A Systematic Review of Self-Reported Ethical Practices in Publications of Cluster Randomised Trials Conducted in Aboriginal and Torres Strait Islander Settings

Cluster randomised trials (CRTs) present unique ethical complexities for research ethics committees, participants, researchers and evidence users. In this design, whole social units (‘clusters’) such as hospitals, schools or entire communities are randomised to interventions. In addition, units of randomisation, intervention and outcome measurement differ within the one study. As a consequence, clearly determining research participants and establishing whose consent is required not only for randomisation and interventions but also data collection are correspondingly difficult. This systematic review describes self-reported ethical practices in research conducted in Australia in which social units comprising Aboriginal and Torres Strait Islander people, their communities or services upon which they rely were randomised as whole clusters to trial interventions. To undertake this systematic review, we developed a study protocol and registered it prospectively on a public database (PROSPERO1 protocol CRD42018106463). Applying this protocol meant we could methodically identify all CRTs conducted in Aboriginal and Torres Strait Islander settings in Australia by finding their peer-reviewed study protocols or articles with main results reporting primary outcomes.https://researchonline.nd.edu.au/nulungu_research/1006/thumbnail.jp

Acceptability and effectiveness of opportunistic referral of smokers to telephone cessation advice from a nurse: a randomised trial in Australian general practice

<p>Abstract</p> <p>Background</p> <p>GPs often lack time to provide intensive cessation advice for patients who smoke. This study aimed to determine the effectiveness of opportunistic referral of smokers by their GP for telephone cessation counselling by a trained nurse.</p> <p>Methods</p> <p>Adult smokers (n = 318) attending 30 GPs in South Western Sydney, Australia were randomly allocated to usual care or referral to a telephone-based program comprising assessment and stage-based behavioural advice, written information and follow-up delivered by a nurse. Self-reported point prevalence abstinence at six and 12 months was compared between groups. Characteristics of patients who accepted and completed the intervention were investigated.</p> <p>Results</p> <p>Of 169 smokers randomised to the intervention, 76 (45%) consented to referral. Compared with smokers in 'pre-contemplation', those further along the stage-of-change continuum were significantly more likely to consent (p = 0.003). Those further along the continuum also were significantly more likely to complete all four calls of the intervention (OR 2.6, 95% CI: 0.8–8.1 and OR 8.6, 95% CI: 1.7–44.4 for 'contemplation' and 'preparation' respectively). At six months, there was no significant difference between groups in point prevalence abstinence (intention to treat) (9% versus 8%, p = 0.7). There was no evidence of differential intervention effectiveness by baseline stage-of-change (p = 0.6) or patient sex (p = 0.5). At 12 months, point prevalence abstinence in the intervention and control groups was 8% and 6% respectively (p = 0.6).</p> <p>Conclusion</p> <p>Acceptance of opportunistic referral for nurse delivered telephone cessation advice was low. This trial did not demonstrate improved quit rates following the intervention. Future research efforts might better focus support for those patients who are motivated to quit.</p> <p>Australian Clinical Trials Registry number</p> <p>ACTRN012607000091404</p

Clinic predictors of better syphilis testing in Aboriginal primary healthcare: A promising opportunity for primary healthcare service managers

Integration of public health and primary healthcare (PHC) is a hallmark of comprehensive PHC to reduce inequitable rates of preventable diseases in communities at risk. In the context of a syphilis outbreak among Indigenous people in Northern Australia, the association between PHC clinic factors and syphilis testing performance (STP) was examined to produce empirical insights for service managers. Data from the Audit and Best Practice for Chronic Disease National Program (2012–14) were analysed to examine associations between clinic factors and STP (proportion of clients ≥15 years who were tested for or offered a test for syphilis in the prior 24 months). Univariate analyses were conducted for 77 clinics and a subset of 67 remote clinics. Multivariate linear regression models were used to determine independent predictors of STP. Syphilis testing performance across PHC clinics ranged from 0 to 93.8% (median 46.5%). In univariate analysis, Delivery system design, which refers to clinic infrastructure, staffing profile and allocation of roles and responsibilities, was significantly associated with higher STP in all clinics (P = 0.004) and in the subset of remote clinics (P = 0.008). Syphilis testing performance was higher in the Northern Territory compared to other states, in remote clinics and clinics serving smaller populations. In multivariate analysis, Delivery system design and jurisdiction remained associated with STP. To better realise the potential of comprehensive PHC, service managers should focus on PHC delivery system design to enhance the current syphilis outbreak response

Feasibility, acceptability and impact of a telephone support service initiated in primary medical care to help Arabic smokers quit

Evidence-based tobacco control in ethnic minorities is compromised by the near absence of rigorous testing of interventions in either prevention or cessation. This randomised controlled trial was designed to evaluate the feasibility, acceptability and impact of a culturally specific cessation intervention delivered in the context of primary medical care in the most culturally diverse region of New South Wales. Adult Arabic smokers were recruited from practices of 29 general practitioners (GPs) in south-west Sydney and randomly allocated to usual care (n¿194) or referred to six sessions of smoking cessation telephone support delivered by bilingual psychologists (n¿213). Although 62.2% of participants indicated that telephone support would benefit Arabic smokers, there were no significant differences at 6 or 12 months between intervention and control groups in point prevalence abstinence rates (11.7% vs 12.9%, P¿0.83; 8.4% vs 11.3%, P¿0.68, respectively) or the mean shift in stage-of-change towards intention to quit. As participants and GPs found telephone support acceptable, we also discuss redesign and the unfulfilled obligation to expand the evidence base in tobacco control from which the ethnic majority already benefits. 2011 La Trobe University