...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>The journal of clinical psychiatry >Participants with schizophrenia retain the information necessary for informed consent during clinical trials
【24h】

Participants with schizophrenia retain the information necessary for informed consent during clinical trials

机译：精神分裂症的参与者保留临床试验期间知情同意所需的信息

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Objective: Cognitive impairment is a characteristic of schizophrenia. This impairment may affect the retention of information required for ongoing knowledgeable participation in clinical trials. This study monitored retention of study-related knowledge - including assessment of therapeutic misconception - in people with stable, DSM-IV schizophrenia during participation in placebo-controlled clinical trials of adjunctive agents. Stability was defined as being on an antipsychotic with no change in medication or dose over the previous 4 weeks. Method: This longitudinal study assessed retention of clinical trial-related consent information. Individuals enrolling in 1 of 8 clinical trials were approached for participation. Participants came from research clinics and community mental health centers. At baseline, clinical trial consent forms were reviewed and study knowledge assessed. Participants were randomized to follow-up assessments at weeks 1, 4, and 8; weeks 4 and 8; or at week 8 only. Clinical trial consent forms were not rereviewed at any follow-up visit. Results: Fifty-nine participants were enrolled; analysis included 52 participants with at least 1 follow-up visit. Study knowledge did not decrease meaningfully in any group. Therapeutic misconception was not observed in participants during the study. The group assessed most frequently demonstrated significant improvement over baseline (t44 = 3.43, P = .001). Retention of study knowledge was not related to symptoms but had a weak correlation with cognitive capacity (R = 0.28, P = .07). Performance did not differ between participants from research clinics and those from community mental health centers. Conclusions: Clinically stable people with schizophrenia enrolling in a placebo-controlled adjunctive medication study, once determined to have capacity to consent to a clinical trial, retained appropriate study knowledge for at least 8 weeks. In the absence of a specific reason to suspect a loss of decisional capacity, there appears to be no need to routinely reevaluate participants during this type of clinical trial.
机译：目的：认知障碍是精神分裂症的特征。这种损害可能会影响知识的持续参与临床试验所需的信息的保留。这项研究监测了与DSM-IV精神分裂症稳定的人在参加辅助剂安慰剂对照临床试验期间相关研究知识的保留，包括对治疗误解的评估。稳定性定义为使用抗精神病药，在过去4周内药物或剂量没有变化。方法：这项纵向研究评估了临床试验相关同意信息的保留。招募了参与8个临床试验中的1个的个体。参与者来自研究诊所和社区心理健康中心。在基线时，审查临床试验同意书并评估研究知识。参与者在第1、4和8周被随机分配到随访评估中。第4和8周;或仅在第8周。在任何后续随访中均未审查临床试验同意书。结果：共有59名参与者入选。分析包括52名参与者，至少接受了1次随访。在任何组中，学习知识都没有显着减少。在研究过程中未观察到治疗误解。评估最频繁的组证明比基线有显着改善（t44 = 3.43，P = .001）。保留学习知识与症状无关，但与认知能力的相关性较弱（R = 0.28，P = .07）。研究诊所的参与者与社区精神卫生中心的参与者的表现没有差异。结论：参加安慰剂对照辅助药物研究的临床稳定的精神分裂症患者，一旦确定具有接受临床试验的能力，就可以保留适当的研究知识至少8周。在没有特定理由怀疑决策能力丧失的情况下，在这种类型的临床试验中似乎没有必要定期重新评估参与者。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号