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AIMS: Fractional flow reserve (FFRCT) using computed tomography coronary angiography (CTCA) determines both the presence of coronary artery disease and vessel-specific ischaemia. We tested whether an evaluation strategy based on FFRCT would improve economic and clinical outcomes compared with standard care. METHODS AND RESULTS: Overall, 1400 patients with stable chest pain in 11 centres were randomized to initial testing with CTCA with selective FFRCT (experimental group) or standard clinical care pathways (standard group). The primary endpoint was total cardiac costs at 9 months. Secondary endpoints were angina status, quality of life, major adverse cardiac and cerebrovascular events, and use of invasive coronary angiography. Randomized groups were similar at baseline. Most patients had an initial CTCA: 439 (63%) in the standard group vs. 674 (96%) in the experimental group, 254 of whom (38%) underwent FFRCT. Mean total cardiac costs were higher by £114 (+8%) in the experimental group, with a 95% confidence interval from -£112 (-8%) to +£337 (+23%), though the difference was not significant (P = 0.10). Major adverse cardiac and cerebrovascular events did not differ significantly (10.2% in the experimental group vs. 10.6% in the standard group) and angina and quality of life improved to a similar degree over follow-up in both randomized groups. Invasive angiography was reduced significantly in the experimental group (19% vs. 25%, P = 0.01). CONCLUSION: A strategy of CTCA with selective FFRCT in patients with stable angina did not differ significantly from standard clinical care pathways in cost or clinical outcomes, but did reduce the use of invasive coronary angiography.
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Angina Estável , Doença da Artéria Coronariana , Estenose Coronária , Reserva Fracionada de Fluxo Miocárdico , Angina Estável/diagnóstico por imagem , Angina Estável/terapia , Angiografia por Tomografia Computadorizada , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico por imagem , Vasos Coronários , Humanos , Valor Preditivo dos Testes , Qualidade de VidaRESUMO
BACKGROUND: No phase 3 trial has yet shown improved survival for patients with pleural or peritoneal malignant mesothelioma who have progressed following platinum-based chemotherapy. The aim of this study was to assess the efficacy and safety of nivolumab, an anti-PD-1 antibody, in these patients. METHODS: This was a multicentre, placebo-controlled, double-blind, parallel group, randomised, phase 3 trial done in 24 hospitals in the UK. Adult patients (aged ≥18 years) with an Eastern Cooperative Oncology Group performance status of 0 or 1, with histologically confirmed pleural or peritoneal mesothelioma, who had received previous first-line platinum-based chemotherapy and had radiological evidence of disease progression, were randomly assigned (2:1) to receive nivolumab at a flat dose of 240 mg every 2 weeks over 30 min intravenously or placebo until disease progression or a maximum of 12 months. The randomisation sequence was generated within an interactive web response system (Alea); patients were stratified according to epithelioid versus non-epithelioid histology and were assigned in random block sizes of 3 and 6. Participants and treating clinicians were masked to group allocation. The co-primary endpoints were investigator-assessed progression-free survival and overall survival, analysed according to the treatment policy estimand (an equivalent of the intention-to-treat principle). All patients who were randomly assigned were included in the safety population, reported according to group allocation. This trial is registered with Clinicaltrials.gov, NCT03063450. FINDINGS: Between May 10, 2017, and March 30, 2020, 332 patients were recruited, of whom 221 (67%) were randomly assigned to the nivolumab group and 111 (33%) were assigned to the placebo group). Median follow-up was 11·6 months (IQR 7·2-16·8). Median progression-free survival was 3·0 months (95% CI 2·8-4·1) in the nivolumab group versus 1·8 months (1·4-2·6) in the placebo group (adjusted hazard ratio [HR] 0·67 [95% CI 0·53-0·85; p=0·0012). Median overall survival was 10·2 months (95% CI 8·5-12·1) in the nivolumab group versus 6·9 months (5·0-8·0) in the placebo group (adjusted HR 0·69 [95% CI 0·52-0·91]; p=0·0090). The most frequently reported grade 3 or worse treatment-related adverse events were diarrhoea (six [3%] of 221 in the nivolumab group vs two [2%] of 111 in the placebo group) and infusion-related reaction (six [3%] vs none). Serious adverse events occurred in 90 (41%) patients in the nivolumab group and 49 (44%) patients in the placebo group. There were no treatment-related deaths in either group. INTERPRETATION: Nivolumab represents a treatment that might be beneficial to patients with malignant mesothelioma who have progressed on first-line therapy. FUNDING: Stand up to Cancer-Cancer Research UK and Bristol Myers Squibb.
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Antineoplásicos Imunológicos/uso terapêutico , Inibidores de Checkpoint Imunológico/uso terapêutico , Mesotelioma Maligno/tratamento farmacológico , Nivolumabe/uso terapêutico , Idoso , Antígeno B7-H1/metabolismo , Método Duplo-Cego , Feminino , Humanos , Masculino , Mesotelioma Maligno/mortalidade , Mesotelioma Maligno/patologia , Neoplasias Peritoneais/tratamento farmacológico , Neoplasias Peritoneais/mortalidade , Neoplasias Peritoneais/patologia , Neoplasias Pleurais/tratamento farmacológico , Neoplasias Pleurais/mortalidade , Neoplasias Pleurais/patologia , Intervalo Livre de Progressão , Recidiva , Taxa de SobrevidaRESUMO
OBJECTIVES: AGILE is a Phase Ib/IIa platform for rapidly evaluating COVID-19 treatments. In this trial (NCT04746183) we evaluated the safety and optimal dose of molnupiravir in participants with early symptomatic infection. METHODS: We undertook a dose-escalating, open-label, randomized-controlled (standard-of-care) Bayesian adaptive Phase I trial at the Royal Liverpool and Broadgreen Clinical Research Facility. Participants (adult outpatients with PCR-confirmed SARS-CoV-2 infection within 5 days of symptom onset) were randomized 2:1 in groups of 6 participants to 300, 600 and 800 mg doses of molnupiravir orally, twice daily for 5 days or control. A dose was judged unsafe if the probability of 30% or greater dose-limiting toxicity (the primary outcome) over controls was 25% or greater. Secondary outcomes included safety, clinical progression, pharmacokinetics and virological responses. RESULTS: Of 103 participants screened, 18 participants were enrolled between 17 July and 30 October 2020. Molnupiravir was well tolerated at 300, 600 and 800 mg doses with no serious or severe adverse events. Overall, 4 of 4 (100%), 4 of 4 (100%) and 1 of 4 (25%) of the participants receiving 300, 600 and 800 mg molnupiravir, respectively, and 5 of 6 (83%) controls, had at least one adverse event, all of which were mild (≤grade 2). The probability of ≥30% excess toxicity over controls at 800 mg was estimated at 0.9%. CONCLUSIONS: Molnupiravir was safe and well tolerated; a dose of 800 mg twice daily for 5 days was recommended for Phase II evaluation.
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COVID-19 , SARS-CoV-2 , Adulto , Teorema de Bayes , Humanos , Projetos de Pesquisa , Resultado do TratamentoRESUMO
BACKGROUND: The clinical effectiveness of neurally adjusted ventilatory assist (NAVA) has yet to be demonstrated, and preliminary studies are required. The study aim was to assess the feasibility of a randomized controlled trial (RCT) of NAVA versus pressure support ventilation (PSV) in critically ill adults at risk of prolonged mechanical ventilation (MV). METHODS: An open-label, parallel, feasibility RCT (n = 78) in four ICUs of one university-affiliated hospital. The primary outcome was mode adherence (percentage of time adherent to assigned mode), and protocol compliance (binary-≥ 65% mode adherence). Secondary exploratory outcomes included ventilator-free days (VFDs), sedation, and mortality. RESULTS: In the 72 participants who commenced weaning, median (95% CI) mode adherence was 83.1% (64.0-97.1%) and 100% (100-100%), and protocol compliance was 66.7% (50.3-80.0%) and 100% (89.0-100.0%) in the NAVA and PSV groups respectively. Secondary outcomes indicated more VFDs to D28 (median difference 3.0 days, 95% CI 0.0-11.0; p = 0.04) and fewer in-hospital deaths (relative risk 0.5, 95% CI 0.2-0.9; p = 0.032) for NAVA. Although overall sedation was similar, Richmond Agitation and Sedation Scale (RASS) scores were closer to zero in NAVA compared to PSV (p = 0.020). No significant differences were observed in duration of MV, ICU or hospital stay, or ICU, D28, and D90 mortality. CONCLUSIONS: This feasibility trial demonstrated good adherence to assigned ventilation mode and the ability to meet a priori protocol compliance criteria. Exploratory outcomes suggest some clinical benefit for NAVA compared to PSV. Clinical effectiveness trials of NAVA are potentially feasible and warranted. TRIAL REGISTRATION: ClinicalTrials.gov, NCT01826890. Registered 9 April 2013.
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Suporte Ventilatório Interativo/normas , Respiração Artificial/métodos , Fatores de Tempo , Adulto , Estudos de Viabilidade , Feminino , Humanos , Unidades de Terapia Intensiva/organização & administração , Unidades de Terapia Intensiva/estatística & dados numéricos , Suporte Ventilatório Interativo/estatística & dados numéricos , Tempo de Internação/estatística & dados numéricos , Londres , Masculino , Pessoa de Meia-Idade , Respiração Artificial/estatística & dados numéricosRESUMO
The prevalence of new psychoactive substances (NPSs) in forensic casework has increased prominently in recent years. This has given rise to significant legal and analytical challenges in the identification of these substances. The requirement for validated, robust and rapid testing methodologies for these compounds is obvious. This study details the analysis of 13 synthesised diphenidine derivatives encountered in casework using presumptive testing, thin layer chromatography and gas chromatography-mass spectrometry (GC-MS). Specifically, the validated GC-MS method provides, for the first time, both a general screening method and quantification of the active components for seized solid samples, both in their pure form and in the presence of common adulterants. Graphical Abstract Chemical synthesis and forensic analysis of 13 diphenidine-derived new psychoactive substance(s).
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Medicina Legal/métodos , Cromatografia Gasosa-Espectrometria de Massas/métodos , Piperidinas/análise , Psicotrópicos/análise , Calibragem , Cromatografia em Camada Fina , Medicina Legal/instrumentação , Limite de Detecção , Piperidinas/química , Psicotrópicos/química , Reprodutibilidade dos TestesRESUMO
AIM: We tested whether operators using manometers attached to self-inflating bags could accurately deliver set targeted peak inspiratory pressures (PIPs) compared to the Neopuff(™) T-piece resuscitator (TPR). METHODS: Participants provided positive pressure ventilation to a leak-free neonatal test lung at a rate of 60 inflations/min and a flow of 8 L/min. Participants used three manometers attached to self-inflating bags and a Neopuff(™) TPR to target PIPs of 20, 30 and 40 cmH2 O on each device. Mean PIPs delivered with each manometer were compared to the 'gold standard' Neopuff(™) TPR. RESULTS: In total, 13 991 inflations delivered by 20 participants were analysed. At all target PIPs, the mean PIP delivered using the Mercury Medical manometer attached to a Laerdal self-inflating bag was significantly higher by 5 cmH2 O (p < 0.01) than the Neopuff(™) TPR. The PIP delivered using both the Ambu(™) and Parker Healthcare manometers attached to their respective devices was similar to that delivered by the Neopuff(™) TPR at all targeted PIPs. CONCLUSION: Accurately targeted PIPs can be achieved when a manometer specifically designed for use on a self-inflating bag is used during manual ventilation. This may be useful in settings where access to a Neopuff(™) TPR or a gas flow source is limited.
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Manometria/estatística & dados numéricos , Respiração com Pressão Positiva/estatística & dados numéricos , Respiração com Pressão Positiva/instrumentaçãoRESUMO
BACKGROUND: Quality improvement (QI) is used by healthcare organisations internationally to improve care. Unless QI explicitly addresses equity, projects that aim to improve care may exacerbate health and care inequalities for disadvantaged groups. There are several QI frameworks used in primary care, but we do not know the extent to which they consider equity. This work aimed to investigate whether primary care QI frameworks consider equity. METHODS: We conducted a search of MEDLINE, EMBASE and key websites to compile a list of the QI frameworks used in primary care. This list was refined by an expert panel. Guidance documents for each of the QI frameworks were identified from national websites or QI organisations. We undertook a document analysis of the guidance using NVivo. RESULTS: We analysed 15 guidance documents. We identified the following themes: (1) there was a limited discussion of equity or targeted QI for disadvantaged groups in the documents, (2) there were indirect considerations of inequalities via patient involvement or targeting QI to patient demographics and (3) there was a greater focus on efficiency than equity in the documents. CONCLUSION: There is limited consideration of equity in QI frameworks used in primary care. Where equity is discussed, it is implicit and open to interpretation. This research demonstrates a need for frameworks to be revised with an explicit equity focus to ensure the distribution of benefits from QI is equitable.
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Atenção Primária à Saúde , Melhoria de Qualidade , Humanos , Atenção Primária à Saúde/normas , Atenção Primária à Saúde/estatística & dados numéricos , Equidade em Saúde/normas , Equidade em Saúde/estatística & dados numéricos , Disparidades em Assistência à Saúde/estatística & dados numéricos , Disparidades em Assistência à Saúde/normasRESUMO
Background: An unequal distribution of the social determinants of health drives health inequalities. Existing training fails to communicate the impossible circumstances that disadvantaged groups face. Game-based learning is increasingly used as an innovative method with the potential to enhance health staff's ability to address health inequalities, but its effectiveness is unknown. Therefore, the aim of this systematic review was to evaluate the effectiveness of 'equity-focused' game-based learning in training health staff. Study design: Systematic Review. Methods: Three databases (Ovid Medline, Embase, Web of Science) and a citation search were systematically searched for articles from January 2010 to July 2023, reporting on effectiveness of 'equity-focused' game-based learning. Titles and abstracts were screened using eligibility criteria to identify relevant studies. Data was extracted and the ROBINS-I tool was used to assess quality. Results: The search identified 7615 articles, of which thirteen were included involving 2412 healthcare workers. A variety of game-based learning tools were found to have an overall positive effect on motivation, knowledge, attitudes, and engagement of health staff. However, the significance of the results varied depending on specific game context. All included studies were judged to have serious to critical risk of bias. Conclusions: Game-based learning has the potential to improve the effectiveness of 'equity-focused' training for health staff. Educators and researchers should further collaborate to expand the tools available and evaluate their effectiveness on long-term clinical practice.
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BACKGROUND: Selective serotonin reuptake inhibitors (SSRIs) are used for the management of anxiety and depression. Existing evidence shows their negative impact on implant osseointegration, survival rates, and peri-implant health. Currently, there are limited data on their effect on peri-implant marginal bone levels. The primary goal of this retrospective study is to evaluate the association between SSRIs use and marginal bone level (MBL) changes around osseointegrated dental implants over time. METHODS: Records from patients who received at least one dental implant between 2010 and 2021 were reviewed. Information related to medical history, SSRI use, and the implant site was obtained from patients' electronic charts. Mesial and distal MBLs were measured relative to the implant platform on digital intraoral radiographs, taken at the time of prosthesis installation and at the most recent follow-up visit. MBL changes were calculated. RESULTS: A total of 152 dental implants from 105 patients were included. The mean follow-up period was 46.97 ± 21.87 months. The mean MBL change was significantly greater for SSRI users (0.41 ± 0.76 mm) compared to non-users (0.04 ± 0.65 mm) [MD = 0.37 mm, p = 0.00, 95% CI: (-0.61)-(-0.15 mm)]. Mesial MBL change of 0.42 ± 0.84 mm and 0.02 ± 0.71 mm was noted for SSRI users and non-users, respectively. The distal MBL change was 0.4 ± 0.93 mm and 0.07 ± 0.73 mm, respectively. Smoking, sex, and implant location did not seem to influence the MBL differences between groups. CONCLUSIONS: Use of SSRIs is associated with greater marginal bone loss around osseointegrated dental implants in function for a mean period of 3.8 years.
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Perda do Osso Alveolar , Implantes Dentários , Humanos , Estudos Retrospectivos , Inibidores Seletivos de Recaptação de Serotonina/farmacologia , Inibidores Seletivos de Recaptação de Serotonina/uso terapêutico , Osseointegração , Osso e Ossos , Perda do Osso Alveolar/diagnóstico por imagem , Seguimentos , Planejamento de Prótese Dentária , Prótese Dentária Fixada por Implante , Implantação Dentária EndósseaRESUMO
BACKGROUND: Malignant mesothelioma is a rapidly lethal cancer that has been increasing at an epidemic rate over the last three decades. Targeted therapies for mesothelioma have been lacking. A previous study called MiST1 (NCT03654833), evaluated the efficacy of Poly (ADP-ribose) polymerase (PARP) inhibition in mesothelioma. This study met its primary endpoint with 15% of patients having durable responses exceeding 1 year. Therefore, there is a need to evaluate PARP inhibitors in relapsed mesothelioma patients, where options are limited. Niraparib is the PARP inhibitor used in NERO. METHODS: NERO is a multicentre, two-arm, open-label UK randomised phase II trial designed to evaluate the efficacy of PARP inhibition in relapsed mesothelioma. 84 patients are being recruited. NERO is not restricted by line of therapy; however, eligible participants must have been treated with an approved platinum based systemic therapy. Participants will be randomised 2:1, stratified according to histology and response to prior platinum-based chemotherapy, to receive either active symptom control (ASC) and niraparib or ASC alone, for up to 24 weeks. Participants will be treated until disease progression, withdrawal, death or development of significant treatment limiting toxicity. Participants randomised to niraparib will receive 200 or 300 mg daily in a 3-weekly cycle. The primary endpoint is progression-free survival, where progression is determined by modified Response Evaluation Criteria in Solid Tumors (mRECIST) or RECIST 1.1; investigator reported progression; or death from any cause, whichever comes first. Secondary endpoints include overall survival, best overall response, 12-week and 24 week disease control, duration of response, treatment compliance and safety/tolerability. If NERO shows niraparib to be safe and biologically effective, it may lead to future late phase randomised controlled trials in relapsed mesothelioma. ETHICS AND DISSEMINATION: The study received ethical approval from London-Hampstead Research Ethics Committee on 06-May-2022 (22/LO/0281). Data from all centres will be analysed together and published as soon as possible. TRIAL REGISTRATION NUMBER: ISCRTN16171129; NCT05455424.
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Mesotelioma Maligno , Mesotelioma , Humanos , Mesotelioma Maligno/tratamento farmacológico , Inibidores de Poli(ADP-Ribose) Polimerases/efeitos adversos , Centros de Cuidados de Saúde Secundários , Mesotelioma/tratamento farmacológico , Mesotelioma/patologia , Reino Unido , Ensaios Clínicos Controlados Aleatórios como Assunto , Estudos Multicêntricos como Assunto , Ensaios Clínicos Fase II como AssuntoRESUMO
The Covid-19 pandemic has required many anthropologists to do fieldwork differently: research that would otherwise have been done face-to-face has been shifted online, sometimes very quickly. When doing research with people with chronic illnesses, it is important to acknowledge both the histories of online ethnography and the way that disability studies has engaged with the internet over time. This article uses the example of my PhD fieldwork, based in Northeast England, to explore how living in an increasingly digital world may impact how medical anthropologists could, and perhaps should, do ethnography.
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COVID-19 , Humanos , Pandemias , Antropologia Médica , Antropologia Cultural , Reino UnidoRESUMO
Repurposing approved drugs may rapidly establish effective interventions during a public health crisis. This has yielded immunomodulatory treatments for severe coronavirus disease 2019 (COVID-19), but repurposed antivirals have not been successful to date because of redundancy of the target in vivo or suboptimal exposures at studied doses. Nitazoxanide is a US Food and Drug Administration (FDA) approved antiparasitic medicine, that physiologically-based pharmacokinetic (PBPK) modeling has indicated may provide antiviral concentrations across the dosing interval, when repurposed at higher than approved doses. Within the AGILE trial platform (NCT04746183) an open label, adaptive, phase I trial in healthy adult participants was undertaken with high-dose nitazoxanide. Participants received 1,500 mg nitazoxanide orally twice-daily with food for 7 days. Primary outcomes were safety, tolerability, optimum dose, and schedule. Intensive pharmacokinetic (PK) sampling was undertaken day 1 and 5 with minimum concentration (Cmin ) sampling on days 3 and 7. Fourteen healthy participants were enrolled between February 18 and May 11, 2021. All 14 doses were completed by 10 of 14 participants. Nitazoxanide was safe and with no significant adverse events. Moderate gastrointestinal disturbance (loose stools or diarrhea) occurred in 8 participants (57.1%), with urine and sclera discoloration in 12 (85.7%) and 9 (64.3%) participants, respectively, without clinically significant bilirubin elevation. This was self-limiting and resolved upon drug discontinuation. PBPK predictions were confirmed on day 1 but with underprediction at day 5. Median Cmin was above the in vitro target concentration on the first dose and maintained throughout. Nitazoxanide administered at 1,500 mg b.i.d. with food was safe with acceptable tolerability a phase Ib/IIa study is now being initiated in patients with COVID-19.
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Antivirais/administração & dosagem , Nitrocompostos/administração & dosagem , Nitrocompostos/efeitos adversos , Nitrocompostos/farmacocinética , Tiazóis/administração & dosagem , Tiazóis/efeitos adversos , Tiazóis/farmacocinética , Adulto , Antivirais/efeitos adversos , Antivirais/farmacocinética , Reposicionamento de Medicamentos , Feminino , Voluntários Saudáveis , Humanos , Masculino , Pessoa de Meia-Idade , Adulto Jovem , Tratamento Farmacológico da COVID-19RESUMO
BACKGROUND: There is an urgent unmet clinical need for the identification of novel therapeutics for the treatment of COVID-19. A number of COVID-19 late phase trial platforms have been developed to investigate (often repurposed) drugs both in the UK and globally (e.g. RECOVERY led by the University of Oxford and SOLIDARITY led by WHO). There is a pressing need to investigate novel candidates within early phase trial platforms, from which promising candidates can feed into established later phase platforms. AGILE grew from a UK-wide collaboration to undertake early stage clinical evaluation of candidates for SARS-CoV-2 infection to accelerate national and global healthcare interventions. METHODS/DESIGN: AGILE is a seamless phase I/IIa platform study to establish the optimum dose, determine the activity and safety of each candidate and recommend whether it should be evaluated further. Each candidate is evaluated in its own trial, either as an open label single arm healthy volunteer study or in patients, randomising between candidate and control usually in a 2:1 allocation in favour of the candidate. Each dose is assessed sequentially for safety usually in cohorts of 6 patients. Once a phase II dose has been identified, efficacy is assessed by seamlessly expanding into a larger cohort. AGILE is completely flexible in that the core design in the master protocol can be adapted for each candidate based on prior knowledge of the candidate (i.e. population, primary endpoint and sample size can be amended). This information is detailed in each candidate specific trial protocol of the master protocol. DISCUSSION: Few approved treatments for COVID-19 are available such as dexamethasone, remdesivir and tocilizumab in hospitalised patients. The AGILE platform aims to rapidly identify new efficacious and safe treatments to help end the current global COVID-19 pandemic. We currently have three candidate specific trials within this platform study that are open to recruitment. TRIAL REGISTRATION: EudraCT Number: 2020-001860-27 14 March 2020 ClinicalTrials.gov Identifier: NCT04746183 19 February 2021 ISRCTN reference: 27106947.
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COVID-19 , Pandemias , Estudos de Coortes , Humanos , SARS-CoV-2 , Resultado do TratamentoRESUMO
This literature review explored common characteristics of successful health promotion interventions that have produced positive outcomes for the diverse populations studied. Health education interventions delivered in structured environments with quarterly monitoring produced the most positive outcomes. Interventions delivered to employees in a "team" format were as successful as interventions delivered one on one. Single disease- or health behavior-focused interventions were more successful than multifocused interventions. Review findings indicate that academic or consultant researchers may lend expertise to research methods and informed consent as employers create health promotion programs they wish to evaluate. Employers may find benefits in conducting health-related studies developed through partnerships or collaborations with academic researchers.
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Educação em Saúde/organização & administração , Promoção da Saúde/organização & administração , Serviços de Saúde do Trabalhador/organização & administração , Seguimentos , Comportamentos Relacionados com a Saúde , Indicadores Básicos de Saúde , Humanos , Estilo de Vida , Avaliação das Necessidades , Pesquisa em Avaliação de Enfermagem , Avaliação de Resultados em Cuidados de Saúde , Desenvolvimento de Programas/métodos , Avaliação de Programas e Projetos de Saúde , Projetos de Pesquisa , Medição de Risco , Local de Trabalho/organização & administraçãoRESUMO
OBJECTIVE: Neonatal mask ventilation is a difficult skill to acquire and maintain. Mask leak is common and can lead to ineffective ventilation. The aim of this study was to determine whether newly available neonatal self-inflating bags and masks could reduce mask leak without additional load being applied to the face. DESIGN: Forty operators delivered 1 min episodes of mask ventilation to a mannequin using the Laerdal Upright Resuscitator, a standard Laerdal infant resuscitator (Laerdal Medical) and a T-Piece Resuscitator (Neopuff), using both the Laerdal snap-fit face mask and the standard Laerdal size 0/1 face mask (equivalent sizes). Participants were asked to use pressure sufficient to achieve 'appropriate' chest rise. Leak, applied load, airway pressure and tidal volume were measured continuously. Participants were unaware that load was being recorded. RESULTS: There was no difference in mask leak between resuscitation devices. Leak was significantly lower when the snap-fit mask was used with all resuscitation devices, compared with the standard mask (14% vs 37% leak, P<0.01). The snap-fit mask was preferred by 83% of participants. The device-mask combinations had no significant effect on applied load. CONCLUSIONS: The Laerdal Upright Resuscitator resulted in similar leak to the other resuscitation devices studied, and did not exert additional load to the face and head. The snap-fit mask significantly reduced overall leak with all resuscitation devices and was the mask preferred by participants.
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Máscaras/efeitos adversos , Respiração Artificial/métodos , Estudos Cross-Over , Desenho de Equipamento , Humanos , Recém-Nascido , Manequins , Respiração Artificial/efeitos adversos , Respiração Artificial/instrumentação , Volume de Ventilação Pulmonar/fisiologiaRESUMO
Acute painful episodes among patients with sickle cell disease may occur in any body part or several sites simultaneously. The reasons for inadequate pain relief for this patient group are complex. Prompt, accurate pain assessment is the cornerstone of effective pain management and a comprehensive, multidisciplinary team strategy is essential, particularly for managing patients with frequent acute pain or chronic pain.