Thinking out of the box: revisiting health surveillance based on medical records.

Despite the considerable advances in the last years, the health information systems for health surveillance still need to overcome some critical issues so that epidemic detection can be performed in real time. For instance, despite the efforts of the Brazilian Ministry of Health (MoH) to make COVID-19 data available during the pandemic, delays due to data entry and data availability posed an additional threat to disease monitoring. Here, we propose a complementary approach by using electronic medical records (EMRs) data collected in real time to generate a system to enable insights from the local health surveillance system personnel. As a proof of concept, we assessed data from São Caetano do Sul City (SCS), São Paulo, Brazil. We used the "fever" term as a sentinel event. Regular expression techniques were applied to detect febrile diseases. Other specific terms such as "malaria," "dengue," "Zika," or any infectious disease were included in the dictionary and mapped to "fever." Additionally, after "tokenizing," we assessed the frequencies of most mentioned terms when fever was also mentioned in the patient complaint. The findings allowed us to detect the overlapping outbreaks of both COVID-19 Omicron BA.1 subvariant and Influenza A virus, which were confirmed by our team by analyzing data from private laboratories and another COVID-19 public monitoring system. Timely information generated from EMRs will be a very important tool to the decision-making process as well as research in epidemiology. Quality and security on the data produced is of paramount importance to allow the use by health surveillance systems.

Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV: A structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: To evaluate the efficacy of two doses of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac in symptomatic individuals, with virological confirmation of COVID-19, two weeks after the completion of the two-dose vaccination regimen, aged 18 years or older who work as health professionals providing care to patients with possible or confirmed COVID-19. To describe the occurrence of adverse reactions associated with the administration of each of two doses of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac up to one week after vaccination in Adults (18-59 years of age) and Elderly (60 years of age or more). TRIAL DESIGN: This is a Phase III, randomized, multicenter, endpoint driven, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of the adsorbed vaccine COVID-19 (inactivated) produced by Sinovac. The adsorbed vaccine COVID-19 (inactivated) produced by Sinovac (product under investigation) will be compared to placebo. Voluntary participants will be randomized to receive two intramuscular doses of the investigational product or the placebo, in a 1: 1 ratio, stratified by age group (18 to 59 years and 60 years or more) and will be monitored for one year by active surveillance of COVID-19. Two databases will be established according to the age groups: one for adults (18-59 years) and one for the elderly (60 years of age or older). The threshold to consider the vaccine efficacious will be to reach a protection level of at least 50%, as proposed by the World Health Organization and the FDA. Success in this criterion will be defined by sequential monitoring with adjustment of the lower limit of the 95% confidence interval above 30% for the primary efficacy endpoint. PARTICIPANTS: Healthy participants and / or participants with clinically controlled disease, of both genders, 18 years of age or older, working as health professionals performing care in units specialized in direct contact with people with possible or confirmed cases of COVID-19. Participation of pregnant women and those who are breastfeeding, as well as those intending to become pregnant within three months after vaccination will not be allowed. Participants will only be included after signing the voluntary Informed Consent Form and ensuring they undergo screening evaluation and conform to all the inclusion and exclusion criteria. All the clinical sites are located in Brazil. INTERVENTION AND COMPARATOR: Experimental intervention: The vaccine was manufactured by Sinovac Life Sciences (Beijing, China) and contains 3 µg/0.5 mL (equivalent to 600 SU per dose) of inactivated SARS-CoV-2 virus, and aluminium hydroxide as adjuvant. Control comparator: The placebo contains aluminium hydroxide in a 0.5 mL solution The schedule of both, experimental intervention and placebo is two 0.5 mL doses IM (deltoid) with a two week interval. MAIN OUTCOMES: The primary efficacy endpoint is the incidence of symptomatic cases of virologically confirmed COVID-19 two weeks after the second vaccination. The virological diagnosis will be confirmed by detection of SARS-CoV-2 nucleic acid in a clinical sample. The primary safety endpoint is the frequency of solicited and unsolicited local and systemic adverse reactions during the period of one week after vaccination according to age group in adult (18-59 years old) and elder (60 years of age or older) subjects. Adverse reactions are defined as adverse events that have a reasonable causal relationship to vaccination. RANDOMISATION: There will be two randomization lists, one for each age group, based on the investigational products to be administered, i.e., vaccine or placebo at a 1: 1 ratio. Each randomization list will be made to include up to 11,800 (18-59 year-old) adults, and 1,260 elderly (60 y-o and older) participants, the maximum number of participants needed per age group. An electronic central randomization system will be used to designate the investigational product that each participant must receive. BLINDING (MASKING): This trial is designed as a double-blind study to avoid introducing bias in the evaluation of efficacy, safety and immunogenicity. The clinical care team, the professionals responsible for the vaccination and the participants will not know which investigational product will be administered. Only pharmacists or nurses in the study who are responsible for the randomization, separation and blinding of the investigational product will have access to unblinded information. The sponsor's operational team will also remain blind. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The total number of participants needed to evaluate efficacy, 13,060 participants, satisfies the needed sample size calculated to evaluate safety. Therefore, the total number obtained for efficacy will be the number retained for the study. Up to 13,060 participants are expected to enter the study, with up to 11,800 participants aged 18 to 59 years and 1,260 elderly participants aged 60 and over. Half of the participants of each group will receive the experimental vaccine and half of them will receive the placebo. The recruitment of participants may be modified as recommended by the Data Safety Monitoring Committee at time of the interim unblinded analysis or blind assessment of the COVID-19 attack rate during the study. TRIAL STATUS: Protocol version 2.0 - 24-Aug-2020. Recruitment started on July 21st, 2020. The recruitment is expected to conclude in October 2020. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT0445659 . Registry on 2 July 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

[The International Classification of Diseases, the Family of International Classifications, the ICD-11, and post-polio syndrome]. / A Classificação Internacional de Doenças, a Família de Classificações Internacionais, a CID-11 e a Síndrome Pós-Poliomielite.

The first International Classification of Diseases (ICD) was approved in 1893 and since then it has been periodically reviewed. The last, 10th revision (ICD-10), was approved in 1989. Since 1989, it was possible to update from ICD revisions, which did not happen before. The next revision (ICD-11) would probably be published in 2015. In 1989, mechanisms were established to update ICD-10, through the creation of the Morbidity Reference Group (MbRG) in 1997 and the Update and Revision Committee (URC) in 2000. The Morbidity Reference Group (MbRG) was created in 2007 to discuss in more detail the issues to update morbidity. A specific code in ICD was not included in the revision of ICD-10 in 1989 for the post-polio syndrome (PPS). However, the ICD new code G14 for PPS was included in ICD-10 since 2010.

Frequency and clinical manifestations of post-poliomyelitis syndrome in a Brazilian tertiary care center.

OBJECTIVE: To determine the frequency and clinical manifestations of patients with post-poliomyelitis syndrome (PPS) in a Brazilian division of neuromuscular disorders. METHODS: A total of 167 patients with prior history of paralytic poliomyelitis was investigated for PPS, based on international diagnostic criteria. Other variables analyzed were: gender, race, age at poliomyelitis infection, age at PPS onset, and PPS symptoms. RESULTS: One hundred and twenty-nine patients presented PPS, corresponding to 77.2% of the studied population. 62.8% were women and 37.2% were men. Mean age of patients with PPS at onset of PPS symptoms was 39.9±9.69 years. Their main clinical manifestations were: new weakness in the previously affected limbs (69%) and in the apparently not affected limbs (31%); joint pain (79.8%); fatigue (77.5%); muscle pain (76%); and cold intolerance (69.8%). CONCLUSIONS: Most patients of our sample presented PPS. In Brazil, PPS frequency and clinical features are quite similar to those of other countries.

Mortality rates due to amyotrophic lateral sclerosis in São Paulo City from 2002 to 2006.

OBJECTIVE: To describe the mortality rates of amyotrophic lateral sclerosis (ALS) in the city of São Paulo as a function of demographics, year, and region. METHOD: This was a retrospective descriptive study. Information was obtained from death certificates registered at the Program for the Improvement of Mortality Information, Municipal Health Department (PRO-AIM/SMS), coded as G12.2 according to International Classification of Diseases (ICD-10), from 2002 to 2006. RESULTS: Over the studied time, were found 326 deaths (51.6% women, overall mean age of 64.1 years). Highest deaths percentages happened in those from 60 to 69 and 70 to 79 years and in white individuals. ALS mortality rates ranged 0.44/100,000 in 2002 and 0.76/100,000 in 2006. No significant changes overtime in administrative districts were found. CONCLUSION: ALS mortality rates in São Paulo were lower in comparison to other countries, however any risk factor in our environment, lifestyle or genetic characteristics were found.

Frequency and clinical manifestations of post-poliomyelitis syndrome in a brazilian tertiary care center / Frequência e manifestações clínicas da síndrome pós-poliomielite em um centro terciário brasileiro

OBJECTIVE: To determine the frequency and clinical manifestations of patients with post-poliomyelitis syndrome (PPS) in a Brazilian division of neuromuscular disorders. METHODS: A total of 167 patients with prior history of paralytic poliomyelitis was investigated for PPS, based on international diagnostic criteria. Other variables analyzed were: gender, race, age at poliomyelitis infection, age at PPS onset, and PPS symptoms. RESULTS: One hundred and twenty-nine patients presented PPS, corresponding to 77.2% of the studied population. 62.8% were women and 37.2% were men. Mean age of patients with PPS at onset of PPS symptoms was 39.9±9.69 years. Their main clinical manifestations were: new weakness in the previously affected limbs (69%) and in the apparently not affected limbs (31%); joint pain (79.8%); fatigue (77.5%); muscle pain (76%); and cold intolerance (69.8%). CONCLUSIONS: Most patients of our sample presented PPS. In Brazil, PPS frequency and clinical features are quite similar to those of other countries.

OBJETIVO: Determinar a frequência e as manifestações clínicas de pacientes com síndrome pós-poliomielite (SPP) em um setor terciário de doenças neuromusculares brasileiro. MÉTODOS: Um total de 167 pacientes com história prévia de poliomielite paralítica foi estudado para diagnóstico de SPP, de acordo com critérios diagnósticos internacionais. Além da SPP, as variáveis analisadas foram: gênero, raça, idade à época da poliomielite aguda e idade no início dos sintomas da SPP. RESULTADOS: Cento e vinte e nove pacientes apresentaram SPP, correspondendo a 77,2% da população estudada. Mulheres constituíram 62,8% dos pacientes e os homens, 37,2%. A média de idade dos pacientes com SPP à época do início dos sintomas foi de 39,9±9,69 anos. Suas principais manifestações clínicas foram: manifestações novas de fraqueza em membros previamente afetados (69%) e em membros aparentemente não afetados (31%); dores articulares (79,8%); fadiga (77,5%); dor muscular (76%) e intolerância ao frio (69,8%). CONCLUSÕES: A maioria dos pacientes da presente casuística apresentou SPP. No Brasil, a frequência e as características clínicas da SPP são similares às observadas em outros países.

Mortality rates due to amyotrophic lateral sclerosis in São Paulo City from 2002 to 2006 / Mortalidade por esclerose lateral amiotrófica no município de São Paulo de 2002 a 2006

OBJECTIVE: To describe the mortality rates of amyotrophic lateral sclerosis (ALS) in the city of São Paulo as a function of demographics, year, and region. METHOD: This was a retrospective descriptive study. Information was obtained from death certificates registered at the Program for the Improvement of Mortality Information, Municipal Health Department (PRO-AIM/SMS), coded as G12.2 according to International Classification of Diseases (ICD-10), from 2002 to 2006. RESULTS: Over the studied time, were found 326 deaths (51.6 percent women, overall mean age of 64.1 years). Highest deaths percentages happened in those from 60 to 69 and 70 to 79 years and in white individuals. ALS mortality rates ranged 0.44/100,000 in 2002 and 0.76/100,000 in 2006. No significant changes overtime in administrative districts were found. CONCLUSION: ALS mortality rates in São Paulo were lower in comparison to other countries, however any risk factor in our environment, lifestyle or genetic characteristics were found.

OBJETIVO: Descrever a taxa de mortalidade da esclerose lateral amiotrófica (ELA) no município de São Paulo (MSP) de 2002 a 2006, segundo tempo, pessoa e espaço. MÉTODO: Estudo descritivo retrospectivo, utilizando dados das declarações de óbitos do Programa de Aprimoramento das Informações de Mortalidade (PROAIM/SMS), com G12.2 segundo Classificação Internacional de Doenças (CID 10), de 2002 a 2006. RESULTADOS: Foram encontrados 326 óbitos, 51,6 por cento mulheres, média de idade de 64,1 anos. Maiores percentuais de mortes foram encontrados nas faixas etárias de 60-69 anos e 70-79 anos e na raça branca. As taxas de mortalidade por ELA variaram de 0,44/100.000 em 2002 para 0,76/100.000 em 2006. Não houve mudanças significativas nos distritos administrativos em relação ao tempo. CONCLUSÃO: Taxas de mortalidade por ELA no MSP são menores, comparadas às de outros países; mas nenhum fator de risco foi encontrado no estudo em relação ao ambiente, modo de vida e características genéticas.

Efetividade da vacina conjugada contra o meningococo C em menores de dois anos / Effectiveness of conjugate vaccine against meningococcus C in under two years

Objetivo: Estimar o impacto da vacina conjugada contra o meningococo C (VCMC), na incidência e mortalidade, nas coortes de nascidos com e sem indicação de vacinação, no município de São Paulo (MSP); e estimar a efetividade direta da VCMC segundo esquema do Programa Nacional de Imunização. Métodos: O impacto foi avaliado por estudo descritivo, abrangendo casos de doença meningocócica (DM) notificados ao MSP, de 1998 a 2012. A definição de caso é a adotada pelo Ministério da Saúde. Descreveu-se o comportamento da DM no MSP para todo período e analisou-se a tendência da incidência e mortalidade da DM global e por faixa etária de 2008 a 2012, utilizando o modelo de Poisson. O impacto da VCMC foi analisado por meio das razões de taxas de incidência e mortalidade nos períodos anterior e posterior a introdução da VCMC. Estimou-se a fração prevenida na população (FPP) para mensurar o impacto, comparando-se taxas de incidência e mortalidade globais da DM, por faixa etária e sorogrupo C, de 2012 com as de 2009. Para estimativa da efetividade da VCMC utilizou-se estudo de caso-controle de base populacional, com quatro controles para cada caso, pareado pela área de residência dos casos. Casos e controles foram selecionados entre nascidos a partir de janeiro/2009. Casos eram aqueles com DM pelo sorogrupo C confirmado por cultura e/ou reação em cadeia de polimerase em tempo real, de 2011 a 2013, internados em hospitais do MSP, notificados à vigilância do município. Controles foram selecionados entre crianças residentes na vizinhança dos casos, sem história de DM. A efetividade da vacina foi estimada pela fórmula (1-odds ratio para vacinação). As odds ratios (OR) não ajustadas e ajustadas e respectivos intervalos de confiança (IC95 por cento ) foram estimados por regressão 11 logística condicional múltipla. A associação entre ser vacinado com VCMC e a variável dependente, DM pelo sorogrupo C, foi mensurada pela estimativa da OR após ajuste para potenciais confundidores. Resultados: O impacto da VCMC na incidência da DM por todos os sorogrupos, mensurado pela FPP foi de 62,7 por cento , 69,6 por cento e 61,4 por cento para, respectivamente menores um, um e dois anos; na DM pelo sorogrupo C de 81,6 por cento e 67,9 por cento para menores de dois anos e de dois a três anos. Houve impacto na taxa de mortalidade global da DM medido pela FPP de 86,2 por cento e 77,8 por cento respectivamente para menores de dois anos e de dois a três anos e na mortalidade da DM pelo sorogrupo C a FPP foi de 84,2 por cento para menores de quatro anos. A efetividade da VCMC foi de 97,7 por cento (IC95 por cento :99,6 por cento -89,6 por cento ) ajustada para idade, número de pessoas no quarto da criança e renda familiar. Conclusões: A estratégia brasileira com a VCMC resultou em elevado impacto nas coortes de nascidos com indicação de vacinação, mais acentuado nas taxas de mortalidade, sugerindo que a vacina confere não só proteção para a doença, mas também para formas mais graves. A VCMC foi altamente efetiva na faixa etária alvo.

Objective: To assess the impact of meningococcal C conjugate vaccine (MCCV), to estimate incidence and mortality rates of meningococcal disease (MD) in birth cohorts recommended and not recommended for vaccination and to measure direct vaccine effectiveness of the National Vaccination Program immunization schedule. Methods: We assessed the impact of MCCV in a descriptive study including cases of MD reported in the city of Sao Paulo, Brazil, from 1998 to 2012. We used the standard case definition recommended by the Brazilian Ministry of Health for MD reporting. We assessed changes in the disease epidemiology in the city for the entire study period and estimated incidence and mortality rates of MD (overall and by age group) from 2008 to 2012 using Poisson regression models. We conducted an impact analysis of MCCV by comparing incidence and mortality rates of MD before and after vaccine introduction. We also estimated the population prevented fraction (PPF) by comparing incidence and mortality rates of MD between 2009 and 2012 in the entire population and by age group and serogroup C. To measure vaccine effectiveness, we carried out a population-based case-control study matched for area of residence with a 4-to-1 ratio of controls to cases. Cases and controls were selected among children born from January 2009. Cases were those children admitted to the citys hospitals who were diagnosed with MD serogroup C (MDC) confirmed by culture and/or real-time polymerase chain reaction and reported to the surveillance system from 2011 to 2013. Controls were selected among children with no history of MD from neighboring areas of cases. We calculated vaccine effectiveness using the formula (1 odds ratio [OR] for 13 vaccination) and estimated crude and adjusted ORs and related 95 per cent confidence intervals (95 per cent CI) by conditional multiple logistic regression. We assessed the association between MCCV vaccination and MDC the dependent variable by estimating OR after adjustment for the potential confounders. Results: There was an impact of MCCV on the incidence of MD in all serogroups, the PPF among children under age one, age one, and age two were 62.7 per cent , 69.6 per cent , and 61.4 per cent , respectively; and in serogroup C, the PPF in children under age two and age two to three were 81.6 per cent and 67.9 per cent . There was also an impact on the overall mortality rate of MD, the PPF in children under age two and age two to three were 86.2 per cent and 77.8 per cent ; and on mortality of MDC, the PPF was 84.2 per cent in children under age four. MCCV effectiveness in children was 97.7 per cent (95 per cent CI 99.6 per cent 89.6 per cent ) after adjusting for age, number of persons per room, and household income. Conclusions: The MCCV strategy implemented in Brazil had a high impact on birth cohorts recommended for vaccination. This impact was more pronounced on mortality rates, which suggests that, in addition to preventing disease, MCCV can prevent more severe forms of MD. MCCV proved highly effective in the age groups targeted.

Síndrome pós-poliomielite (SPP): orientações para profissionais de saúde

As doenças neuromusculares representam um grupo de afecções que comprometem a unidade motora, ou seja, o corpo celular do neurônio motor inferior, o seu prolongamento, a junção neuromuscular ou o tecido muscular. Dentre as doenças neuromusculares, encontram-se as lesões neuronais motoras, que são condições nas quais há alterações morfológicas ou bioquímicas que ocorrem no corpo do neurônio. A lesão neuronal motora caracteriza-se por envolvimento do corpo celular do neurônio motor inferior (NMI). As principais doenças são: poliomielite anterior aguda (Pólio), atrofia muscular espinhal progressiva (AMEP) e doença do neurônio motor (DNM). A síndrome pós-poliomielite(SPP)é um transtorno neurológico, denro do capítulo dos efeitos tardios da poliomielite, caracterizados por nova fraqueza muscular e/ou fadiga muscular anormal em indivíduos que tiveram poliomielite aguda, muitos anos antes. A SPP encontra-se na categoria das doenças do nerônio motor (neuronopatia motora) em virtude dos quadros clínico e histológico estarem intimamente relacionados com disfunção dos neurônios motores inferiores.