Health Human Research Ethics Committee Research Articles

Sepsis call emergency department pharmacist service: a single healthcare network cohort study

AbstractBackgroundSepsis and septic shock are common emergency department (ED) presentations, with current guidelines recommending early administration of antibiotics to reduce mortality.AimSepsis calls with pharmacist attendance have been introduced at two EDs, and the aim of this study was to evaluate the impact of this service on outcomes of all septic patients.MethodAt a multisite, single healthcare network, located in Victoria, Australia, emergency medicine pharmacists were trained in assisting medical staff in antibiotic selection, dosing, and delivering antibiotics directly to nursing staff. The sepsis call service was introduced in May 2022 at one site and in March 2023 at another site, with time to first antibiotic administration, morbidity, and mortality being compared to the outcomes of patients from the same EDs from January–April 2022 (group 1). Post the sepsis call introduction, two cohorts were compared: sepsis call attended patients without a pharmacist (group 2) and with a pharmacist (group 3). This project was exempt due to the local policy requirements that constitute research by the Monash Health Human Research Ethics Committee (Reference no: RES‐23‐0000‐237Q). The justification for this ethics exemption was as follows: the study was retrospective, included privacy protections for patients' data, and presented no increased risk to patient care.ResultsThe study included 201 patients, with time to first antibiotic administration on average 302.0 min in group 1, 201.3 min (p = 0.007) in group 2, and 89.8 min (p < 0.001) in group 3. Mortality (p = 0.306), rates of acute kidney injury (p = 0.111), intensive care unit (ICU) admission (p = 0.002), and need for dialysis (p = 0.497) were all reduced in group 3. Adherence to antibiotic guidelines was increased in group 3 (p < 0.001).ConclusionEmergency medicine pharmacist contribution led to reduced time to first antibiotic, an improved adherence to antibiotic guidelines, and positive trends in secondary clinical outcomes. Further research is required to determine the significance of improvements in mortality, intensive care unit admissions, and renal impairment.

Protocol for a hybrid effectiveness-implementation clinical trial evaluating video-assisted electronic consent vs standard consent for patients initiating and continuing haemodialysis in Australia (eConsent HD)

IntroductionCommunicating complex information about haemodialysis (HD) and ensuring it is well understood remains a challenge for clinicians. Informed consent is a high-impact checkpoint in augmenting patients’ decision awareness and engagement...

Intravenous amoxicillin‐clavulanic acid: prescribing practices in Australian hospitals

AbstractBackgroundOral amoxicillin‐clavulanic acid, a broad‐spectrum antimicrobial and one of the most commonly prescribed antimicrobials in Australia, has demonstrated poor prescribing guideline compliance and appropriateness. This may have inadvertent impacts on patient care and safety, from adverse drug reactions to antimicrobial resistance. Intravenous (IV) amoxicillin‐clavulanic acid was first registered in Australia in 2017, reflecting a subsequent and immediate increase in use. There is a need to assess the quality of such prescribing.AimTo describe the quality of IV amoxicillin‐clavulanic acid prescriptions through assessing guideline compliance and appropriateness of use in Australian hospitals.MethodA retrospective data analysis of IV amoxicillin‐clavulanic acid prescriptions from the Hospital National Antimicrobial Prescribing Survey database between 2013 and 2021. The main outcomes measured were guideline compliance and appropriateness. Ethical approval was granted by the Melbourne Health Human Research Ethics Committee (HREC/74195/MH‐2022).ResultsThe proportion of prescriptions for IV amoxicillin‐clavulanic acid, compared to all other antimicrobials, increased from 0.02% (2013) to 2.3% (2021). Guideline compliance and appropriateness have overall decreased (by 18.9% and 16.7%, respectively). Over time, national guidelines predominantly replaced local guidelines as the primary guideline source for prescribing. The most common reason for inappropriateness was unnecessarily broad spectrum of activity (39.5%).ConclusionIntravenous amoxicillin‐clavulanic acid prescribing continues to increase throughout Australian hospitals, with notable reductions in guideline compliance and appropriateness. Since 2019, the increase in these outcomes coincided with updated national prescribing guidelines, evident by prescribers utilising national over local guidelines. These findings reinforce the concept that antimicrobial stewardship initiatives, including auditing, robust national guidelines and education, are crucial to optimise IV amoxicillin‐clavulanic acid prescribing.

Generating evidence to inform responsive and effective actions for Aboriginal and Torres Strait Islander adolescent health and well-being: a mix method protocol for evidence integration ‘the Roadmap Project’

BackgroundAustralia does not have a national strategy for Aboriginal and Torres Strait Islander adolescent health and as a result, policy and programming actions are fragmented and may not be responsive...

Comprehensive observational study evaluating the enduring effectiveness of 4CMenB, the meningococcal B vaccine against gonococcal infections in the Northern Territory and South Australia, Australia: study protocol

IntroductionThe effectiveness of antibiotics for treating gonococcal infections is compromised due to escalating antibiotic resistance; and the development of an effective gonococcal vaccine has been challenging. Emerging evidence suggests that...

‘Joining the Dots: Linking Prenatal Drug Exposure to Childhood and Adolescence’ – research protocol of a population cohort study

IntroductionPrenatal drug exposure (PDE) is one of the most important causes of child harm, but comprehensive information about the long-term outcomes of the families is difficult to ascertain. The Joining...

Medication error reporting attitudes and practices in a regional Australian hospital: a qualitative study

AbstractBackgroundMedication errors are events that may cause or lead to inappropriate medication use or patient harm. Australians living outside metropolitan areas have poorer health outcomes than those living in urban areas. Medication error reporting (MER) practices vary due to the attitude of healthcare professionals (HCPs). MER can improve patient safety in community and hospital settings.AimTo explore HCPs' attitudes, practices, and recommendations towards MER in a regional hospital setting in Australia.MethodSemistructured interviews were employed to identify the attitudes, practices, and recommendations of HCPs for the best utilisation of medication error reports. The study recruited HCPs (nurses, pharmacists, and doctors) working in all clinical areas from November 2021–February 2022. Interviews were recorded and transcribed via thematic analysis. Ethics approval was obtained from the Goulburn Valley Health (GVH) Human Research Ethics Committee (Reference no: GVH 35/21). Informed consent was obtained from participants via an information sheet and completion of a written consent form.ResultsInterviews with twelve HCPs elucidated four themes: barriers and enablers to reporting, and perceived benefits and recommendations for medication error reports. There was good understanding among regional HCPs about the benefits of MER. Attitudes and practices varied, with nurses reporting more medication errors than doctors, and pharmacists being concerned about the impact of reporting on interprofessional relations. Their recommendations involved standardising medication error definition and improving electronic system education.ConclusionDespite HCPs' understanding of the role of MER, their practices varied. We recommend improved protected time for learning, training with the incident reporting software, education about medication errors, and formalisation of test feedback to clinicians. The implementation of workplace cultural practice changes to improve organisational systems and enhance error reporting without fear of repercussions, and the adoption of additional solutions such as electronic prescribing are also encouraged.

A mixed methods study protocol to identify research priorities for perioperative medicine in Australia

BackgroundClinical research in perioperative medicine requires the perspectives of patients and caregivers to increase its relevance and quality, benefiting both researchers and the community. Identifying these priorities will enable researchers, funders, and governing bodies to efficiently use scarce funding and resources. We aim to identify the top 10 research priorities in perioperative medical research in Australia. MethodsA mixed-methods, exploratory-sequential design will be conducted. The study will include five phases. Initially, a published open-ended survey gathered responses from the population (researchers, healthcare workers, and consumers) regarding uncertainties/questions relevant to the population about perioperative medical research. We collected 544 questions and quantitatively analysed and grouped them according to the Standardised Endpoints in Perioperative Medicine–Core Outcomes Measures in Perioperative and Anaesthetic Care (StEP–COMPAC) endpoints. Using multicriteria decision-making software, workshops combining the population will be conducted to determine the top 10 priorities for perioperative medicine research for the Australian population. Ethics and disseminationEthical approval to conduct the study was obtained from the Alfred Health (Australia) Human Research Ethics Committee (ID: 171/19). The findings will be disseminated in peer review publications, conferences, and dissemination across perioperative research networks. The top 10 priorities will be available to inform research funders, grant submissions, guidelines, and the population.

Improving Medication Safety in Cancer Services for Ethnic Minority Consumers: Protocol for a Pilot Feasibility and Acceptability Study of a Co-Designed Consumer Engagement Intervention.

People from ethnic minorities are often exposed to unsafe care contributing to poorer health care outcomes. Medication safety is a high-risk area requiring intervention to improve care outcomes. Using an adapted, experience-based co-design process with cancer service staff and patients from ethnic minorities, a medication communication tool was created: Making it Meaningful (MiM). We aim to test whether the MiM tool is feasible and acceptable for use with ethnic minority consumers in cancer services in Australia. A single site, controlled before and after this pilot study, will be used. Patients from Mandarin- and Russian-speaking backgrounds are eligible for inclusion. In total, 40 patients from these cultural backgrounds will be recruited and stratified by language to the intervention and control groups, with 20 participants in the intervention and 20 in the control group. Further, 4 health practitioners will be recruited and trained to use the MiM. Clinicians providing care for patients in the intervention will use the MiM during their usual appointment while providing medication communication using standard care processes for the control group. Telephone surveys will be conducted with participants at 3 time points, T1 before the intervention, T2 1 week post intervention, and T3 1 month post intervention, to assess knowledge and self-efficacy in medication management, perceived usability, and acceptability of the MiM. Qualitative interviews with clinicians who have used the MiM will be conducted 1 month postintervention to explore their perceptions of MiM feasibility and acceptability. Ethical approval for this research has been provided by the South Eastern Sydney Area Health Human Research Ethics Committee (HRECXXX). Bilingual field-workers, 1 Mandarin-speaking and 1 Russian-speaking, are contacting eligible patients to enroll. It is anticipated that recruitment will be completed by October 2023, with data collection completed by December 2023. Using experience-based co-design, we identified communication about medication, particularly between appointments, as a key issue impacting the safety of care for patients from ethnic minorities accessing cancer services. Increasing consumer engagement in medication management was identified as a strategy to reduce medication safety problems in cancer care; the MiM strategy was developed to address this issue. It is anticipated that by using the MiM, patient knowledge about prescribed medications and confidence in medication management will increase. Evidence from the pilot study will be used to inform a full-scale trial of the MiM tool with a range of ethnic minority communities accessing cancer services. A full-scale trial will seek to determine whether the MiM intervention is effective in knowledge and confidence about medication management, but also whether this improves patient outcomes in cancer care. Australian New Zealand Clinical Trials ACTRN12622001260718p; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384658&isReview=true. DERR1-10.2196/49902.

ACEMID cohort study: protocol of a prospective cohort study using 3D total body photography for melanoma imaging and diagnosis

IntroductionThree-dimensional (3D) total body photography may improve early detection of melanoma and facilitate surveillance, leading to better prognosis and lower healthcare costs. The Australian Centre of Excellence in Melanoma Imaging...

Two-step offer and return of multiple types of additional genomic findings to families after ultrarapid trio genomic testing in the acute care setting: a study protocol

IntroductionAs routine genomic testing expands, so too does the opportunity to look for additional health information unrelated to the original reason for testing, termed additional findings (AF). Analysis for many...

Developing best practice principles for the provision of programs and services to people transitioning from custody to the community: study protocol for a modified Delphi consensus exercise

IntroductionThere is a lack of standard nomenclature and a limited understanding of programmes and services delivered to people in prisons as they transition into the community to support their integration...

Primary healthcare needs and service utilisation of people with disability: a data linkage protocol

IntroductionGeneral practitioners (GPs) play a crucial role in the early management and treatment of the comorbidities and complications experienced by people with disability. However, GPs experience multiple constraints, including limited...

Local anaesthetic infiltration in rubber band ligation of rectal haemorrhoids: study protocol for a three-arm, double-blind randomised controlled trial (PLATIPUS trial)

IntroductionRubber band ligation (‘banding’) is a common approach for the management of symptomatic haemorrhoids. However, up to 90% of patients experience postprocedural pain, and there is no consensus regarding the...

Diagnosis of vocal cord dysfunction / inducible laryngeal obstruction-A Delphi study protocol.

Currently there is no consistent and widely accepted approach to the diagnosis of vocal cord dysfunction/inducible laryngeal obstruction (VCD/ILO). Harmonised diagnostic methods are vital to enable optimal diagnosis, advance management and enable research. We aim to obtain consensus on how expert clinicians recognise and diagnose VCD/ILO. Two-round modified Delphi, with workshop validation. Institutional Board Review was obtained from the Monash Health Human Research Ethics Committee. The dissemination plan is for presentation and publication. Registered at Australia and New Zealand Clinical Trials Registry ACTRN12621001520820p.

Cryopreserved platelets compared with liquid-stored platelets for the treatment of surgical bleeding: protocol for two multicentre randomised controlled blinded non-inferiority trials (the CLIP-II and CLIPNZ-II trials)

IntroductionCryopreservation at −80°C in dimethylsulphoxide extends platelet shelf-life from 7 days to 2 years. Only limited comparative trial data supports the safety and effectiveness of cryopreserved platelets as a treatment...

Biofeedback Enabled CALM (BeCALM)—the feasibility of biofeedback on procedural anxiety during radiation therapy: study protocol for a pilot randomised controlled trial

IntroductionPatients undergoing treatment for cancer who require radiation therapy (RT) report anxiety specifically relating to the RT procedure. Procedural anxiety can be detrimental to treatment delivery, causing disruptions to treatment...

Career reflections of retired surgeons.

Career reflections of retired surgeons.

Effects of COVID-19 Quarantine Period on Fertility Patients and IVF Clinic Management Worldwide

Background: The initial months of 2020 experienced a rapid spread of a new Coronavirus named SARS-2. The World Health Organisation declared a global pandemic on 11th March 2020. Due to the new strain of the virus, little was known regarding COVID-19 and its effects on fertility and pregnancy. Aim: To explore how fertility clinics and ART treatments proceeded post COVID-19 lockdowns and how this affected fertility patients. Method: We surveyed fertility clinics world-wide with an online questionnaire through the platform RedCap. The questionnaire contained 33 questions focusing on the differences of country responses to guidelines and regulations. Scientific directors, medical directors and lab managers were contacted via email with the questionnaire link. The questionnaire was approved by Monash Health Human Research Ethics Committee and focused on the initial COVID-19 lockdown. Results: There were 34 individual country responses, Asia (11), Europe (10), Africa (3), North America (3), Oceania (2) and South America (5). Of the 34 countries, 7 countries did not experience a complete cessation of all procedures. Most countries followed their government health recommendations and clinic policies. IVF/ICSI and frozen embryo transfer (FET) procedures proved to be the most delayed treatments. Sixteen countries reported to have an increase in freeze-all cycles compared to fresh transfers. Patients had to undergo a SARS-CoV-2 test in 50% of countries. Additional counselling for patients during the pandemic was implemented in 22 countries. Conclusion: During the COVID-19 pandemic most fertility services were suspended, allowing insight into the implications of a shutdown. In conclusion, a protocol for scenarios of this nature would benefit future events. A protocol including increased phycological support, continuation of care, including telehealth and guidelines for prioritizing couples who need treatment most urgently.

Study protocol: Australasian Registry of Severe Cutaneous Adverse Reactions (AUS-SCAR)

IntroductionSevere cutaneous adverse reactions (SCAR) are a group of T cell-mediated hypersensitivities associated with significant morbidity, mortality and hospital costs. Clinical phenotypes include Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN),...