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 Staying Quit After Release (SQuARe) trial protocol: a randomised controlled trial of a multicomponent intervention to maintain smoking abstinence after release from smoke-free prisons in Victoria, Australia

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e027307
Author(s):  
Jesse T Young ◽  
Cheneal Puljević ◽  
Alexander D Love ◽  
Emilia K Janca ◽  
Catherine J Segan ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Randomised Controlled Trial ◽  
Research Ethics ◽  
Controlled Trial ◽  
Ethics Committee ◽  
Smoking Abstinence ◽  
Human Research ◽  
Research Ethics Committee ◽  
Human Research Ethics ◽  
Randomised Controlled

IntroductionSmoke-free policies have been introduced in prisons internationally. However, high rates of relapse to smoking after release from prison indicate that these policies typically result in short-term smoking cessation only. These high rates of relapse, combined with a lack of investment in relapse prevention, highlight a missed opportunity to improve the health of a population who smoke tobacco at two to six times the rate of the general population. This paper describes the rationale and design of a randomised controlled trial, testing the effectiveness of a caseworker-delivered intervention promoting smoking cessation among former smokers released from smoke-free prisons in Victoria, Australia.Methods and analysisThe multicomponent, brief intervention consists of behavioural counselling, provision of nicotine spray and referral to Quitline and primary care to promote use of government-subsidised smoking cessation pharmacotherapy. The intervention is embedded in routine service delivery and is administered at three time points: one prerelease and two postrelease from prison. Control group participants will receive usual care. Smoking abstinence will be assessed at 1 and 3 months postrelease, and confirmed with carbon monoxide breath testing. Linkage of participant records to survey and routinely collected administrative data will provide further information on postrelease use of health services and prescribed medication.Ethics and disseminationEthical approval has been obtained from the Corrections Victoria Research Committee, the Victorian Department of Justice Human Research Ethics Committee, the Department of Human Services External Request Evaluation Committee and the University of Melbourne Human Research Ethics Committee. Results will be submitted to major international health-focused journals. In case of success, findings will assist policymakers to implement urgently needed interventions promoting the maintenance of prison-initiated smoking abstinence after release, to reduce the health disparities experienced by this marginalised population.Trial registration numberACTRN12618000072213; Pre-results.

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 The NICE-GUT trial protocol: a randomised, placebo controlled trial of oral nitazoxanide for the empiric treatment of acute gastroenteritis among Australian Aboriginal children

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e019632 ◽  
Author(s):  
Claire S Waddington ◽  
Charlie McLeod ◽  
Peter Morris ◽  
Asha Bowen ◽  
Mark Naunton ◽  
...  
Keyword(s):  
Research Ethics ◽  
Acute Gastroenteritis ◽  
Controlled Trial ◽  
Ethics Committee ◽  
Human Research ◽  
Research Ethics Committee ◽  
Australian Aboriginal ◽  
Human Research Ethics ◽  
Aboriginal Children ◽  
The Impact

IntroductionDiarrhoeal disease is the second leading cause of death in children under 5 years globally, killing 525 000 annually. Australian Aboriginal and Torres Strait Islander (hereafter Aboriginal) children suffer a high burden of disease. Randomised trials in other populations suggest nitazoxanide accelerates recovery for children with Giardia, amoebiasis, Cryptosporidium, Rotavirus and Norovirus gastroenteritis, as well as in cases where no enteropathogens are found.Methods and analysisThis double blind, 1:1 randomised, placebo controlled trial is investigating the impact of oral nitazoxanide on acute gastroenteritis in hospitalised Australian Aboriginal children aged 3 months to <5 years. Dosing is based on age-based dosing. The primary endpoint is the time to resolution of ‘significant illness’ defined as the time from randomisation to the time of clinical assessment as medically ready for discharge, or to the time of actual discharge from hospital, whichever occurs first. Secondary endpoints include duration of hospitalisation, symptom severity during the period of significant illness and following treatment, duration of rehydration and drug safety. Patients will be followed for medically significant events for 60 days. Analysis is based on Bayesian inference. Subgroup analysis will occur by pathogen type (bacteria, virus or parasite), rotavirus vaccination status, age and illness severity.Ethics and disseminationEthics approval has been granted by the Central Australian Human Research Ethics Committee (HREC-14–221) and the Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (HREC2014-2172). Study investigators will ensure that the trial is conducted in accordance with the principles of the Declaration of Helsinki. Individual participant consent will be obtained. Results will be disseminated via peer-reviewed publication.Trial registration numberACTRN12614000381684.

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 Use of a patient-centred educational exchange (PCEE) to improve patient’s self-management of medicines after a stroke: a randomised controlled trial study protocol

BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e022225 ◽  
Author(s):  
Judith Ann Coombes ◽  
Debra Rowett ◽  
Jennifer A Whitty ◽  
W Neil Cottrell
Keyword(s):  
Randomised Controlled Trial ◽  
Secondary Prevention ◽  
Usual Care ◽  
Research Ethics ◽  
Controlled Trial ◽  
Educational Exchange ◽  
Human Research ◽  
Human Research Ethics ◽  
Prescription Refill ◽  
Randomised Controlled

IntroductionNational and international guidelines make recommendations for secondary prevention of stroke including the use of medications. A strategy which engages patients in a conversation to personalise evidence-based educational material (patient-centred educational exchange; PCEE) may empower patients to better manage their medications.Methods and analysisThis protocol outlines a non-blinded randomised controlled trial. Consenting patients admitted with a diagnosis of stroke or transient ischaemic attack will be randomised 1:1 to receive either a PCEE composed of two sessions, one at the bedside before discharge and one by telephone at least 10 days after discharge from hospital in addition to usual care (intervention) or usual care alone (control). The primary aim of this study is to determine whether a PCEE improves adherence to antithrombotic, antihypertensive and lipid-lowering medications prescribed for secondary prevention of stroke over the 3 months after discharge, measured using prescription-refill data. Secondary aims include investigation of the impact of the PCEE on adherence over 12 months using prescription-refill data, self-reported medication taking behaviour, self-reported clinical outcomes (blood pressure, cholesterol, adverse medication events and readmission), quality of life, the cost utility of the intervention and changes in beliefs towards medicines and illness.Ethics and disseminationCommunication of the trial results will provide evidence to aid clinicians in conversations with patients about medication taking behaviour related to stroke prevention. The targeted audiences will be health practitioners and consumers interested in medication taking behaviour in chronic diseases and in particular those interested in secondary prevention of stroke.The trial has ethics approval from Metro South Human Research Ethics Committee (HREC/15/QPAH/531) and The University of Queensland Institutional Human Research Ethics (2015001612).Trial registration numberACTRN12615000888561; Pre-results.

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.

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