Research Ethics Committee Research Articles

Glycaemia and ischaemia-reperfusion brain injury in patients with ischaemic stroke treated with mechanical thrombectomy (GLIAS-MT): an observational, unicentric, prospective study protocol

IntroductionPoststroke hyperglycaemia is an independent risk factor for poorer outcomes in patients treated with mechanical thrombectomy (MT) and is associated with a lower probability of functional recovery and higher mortality...

Does an expanded allied health student training programme in regional New South Wales (Australia) result in a positive social return on investment? A protocol for a single-university education-based economic evaluation

Introduction20 years ago, health professional student placements in rural areas of Australia were identified as an important rural recruitment strategy and funding priority. Since then, there has been a growing...

Systemic acupuncture application does not change muscle performance parameters in women: A randomized, controlled, double-blind pilot study

Background/objectiveAcupuncture is used for therapeutic purposes. The possible beneficial role of this therapy may be as an ergogenic resource for the performance of fitness variables in exercise and sports. To date, acupuncture has been associated with increases in muscle strength, aerobic power, and vertical jump performance, but the evidence is still inconclusive. This study aimed to verify the immediate effects of a single session of acupuncture on lower-limb muscle performance in 31 young, physically active women. MethodsThis randomized, controlled, double-blind pilot study was approved by the Research Ethics Committee and in the Brazilian Registry of Randomized Clinical Trials. After warming up on a treadmill, the participants underwent the vertical jump test, followed by an isometric strength test of the extensor muscles of both knees. Immediately after the tests, participants were randomly divided into the following groups: sham (SG), acupuncture (AG), and control (CG). After each intervention, all participants repeated the warm-up and functional tests. ResultsThere was a significant decrease in the mean and peak values of vertical jump height, in the sham and acupuncture groups, respectively. Furthermore, none of the groups showed changes in isometric muscle strength. ConclusionIt was concluded that the proposed acupuncture protocol did not promote improve in lower-limb muscle performance parameters in young, physically active women.

Suicide Attempts and Influencing Factors

Objective: The objective of this study is to evaluate the applications to the Emergency Departments in …. province between 2019 and 2023 due to suicide attempts and to provide guidance for social preventive programmes. Material and Method: This cross-sectional study was conducted with the approval of the …. University Non-Interventional Research Ethics Committee, dated 21 September 2023 and numbered 176-176-09. The study examined The archive of the …. Provincial Health Directorate was consulted to obtain records of cases of suicide attempts among individuals aged 13 years and over between the years 2019-2023. These records were examined between 1 November-31 December 2023. Results: A total of 947 patients participated in the study, 635 of whom were women. The majority of suicide attempts (43.2%) occurred between the ages of 13 and 24 years. The highest number of suicide attempts occurred between 18:00 and 23:59 (40.5%) and in summer (29.8%). The highest number of suicide attempts occurred in August (10.5%). The majority of those who attempted suicide were primary school graduates (47.0%) and unemployed (39.4%). The suicide attempt rate of farmers (42.9%) was significantly higher than other occupational groups (p=0.009). Family problems (31.3%) were the most common reason for suicide attempt. The most common method of suicide attempt was drug-toxic substance use (92.6%). Among the study participants, 21.1% had attempted suicide previously. Among those who attempted suicide, 24.2% had a previous psychiatric diagnosis. Medication (activated charcoal) was administered to 60.4% of the suicide attempters, while psychiatric consultation was requested for 11.5%. A total of 69.5% of the suicide attempts resulted in a single interview. Conclusion: Most of the suicide attempters were adolescent and young age group, female, illiterate, primary school graduate and unemployed. According to our study, the most common causes and methods of suicide attempts were familial problems and drug-toxic substance use. It is recommended that regulations should be implemented to ensure psychiatric consultation for all suicide attempters and that the follow-up and treatment of suicide attempters should be carried out by a team consisting of family physicians, psychiatrists, psychologists and social workers.

Implementation of time-limited parenteral hydromorphone in people with treatment-resistant injecting opioid use disorder: a protocol for a single-site, uncontrolled, open-label study to assess feasibility, safety and cost

IntroductionSupervised injectable opioid treatment (SIOT) is an evidence-based intervention targeting opioid-dependent people for whom existing treatments have been ineffective. This project will primarily assess the feasibility and the acceptability of...

Toothbrushing programme in Saudi Arabia ‘TOPS’: a study protocol for a cluster randomised controlled trial in kindergartens, Riyadh

IntroductionDental caries among children is a major global health problem and is a particular public health challenge in Saudi Arabia. Dental caries cause pain, infection and negatively impact quality of...

Protocol of a cost-effectiveness analysis of a combined intervention for depression and parenting compared with enhanced standard of care for perinatally depressed, HIV-positive women and their infants in rural South Africa

IntroductionPoverty, HIV and perinatal depression represent a triple threat to public health in sub-Saharan Africa because of their combined negative effects on parenting and child development. In the resource-constrained context...

Protocol for the process evaluation of the GOAL trial: investigating how comprehensive geriatric assessment (CGA) improves patient-centred goal attainment in older adults with chronic kidney disease in the outpatient setting

IntroductionThe GOAL Cluster Randomised Controlled Trial (NCT04538157) is now underway, investigating the impact of comprehensive geriatric assessment (CGA) for frail older people with chronic kidney disease (CKD). The primary outcome...

Patient and carer transition outcomes and experiences at the Westmead Centre for Adolescent and Young Adult Health, Westmead, Australia: protocol for a longitudinal cohort study

IntroductionThe Westmead Centre for Adolescent and Young Adult Health is a purpose-built facility supporting integrated care for young patients with a variety of long-term health conditions transitioning from paediatric services...

Understanding the impact of distance and disadvantage on lung cancer care and outcomes: a study protocol

BackgroundLung cancer is the third most common cancer in the UK and the leading cause of cancer mortality globally. NHS England guidance for optimum lung cancer care recommends management and treatment by a specialist team, with experts concentrated in one place, providing access to specialised diagnostic and treatment facilities. However, the complex and rapidly evolving diagnostic and treatment pathways for lung cancer, together with workforce limitations, make achieving this challenging. This place-based, behavioural science-informed qualitative study aims to explore how person-related characteristics interact with a person’s location relative to specialist services to impact their engagement with the optimal lung pathway, and to compare and contrast experiences in rural, coastal, and urban communities. This study also aims to generate translatable evidence to inform the evidence-based design of a patient engagement intervention to improve lung cancer patients’ and informal carers’ participation in and experience of the lung cancer care pathway.MethodsA qualitative cross-sectional interview study with people diagnosed with lung cancer < 6 months before recruitment (in receipt of surgery, radical radiotherapy, or living with advanced disease) and their informal carers. Participants will be recruited purposively from Barts Health NHS Trust and United Lincolnshire Hospitals NHS Trusts to ensure a diverse sample across urban and rural settings. Semi-structured interviews will explore factors affecting individuals’ capability, opportunity, and motivation to engage with their recommended diagnostic and treatment pathway. A framework approach, informed by the COM-B model, will be used to thematically analyse facilitators and barriers to patient engagement.DiscussionThe study aligns with the current policy priority to ensure that people with cancer, no matter where they live, can access the best quality treatments and care. The evidence generated will be used to ensure that lung cancer services are developed to meet the needs of rural, coastal, and urban communities. The findings will inform the development of an intervention to support patient engagement with their recommended lung cancer pathway.Protocol registrationThe study received NHS Research Ethics Committee (Ref: 23/SC/0255) and NHS Health Research Authority (IRAS ID 328531) approval on 04/08/2023. The study was prospectively registered on Open Science Framework (16/10/2023; https://osf.io/njq48).

Patient experience in bariatric surgery: protocol of a French narrative inquiry and qualitative analysis

IntroductionThe quality of hospital care, especially surgery, is traditionally assessed using indicators derived from healthcare databases or safety indicators. Given the growing importance of placing the patient at the heart...

The Effects of Open and Closed Kinetic Chain Exercises on Visual Reaction Times and Certain Motor Skills in Young Male Boxers

This study aimed to determine the effects of open kinetic chain (OKC) and closed kinetic chain (CKC) exercises on visual reaction times and certain motor skills in young male boxers. Twelve young male athletes (mean age: 16.92±1.08 years) voluntarily participated in this study, which employed a pretest-posttest experimental research model, a quantitative research method, without a control group. The Ethics Committee Approval required for the research was received from Muş Alparslan University Scientific Research and Publication Ethics Committee with decision number 9/73 dated 08.11.2023. Prior to and following training in OKC and CKC exercises, the athletes were tested on visual reaction times, vertical jumping, and flexibility. The paired samples t-test was applied to normally distributed data. According to our findings, there were no significant differences in the visual reaction time and flexibility tests with respect to the pre- and post-test results for the OKC exercises (p ˃ .05), although a significant difference was detected for the vertical jump test (p ˂ .05), with the post-test values determined to be lower than the pre-test values. While there were no significant differences in the CKC exercise pre-and post-test results for the vertical jump and flexibility tests (p ˃.05), a significant difference was observed in the visual reaction test (p ˂ .05), for which the post-test values were lower than the pre-test values. Based on these results, OKC exercises were determined to have a negative impact on jumping ability, whereas CKC exercises exhibited positive effects on visual reaction times. The use of CKC exercises can thus be recommended for studies aimed at improving visual reaction performance in young male boxers.

HIV-1 subtype-specific drug resistance on dolutegravir-based antiretroviral therapy: protocol for a multicentre study (DTG RESIST)

IntroductionHIV drug resistance poses a challenge to the United Nation’s goal of ending the HIV/AIDS epidemic. The integrase strand transfer inhibitor (InSTI) dolutegravir, which has a higher resistance barrier, was...

Does regional implementation of a clinical pathway for older adult patients with pelvic fragility fractures after low-energy trauma improve patient outcomes (PELVIC): a multicentre, stepped-wedge, randomised controlled trial

IntroductionPatients with pelvic fragility fractures suffer from high morbidity and mortality rates. Despite the high incidence, there is currently no regional or nationwide treatment protocol which results in a wide...

Factorial randomised controlled trial to examine the potential effect of a text message-based intervention on reducing adolescent susceptibility to e-cigarette use: a study protocol

IntroductionAdolescent e-cigarette use, globally and within Australia, has increased in recent years. In response, public health agencies have called for the development of education and communication programmes targeting adolescents. Despite...

Palatability evaluation of orally disintegrating tablets using a visual analog scale in clinical trials.

Visual analog scale (VAS) can be used to evaluate multiple parameters. There have been no reports on the verification of order effects or reproducibility of the VAS method for overall palatability of oral dosage forms. The purpose of this study was to assess the validity of a method for evaluating the palatability of orally disintegrating tablets (ODTs) using a 100-mm VAS. We conducted clinical trials to evaluate the overall palatability, taste, and scent of 3 ODTs (F1, F2, F3) that contained famotidine (20, 10, and 5mg, respectively). The study protocol was approved by the Research Ethics Committee of the University of Shizuoka, Japan (No. 21-36). To investigate the intergroup reproducibility of the VAS evaluation, 40 participants were divided into three groups, and each group underwent human gustatory sensation test of F1, F2, and F3, performed using a crossover design with 6 different tasting sequences. To evaluate intragroup reproducibility of the VAS evaluation, the participants assessed the same ODTs twice. The VAS scores for overall palatability followed the same order (F3>F2>F1) in all groups. The VAS scores for the overall palatability of F1, F2, and F3 did not significantly differ between the first and second evaluations. The Kruskal-Wallis test indicated a minimal impact of the assessment order on ODT evaluations. We confirm the reliability and reproducibility of the VAS method for evaluating ODT palatability. The VAS method for assessing ODT palatability provides accurate information and can contribute to the design and manufacture of patient-friendly pharmaceutical products.

Effects of the intermittent theta burst stimulation on gait, balance and lower limbs motor function in stroke: study protocol for a double-blind randomised controlled trial with multimodal neuroimaging assessments

IntroductionApproximately, 50% of stroke survivors experience impaired walking ability 6 months after conventional rehabilitation and standard care. However, compared with upper limb motor function, research on lower limbs rehabilitation through...

Childhood Health and Educational outcomes afteR perinatal Brain injury (CHERuB): protocol for a population-matched cohort study

IntroductionOver 3000 infants suffer a brain injury around the time of birth every year in England. Although these injuries can have important implications for children and their families, our understanding...

Cortical–striatal network functional connectivity markers in poststroke fatigue: a single-centre fMRI case–control study protocol

IntroductionStructural and functional abnormalities in the cortical–striatal network (CSN) are hypothesised to play a key role in the pathogenesis of neurological disease-associated fatigue. Some small-scale functional MRI (fMRI) studies have...

Using polygenic risk modification to improve breast cancer prevention: study protocol for the PRiMo multicentre randomised controlled trial

IntroductionEstablished personal and familial risk factors contribute collectively to a woman’s risk of breast or ovarian cancer. Existing clinical services offer genetic testing for pathogenic variants in high-risk genes to...