Efficacy and safety of uncovered self-expandable metal stents for distal malignant biliary obstruction in unresectable non-pancreatic cancer.

Objectives: The efficacy of uncovered self-expandable metal stents (UCSEMS) versus fully covered self-expandable metal stents for distal malignant biliary obstruction remains controversial. Additionally, the heterogeneity of the disease conditions has been indicated in previous studies because pancreatic and non-pancreatic cancers have different characteristics in clinical course. Therefore, the etiology of biliary obstruction necessitates investigations stratified by primary disease. This study aimed to evaluate the outcomes of UCSEMS, specifically for non-pancreatic cancer-induced distal malignant biliary obstruction. Methods: We conducted a single-center retrospective review to evaluate the time to recurrent biliary obstruction and frequency of adverse events (AEs) in patients receiving UCSEMS for unresectable non-pancreatic cancer-induced malignant biliary obstruction. Results: Overall, 32 patients were enrolled in the study between January 2016 and December 2023. The median time to recurrent biliary obstruction was 140 days. AE rates were low at 3.1% for both pancreatitis and cholecystitis, suggesting a potential benefit of UCSEMS in reducing post-procedural AEs. Conclusion: UCSEMS may reduce the risk of post-procedural AEs and should be considered in patients at high risk of post-endoscopic retrograde cholangiopancreatography pancreatitis. However, the patency period may be shorter, necessitating future comparative research with fully covered self-expandable metal stents to determine the optimal stent choice.

Nivel de cumplimiento de metas internacionales de seguridad en un Sanatorio privado 2023 / Level of compliance with international safety goals in a private Sanatorium 2023

La presente investigación pretende evaluar el nivel de cumplimiento de las metas internacionales, que representan el foco principal para la mejora de calidad y seguridad de atención de los pacientes. La seguridad del paciente involucra a todos los estudios, prácticas y acciones promovidas por las instituciones sanitarias para disminuir y eliminar los riesgos de daños innecesarios relacionados con el cuidado de la salud. Metodología: Estudio descriptivo, observacional y transversal. De fuentes primaria y secundaria, Resultados: se abordaron las metas N° 1 la cual consiste en Identificar a los pacientes correctamente y la meta N° 6 la cual se refiere a Reducir el riesgo de lesiones en pacientes como resultado de caídas. En primer lugar, se destaca el cumplimiento en la identificación correcta del paciente y en segunda instancia la mejora del cumplimiento de medidas de prevención de caídas. Conclusión: Esta proximidad de los valores obtenidos genera un aspecto positivo para mejorar la seguridad de los pacientes y que, si bien el cumplimiento de las metas no es el deseado, es cercano al porcentaje planteado. Lo que en definitiva hace a este estudio un antecedente importante en la mejora continua con vista al futuro cercano[AU]

This research aims to evaluate the level of compliance with international goals, which represent the main focus for improving the quality and safety of patient care. Patient safety involves all studies, practices and actions promoted by health institutions to reduce and eliminate the risks of unnecessary harm related to health care. Methodology: Descriptive, observational and transversal study. From primary and secondary sources, Results: goals No. 1 were addressed, which consists of Identifying patients correctly and goal No. 6, which refers to Reducing the risk of injuries in patients as a result of falls. Firstly, compliance with correct patient identification stands out and secondly, improvement in compliance with fall prevention measures. Conclusion: This proximity of the values obtained generates a positive aspect to improve patient safety and that, although the fulfillment of the goals is not as desired, it is close to the proposed percentage. Which ultimately makes this study an important precedent in continuous improvement for the near future[AU]

Esta pesquisa tem como objetivo avaliar o nível de cumprimento das metas internacionais, que representam o foco principal para a melhoria da qualidade e segurança do atendimento ao paciente. A segurança do paciente envolve todos os estudos, e ações promovidas pelas instituições de saúde para reduzir e eliminar os riscos de danos desnecessários relacionados à assistência à saúde. Metodologia: Estudo descritivo, observacional e transversal. De fontes primárias e secundárias, dependendo do indicador e do objetivo para o qual a medição está sendo realizada. Resultados: Nesta pesquisa serão abordadas as metas nº1, que consiste em Identificar corretamente os pacientes e a meta nº 6, que es Reduzir o risco de lesões nos pacientes em decorrência de quedas. Foi realizado nos dois locais. Em primeiro lugar, destaca-se o cumprimento da correta identificação do paciente e, em segundo lugar, a melhoria no cumprimento das medidas de prevenção de quedas. Conclusão: Essa proximidade dos valores obtidos gera um aspecto positivo para melhorar a segurança do paciente e que, embora o cumprimento das metas não seja o desejado, está próximo do percentual proposto. O que acaba por tornar este estudo um precedente importante na melhoria contínua com vista ao futuro próximo.

AI as a Medical Device Adverse Event Reporting in Regulatory Databases: Protocol for a Systematic Review.

BACKGROUND: The reporting of adverse events (AEs) relating to medical devices is a long-standing area of concern, with suboptimal reporting due to a range of factors including a failure to recognize the association of AEs with medical devices, lack of knowledge of how to report AEs, and a general culture of nonreporting. The introduction of artificial intelligence as a medical device (AIaMD) requires a robust safety monitoring environment that recognizes both generic risks of a medical device and some of the increasingly recognized risks of AIaMD (such as algorithmic bias). There is an urgent need to understand the limitations of current AE reporting systems and explore potential mechanisms for how AEs could be detected, attributed, and reported with a view to improving the early detection of safety signals. OBJECTIVE: The systematic review outlined in this protocol aims to yield insights into the frequency and severity of AEs while characterizing the events using existing regulatory guidance. METHODS: Publicly accessible AE databases will be searched to identify AE reports for AIaMD. Scoping searches have identified 3 regulatory territories for which public access to AE reports is provided: the United States, the United Kingdom, and Australia. AEs will be included for analysis if an artificial intelligence (AI) medical device is involved. Software as a medical device without AI is not within the scope of this review. Data extraction will be conducted using a data extraction tool designed for this review and will be done independently by AUK and a second reviewer. Descriptive analysis will be conducted to identify the types of AEs being reported, and their frequency, for different types of AIaMD. AEs will be analyzed and characterized according to existing regulatory guidance. RESULTS: Scoping searches are being conducted with screening to begin in April 2024. Data extraction and synthesis will commence in May 2024, with planned completion by August 2024. The review will highlight the types of AEs being reported for different types of AI medical devices and where the gaps are. It is anticipated that there will be particularly low rates of reporting for indirect harms associated with AIaMD. CONCLUSIONS: To our knowledge, this will be the first systematic review of 3 different regulatory sources reporting AEs associated with AIaMD. The review will focus on real-world evidence, which brings certain limitations, compounded by the opacity of regulatory databases generally. The review will outline the characteristics and frequency of AEs reported for AIaMD and help regulators and policy makers to continue developing robust safety monitoring processes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/48156.

Blood pressure changes during ketamine infusion for the treatment of depression.

OBJECTIVE: This study aimed to examine blood pressure changes during ketamine infusion for depression and exploring the factors associated with these changes. METHOD: This study is a retrospective chart-review of patients with depression undergoing ketamine infusion at Yale Psychiatry Hospital during a 7-year period. Blood pressure (BP) was recorded every 10 min during the infusion. Surges in systolic and diastolic blood pressure (SBP, DBP), along with severe hypertension events, were analyzed in relation to patient demographics. RESULTS: A total of 138 patients received a total of 2342 infusions. SBP and DBP peaked at 40 min after the start of the infusion with a mean change of 16.0 (SD: 11.2) and 11.0 mmHg (SD: 8.45) respectively. Severe hypertension was observed in 17 patients (12.5%) and 23 infusion sessions (0.98%), occuring more frequently during the first three infusions (43.4%). Age (OR = 1.04 [1.02,1.05], p-value <0.001) was significantly associated with a surge in SBP and all patients with a past medical history of hypertension experienced a BP surge during their infusions. CONCLUSION: Ketamine infusions can cause significant blood pressure increases, particularly in older and hypertensive patients, highlighting the need for careful cardiovascular monitoring to mitigate risks during treatment.

Safety and efficacy of Symani robotic-assisted microsurgery: Assessment of vascular anastomosis patency, thrombus, and stenosis in a randomized preclinical study.

INTRODUCTION: The Symani surgical system undergoes scrutiny in this study as part of a series of preclinical investigations. Previous studies compared the precision of robotic-assisted anastomoses with manual techniques. This study aimed to evaluate the critical, histological, and gross parameters at the site of anastomosis and at distant sites in a rat model to provide insights into the safety and efficacy of robotic-assisted microsurgery to enhance its potential for clinical adoption. MATERIALS AND METHODS: Experienced microsurgeons performed arterial and venous anastomoses in 16 Wistar rats, randomized into four treatment groups: robotic artery, robotic vein, manual artery, and manual vein. Various parameters were evaluated at two time points (T0 and T30) on the day of the procedure and at Day 28 (T28d). In the second phase of the study, the animals underwent necropsy, histopathologic analysis, micro-CT scans, and angiography imaging of the anastomosis sites, major organs, and distant target organs by a blinded assessor. RESULTS: Patency rates were 100% at T0 and T30 for all anastomoses and stayed at 100% on T28d for the robotic subgroups; however, it decreased to 87.5% for manual arterial anastomoses owing to a case of obstructive thrombus. No evidence of clot migration was observed. Blood flow parameters and procedure times did not differ significantly. The blinded semiquantitative histological analysis revealed no significant disparities between the robotic and manual anastomoses across various pathological indicators. No gross abnormalities were detected in musculoskeletal examinations. CONCLUSION: This preclinical study demonstrated the safety of the Symani surgical system. Results suggest equivalence between robotic and manual techniques regarding thrombus formation at the anastomotic site and distal organs.

Valorization of fish processing by-products for protein hydrolysate recovery: Opportunities, challenges and regulatory issues.

Protein-rich fish processing by-products, often called rest raw materials (RRM), account for approximately 60% of the total fish biomass. However, a considerable amount of these RRM is utilized for low-value products such as fish meal and silage. A promising and valuable approach for maximizing the utilization of RRM involves the extraction of bioactive fish protein hydrolysate (FPH). This review assesses and compares different hydrolyzation methods to produce FPH. Furthermore, the review highlights the purification strategy, nutritional compositions, and bioactive properties of FPH. Finally, it concludes by outlining the application of FPH in food products together with various safety and regulatory issues related to the commercialization of FPH as a protein ingredient in food. This review paves the way for future applications by highlighting efficient biotechnological methods for valorizing RRM into FPH and addressing safety concerns, enabling the widespread utilization of FPH as a valuable and sustainable source of protein.

Background incidence rates of health outcomes of interest for COVID-19 vaccine safety monitoring in a US population: a claims database analysis.

OBJECTIVE: To evaluate background incidence rates of 59 health outcomes of interest (HOI) in a diverse population, including important subpopulations, during the pre-COVID-19 era (1 January 2017-31 December 2019) and the COVID-19 era (1 March 2020-31 December 2020), before the introduction of COVID-19 vaccines. DESIGN: Observational retrospective cohort study. Annual incidence rates and 95% confidence intervals (CIs) of HOIs were estimated for each population of interest, stratified by: age, sex, age and sex and seasonality. DATA SOURCE: Optum's de-identified Clinformatics Data Mart Database (CDM). PARTICIPANTS: Individuals from the US general population and four subgroups of interest: influenza-vaccinated, paediatric (<18 years of age), elderly (≥65 years of age) and pregnant women. RESULTS: During the COVID-19 era, the incidence of several cardiac conditions, coagulation disorders and acute liver injury increased across all populations assessed while the rates of some dermatological and neurological HOIs decreased relative to the pre-COVID-19 era. The incidence of acute respiratory distress syndrome (ARDS) varied considerably by subgroup: among the elderly, it decreased annually during the pre-COVID-19 era but peaked during the COVID-19 era; among pregnant women, it slightly increased annually during the pre-COVID-19 era and substantially increased during the COVID-19 era; among paediatrics, it decreased annually over the entire study. The incidence of the majority of HOIs increased with age, but were generally comparable between sexes with few exceptions. Cardiac, gastrointestinal, neurological and haematological HOIs, along with acute kidney injury and ARDS, were more common in males, whereas several immunological HOIs and chilblain-like lesions were more common in females. Pregnancy-related HOIs did not increase during the COVID-19 era, except for spontaneous abortions which increased annually over the entire study. CONCLUSION: These observations help contextualise fluctuations in background rates of adverse events noted during the COVID-19 era, and provide insight on how their use may impact safety surveillance for other vaccines.

Patient and caregiver perspectives on causes and prevention of ambulatory adverse events: multilingual qualitative study.

CONTEXT: Ambulatory adverse events (AEs) affect up to 25% of the global population and cause over 7 million preventable hospital admissions around the world. Though patients and caregivers are key actors in promoting and monitoring their own ambulatory safety, healthcare teams do not traditionally partner with patients in safety efforts. We sought to identify what patients and caregivers contribute when engaged in ambulatory AE review, focusing on under-resourced care settings. METHODS: We recruited adult patients, caregivers and patient advisors who spoke English, Spanish and/or Cantonese, from primary care clinics affiliated with a public health network in the USA. All had experience taking or managing a high-risk medication (blood thinners, insulin or opioid). We presented two exemplar ambulatory AEs: one involving a warfarin drug-drug interaction, and one involving delayed diagnosis of colon cancer. We conducted semistructured focus groups and interviews to elicit participants' perceptions of causal factors and potential preventative measures for similar AEs. The study team conducted a mixed inductive-deductive qualitative analysis to derive major themes. FINDINGS: The sample included 6 English-speaking patients (2 in the focus group, 4 individual interviews), 6 Spanish-speaking patients (individual interviews), 4 Cantonese-speaking patients (2 in the focus group, 2 interviews), and 6 English-speaking patient advisors (focus group). Themes included: (1) Patients and teams have specific safety responsibilities; (2) Proactive communication drives safe ambulatory care; (3) Barriers related to limited resources contribute to ambulatory AEs. Patients and caregivers offered ideas for operational changes that could drive new safety projects. CONCLUSIONS: An ethnically and linguistically diverse group of primary care patients and caregivers defined their agency in ensuring ambulatory safety and offered pragmatic ideas to prevent AEs they did not directly experience. Patients and caregivers in a safety net health system can feasibly participate in AE review to ensure that safety initiatives include their valuable perspectives.

Supporting victim-survivors during investigations of health practitioner misconduct: early learnings from a trauma-informed service.

OBJECTIVE: In 2021, the Australian Health Practitioner Regulation Agency established a support service to provide additional assistance to victim-survivors involved in complaints related to sexual boundary violations. This study evaluates the first stages of service delivery to understand participants' experiences with the service, gauge the service's reception, and improve support provided in future. DESIGN: Programme data was analysed descriptively to understand uptake and participant engagement since inception. Semistructured interviews with a purposive convenience sample of participants who had recently completed service engagement were conducted over 6 months and analysed using reflexive thematic analysis. Findings were triangulated to judge the effectiveness of the support provided by the service and highlight learning and development opportunities. RESULTS: During the study period, 275 participants were referred to the programme and 175 (64%) of those referred had engaged with the service. At the time of analysis, less than a quarter (21%) had refused support or disengaged following referral. Participants reported appreciation of and satisfaction with the support they received from the service and strongly reiterated the need for support in this context. Flexibility and quality communication as part of the service model was associated with participants feeling supported through three main themes: safety and connection, guidance and process navigation and representation and advocacy. CONCLUSION: Good uptake of the service and positive feedback from participants suggests that the programme has been a valuable and well-received initiative. Exploration of engagement trends as well as a more nuanced analysis of the benefits of support provided would augment these findings.

Cultural blind spots: Identifying hidden psychosocial hazards in the workplace.

ISSUE ADDRESSED: This article presents a framework to identify hidden psychosocial hazards and emerging mental health risks in the workplace, thereby assisting Persons Conducting a Business or Undertaking. The framework adds value to the processes outlined in SafeWork NSW's Code of Practice for Managing Psychosocial Hazards At Work. Specifically, the article documents a framework to analyse microcultures and back stage sites of enactment where psychosocial hazards and risks may be hidden or obscured in workplace settings. BACKGROUND: The article's framework aims to bring to the surface both the intra and interpersonal tensions employees experience in the social reality they inhabit while they perform their work, thereby positively contributing to organisations and PCBUs by helping them create healthy workplace cultures and psychological safety. METHODS: Specifically, the article discusses partnering with an organisational ethnographer when a PCBU embarks upon psychosocial investigations to: gain access, select employee participants, start conversations, establish rapport, build trust, collect and analyse data. CONCLUSION: This article theoretically contributes to health promotion literatures by offering organisations a complementary way of extracting deeper insights and understandings of psychosocial hazards and emerging mental health risks which are not apparent with traditional methods of inquiry.

From FUSE to a hands-on electrosurgery course using a cadaveric model.

INTRODUCTION: Surgical procedures in contemporary practice frequently employ energy-based devices, yet comprehensive education surrounding their safety and effectiveness remains deficient. We propose an innovative course for residents that aims to provide basic electrosurgery knowledge and promote the safe use of these devices. METHODS: We developed a simulated training course for first-year general surgery and orthopedic residents. First, a survey was conducted regarding their knowledge perception about energy devices. The course consisted of two online theoretical sessions, followed by three in-person practical sessions. First-year residents performed three video-recorded attempts using a cadaveric model and were assessed through a digital platform using the Objective Structured Assessment of Technical Skill (OSATS), a Specific Rating Scale (SRS), and a surgical energy-based devices scale (SEBS). Third-year residents were recruited as a control group. RESULTS: The study included 20 first-year residents and 5 third-year residents. First-year residents perceived a knowledge gap regarding energy devices. Regarding practical performance, both OSATS and checklist scores were statistically different between novices at their first attempt and the control group. When we analyzed the novice's performance, we found a significant increase in OSATS (13 vs 21), SRS (13 vs 17.5), and SEBS (5 vs 7) pre- and post-training scores. The amount of feedback referred to skin burns with the electro-scalpel reduced from 18 feedbacks in the first attempt to 2 in the third attempt (p-value = 0.0002). When comparing the final session of novices with the control group, no differences were found in the SRS (p = 0.22) or SEBS (p = 0.97), but differences remained in OSATS (p = 0.017). CONCLUSION: This study supports the implementation of structured education in electrosurgery among surgical trainees. By teaching first-year residents about electrosurgery, they can acquire a skill set equivalent to that of third-year residents. The integration of such courses can mitigate complications associated with energy device misuse, ultimately enhancing patient safety.

Comparison of Small (70-150 µm) and Intermediate (100-300 µm) Size Drug-Eluting Embolics for Transarterial Chemoembolization of Small Hepatocellular Carcinomas (≤3 cm).

PURPOSE: To compare oncologic outcomes of transarterial chemoembolization (TACE) using 70-150 µm and 100-300 µm drug-eluting beads (DEBs) to treat small hepatocellular carcinoma (HCC). METHODS: This retrospective study included 93 patients with small HCC (≤3cm) who underwent first TACE with DEB: 43 with 70-150 µm DEBs and 50 with 100-300 µm DEBs. Initial tumor response was assessed using per-patient and per-lesion analysis. Progression-free survival (PFS) and target tumor PFS were analyzed for patients and lesions with initial complete response (CR). Overall survival (OS) and safety outcomes were also evaluated. RESULTS: At 1 month, initial CR rates were 72.1% in the 70-150 µm group and 70.0% in the 100-300 µm group. PFS was significantly longer in the 70-150 µm group (median, 26 months) compared with the 100-300 µm group (median, 11 months; log-rank p=0.049), with comparable OS results (p=0.096). Per-lesion analysis found that target tumor PFS was significantly longer in the 70-150 µm group (median, 30 months) compared with the 100-300 µm group (median, 13 months; p=0.009). Subgroup analysis revealed the 70-150 µm group had significantly longer target tumor PFS compared with the 100-300 µm group in the 1.0-2.0 cm subgroup (p=0.017), but not in the 2.1-3.0 cm subgroup (p=0.117). No significant differences in adverse events were observed between the two groups. CONCLUSION: The 70-150 µm and 100-300 µm DEB-TACE resulted in comparable tumor response and short-term safety in small HCCs (≤3cm). However, in cases where CR was achieved, treatment with smaller beads demonstrated longer PFS and target tumor PFS.

Phase 1 pharmacokinetic and safety study of soticlestat in participants with mild or moderate hepatic impairment or normal hepatic function.

This phase 1, open-label, three-arm study (NCT05098054) compared the pharmacokinetics and safety of soticlestat (TAK-935) in participants with hepatic impairment. Participants aged ≥18 to <75 years had moderate (Child-Pugh B) or mild (Child-Pugh A) hepatic impairment or normal hepatic function (matched to hepatic-impaired participants by sex, age, and body mass index). Soticlestat was administered as a single oral 300 mg dose. Pharmacokinetic parameters of soticlestat and its metabolites TAK-935-G (M3) and M-I were assessed and compared by group. The incidence of treatment-emergent adverse events (TEAEs) and other safety parameters were also monitored. The pharmacokinetic analyses comprised 35 participants. Participants with moderate hepatic impairment had lower proportions of bound and higher proportions of unbound soticlestat than participants with mild hepatic impairment and normal hepatic function. Total plasma soticlestat pharmacokinetic parameters (maximum observed concentration [Cmax], area under the concentration-time curve from time 0 to time of last quantifiable concentration [AUClast], and AUC from time 0 to infinity [AUC∞]) were approximately 115%, 216%, and 199% higher with moderate and approximately 45%, 35%, and 30% higher with mild hepatic impairment, respectively, than healthy matched participants. Moderate hepatic impairment decreased the liver's ability to metabolize soticlestat to M-I; glucuronidation to M3 was also affected. Mild hepatic impairment resulted in a lower total plasma M-I exposure, but glucuronidation was unaffected. TEAEs were similar across study arms, mild, and no new safety findings were observed. A soticlestat dose reduction is required for individuals with moderate but not mild hepatic impairment.

Effect of Mild or Moderate Hepatic Impairment on the Pharmacokinetics of Avacopan, a Small-Molecule Complement C5a Receptor Antagonist, for the Treatment of Antineutrophil Cytoplasmic Autoantibody-Associated Vasculitis.

Avacopan is currently approved in several regions of the world as an oral treatment in combination with standard therapy, including glucocorticoids, for adult patients with severe active antineutrophil cytoplasmic autoantibody-associated vasculitis. In vitro and clinical studies have established that avacopan is primarily eliminated through cytochrome P450 3A4 metabolism. This Phase 1, open-label, single-dose study (ClinicalTrials.gov identifier: NCT06004934) was conducted to evaluate the effect of mild (n = 8) or moderate (n = 8) hepatic impairment compared with normal hepatic function (n = 8) on the pharmacokinetics, safety, and tolerability of a single oral dose of 30 mg of avacopan in patients without active antineutrophil cytoplasmic autoantibody-associated vasculitis. Relative to participants with normal hepatic function, in participants with mild or moderate hepatic impairment, the avacopan area under the plasma concentration-time curve from time 0 to infinity geometric mean ratios (90% confidence intervals) were 1.3 (0.9-2.0) and 1.1 (0.6-2.0), respectively, and the avacopan maximum plasma concentration geometric mean ratios (90% CIs) were 1.0 (0.8-1.3) and 0.8 (0.6-1.1), respectively. The geometric mean ratios of metabolite M1 also revealed no pharmacokinetically relevant increase in the peak exposure of M1 in participants with mild or moderate hepatic impairment. Thus, no avacopan dosage adjustment is necessary for patients with mild or moderate hepatic impairment.

Drinking water safety evaluation in the selected sub-Saharan African countries: A case study of Madagascar, Uganda and Rwanda.

In the sub-Saharan region of Africa, access to safe drinking water remains limited in many countries. This study provides an overview of the quality of surface water and groundwater in rural and peri-urban areas of Madagascar, Uganda, and Rwanda. Selected physico-chemical parameters, inorganic species (including inorganic ions), and organic pollution indicators, such as total organic carbon, non-ionic surfactants, cationic surfactants, anionic surfactants, sum of phenolic compounds and formaldehyde, were analysed. Principal component analysis was applied to assess the variability of the water quality and identify regional dependencies. The inorganic ion composition in the majority of the studied samples meets WHO and EU requirements for drinking water intended for human consumption and poses no human health risk. However, an individual non-cancer-causing health index for nitrates and the values of Water Quality Index show a possible threat of ingesting the studied drinking water. The presence of surfactants (0.1-0.65 mgL-1), phenolic compounds (0.025-1.76 mgL-1) and formaldehyde (0.04-0.32 mgL-1) may also pose a risk to human, animal, and aquatic life. Additionally, in-situ measurements for E. coli and Total Coliforms conducted during the last field campaign in Madagascar (2022) revealed that all studied drinking water sources ranged from intermediate risk to unsafe. This result calls for the urgent need to enhance WASH (water, sanitation, and hygiene) services in the studied areas. The presence of both chemical and microbiological pollutants shows the need for the local authorities to develop and implement a catchment management plan to ensure the protection of water resources from potential pollution, and raise community awareness about the impact of human activity on water resources.

A phase 2a study investigating the effects of ritlecitinib on brainstem auditory evoked potentials and intraepidermal nerve fiber histology in adults with alopecia areata.

Reversible axonal swelling and brainstem auditory evoked potential (BAEP) changes were observed in standard chronic (9-month) toxicology studies in dogs treated with ritlecitinib, an oral Janus kinase 3/tyrosine kinase expressed in hepatocellular carcinoma family kinase inhibitor, at exposures higher than the approved 50-mg human dose. To evaluate the clinical relevance of the dog toxicity finding, this phase 2a, double-blind study assessed BAEP changes and intraepidermal nerve fiber (IENF) histology in adults with alopecia areata treated with ritlecitinib. Patients were randomized to receive oral ritlecitinib 50 mg once daily (QD) with a 4-week loading dose of 200 mg QD or placebo for 9 months (placebo-controlled phase); they then entered the active-therapy extension and received ritlecitinib 50 mg QD (with a 4-week loading dose of 200 mg in patients switching from placebo). Among the 71 patients, no notable mean differences in change from baseline (CFB) in Waves I-V interwave latency (primary outcome) or Wave V amplitude on BAEP at a stimulus intensity of 80 dB nHL were observed in the ritlecitinib or placebo group at Month 9, with no notable differences in interwave latency or Wave V amplitude between groups. The CFB in mean or median IENF density and in percentage of IENFs with axonal swellings was minimal and similar between groups at Month 9. Ritlecitinib treatment was also not associated with an imbalanced incidence of neurological and audiological adverse events. These results provide evidence that the BAEP and axonal swelling finding in dogs are not clinically relevant in humans.

The Moment of Patient Safety: Iatrogenic Injury, Clinical Error and Cultures of Healthcare in the NHS.

This article explores the 'the moment of patient safety'-the period around 2000 when patient safety became a key policy concern of the British National Health Service (NHS), and other healthcare systems. While harm caused by medical care (iatrogenic injury) had long been acknowledged by clinicians and scientists, from 2000 a new systemic language of patient safety emerged in the NHS that promoted novel managerial and regulatory approaches to patient harm. This language reflected the state's increasing role in regulating healthcare, as well as the erosion of medical autonomy and the rise of new forms of bureaucratic management. Acknowledging a transnational, intellectual context behind the rise of policy interest in patient safety-for example, the application of insights from the industrial safety sciences-this article examines the role played by domestic cultural factors, such as medical negligence litigation and healthcare scandals, in helping to define the new language in Britain.

Clinician Perspectives on Suicide Safety Planning and Its Implementation.

OBJECTIVE: The safety planning intervention is an evidence-based practice shown to reduce suicide risk, but implementation of high-quality safety planning has proven challenging. We aimed to understand clinician perspectives on the safety planning intervention to inform future implementation efforts. METHOD: This cross-sectional survey of clinicians who care for patients at risk of suicide in an academic medical center asked about comfort levels and fidelity to components of the safety planning intervention and assessed implementation barriers and facilitators. We used exploratory data analysis and regression analysis to explore clinician perspectives and assess the relationship between formal training and implementation. RESULTS: Ninety-two clinicians responded to the survey. Two-thirds of participants (64.9%) endorsed using all six core elements of the safety planning intervention. Participants who reported receiving formal training in safety planning were significantly more likely to report being comfortable completing a safety plan (p < .001); those with higher levels of comfort were significantly more likely to endorse using all of the core elements of the safety planning intervention (p < .001). CONCLUSIONS: Training in the evidence-based safety planning intervention is associated with clinician comfort and awareness of the core elements of the intervention. Our results suggest that there are gaps in clinician training and that formal safety planning intervention training could have a positive effect on clinician comfort and treatment fidelity.