Bipolar Disorders Programme, Hospital Clínic, University of Barcelona, IDIBAPS, CIBERSAM, Villarroel 170, 08036 Barcelona, Spain.
BMC Psychiatry. 2011 Apr 11;11:58. doi: 10.1186/1471-244X-11-58.
Studies in bipolar disorder (BD) to date are limited in their ability to provide a whole-disease perspective--their scope has generally been confined to a single disease phase and/or a specific treatment. Moreover, most clinical trials have focused on the manic phase of disease, and not on depression, which is associated with the greatest disease burden. There are few longitudinal studies covering both types of patients with BD (I and II) and the whole course of the disease, regardless of patients' symptomatology. Therefore, the Wide AmbispectiVE study of the clinical management and burden of Bipolar Disorder (WAVE-bd) (NCT01062607) aims to provide reliable information on the management of patients with BD in daily clinical practice. It also seeks to determine factors influencing clinical outcomes and resource use in relation to the management of BD.
WAVE-bd is a multinational, multicentre, non-interventional, longitudinal study. Approximately 3000 patients diagnosed with BD type I or II with at least one mood event in the preceding 12 months were recruited at centres in Austria, Belgium, Brazil, France, Germany, Portugal, Romania, Turkey, Ukraine and Venezuela. Site selection methodology aimed to provide a balanced cross-section of patients cared for by different types of providers of medical aid (e.g. academic hospitals, private practices) in each country. Target recruitment percentages were derived either from scientific publications or from expert panels in each participating country. The minimum follow-up period will be 12 months, with a maximum of 27 months, taking into account the retrospective and the prospective parts of the study. Data on demographics, diagnosis, medical history, clinical management, clinical and functional outcomes (CGI-BP and FAST scales), adherence to treatment (DAI-10 scale and Medication Possession Ratio), quality of life (EQ-5D scale), healthcare resources, and caregiver burden (BAS scale) will be collected. Descriptive analysis with common statistics will be performed.
This study will provide detailed descriptions of the management of BD in different countries, particularly in terms of clinical outcomes and resources used. Thus, it should provide psychiatrists with reliable and up-to-date information about those factors associated with different management patterns of BD.
ClinicalTrials.gov: NCT01062607.
迄今为止，双相障碍（BD）的研究在提供全疾病视角方面能力有限——其范围通常仅限于单一疾病阶段和/或特定治疗。此外，大多数临床试验都集中在疾病的躁狂阶段，而不是与最大疾病负担相关的抑郁阶段。几乎没有涵盖 BD（I 型和 II 型）两种类型患者和整个疾病过程的纵向研究，无论患者的症状如何。因此，双相障碍的广泛双向临床管理和负担研究（WAVE-bd）（NCT01062607）旨在提供有关日常临床实践中 BD 患者管理的可靠信息。它还旨在确定与 BD 管理相关的影响临床结果和资源利用的因素。
WAVE-bd 是一项多国家、多中心、非干预性、纵向研究。大约 3000 名被诊断为 BD 型 I 或 II 型的患者，在过去 12 个月内至少有一次情绪事件，在奥地利、比利时、巴西、法国、德国、葡萄牙、罗马尼亚、土耳其、乌克兰和委内瑞拉的中心招募。站点选择方法旨在为不同类型的医疗援助提供者（例如学术医院、私人诊所）所照顾的患者提供平衡的横断面。每个参与国家的目标招募百分比要么来自科学出版物，要么来自专家小组。考虑到研究的回顾性和前瞻性部分，最低随访期将为 12 个月，最长为 27 个月。将收集人口统计学、诊断、病史、临床管理、临床和功能结果（CGI-BP 和 FAST 量表）、治疗依从性（DAI-10 量表和用药率）、生活质量（EQ-5D 量表）、医疗资源和照顾者负担（BAS 量表）的数据。将进行描述性分析和常见统计分析。
这项研究将提供不同国家 BD 管理的详细描述，特别是在临床结果和使用的资源方面。因此，它应该为精神科医生提供有关与 BD 不同管理模式相关的那些因素的可靠和最新信息。
ClinicalTrials.gov：NCT01062607。
