This protocol presents the design of a randomised controlled trial to investigate the effectiveness of a SMS-based mobile intervention (MyTeen) for parents of adolescents on promoting parental competence and mental health literacy.Methods: A parallel two-arm randomised controlled trial will be conducted in New Zealand, aiming to recruit 214 parents or primary caregivers of adolescents aged 10-15 years via community outreach and social media. Eligible participants will be allocated 1:1 into the control or the intervention group, stratified by ethnicity. The intervention group will receive a tailored programme of text messages aimed at improving their parental competence and mental health literacy, over 4 weeks. The control group (care-as-usual) will receive no intervention from the research team, but can access alternative services if they wish, and will be offered the intervention programme upon completion of a 3-month post-randomisation follow-up assessment. Data will be obtained at baseline, post intervention (1-month), and 3-month follow up. The primary outcome is parental competence assessed by the Parental Sense of Competence Scale at 1-month follow up. Secondary outcomes include: mental health literacy; knowledge of help-seeking; parental distress; parent-adolescent communication; and programme satisfaction.Discussion: To our knowledge this is the first randomised controlled trial on the effectiveness of delivering a parenting support intervention for parents of adolescents solely via a SMS-based mobile intervention. If effective, it could have great potential to reach and support parents of adolescents.Trial Registration: Australian New Zealand Clinical Trial Registry ( ACTRN12618000117213 ) Registered on 29/01/2018. [ABSTRACT FROM AUTHOR]

STUDY QUESTION Can one tablet containing aspirin, statin, and blood pressure lowering agents improve adherence and risk factor control compared with usual care of patients at high risk of cardiovascular disease in primary care? SUMMARY ANSWER Fixed dose combination treatment improved adherence to all the recommended drugs, but improvements in clinical risk factors were small and did not reach statistical significance. WHAT IS KNOWN AND WHAT THIS PAPER ADDS Two recent long term trials indicate large improvements in self reported adherence to the recommended drugs and modest improvements in risk factor control in high risk patients receiving fixed dose combination treatment. The main findings of this trial were consistent with those of the earlier trials, and acceptability for this treatment was high among general practitioners and patients. [ABSTRACT FROM AUTHOR]

Abstract: Background: Cardiovascular disease (CVD) is the leading cause of death, and principal reason for the large difference in life expectancy between indigenous Māori and the non-indigenous population in New Zealand. CVD guidelines recommend that people who are at high risk or who have had previous CVD should be offered aspirin, blood pressure lowering and lipid lowering therapies. However, prescribing and adherence rates are low and CVD events remain high. Aim: To assess whether a medication strategy using a fixed dose combination pill (‘polypill’) could improve prescribing and adherence to recommended medications, lower blood pressure and improve lipids compared with current care over 12months. Methods: IMProving Adherence using Combination Therapy (IMPACT) is an open-label randomised controlled trial comparing a once-daily polypill containing four preventive medications with usual care. Six hundred participants who have had previous CVD events or are at high risk of CVD will be enrolled, including 300 Māori. Participants are identified, enrolled and prescribed either the polypill or current medications at their usual primary health care practice, with medications (including the polypill) dispensed through local community pharmacies. The polypill contains 75mg aspirin, 40mg simvastatin, 10mg lisinopril and either 12.5mg hydrochlorothiazide or 50mg atenolol. Primary outcomes are adherence to guidelines-recommended medications and changes in systolic blood pressure and low density lipoprotein at 12months. Secondary outcomes include other lipids, medication dispensing, barriers to adherence, CVD and other serious adverse events, quality of life and prescriber acceptability. The trial is registered with the Australian New Zealand Clinical Trial Registry (ACTRN12606000067572). [Copyright &y& Elsevier]