Dataset Information

Pharmacological treatment profiles in the FACE-BD cohort: Treatment description and complete data for bipolar subtypes.

ABSTRACT: In the current study, we provide the list of pharmacological interventions applied during the one-year follow-up period of the Pharmacological treatment profiles in the FACE-BD cohort study. These data show the treatments used in the new clusters formed in this previous study and also in usual bipolarity subtypes. The proportion of each treatment used during the follow-up was calculated. Days on each treatment were also included in this dataset. The complete clinical and paraclinical data analyzed for clusters and bipolar subtypes were included in this dataset. Socio-demographic self-administered and clinician-administered scales, clinical evaluation during the follow-up, psychiatric and somatic comorbidities, and blood tests are shown in this material.

SUBMITTER: Brodeur S

PROVIDER: S-EPMC8027517 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature

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Pharmacological treatment profiles in the FACE-BD cohort: Treatment description and complete data for bipolar subtypes.

Brodeur Sébastien S Terrisse Hugo H Pouchon Arnaud A Godin Ophelia O Aouizerate Bruno B Aubin Valerie V Bellivier Frank F Belzeaux Raoul R Bougerol Thierry T Courtet Philippe P Dubertret Caroline C Gard Sebastien S Haffen Emmanuel E Henry Chantal C Leboyer Marion M Olié Emilie E Roux Paul P Samalin Ludovic L Schwan Raymund R Etain Bruno B Bosson Jean-Luc JL Polosan Mircea M

Data in brief 20210325

In the current study, we provide the list of pharmacological interventions applied during the one-year follow-up period of the Pharmacological treatment profiles in the FACE-BD cohort study. These data show the treatments used in the new clusters formed in this previous study and also in usual bipolarity subtypes. The proportion of each treatment used during the follow-up was calculated. Days on each treatment were also included in this dataset. The complete clinical and paraclinical data analyz ...[more]

PMID: 33855141

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Project description:BackgroundShared decision-making (SDM) is a model of interaction between doctors and patients in which both actors contribute to the medical decision-making process. SDM has raised great interest in mental healthcare over the last decade, as it is considered a fundamental part of patient-centered care. However, there is no research evaluating the efficacy of SDM compared to usual care (CAU), as it relates to quality of care and more specifically treatment adherence, in bipolar disorder (BD).Methods/designThis is a 12-month multi-centre, cluster-randomized controlled trial comparing the efficacy of SDM to CAU. Adult BD patients (n = 300) will be eligible after stabilization for at least 4 weeks following an acute mood episode. The intervention will consist of applying the standardized SDM process as developed by the Ottawa Hospital Research Institute in order to choose the maintenance treatment of BD. A multidisciplinary team developed a decision aid "choose my long-term treatment with my doctor" for BD patients to clarify possible therapeutic options. Primary outcome will assess the patient's level of adherence (based on hetero-evaluation) of ongoing treatment at 12 months. Secondary outcomes will assess the difference between the 2 groups of patients in terms of adherence to maintenance drug therapy based on other measures (self-assessment scale and plasma levels of mood stabilizers). Additionally, other dimensions will be assessed: decisional conflict, satisfaction with care and involvement in decision making, beliefs about treatment, therapeutic relationship, knowledge about information for medical decision and clinical outcomes (depression, mania, functioning and quality of life). The primary endpoint will be analysed without adjustment by comparison of adherence scores between the two groups using Student t-tests or Mann-Whitney tests according to the variable distribution. A set of secondary analyses will be adjusted for covariates of clinical interest using generalized linear mixed regression models.DiscussionThis will be the first study evaluating the effect of an SDM intervention on patient adherence in BD. This is also an innovative protocol because it proposes the development of an evidence-based tool that should help patients and clinicians to initiate discussions regarding the use of BD treatment.Trial registrationThe study has been registered with ClinicalTrials.gov as NCT03245593 .

Dataset Information

Pharmacological treatment profiles in the FACE-BD cohort: Treatment description and complete data for bipolar subtypes.

Publications

Pharmacological treatment profiles in the FACE-BD cohort: Treatment description and complete data for bipolar subtypes.

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