Institute for Health Policy, Management & Evaluation, University of Toronto, Toronto, Ontario Canada.
Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario Canada.
PLoS One. 2019 Apr 18;14(4):e0215225. doi: 10.1371/journal.pone.0215225. eCollection 2019.
Selection of optimal outcome measures is a critical step in a systematic review; inclusion of uncommon or non-validated outcome measures can impact the uptake of systematic review findings. Our goals were to identify the validity and reliability of outcome measures used in primary studies to assess cognition, function, behaviour and global status; and, to use these data to select outcomes for a systematic review (SR) on treatment efficacy of cognitive enhancers for Alzheimer's Dementia (AD).
Articles fulfilling the eligibility criteria of the SR were included in a charting exercise to catalogue outcome measures reported. Outcome measures were then assessed for validity and reliability. Two independent reviewers abstracted data on outcome measures and validity and reliability reported for cognition, function, behaviour and global status.
129 studies were included in the charting exercise; 57 outcome measures were identified for cognition, 21 for function, 13 for behaviour and 10 for global status. A total of 35 (61%) cognition measures, 10 (48%) functional measures, 8 (61%) behavioural measures and four (40%) of global status measures were only used once in the literature. Validity and reliability information was found for 51% of cognition measures, 90% of function and global status measures and 100% of behavioural measures.
While a large number of outcome measures were used in primary studies, many of these were used only once. Reporting of validity and reliability varied in AD studies of cognitive enhancers. Core outcome sets should be used when available; when they are not available researchers need to balance frequency of reported outcome measures, their respective validity and reliability, and preferences of knowledge users.
CRD#42012001948.
在系统评价中，选择最佳的结局指标是至关重要的一步；纳入不常见或未经验证的结局指标可能会影响系统评价结果的应用。我们的目标是确定用于评估认知、功能、行为和总体状况的主要研究中使用的结局指标的有效性和可靠性；并利用这些数据为一项关于认知增强剂治疗阿尔茨海默病（AD）疗效的系统评价（SR）选择结局指标。
符合 SR 纳入标准的文章被纳入图表制作中，以列出报告的结局指标。然后评估结局指标的有效性和可靠性。两位独立的审查员提取了关于认知、功能、行为和总体状况报告的结局指标以及有效性和可靠性的数据。
图表制作共纳入 129 项研究，确定了 57 项认知结局指标、21 项功能结局指标、13 项行为结局指标和 10 项总体状况结局指标。在文献中，仅有 35 项（61%）认知测量、10 项（48%）功能测量、8 项（61%）行为测量和 4 项（40%）总体状况测量仅使用过一次。只有 51%的认知测量、90%的功能和总体状况测量以及 100%的行为测量有有效性和可靠性信息。
尽管主要研究中使用了大量的结局指标，但其中许多指标仅使用过一次。AD 认知增强剂研究中对有效性和可靠性的报告存在差异。当可用时应使用核心结局指标；当不可用时，研究人员需要平衡报告结局指标的频率、各自的有效性和可靠性以及知识使用者的偏好。
CRD#42012001948。
