Search

Introdução A comunicação transparente e de fácil compreensão pode auxiliar leitores e gestores de saúde na interpretação dos resultados de revisões sistemáticas (RS). O grupo GRADE desenvolveu uma abordagem para melhorar a comunicação dos resultados de RS de intervenções na língua inglesa. Este trabalho tem como objetivo realizar a adaptação transcultural desta abordagem para a língua portuguesa falada no Brasil. Métodos Está sendo realizado o processo de adaptação transcultural para o Brasil da abordagem de comunicação dos resultados (publicada em 2020) em seis etapas: 1) tradução da versão original por dois tradutores; 2) síntese das traduções; 3) retrotradução da versão consolidada; 4) avaliação por 10 especialistas em GRADE brasileiros; 5) pré-teste aplicando a versão validada por especialistas em 150 profissionais que produzem e/ou utilizam RS; 6) avaliação quantitativa e qualitativa dos resultados. Resultados Atualmente, o estudo encontra-se na etapa 5. Um dos desafios foi ajustar os termos referentes à classificação de certeza da evidência baixa e moderada: a tradução do termo ”may”, usado para certeza da evidência baixa, foi considerada pelos especialistas como certeza moderada. Como modificação mais relevante, entendeu-se que a utilização do termo “moderado” para tamanho de efeito poderia gerar confusão, visto que também é utilizado para a classificação da certeza da evidência. Dessa forma, foi proposto utilizar “efeito médio”, como alternativa para “efeito moderado”. Após ajustes, foi elaborado um formulário on-line para ser respondido por profissionais que produzem e/ou utilizam RS, sendo dividido em três partes: 1) termo de consentimento livre e esclarecido eletrônico, 2) questionário de caracterização do participante; e 3) quatro perguntas sobre a aceitabilidade das frases propostas para comunicar os resultados da revisão sistemática. As quatro perguntas são sorteadas de forma aleatória de um banco com 16 perguntas. Discussão e conclusões As principais contribuições referem-se aos ajustes de termos em inglês que são indicados para diferentes interpretações, mas que possuem uma tradução similar em português. O sistema GRADE, adotado oficialmente no Brasil desde 2014, apresenta uma lacuna importante que reside na falta de um procedimento sistemático para a tradução e adaptação de seus termos, alinhando a terminologia em inglês com o português. Essa ausência pode levar a interpretações divergentes em relação ao proposto originalmente pelo sistema. Através de processos de adaptação cultural, é possível assegurar um maior nível de compreensão e clareza, amplificando, assim, a eficácia da sua utilização no processo de tomada de decisão por parte de diferentes stakeholders.

Background: The World Health Organization (WHO) and the International Labour Organization (ILO) have produced the WHO/ILO Joint Estimates of the Work-related Burden of Disease and Injury (WHO/ILO Joint Estimates). For these, systematic reviews of studies estimating the prevalence of exposure to selected occupational risk factors have been conducted to provide input data for estimations of the number of exposed workers. A critical part of systematic review methodology is to assess the quality of evidence across studies. In this article, we present the approach applied in these WHO/ILO systematic reviews for performing such assessments on studies of prevalence of exposure. It is called the Quality of Evidence in Studies estimating Prevalence of Exposure to Occupational risk factors (QoE-SPEO) approach. We describe QoE-SPEO’s development to date, demonstrate its feasibility reporting results from pilot testing and case studies, note its strengths and limitations, and suggest how QoE-SPEO should be tested and developed further. Methods: Following a comprehensive literature review, and using expert opinion, selected existing quality of evidence assessment approaches used in environmental and occupational health were reviewed and analysed for their relevance to prevalence studies. Relevant steps and components from the existing approaches were adopted or adapted for QoE-SPEO. New steps and components were developed. We elicited feedback from other systematic review methodologists and exposure scientists and reached consensus on the QoE-SPEO approach. Ten individual experts pilot-tested QoE-SPEO. To assess inter-rater agreement, we counted ratings of expected (actual and non-spurious) heterogeneity and quality of evidence and calculated a raw measure of agreement (Pi) between individual raters and rater teams for the downgrade domains. Pi ranged between 0.00 (no two pilot testers selected the same rating) and 1.00 (all pilot testers selected the same rating). Case studies were conducted of experiences of QoE-SPEO’s use in two WHO/ILO systematic reviews. Results: We found no existing quality of evidence assessment approach for occupational exposure prevalence studies. We identified three relevant, existing approaches for environmental and occupational health studies of the effect of exposures. Assessments using QoE-SPEO comprise three steps: (1) judge the level of expected heterogeneity (defined as non-spurious variability that can be expected in exposure prevalence, within or between individual persons, because exposure may change over space and/or time), (2) assess downgrade domains, and (3) reach a final rating on the quality of evidence. Assessments are conducted using the same five downgrade domains as the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach: (a) risk of bias, (b) indirectness, (c) inconsistency, (d) imprecision, and (e) publication bias. For downgrade domains (c) and (d), the assessment varies depending on the level of expected heterogeneity. There are no upgrade domains. The QoE-SPEO’s ratings are “very low”, “low”, “moderate”, and “high”. To arrive at a final decision on the overall quality of evidence, the assessor starts at “high” quality of evidence and for each domain downgrades by one or two levels for serious concerns or very serious concerns, respectively. In pilot tests, there was reasonable agreement in ratings for expected heterogeneity; 70% of raters selected the same rating. Inter-rater agreement ranged considerably between downgrade domains, both for individual rater pairs (range Pi: 0.36–1.00) and rater teams (0.20–1.00). Sparse data prevented rigorous assessment of inter-rater agreement in quality of evidence ratings. Conclusions: We present QoE-SPEO as an approach for assessing quality of evidence in prevalence studies of exposure to occupational risk factors. It has been developed to its current version (as presented here), has undergone pilot testing, and was applied in the systematic reviews for the WHO/ILO Joint Estimates. While the approach requires further testing and development, it makes steps towards filling an identified gap, and progress made so far can be used to inform future work in this area.

Background: As part of the development of the World Health Organization (WHO)/International Labour Organization (ILO) Joint Estimates of the Work-related Burden of Disease and Injury, WHO and ILO carried out several systematic reviews to determine the prevalence of exposure to selected occupational risk factors. Risk of bias assessment for individual studies is a critical step of a systematic review. No tool existed for assessing the risk of bias in prevalence studies of exposure to occupational risk factors, so WHO and ILO developed and pilot tested the RoB-SPEO tool for this purpose. Here, we investigate the assessor burden, inter-rater agreement, and user experience of this new instrument, based on the abovementioned WHO/ILO systematic reviews. Methods: Twenty-seven individual experts applied RoB-SPEO to assess risk of bias. Four systematic reviews provided a total of 283 individual assessments, carried out for 137 studies. For each study, two or more assessors independently assessed risk of bias across the eight RoB-SPEO domains selecting one of RoB-SPEO’s six ratings (i.e., “low”, “probably low”, “probably high”, “high”, “unclear” or “cannot be determined”). Assessors were asked to report time taken (i.e. indicator of assessor burden) to complete each assessment and describe their user experience. To gauge assessor burden, we calculated the median and inter-quartile range of times taken per individual risk of bias assessment. To assess inter-rater reliability, we calculated a raw measure of inter-rater agreement (Pi) for each RoB-SPEO domain, between Pi = 0.00, indicating no agreement and Pi = 1.00, indicating perfect agreement. As subgroup analyses, Pi was also disaggregated by systematic review, assessor experience with RoB-SPEO (≤10 assessments versus > 10 assessments), and assessment time (tertiles: ≤25 min versus 26–66 min versus ≥ 67 min). To describe user experience, we synthesised the assessors’ comments and recommendations. Results: Assessors reported a median of 40 min to complete one assessment (interquartile range 21–120 min). For all domains, raw inter-rater agreement ranged from 0.54 to 0.82. Agreement varied by systematic review and assessor experience with RoB-SPEO between domains, and increased with increasing assessment time. A small number of users recommended further development of instructions for selected RoB-SPEO domains, especially bias in selection of participants into the study (domain 1) and bias due to differences in numerator and denominator (domain 7). Discussion: Overall, our results indicated good agreement across the eight domains of the RoB-SPEO tool. The median assessment time was comparable to that of other risk of bias tools, indicating comparable assessor burden. However, there was considerable variation in time taken to complete assessments. Additional time spent on assessments may improve inter-rater agreement. Further development of the RoB-SPEO tool could focus on refining instructions for selected RoB-SPEO domains and additional testing to assess agreement for different topic areas and with a wider range of assessors from different research backgrounds.

Background: The World Health Organization (WHO) and the International Labour Organization (ILO) are developing joint estimates of the work-related burden of disease and injury (WHO/ILO Joint Estimates), with contributions from a large network of individual experts. Evidence from mechanistic data and prior studies suggests that exposure to long working hours may cause stroke. In this paper, we present a systematic review and meta-analysis of parameters for estimating the number of deaths and disability-adjusted life years from stroke that are attributable to exposure to long working hours, for the development of the WHO/ILO Joint Estimates. Objectives: We aimed to systematically review and meta-analyse estimates of the effect of exposure to long working hours (three categories: 41–48, 49–54 and ≥55 h/week), compared with exposure to standard working hours (35–40 h/week), on stroke (three outcomes: prevalence, incidence, and mortality). Data sources: A protocol was developed and published, applying the Navigation Guide to systematic reviews as an organizing framework where feasible. We searched electronic databases for potentially relevant records from published and unpublished studies, including Ovid MEDLINE, PubMed, EMBASE, Scopus, Web of Science, CISDOC, PsycINFO, and WHO ICTRP. We also searched grey literature databases, Internet search engines, and organizational websites; hand-searched reference lists of previous systematic reviews; and consulted additional experts. Study eligibility and criteria: We included working-age (≥15 years) individuals in the formal and informal economy in any WHO and/or ILO Member State but excluded children (aged

Background: The World Health Organization (WHO) and the International Labour Organization (ILO) are developing joint estimates of the work-related burden of disease and injury (WHO/ILO Joint Estimates). For this, systematic reviews of studies estimating the prevalence of exposure to selected occupational risk factors will be conducted to provide input data for estimations of the number of exposed workers. A critical part of systematic review methods is to assess risk of bias (RoB) of individual studies. In this article, we present and describe the development of such a tool, called the Risk of Bias in Studies estimating Prevalence of Exposure to Occupational risk factors (RoB-SPEO) tool; report results from RoB-SPEO's pilot testing; note RoB-SPEO's limitations; and suggest how the tool might be tested and developed further. Methods: Selected existing RoB tools used in environmental and occupational health systematic reviews were reviewed and analysed. From existing tools, we identified domains for the new tool and, if necessary, added new domains. For each domain, we then identified and integrated components from the existing tools (i.e. instructions, domains, guiding questions, considerations, ratings and rating criteria), and, if necessary, we developed new components. Finally, we elicited feedback from other systematic review methodologists and exposure scientists and agreed upon RoB-SPEO. Nine experts pilot tested RoB-SPEO, and we calculated a raw measure of inter-rater agreement (Pi) for each of its domain, rating Pi 0.80 as almost perfect agreement. Results: Our review found no standard tool for assessing RoB in prevalence studies of exposure to occupational risk factors. We identified six existing tools for environmental and occupational health systematic reviews and found that their components for assessing RoB differ considerably. With the new RoB-SPEO tool, assessors judge RoB for each of eight domains: (1) bias in selection of participants into the study; (2) bias due to a lack of blinding of study personnel; (3) bias due to exposure misclassification; (4) bias due to incomplete exposure data; (5) bias due to conflict of interest; (6) bias due to selective reporting of exposures; (7) bias due to difference in numerator and denominator; and (8) other bias. The RoB-SPEO's ratings are low, probably low, probably high, high or no information. Pilot testing of the RoB-SPEO tool found substantial inter-rater agreement for six domains (range of Pi for these domains: 0.51–0.80), but poor agreement for two domains (i.e. Pi of 0.31 and 0.33 for biases due to incomplete exposure data and in selection of participants into the study, respectively). Limitations of RoB-SPEO include that it has not yet been fully performance-tested. Conclusions: We developed the RoB-SPEO tool for assessing RoB in prevalence studies of exposure to occupational risk factors. The tool will be applied and its performance tested in the ongoing systematic reviews for the WHO/ILO Joint Estimates.

Objetivo: discutir o processo regulatório de medicamentos para doenças raras no Brasil, com base no caso Zolgensma®, e avaliar criticamente as evidências disponíveis até o momento sobre a eficácia e a segurança do Zolgensma® no tratamento da atrofia muscular espinhal (AME). Metodologia: estudo descritivo realizado no Núcleo de Avaliação de Tecnologias em Saúde do Hospital Sírio-Libanês (NATS-HSL) em junho de 2019. Resultados: em abril de 2019, o uso do Zolgensma® para AME foi regulamentado nos Estados Unidos com base em dois estudos clínicos abertos (sem mascaramento), sem grupo comparador paralelo (e, portanto, não randomizados). Essas limitações metodológicas aumentam a incerteza nos resultados encontrados. A Agência Nacional de Vigilância Sanitária (Anvisa) aprovou estratégias para regulamentar o processo e os prazos de análise das submissões de registro de novos medicamentos para doenças raras, caso do Zolgensma®. Conclusão: faz-se necessário ampliar o debate em torno do processo de regulamentação e de incorporação de medicamentos órfãos para doenças raras no Brasil. O debate deve incluir as evidências relacionadas aos efeitos – benefícios e riscos – desses medicamentos, e maior clareza nos critérios para concessão de registro e recomendação de incorporação em sistemas de saúde.

Este artigo relata as conclusões da reunião de consenso com médicos especialistas sobre diagnóstico de narcolepsia baseada na revisão dos artigos sobre narcolepsia listados no Medline entre 1980 e 2010. A narcolepsia é uma doença crônica de início entre a primeira e segunda décadas de vida do indivíduo. Os sintomas essenciais são cataplexia e sonolência excessiva. A cataplexia é definida como episódios súbitos, recorrentes e reversíveis de fraqueza da musculatura esquelética desencadeados por situações de conteúdo emocional. Os sintomas acessórios são alucinações hipnagógicas, paralisia do sono e sono fragmentado. Critérios de diagnóstico clínico de acordo com a Classificação Internacional dos Transtornos do Sono são de sonolência excessiva e cataplexia. Recomenda-se a realização de polissonografia seguida do teste de latência múltipla do sono em um laboratório de sono para confirmação e diagnóstico de comorbidades. Quando não houver cataplexia, deve haver duas ou mais sonecas com sono REM no teste de latência múltipla do sono. Tipagem HLA-DQB1*0602 positiva com níveis de hipocretina-1 abaixo de 110pg/mL devem estar presentes para o diagnóstico de narcolepsia sem cataplexia e sem sonecas com sono REM.This manuscript contains the conclusion of the consensus meeting on the diagnosis of narcolepsy based on the review of Medline publications between 1980-2010. Narcolepsy is a chronic disorder with age at onset between the first and second decade of life. Essential narcolepsy symptoms are cataplexy and excessive sleepiness. Cataplexy is defined as sudden, recurrent and reversible attacks of muscle weakness triggered by emotions. Accessory narcolepsy symptoms are hypnagogic hallucinations, sleep paralysis and nocturnal fragmented sleep. The clinical diagnosis according to the International Classification of Sleep Disorders is the presence of excessive sleepiness and cataplexy. A full in-lab polysomnography followed by a multiple sleep latency test is recommended for the confirmation of the diagnosis and co-morbidities. The presence of two sleep-onset REM period naps in the multiple sleep latency test is diagnostic for cataplexy-free narcolepsy. A positive HLA-DQB1*0602 with lower than 110pg/mL level of hypocretin-1 in the cerebrospinal fluid is required for the final diagnosis of cataplexy- and sleep-onset REM period -free narcolepsy.

Este artigo relata as conclusões da reunião de consenso da Associação Brasileira de Sono com médicos especialistas brasileiros sobre o tratamento da narcolepsia, baseado na revisão dos artigos sobre narcolepsia publicados entre 1980 e 2010. Os objetivos do consenso são valorizar o uso de agentes avaliados em estudos randomizados placebo-controlados, emitir recomendações de consenso para o uso de outras medicações e informar pontos importantes a respeito da segurança e efeitos adversos das medicações. O tratamento da narcolepsia é baseado em diversas classes de agentes, estimulantes para sonolência excessiva, agentes antidepressivos para cataplexia e hipnóticos para sono noturno fragmentado. Medidas comportamentais são igualmente importantes e recomendadas universalmente. Todos os ensaios clínicos terapêuticos foram classificados de acordo com o nível de qualidade da evidência. Recomendações terapêuticas individualizadas para cada tipo de sintoma e recomendações gerais foram formuladas pelos autores. Modafinila é indicada como a primeira escolha para o tratamento da sonolência diurna. Agentes de segunda escolha para o tratamento da sonolência excessiva são metilfenidato de liberação lenta seguido pelo mazindol. Reboxetina, clomipramina, venlafaxina, desvenlafaxina e os inibidores seletivos de recaptação de serotonina em doses altas são a primeira escolha para o tratamento da cataplexia. Hipnóticos são utilizados para o tratamento do sono noturno fragmentado. Antidepressivos e hipnóticos são igualmente utilizados para o tratamento das alucinações hipnagógicas e paralisia do sono.This manuscript contains the conclusion of the consensus meeting of the Brazilian Sleep Association with Brazilian sleep specialists on the treatment of narcolepsy based on the review of medical literature from 1980 to 2010. The manuscript objectives were to reinforce the use of agents evaluated in randomized placebo-controlled trials and to issue consensus opinions on the use of other available medications as well as to inform about safety and adverse effects of these medications. Management of narcolepsy relies on several classes of drugs, namely, stimulants for excessive sleepiness, antidepressants for cataplexy and hypnotics for disturbed nocturnal sleep. Behavioral measures are likewise valuable and universally recommended. All therapeutic trials were analyzed according to their class of evidence. Recommendations concerning the treatment of each single symptom of narcolepsy as well as general recommendations were made. Modafinil is the first-line pharmacological treatment of excessive sleepiness. Second-line choices for the treatment of excessive sleepiness are slow-release metylphenidate followed by mazindol. The first-line treatments of cataplexy are the antidepressants, reboxetine, clomipramine, venlafaxine, desvenlafaxine or high doses of selective serotonin reuptake inibitors antidepressants. As for disturbed nocturnal sleep the best option is still hypnotics. Antidepressants and hypnotics are used to treat hypnagogic hallucinations and sleep paralysis.