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Revised information requirements for endocrine disruptor (ED) assessment of chemicals under the European Union's Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation have been proposed. Implementation will substantially increase demands for new data to inform ED assessment. This article evaluates the potential animal use and financial resource associated with two proposed ED policy options, and highlights areas where further clarification is warranted. This evaluation demonstrates that studies potentially conducted to meet the proposed requirements could use tens of millions of animals, and that the approach is unlikely to be feasible in practice. Given the challenges with implementing either policy option and the need to minimise the reliance on animal testing, further consideration and clarification is needed on several aspects prior to implementation of the requirements. This includes how testing will be prioritised in a proportionate approach; how to harness new approach methodologies to waive higher-tier animal testing; and need for provision of clear guidance particularly in applying weight-of-evidence approaches. There is now a clear opportunity for the European Commission to lead the way in developing a robust and transparent ED assessment process for industrial chemicals which fully implements replacement, refinement, and reduction of the use of animals (the 3Rs).
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Disruptores Endócrinos , União Europeia , Disruptores Endócrinos/toxicidade , Animais , Medição de Risco , Alternativas aos Testes com Animais/métodos , Testes de Toxicidade/métodos , HumanosRESUMO
The Xenopus Eleutheroembryonic Thyroid Assay (XETA) was recently published as an OECD Test Guideline for detecting chemicals acting on the thyroid axis. However, the OECD validation did not cover all mechanisms that can potentially be detected by the XETA. This study was therefore initiated to investigate and consolidate the applicability domain of the XETA regarding the following mechanisms: thyroid hormone receptor (THR) agonism, sodium-iodide symporter (NIS) inhibition, thyroperoxidase (TPO) inhibition, deiodinase (DIO) inhibition, glucocorticoid receptor (GR) agonism, and uridine 5'-diphospho-glucuronosyltransferase (UDPGT) induction. In total, 22 chemicals identified as thyroid-active or -inactive in Amphibian Metamorphosis Assays (AMAs) were tested using the XETA OECD Test Guideline. The comparison showed that both assays are highly concordant in identifying chemicals with mechanisms of action related to THR agonism, DIO inhibition, and GR agonism. They also consistently identified the UDPGT inducers as thyroid inactive. NIS inhibition, investigated using sodium perchlorate, was not detected in the XETA. TPO inhibition requires further mechanistic investigations as the reference chemicals tested resulted in opposing response directions in the XETA and AMA. This study contributes refining the applicability domain of the XETA, thereby helping to clarify the conditions where it can be used as an ethical alternative to the AMA.
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Bioensaio , Disruptores Endócrinos , Metamorfose Biológica , Simportadores , Glândula Tireoide , Animais , Glândula Tireoide/efeitos dos fármacos , Glândula Tireoide/metabolismo , Metamorfose Biológica/efeitos dos fármacos , Bioensaio/métodos , Disruptores Endócrinos/toxicidade , Xenopus laevis , Receptores dos Hormônios Tireóideos/metabolismo , Receptores dos Hormônios Tireóideos/agonistas , Iodeto Peroxidase/metabolismoRESUMO
BACKGROUND: Total elbow replacement (TER) is an accepted treatment for complex intra-articular distal humerus fractures in elderly patients. Distal humeral hemiarthroplasty (HA) is also a potential surgical option for unreconstructable fractures and avoids the concerns regarding mechanical wear and functional restrictions associated with TER. In the current literature, there are limited data available to compare the revision rates of HA and TER for the treatment of fracture. We used data from a large national arthroplasty registry to compare the outcome of HA and TER undertaken for fracture/dislocation and to assess the impact of demographics and implant choice on revision rates. METHODS: Data obtained from the Australian Orthopaedic Association National Joint Replacement Registry from May 2, 2005, to December 31, 2021, included all procedures for primary elbow replacement with primary diagnosis of fracture or dislocation. The analyses were performed using Kaplan-Meier estimates of survivorship and hazard ratios (HRs) from Cox proportional hazards models. RESULTS: There were 293 primary HA and 631 primary TER procedures included. The cumulative percentage revision (CPR) rate at 9 years was 9.7% for HA (95% confidence interval [CI] 6.0, 15.7), and 11.9% (95% CI 8.5, 16.6) for TER. When adjusted for age and gender, there was a significantly higher risk of revision after 3 months for TER compared to HA (HR 2.47, 95% CI 1.22, 5.03, P = .012). There was no difference in the rate of revision for patients aged <55 years or ≥75 years when HA and TER procedures were compared. In primary TER procedures, loosening was the most common cause of revision (3.6% of primary TER procedures), and the most common type of revision in primary TER involved revision of the humeral component only (2.6% of TER procedures). TER has a higher rate of first revision for loosening compared to HA (HR 4.21, 95% CI 1.29, 13.73; P = .017). In HA procedures, instability (1.7%) was the most common cause for revision. The addition of an ulna component was the most common type of revision (2.4% of all HA procedures). CONCLUSION: For the treatment of distal humerus fractures, HA had a lower revision rate than TER after 3 months when adjusted for age and gender. Age <55 or ≥75 years was not a risk factor for revision when HA was compared to TER. Loosening leading to revision is more prevalent in TER and increases with time. In HA, the most common type of revision involved addition of an ulna component with preservation of the humeral component.
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Artroplastia de Substituição do Cotovelo , Hemiartroplastia , Fraturas Distais do Úmero , Fraturas do Úmero , Idoso , Humanos , Artroplastia de Substituição do Cotovelo/métodos , Fraturas do Úmero/cirurgia , Resultado do Tratamento , Austrália/epidemiologia , Úmero/cirurgia , Sistema de Registros , ReoperaçãoRESUMO
BACKGROUND: Sustainable career advancement opportunities for pharmacy technicians will be a critical part of patient-centered community pharmacy environments as the role of the pharmacist provider expands. OBJECTIVES: (1) To determine the impact of a Pharmacy Technician Certification Board pharmacy (PTCB) certification on career advancement and professional growth metrics; (2) To assess technicians' role in advanced pharmacy services before and after certification; and (3) To identify changes in pharmacist services when a certified pharmacy technician (CPhT) was added to the provider team. METHODS: A 73-question web-based survey was distributed to all PTCB certified pharmacy technicians (CPhT) in the United States, Washing D.C., Puerto Rico, Guam, and the US Virgin Islands. The survey was distributed by PTCB in April 2021 with a 28-day collection period. The survey included multiple choice, rating scale, and free text questions centered on five domains: Practice experience, Career aspirations, Compensation, Pharmacy practice motivations, and Impact of COVID-19 pandemic. RESULTS: 23,007 CPhTs completed the survey. Respondents were primarily female (85.5%), age 30-39 (32.8%), and ≥ 10 years CPhT experience (42.8%). The majority of respondents cited improvement of patient health (77.4%), career advancement opportunities (53.5%), the ability to expand their role during emergencies (e.g., COVID-19) (52.6%), and future career advancement opportunities (51.7%) as benefits of CPhT certification. Increases in job responsibility after certification included changes occurring in roles related to clinical pharmacy services, patient education, preventive health services, provider communication, and staff training. Respondents agreed that PTCB-certification allowed for the expansion of pharmacists' services where they practiced, including clinical services (18.5%), patient education (18.3%), and preventive health services (18.1%). CONCLUSION: CPhT's value certification for its benefits on career advancement, personal growth, and salary enhancement. Affirmation of skill and training through certification is also recognized to positively influence patient care and the pharmacy's ability to provide advanced patient care and services.
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AIM: The incidence of benign colonic anastomotic stricture is approximately 2% in patients undergoing left hemicolectomy or anterior resection and as high as 16% in patients undergoing low anterior or intersphincteric resection. In the majority, rather than complete occlusion, a stenosis forms, which can be managed with endoscopic balloon dilatation, a self-expanding metallic stent or endoscopic electroincision. In the less common scenario of a completely occluded colonic anastomosis, surgery is often required. In this study, we aim to describe the technique we used to treat this condition non-operatively METHOD: We describe a case series of three patients with benign complete occlusion of their colorectal anastomosis and how we managed them nonoperatively with a colonic/rectal endoscopic ultrasound (EUS) anastomosis technique and a Hot lumen-apposing metallic stent. RESULTS: We demonstrate that the technical and clinical success for this technique is 100%. CONCLUSIONS: We believe that the technique we describe is effective and safe. It should be widely reproducible in centres with expertise in interventional EUS, given the similarity to well-established procedures such as EUS-guided gastroenterostomy. Patient selection and timing of reversal of ileostomy need careful consideration, especially in patients with a history of keloid formation. Given the shorter hospital stay and reduced invasiveness of this technique, we believe it should be considered for all patients who have complete benign occlusion of a colonic anastomosis. However, given the small number of cases and short period of follow-up, the long-term outcome of this technique is not known. More studies with higher power and a longer period of follow-up should be conducted to further ascertain the effectiveness of this technique.
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Colostomia , Obstrução Intestinal , Humanos , Colostomia/métodos , Colo/diagnóstico por imagem , Colo/cirurgia , Endossonografia/métodos , Anastomose Cirúrgica/métodos , Obstrução Intestinal/etiologia , Stents/efeitos adversos , Ultrassonografia de Intervenção , Estudos RetrospectivosRESUMO
Vitellogenin (VTG) is a biomarker for possible endocrine activity of chemicals acting via the estrogen, androgen, or steroidogenesis pathways. VTG is assessed in standardised fish guideline studies conducted for regulatory safety assessment of chemicals. VTG data can be highly variable leading to concerns for potential equivocal, false positive and/or negative outcomes. Consequently, additional fish testing may be required to address uncertainties in the VTG response, and possibly erroneous/missed identification of endocrine activity. To better understand the technical challenges of VTG assessment and reporting for regulatory purposes, a survey was sent to 27 testing laboratories performing these analyses. The survey results from 16 respondents (6 from the UK, 3 from the USA, and 7 from the EU) were analysed and discussed in a follow-up webinar. High variability in background VTG concentrations was widely acknowledged and thought to be associated with fish batch, husbandry, laboratory practices, and several methodological aspects. These include sample collection and storage, VTG quantification, data handling, and the benchmarks used for data acceptability. Information gathered in the survey provides a basis for improving and harmonizing the measurement of VTG in fish, and an opportunity to reassess the suitability of current acceptability criteria in test guidelines.
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Vitelogeninas , Poluentes Químicos da Água , Animais , Vitelogeninas/metabolismo , Laboratórios , Peixes/metabolismo , Estrogênios/metabolismo , Sistema Endócrino , Poluentes Químicos da Água/análiseRESUMO
Vitellogenin (VTG), a biomarker for endocrine activity, is a mechanistic component of the regulatory assessment of potential endocrine-disrupting properties of chemicals. This review of VTG data is based on changes reported for 106 substances in standard fish species. High intra-study and inter-laboratory variability in VTG concentrations was confirmed, as well as discrepancies in interpretation of results based on large differences between fish in the dilution water versus solvent control, or due to the presence of outlier measurements. VTG responses in fish were ranked against predictions for estrogen receptor agonist activity and aromatase inhibition from bioactivity model output and ToxCast in vitro assay results, respectively. These endocrine mechanisms explained most of the VTG responses in the absence of systemic toxicity, the magnitude of the VTG response being proportional to the in vitro potency. Interpretation of the VTG data was sometimes confounded by an alternative endocrine mechanism of action. There was evidence for both false positive and negative responses for VTG synthesis, but overall, it was rare for substances without endocrine activity in vitro to cause a concentration-dependent VTG response in fish in the absence of systemic toxicity. To increase confidence in the VTG results, we recommend improvements in the VTG measurement methodologies and greater transparency in reporting of VTG data (including quality control criteria for assay performance). This review supports the application of New Approach Methodologies (NAMs) by demonstrating that endocrine activity in vitro from mammalian cell lines is predictive for in vivo VTG response in fish, suggesting that in vitro mechanistic data could be used more broadly in decision-making to help reduce animal testing.
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Disruptores Endócrinos , Poluentes Químicos da Água , Animais , Vitelogeninas/metabolismo , Peixes/metabolismo , Estrogênios/metabolismo , Disruptores Endócrinos/toxicidade , Disruptores Endócrinos/metabolismo , Poluentes Químicos da Água/análise , Mamíferos/metabolismoRESUMO
Children and young people in contact with forensic child and adolescent mental health services present with more complex needs than young people in the general population. Recent policy in child and adolescent mental health has led to the implementation of new workstreams and programmes to improve service provision. This research examines the characteristics of children and young people referred to recently commissioned Community Forensic Child and Adolescent Services (F:CAMHS) and service activity during the first 24 months of service. The study is a national cohort study to describe the population and investigate service provision and access across England. Secondary data on 1311 advice cases and 1406 referrals are included in analysis. Findings show that 71.9% of the sample had accessed mainstream CAMHS before their referral, 50.9% had experienced/witnessed multiple traumatic events and 58.4% of young people presented with multiple difficulties. The results of the study highlight the complexity of the cohort and a need for interagency trauma-informed working. This is the first study to describe the characteristics of children and young people referred to Community F:CAMHS and provides valuable information on pathways and needs to inform service policy and provision.
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Serviços de Saúde do Adolescente , Serviços de Saúde Mental , Humanos , Criança , Adolescente , Estudos de Coortes , Inglaterra , Encaminhamento e ConsultaRESUMO
BACKGROUND: Different techniques exist for the imaging of lateral lymph nodes in rectal cancer. OBJECTIVE: This study aimed to compare the diagnostic accuracy of pelvic MRI, 18 F-FDG-PET/CT, and 18 F-FDG-PET/MRI for the identification of lateral lymph node metastases in rectal cancer. DATA SOURCES: Data sources include PubMed, Embase, Cochrane Library, and Google Scholar. STUDY SELECTION: All studies evaluating the diagnostic accuracy of pelvic MRI, 18 F-FDG-PET/CT, and 18 F-FDG-PET/MRI for the preoperative detection of lateral lymph node metastasis in patients with rectal cancer were selected. INTERVENTIONS: The interventions were pelvic MRI, 18 F-FDG-PET/CT, and/or 18 F-FDG-PET/MRI. MAIN OUTCOME MEASURES: Definitive histopathology was used as a criterion standard. RESULTS: A total of 20 studies (1,827 patients) were included out of an initial search yielding 7,360 studies. The pooled sensitivity of pelvic MRI was 0.88 (95% CI, 0.85-0.91), of 18 F-FDG-PET/CT was 0.83 (95% CI, 0.80-0.86), and of 18 F-FDG-PET/MRI was 0.72 (95% CI, 0.51-0.87) for the detection of lateral lymph node metastasis. The pooled specificity of pelvic MRI was 0.85 (95% CI, 0.78-0.90), of 18 F-FDG-PET/CT was 0.95 (95% CI, 0.86-0.98), and of 18 F-FDG-PET/MRI was 0.90 (95% CI, 0.78-0.96). The area under the curve was 0.88 (95% CI, 0.85-0.91) for pelvic MRI and was 0.83 (95% CI, 0.80-0.86) for 18 F-FDG-PET/CT. LIMITATIONS: Heterogeneity in terms of patients' populations, definitions of suspect lateral lymph nodes, and administration of neoadjuvant treatment. CONCLUSIONS: For the preoperative identification of lateral lymph node metastasis in rectal cancer, this review found compelling evidence that pelvic MRI should constitute the imaging modality of choice. In contrast, to confirm the presence of lateral lymph node metastasis, 18 F-FDG-PET/MRI modalities allow discarding false positive cases because of increased specificity. PROSPERO REGISTRATION NUMBER: CRD42020200319.
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Fluordesoxiglucose F18 , Neoplasias Retais , Humanos , Metástase Linfática/diagnóstico por imagem , Metástase Linfática/patologia , Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada/métodos , Compostos Radiofarmacêuticos , Testes Diagnósticos de Rotina , Sensibilidade e Especificidade , Linfonodos/diagnóstico por imagem , Linfonodos/patologia , Tomografia por Emissão de Pósitrons/métodos , Neoplasias Retais/diagnóstico por imagem , Neoplasias Retais/cirurgia , Neoplasias Retais/patologiaRESUMO
PURPOSE: There is no consensus in the literature regarding the association between operative blood loss and postoperative outcomes in colorectal surgery, despite evidence suggesting a link. Therefore, this systematic review assesses the association between operative blood loss, perioperative and long-term outcomes after colorectal surgery. METHODS: A literature search of MEDLINE, EMBASE, Science Citation Index Expanded and Cochrane was performed to identify studies reporting on operative blood loss in colorectal surgery. RESULTS: The review included forty-nine studies reporting on 61,312 participants, with a mean age ranging from 53.4 to 78.1 years. The included studies demonstrated that major operative blood loss was found to be a risk factor for mortality, anastomotic leak, presacral abscess, and postoperative ileus, leading to an increased duration of hospital stay. In the long term, the studies suggest that significant blood loss was an independent risk factor for future small bowel obstruction due to colorectal cancer recurrence and adhesions. Studies found that survival was significantly reduced, whilst the risk of colorectal cancer recurrence was increased. Reoperation and cancer-specific survival were not associated with major blood loss. CONCLUSION: The results of this systematic review suggest that major operative blood loss increases the risk of perioperative adverse events and has short and long-term repercussions on postoperative outcomes. Laparoscopic and robotic surgery, vessel ligation technology and anaesthetic considerations are essential for reducing blood loss and improving outcomes. This review highlights the need for further high quality, prospective, multicentre trials with a greater number of participants, and accurate and standardised methods of measuring operative blood loss.
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Cirurgia Colorretal , Procedimentos Cirúrgicos do Sistema Digestório , Laparoscopia , Idoso , Perda Sanguínea Cirúrgica , Cirurgia Colorretal/efeitos adversos , Humanos , Laparoscopia/efeitos adversos , Pessoa de Meia-Idade , Duração da Cirurgia , Complicações Pós-Operatórias/etiologia , Estudos ProspectivosRESUMO
INTRODUCTION: This How-I-Do-It article presents a modified Deloyers procedure by mean of the case of a 67-year-old female with adenocarcinoma extending for a long segment and involving the splenic flexure and proximal descending colon who underwent a laparoscopic left extended hemicolectomy (LELC) with derotation of the right colon and primary colorectal anastomosis. BACKGROUND: While laparoscopic extended right colectomy is a well-established procedure, LELC is rarely used (mainly for distal transverse or proximal descending colon carcinomas extending to the area of the splenic flexure). LELC presents several technical challenges which are demonstrated in this How-I-Do-It article. TECHNIQUE AND METHODS: Firstly, the steps needed to mobilize the left colon and procure a safe approach to the splenic flexure are described, especially when a tumor is closely related to it. This is achieved by mobilization and resection of the descending colon, while maintaining a complete mesocolic excision to the level of the duodenojejunal ligament for the inferior mesenteric vein and flush to the aorta for the inferior mesenteric artery. Subsequently, we depict the adjuvant steps required to enable a primary anastomosis by trying to mobilize the transverse colon and release as much of the mesocolic attachments at the splenic flexure area. Finally, we present the rare instance when a laparoscopic derotation of the ascending colon is required to provide a tension-free anastomosis. The resection is completed by delivery of the fully derotated ascending colon and hepatic flexure through a suprapubic mini-Pfannenstiel incision. The primary colorectal anastomosis is subsequently fashioned in a tension-free way and provides for a quick postoperative recovery of the patient. RESULTS: This modified Deloyers procedure preserves the middle colic since the fully mobilized mesocolon allows for a tension-free anastomosis while maintaining better blood supply to the mobilized stump. Also, by eliminating the need for a mesenteric window and the transposition of the caecum, we allow the small bowel to rest over the anastomosis and the mobilized transverse colon and reduce the possibility of an internal herniation of the small bowel into the mesentery. CONCLUSIONS: Laparoscopic derotation of the right colon and a partial, modified Deloyers procedure preserving the middle colic vessels are feasible techniques in experienced hands to provide primary anastomosis after LELC with improved functional outcome. Nevertheless, it is important to consider anatomical aspects of the left hemicolectomy along with oncological considerations, to provide both a safe oncological resection along with good postoperative bowel function.
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Adenocarcinoma , Cólica , Colo Transverso , Neoplasias do Colo , Laparoscopia , Adenocarcinoma/cirurgia , Idoso , Anastomose Cirúrgica , Colectomia , Colo Transverso/cirurgia , Neoplasias do Colo/cirurgia , Feminino , HumanosRESUMO
Background: Opioid use disorder affects millions of Americans, but only a fraction receive treatment. This may be due in part to inaccurate information available about buprenorphine waivered practitioners (waivered practitioners) and Opioid Treatment Programs (OTPs) on public, federally-sponsored locator databases. We aimed to assess the accuracy of publicly-listed locator information for waivered practitioners and OTPs across the US. Methods: Using a cross-sectional study design, we randomly sampled waivered practitioners (n = 253; 0.5%) and licensed OTPs (n = 165; 10%) that were publicly-listed on a federally-sponsored database. We used a three-pronged approach to assess the accuracy of the information available by concurrently administering a phone survey (making up to 3 attempts to contact), conducting online searches, and reviewing provider information on state board websites (practitioners only) between August and November 2020. We used descriptive analyses and inferential statitistics to analyze the data. Results: Among n = 418 waivered practitioners and OTPs sampled, many were located in the South and in an urban area. For the phone survey, researchers were able to reach OTPs nearly twice as often as waivered practitioners. Of those reached, n = 19 waivered practitioners and n = 40 OTPs agreed to participate, and we found most had up-to-date contact information. OTPs yielded significantly more online search results and matching contact information than waivered practitioners (p < 0.001). Most waivered practitioners were located on state licensing board websites, but few had contact information listed, and only one listed the practitioner's waiver status. Conclusions: Waivered practitioners and OTPs were difficult to reach via phone but easier to find online and on state licensing board websites; when they were reached via phone, their contact information was very accurate. Whether challenges locating a waivered practitioner or OTP is associated with lower treatment utilization should be evaluated.
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Buprenorfina , Transtornos Relacionados ao Uso de Opioides , Analgésicos Opioides/uso terapêutico , Buprenorfina/uso terapêutico , Estudos Transversais , Humanos , Tratamento de Substituição de Opiáceos , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Estados UnidosRESUMO
BACKGROUND: The opioid epidemic continues to have a significant negative impact on public health in the United States. Community pharmacies represent an important care setting in confronting the opioid epidemic. However, they continue to be an underutilized care access point. Pharmacy technicians are often the first and most frequent pharmacy personnel to interact with people receiving a prescription for opioid medications. There is a paucity of studies conducted with pharmacy technicians as it pertains to interactions with these patients. OBJECTIVES: To explore community pharmacy technicians' roles and their personal experiences when interacting with patients who are receiving a prescription for opioid medications. METHODS: A qualitative design was employed in use of focus groups (FGs) conducted virtually across several regions of the United States. Audio recordings of U.S. FGs were transcribed verbatim and imported via Dedoose (v2.0, Dedoose, Manhattan Beach, CA,) for further data assessment using thematic analysis. The researchers used the Consolidated Criteria for Reporting Qualitative Research. RESULTS: In total, 46 pharmacy technicians participated in 8 FGs. The average length of time for FG was 56 minutes. The mean for the work experience was 7 years, with a range of 1 to 44. Of 46 subjects, 34 were working in a community setting, and the rest were in a hospital setting. Most of the subjects practiced in Tennessee and California at the time of the study. Two themes emerged from the data: "Interactions between pharmacy technicians and patients who are using opioid prescriptions," and "Interactions between pharmacy technicians and the pharmacy team while dispensing opioid prescriptions." CONCLUSION: Pharmacy technicians serve as a key health care system touchpoint in the community pharmacy. Although pharmacy technicians are exposed to people receiving a prescription for opioid medications, they feel under-resourced and ill-quipped to adequately serve this patient population.
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Serviços Comunitários de Farmácia , Farmácias , Analgésicos Opioides/efeitos adversos , Humanos , Epidemia de Opioides , Farmacêuticos , Técnicos em Farmácia , Estados UnidosRESUMO
BACKGROUND: Ensuring opportunities exist to dispose of unused or unwanted drugs that are appropriate, accessible, and affordable is critical to avoid misuse and lasting harm to the environment. OBJECTIVE: The objectives of this study were to identify state statutes promulgated in all 50 states and the District of Columbia (DC) facilitating disposal of unused or unwanted drugs in the community setting and assess their characteristics. METHODS: A retrospective review of state statutes in all 50 U.S. states and DC between October 2020 and May 2022 was conducted. Statutes using terms "drug and disposal or collection" and that were intended to facilitate disposal of unused or unwanted drugs were included. Drug donation programs or repositories, drug returns to the pharmacy, charitable clinics, and others not intended to dispose or unused or unwanted drugs were excluded. Publicly available resources and Westlaw, a legal resource, were used to identify state statutes. Descriptive statistics were used to describe the findings. RESULTS: Of the 50 U.S. states and DC, we found that most states enacted a statute pertaining to drug disposal (63%; n = 32) as of May 2022. Of states with a drug disposal statute, few had funding mechanisms or required pharmacy participation. Most statutes specified the type of product that may be accepted for disposal, what site may accept them, and who may dispose of the product. Few states specified which health care provider or other individual may accept the product(s) for disposal. CONCLUSION: Most states have enacted statutes facilitating drug disposal, but their characteristics varied widely. Opportunities may exist at the state level to further incentivize proper drug disposal, and further research is needed to measure possible effects of these state statutes.
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Eliminação de Resíduos de Serviços de Saúde , Preparações Farmacêuticas , Humanos , Estados Unidos , Eliminação de Resíduos de Serviços de Saúde/legislação & jurisprudência , Eliminação de Resíduos de Serviços de Saúde/métodos , Estudos Retrospectivos , Legislação como AssuntoRESUMO
BACKGROUND: The present case-series describes the first full-robotic colorectal resections performed with the new CMR Versius platform (Cambridge Medical Robotics Surgical, 1 Evolution Business Park, Cambridge, United Kingdom) by an experienced robotic surgeon. METHODS: In a period between July 2020 and December 2020, patients aged 18 years or older, who were diagnosed with colorectal cancer and were fit for minimally invasive surgery, underwent robotic colorectal resection with CMR Versius robotic platform at "Casa di Cura Cobellis" in Vallo della Lucania,Salerno, Italy. Three right colectomies, 2 sigmoid colectomies and 1 anterior rectal resection were performed. All the procedures were planned as fully robotic. Surgical data were retrospectively reviewed from a prospectively collected database. RESULTS: Four patients were male and 2 patients were female with a median (range) age of 66 (47-72) years. One covering ileostomy was created. Full robotic splenic flexure mobilization was performed. No additional laparoscopic gestures or procedures were performed in this series except for clipping and stapling which were performed by the assistant surgeon due to the absence of robotic dedicated instruments. Two ileocolic anastomoses, planned as robotic-sewn, were performed extracorporeally. One Clavien-Dindo II complication occurred due to a postoperative blood transfusion. Median total operative time was 160 (145-294) min for right colectomies, 246 (191-300) min for sigmoid colectomies and 250 min for the anterior rectal resection. CONCLUSIONS: The present series confirms the feasibility of full-robotic colorectal resections while highlighting the strengths and the limitations of the CMR Versius platform in colorectal surgery. New devices will need more clinical development to be comparable to the current standard.
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Neoplasias Colorretais , Cirurgia Colorretal , Laparoscopia , Procedimentos Cirúrgicos Robóticos , Colectomia/métodos , Neoplasias Colorretais/cirurgia , Feminino , Humanos , Laparoscopia/métodos , Masculino , Estudos Retrospectivos , Procedimentos Cirúrgicos Robóticos/métodosRESUMO
The Amphibian Metamorphosis Assay (AMA) is used to identify substances that potentially interfere with the normal function of the hypothalamic-pituitary-thyroid (HPT) axis. Although numerous AMA studies have been performed since the establishment of this assay a decade earlier, a comprehensive, large-scale examination of histopathology data obtained from control larvae has not been performed. The current investigation reviewed 51 AMA experiments conducted at 7 different laboratories in Europe and North America. Dilution water control and/or solvent control specimens from each study (1,335 animals total) had been evaluated microscopically by one of eight anatomic pathologists. In order of descending frequency, the most common findings in prometamorphic Xenopus laevis controls were the core criteria of follicular cell (FC) hypertrophy, FC hyperplasia, thyroid hypertrophy, and thyroid atrophy, respectively. Less frequently recorded were non-core and ad hoc diagnoses, the toxicological relevance and utility of which were in some cases uncertain. As anticipated, the prevalence of FC hypertrophy and FC hyperplasia diagnoses were at least partially dependent on the Nieuwkoop and Faber (NF) stage at sacrifice. The recorded frequencies of each of the four core diagnoses also differed according to pathologist, which suggests that pathologist diagnostic interpretation is a potential source of variability across AMA study outcomes. Based on the current examination of the AMA historical data, and further hands-on experience with this assay, diagnostic approaches to evaluating the histopathology endpoint are discussed, and several recommendations are proposed for the refinement of core diagnostic criteria assessment.
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Metadados , Glândula Tireoide , Animais , Hiperplasia , Hipertrofia , Xenopus laevisRESUMO
INTRODUCTION: Colorectal cancer (CRC) is the fourth leading cause of death with 1.4 million new cases occurring annually worldwide. High-quality clinical practice guidelines are needed to tailor high-quality individualized treatment. The aim of the present study was to evaluate the methodological quality of the current guidelines for the management of acute malignant left-sided colonic bowel obstruction. METHODS: A systematic search of the literature was carried out using electronic databases. The Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument was used to assess the quality of each guideline. RESULTS: Search results returned a total of 14 guidelines appropriate for assessment. Both domain I (scope and purpose) and domain VI (editorial independence) were assessed with the same median score of 83%. The lowest scoring domain was domain V (applicability), scoring only 43%. The 2 guidelines that had the highest score were the National Institute for Health and Care Excellence (NICE) and Scottish Intercollegiate Guidelines Network (SIGN), each scoring 100%. However, there were significant variations in terms of quality. The NICE and New Zealand guidelines were voted unanimously for use unchanged, whilst 8 other guidelines were voted for use with modifications. CONCLUSION: Variation in guideline quality in CRC is a concern despite some clearly excellent published guidelines. All guidelines score poorly when it comes to describing how the guidelines could be applied. Lack of patient participation in guideline development is also a shortcoming that requires urgent redress.
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Neoplasias do Colo/complicações , Obstrução Intestinal/diagnóstico , Obstrução Intestinal/terapia , Guias de Prática Clínica como Assunto/normas , Humanos , Obstrução Intestinal/etiologia , Participação do PacienteRESUMO
BACKGROUND: The purpose of this systematic review and meta-analysis was to determine the prevalence of the number of sigmoid arteries (SA) and variations in their origins. METHODS: A thorough systematic search of literature through February 2020 was conducted on major electronic databases to identify eligible studies. Data were extracted and pooled into a meta-analysis using Metafor package in R. The primary outcome was the variations in the SA origin (according to modified Zebrowski classification), and the secondary outcome was the prevalence of the number of SA. RESULTS: A total of 22 studies (n = 2653 patients) were included. Type 1 modified Zebrowski (separated origins or common trunk of the SA originating from descending recto-sigmoid trunk (DRST)) was the most common origin type of the SA (pooled prevalence estimate (PPE) = 49.67% (95% CI 32. 67- 66.71)), while type 3 (separated origins or common trunk of 1 or 2 SA originating from DRST or superior rectal artery (SRA) and 1 or 2 SA originating from DRST or SRA) was the least common (PPE = 0.18%; 95% CI 0.00-2.82)). Of the Type 1 variants, the not specified (N.S) variant was by far the most prevalent. The number of SA ranged from one to five, with three being the mode (PPE = 42.3%). CONCLUSION: This is the most comprehensive analysis of arterial vascular anatomy of the sigmoid colon. In light of the highly variable anatomical pattern displayed by the SA, thorough pre-operative knowledge of their anatomy can be crucial in minimizing incidences of iatrogenic injury.
Assuntos
Artérias , Reto , Humanos , Reto/cirurgiaRESUMO
BACKGROUND AND AIMS: The success of invasive plants can be attributed to many traits including the ability to adapt to variable environmental conditions. Whether by adaptation, acclimation or phenotypic plasticity, these plants often increase their resource-use efficiency and, consequently, their fitness. The goal of this study was to examine the hydraulic and eco-physiological attributes of sun and shade populations of Pteridium aquilinum, a weedy fern, to determine whether the presence of vessels and other hydraulic attributes affects its success under a variety of light conditions. METHODS: Hydraulic traits such as cavitation resistance, hydraulic conductivity, photosynthesis and water potential at turgor loss point were measured on fronds from sun and shade populations. Anatomical and structural traits such as conduit diameter and length, stomatal density and vein density were also recorded. Diurnal measures of leaf water potential and stomatal conductance complement these data. KEY RESULTS: Gas exchange was nearly double in the sun plants, as was water-use efficiency, leaf-specific conductivity, and stomatal and vein density. This was largely achieved by a decrease in leaf area, coupled with higher xylem content. There was no significant difference in petiole cavitation resistance between the sun and shade leaves, nor in xylem-specific conductivity. Hydraulic conduit diameters were nearly equivalent in the two leaf types. CONCLUSIONS: Shifts in leaf area and xylem content allow P. aquilinum to occupy habitats with full sun, and to adjust its physiology accordingly. High rates of photosynthesis explain in part the success of this fern in disturbed habitats, although no change was observed in intrinsic xylem qualities such as cavitation resistance or conduit length. This suggests that P. aquilinum is constrained by its fundamental body plan, in contrast to seed plants, which show greater capacity for hydraulic adjustment.
Assuntos
Pteridium , Aclimatação , Fotossíntese , Folhas de Planta , Água , XilemaRESUMO
The European Chemical Agency and European Food Safety Authority recommend that gross pathology findings, from avian reproduction studies, be used to support assessment of potential endocrine disrupting properties of active pesticidal and biocidal substances. In open literature, little information is available on the utility of gross pathology data for informing endocrine evaluations. Here the gross pathology data from historical control groups of 51 northern bobwhite and 51 mallard reproduction tests is analyzed to evaluate the utility of such information. Incidence of gross morphology findings in untreated birds may aid the interpretation of some gross abnormalities, potentially indicative of an endocrine interaction (e.g. reproductive condition). Statistical analysis of the historical control data indicates that gross pathology is not likely to be useful for detecting endocrine effects as abnormalities with relatively high increases in prevalence (more than 20-30%, depending on prevalence in controls) are reliably interpreted as a treatment response. Gross pathology changes are only indicative and not diagnostic of endocrine interactions making it difficult to distinguish gross pathology abnormalities, due to endocrine-mediated effects, from systemic toxicity. This work demonstrates the utility of using historical control analyses to establish the value and properties of selected endpoints for regulatory applications.