Li Ka Shing Knowledge Institute, St, Michael's Hospital, 209 Victoria Street, East Building, Toronto, ON, M5B 1T8, Canada.
Syst Rev. 2012 May 30;1:25. doi: 10.1186/2046-4053-1-25.
Elderly individuals who have memory problems without significant limitations in activities of daily living are often diagnosed as having mild cognitive impairment (MCI). Some of these individuals progress to dementia. Several cognitive enhancers (for example donepezil, galantamine, rivastigmine, memantine) have been approved for use in people with Alzheimer's dementia but their use in patients with MCI is unclear. We aimed to determine the comparative effectiveness, safety, and cost of cognitive enhancers for MCI through a systematic review and network (that is, indirect comparisons) meta-analysis.
DESIGN/METHODS: We will include studies that examine the use of cognitive enhancers compared to placebo, supportive care, or other cognitive enhancers among patients diagnosed with MCI. Outcomes of interest include cognition and function (primary outcomes), as well as behavior, quality of life, safety, and cost (secondary outcomes). We will include all experimental studies (randomized controlled trials, quasi-randomized controlled trials, controlled clinical trials), quasi-experimental studies (controlled before-after, interrupted time series), and observational studies (cohort, case-control). Studies will be included regardless of publication status (that is, we will include unpublished studies), year, or language of dissemination.To identify potentially relevant material, we will search the following electronic databases from inception onwards: MEDLINE, Cochrane Central Register of Controlled Trials, EMBASE, CINAHL, and Ageline. The electronic database search will be supplemented by scanning the reference lists of included studies, searching Google and organization websites for unpublished or difficult to locate material literature, and contacting experts.Two reviewers will independently screen the studies for inclusion using the eligibility criteria established a priori and independently extract data. Risk of bias will be assessed using the Cochrane Risk of Bias tool for experimental and quasi-experimental studies and the Newcastle Ottawa Scale for observational epidemiology studies. Meta-analysis and network meta-analysis are planned, if the studies are deemed statistically, methodologically, and clinically homogenous.
Our systematic review will provide important information regarding the benefits, costs, and harms of cognitive enhancers for patients with MCI. This information can be used to assist healthcare providers, policy-makers, MCI patients and their family regarding the use of these agents. PROSPERO REGISTRY NUMBER: CRD42012002234.
记忆力有问题但日常生活活动无明显受限的老年人常被诊断为轻度认知障碍（MCI）。其中一些人会进展为痴呆。几种认知增强剂（例如多奈哌齐、加兰他敏、利伐斯的明、美金刚）已获准用于阿尔茨海默病痴呆患者，但它们在 MCI 患者中的使用情况尚不清楚。我们旨在通过系统评价和网络（即间接比较）荟萃分析来确定认知增强剂在 MCI 中的比较效果、安全性和成本。
方法/设计： 我们将纳入研究，这些研究比较了认知增强剂与安慰剂、支持性护理或其他认知增强剂在 MCI 患者中的使用。主要结局包括认知和功能（主要结局），以及行为、生活质量、安全性和成本（次要结局）。我们将纳入所有实验研究（随机对照试验、准随机对照试验、对照临床试验）、准实验研究（对照前后、中断时间序列）和观察性研究（队列、病例对照）。无论研究发表状态如何（即我们将纳入未发表的研究）、年份或传播语言，都将纳入研究。为了确定潜在的相关资料，我们将从开始起搜索以下电子数据库：MEDLINE、Cochrane 对照试验中心注册库、EMBASE、CINAHL 和 Ageline。电子数据库搜索将通过扫描纳入研究的参考文献列表、搜索 Google 和组织网站以获取未发表或难以找到的文献资料以及联系专家来补充。两名评审员将使用事先确定的纳入标准独立筛选研究，并独立提取数据。使用 Cochrane 对实验和准实验研究的偏倚风险工具和纽卡斯尔-渥太华量表对观察性流行病学研究进行风险评估。如果研究在统计学、方法学和临床方面被认为是同质的，则计划进行荟萃分析和网络荟萃分析。
我们的系统评价将提供关于认知增强剂对 MCI 患者的益处、成本和危害的重要信息。这些信息可用于协助医疗保健提供者、决策者、MCI 患者及其家属使用这些药物。PROSPERO 注册号：CRD42012002234。
