scholarly journals Supporting Aboriginal Community Controlled Health Services to deliver alcohol care: protocol for a cluster randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e030909 ◽  
Author(s):  
Kristie H Harrison ◽  
KS Kylie Lee ◽  
Timothy Dobbins ◽  
Scott Wilson ◽  
Noel Hayman ◽  
...  
Keyword(s):  
Research Ethics ◽  
Indigenous Peoples ◽  
Brief Intervention ◽  
Relapse Prevention ◽  
Aboriginal Health ◽  
Ethics Committee ◽  
Aboriginal Community ◽  
Research Ethics Committee ◽  
Human Research Ethics ◽  
Treatment Provision

IntroductionIndigenous peoples who have experienced colonisation or oppression can have a higher prevalence of alcohol-related harms. In Australia, Aboriginal Community Controlled Health Services (ACCHSs) offer culturally accessible care to Aboriginal and Torres Strait Islander (Indigenous) peoples. However there are many competing health, socioeconomic and cultural client needs.Methods and analysisA randomised cluster wait-control trial will test the effectiveness of a model of tailored and collaborative support for ACCHSs in increasing use of alcohol screening (with Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)) and of treatment provision (brief intervention, counselling or relapse prevention medicines).SettingTwenty-two ACCHSs across Australia.RandomisationServices will be stratified by remoteness, then randomised into two groups. Half receive support soon after the trial starts (intervention or ‘early support’); half receive support 2 years later (wait-control or ‘late support’).The supportCore support elements will be tailored to local needs and include: support to nominate two staff as champions for increasing alcohol care; a national training workshop and bimonthly teleconferences for service champions to share knowledge; onsite training, and bimonthly feedback on routinely collected data on screening and treatment provision.Outcomes and analysisPrimary outcome is use of screening using AUDIT-C as routinely recorded on practice software. Secondary outcomes are recording of brief intervention, counselling, relapse prevention medicines; and blood pressure, gamma glutamyltransferase and HbA1c. Multi-level logistic regression will be used to test the effectiveness of support.Ethics and disseminationEthical approval has been obtained from eight ethics committees: the Aboriginal Health and Medical Research Council of New South Wales (1217/16); Central Australian Human Research Ethics Committee (CA-17-2842); Northern Territory Department of Health and Menzies School of Health Research (2017-2737); Central Queensland Hospital and Health Service (17/QCQ/9); Far North Queensland (17/QCH/45-1143); Aboriginal Health Research Ethics Committee, South Australia (04-16-694); St Vincent’s Hospital (Melbourne) Human Research Ethics Committee (LRR 036/17); and Western Australian Aboriginal Health Ethics Committee (779).Trial registration numberACTRN12618001892202; Pre-results.

Re: Variation in Human Research Ethics Committee and governance processes throughout Australia: a need for a uniform approach

2021 ◽  
Vol 91 (11) ◽  
pp. 2545-2545
Author(s):  
Guy Henry Morton Stanley ◽  
Ryckie George Wade ◽  
Sara Potts ◽  
Nichola Wilson ◽  
Michael Findlay
Keyword(s):  
Research Ethics ◽  
Ethics Committee ◽  
Human Research ◽  
Research Ethics Committee ◽  
Uniform Approach ◽  
Human Research Ethics ◽  
Governance Processes

scholarly journals Understanding and responding to the cost and health impact of short-term health staffing in remote and rural Aboriginal and Torres Strait Islander community-controlled health services: a mixed methods study protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e043902
Author(s):  
Michelle S Fitts ◽  
John Humphreys ◽  
Terry Dunbar ◽  
Lisa Bourke ◽  
Edward Mulholland ◽  
...  
Keyword(s):  
Health Services ◽  
Research Ethics ◽  
Primary Healthcare ◽  
Ethics Committee ◽  
Mixed Methods Study ◽  
Short Term ◽  
Human Research ◽  
Research Ethics Committee ◽  
Human Research Ethics ◽  
The Impact

IntroductionAccess to high-quality primary healthcare is limited for remote residents in Australia. Increasingly, remote health services are reliant on short-term or ‘fly-in, fly-out/drive-in, drive-out’ health workforce to deliver primary healthcare. A key strategy to achieving health service access equity, particularly evident in remote Australia, has been the development of Aboriginal Community Controlled Health Services (ACCHSs). This study aims to generate new knowledge about (1) the impact of short-term staffing in remote and rural ACCHSs on Aboriginal and Torres Strait Islander communities; (2) the potential mitigating effect of community control; and (3) effective, context-specific evidence-based retention strategies.Methods and analysisThis paper describes a 3-year, mixed methods study involving 12 ACCHSs across three states. The methods are situated within an evidence-based programme logic framework for rural and remote primary healthcare services. Quantitative data will be used to describe staffing stability and turnover, with multiple regression analyses to determine associations between independent variables (population size, geographical remoteness, resident staff turnover and socioeconomic status) and dependent variables related to patient care, service cost, quality and effectiveness. Qualitative assessment will include interviews and focus groups with clinical staff, clinic users, regionally-based retrieval staff and representatives of jurisdictional peak bodies for the ACCHS sector, to understand the impact of short-term staff on quality and continuity of patient care, as well as satisfaction and acceptability of services.Ethics and disseminationThe study has ethics approval from the Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (project number DR03171), Central Australian Human Research Ethics Committee (CA-19-3493), Western Australian Aboriginal Health Ethics Committee (WAAHEC-938) and Far North Queensland Human Research Ethics Committee (HREC/2019/QCH/56393). Results will be disseminated through peer-reviewed journals, the project steering committee and community/stakeholder engagement activities to be determined by each ACCHS.

scholarly journals The ORVAC trial protocol: a phase IV, double-blind, randomised, placebo-controlled clinical trial of a third scheduled dose of Rotarix rotavirus vaccine in Australian Indigenous infants to improve protection against gastroenteritis

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e032549 ◽  
Author(s):  
Bianca Fleur Middleton ◽  
Mark A Jones ◽  
Claire S Waddington ◽  
Margaret Danchin ◽  
Carly McCallum ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Research Ethics ◽  
Ethics Committee ◽  
Northern Territory ◽  
Rotavirus Vaccine ◽  
Additional Dose ◽  
Human Research ◽  
Research Ethics Committee ◽  
Human Research Ethics ◽  
Indigenous Children

IntroductionRotavirus vaccines were introduced into the Australian National Immunisation Program in 2007. Despite this, Northern Territory Indigenous children continue to be hospitalised with rotavirus at a rate more than 20 times higher than non-Indigenous children in other Australian jurisdictions, with evidence of waning protection in the second year of life. We hypothesised that scheduling an additional (third) dose of oral human rotavirus vaccine (Rotarix, GlaxoSmithKline) for children aged 6 to <12 months would improve protection against clinically significant all-cause gastroenteritis.Methods and analysisThis Bayesian adaptive clinical trial will investigate whether routinely scheduling an additional dose of Rotarix for Australian Indigenous children aged 6 to <12 months old confers significantly better protection against clinically important all-cause gastroenteritis than the current two-dose schedule at 2 and 4 months old. There are two coprimary endpoints: (1) seroconversion from baseline serum anti-rotavirus immunoglobulin A (IgA) titre <20 U/mL prior to an additional dose of Rotarix/placebo to serum anti-rotavirus IgA titre >20 U/mL following the administration of the additional dose of Rotarix/placebo and (2) time from randomisation to medical attendance (up to age 36 months old) for which the primary reason is acute gastroenteritis/diarrhoea. Secondary endpoints include the change in anti-rotavirus IgA log titre, time to hospitalisation for all-cause diarrhoea and for rotavirus-confirmed gastroenteritis/diarrhoea, and rotavirus notification. Analysis will be based on Bayesian inference with adaptive sample size.Ethics, registration and disseminationEthics approval has been granted by Central Australian Human Research Ethics Committee (HREC-16-426) and Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (HREC-2016-2658). Study investigators will ensure the trial is conducted in accordance with the principles of the Declaration of Helsinki and with the ICH Guidelines for Good Clinical Practice. Individual participant consent will be obtained. Results will be disseminated via peer-reviewed publication. The trial is registered with Clinicaltrials.gov (NCT02941107) and important modifications to this protocol will be updated.Trial registration numberNCT02941107; Pre-results.

scholarly journals Innovative Telemonitoring Enhanced Care Programme for Chronic Heart Failure (ITEC-CHF) to improve guideline compliance and collaborative care: protocol of a multicentre randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e017550
Author(s):  
Hang Ding ◽  
Rajiv Jayasena ◽  
Andrew Maiorana ◽  
Alison Dowling ◽  
Sheau Huey Chen ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trial ◽  
Research Ethics ◽  
Controlled Trial ◽  
Ethics Committee ◽  
Care Programme ◽  
Human Research ◽  
Research Ethics Committee ◽  
Human Research Ethics ◽  
Randomised Controlled

IntroductionChronic heart failure (CHF) is a life-threatening chronic disease characterised by periodic exacerbations and recurrent hospitalisations. In the management of CHF, patient compliance with evidence-based clinical guidelines is essential, but remains difficult practically. The objective of this study is to examine whether an Innovative Telemonitoring Enhanced Care Programme for CHF (ITEC-CHF) improves patients’ compliance, and associated health and economic outcomes.Methods and analysisAn open multicentre randomised controlled trial has been designed. Patients will be recruited and randomised to receive either ITEC-CHF (n=150) or usual care CHF (n=150) for at least 6 months. ITEC-CHF combines usual care and an additional telemonitoring service including remote weight monitoring, structured telephone support and nurse-led collaborative care. The primary outcomes are the compliance rates with the best-practice guidelines for daily weight monitoring. The secondary outcomes include the compliance with other guideline recommendations (health maintenance, medication, diet and exercise), health (health-related quality of life, risk factors, functional capacity and psychological states) and economic outcomes related to the use of healthcare resources such as hospital readmissions and general practitioner/emergency department visits.Ethics and disseminationThe clinical trial has been approved by Peninsula Health Human Research Ethics Committee (HREC Reference: HREC/14/PH/27), Royal Perth Hospital Human Research Ethics Committee (Reference: 15-081) and the Curtin University Human Research Ethics Committee (Reference: HR 181/2014). We will disseminate the final results to the public via conferences and journal publications. A final study report will also be provided to the ethics committees.Trial registration numberRegistered with Australian New Zealand Clinical Trial Registry (ACTRN12614000916640).

scholarly journals Evaluation of two population screening programmes for BRCA1/2 founder mutations in the Australian Jewish community: a protocol paper

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e041186
Author(s):  
Nicole E Cousens ◽  
Jane Tiller ◽  
Bettina Meiser ◽  
Kristine Barlow-Stewart ◽  
Simone Rowley ◽  
...  
Keyword(s):  
Research Ethics ◽  
Population Based ◽  
Ethics Committee ◽  
Founder Mutations ◽  
Human Research ◽  
Research Ethics Committee ◽  
Human Research Ethics ◽  
Pathogenic Variants ◽  
Increased Risk ◽  
Study Results

IntroductionPeople of Ashkenazi Jewish (AJ) ancestry are more likely than unselected populations to have a BRCA1/2 pathogenic variant, which cause a significantly increased risk of breast, ovarian and prostate cancer. Three specific BRCA1/2 pathogenic variants, referred to as BRCA-Jewish founder mutations (B-JFM), account for >90% of BRCA1/2 pathogenic variants in people of AJ ancestry. Current practice of identifying eligible individuals for BRCA testing based on personal and/or family history has been shown to miss at least 50% of people who have one of these variants. Here we describe the protocol of the JeneScreen study—a study established to develop and evaluate two different population-based B-JFM screening programmes, offered to people of Jewish ancestry in Sydney and Melbourne, Australia.Methods and analysisTo rmeasure the acceptability of population-based B-JFM screening in Australia, two screening programmes using different methodologies have been developed. The Sydney JeneScreen programme provides information and obtains informed consent by way of an online tool. The Melbourne JeneScreen programme does this by way of community sessions attended in person. Participants complete questionnaires to measure clinical and psychosocial outcomes at baseline, and for those who have testing, 2 weeks postresult. Participants who decline testing are sent a questionnaire regarding reasons for declining. Participants with a B-JFM are sent questionnaires 12-month and 24-month post-testing. The questionnaires incorporate validated scales, which measure anxiety, decisional conflict and regret, and test-related distress and positive experiences, and other items specifically developed or adapted for the study. These measures will be assessed for each programme and the two population-based B-JFM screening methods will be compared.Ethics and disseminationInstitutional Human Research Ethics Committee approval was obtained from the South Eastern Area Health Service Human Research Ethics Committee: HREC Ref 16/125.Following the analysis of the study results, the findings will be disseminated widely through conferences and publications, and directly to participants in writing.

scholarly journals Human Research Ethics Committee Experiences and Views About Children’s Participation in Research: Results From the MESSI Study

2021 ◽  
pp. 155626462110482
Author(s):  
Stephanie Taplin ◽  
Jenny Chalmers ◽  
Judith Brown ◽  
Tim Moore ◽  
Anne Graham ◽  
...  
Keyword(s):  
Research Ethics ◽  
Social Research ◽  
Ethics Committee ◽  
Ethical Review ◽  
Human Research ◽  
Research Ethics Committee ◽  
Human Research Ethics ◽  
Research With Children ◽  
Age Appropriate ◽  
Participation In Research

As part of a larger study, Australian Human Research Ethics Committee (HREC) members and managers were surveyed about their decision-making and views about social research studies with child participants. Responses of 229 HREC members and 42 HREC managers are reported. While most HREC members had received ethical training, HREC training and guidelines specific to research involving children were rare. Most applications involving children had to go through a full ethical review, but few adverse events were reported to HRECs regarding the conduct of the studies. Revisions to study proposals requested by HRECs were mostly related to consent processes and age-appropriate language. One-third of HREC members said that they would approve research on any topic. Most were also concerned that the methodology was appropriate, and the risks and benefits were clearly articulated. Specific training and guidance are needed to increase HREC members’ confidence to judge ethical research with children.

Renal Iron Load in Sickle Cell Disease Correlates with Hemolysis and Transfusion History, but Not with Hepatic Iron

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 2129-2129
Author(s):  
Nisha Vasavda ◽  
Lucía Gutiérrez ◽  
Michael J House ◽  
Emma Drašar ◽  
Tim G St Pierre ◽  
...  
Keyword(s):  
Research Ethics ◽  
Iron Concentration ◽  
Organ Damage ◽  
Ethics Committee ◽  
Iron Loading ◽  
Liver Iron ◽  
Research Ethics Committee ◽  
Renal Hyperfiltration ◽  
Human Research Ethics ◽  
Transfusion History

Abstract Abstract 2129 Background: Sickle cell disease (SCD) is characterised by chronic hemolysis and frequent, painful vaso-occlusive episodes, eventually leading to organ damage. Overall, renal failure is found in approximately 11% of SCD patients, and incidence increases with age. Both the vaso-occlusive and hemolytic aspects of SCD have been implicated in renal failure, as assessed by glomerular filtration rate (GFR) and microalbuminurea. Additionally, the increasing use of blood transfusion therapy in SCD has resulted in a sub-population with secondary iron overload, also leading to organ damage. Differential organ iron loading has been noted in the two major hemoglobin disorders; cardiac iron toxicity is common in β-thalassemia patients with high liver iron concentration (LIC), whereas this is uncommon in SCD patients for an equivalent LIC. Relatively limited research has been carried out regarding renal iron loading in SCD. This study investigates the clinical significance and etiology of renal iron accumulation in SCD patients. Participants and Methods: 41 patients from the specialist hematology clinic at King's College Hospital, London had already had an assessment of hepatic iron loading by spin density projection assisted R2-MRI (FerriScan®) as part of their clinical care programme and/or as part of another study approved by the NHS Research Ethics Committee (REC 05/Q0703/21). One patient was excluded due to prior chelation therapy; the remaining 40 were chelation naïve. Owing to the retrospective nature of the study, the REC confirmed that informed consent was not required of patients for this study. Renal R2 (R-R2) values were derived from monoexponential fits to kidney image data obtained during LIC assessment in order to assess kidney iron concentration. R-R2 data were also collected from 17 healthy control participants to provide a reference range. Control data were acquired with approval from the Fremantle Hospital Human Research Ethics Committee (08/404) and the University of Western Australia Human Research Ethics Committee. Clinical data were collected retrospectively for the 2 year period prior to the MRI scan. Thresholds for renal hyperfiltration and microalbuminurea were MDRD eGFR ≥140 ml/min/1.73m2 and albumin:creatinine ratio ≥4.5 mg/mmol, respectively. Lifetime blood transfusion history (top-up units) was recorded up to the date of the R2-MRI scan. Results: Mean R-R2 (expressed in units of s−1) was significantly higher (p<0.0001) in the SCD patients (26.87 ± SD 8.89 s−1) compared with healthy controls (17.77 ± SD 2.94 s−1). R-R2 values correlated with transfusion history (r2=0.23, p=0.004) but not with LIC. Highly significant correlations were seen between R-R2 and bilirubin (r2=0.39, p<0.0001) and lactate dehydrogenase levels (r2=0.37, p<0.0001), known markers of hemolysis. SCD patients with co-inherited α thalassemia had a lower mean R2 (23.45 ± SD 6.1 s−1) than those without (28.94 ± 9.6 SD s−1), which approached significance (p=0.070). Patients were stratified into those with evidence of renal hyperfiltration and those without. Mean R-R2 was significantly higher (p=0.019) in patients with renal hyperfiltration (according to the described MDRD eGFR criteria) than those without (30.48 ± SD 6.6 s−1vs. 23.3 ± SD 10.3 s−1, respectively). A weak but significant negative correlation was observed between renal R2 and age (r2=0.12, p=0.03). The renal hyperfiltration group were also significantly younger (p=0.003) than those with normal filtration rates (29.8 ± SD 11.26 vs. 42.3 ± SD 11.24 years). No significant relationship was observed between R-R2 and microalbuminurea. Conclusion: We showed that R-R2 is not related to liver iron concentration, but does correlate with transfusion history and markers of hemolysis. Given the lack of correlation with LIC, we believe that the correlation with transfusion history is not causative, but rather reflects the increased clinical severity; those patients with more severe disease and anemia requiring more frequent transfusions. Though not significant, mean renal R2 was noticeably lower in patients who have co-inherited α-thalassemia, in keeping with the reduced hemolysis and protective effect of α-thalassemia on renal impairment in SCD. Disclosures: St Pierre: Resonance Health: Consultancy, Equity Ownership, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Novartis: Consultancy, Research Funding, Speakers Bureau.

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