Clinical Oversight Research Articles

Postoperative Otoplasty Care With ChatGPT-4: A Study on Artificial Intelligence (AI)-Assisted Patient Concern and Education.

Otoplasty is a cosmetic surgery that is performed to alter the size, shape, or position of the ear by using permanent stitches. Its main purpose is to correct protruding ears, a condition known as prominauris. After the surgery, it is crucial to provide proper care to ensure successful recovery. However, obtaining timely medical advice can be difficult, especially in remote areas or places with limited resources. To address this issue, incorporating advanced artificial intelligence (AI) tools like Chat Generative Pre-trained Transformer (ChatGPT)-4 into postsurgical care could help fill the gap in patient education and support. This study aims to assess whether ChatGPT4 can be a reliable, accurate, and effective method for answering the most common patient questions and concerns post-otoplasty. The main objective was to assess the AI chatbot's capacity to deliver precise, concise, and pertinent information, especially in situations where health care professionals are limited in availability. In this study, over 50 patients were engaged, and ChatGPT4 was employed to present the same 5 common postoperative questions post-otoplasty surgery care. The AI chatbot's responses were analyzed for accuracy, response time, clarity, and relevance. The chatbot could potentially provide timely assistance, answer questions, and address concerns related to postsurgical care in otoplasty. The responses exhibited a perfect accuracy rate of 100%, closely corresponding to existing medical guidelines. This study explores the potential of AI-driven solutions to enhance patient education and support, especially in areas where access to health care professionals may be limited. However, professional medical advice is crucial in postoperative care and cannot be replaced by ChatGPT-4. By leveraging AI tools like chatbots, individuals in remote or resource-limited settings can potentially receive valuable information and guidance, contributing to successful rehabilitation and overall health care outcomes. Ethical considerations around the use of AI in health care must also be carefully addressed to ensure patient privacy, data security, and appropriate clinical oversight.

The changing landscape of antimicrobial resistance and use in South Africa: The need for access to new antibiotics: A position paper.

Antibiotic resistance is a global threat, with a disproportionate burden of mortality in low- and middle-income countries. It is increasing in both the public and private healthcare sectors within South Africa, especially in Gram-negative organisms, and is associated with increased use of World Health Organization watch and reserve antibiotics. There is a need for improved access to new antibiotics to treat infections caused by drug-resistant organisms in order to limit side-effects and improve patient outcomes of currently available antibiotics. We propose the responsible introduction of these new antibiotics with both administrative and clinical oversight in order to preserve the longevity of these precious antibiotics.

Family member and service provider experiences and perspectives of a digital surveillance and service navigation approach in multicultural context: a qualitative study in identifying the barriers and enablers to Watch Me Grow-Electronic (WMG-E) program with a culturally diverse community

BackgroundChildren and families from priority populations experienced significant psychosocial and mental health issues to the COVID-19 pandemic. Yet they also faced significant barriers to service access, particularly families from culturally and linguistically diverse (CALD) backgrounds. With most child and family health nurse clinics ceasing in-person consultations due to the pandemic, many children missed out on health and developmental checks. The aim of this study was to investigate the perspectives and experiences of family members and service providers from an urban, CALD community regarding the implementation of a digital, developmental surveillance, Watch Me Grow-Electronic (WMG-E) program.MethodsSemi-structured interviews were conducted with 17 family members, service navigators, and service providers in a multicultural community in South Western Sydney, Australia. This qualitative study is an implementation evaluation which formed as part of a larger, two-site, randomised controlled trial of the WMG-E program. A reflexive thematic analysis approach, using inductive coding, was adopted to analyse the data.ResultsParticipants highlighted the comprehensive and personalised support offered by existing child and family health services. The WMG-E was deemed beneficial because the weblink was easy and quick to use and it enabled access to a service navigator who support family access to relevant services. However, the WMG-E was problematic because of technology or language barriers, and it did not facilitate immediate clinician involvement when families completed the weblink.ConclusionsFamilies and service providers in this qualitative study found that using WMG-E empowered parents and caregivers to access developmental screening and learn more about their child’s development and engage with relevant services. This beds down a new and innovative solution to the current service delivery gap and create mechanisms that can engage families currently not accessing services, and increases knowledge around navigating the health and social care services. Notwithstanding the issues that were raised by families and service providers, which include accessibility challenges for CALD communities, absence of clinical oversight during screening, and narrow scope of engagement with available services being offered, it is worth noting that improvements regarding these implementation factors must be considered and addressed in order to have longevity and sustainability of the program.Trial registration.The study is part of a large randomised controlled trial (Protocol No. 1.0, Version 3.1) was registered with ANZCTR (registration number: ACTRN12621000766819) on July 21st, 2021 and reporting of the trial results will be according to recommendations in the CONSORT Statement.

Lessons from enriching Tanzania’s clinical research ethics clinical trials oversight and pharmacovigilance through the ASCEND project

Engaging in clinical trials in Africa not only enhances researchers' comprehension of local health concerns but also plays a crucial role in tackling global health challenges. In Tanzania, there has been a surge of clinical research for the past 10 years indicating a need to improve ethical and clinical trial regulatory capacity. Several initiatives to address the clinical trial regulatory and ethics challenges have been done. Lessons from such initiatives are important to inform evidence-based decision-making for sustainability. The ASCEND project with the theme of “Moving Tanzania’s Clinical Research Ethics and Medicines Regulatory Capacity to the Next Level: Fostering Medicine Quality, Safety and Good Clinical Practice (GCP) on Clinical Trials” was implemented in Tanzania Mainland and Zanzibar from November 2020 to December 2023. A thorough review of the project implementation reports and on deliverables was conducted to identify the lessons learned. Inductive content analysis was used to analyze the information. A total of seven lessons were deduced from the reviewed documents. These include capacity building through training on clinical trials review and approval process, research ethics and GCP inspection which cannot be overlooked; engaging the community in reporting adverse drug events is worth considering; digitalization of electronic systems enhances clinical trial control and creates a dynamic regulatory ecosystem; compliance to requirements for clinical trials conduct is enhanced by training of early and mid-career researchers; networking and broad stakeholders’ engagement and participation in ethics and regulations governing clinical trials is a cornerstone for strengthening collaboration between researchers and regulators; the need for electronic systems for monitoring and evaluation of the project is inevitable and the need for adhering to project timelines is crucial for successful implementation of the project. Sustainability is the take-home message from the ASCEND project and should inform stakeholders for future improvement. Continuous investment and advancement in research ethics and regulatory oversight across Africa should be prioritized.

Capacity Assessment of the National Medicines Regulatory Authority in a Low -Income Country.

Access to medical products of the required efficacy, quality and safety is essential for everyone's health and wellbeing. To achieve this milestone, every country needs a robust and strong performing National Regulatory Authority (NRA) that is independent and outcome oriented. With the help of the World Health Organization (WHO), the global benchmarking tool is the gold standard used to assess the regulatory capacity of NRAs. This study assessed the capacity of the National Medicines Regulatory Authority in Sierra Leone to perform its regulatory functions. This descriptive cross-sectional study used both qualitative and quantitative approaches. A self-administered questionnaire was used for the quantitative approach, and the qualitative aspect consisted of a desk review looking at key regulatory documents such as laws, regulations, policies, guidelines, standard operating procedures and reports. The data collection tool used was the WHO global benchmarking tool (GBT) for "Evaluation of National Regulatory System of Medical Product Version VI. The majority of the participants had a postgraduate degree (60%), and 72% had over 10 years of experience working at the NRA. Out of 251 sub-indicators assessed, 85 (34%) sub-indicators were fully implemented. Of the eight (8) functions assessed, sub-indicators related to clinical trial oversight and vigilance were the most implemented, with 67% and 62%, respectively. Of the 9 indicators assessed, 79% of the sub-indicators that are related to quality and risk management were implemented. The results of this study showed that PBSL operates at maturity level 1. The absence of laws and regulations that give PBSL the mandate to perform its regulatory functions was a major challenge even though other indicators were met. The study reported other challenges toward effective functioning, including but not limited to a lack of sufficient staff, weak enforcement of the sale of medicines and a poorly equipped quality control laboratory.

Evaluation of peripheral blood inflammatory biomarkers in sickle cell disease with and without retinopathy.

The aim of this study was to evaluate the clinical significance of blood-cell associated inflammation markers in patients with sickle cell disease (SCD) and sickle cell retinopathy (SCR). Neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR), monocyte to lymphocyte ratio (MLR), systemic immune inflammation index (SIII), systemic inflammation response index (SIRI), systemic inflammation modulation index (SIMI) and aggregate systemic inflammation index (AISI) were calculated. This study included 45 healthy controls (Group 1) and 100 SCD (Group 2). Patients in Group 2 were then divided into two groups: without SCR (Group 3) and with SCR (Group 4), and patients with SCR (Group 4) were further divided into two groups: non-proliferative sickle cell retinopathy (NPSCR) (Group 5) and proliferative sickle cell retinopathy (PSCR) (Group 6). The mean values for NLR, PLR, SIII, SIRI, AISI, and SIMI were significantly higher in Group 2 compared to Group 1 (p = 0.011 for NLR, p = 0.004 for SIII, and p < 0.001 for others). Furthermore, AISI and SIMI parameters demonstrated statistically significant discriminatory power to distinguish Group 5 from Group 6 (p = 0.0016 and p = 0.0006, respectively). Given the critical role of inflammatory mechanisms in the pathogenesis of SCD and its related complications, the assessment of blood-cell-associated inflammatory markers may present a pragmatic and advantageous approach to the clinical oversight and therapeutic intervention of SCD.

Innovative solution or cause for concern? The use of continuous glucose monitors in people not living with diabetes: A narrative review.

Continuous glucose monitors (CGMs) have expanded their scope beyond indicated uses for diabetes management and are gaining traction among people not living with diabetes (PNLD). CGMs track in time glucose levels and are proposed as tools for the early detection of abnormal glucose and a potential solution for its normalisation through behavioural change, particularly, diet personalisation and motivation of physical activity. This becomes relevance given the growing incidence of metabolic conditions, such as type 2 diabetes mellitus (T2DM). Clinical guidelines, however, do not recommend CGMs in contexts outside type 1 diabetes (T1DM) or insulin-treated T2DM. Therefore, there is a visible disconnect between the indicated and real-world usage of these medical devices. While the commercial market for CGMs in PNLD is expanding rapidly, a comprehensive and evidence-based evaluation of the devices' utility in this population has not been done. Therefore, this review aims to formulate a working model for CGM utility in PNLD as proposed by the 'health and wellness' market that advertises and distributes it to these individuals. We aim to critically analyse the available research addressing components of the working model, that is (1) detection of abnormal glucose; (2) behavioural change, and (3) metabolic health improvement. We find a lack of consistent and high-quality evidence to support the utility of CGMs for these purposes. We identify significantly under-reserved areas including clinical benchmarks and scoring procedures for CGM measures, device acceptability, and potential adverse effects of CGMs on eating habits in PNLD. We also raise concerns about the robustness of available CGM research. In the face of these research gaps, we urge for the commercial claims suggesting the utility of the device in PNLD to be labelled as misleading. We argue that there is a regulatory inadequacy that fuels 'off-label' CGM distribution and calls for the strengthening of post-market clinical follow-up oversight for CGMs. We hope this will help to avert the continued misinformation risk to PNLD and 'off-label' exacerbation of health disparities.

Role of Virtual Rehabilitation in Total Knee Arthroplasty: Functional Outcomes and Cost-Effectiveness

This review article aims to explore the role of virtual rehabilitation in total knee arthroplasty in terms of functional outcomes and cost-effectiveness. Total knee arthroplasty (TKA) is a widely performed surgery for end-stage knee osteoarthritis, requiring supervised rehabilitation for rapid recovery and pain relief. Virtual rehabilitation has been evolving as an alternative to the traditional rehabilitation program in the recent years especially during the predicament of COVID-19 pandemic. Virtual rehabilitation leverages virtual reality (VR) technology to provide innovative, engaging, and measurable rehabilitation services that can complement or replace traditional therapy approaches. Virtual reality and telerehabilitation represent evolving fields in TKA rehabilitation, offering advantages over traditional therapy in terms of cost-effectiveness, improved outcomes, enhanced exercise adherence, and reduced barriers to accessing postoperative therapy. Despite the need for more research and standardized protocols, VR-based rehabilitation holds significant potential for optimizing the recovery process for patients undergoing TKA. The research indicates that VR-based rehabilitation programs for TKA patients have utilized a variety of interactive virtual environments, gaming activities, and feedback mechanisms to supplement traditional physical therapy exercises. Virtual rehabilitation for TKA encourages clinician-patient interaction beyond the hospital setting and offers the advantages of cost savings, convenience, at-home monitoring, and coordination of care, improved functional outcomes, increased exercise adherence, better balance performance, and psychological benefits like reduced stress and anxiety, all of which are geared to improve adherence and overall patient satisfaction. This review article outlines the importance of virtual rehabilitation in TKA, emphasizing cost-effectiveness and improved balance and function while maintaining enhanced adherence and exercise performance. This article also delves into the mode of administration of VR-based rehabilitation and its delivery, safety concerns, advantages and disadvantages, as well as the most common VR-based rehabilitation protocols for TKA. Further, it discusses the implications of virtual rehabilitation in the healthcare system and future directions for virtual rehabilitation in TKA. In conclusion, the evidence indicates that virtual physical therapy (PT) with remote clinical oversight is a safe, effective, and more cost-effective alternative to traditional in-person PT for patients undergoing TKA. Keywords: Virtual rehabilitation, virtual physical therapy, telehealth, telerehabilitation, total knee arthroplasty.

Evaluation of the Quality of Life and the Demographic and Clinical Characteristics of Patients With Pemphigus With Oral Mucosal İnvolvement: A Multicenter Observational Study.

Pemphigus vulgaris (PV) is an autoimmune disease primarily affecting the oral mucosa. This study aimed to determine the demographic, clinical and treatment characteristics of PV patients with oral mucosal involvement and to assess the impact on their quality of life. We conducted a prospective observational study among 106 patients diagnosed with PV and presenting oral mucosal involvement. Demographic data, clinical and treatment characteristics, and quality of life questionnaires were recorded. The study included 106 patients, 55 (51.89%) were male and there was a predominance of the mucocutaneous subtype in 83 individuals (78.38%). Oral mucosa was the initial site of manifestation in 44 patients (41.51%). Bilateral buccal mucosa was the most frequently affected site. The predominant symptom reported was a burning sensation, noted in 91 patients (85.85%). Oral mucosal examination revealed erosions in 85.85% of the patients. Systemic steroids were the most commonly administered treatment, and rituximab was used in 18 patients (16.98%). A positive and significant correlation was found between pemphigus severity and Oral Health Impact Profile-14, Dermatology Life Quality Index and Dermatological Quality of Life Scale scores (P < 0.05). The presence of superficial ulcers, flaccid bullae, lesion diameter ≥1 cm, and >10 lesions were factors that markedly diminished quality of life. Complete response to treatment was noted in all patients administered rituximab. The most common area of involvement was bilateral buccal mucosa, and the severity of PV closely correlated with a decline in quality of life measures. These results highlight the need for careful clinical oversight of PV, taking into account its effects on patients quality of life.

Comprehensive analysis and prognostic assessment of senescence-associated genes in bladder cancer

BackgroundThe prevalence and mortality of bladder cancer (BLCA) present a significant medical challenge. While the function of senescence-related genes in tumor development is recognized, their prognostic significance in BLCA has not been thoroughly explored.MethodsBLCA transcriptome datasets were sourced from the TCGA and GEO repositories. Gene groupings were determined through differential gene expression and non-negative matrix factorization (NMF) methodologies. Key senescence-linked genes were isolated using singular and multivariate Cox regression analyses, combined with lasso regression. Validation was undertaken with GEO database information. Predictive models, or nomograms, were developed by merging risk metrics with clinical records, and their efficacy was gauged using ROC curve methodologies. The immune response’s dependency on the risk metric was assessed through the immune phenomenon score (IPS). Additionally, we estimated IC50 metrics for potential chemotherapeutic agents.ResultsReviewing 406 neoplastic and 19 standard tissue specimens from the TCGA repository facilitated the bifurcation of subjects into two unique clusters (C1 and C2) according to senescence-related gene expression. After a stringent statistical evaluation, a set of ten pivotal genes was discerned and applied for risk stratification. Validity tests for the devised nomograms in forecasting 1, 3, and 5-year survival probabilities for BLCA patients were executed via ROC and calibration plots. IC50 estimations highlighted a heightened responsiveness in the low-risk category to agents like cisplatin, cyclopamine, and sorafenib.ConclusionsIn summation, our research emphasizes the prospective utility of risk assessments rooted in senescence-related gene signatures for enhancing BLCA clinical oversight.

A case report of three people experiencing intractable autonomic dysreflexia following instillation of Uro-Tainer® Polyhexanide 0.02%

IntroductionHistorically, bladder washouts were used to instil therapeutic reagents directly into the bladder. This practice has expanded to include instillation of solutions that deal with catheter issues such as encrustation or formation of bio-film. They appear to provide a promising strategy for people with long term catheters. These products are readily available to purchase, but there is concern that people are using these solutions without a complete understanding of the purpose for the rinse and without clinical guidance to monitor response to treatment.Case presentationThese case studies include three people living with spinal cord injury (SCI) who developed severe autonomic dysreflexia (AD) when a catheter rinse was carried out using a particular solution. Each of the cases developed immediate and, in some cases, intractable AD requiring further intervention to resolve symptoms.DiscussionCatheter-associated urinary tract infection is a significant cause of morbidity and mortality in people living with SCI. Long-term catheters provide a vector for opportunistic micro-organisms to form bio-film and create an environment that promotes formation of struvite calculi, thus increasing the risk of chronic catheter blockage and urinary tract infection. Whilst these solutions are used to reduce these risks, they also pose additional risks to people susceptible to AD. These cases highlight the need for judicious patient selection and clinical oversight and management of adverse events when using catheter rinse solutions in certain people living with SCI. This is supported by a decision-making algorithm and a response to AD algorithm.This case report was prepared following the CARE Guidelines (supplementary file 1).

A 5-Year Review of a Tracheostomy Quality Improvement Initiative: Reducing Adverse Event Frequency and Severity.

The number of tracheostomies performed annually in resource-rich countries is estimated at 250,000. While an essential procedure, approximately 20% to 30% of patients will experience at least 1 tracheostomy-related adverse event. Within tracheostomy careand across wider health care environments, quality improvement (QI) programs have been shown to reduce patient harm and improve outcomes. Herein we report on a 5-year long, tracheostomy QI initiative aimed at improving patient experience and reducing the frequency and severity of adverse events. A 5-year (ongoing) QI initiative led by the Cardiff and Vale University Health Board tracheostomy team, within a tertiary, 1000-bedded hospital in South Wales, United Kingdom. The QI initiative has focused on 3 main themes: (1) Education and training; (2) Clinical oversight and decision making; and (3) improved data collection. Data were collected from existing tracheostomy databases. Over the past 5 years, we have observed a sustained reduction in both the frequency and severity of adverse events, with less than 1 patient per 100 experiencing a moderate or severe adverse event. This has resulted in improvements in patient experience and a cost reduction of £GBP364,726 per annum. Our 5-year ongoing tracheostomy QI initiative has resulted in improved outcomes with increased achievement of tracheostomy weaning markers and sustained reductions in both the frequency and severity of adverse events. A continuous focus on QI is associated with improved patient and service outcomes. These improvements can be spread and scaled to benefit more patients and organizations.

ClinGen variant curation expert panel recommendations for classification of variants in GAMT, GATM and SLC6A8 for cerebral creatine deficiency syndromes

Cerebral creatine deficiency syndromes (CCDS) are inherited metabolic phenotypes of creatine synthesis and transport. There are two enzyme deficiencies, guanidinoacetate methyltransferase (GAMT), encoded by GAMT and arginine-glycine amidinotransferase (AGAT), encoded by GATM, which are involved in the synthesis of creatine. After synthesis, creatine is taken up by a sodium-dependent membrane bound creatine transporter (CRTR), encoded by SLC6A8, into all organs. Creatine uptake is very important especially in high energy demanding organs such as the brain, and muscle. To classify the pathogenicity of variants in GAMT, GATM, and SLC6A8, we developed the CCDS Variant Curation Expert Panel (VCEP) in 2018, supported by The Clinical Genome Resource (ClinGen), a National Institutes of Health (NIH)-funded resource. We developed disease-specific variant classification guidelines for GAMT-, GATM-, and SLC6A8-related CCDS, adapted from the American College of Medical Genetics/Association of Molecular Pathology (ACMG/AMP) variant interpretation guidelines. We applied specific variant classification guidelines to 30 pilot variants in each of the three genes that have variants associated with CCDS. Our CCDS VCEP was approved by the ClinGen Sequence Variant Interpretation Working Group (SVI WG) and Clinical Domain Oversight Committee in July 2022. We curated 181 variants including 72 variants in GAMT, 45 variants in GATM, and 64 variants in SLC6A8 and submitted these classifications to ClinVar, a public variant database supported by the National Center for Biotechnology Information. Missense variants were the most common variant type in all three genes. We submitted 32 new variants and reclassified 34 variants with conflicting interpretations. We report specific phenotype (PP4) using a points system based on the urine and plasma guanidinoacetate and creatine levels, brain magnetic resonance spectroscopy (MRS) creatine level, and enzyme activity or creatine uptake in fibroblasts ranging from PP4, PP4_Moderate and PP4_Strong. Our CCDS VCEP is one of the first panels applying disease specific variant classification algorithms for an X-linked disease. The availability of these guidelines and classifications can guide molecular genetics and genomic laboratories and health care providers to assess the molecular diagnosis of individuals with a CCDS phenotype.

Illicit Cannabis Use to Self-Treat Chronic Health Conditions in the United Kingdom: Cross-Sectional Study.

In 2019, it was estimated that approximately 1.4 million adults in the United Kingdom purchased illicit cannabis to self-treat chronic physical and mental health conditions. This analysis was conducted following the rescheduling of cannabis-based medicinal products (CBMPs) in the United Kingdom but before the first specialist clinics had started treating patients. The aim of this study was to assess the prevalence of illicit cannabis consumption to treat a medically diagnosed condition following the introduction of specialist clinics that could prescribe legal CBMPs in the United Kingdom. Adults older than 18 years in the United Kingdom were invited to participate in a cross-sectional survey through YouGov between September 22 and 29, 2022. A series of questions were asked about respondents' medical diagnoses, illicit cannabis use, the cost of purchasing illicit cannabis per month, and basic demographics. The responding sample was weighted to generate a sample representative of the adult population of the United Kingdom. Modeling of population size was conducted based on an adult (18 years or older) population of 53,369,083 according to 2021 national census data. There were 10,965 respondents to the questionnaire, to which weighting was applied. A total of 5700 (51.98%) respondents indicated that they were affected by a chronic health condition. The most reported condition was anxiety (n=1588, 14.48%). Of those enduring health conditions, 364 (6.38%) purchased illicit cannabis to self-treat health conditions. Based on survey responses, it was modeled that 1,770,627 (95% CI 1,073,791-2,467,001) individuals consume illicit cannabis for health conditions across the United Kingdom. In the multivariable logistic regression, the following were associated with an increased likelihood of reporting illicit cannabis use for health reasons-chronic pain, fibromyalgia, posttraumatic stress disorder, multiple sclerosis, other mental health disorders, male sex, younger age, living in London, being unemployed or not working for other reasons, and working part-time (P<.05). This study highlights the scale of illicit cannabis use for health reasons in the United Kingdom and the potential barriers to accessing legally prescribed CBMPs. This is an important step in developing harm reduction policies to transition these individuals, where appropriate, to CBMPs. Such policies are particularly important considering the potential risks from harmful contaminants of illicit cannabis and self-treating a medical condition without clinical oversight. Moreover, it emphasizes the need for further funding of randomized controlled trials and the use of novel methodologies to determine the efficacy of CBMPs and their use in common chronic conditions.

Highlighting the Benefits of the Clinical Education Resource Nurse for New Graduate Nurses.

Nurse residency programs provide a valuable transition to practice environment for graduate nurses. The Clinical Education Resource Nurse (CERN) role offers continued clinical assistance to graduate nurses who have completed orientation with a preceptor during the 1st year of practice including education and continued clinical oversight when needed. This column defines the role of CERN and provides a description of the clinical application and support provided.

Assessing operational readiness: Regulatory landscape and compliance in zimbabwe for medical devices and in vitro diagnostic medical devices.

The regulation of medical devices and In Vitro Diagnostic (IVD) medical devices have lagged significantly, especially in low- and middle-income countries. Disparities in regulating medical and IVD medical devices in Africa are below the global average. This may translate to poor access to quality-assured medical and IVD devices, resulting in undesirable health outcomes. Operational readiness to regulate medical and IVD devices at the Medicines Control Authority of Zimbabwe (MCAZ) was assessed. The aim was to determine the strengths and gaps and propose an action plan that can be monitored and evaluated to assess progress over time. We used the World Health Organization (WHO) Global Benchmarking Tool for medical devices and IVDs methodology to evaluate regulatory oversight of these products. Purposive sampling was used for data collection using researcher-administered global benchmarking tool factsheets and document reviews to evaluate the implementation of the regulatory functions. The regulatory functions assessed were the National Regulatory System, Registration and Market Authorization, Vigilance, Market Surveillance and Control, Licensing Establishment, Regulatory Inspection, Laboratory Testing, and Clinical Trials Oversight. The MCAZ attained maturity level 1, with a regulatory system score of 79%, registration and market authorization 44%, vigilance 27%, market surveillance and control 40%, licensing establishment 62%, regulatory inspection 68%, laboratory testing 88%, and clinical trials 18%. Condoms and gloves were the only regulated medical devices in Zimbabwe. IVDs were not regulated by the MCAZ. This review showed that the regulatory system is not robust, fit for purpose, responsive, transparent, or proportionate to the risk classification of medical devices and IVDs. It is crucial to amend the Medicines and Allied Substance Control Act to incorporate the definition and classification of medical devices and IVDs, regulatory authority establishment, licensing and registration, quality management system, conformity assessment, post-market surveillance, labeling and instructions for use, capacity building and training, and international harmonization.

Review: Medical directors - Is there a need for reform?

Medical leadership remains integral to the health system amidst a growing burden of ill health and disease, rising patient expectations and medical and technological advancements. The study objectives were to (a) provide a perspective through a rapid review of medical director roles and responsibilities in public and private hospital settings across several Organisation for Economic Co-operation and Development (OECD) and Non-Organisation for Economic Co-operation and Development countries, and (b) provide recommendations on how health system performance could be strengthened. A rapid review of Medical Director job descriptions in public and private hospitals was carried out. Medical Directors are influential leaders in organisational decision-making and quality improvement; however, their role has shifted from clinical oversight to several managerial and leadership roles. We report some variation in their role and responsibilities, in the 'intensity of job requirements' and 'complexity of managing resources' dimensions. The changing expectations of medical directors and the variation in their roles and responsibiliteis may contribute to inefficiencies and misalignment within health systems. There may be a need to pursue reform to assure alignment with health system objectives, albeit reform may require different approaches to meet the needs of different health systems. Further research is needed to explore how reform of medical directors' roles and responsibilities can be quantified to demonstrate improvement within health systems.

Psychological support after stroke: unmet needs and workforce requirements of clinical neuropsychological provision for optimal rehabilitation outcomes.

Stroke services must detect and manage psychological and neuropsychological problems that occur after stroke, such as cognitive and language impairments, post-stroke apathy, post-stroke emotionalism, depression, anxiety, post-traumatic stress disorder, personality changes and suicidality. Stroke neuropsychology plays a key role in the assessment, understanding and management of these consequences of stroke, as well as contributing to complex case management, staff supervision and training. Where these provisions are absent from the stroke rehabilitation pathway, this significantly limits potential rehabilitation outcomes. To manage the scale of psychological and neuropsychological needs post stroke, clinical guidance recommends the use of a matched care system, in which these needs are triaged and matched with corresponding levels of support. Recent workforce guidelines provide clear professional recommendations for psychological staffing skill mix and threshold requirements for clinical oversight and clinical governance assurances.

Comparison of Automated Spike Detection Software in Detecting Epileptiform Abnormalities on Scalp-EEG of Genetic Generalized Epilepsy Patients.

Despite availability of commercial EEG software for automated epileptiform detection, validation on real-world EEG datasets is lacking. Performance evaluation of two software packages on a large EEG dataset of patients with genetic generalized epilepsy was performed. Three epileptologists labelled IEDs manually of EEGs from three centres. All Interictal epileptiform discharge (IED) markings predicted by two commercial software (Encevis 1.11 and Persyst 14) were reviewed individually to assess for suspicious missed markings and were integrated into the reference standard if overlooked during manual annotation during a second phase. Sensitivity, precision, specificity, and F1-score were used to assess the performance of the software packages against the adjusted reference standard. One hundred and twenty-five routine scalp EEG recordings from different subjects were included (total recording time, 310.7 hours). The total epileptiform discharge reference count was 5,907 (including spikes and fragments). Encevis demonstrated a mean sensitivity for detection of IEDs of 0.46 (SD 0.32), mean precision of 0.37 (SD 0.31), and mean F1-score of 0.43 (SD 0.23). Using the default medium setting, the sensitivity of Persyst was 0.67 (SD 0.31), with a precision of 0.49 (SD 0.33) and F1-score of 0.51 (SD 0.25). Mean specificity representing non-IED window identification and classification was 0.973 (SD 0.08) for Encevis and 0.968 (SD 0.07) for Persyst. Automated software shows a high degree of specificity for detection of nonepileptiform background. Sensitivity and precision for IED detection is lower, but may be acceptable for initial screening in the clinical and research setting. Clinical caution and continuous expert human oversight are recommended with all EEG recordings before a diagnostic interpretation is provided based on the output of the software.

Patient perspectives on home-spirometry in interstitial lung disease: a qualitative co-designed study

BackgroundOpportunities for home-monitoring are increasing exponentially. Home- spirometry is reproducible and reliable in interstitial lung disease (ILD), yet patients’ experiences are not reported. Given the morbidity and mortality associated with...