Best-practice prevention alone or with conventional or biological caries management for 3- to 7-year-olds:the FiCTION three-arm RCT

Background Historically, lack of evidence for effective management of decay in primary teeth has caused uncertainty, but there is emerging evidence to support alternative strategies to conventional fillings, which are minimally invasive and prevention orientated. Objectives The objectives were (1) to assess the clinical effectiveness and cost-effectiveness of three strategies for managing caries in primary teeth and (2) to assess quality of life, dental anxiety, the acceptability and experiences of children, parents and dental professionals, and caries development and/or progression. Design This was a multicentre, three-arm parallel-group, participant-randomised controlled trial. Allocation concealment was achieved by use of a centralised web-based randomisation facility hosted by Newcastle Clinical Trials Unit. Setting This trial was set in primary dental care in Scotland, England and Wales. Participants Participants were NHS patients aged 3–7 years who were at a high risk of tooth decay and had at least one primary molar tooth with decay into dentine, but no pain/sepsis. Interventions Three interventions were employed: (1) conventional with best-practice prevention (local anaesthetic, carious tissue removal, filling placement), (2) biological with best-practice prevention (sealing-in decay, selective carious tissue removal and fissure sealants) and (3) best-practice prevention alone (dietary and toothbrushing advice, topical fluoride and fissure sealing of permanent teeth). Main outcome measures The clinical effectiveness outcomes were the proportion of children with at least one episode (incidence) and the number of episodes, for each child, of dental pain or dental sepsis or both over the follow-up period. The cost-effectiveness outcomes were the cost per incidence of, and cost per episode of, dental pain and/or dental sepsis avoided over the follow-up period. Results A total of 72 dental practices were recruited and 1144 participants were randomised (conventional arm, n = 386; biological arm, n = 381; prevention alone arm, n = 377). Of these, 1058 were included in an intention-to-treat analysis (conventional arm, n = 352; biological arm, n = 352; prevention alone arm, n = 354). The median follow-up time was 33.8 months (interquartile range 23.8–36.7 months). The proportion of children with at least one episode of pain or sepsis or both was 42% (conventional arm), 40% (biological arm) and 45% (prevention alone arm). There was no evidence of a difference in incidence or episodes of pain/sepsis between arms. When comparing the biological arm with the conventional arm, the risk difference was –0.02 (97.5% confidence interval –0.10 to 0.06), which indicates, on average, a 2% reduced risk of dental pain and/or dental sepsis in the biological arm compared with the conventional arm. Comparing the prevention alone arm with the conventional arm, the risk difference was 0.04 (97.5% confidence interval –0.04 to 0.12), which indicates, on average, a 4% increased risk of dental pain and/or dental sepsis in the prevention alone arm compared with the conventional arm. Compared with the conventional arm, there was no evidence of a difference in episodes of pain/sepsis among children in the biological arm (incident rate ratio 0.95, 97.5% confidence interval 0.75 to 1.21, which indicates that there were slightly fewer episodes, on average, in the biological arm than the conventional arm) or in the prevention alone arm (incident rate ratio 1.18, 97.5% confidence interval 0.94 to 1.48, which indicates that there were slightly more episodes in the prevention alone arm than the conventional arm). Over the willingness-to-pay values considered, the probability of the biological treatment approach being considered cost-effective was approximately no higher than 60% to avoid an incidence of dental pain and/or dental sepsis and no higher than 70% to avoid an episode of pain/sepsis. Conclusions There was no evidence of an overall difference between the three treatment approaches for experience of, or number of episodes of, dental pain or dental sepsis or both over the follow-up period

A clinical and cost-effectiveness trial of a parent group intervention to manage challenging restricted and repetitive behaviours in young children with autism spectrum disorder: study protocol for a randomised controlled trial

Background Restricted and repetitive behaviours vary greatly across the autism spectrum, and although not all are problematic some can cause distress and interfere with learning and social opportunities. We have, alongside parents, developed a parent group based intervention for families of young children with autism, which aims to offer support to parents and carers; helping them to recognise, understand and learn how to respond to their child’s challenging restricted repetitive behaviours. Methods The study is a clinical and cost-effectiveness, multi-site randomised controlled trial of the Managing Repetitive Behaviours (MRB) parent group intervention versus a psychoeducation parent group Learning About Autism (LAA) (n = 250; 125 intervention/125 psychoeducation; ~ 83/site) for parents of young children aged 3–9 years 11 months with a diagnosis of autism. All analyses will be done under intention-to-treat principle. The primary outcome at 24 weeks will use generalised estimating equation (GEE) to compare proportion of children with improved RRB between the MRB group and the LAA group. The GEE model will account for the clustering of children by parent groups using exchangeable working correlation. All secondary outcomes will be analysed in a similar way using appropriate distribution and link function. The economic evaluation will be conducted from the perspective of both NHS costs and family access to local community services. A ‘within trial’ cost-effectiveness analysis with results reported as the incremental cost per additional child achieving at least the target improvement in CGI-I scale at 24 weeks. Discussion This is an efficacy trial to investigate the clinical and cost-effectiveness of a parent group based intervention designed to help parents understand and manage their child’s challenging RRB. If found to be effective, this intervention has the potential to improve the well-being of children and their families, reduce parental stress, greatly enhance community participation and potential for learning, and improve longer-term outcomes

Minithoracotomy vs Conventional Sternotomy for Mitral Valve Repair: A Randomized Clinical Trial

Importance: The safety and effectiveness of mitral valve repair via thoracoscopically-guided minithoracotomy (minithoracotomy) compared with median sternotomy (sternotomy) in patients with degenerative mitral valve regurgitation is uncertain. Objective: To compare the safety and effectiveness of minithoracotomy vs sternotomy mitral valve repair in a randomized trial. Design, Setting, and Participants: A pragmatic, multicenter, superiority, randomized clinical trial in 10 tertiary care institutions in the UK. Participants were adults with degenerative mitral regurgitation undergoing mitral valve repair surgery. Interventions: Participants were randomized 1:1 with concealed allocation to receive either minithoracotomy or sternotomy mitral valve repair performed by an expert surgeon. Main Outcomes and Measures: The primary outcome was physical functioning and associated return to usual activities measured by change from baseline in the 36-Item Short Form Health Survey (SF-36) version 2 physical functioning scale 12 weeks after the index surgery, assessed by an independent researcher masked to the intervention. Secondary outcomes included recurrent mitral regurgitation grade, physical activity, and quality of life. The prespecified safety outcomes included death, repeat mitral valve surgery, or heart failure hospitalization up to 1 year. Results: Between November 2016 and January 2021, 330 participants were randomized (mean age, 67 years, 100 female [30%]); 166 were allocated to minithoracotomy and 164 allocated to sternotomy, of whom 309 underwent surgery and 294 reported the primary outcome. At 12 weeks, the mean between-group difference in the change in the SF-36 physical function T score was 0.68 (95% CI, −1.89 to 3.26). Valve repair rates (≈ 96%) were similar in both groups. Echocardiography demonstrated mitral regurgitation severity as none or mild for 92% of participants at 1 year with no difference between groups. The composite safety outcome occurred in 5.4% (9 of 166) of patients undergoing minithoracotomy and 6.1% (10 of 163) undergoing sternotomy at 1 year. Conclusions and relevance: Minithoracotomy is not superior to sternotomy in recovery of physical function at 12 weeks. Minithoracotomy achieves high rates and quality of valve repair and has similar safety outcomes at 1 year to sternotomy. The results provide evidence to inform shared decision-making and treatment guidelines. Trial Registration: isrctn.org Identifier: ISRCTN1393045

Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570

Encontros e desencontros entre jovens e a escola: sentidos da experiência escolar na educação de jovens e adultos - EJA

Exportado OPUSMade available in DSpace on 2019-08-13T22:31:50Z (GMT). No. of bitstreams: 1 encontros_e_desencontros_entre_os_jovens_e_a_escola.pdf: 2130774 bytes, checksum: 2da0c37c98b38e2ff520ea210c3eebc2 (MD5) Previous issue date: 15A investigação tem como objeto a relação dos jovens com a escola e os sentidos que eles próprios atribuem à sua experiência escolar. Os processos de desmodernização e desinstitucionalização das sociedades contemporâneas demandam novas funções da escola e novas desigualdades atingem, sobretudo, os jovens pobres de periferia urbana e de camadas populares. Estes se vêem obrigados a procurar alternativas educacionais como os cursos supletivos noturnos, ou interrompem seus estudos, gerando um círculo vicioso entre fracasso escolar e abandono do ensino regular. Os sujeitos foram os alunos jovens entre 15 e 27 anos, da modalidade de ensino noturno EJA - Educação de Jovens e Adultos - de uma escola pública municipal de Belo Horizonte, pois a EJA visa atender a um público cujas especificidades não são atendidas pelo Ensino Regular Comum nem pela Suplência do ensino público. A EJA também apresenta uma história de abertura a mudanças pedagógicas e de integração das culturas populares. Os jovens de hoje precisam construir projetos e atribuir uma utilidade social aos estudos técnico-científicos e investir em seus gostos intelectuais e interesses culturais. O intuito, portanto, foi compreender os sentidos desta nova experiência escolar de EJA para os jovens e investigar se a escola atende a estas novas demandas juvenis, uma educação para/com os jovens. A escola investigada permanece importante instância de socialização e, através de inovações na área cultural, propiciou significativas experiências de subjetivação aos jovens; no entanto, a função de transmissão de conhecimentos e de preparação de competências para o mercado de profissões se mostrou deficitária. Constatamos diferentes modos de relação dos jovens com a escola e de construção da experiência escolar, que se diferenciam em intensidade: integrada com subjetivação; paralela e estrategista; de adesão sem distanciamento crítico e de subjetivação contra a escola. A investigação em campo durou quinze meses de período letivo, numa freqüência média de uma vez por semana,entre setembro de 2005 e junho de 2007. Foi utilizada a pesquisa participante: observações etnográficas, intervenções a partir da inserção nas atividades escolares extra-classe, oficinas de teatro espontâneo, entrevistas coletivas e individuais. Utilizamos as contribuições teóricas de TOURAINE - a perspectiva da Escola do Sujeito - e de DUBET - a Teoria da Experiência - que aplica as lógicas de ação à construção de identidades e à experiência escolar.The investigation has as object the youths' relationship with the school and the meaning that themselves attribute to his/her school experience. The dismodernization and disinstitutionalization processes of the contemporary societies demand new functions from the school and new inequalities reach, above all, the poor youths fromurban periphery and popular classes. They see temselves forced to seek other education alternatives as the night shift adult education or interrupt their studies, creating a vicious circle between school failure and abandonment of the regular teaching. The subjects were the young students between 15 and 27 years, of the modality of night shift teaching EYA - Education of Youths and Adults -of a municipal public school of Belo Horizonte, because EYA assists to a public whose conditions are not assisted by the Common Regular Teaching nor by the public education. EYA also presents a history of opening to pedagogic changes and popular cultures integration. The youths of the present time need to construct projects and to attribute a social usefulness to the technician-scientific studies and to invest in their intellectual tastes and cultural interests. The intention, therefore, it was to understand the senses of this new school experience of EYA for the youths and to investigate if the school assists these new juvenile demands, an education for and with the youths. The investigated school stays important socialization instance and, through innovations in the cultural area, it propitiated significant subjectivation experiences to the youths; however, the function of transmission of knowledge and of preparation of competences to the market of professions was shown deficient. We verified different manners of the youths' relationship with the school and of construction of the school experience, that differ in intensity: integrated with subjectivation; parallel and strategist; of adhesion without critical estrangement and of subjectivation against the school. The investigation in field lasted fifteen months of school period, in a medium frequency at once a week, between September of 2005 and June of 2007. The participant research was used: ethnographic observations, interventions starting from the insert in the activities school extra-class, workshops of spontaneous theater, individual and collective interviews. We used TOURAINE's theoretical contributions - the perspective of the Subject's School - and the DUBETs Theory of the Experience - that applies the action logics to the construction of identities and the school experience

Effect of Antiplatelet Therapy on Survival and Organ Support–Free Days in Critically Ill Patients With COVID-19

International audienc