Estudos categorizados como awaiting classification em revisões sistemáticas Cochrane: frequência, justificativas e adequação às recomendações do Cochrane Handbook

Objectives: To identify the reasons for considering a study as an “awaiting classification study” (ACS) in Cochrane reviews and to propose a guidance for management and reporting the decision for encoding a study as an ACS. Study Design and Setting: A cross-sectional analysis of Cochrane reviews, conducted in the Universidade Federal de São Paulo (UNIFESP), Brazil. Methods: All Cochrane systematic reviews of interventions published in the issues 1 to 6/2019 of the Cochrane Library were assessed. The reviews were manually identified in the Cochrane Library website and its references were manually extracted by two independent authors and organized in a pre-established form. Disagreements in the selection and extraction process were solved by consulting a third researcher. The justifications to consider the classified studies as ACS were distributed in 13 distinct categories. Results: We included 260 Cochrane reviews that classify the study 426 as ACS. The categories more frequently observed to classify the study as ACS were: no sufficient information to include or to exclude (111, 26.06%), justification not reported/not clear (82, 19.25%), study completed but without published results (64, 15.02%) and full text unavailable (62, 14,56%). Other alleged reasons were more infrequent. A guide for authors, reviewers and editors of systematic reviews was proposed to facilitate and make the process of classification more transparent. A checklist was also proposed and may be useful to manage and report ACS in future reviews. We suggested reasons for considering a study an ACS and proposed a checklist that may be useful to proper manage and report ACS in future reviews. Conclusion: The findings of this study showed that the main justification to categorize the studies as ACS were often inadequate or underreported by the review authors. This can be considered a shortcoming that compromise the transparency, reliability and reproducibility of Cochrane reviews. The adoption of a standardized checklist may be an initial strategy to improve this scenario. Future actions are warranted to better understand the impact of ACS in Cochrane systematic reviews and other systematic reviews.Objetivos: Identificar as razões para considerar o estudo como “awaiting classification study” (ACS) em revisões sistemáticas Cochrane e propor um guia para relatar as decisões e categorizar o estudo como ACS. Desenho de estudo e local: Estudo transversal de revisões sistemáticas Cochrane, conduzido na Universidade Federal de São Paulo (Unifesp). Métodos: Foram avaliadas todas as revisões sistemáticas Cochrane de intervenção publicadas na Cochrane Library nas edições 1 a 6 do ano de 2019. As revisões foram identificadas manualmente na página da Cochrane Library e suas referências foram extraídas por dois pesquisadores independentes e organizadas em uma planilha padronizada pré-estabelecida. Divergências no processo de seleção e extração de dados foram resolvidas pela consulta de um terceiro pesquisador. As justificativas para considerar os estudos classificados como ACS foram então distribuídas em 13 categorias distintas. Resultados: Foram incluídas 260 revisões sistemáticas que classificaram 462 estudos como ACS. As categorias mais frequentemente observadas para a classificação do estudos como ACS foram: ausência de informações suficientes para decidir sobre a inclusão ou não do estudo na revisão (111, 26,06%), justificativa não apresentada ou relatada de modo insuficiente (82, 19,25%), estudo finalizado mas sem resultados publicados (64, 15,02%) e texto completo indisponível (62, 14,56%). Outras justificativas foram mais infrequentes. Foi proposto um guia para autores, revisores e editores de revisões sistemáticas para facilitar e tornar o processo de classificação mais transparente. Também foi proposto um checklist que poderá ser útil para conduzir e relatar ACS em revisões futuras. Conclusão: Os achados deste estudo mostraram que as principais justificativas para categorizar os estudos como ACS foram frequentemente inadequadas ou relatadas de modo inadequado pelos autores das revisões sistemáticas. Esta limitação pode comprometer a transparência, a confiança e a reprodutibilidade de revisões sistemáticas Cochrane. A adoção de um checklist padronizado pode ser uma estratégia inicial para melhorar este cenário. Ações futuras ainda são necessárias para entender melhor o impacto dos ACS em revisões sistemáticas Cochrane e outras revisões.Dados abertos - Sucupira - Teses e dissertações (2019

Hydroxychloroquine and chloroquine for COVID-19 infection. Rapid systematic review

CONTEXT: Based on the results of preliminary studies, the off-label use of hydroxychloroquine for COVID-19 infection has been observed in practice. OBJECTIVES: To identify, systematically assess and summarize the best available evidence on the efficacy and safety of the use of hydroxychloroquine and chloroquine for COVID-19 infection. METHODS: Rapid systematic review. RESULTS: After the selection process, 30 studies were included: one open-label randomized trial, one open-label non-randomized trial and 28 ongoing studies. The outcome 'detection of viral load in oral swab' (surrogate outcome) was evaluated by both studies, involving a total of 72 participants. The findings of the studies were discordant: one study observed a higher frequency of negative viral load associated with hydroxychloroquine on day-7, while the other study did not observe any difference between hydroxychloroquine and the control group (standard treatment) on day-6. Both studies have methodological limitations when evaluated by specific tools according to study design (Cochrane Bias Risk Table and ROBINS-I). CONCLUSION: This rapid systematic review identified two clinical studies (with available data), with limited methodological quality, that evaluated the effects of hydroxychloroquine for COVID-19 infection. Based on the findings of these two studies, the efficacy and safety of hydroxychloroquine and chloroquine in patients with COVID-19 is still uncertain (very low evidence certainty) and its routine use for this situation should not be recommended until the results of ongoing studies could provide a proper assessment of their effects

What is an “ongoing” clinical trial? An analysis of different sources revealed heterogeneous definitions of when a clinical trial starts and ends: a meta-research study

ABSTRACT BACKGROUND: Although the concept of an “ongoing study” seems self-explanatory, it is difficult to determine whether a trial is underway. OBJECTIVE: To analyze the definitions of “ongoing clinical trial” across different clinical trial registries, methodological guidelines, and other sources. DESIGN AND SETTING: This meta-research study was conducted at the Universidade Federal de São Paulo (UNIFESP), Brazil. METHODS: We performed a cross-sectional analysis of relevant clinical trial registry databases, methodological guidelines for conducting systematic reviews, and other sources that would define or regulate clinical trials. RESULTS: We identified various heterogeneous definitions used by eligible sources at both the start and end of a clinical trial. The starting criteria used were as follows: when the team is planning the protocol, when permission is given to conduct the study, or when the first participant is enrolled. Some sources used the time at which the last outcome data was collected as a criterion to determine the end of the trial. The International Committee of Medical Journal Editors stated that a study is still “ongoing” during the analysis process. Several sources use a vague definition or present no clear criteria for defining the start or end of a study. CONCLUSION: The concept of “ongoing clinical trials” lacks a transparent and homogeneous definition across relevant sources. A consensus on this concept is important to facilitate the evaluation of available evidence and conduct research synthesis. Further efforts are necessary to determine the best definition for the start and end of a clinical trial