Bipolar disorder measures in clinical care

拟议的项目目标是确定哪种经过验证的双相情感障碍工具最多 在临床护理中能被患者和临床医生接受和帮助，说明首选 该仪器可用于在常规护理中高保真地监测结果，并评估其可行性 在一项随机试验中比较基于测量的护理(MBC)和常规护理的有效性。 许多双相情感障碍患者都有波动的抑郁和躁狂症状， 会损害功能，降低生活质量。基于测量的护理(MBC)是一种新兴的最佳 包括对临床状态进行系列评估并使用这些结果为临床决策提供信息的实践 制作。当实施时，MBC会帮助临床医生调整治疗，使之“对准治疗目标”。 然而，还没有研究确定在临床护理中使用首选的双相情感障碍措施。 此外，双相情感障碍患者采用MBC的吸收率特别低。 常规护理。在对双相情感障碍的系列评估中使用哪种方法缺乏共识 临床状态紊乱可能是由于难以评估双相情感障碍患者的临床状态所致。 无序。有多种方法可以测量临床状态，包括测量功能或 症状，当测量症状时，有必要测量两种抑郁的变化 和躁狂症状。具体地说，对于如何解释症状分级可能存在不确定性 关于权衡抑郁和躁狂症状严重性的结果(特别是 当它们在时间点之间以相反的方向变化时)。有必要确定最佳的 用于双相情感障碍患者的单核细胞检测。本R34的目标包括：1)使用 定性方法，从双相情感障碍患者那里获得信息以选择首选的工具 用于监测双相情感障碍的临床状态是可接受的、有帮助的和可以理解的 通知何时改变治疗方法。在目标1中，我们期望确定和识别MBC仪器，该仪器 被诊断为双相情感障碍的患者被认为是可接受的、有帮助的和可以理解的。 接下来，在目标2)中，在单臂开放试验中，评估MBC使用首选的治疗工具的可行性 双相情感障碍和评估对协议的忠诚度，包括仪器管理、评分和 查看结果。在目标2中，我们希望实现对MBC协议的高保真。在目标3)中进行 MBC与首选工具的随机实用试验有效性比较 双相情感障碍转为常规治疗。我们将测试Aim 3假设，即治疗调整将会发生 在MBC组中比常规护理组更常见，并且探索性假设症状 与常规护理组相比，MBC组双相情感障碍的发生率下降得更多。这些发现将 支持R01应用程序进行最终的随机试验。

The proposed project goal is to determine which validated bipolar disorder instrument is most acceptable and helpful to patients and clinicians in clinical care, demonstrate that the preferred instrument can be used to monitor outcomes with high fidelity in routine care, and assess the feasibility of comparing effectiveness of measurement-based care (MBC) to usual care in a randomized trial. Many individuals with bipolar disorder experience fluctuating depressive and manic symptoms which can impair functioning and reduce quality of life. Measurement based care (MBC) is an emerging best practice involving serial assessment of clinical status and using those findings to inform clinical decision making. When implemented with fidelity, MBC helps clinicians adjust treatment to “treat to target”. However, no studies have determined preferred bipolar disorder measures for use in clinical care. Furthermore, adoption of MBC for individuals with bipolar disorder has had especially low uptake in routine care. The lack of consensus about which measure to use in serial assessment of bipolar disorder clinical status is likely due to the difficulty of assessing clinical status for patients with bipolar disorder. There are multiple ways to measure clinical status including measuring functioning or symptoms, and when measuring symptoms, there is a need to measure changes in both depressive and manic symptoms. Specifically, there may be uncertainty about how to interpret symptom scale results with respect to weighing the importance of depression and manic symptom severity (particularly when they vary in opposite directions between time points). There is a need to determine the optimal measure for use in MBC for individuals with bipolar disorder. Aims of this R34 include: 1) Using qualitative methods, obtain input from people with bipolar disorder to choose the preferred instrument for monitoring bipolar disorder clinical status that is acceptable, helpful, and understandable in informing when to change treatment. In Aim 1 we expect to identify an Identify an MBC instrument that is perceived to be acceptable, helpful, and understandable to patients diagnosed with bipolar disorder. Next, in Aim 2) In a single arm open trial, assess the feasibility of MBC with the preferred instrument for bipolar disorder and assess fidelity to the protocol including instrument administration, scoring, and reviewing results. In Aim 2 we expect to achieve high fidelity to the MBC protocol. In Aim 3) Conduct a randomized pragmatic pilot effectiveness trial comparing the MBC with the preferred instrument for bipolar disorder to usual care. We will test the Aim 3 hypothesis that treatment adjustments will occur more often in the MBC group than the usual care group, and the exploratory hypothesis that symptoms of bipolar disorder will decrease more in the MBC group than the usual care group. These findings will support an R01 application to conduct a definitive randomized trial.