In clinical trials, standardized assessment conducted by research staff facilitates identification of treatment benefit. Narrative notes completed by clinicians offer a novel source to characterize and contextualize outcomes. In this study, we examine qualitative analysis of clinical notes as a method to augment quantitative outcome measures and supply meaningful context in clinical trials. Two hundred eighty-four clinical progress notes from 19 participants with schizophrenia or schizoaffective disorder assigned to receive either auditory-targeted cognitive training or treatment as usual were included. Qualitative analysis of weekly progress notes written by clinicians involved in ongoing care of the participants was used to identify overall outcome trajectories and specific changes in program participation, social functioning, and symptom severity. Trajectories were compared with the parent study's 2 primary outcome measures. Qualitative analysis identified personalized and complex trajectories for individual participants. Approximately half the participants improved overall. Most participants displayed improved program participation and social functioning, whereas most participants experienced symptom deterioration. Engagement in targeted cognitive training did not impact change in trajectories. Qualitative trajectories were congruent (e.g., both indicated improvement) with the 2 primary outcome measures for 26-36% of the participants depending on the comparison. Including qualitative analysis of clinician progress notes provides useful context and identifies underlying processes not captured in quantitative data. However, they cannot replace quantitative outcome measurement. Better alignment with clinician- and patient-targeted outcomes may strengthen clinical trials. Qualitative analysis of routinely collected data can benefit research and programmatic decision making in usual care settings. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

中文翻译：

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恢复之路的情境化：一种评估临床试验结果轨迹的新方法。

在临床试验中，研究人员进行的标准化评估有助于确定治疗效果。临床医生完成的叙述笔记提供了一个新的来源来描述和背景化结果。在这项研究中，我们检查了临床记录的定性分析，将其作为一种方法来增强定量结果测量并在临床试验中提供有意义的背景。包括来自 19 名精神分裂症或分裂情感障碍参与者的 284 份临床进展记录，这些参与者被分配接受听觉靶向认知训练或照常治疗。对参与持续护理参与者的临床医生撰写的每周进度记录进行定性分析，用于确定总体结果轨迹和项目参与、社会功能、和症状的严重程度。轨迹与父研究的 2 项主要结果指标进行了比较。定性分析为个体参与者确定了个性化和复杂的轨迹。大约一半的参与者总体上有所改善。大多数参与者表现出改善的计划参与和社会功能，而大多数参与者的症状恶化。参与有针对性的认知训练不会影响轨迹的变化。根据比较，定性轨迹与 26-36% 的参与者的 2 项主要结果测量一致（例如，均表明有所改善）。包括对临床医生进度记录的定性分析提供了有用的背景，并确定了定量数据中未捕获的潜在过程。然而，它们不能取代定量结果衡量。更好地与临床医生和患者的目标结果保持一致可能会加强临床试验。对常规收集的数据进行定性分析可以有益于常规护理环境中的研究和规划决策。（PsycInfo 数据库记录 (c) 2020 APA，保留所有权利）。