Addressing Challenges in Schizophrenia Research

描述（由申请人提供）：该K23指导患者导向研究职业发展奖将使候选人能够发展成为精神分裂症干预研究的独立研究者和学者所需的技能和经验。候选人正在从卫生服务过渡到干预研究，以便直接解决他作为临床医生所面临的问题。工作的主要重点将是药物依从性。最重要的假设是，药物不依从性是影响良好结果的多因素障碍，可以通过解决潜在原因的特定干预措施或干预措施组合来克服。另一个重点是精神分裂症患者的决策能力，这对药物依从性和人类受试者保护具有重要意义。职业目标是：1)提高对与临床试验设计和分析方法相关的理论、概念和方法的理解；2)获得对弱势群体中人类受试者保护的问题和理论基础的额外接触，重点是决策能力；3)在药物依从性和决策能力领域建立作为研究者的可信度；4)设计并试点一项新的临床有效性试验，研究一组高危精神分裂症患者的药物依从性和结果。有经验的导师指导下的研究是职业发展计划的主要组成部分。课程、辅导和研讨会将是进一步发展方法技能和发展治疗依从性和决策能力方面的专业知识的机制。将进行两个研究项目。项目1将使用从精神分裂症临床抗精神病药物干预有效性试验（CATIE）中收集的数据，对药物依从性、疾病意识和决策能力进行新的纵向评估。项目2将建立一项纵向有效性试验的可行性，以检查一种干预措施，以改善精神分裂症患者的药物依从性和预后。该试点研究将建立在项目1中所学到的基础上，并将指导设计并为随后的R01应用提供初步数据。在职业发展阶段结束时，申请人将具备领导旨在提高治疗依从性的干预研究所需的技能和经验。申请人的职业生涯将侧重于设计和测试干预措施，以改善严重受精神分裂症影响的人的结果。

DESCRIPTION (provided by applicant): This K23 Mentored Patient-Oriented Research Career Development Award will enable the candidate to develop the skills and experience necessary to become an independent investigator and scholar in interventions research for schizophrenia. The candidate is making a transition from health services to interventions research in order to address directly problems he has confronted as a clinician. The primary focus of work will be medication adherence. The overarching hypothesis is that medication non-adherence is a multifactorial barrier to good outcomes that is surmountable with specific interventions, or combinations of interventions, that address the underlying causes. An additional focus is on the decision-making capacity of persons with schizophrenia, which has important implications for medication adherence and for human subjects protections. The career objectives are to: 1) Improve understanding of the theory, concepts, and methodology related to design and analysis methods for clinical trials, 2) Gain additional exposure to issues and theoretical underpinnings of human subjects protections in vulnerable populations, with an emphasis on decision-making capacity, 3) Establish credibility as an investigator in the area of medication adherence and decision-making capacity, 4) Design and pilot test a novel clinical effectiveness trial addressing medication adherence and outcomes in a group of schizophrenic patients at high risk of non-adherence. Supervised research with experienced mentors is the main component of the career development plan. Coursework, tutorials, and workshops will be the mechanism to further develop methodologic skills and to develop expertise in treatment adherence and decision-making capacity. Two research projects will be pursued. Project 1 will use data collected in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia trial to conduct a novel longitudinal evaluation of medication adherence, awareness of illness, and decision-making capacity. Project 2 will establish the feasibility of a longitudinal effectiveness trial examining an intervention to improve medication adherence and outcomes in schizophrenia. This pilot study will build upon what is learned in Project 1 and will guide the design and provide preliminary data for a subsequent R01 application. At the end of the career development period, the applicant will have the skills and experience needed to lead studies of interventions designed to improve treatment adherence. The applicant's career will focus on designing and testing interventions to improve outcomes of persons who are severely affected by schizophrenia.