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OBJECTIVE: To determine whether the addition of inhaled methoxyflurane to periprostatic infiltration of local anaesthetic (PILA) during transrectal ultrasonography-guided prostate biopsies (TRUSBs) improved pain and other aspects of the experience. PATIENTS AND METHODS: We conducted a multicentre, placebo-controlled, double-blind, randomized phase 3 trial, involving 420 men undergoing their first TRUSB. The intervention was PILA plus a patient-controlled device containing either 3 mL methoxyflurane, or 3 mL 0.9% saline plus one drop of methoxyflurane to preserve blinding. The primary outcome was the pain score (0-10) reported by the participant after 15 min. Secondary outcomes included ratings of other aspects of the biopsy experience, willingness to undergo future biopsies, urologists' ratings, biopsy completion, and adverse events. RESULTS: The mean (SE) pain scores 15 min after TRUSB were 2.51 (0.22) in those assigned methoxyflurane vs 2.82 (0.22) for placebo (difference 0.31, 95% confidence interval [CI] -0.75 to 0.14; P = 0.18). Methoxyflurane was associated with better scores for discomfort (difference -0.48, 95% CI -0.92 to -0.03; P = 0.035, adjusted [adj.] P = 0.076), whole experience (difference -0.50, 95% CI -0.92 to -0.08; P = 0.021, adj. P = 0.053), and willingness to undergo repeat biopsies (odds ratio 1.67, 95% CI 1.12-2.49; P = 0.01) than placebo. Methoxyflurane resulted in higher scores for drowsiness (difference +1.64, 95% CI 1.21-2.07; P < 0.001, adj. P < 0.001) and dizziness (difference +1.78, 95% CI 1.31-2.24; P < 0.001, adj. P < 0.001) than placebo. There was no significant difference in the number of ≥ grade 3 adverse events. CONCLUSIONS: We found no evidence that methoxyflurane improved pain scores at 15 min, however, improvements were seen in patient-reported discomfort, overall experience, and willingness to undergo repeat biopsies.
Assuntos
Próstata , Neoplasias da Próstata , Anestesia Local , Anestésicos Locais/uso terapêutico , Biópsia/efeitos adversos , Biópsia/métodos , Humanos , Lidocaína/uso terapêutico , Masculino , Metoxiflurano , Dor/tratamento farmacológico , Dor/etiologia , Dor/prevenção & controle , Medição da Dor , Próstata/diagnóstico por imagem , Próstata/patologia , Neoplasias da Próstata/patologia , UltrassonografiaRESUMO
Sleep-related infant deaths continue to be a major, largely preventable cause of infant mortality, especially in Georgia. The Georgia Department of Public Health (DPH), as part of a multi-pronged safe infant sleep campaign, implemented a hospital initiative to (1) provide accurate safe infant sleep information to hospital personnel; (2) support hospitals in implementing and modeling safe sleep practices; and (3) provide guidance on addressing caregiver safe sleep concerns. A process evaluation was conducted to determine progress toward four goals set out by DPH: (1) all birthing hospitals have a safe infant sleep policy; (2) all safe infant sleep policies reference the AAP 2011 recommendations; (3) all safe infant sleep policies specify the type and/or content of patient safe sleep education; and (4) all hospitals require regular staff training on safe sleep recommendations. Data were collected via structured interviews and document review of crib audit data and safe sleep policies. All 79 birthing hospitals in the state participated in the statewide campaign. Prior to the initiative, 44.3% of hospitals had a safe sleep policy in place; currently, 87.3% have a policy in place. The majority (91.4%) of hospitals have provided safe sleep training to their staff at this time. Important lessons include: (1) Engagement is vital to success; (2) A comprehensive implementation guide is critical; (3) Piloting the program provides opportunities for refinement; (4) Ongoing support addresses barriers; and (5) Senior leadership facilitates success.
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Cuidadores/educação , Administração Hospitalar/normas , Educação de Pacientes como Assunto/organização & administração , Morte Súbita do Lactente/prevenção & controle , Georgia/epidemiologia , Humanos , Lactente , Mortalidade Infantil/tendências , Recém-Nascido , Capacitação em Serviço/organização & administração , Educação de Pacientes como Assunto/normas , PolíticasAssuntos
Anemia Ferropriva , Ferro , Constrição , Feminino , Hepcidinas , Humanos , Gravidez , Cordão Umbilical , Clampeamento do Cordão UmbilicalRESUMO
BACKGROUND AND AIMS: Specialist nutritional support is important during treatment for oesophagogastric (OG) cancer yet current practice remains unstandardised across the UK. The National Oesophagogastric Nutrition Audit (NONA) aimed to describe the current landscape of OG dietetic services in the UK and Ireland, with a specific focus on resource allocation, barriers to dietetic support, and the provision of support throughout the cancer pathway. METHODS: Tertiary cancer units, secondary care, and community services across the UK and Ireland were invited to complete a 28-point electronic questionnaire. Team leaders and senior specialist OG dietitians were the target respondents. All data points were peer-reviewed, piloted, and revised by the NONA steering committee before distribution. Data points covered a range of areas related to resources, skill mix, provision of support throughout the cancer pathway, and involvement with national audit and research. RESULTS: Complete responses were received from 50 individual units (tertiary surgical units, n = 35 and tertiary oncology units, n = 10). Secondary care and community services were underrepresented (n = 5). Of the units proving tertiary cancer care, the majority (77%) agreed or strongly agreed they were able to provide adequate nutritional care in the post-operative period. However, confidence dropped significantly in the early diagnostic phase and in the neoadjuvant period, with 52% and 67% of tertiary units disagreeing that they could provide adequate dietetic support during these parts of the cancer pathway, respectively. Inadequate funding, understaffing, and the prioritisation of inpatients were commonly reported barriers. There was significant variation in practice regarding nutritional assessment, service structure, and staffing resource allocation across specialist units. CONCLUSION: The NONA survey provides a 'real-world' landscape of nutritional care for patients with OG cancer. Lack of funding, resource, and evidence-base may explain the variation seen in services provided across the UK. Further research and consensus is required to help standardise nutritional care, guide service specification, and improve nutritional outcomes for patients with OG cancer.
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Dietética , Terapia Nutricional , Neoplasias Gástricas , Humanos , Neoplasias Gástricas/terapia , Estado Nutricional , Apoio NutricionalRESUMO
INTRODUCTION: There is a strong theoretical rationale for combining checkpoint blockade with cytotoxic chemotherapy in pleural mesothelioma and other cancers. Two recent single-arm, phase 2 trials [DuRvalumab with chEmotherapy as first-line treAtment in advanced pleural Mesothelioma (DREAM) and Phase II multicenter study of anti-PD-L1, durvalumab, in combination with cisplatin and pemetrexed for the first-line treatment of unresectable malignant pleural mesothelioma (PrE0505)] combining the programmed death ligand-1 (PD-L1) inhibitor durvalumab with standard first-line chemotherapy exceeded prespecified safety and activity criteria to proceed to a phase 3 confirmatory trial to assess this combination. We present the protocol of the DREAM3R trial. METHODS AND ANALYSIS: This multicentre open-label randomised trial will recruit 480 treatment-naïve adults with advanced pleural mesothelioma, randomised (2:1) to either 3-weekly durvalumab 1500 mg plus 3-weekly doublet chemotherapy (cisplatin 75 mg/m2 or carboplatin, Area Under the Curve,AUC 5 and pemetrexed 500 mg/m2) 4-6 cycles, followed by 4-weekly durvalumab 1500 mg until disease progression, unacceptable toxicity or patient withdrawal; OR doublet chemotherapy alone for 4-6 cycles, followed by observation. The target accrual time is 27 months, with follow-up for an additional 24 months. This provides over 85% power if the true HR for overall survival (OS) is 0.70, with two-sided alpha of 0.05, assuming a median OS of 15 months in the control group. Randomisation is stratified by age (18-70 years vs >70), sex, histology (epithelioid vs non-epithelioid), platinum agent (cisplatin vs carboplatin) and region (USA vs Australia/New Zealand vs Other). The primary endpoint is OS. Secondary endpoints include progression-free survival, objective tumour response (by mRECIST V.1.1 and iRECIST), adverse events, health-related quality of life and healthcare resource use. Tertiary correlative objectives are to explore and validate potential prognostic and/or predictive biomarkers (including features identified in the DuRvalumab with chEmotherapy as first-line treAtment in advanced pleural Mesothelioma (DREAM) and PrE0505 studies, PD-L1 expression, tumour mutational burden, genomic characteristics and human leukocyte antigen subtypes) in tissue and serial blood samples. An imaging databank will be assembled for validation of radiological measures of response, and studies of possible radiomic biomarkers in mesothelioma. ETHICS AND DISSEMINATION: The protocol was approved by human research ethics review committees for all participating sites. Results will be disseminated in peer-reviewed journals and at scientific conferences. DRUG SUPPLY: AstraZeneca. PROTOCOL VERSION: CTC 0231 / TOGA 18/001 / PrE0506 3.0, 29 July 2021. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT04334759 ACTRN 12620001199909.
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Neoplasias Pulmonares , Mesotelioma Maligno , Mesotelioma , Adolescente , Adulto , Idoso , Anticorpos Monoclonais , Protocolos de Quimioterapia Combinada Antineoplásica , Ensaios Clínicos Fase III como Assunto , Humanos , Neoplasias Pulmonares/tratamento farmacológico , Mesotelioma/tratamento farmacológico , Mesotelioma/patologia , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Adulto JovemRESUMO
AIM: Obtain an overview of the current sleep habits and sleep hygiene practices in a group of intermediate-aged students, and establish whether these students achieve adequate sleep according to the New Zealand education and health guidelines. METHODS: A standardised sleep health questionnaire and seven-day sleep diary were completed by 163 participants (aged 11-13; 62% female) from a cross-section of five Christchurch schools. RESULTS: In this group, 71% of students reported 9-11 hours of sleep per night (averaged over seven days). Total sleep time was independent of gender and the day of the week. Bedtimes and wake-times were earlier from Monday-Thursday compared to the weekend (p<0.0001). Fifty-nine percent of students used a device in the hour before bed. Pre-bedtime device users were more likely to achieve less sleep than non-device users (p<0.001). The majority of students (66%) did not choose their bedtime. CONCLUSIONS: In this group of students, the majority achieved a sleep duration within the advised Ministry of Education and Sleep Health Foundation guidelines, despite non-recommended sleep hygiene practices in the pre-bed routine. Parental guidance, with respect to bed times and reduction in device usage before sleep are two factors that could be employed to improve sleep in this group.
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Sono/fisiologia , Adolescente , Estudos Transversais , Feminino , Humanos , Masculino , Nova Zelândia , Instituições Acadêmicas , Inquéritos e QuestionáriosRESUMO
AIM: To measure changes in alcohol-related emergency department (ED) attendances after introduction of the Sale and Supply of Alcohol Act 2012. METHODS: Cross-sectional survey of Christchurch ED attendees in three-week sampling periods in 2013 and 2017. Participants had consumed alcohol within four hours, or their drinking had directly contributed to the attendance. The quantity of alcohol consumed and places of purchase and consumption for the index drinking episode were recorded. RESULTS: From 2013 to 2017 there was a non-significant (p=.41) reduction in the proportion of ED attendees eligible for the study, from 253/3400 (7.4%) to 258/3721 (6.9%). Among participants (n=169 in 2013, n=139 in 2017), liquor store purchasing increased from 41.7% in 2013 to 56.1% in 2017 (p<.01) but there was no significant change in quantity consumed in the index episode; last drink location; percentage of participants with an injury-related attendance; or pre-drinking. In both waves, most participants had purchased alcohol from off-licence venues and consumed their last drink at a private location. CONCLUSION: Alcohol-related ED attendances remained common after the Sale and Supply of Alcohol Act 2012 was introduced, and they mainly occurred in people who sourced alcohol from off-licence outlets and had their last drink at private locations.