Human Research Ethics Committee Research Articles

Examining tools for assessing the impact of chronic pain on emotional functioning in children and young people with cerebral palsy: stakeholder preference and recommendations for modification.

To firstly identify tools for assessing the impact of chronic pain on emotional functioning in children and young people with cerebral palsy (CP), and secondly identify suggestions to improve their relevance, comprehensiveness, comprehensibility and feasibility for the CP population. Improving assessment of the impact of pain on emotional functioning can enhance quality of life by improving access to interventions for pain-related physical disability, anxiety and depression. Ethics approval was granted through the Women's and Children's Health Network Human Research Ethics Committee (2022/HRE00154). A mixed methods study with people with lived experience and clinicians, and guided by the Consensus-based Standards for Measurement Instruments (COSMIN), was undertaken. An online survey identified the highest rated tools for validation and/or modification for young people with CP and chronic pain. Focus groups and interviews investigated content validity and feasibility of the tools identified as highest rated. The Fear of Pain Questionnaire for Children-SF (FOPQ-C-SF) and Modified Brief Pain Inventory (mBPI) were the highest rated for pain coping and multidimensional assessment (respectively) from the online survey (n = 61) of eight tools presented. Focus group and interview data (n = 30), including 58 unique modification suggestions, were coded to six categories: accessibility, comprehensibility, feasibility, relevance, presentation and comprehensiveness. Potential modifications have been identified to improve the appropriateness and feasibility of the FOPQ-C-SF and mBPI for children and young people with CP. Future research should implement and test these modifications, prioritising the involvement of people with lived experience to ensure their needs are met alongside clinicians.

Efficacy and safety of pentosan polysulfate sodium in people with symptomatic knee osteoarthritis and dyslipidaemia: protocol of the MaRVeL trial

IntroductionKnee osteoarthritis (OA) is the most prevalent arthritis type and a leading cause of chronic mobility disability. While pain medications provide only symptomatic pain relief; growing evidence suggests pentosan polysulfate...

Protocol for a pragmatic randomised controlled feasibility study of MS WorkSmart: an online intervention for Australians with MS who are employed

IntroductionMultiple sclerosis (MS) causes a wide variety of symptoms. Loss of income due to sickness and early retirement comprise one-third of the total cost of MS in Australia. An intervention...

Clothing and Equipment Fit Among Male and Female Canadian Armed Forces Members.

The fit of military clothing and equipment is essential for the health and safety of military operators. Given the aim of increasing the proportion of women and the known biological and morphological differences between male and female soldiers, an understanding of fit across different items of kit is needed. The aim of this study was to quantify subjective fit ratings of 8 items of military clothing and equipment, including combat shirt, combat pants, rucksack, small pack, tactical vest, fragmentation vest, helmet, and ballistic eyewear as a function of relative stature and occupational group among male and female Canadian Armed Forces members. An online survey was distributed to male and female Canadian Armed Forces members, where fit was reported by participants according to a 7-point Likert acceptability scale. Participants were binned into 1 of 6 (3 males, 3 females) standing stature categories based on percentiles in a male and female distribution that included (1) under 35th percentile stature, (2) 35th to 80th percentile stature, and (3) over 80th percentile stature. Additionally, participants were separated according to occupational group: Group A: Infantry, Combat Engineer, Artillery, Armored; group B: Signals, Medical Technician, Intelligence, Signals Intelligence/Cyber Ops; group C: Supply Technician, Weapons Technician, Vehicle Technician, Electronic-Optronic Technician, Ammunition Technician; other: Not in other groups, examples include: Financial Services Administrator, Cook. This study was approved by the Defence Research and Development Canada Human Research Ethics Committee under protocol 2019-048, Amendment 2. There were significant effects attributable to stature category and occupational group on the fit of equipment. Specifically, fit acceptability of the rucksack helmet, small pack, and tactical vest was significantly affected by occupational group. Differences between stature categories were detected in all items with the exception of the small pack. Military equipment fit has previously been shown to have implications for protection, performance, and mobility. The results of the investigation demonstrate different patterns of fit acceptability in male and female soldiers across items of clothing and equipment and may require different solutions.

Design and development of the clinical pharmacy key performance indicators dashboard for equity of service provision at regional and rural hospitals in North Queensland, Australia

AbstractBackgroundProvision of a Medication Action Plan (MAP) on admission and a Discharge Medication Record (DMR) are associated with reduced medication‐related harm.AimTo report factors associated with the provision of MAPs and DMRs in rural and regional hospitals in Queensland, Australia.MethodA literature search, environmental scan and department consultations were conducted to develop Clinical Pharmacy Key Performance Indicators (cpKPIs) and design a cpKPI dashboard. Two of the five KPIs included in the dashboard, relating to medication action plans on admission and medication records on discharge, were reported for all the hospitals and were included in the study. A retrospective, period‐prevalence study was conducted to evaluate the coverage and equity of clinical pharmacy service provision for patients admitted for longer than 24 h. The proportions of patients who received MAPs and DMRs were stratified by age, gender, Indigeneity and hospital type. Statistical analysis used chi‐squared tests and logistic regression in R. This project was exempt due to the local policy requirements that constitute research by the Far North Queensland Human Research Ethics Committee (Reference no: EX/2023/QCH/94383‐1684QA). The justification for this exemption is as follows: the project was determined to be negligible risk research and involved the use of existing collection of data or records that contain only non‐identifiable data about human beings.ResultsIn total, 13 818 patients (37.9% of admissions) received a MAP and 11 631 patients (32.7% of discharges) received a DMR. The proportion of MAPs and DMRs was significantly higher in rural hospitals than in regional hospitals (MAP 50.6% vs 34.6%, DMR 33.1% vs 31.3%) and for male patients than female patients (MAP 42.2% vs 33.7%, DMR 36.4% vs 29.2%). When stratified by age, First Nations patients received a higher proportion of MAPs and DMRs in each age group, except for age 85 years and over. The proportion of First Nations patients aged 50 years and over who received MAP was lower compared to that for non‐Indigenous patients aged 65 years and over (56.3% vs 59.8%), whilst the proportion for DMRs was similar (50.4% vs 49.3%).ConclusionThe study defined the clinical pharmacy key performance indicators for measuring equity of clinical pharmacy service provision in Australia. When adjusted for a difference in life expectancy, the proportion of MAPs for First Nations patients was lower compared to the proportion of MAPs for non‐Indigenous patients. Further improvements are required to achieve equity of service provision for First Nations patients and female patients.

Exercise Responses During Outdoor Versus Virtual Reality Indoor Arm+FES-Leg Cycling in Individuals with Spinal Cord Injury.

Background: Virtual reality (VR)-enhanced indoor hybrid cycling in people with spinal cord injury (SCI) can be comparable to outdoor hybrid cycling. Method: Eight individuals with chronic thoracic-lesion SCI performed voluntary arm and electrically assisted leg cycling on a hybrid recumbent tricycle. Exercises were conducted outdoors and indoors incorporating VR technology in which the outdoor environment was simulated on a large flat screen monitor. Electrical stimulation was applied bilaterally to the leg muscle groups. Oxygen uptake (VO2), heart rate, energy expenditures, and Ratings of Perceived Exertion were measured over a 30-minute outdoor test course that was also VR-simulated indoors. Immediately after each exercise, participants completed questionnaires to document their perceptual-psychological responses. Results: Mean 30-minute VO2 was higher for indoor VR exercise (average VO2-indoor VR-exercise: 1316 ± mL/min vs. outdoor cycling: 1255 ± 53 mL/min; highest VO2-indoor VR-exercise: 1615 ± 67 mL/min vs. outdoor cycling: 1725 ± 67 mL/min). Arm and leg activity counts were significantly higher during indoor VR-assisted hybrid functional electrical stimulation (FES) cycling than outdoors; 42% greater for the arms and 23% higher for the legs (P < 0.05). Similar responses were reported for exercise effort and perceptual-psychological outcomes during both modes. Conclusion: This study proposes that combining FES and VR technology provides new opportunities for physical activity promotion or exercise rehabilitation in the SCI population, since these modes have similar "dose-potency" and self-perceived effort. Human Research Ethics Committee of the University of Sydney Ref. No. 01-2010/12385.

Australian trial of behavioural activation for people with schizophrenia experiencing negative symptoms: a feasibility randomised controlled trial protocol

IntroductionNegative symptoms are frequently experienced by people with schizophrenia. People with negative symptoms often have impaired social functioning and reduced quality of life. There is some evidence that cognitive–behavioural therapy...

Abstract PO5-14-04: FTIR Spectroscopy Analysis of Lipid Region: Distinguishing Breast Cancer from Benign Breast Diseases Using PCA-SVM

Abstract Background: Breast cancer (BC) is the most diagnosed type worldwide, with 2.26 million new cases in 2020. Mammography is the preferred screening method, but it has limitations such as radiation exposure and low sensitivity in dense breasts. Therefore, there is a need for accurate diagnostic methods to detect breast cancer and distinguish benign conditions. Objective: This study aimed to develop an automated tool for the comparison of lipid spectral region in benign breast disease (BBD) and breast cancer (BC) to determine their potential diagnostic value using Fourier Transform Infrared Spectroscopy (ATR-FTIR). Methods: This study was conducted at a Clinical Hospital in Uberlandia, MG, Brazil, after approval by the Human Research Ethics Committee of the Federal University of Uberlandia, and all subjects provided written informed consent. Women who went to the Clinical Hospital for breast surgery were invited to participate in the study as volunteers. After surgery and histopathological analysis, the tumors and lesions found were classified according to histological type, staging, and the status of ER, PR, and HER2 receptors. A total of 60 women participated in the study, of whom 27 had BBD, and 33 had BC. Spectra were measured in the wavenumber range of 4000 cm-1 to 650 cm-1 using an Agilent Cary 600 Series FTIR spectrometer coupled to an MCT detector. The air spectrum was used as a background before each sample analysis. The sample spectra were obtained in triplicate, with a spectral resolution of 4 cm-1, and 128 scans were performed for each measurement. The infrared spectra were analyzed after undergoing preprocessing, which involved positive baseline rubberband normalization, normalization by minimum and maximum, and application of the second derivative. Results: The region of 3050-2800 cm-1 was able to differentiate BC from BBD using principal component analysis (PCA) followed by the support vector machine algorithm (PCA-SVM) with an accuracy of 80%, sensitivity of 88%, and specificity of 70%. This range corresponds to the vibration of lipids, and it is known that changes in the contents of biomolecules in the serum, an increase or decrease, can be related to the presence or absence of BC. The implementation of this approach in clinical practice may automate the diagnosis of BC, monitoring whether changes in therapy or interventions are necessary throughout the treatment. FTIR can potentially assist in clinical decision-making regarding follow-up or biopsy recommendations, avoiding unnecessary biopsies that are more invasive and expensive than blood collection, and which often cause significant anxiety to the patient even if the lesion is not highly suspicious. Conclusion: This study shows that it is possible to detect BC with good accuracy through a minimally invasive, fast, and cost-effective method analyzing the lipid spectral region using principal component analysis (PCA) followed by the support vector machine algorithm (PCA-SVM). Citation Format: Juliana Pereira, Alinne Faria, Izabella Ferreira, Letícia Santos, Donizeti Santos, Marcelo Maia, Ohanna Costa, Raul Freitas, Carlos Paiva, Yara Maia. FTIR Spectroscopy Analysis of Lipid Region: Distinguishing Breast Cancer from Benign Breast Diseases Using PCA-SVM [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-14-04.

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...

Erdosteine in children and adults with bronchiectasis (BETTER trial): study protocol for a multicentre, double-blind, randomised controlled trial

IntroductionBronchiectasis is a worldwide chronic lung disorder where exacerbations are common. It affects people of all ages, but especially Indigenous populations in high-income nations. Despite being a major contributor to...

EXERCISE PHYSIOLOGIST-LED PAIN SCIENCE COACHING VIA TELEHEALTH IMPROVED PAIN AND FUNCTION IN LIFE INSURANCE CLAIMANTS: A PRAGMATIC COHORT STUDY

INTRODUCTION &amp; AIMS Personal injury and illness compensation claimants are more likely to experience persistent pain and poorer clinical/vocational outcomes than non-compensated clients. Evidence supports the effectiveness of pain science coaching to help people understand and re-train their pain system. This consequently reduces pain intensity, improves function and quality of life. However, the effectiveness of telehealth-delivered, exercise physiologist-led pain science coaching is yet to be evaluated. This study aimed to determine the effectiveness of an accredited exercise physiologist-led pain science coaching intervention via telehealth in Australian life insurance claimants. METHODS This pragmatic cohort study included 1,275 claimants receiving a pain science coaching intervention supported by life insurance compensation. Ethics was approved via Deakin University Human Research Ethics Committee (2023-347). Outcome measures were pain intensity (11 item numerical pain rating scale, range: 0-10 points) and function (two 11-item patient-specific functional scale, range: 0-20 points). Linear mixed models determined within-group change over time. RESULTS Clients (female: 75%, male: 25%) had a mean (SD) age of 50 (10) years (range: 20-69 years) and claim duration of 2 (2) years (range: 0-20 years). Mean (SD) intervention duration was 10 (6) weeks (range: 3-41 weeks), financial cost was A$1,149 (A$202; range: A$510-A$2,040) and included 5 (1) hours (range: 2-11 hours) of pain science coaching. Following the intervention, pain intensity decreased 25% (estimated marginal mean change [95%CI]: -1.49 [-1.59, -1.40] points, P&amp;lt;0.001) and function increased 76% (4.41 [4.21, 4.62] points, P&amp;lt;0.001). Changes surpassed established clinically meaningful effect thresholds for pain intensity (1.17 points) and function (2.6 points). Client Net Promotor Score was +60 (Australian Healthcare Index benchmark ≥ +30) and 91% were satisfied with the intervention. CONCLUSION An exercise physiologist-led pain science coaching intervention resulted in clinically meaningful improvements in pain intensity and function in compensation claimants. Clients reported high satisfaction rates.

Metformin for low back pain: Study protocol for a randomised, double-blind, placebo-controlled trial

BackgroundChronic low back pain is a major cause of pain and disability with limited effective therapies. Metformin is a safe, inexpensive, well-tolerated drug that has pleotropic effects, including effects on pain pathways that may influence low back pain. The aim of this randomised, double-blind, placebo-controlled trial is to determine whether metformin reduces low back pain over 4 months in individuals with chronic low back pain. Methods and analysisOne hundred and twenty-three participants with chronic low back pain will be recruited from the community in Melbourne, Australia, and randomly allocated in a 1:1 ratio to receive either metformin 2g or identical placebo daily for 4 months. The primary outcome will be change in pain intensity assessed using a 100 ​mm visual analogue scale at 4 months and the secondary outcomes will be change in low back disability, physical activity and narcotic use. Adverse events will be recorded. The primary analysis will be by intention to treat. DiscussionGiven the societal burden of LBP and the limited effective treatment options available, this study that evaluates the efficacy of metformin in LBP, if proves to be effective, will offer an important therapeutic approach for this disabling condition. Ethics and disseminationEthics approval has been obtained from the Alfred Hospital Ethics Committee (392/21) and Monash University Human Research Ethics Committee (30607). Written informed consent will be obtained from all the participants. The findings will be disseminated through peer-review publications and conference presentations. Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12621001453875 (registered 25th October 2021).

Exploring type 2 diabetes self-management practices in rural Bangladesh: facilitators, barriers and expectations—a qualitative study protocol

BackgroundType 2 diabetes mellitus (T2DM) is a global public health crisis impacting low-income and middle-income countries such as Bangladesh. While self-management is encouraged for individuals with T2DM, there is a...

ASSESSMENT OF SLEEP HEALTH IN ELITE FEMALE BASKETBALL PLAYERS DURING INTERNATIONAL COMPETITION: A CASE STUDY

INTRODUCTION &amp; AIMS Sleep health is recognised as an essential component to optimise overall wellbeing and athletic performance. However, athletes frequently report sleep disturbance prior to and during competition, with nearly a quarter of athletes experiencing moderate to severe sleep problems international travel and subsequent competition. The Athlete Sleep Screening Questionnaire (ASSQ) was developed as a sleep screening tool to detect clinically significant sleep disturbances and daytime dysfunction in athletes. The purpose of this study was to assess sleep health (sleep disturbances, sleep difficulty and daytime dysfunction) via a sleep screening tool in elite female basketball players during international competition. METHODS Participants were 12 elite female basketball players (New Zealand Women’s Senior National Team, Tall Ferns) competing at the 2021 International Basketball Federation Women’s Asia Cup in Amman Jordan. The Athlete Sleep Screening Questionnaire (16 item) was used to assess sleep health and associated factors during the 7-day tournament to determine the impact of international travel. The ASSQ was scored according to previous validated methods to determine chronotype, sleep difficulty score, clinical sleep problem category (none, mild, moderate, or severe), and potential referral to a sleep physician for assessment due to poor sleep health. Categorical variables were summarised with frequency and percent. The study was approved by the University of Southern Queensland Human Research Ethics Committee (H21REA182). RESULTS Clinical sleep problems, as categorised by sleep difficulty score ≥ 8, were reported in 33% of the athletes, with 25% classified as moderate and 8% classified as severe. Fifty percent of the athletes reported sleep disturbance during travel, while 42% reported daytime dysfunction when travelling for competition. According to chronotype classification, 75% of athletes were categorised into evening type, 33% ‘definitely evening’ type sub-category, with 25% categorised into morning type. In total, 42.0% of athletes (5 players) were identified for further assessment. CONCLUSION This study highlights the effective use of the ASSQ as an easy to administer sleep screening tool to determine sleep health in elite female basketball players. The ASSQ provides a method of accurately identifying athletes that would benefit from sleep hygiene education, sleep travel management and subsequent preventative measures related to clinically significant sleep problems. In this case study, a substantial portion of elite female basketball players appear to suffer from suboptimal sleep and would likely benefit from interventions targeting sleep health. This is an important consideration and provides valuable insights into indicators of sleep health in the management of female athlete sleep health and wellbeing during international competition.

Study protocol - assessing parkrun for walking rehabilitation for people living with, and beyond, cancer: acceptability, adherence, social support and physical function

IntroductionDue to a variety of barriers, the majority of cancer survivors do not do enough physical activity to meet current recommendations. This study will assess the feasibility of participation in parkrun walk-run events as a novel mode of community rehabilitation exercise.MethodsThis protocol describes a single-arm intervention study with participants acting as their own controls. The study accepts adults diagnosed with any type of cancer, undergoing treatment or in remission. Participants must be able to walk and have medical clearance to exercise. A sample of 100 participants will be recruited across the Sunshine Coast over two years. Data will be collected over 9-months at 4 time points: Baseline (T1); after 4-weeks of usual daily activities and cancer management prior to parkrun participation(T2); after a 6-month parkrun intervention (T3); at 2-month follow-up (T4). The primary objectives are to assess the acceptability of, and adherence to, parkrun as rehabilitation exercise. Secondary outcomes include wellness, health-related quality of life, anxiety, depression, mood, physical function, parkrun metrics, dietary intake, and diet and exercise behaviour.ConclusionThis study will be the first to examine the long-term effects of parkrun as a cancer rehabilitation modality with regard to physical function, psychosocial outcomes and dietary intake.Trial registrationAustralian and New Zealand Clinical Trials Registry ACTRN12623000473662 registered 09/05/2023.Approved by UniSC Human Research Ethics Committee (A221828) and the UK parkrun Research Board. Original protocol. Authors SB, RB, HHW, MM, YK.

Fetal alcohol spectrum disorder and attention deficit hyperactivity disorder stimulant trial in children: an N-of-1 pilot trial to compare stimulant to placebo (FASST): protocol

IntroductionFetal alcohol spectrum disorder (FASD) is a neurodevelopmental disorder caused by alcohol exposure during pregnancy. FASD is associated with neurodevelopmental deviations, and 50%–94% of children with FASD meet the Diagnostic...

Short-duration aerobic high-intensity intervals versus moderate exercise training intensity in patients with peripheral artery disease: study protocol for a randomised controlled trial (the Angiof-HIIT Study)

IntroductionSupervised exercise training is among the first-line therapies for patients with peripheral artery disease (PAD). Current recommendations for exercise include guidance focusing on claudication pain, programme and session duration, and...

Australasian Malignant PLeural Effusion (AMPLE)-4 trial: study protocol for a multi-centre randomised trial of topical antibiotics prophylaxis for infections of indwelling pleural catheters

BackgroundMalignant pleural effusion (MPE) is a debilitating condition as it commonly causes disabling breathlessness and impairs quality of life (QoL). Indwelling pleural catheter (IPC) offers an effective alternative for the management of MPE. However, IPC-related infections remain a significant concern and there are currently no long-term strategies for their prevention. The Australasian Malignant PLeural Effusion (AMPLE)-4 trial is a multicentre randomised trial that evaluates the use of topical mupirocin prophylaxis (vs no mupirocin) to reduce catheter-related infections in patients with MPE treated with an IPC.MethodsA pragmatic, multi-centre, open-labelled, randomised trial. Eligible patients with MPE and an IPC will be randomised 1:1 to either regular topical mupirocin prophylaxis or no mupirocin (standard care). For the interventional arm, topical mupirocin will be applied around the IPC exit-site after each drainage, at least twice weekly. Weekly follow-up via phone calls or in person will be conducted for up to 6 months. The primary outcome is the percentage of patients who develop an IPC-related (pleural, skin, or tract) infection between the time of catheter insertion and end of follow-up period. Secondary outcomes include analyses of infection (types and episodes), hospitalisation days, health economics, adverse events, and survival. Subject to interim analyses, the trial will recruit up to 418 participants.DiscussionResults from this trial will determine the efficacy of mupirocin prophylaxis in patients who require IPC for MPE. It will provide data on infection rates, microbiology, and potentially infection pathways associated with IPC-related infections.Ethics and disseminationSir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee has approved the study (RGS0000005920). Results will be published in peer-reviewed journals and presented at scientific conferences.Trial registrationAustralia New Zealand Clinical Trial Registry ACTRN12623000253606. Registered on 9 March 2023.

Multicentre double-blind randomised placebo-controlled trial evaluating the efficacy of the meningococcal B vaccine, 4CMenB (Bexsero), against Neisseria gonorrhoeae infection in men who have sex with men: the GoGoVax study protocol

IntroductionGonorrhoea, the sexually transmissible infection caused by Neisseria gonorrhoeae, has a substantial impact on sexual and reproductive health globally with an estimated 82 million new infections each year worldwide. N....

Web-based cognitive rehabilitation intervention for cancer-related cognitive impairment following chemotherapy for aggressive lymphoma: protocol for a randomised pilot trial

IntroductionCancer-related cognitive impairment is common among people diagnosed with and treated for cancer. This can be a distressing and disabling side effect for impacted individuals. Interventions to mitigate cognitive dysfunction...