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BACKGROUND: PROUD participants were randomly assigned to receive pre-exposure prophylaxis (PrEP) immediately or after a deferred period of one-year. We report on the acceptability of this open-label wait-listed trial design. METHODS: Participants completed an acceptability questionnaire, which included categorical study acceptability data and free-text data on most and least liked aspects of the study. We also conducted in-depth interviews (IDI) with a purposely selected sub-sample of participants. RESULTS: Acceptability questionnaires were completed by 76% (415/544) of participants. After controlling for age, immediate-group participants were almost twice as likely as deferred-group participants to complete the questionnaire (AOR:1.86;95%CI:1.24,2.81). In quantitative data, the majority of participants in both groups found the wait-listed design acceptable when measured by satisfaction of joining the study, intention to remain in the study, and interest in joining a subsequent study. However, three-quarters thought that the chance of being in the deferred-group might put other volunteers off joining the study. In free-text responses, data collection tools were the most frequently reported least liked aspect of the study. A fifth of deferred participants reported 'being deferred' as the thing they least liked about the study. However, more deferred participants disliked the data collection tools than the fact that they had to wait a year to access PrEP. Participants in the IDIs had a good understanding of the rationale for the open-label wait-listed study design. Most accepted the design but acknowledged they were, or would have been, disappointed to be randomised to the deferred group. Five of the 25 participants interviewed reported some objection to the wait-listed design. CONCLUSION: The quantitative and qualitative findings suggest that in an environment where PrEP was not available, the rationale for the wait-listed trial design was well understood and generally acceptable to most participants in this study.

L’utilisation des bases de données médico-administratives pour les études sur des questions de santé mentale est très fréquente compte tenu du grand nombre de personnes représentées dans ces bases de données et aussi du fait qu’elles portent sur plusieurs années. Plusieurs défis, liés par exemple à l’identification des personnes ayant une maladie d’intérêt ou exposées à un facteur de risque, sont à surmonter à travers des études de validation pour garantir une utilisation optimale de ces ressources. Par ailleurs, des limites (absence de certaines informations pertinentes) et la couverture d’une seule partie de la population par le régime public d’assurance médicaments du Québec sont à considérer dans l’interprétation et la généralisation des résultats des recherches à partir de ces bases de données.Dans cet article, nous avons réalisé un survol de l’utilisation des bases de données médico-administratives pour des études épidémiologiques, en utilisant comme exemple le cas spécifique de la dépression. Nous avons en particulier utilisé ces bases de données pour déterminer l’incidence de la dépression parmi les personnes diabétiques du Québec. Cela a nécessité l’utilisation d’un algorithme préalablement validé (dans une autre province) que nous avons modifié pour définir et identifier les cas de dépression dans les bases de données de la Régie de l’assurance maladie du Québec (RAMQ). Nous avons observé une incidence de dépression de 9,47/1000 personnes-années sur un suivi de 8 ans. Enfin, nous avons évalué l’impact de la dépression sur l’adhésion et la persistance aux traitements antidiabétiques ainsi que les facteurs qui affectent l’utilisation des médicaments par ces patients. Nos résultats suggèrent que la dépression a un impact négatif sur l’utilisation des médicaments antidiabétiques et permettent d’identifier des pistes de solution., The use of medico-administrative databases for studies on mental health issues is very common because of the large number of people in these databases and the possibility to carry out long-term studies. Several challenges, such as identifying people with a disease of interest or being exposed to a risk factor, have to be overcome through validation studies to ensure an optimal use of these resources. Moreover, limits (lack of certain relevant information) and the coverage of about 40% of Quebec’s population by the public drug plan are to be considered in the interpretation and generalization of research results based on these data sources.In the specific case of depression, we used these databases to determine the incidence of depression among diabetic individuals in Quebec. This required the use of a previously validated algorithm (validated in another province) that we modified to define and identify the cases of depression in the RAMQ databases. We observed an incidence of depression of 9.47 persons years over a follow-up of 8 years. Finally, we assessed the impact of depression on adherence and persistence with antidiabetic drugs as well as the factors that affect patients’ use of these drugs. Our results suggest that depression has a negative impact on the use of antidiabetic drugs and allow the identification of possible solutions.

[Figure][1] As I have written before, the health care community in San Diego has universally come together for the rather audacious aim of reducing the number of heart attacks and strokes in our county by 50% in 5 years. The basis of this effort is to have all citizens reach guideline