Understanding intent to treat analyses: An important lesson from the international cooperative study on the timing of aneurysm surgery.

BACKGROUND AND PURPOSE: Intent-to-treat analyses (ITT) are the best way to analyze randomized clinical trials because they preserve the benefits of randomization: to provide an unbiased assessment of relative treatment effects. Yet they play a more fundamental role, which can be demonstrated with observational studies. METHODS: We use a hypothetical RCT to explain why ITT analyses are more appropriate to analyze RCT results. We review the International Cooperative Study on the Timing of Aneurysm Surgery (ICSTAS), a landmark observational study on the management of ruptured aneurysm patients. We discuss the impact of the ICSTAS lesson on the interpretation of future observational studies using Big Data. RESULTS: Per-protocol (or as-treated) analyses can be misleading: The ICSTAS study provided 'as-treated' results clearly in favour of delayed surgery, while overall management or ITT results showed no difference between early and delayed surgery. A contemporary RCT showed that early surgery was best. ICSTAS' lesson is that observational studies can provide misleading results when intent-to-treat categories are not predefined in the first place. CONCLUSION: Intent-to treat analyses are the most appropriate way to analyze data, whether from randomized trials or observational studies. This observation has momentous consequences. A science of medical practice is impossible without predefined questions regarding optimal care.

Apontamentos metodológicos da pesquisa-intervenção no contexto da assistência social: conexões entre universidade e equipe / Methodological notes at intervention research in the context of social assistance: connections between university and the professional team / Notes methodologiques sur la recherche-intervention dans le cadre de de l'assistance sociale: rapports entre université et équipe

Este texto apresenta reflexões acerca da participação da equipe de profissionais no processo de pesquisa-intervenção institucionalista. Essa discussão se fundamenta nos resultados parciais da pesquisa financiada pelo CNPq/FAPEMIG, que tem como objetivo analisar as relações no território de um Centro de Referência em Assistência Social (CRAS) em Belo Horizonte, enfatizando o modo de gestão do trabalho social entre a equipe e com as famílias. Este estudo tem a pesquisa-intervenção institucionalista como metodologia e as ideias de René Lourau e Deleuze e Guattari como marco teórico. A partir das assembleias e das restituições realizadas com a equipe, rastreamos os efeitos do estudo no cotidiano de trabalho da equipe. Concluímos que essa metodologia participativa envolve a construção de vários dispositivos que têm efeitos transformadores sobre as práticas sociais estudadas.

This article discuss the participation of professional team in the research process of an institutionalist intervention research. This discussion is based on the partial results of a research funded by CNPq / FAPEMIG. The research aims to analyze relationships in the territory of a Reference Center of Social Assistance (CRAS) in Belo Horizonte, emphasizing the management style of social work between staff and with families. This study has as methodology an institutionalist intervention research and the ideas of René Lourau and Deleuze and Guattari as theoretical framework. From the meetings and restitutions made with the team, we track the effects of the study in the daily work of the team. We concluded that this participative methodology involves the construction of several devices that have transformative effects on social practices studied.

Cet article présente des réflexions sur la participation de l'équipeprofessionnelle dans le processus de recherche intervention institutionnaliste. Cette analyse est fondée sur les résultats partiels de la recherche financée par le CNPq et par la FAPEMIG qui vise à analyser les relations dans le territoire d'un Centre de Référence pour l'Assistance Sociale (CRAS) à Belo Horizonte, en mettant l'accent sur le mode de gestion du travail social entre l'équipe et avec les familles. Cette étude a la méthodologie de recherche d'intervention et les idéesde René Lourau et Deleuze et Guattari comme son cadre théorique. De ces réunions et des restitutions qui ont eu lieu avec l l'équipe nous avons suivi les effets de l'étude dans le travail quotidien de l'équipe. Nous concluons que cette méthodologie participative implique la construction de plusieurs dispositifs qui ont des effets de transformation sur les pratiques sociales étudiées.