Human Ethics Committee Approval Research Articles

Understanding the Relationship Between User Game Preferences and Depressive Symptoms: A Pilot Study.

Objective: Following the initial measures taken to manage the repercussions of the COVID-19 pandemic, mental health conditions have become a critical concern. Mental health has become a foremost priority not only for health care providers but also for many other organizations, such as educational institutions, companies, and government agencies. A significant proportion of the Australian population having experienced mental disorders highlights the need for effective interventions. Those with pre-existing mental health issues experienced particularly pronounced effects. Among these challenges, advancements in technology offer new possibilities for mental health support. Videogames have shown effectiveness in mitigating symptoms of depression. Previous research has shown that game interface preferences correlate with players' emotional responses. This study aims to use MoodJumper, a game we designed, developed, and evaluated to examine the choice of game preferences in individuals with depressive symptoms. Materials and Methods: A pilot study was carried out after obtaining the Human Ethics committee's approval (n = 20). The participants were asked to fill out a Patient Health Questionnaire-9 (PHQ-9) questionnaire. They then played with the MoodJumper game for 20-30 minutes. Upon completing the game session, they were asked to fill out a questionnaire regarding their experience. Results: The results indicate a nonsignificant correlation between music preference, the direction of movement, and depressive symptoms meaning no significant relationship was found between depressive symptoms and chosen settings. However, a significant negative correlation was found between decision-making ability regarding game preferences and Patient Health Questionnaire-9 scores showing the difficulty of choosing preferred settings when having depressive symptoms. Conclusion: This contribution paves the way for designing and evaluating more impactful game experiences for individuals with mental health challenges.

Novel Strategy to Assess the Neurotoxicity of Organic Solvents Such as Glycol Ethers: Protocol for Combining In Vitro and In Silico Methods With Human-Controlled Exposure Experiments.

Chemicals are not required to be tested systematically for their neurotoxic potency, although they may contribute to the development of several neurological diseases. The absence of systematic testing may be partially explained by the current Organisation for Economic Co-operation and Development (OECD) Test Guidelines, which rely on animal experiments that are expensive, laborious, and ethically debatable. Therefore, it is important to understand the risks to exposed workers and the general population exposed to domestic products. In this study, we propose a strategy to test the neurotoxicity of solvents using the commonly used glycol ethers as a case study. This study aims to provide a strategy that can be used by regulatory agencies and industries to rank solvents according to their neurotoxicity and demonstrate the use of toxicokinetic modeling to predict air concentrations of solvents that are below the no observed adverse effect concentrations (NOAECs) for human neurotoxicity determined in in vitro assays. The proposed strategy focuses on a complex 3D in vitro brain model (BrainSpheres) derived from human-induced pluripotent stem cells (hiPSCs). This model is accompanied by in vivo, in vitro, and in silico models for the blood-brain barrier (BBB) and in vitro models for liver metabolism. The data are integrated into a toxicokinetic model. Internal concentrations predicted using this toxicokinetic model are compared with the results from in vivo human-controlled exposure experiments for model validation. The toxicokinetic model is then used in reverse dosimetry to predict air concentrations, leading to brain concentrations lower than the NOAECs determined in the hiPSC-derived 3D brain model. These predictions will contribute to the protection of exposed workers and the general population with domestic exposures. The Swiss Centre for Applied Human Toxicology funded the project, commencing in January 2021. The Human Ethics Committee approval was obtained on November 16, 2022. Zebrafish experiments and in vitro methods started in February 2021, whereas recruitment of human volunteers started in 2022 after the COVID-19 pandemic-related restrictions were lifted. We anticipate that we will be able to provide a neurotoxicity testing strategy by 2026 and predicted air concentrations for 6 commonly used propylene glycol ethers based on toxicokinetic models incorporating liver metabolism, BBB leakage parameters, and brain toxicity. This study will be of great interest to regulatory agencies and chemical industries needing and seeking novel solutions to develop human chemical risk assessments. It will contribute to protecting human health from the deleterious effects of environmental chemicals. DERR1-10.2196/50300.

Aetiologies of Acute Complications in Autoimmune Rheumatologic Diseases: A Hospital-Based Cross-Sectional Study.

Autoimmune rheumaticdiseases (ARD) present unique challenges in clinical practice. Many of them present in medical emergencies in an unstable state and need immediate evaluation for further plans of action. The clinical conundrum is to distinguish between sepsis, disease flare, or Addisonian crisis (AC) (secondary to steroid withdrawal). This may be further complicated by overlapping clinical features like shock/fever and the coexistence of a combination of the above pathophysiologic mechanisms (e.g. AC with sepsis or AC with disease flare). The known biomarkers may not perform optimally to distinguish them and additional supportive investigations like imaging, cultures, autoimmune serological markers, etc. are needed. Ultimately the boundaries between "the art of medicine" and "the science of medicine" may get blurred, as the established literature evidence falls short and the expert opinion is needed in a time-sensitive manner. In this pragmatic study, researchers have attempted to explore the presentation of rheumatologic emergencies on the above three differentials (sepsis, disease flare, and AC). In this hospital-based cross-sectional study, adult patients(age >18 years) with ARDwhohad unplanned hospital admission due to acute worseningwere enrolled. This study was conducted over one year, after getting the Institutional Human Ethics Committee's approval. All relevant hematological, immunological, and hormonal parameters(specifically morning cortisol) were collected and analyzed. The aim was to find the individual and combined prevalence of sepsis, disease flare, or AC in this study group. Forty-onepatients were analyzed, with females in the majority (95%) and the dominant age group being 26-49 years (56.1%). A majority had a diagnosis of rheumatoid arthritis (RA) (56.1%) or systemic lupus erythematosus (SLE) (31.7%); the rest were other connective tissue diseases (12.2%). High-risk Quick Sequential Organ Failure Assessment score (qSOFA) score 2-3 was present in 29.3% while the rest had low-risk scores (qSOFA score 0-1). Thirty-two percenthad severe disease activity, 46% had mild to moderate disease activity, and 22% of patients had no disease activity. While 78% of patients had low procalcitonin (PCT) values <0.5 microgm/L (low risk of sepsis), 15% had <20 microgm/L, and 7% percentage of patients had serum levels >20 microgm/L (high risk of sepsis). A total of 73.2% of patients had no evidence of infection while 26.8% had either microbiological/radiological evidence of infection. Only 7% of all patients had the presence of an AC. qSOFA scores didn't statistically correlate with a diagnosis of infection or AC but positively correlated with PCT and C-reactive protein (CRP) values. Serum PCT didn't correlate with the presence of infection with statistically significance (p-value 0.217). Infections and sepsis are the most important considerations in the emergency presentations of ARDs. Disease flare and AC are also important differentials. Current inflammatory biomarkers like serum CRP and PCT may be less valuable for discriminating between infectious and non-infectious sepsis, especially in chronic inflammatory diseases like ARDs. qSOFA scores may have a prognostic role with less discriminant value. Management of ARD emergencies needs better biomarkers and more research is warranted.

Ultrasound: Can it replace MRI in the evaluation of the rotator cuff tears?

ObjectiveTo assess ultrasound accuracy in rotator cuff tears detection with delineation of the extent of the injury (partial/full thickness tear) compared to MRI. MethodsForty patients were referred with clinical suspicion of rotator cuff tear. Human ethics committee approval was obtained. Ultrasound and MRI were done for all patients by 2 different radiologists being blind to the results of the other examination to minimize the bias. Surgery or arthroscopy was considered when conservative treatment failure for 6months, or when rotator cuff repair was indicated. ResultsUltrasound detected different tendon pathologies (tendinitis, partial and full thickness tears), in addition to the causal factors. Compared to MRI, ultrasound sensitivity for tendinitis detection was 85% with 86% NPV and 90% accuracy, while for partial thickness tears, its sensitivity, specificity, PPV, NPV and accuracy were 88%, 89%, 94%, 80% and 83% respectively. But in full thickness tears its sensitivity and specificity were 100% each. ConclusionUltrasound and MRI are comparable in both sensitivity and specificity. Since US is less expensive and more available, it could be considered as the screening method when rotator cuff integrity is the main question, if well-trained radiologists and high resolution equipments are available.

Clinical evaluation of non‐carious cervical lesion restorations using a HEMA‐free adhesive: three‐year results

The use of all-in-one resin-based adhesives in clinical practice has continued to increase. The aim of this study was to evaluate retention and marginal staining of a HEMA-free all-in-one adhesive Go! (SDI, Australia) and Ice resin composite in non-carious cervical lesions (NCCLs). Forty-one restorations were placed in 13 patients (age range 44-72 years). Human Ethics Committee approval from the University of Melbourne and Dental Health Services Victoria was obtained. Restorations were bonded and placed according to the manufacturer's instructions. Enamel etching was performed on NCCL margins after cleaning with pumice and water. Patients were recalled at six months and one, two and three years. Restorations were evaluated for retention and marginal staining, and photographic records of restorations were obtained. At three years, six patients were available for recall with 23 restoration sites reviewed. At the six-month recall, three restorations had been lost, with a further two lost at two years. At three years, an overall cumulative retention rate of 85% was calculated using survival analysis. Fifteen of the 23 restorations showed slight marginal staining. At three years, the overall retention rate of 85% indicates a satisfactory result for this new adhesive. Marginal staining was regarded as minimal.

67 Double blind randomised controlled trial of topical cophenylcaine forte spray in prostatic biopsy

Introduction: It is well known patients find prostate biopsy uncomfortable, and in many instances painful. There may also be discomfort and embarrassment of postbiopsy bleeding. Cophenylcaine Forte spray (Lignocaine Hydrochloride 5.0%, Phenylephrine Hydrochloride 0.5%) is a drug with local anaesthetic and vasoconstrictor properties currently used as a topical preparation in Ear, Nose and Throat surgery. It is suggested that topical application of Cophenylcaine Forte spray to the rectal mucosa prior to prostate biopsy will reduce the discomfort associated with the insertion of the ultrasound probe into the rectum and possibly reduce postbiopsy bleeding. We are unaware of any previous studies addressing these issues.Methods: After human ethics committee approval and informed consent, 30 consecutive patients presenting for prostate biopsy were randomised to receive either Cophenylcaine Forte spray or placebo saline spray topically to the rectal mucosa ten minutes prior to biopsy. All patients then proceeded to have a 12 core prostate biopsy performed with bilateral periprostatic block (Lignocaine 1.0%, 10 ml) under transrectal ultrasound guidance by a single operator. An investigator questionnaire consisting of pre and postbiopsy pulse and blood pressure and a visual analogue score for observed patient discomfort and bleeding were completed by the single investigator. In addition, a patient questionnaire 30 min postprocedure and the day after the procedure were also completed assessing discomfort and postbiopsy bleeding from the patient's perspective. Patients with painful anorectal abnormalities or anal stenosis were excluded and biopsied under general anaesthetic.Results: No statistically significant differences were observed between the two treatment groups for any of the parameters considered. Specifically there was no improvement in rectal discomfort or bleeding with the use of Cophenylcaine Forte spray.Conclusion: Cophenylcaine Forte topical rectal spray appears to make no difference to patient discomfort, postbiopsy bleeding or ease of the procedure during transrectal ultrasound and prostate biopsy.