Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Background: In this study, we aimed to evaluate the effects of tocilizumab in adult patients admitted to hospital with COVID-19 with both hypoxia and systemic inflammation. Methods: This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. Those trial participants with hypoxia (oxygen saturation <92% on air or requiring oxygen therapy) and evidence of systemic inflammation (C-reactive protein ≥75 mg/L) were eligible for random assignment in a 1:1 ratio to usual standard of care alone versus usual standard of care plus tocilizumab at a dose of 400 mg–800 mg (depending on weight) given intravenously. A second dose could be given 12–24 h later if the patient's condition had not improved. The primary outcome was 28-day mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936). Findings: Between April 23, 2020, and Jan 24, 2021, 4116 adults of 21 550 patients enrolled into the RECOVERY trial were included in the assessment of tocilizumab, including 3385 (82%) patients receiving systemic corticosteroids. Overall, 621 (31%) of the 2022 patients allocated tocilizumab and 729 (35%) of the 2094 patients allocated to usual care died within 28 days (rate ratio 0·85; 95% CI 0·76–0·94; p=0·0028). Consistent results were seen in all prespecified subgroups of patients, including those receiving systemic corticosteroids. Patients allocated to tocilizumab were more likely to be discharged from hospital within 28 days (57% vs 50%; rate ratio 1·22; 1·12–1·33; p<0·0001). Among those not receiving invasive mechanical ventilation at baseline, patients allocated tocilizumab were less likely to reach the composite endpoint of invasive mechanical ventilation or death (35% vs 42%; risk ratio 0·84; 95% CI 0·77–0·92; p<0·0001). Interpretation: In hospitalised COVID-19 patients with hypoxia and systemic inflammation, tocilizumab improved survival and other clinical outcomes. These benefits were seen regardless of the amount of respiratory support and were additional to the benefits of systemic corticosteroids. Funding: UK Research and Innovation (Medical Research Council) and National Institute of Health Research

Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial

Background: Many patients with COVID-19 have been treated with plasma containing anti-SARS-CoV-2 antibodies. We aimed to evaluate the safety and efficacy of convalescent plasma therapy in patients admitted to hospital with COVID-19. Methods: This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. The trial is underway at 177 NHS hospitals from across the UK. Eligible and consenting patients were randomly assigned (1:1) to receive either usual care alone (usual care group) or usual care plus high-titre convalescent plasma (convalescent plasma group). The primary outcome was 28-day mortality, analysed on an intention-to-treat basis. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936. Findings: Between May 28, 2020, and Jan 15, 2021, 11558 (71%) of 16287 patients enrolled in RECOVERY were eligible to receive convalescent plasma and were assigned to either the convalescent plasma group or the usual care group. There was no significant difference in 28-day mortality between the two groups: 1399 (24%) of 5795 patients in the convalescent plasma group and 1408 (24%) of 5763 patients in the usual care group died within 28 days (rate ratio 1·00, 95% CI 0·93–1·07; p=0·95). The 28-day mortality rate ratio was similar in all prespecified subgroups of patients, including in those patients without detectable SARS-CoV-2 antibodies at randomisation. Allocation to convalescent plasma had no significant effect on the proportion of patients discharged from hospital within 28 days (3832 [66%] patients in the convalescent plasma group vs 3822 [66%] patients in the usual care group; rate ratio 0·99, 95% CI 0·94–1·03; p=0·57). Among those not on invasive mechanical ventilation at randomisation, there was no significant difference in the proportion of patients meeting the composite endpoint of progression to invasive mechanical ventilation or death (1568 [29%] of 5493 patients in the convalescent plasma group vs 1568 [29%] of 5448 patients in the usual care group; rate ratio 0·99, 95% CI 0·93–1·05; p=0·79). Interpretation: In patients hospitalised with COVID-19, high-titre convalescent plasma did not improve survival or other prespecified clinical outcomes. Funding: UK Research and Innovation (Medical Research Council) and National Institute of Health Research

O programa de saúde escolar no município de Ribeirão Preto El programa de salud escolar en el municipio de Ribeirão Preto The primary school health care program at the municipality of Ribeirão Preto

O presente artigo relata a trajetória do Programa de Assistência Primária de Saúde Escolar (PROASE) no município de Ribeirão Preto e traz algumas reflexões sobre esta proposta.<br>El presente estudio relata el trayecto del Programa de Atención Primaria de Salud Escolar (PROASE) en el municipio de Ribeirão Preto y trae algunas reflexiones sobre esta propuesta.<br>The present article reports on the trajectory of the Primary School Health Care Program (PROASE) at the municipality of Ribeirão Preto and describes some reflections about this proposal

Organização do sistema de referência e contra-referência no contexto do Sistema Único de Saúde: a percepção de enfermeiro Counter-reference and reference system organization in the health system context: nurses' perception

Este estudo teve como objetivo compreender e desvelar a percepção de enfermeiros sobre o sistema de referência e contra-referência, no contexto do Sistema Único de Saúde do município de Botucatu ISP/BR, a partir da experiência vivenciada na prática. Para tanto, optamos pela pesquisa qualitativa, na modalidade do fenômeno situado, vertente metodológica da fenomenologia. Num primeiro momento, buscamos realizar uma revisão histórica sobre o processo de construção do Sistema Único de Saúde no Brasil e o significado do sistema de referência e contra-referência neste contexto. A construção dos resultados foi realizada a partir das análises ideográfica e nomotética dos depoimentos de treze enfermeiras, tendo emergido destes treze temas, posteriormente agrupados em três categorias principais: o funcionamento do sistema de referência e contra-referência, as possibilidades de encaminhamento da clientela e fatores estruturais do sistema local, desvelando que a referência e contra-referência ainda não passa de um horizonte e só funciona quando há empenho pessoal dos profissionais isoladamente.<br>This study aimed to understand and to care counter-reference and reference system upon the context of the Health System in Botucatu-SP, Brazil from the nurses who experience this practice. We adopted a qualitative research, situated fenomena model, methodologically derived from phenomenology. In the first part of this study there is a brief presentatiori record about the Health System in Brazil contextualizing as it follows counter-reference and reference system. Results were obtained through ideographic analysis and nomothetic analysis from the testimony of 13 nurses interviewed, bringing 13 themes, reduced into 3 categories: counter-reference and reference system operation, guiding possibilities and local system structural factors. This study showed that this purpose is still an horizont that depend's the isolately professional liability

Avaliação de desempenho de serviços de saúde Evaluation of the performance of health services

A partir da literatura recente (até 1988) a respeito da avaliação de serviços de saúde em geral e do desempenho hospitalar em particular, destacam-se os diferentes aspectos conceituais e metodológicos envolvidos, começando pelas primeiras tentativas no seio do Colégio Americano de Cirurgiões, passando pela criação e evolução da Comissão Conjunta de Acreditação de Hospitais americana, até os esforços e elaborações conceituais e metodológicas mais recentes. São destacados a metodologia dos grupos diagnósticos homogêneos ("diagnosis related groups" ou "DRGs") e os indicadores de gravidade ("severity of illness"). É comentada a evolução desse incipiente campo de conhecimento e de prática no ambiente nacional. São comentadas as origens do recente interesse internacional a respeito do problema, ou seja, o aumento generalizado de custos dos serviços de saúde, crescente aumento de demandas judiciais em alguns países e ainda o acentuado incremento de complexidade dos atos em muitas especialidades. Destacam-se as fontes de informação correntemente utilizadas no processo, ou seja, a observação direta (estudos caso/controle), os prontuários médicos e os instrumentos-resumo, freqüentemente utilizados para remuneração do atendimento. Mencionam-se as profundas influências na prática de saúde que o processo de avaliação tem introduzido, particularmente a padronização de procedimentos, o estadiamento de agravos, os estudos de trajetória, os relacionados a situações traçadoras ("tracers") e a alternativa que mais tem influenciado a prática de situações complexas de saúde, que são os protocolos diagnóstico-terapêutico s já amplamente utilizados em algumas áreas como a do tratamento de câncer, inclusive no Brasil.<br>Recent literature (up to 1988) on health service assessment in general and especially on hospital service assessment is reviewed, with special attention to its conceptual and methodological aspects. The history of this process is also examined, from the first attempts by the American College of Surgeons, through the Joint Commission for Hospital Accreditation activities up to more recent efforts. The Diagnosis Related Group methodology is commented especially, as well as its more recent complement, the severity of illness inidicators. Progress made in this field is briefly examined as in the light of the Brazilian situation. The origins of the growing international concern with this field are enumerated: soaring costs of health services; the recent growth in the number of medical malpractice suits; and the sharp increase in the complexity of health services. The sources of information used in the process, such as immediate observation (case-control type studies), medical records, and summary instruments already in use for payment or financial control purposes, are commented on. Mention is made of the deep influences of the assessment process on practice as in the case of the standardization of practices and procedures, staging of the pathological processes, trajectory-type studies; the utilization of tracer situations, and, finally, the most influencial on practice of all these assessment instruments: the diagnosis and treatment protocols, already in wide use in some medical fields such as cancer treatment even in developing countries