Recommendations For Best Practices Research Articles

Health Care for Unaccompanied Immigrant Children in US Communities: A Guide for Pediatric Practitioners.

Children who arrived at the United States border without a parent or legal guardian (ie, unaccompanied children) are present in communities throughout the country in growing numbers. For them to receive the highest-quality medical and mental services available, pediatric practitioners should have a foundational understanding of their unique set of circumstances and experiences. However, formal education on how to care for this specific immigrant subpopulation is not routinely incorporated into pediatric training programs, and limited clinical guidance is available in the published literature. This article provides best-practice recommendations for pediatric practitioners caring for unaccompanied children after their release from government custody, incorporating guidance for clinical encounters as well as suggestions of processes to meet their health-related social needs and advocacy actions to improve their well-being. [Pediatr Ann. 2024;53(5):e178-e182.].

Open access for community partners, impactful outputs for scholars: Leveraging scholarly communication movements to enhance reciprocity in community based research

Many corners of the academy are actively working to build bridges between research in the ivory tower to outcomes and needs in the community. Our study seeks to unify two such efforts – community-based/service-learning research and open access scholarly communication. Open access is an implicit value in community-based and service-learning research, and is part of the symbiotic relationship value, but has not been explicitly discussed, framed, or embraced as a value or goal. We explore existing literature on the desire for research-informed practices from community members and practitioners, the current state of open informational practices from scholarly publications dedicated to work happening in community spaces, and make recommendations for good practices for editors, publishers, researchers, and institutions looking to link the work of scholars to the needs of the community and evaluate impact.

An Assessment of Waste Management in Slum Communities in Freetown. It’s Implications on the Health and Safety of Inhabitants

Purpose: The study objective is to assess the state of Solid Waste Management (SWM) in slum communities in Freetown, its factors and effects on the safety and wellbeing of slum dwellers together with the challenges faced by authorities in combatting inadequate SWM system in slum and to provide recommendations with regards to interventions to promote adequate waste management in slums.
 Materials and Methods: The study took place in three slum areas around Freetown in Sierra Leone. A total sample size of 400 respondents comprising of household heads were selected. A self-administered structured questionnaire was given to a total of 400 respondents of household heads above eighteen years old. Only 392 of the 400 respondents that were initially targeted for the study completed their questionnaires at the end of the survey. The data collected was presented in tables and statistical analytical techniques or methods such as percentages and graphs were used to analyse the data and to find out the factors, effects and challenges associated with inappropriate solid waste management services in slum areas in Freetown.
 Findings: According to the study, it was found that the major categories of waste generated in households were biodegradable and food (39%) while plastic remains (31%). Most households stored their wastes in polythene bags (59.1%) and sacks (20.2%) before disposal and 10.3% of the households did not have waste storage containers and kept their wastes outside the house in the open. Poor knowledge in waste segregation practices with very minimal recycling, reuse of wastes and a resultant poor waste management system were observed in slum communities. The study helps provide a much-needed data on solid waste management (SWM) in Freetown for authorities and other stakeholders as there are limited sources of data on waste management in Sierra Leone. It also provides further literature on waste management issues for further research, policy development by the authorities and recommendations for best practice by communities and stakeholders.
 Implications to Practice and Policy: It was recommended that waste management should be prioritized as a social service, with adequate budget lines. Engage several stakeholders in the management of waste to generate a sense of responsibility and interest from all stakeholders.

Managing potential adverse events during treatment with enfortumab vedotin + pembrolizumab in patients with advanced urothelial cancer.

Cisplatin-based chemotherapy has been the standard of care for patients with locally advanced or metastatic urothelial cancer (la/mUC). Enfortumab vedotin, an antibody-drug conjugate directed to Nectin-4, and pembrolizumab, an immune checkpoint inhibitor, are two therapies that have individually provided a survival benefit in patients with la/mUC. The combination regimen of enfortumab vedotin plus pembrolizumab was evaluated in EV-302 (KEYNOTE-A39; NCT0422385), a phase 3 study that showed statistically significant and clinically meaningful improvement in overall survival, progression-free survival, and a key secondary endpoint of overall response rate versus chemotherapy. Based on these results and those from the EV-103 (KEYNOTE-869; NCT03288545) Dose Escalation cohort, Cohort A, and Cohort K, enfortumab vedotin plus pembrolizumab was granted approval from the US Food and Drug Administration for the treatment of adults with la/mUC. While guidelines and recommendations for the management of adverse events (AEs) have been developed for immune checkpoint inhibitor monotherapy and enfortumab vedotin monotherapy, additional guidance is needed for managing AEs that occur with enfortumab vedotin plus pembrolizumab. As monotherapies, enfortumab vedotin and pembrolizumab are both associated with some of the AEs observed with the combination, such as skin reactions, pneumonitis, and diarrhea, which may confound the attribution of the AE to a specific agent and thereby complicate clinical management. In this manuscript, we aim to provide recommendations for best practice for patient care and the management of AEs of clinical interest for patients with la/mUC receiving enfortumab vedotin plus pembrolizumab, including skin reactions, peripheral neuropathy, hyperglycemia, and pneumonitis. These recommendations were developed based on published guidelines, expert opinions, and the clinical experience of the authors, which include oncologist, advanced practice provider, nursing, and pharmacy perspectives. In addition, guidance on patient education and communication is provided. With vigilant monitoring, early detection, and prompt intervention of treatment-emergent AEs based on recommended approaches described herein, it is the authors' experience that most AEs can be managed with supportive therapy and dose modification/interruptions, allowing patients to continue treatment.

National standardisierter Broad Consent in der Praxis: erste Erfahrungen, aktuelle Entwicklungen und kritische Betrachtungen

ZusammenfassungHintergrundDie Digitalisierung im Gesundheitswesen verspricht eine Sekundärnutzung von Patientendaten im Sinne eines lernenden Gesundheitssystems. Die Arbeitsgruppe Consent der Medizininformatik-Initiative (MII) hat mit einheitlichen Einwilligungsdokumenten eine ethische und rechtliche Grundlage hierfür geschaffen. Beschrieben wird die systematisch begleitete Einführung dieser Dokumente an den Standorten der MII.MethodenDie Begleitung der Einführung umfasste regelmäßige Online-Umfragen, die vertiefte Analyse der Einführungsprozesse an ausgewählten Standorten sowie die Untersuchung der jeweils eingesetzten Dokumente. Zudem wurden Anfragen und Rückmeldungen einer Vielzahl von Stakeholdern ausgewertet.ErgebnisseDie Online-Umfragen ergaben, dass 27 der 32 befragten Standorte nach und nach die Einwilligungsdokumente produktiv eingeführt haben, mit aktuell insgesamt 173.289 Einwilligungen. Die Analyse der Umsetzungsverfahren offenbarte heterogene organisatorische Rahmenbedingungen an den Standorten. Anforderungen verschiedener Stakeholder konnten durch die Erarbeitung und Bereitstellung ergänzender Versionen der Einwilligungsdokumente und zusätzlicher Informationsmaterialien erfüllt werden.DiskussionDie Einführung der Einwilligungsdokumente der MII an den Universitätskliniken schafft eine einheitliche Rechtsgrundlage für die Sekundärnutzung von Patientendaten. Die flächendeckende Implementierung innerhalb der Standorte bleibt jedoch herausfordernd. Minimalanforderungen an die Patientenaufklärung und ergänzende Best-Practice-Empfehlungen sind hierfür zu erarbeiten. Die Weiterentwicklung des nationalen Rechtsrahmens für die Forschung wird die hier entwickelten Mitsprache- und Transparenzmechanismen für Betroffene nicht obsolet machen.

Evaluating manual versus automated benthic foraminiferal δ18O alignment techniques for developing chronostratigraphies in marine sediment records

Abstract. Paleoceanographic interpretations of Plio-Pleistocene climate variability over the past 5 million years rely on the evaluation of event timing of proxy changes in sparse records across multiple ocean basins. In turn, orbital-scale chronostratigraphic controls for these records are often built from stratigraphic alignment of benthic foraminiferal stable oxygen isotope (δ18O) records to a preferred dated target stack or composite. This chronostratigraphic age model approach yields age model uncertainties associated with alignment method, target selection, the assumption that the undated record and target experienced synchronous changes in benthic foraminiferal δ18O values, and the assumption that any possible stratigraphic discontinuities within the undated record have been appropriately identified. However, these age model uncertainties and their impact on paleoceanographic interpretations are seldom reported or discussed. Here, we investigate and discuss these uncertainties for conventional manual and automated tuning techniques based on benthic foraminiferal δ18O records and evaluate their impact on sedimentary age models over the past 3.5 Myr using three sedimentary benthic foraminiferal δ18O records as case studies. In one case study, we present a new benthic foraminiferal δ18O record for International Ocean Discovery Program (IODP) Site U1541 (54°13′ S, 125°25′ W), recently recovered from the South Pacific on IODP Expedition 383. The other two case studies examine published benthic foraminiferal δ18O records of Ocean Drilling Program (ODP) Site 1090 and the ODP Site 980/981 composite. Our analysis suggests average age uncertainties of 3 to 5 kyr associated with manually derived versus automated alignment, 1 to 3 kyr associated with automated probabilistic alignment itself, and 2 to 6 kyr associated with the choice of tuning target. Age uncertainties are higher near stratigraphic segment ends and where local benthic foraminiferal δ18O stratigraphy differs from the tuning target. We conclude with recommendations for community best practices for the development and characterization of age uncertainty of sediment core chronostratigraphies based on benthic foraminiferal δ18O records.

Tackling assay interference associated with small molecules.

Biochemical and cell-based assays are essential to discovering and optimizing efficacious and safe drugs, agrochemicals and cosmetics. However, false assay readouts stemming from colloidal aggregation, chemical reactivity, chelation, light signal attenuation and emission, membrane disruption, and other interference mechanisms remain a considerable challenge in screening synthetic compounds and natural products. To address assay interference, a range of powerful experimental approaches are available and in silico methods are now gaining traction. This Review begins with an overview of the scope and limitations of experimental approaches for tackling assay interference. It then focuses on theoretical methods, discusses strategies for their integration with experimental approaches, and provides recommendations for best practices. The Review closes with a summary of the critical facts and an outlook on potential future developments.

The use of faecal microbiota transplant as treatment for recurrent or refractory Clostridioides difficile infection and other potential indications: second edition of joint British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS) guidelines

The first British Society of Gastroenterology (BSG) and Healthcare Infection Society (HIS)-endorsed faecal microbiota transplant (FMT) guidelines were published in 2018. Over the past 5 years, there has been considerable growth in the evidence base (including publication of outcomes from large national FMT registries), necessitating an updated critical review of the literature and a second edition of the BSG/HIS FMT guidelines. These have been produced in accordance with National Institute for Health and Care Excellence-accredited methodology, thus have particular relevance for UK-based clinicians, but are intended to be of pertinence internationally. This second edition of the guidelines have been divided into recommendations, good practice points and recommendations against certain practices. With respect to FMT for Clostridioides difficile infection (CDI), key focus areas centred around timing of administration, increasing clinical experience of encapsulated FMT preparations and optimising donor screening. The latter topic is of particular relevance given the COVID-19 pandemic, and cases of patient morbidity and mortality resulting from FMT-related pathogen transmission. The guidelines also considered emergent literature on the use of FMT in non-CDI settings (including both gastrointestinal and non-gastrointestinal indications), reviewing relevant randomised controlled trials. Recommendations are provided regarding special areas (including compassionate FMT use), and considerations regarding the evolving landscape of FMT and microbiome therapeutics.

Adverse Events Reporting in Digital Interventions Evaluations for Psychosis: A Systematic Literature Search and Individual Level Content Analysis of Adverse Event Reports.

Digital health interventions (DHIs) have significant potential to upscale treatment access to people experiencing psychosis but raise questions around patient safety. Adverse event (AE) monitoring is used to identify, record, and manage safety issues in clinical trials, but little is known about the specific content and context contained within extant AE reports. This study aimed to assess current AE reporting in DHIs. A systematic literature search was conducted by the iCharts network (representing academic, clinical, and experts by experience) to identify trials of DHIs in psychosis. Authors were invited to share AE reports recorded in their trials. A content analysis was conducted on the shared reports. We identified 593 AE reports from 18 DHI evaluations, yielding 19 codes. Only 29 AEs (4.9% of total) were preidentified by those who shared AEs as being related to the intervention or trial procedures. While overall results support the safety of DHIs, DHIs were linked to mood problems and psychosis exacerbation in a few cases. Additionally, 27% of studies did not report information on relatedness for all or at least some AEs; 9.6% of AE reports were coded as unclear because it could not be determined what had happened to participants. The results support the safety of DHIs, but AEs must be routinely monitored and evaluated according to best practice. Individual-level analyses of AEs have merit to understand safety in this emerging field. Recommendations for best practice reporting in future studies are provided.

A systematic evaluation of text mining methods for short texts: Mapping individuals’ internal states from online posts

Short texts generated by individuals in online environments can provide social and behavioral scientists with rich insights into these individuals’ internal states. Trained manual coders can reliably interpret expressions of such internal states in text. However, manual coding imposes restrictions on the number of texts that can be analyzed, limiting our ability to extract insights from large-scale textual data. We evaluate the performance of several automatic text analysis methods in approximating trained human coders’ evaluations across four coding tasks encompassing expressions of motives, norms, emotions, and stances. Our findings suggest that commonly used dictionaries, although performing well in identifying infrequent categories, generate false positives too frequently compared to other methods. We show that large language models trained on manually coded data yield the highest performance across all case studies. However, there are also instances where simpler methods show almost equal performance. Additionally, we evaluate the effectiveness of cutting-edge generative language models like GPT-4 in coding texts for internal states with the help of short instructions (so-called zero-shot classification). While promising, these models fall short of the performance of models trained on manually analyzed data. We discuss the strengths and weaknesses of various models and explore the trade-offs between model complexity and performance in different applications. Our work informs social and behavioral scientists of the challenges associated with text mining of large textual datasets, while providing best-practice recommendations.

Base de données Enthalpies : évidence et théorie appliquée à la pratique en stérilisation

In order to share their knowledge, sterilization unit managers publish the results of their work in journals or at scientific conferences. The aim of Enthalpies is to list all such work in a single database. The work presented describes the construction of this database and the assessment of its feasibility for the washing step. The first step was to carry out a literature review. Only articles published over 10years (2013-2023) in connection with the ten-year washing stage were included. Then, each publication was categorized, coded, graded and summarized by a pharmacist-internal pair. All this data was collated in an Excel® spreadsheet, and from the data categorization a tree structure was created, enabling the interface between the user and the platform hosting Enthalpies to be understood. Eighty-one publications were identified. These were categorized into 6 themes and 27 sub-themes. A reading grid was drawn up for each publication. Genially®, an online platform, was chosen to host our database. Enthalpies was not designed to issue recommendations for best practice. However, by collating published scientific data, this tool can be used to assist decision-making. It represents an innovative solution for providing a literature review in the field of hospital sterilization.

Antibioprophylaxie chirurgicale et medicale courte de l’enfant

Antibiotic prophylaxis aims to counteract bacterial proliferation in order to reduce the risk of infection in a patient. The emergence of multi-resistant bacteria, which can lead to therapeutic impasses, has prompted the international medical community to regularly propose programs to optimize the use of antibiotics. In collaboration with the SFAR (Société Française d'Anesthésie Réanimation), the GPIP has updated its recommendations for good practice in surgical antibiotic prophylaxis in children, and for short antibiotic prophylaxis in medicine. These recommendations provide a general framework based on the analysis of national and international data, and more often than not on expert opinion, and are intended to support the implementation of local antibiotic prophylaxis protocols specific to each team.

Addressing the Comorbidity Between Epilepsy and Psychiatric Disorders

IntroductionThe intricate and multifaceted nature of the link between epilepsy and psychiatric diseases is evident. Patients diagnosed with epilepsy frequently exhibit concurrent psychiatric illnesses, including but not limited to depression, anxiety, psychosis, and attention-deficit disorders. Gaining a comprehensive understanding of the fundamental mechanisms and implementing efficacious ways to effectively address this co-occurring medical condition is crucial in order to achieve the most advantageous results for patients.ObjectivesThe objective of this study is to examine the frequency, neurobiological bases, and consequences for treatment of psychiatric comorbidities in patients diagnosed with epilepsy. The study aims to offer a thorough understanding of the subject and promote interdisciplinary collaboration.MethodsA systematic review of literature was conducted, focusing on clinical studies, neuroimaging findings, and neurochemical changes in patients with both epilepsy and psychiatric disorders. Additionally, best-practice recommendations for the clinical management of this patient population were identified.ResultsThe results suggest that the coexistence of epilepsy and psychiatric diseases may be affected by neuroinflammation, abnormalities in neurotransmitters, and shared genetic factors. In addition, the implementation of integrated therapy techniques that include both neurological and psychological components has demonstrated encouraging findings in enhancing patient outcomes.ConclusionsThe identification and proficient management of psychiatric comorbidities in individuals with epilepsy are of utmost significance. The establishment of interdisciplinary collaboration between neurologists and psychiatrists, supported by continuous research, is necessary in order to provide comprehensive treatment and enhance the overall well-being of individuals affected by these conditions.Disclosure of InterestNone Declared

Methods for Including Adverse Events in Economic Evaluations: Suggestions for Improvement

ObjectiveInclusion of relevant effectiveness and safety outcomes in economic evaluation of health technologies is required to aid efficient healthcare decisions. Our objective was to identify the key issues related to the inclusion of adverse events (AEs) in economic evaluation and explore perspectives for good practice recommendations to handle these issues. MethodsWe focused on the frequently encountered methodological issues related to the integration of AEs in economic evaluations of health technologies. We distinguished the following elements: the incorporation of AEs in decision models, the terminology of AEs, the estimation of AEs consequences in terms of quality of life (QoL) and costs, and the exploration of the uncertainty related to the impact of AEs on the economic results. ResultsWe illustrated and discussed each of the identified issues by giving health technology assessment examples. We focused on the extent to which the integration of AEs in decision models can be improved by dealing with the lack of relevant real-world safety data, estimating the consequences of AEs (eg, for costs and QoL loss), exploring the impacts of AEs that are not adequately captured in current measurement of health-related QoL, and identifying the need for development of a good terminology of relevant types of AEs to be incorporated in economic evaluation. ConclusionBased on a reflection the key methodological issues related to the incorporation of adverse drug events in economic evaluations, we suggested several recommendations to serve a starting point for health technology assessment agencies and researchers to develop good research practices in this field.

Expert consensus recommendations for improving and standardising the assessment of patients with generalised myasthenia gravis.

Regular and consistent disease assessment could provide a clearer picture of burden in generalised myasthenia gravis (gMG) and improve patient care; however, the use of assessment tools in practice lacks standardisation. This modified Delphi approach was taken to review current evidence on assessment tool use in gMG and develop expert-derived consensus recommendations for good practice. A European expert panel of 15 experienced gMG neurologists contributed to development of this consensus, four of whom formed a lead Sub-committee. The PICO (Population, Intervention, Control, Outcomes) framework was used to define six clinical questions on gMG assessment tools, a systematic literature review was conducted, and evidence-based statements were developed. According to a modified Delphi voting process, consensus was reached when ≥70% of the experts rated agreement with a statement as ≥8 on a scale of 1-10. Eighteen expert- and evidence-based consensus statements based on six themes were developed. Key recommendations include: consistent use of the Myasthenia Gravis Activities of Daily Living score (MG-ADL) across clinical settings, followed by a simple question (e.g., Patient Acceptable Symptom State [PASS]) or scale to determine patient satisfaction in clinical practice; use of a Quantitative Myasthenia Gravis [QMG] or quality of life [QoL] assessment when the MG-ADL indicates disease worsening; and consideration of symptom state to determine the timing and frequency of recommended assessments. Expert panel consensus was reached on all 18 statements after two voting rounds. This process provided evidence- and expert consensus-based recommendations for the use of objective and subjective assessment tools across gMG research and care to improve management and outcomes for patients.

Machine learning approach to identify malaria risk in travelers using real-world evidence

BackgroundPre-travel consultation and chemoprophylaxis measures for malaria are a key component in the prevention of imported malaria in travelers. In this study we report a predictive tool for assessing personalized malaria risk in travelers based on the analysis of electronic medical records from travel consultations. The tool aims to guide physicians in the recommendation of appropriate prophylaxis prior to their trip. We also provide best-practice recommendations for pre-processing noisy and highly sparse real world evidence data. MethodsWe leveraged a large EMR dataset, containing demographic information about travelers and their destination. The data has been previously preprocessed using various strategies to handle missing and unbalanced data. We compared multiple machine learning approaches to assess the risk of malaria acquisition in travelers during their travels. Additionally, a feature importance analysis was performed using SHAP (SHapley Additive Explanations) values to identify patterns associated with malaria risk. ResultsOur study revealed that our XGB models achieved high predictive capacity (AUC >0.80). The most significant features predicting malaria infection during travel included travel destinations with low malaria risk, vaccination history, number of countries visited, age, and trip duration. Remarkably, we were able to obtain a reduced model with only five features. When comparing this model with a population of travelers recommended for malaria chemoprophylaxis, we observed that it was deemed necessary in only 40% of these travelers. This suggests that 60% received chemoprophylaxis despite having a low personalized risk of malaria. ConclusionWe have developed an algorithmic tool that utilizes a concise survey to generate a personalized travel risk assessment, effectively minimizing the prescription of unnecessary malaria chemoprophylaxis. Through the identification of patterns linked to predictions, our model significantly enhances the efficacy of pre-travel consultations.

The initial visibility of updated recommendations on preseason heat safety in high school athletics among United States athletic trainers.

Updated recommendations on preseason heat safety in high school (HS) athletics ("2021 Consensus Statements") were published in April 2021. This cross-sectional survey study explored the initial roll-out of the 2021 Consensus Statements, including their visibility among United States HS athletic trainers (ATs) and perceived levels of confidence in implementing them. Recruitment occurred first, from a random selection of ATs from the Board of Certification, Inc., and second, an open invitation via social media. An online cross-sectional questionnaire had participating ATs note whether they had seen the 2021 Consensus Statements. If yes, ATs reported their perceived level of confidence in implementing them (5-point-ordinal scale from "not at all confident" to "very confident); if no, ATs disclosed (open-ended) why they had not yet seen them. Descriptive statistics were calculated for quantitative variables; template analysis identified codes related to visibility of and confidence in implementing 2021 Consensus Statements. Nearly half (45.7%) of 116 responding HS ATs reported having seen at least one 2021 Consensus Statements; 23.3% had reviewed all three. Common reasons among the 63 that had not seen them included: not aware they were published (n = 22), have yet to read them (n = 19), and believed they could not access the journal (n = 10). Of the 53 ATs having seen at least one of the 2021 Consensus Statements, 67.9% (n = 36) were very/fairly confident in implementing them at their HS. Reasons for confidence included their schools ensuring up-to-date EHI prevention and management practices (n = 18) and athletics constituent support (n = 8). This exploratory study observed proportions of surveyed HS ATs that had not seen the 2021 Consensus Statements and were not confident in implementing them. Findings highlight the need to continue improving messaging about access to best-practice recommendations. Further, continued efforts inclusive of active and passive dissemination strategies across all athletics constituents are needed to aid proper implementation.

Breathing patterns and associated cardiovascular changes in intermittently breathing animals: (Partially) correcting a semantic quagmire.

Many animal species do not breathe in a continuous, rhythmic fashion, but rather display a variety of breathing patterns characterized by prolonged periods between breaths (inter-breath intervals), during which the heart continues to beat. Examples of intermittent breathing abound across the animal kingdom, from crustaceans to cetaceans. With respect to human physiology, intermittent breathing-also termed 'periodic' or 'episodic' breathing-is associated with a variety of pathologies. Cardiovascular phenomena associated with intermittent breathing in diving species have been termed 'diving bradycardia', 'submersion bradycardia', 'immersion bradycardia', 'ventilation tachycardia', 'respiratory sinus arrhythmia' and so forth. An examination across the literature of terminology applied to these physiological phenomena indicates, unfortunately, no attempt at standardization. This might be viewed as an esoteric semantic problem except for the fact that many of the terms variously used by different authors carry with them implicit or explicit suggestions of underlying physiological mechanisms and even human-associated pathologies. In this article, we review several phenomena associated with diving and intermittent breathing, indicate the semantic issues arising from the use of each term, and make recommendations for best practice when applying specific terms to particular cardiorespiratory patterns. Ultimately, we emphasize that the biology-not the semantics-is what is important, but also stress that confusion surrounding underlying mechanisms can be avoided by more careful attention to terms describing physiological changes during intermittent breathing and diving.

Adapting the in vitro micronucleus assay (OECD Test Guideline No. 487) for testing of manufactured nanomaterials: recommendations for best practices.

The current Organisation for Economic Co-Operation and Development test guideline number 487 (OECD TG No. 487) provides instruction on how to conduct the in vitro micronucleus assay. This assay is one of the gold standard approaches for measuring the mutagenicity of test items; however, it is directed at testing low molecular weight molecules and may not be appropriate for particulate materials (e.g. engineered nanoparticles [ENPs]). This study aimed to adapt the in vitro micronucleus assay for ENP testing and underpins the development of an OECD guidance document. A harmonized, nano-specific protocol was generated and evaluated by two independent laboratories. Cell lines utilized were human lymphoblastoid (TK6) cells, human liver hepatocytes (HepG2) cells, Chinese hamster lung fibroblast (V79) cells, whole blood, and buffy coat cells from healthy human volunteers. These cells were exposed to reference ENPs from the Joint Research Council (JRC): SiO2 (RLS-0102), Au5nm and Au30nm (RLS-03, RLS-010), CeO2 (NM212), and BaSO4 (NM220). Tungsten carbide-cobalt (WC/Co) was used as a trial particulate positive control. The chemical controls were positive in all cell cultures, but WC/Co was only positive in TK6 and buffy coat cells. In TK6 cells, mutagenicity was observed for SiO2- and both Au types. In HepG2 cells, Au5nm and SiO2 showed sub-two-fold increases in micronuclei. In V79 cells, whole blood, and buffy coat cells, no genotoxicity was detected with the test materials. The data confirmed that ENPs could be tested with the harmonized protocol, additionally, concordant data were observed across the two laboratories with V79 cells. WC/Co may be a suitable particulate positive control in the in vitro micronucleus assay when using TK6 and buffy coat cells. Detailed recommendations are therefore provided to adapt OECD TG No. 487 for testing ENP.

A qualitative exploration of the use of telehealth for opioid treatment: Implications for nurse-managed care.

To characterise experiences with telehealth for Medications for Opioid Use Disorder (MOUD) services among patients, prescribers, nurses and substance use counsellors to inform future best practices. We engaged a qualitative descriptive study design. Semi-structured interviews were conducted with prescribers (nurse practitioners and physicians, n = 20), nurses and substance use counsellors (n = 7), and patients (n = 20) between June and September 2021. Interviews were verbatim transcribed. Thematic analysis was conducted using a qualitative descriptive method. Among both providers and patients, four themes were identified: (1) Difficulties with telehealth connection (2) Flexibility in follow-up and retention, (3) Policy changes that enabled expanded care, (4) Path forward with telehealth. Two additional findings emerged from provider interviews: (1) Expansion of nurse-managed office-based opioid treatment, and (2) Novel methods to engage patients. Patients and providers continued to view telehealth as an acceptable means for delivery and management of MOUD, particularly when utilised in a hybrid manner between in-person visits. Nurse-managed care for this service was evident as nurses extended the breadth of services offered and utilised novel methods such as text messages and management of 'call-in' lines to engage patients. Use of telehealth for MOUD should be incorporated into practice settings to reach patients in a flexible manner. Nurses in particular can use this medium to extend office-based opioid treatment by conducting assessments and expanding capacity for other wrap-around services. We identify recommendations for best practices in the use of telehealth for opioid use disorder management and highlight the value of nurse-managed care. The consolidated criteria for reporting qualitative research. Patients with opioid use disorder and prescribers with experience using telehealth were interviewed for this study.