Outcomes measures in a decade of dementia and mild cognitive impairment trials.
Outcomes measures in a decade of dementia and mild cognitive impairment trials.
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DOI：
10.1186/s13195-016-0216-8
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发表时间：
2016-11-21
期刊：
影响因子：
--
通讯作者：
Quinn TJ
中科院分区：
文献类型：
--
作者：
Harrison JK;Noel-Storr AH;Demeyere N;Reynish EL;Quinn TJ
在研究中，为了对干预措施的影响进行全面评估，结果测量应反映病情的生活经历。在痴呆症研究中，这需要使用能够捕捉疾病影响范围的结果测量，而不仅限于认知功能。特别是，监管机构建议评估认知障碍的功能影响，但对于痴呆症研究结果评估的最佳方法尚未达成共识。我们的目的是描述痴呆和轻度认知障碍 (MCI) 干预研究中使用的结果测量，特别关注那些评估以患者为中心的功能表现和生活质量结果的测量。我们对文献进行了重点审查，并对内部和外部有效性进行了多重嵌入式检查。我们使用了 Cochrane 痴呆症和认知改善小组的痴呆症研究登记册 ALOIS。检索 ALOIS 以获得 10 年间（2004-2014 年）所有注册痴呆症和 MCI 干预研究的记录。我们包括已发表和未发表的材料。结果分为认知、功能、生活质量、情绪、行为、整体/疾病严重程度和制度化。从最初返回的 3271 条记录中，我们总共纳入了 805 条记录，其中包括 676 条痴呆症试验记录和 129 条 MCI 试验记录。其中，78% (630) 来自同行评审出版物，60% (487) 报告了药物干预的结果。 70% (563) 的人报告了认知结果，相比之下，29% (237) 的人报告了功能表现的测量结果，只有 13% (102) 的人报告了生活质量的测量结果。我们发现用于捕获这些结果的工具存在显着的异质性，经常使用非标准化测试。这种对认知表现的关注质疑痴呆症干预研究评估与个体患者及其护理人员相关的结果措施的程度。测量方法的异质性、定制工具的使用以及测试策略的不良描述都表明需要采用更加标准化的方法来进行和报告结果评估。本文的在线版本 (doi:10.1186/s13195-016-0216-8) 包含补充材料，可供授权用户使用。
In a research study, to give a comprehensive evaluation of the impact of interventions, the outcome measures should reflect the lived experience of the condition. In dementia studies, this necessitates the use of outcome measures which capture the range of disease effects, not limited to cognitive functioning. In particular, assessing the functional impact of cognitive impairment is recommended by regulatory authorities, but there is no consensus on the optimal approach for outcome assessment in dementia research. Our aim was to describe the outcome measures used in dementia and mild cognitive impairment (MCI) intervention studies, with particular interest in those evaluating patient-centred outcomes of functional performance and quality of life. We performed a focused review of the literature with multiple embedded checks of internal and external validity. We used the Cochrane Dementia and Cognitive Improvement Group’s register of dementia studies, ALOIS. ALOIS was searched to obtain records of all registered dementia and MCI intervention studies over a 10-year period (2004–2014). We included both published and unpublished materials. Outcomes were categorised as cognitive, functional, quality of life, mood, behaviour, global/disease severity and institutionalisation. From an initial return of 3271 records, we included a total of 805 records, including 676 dementia trial records and 129 MCI trial records. Of these, 78 % (630) originated from peer-reviewed publications and 60 % (487) reported results of pharmacological interventions. Cognitive outcomes were reported in 70 % (563), in contrast with 29 % (237) reporting measures of functional performance and only 13 % (102) reporting quality of life measures. We identified significant heterogeneity in the tools used to capture these outcomes, with frequent use of non-standardised tests. This focus on cognitive performance questions the extent to which intervention studies for dementia are evaluating outcome measures which are relevant to individual patients and their carers. The heterogeneity in measures, use of bespoke tools and poor descriptions of test strategy all support the need for a more standardised approach to the conduct and reporting of outcomes assessments. The online version of this article (doi:10.1186/s13195-016-0216-8) contains supplementary material, which is available to authorized users.
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影响因子：
7.2
作者：
Wancata, Johannes;Borjesson-Hanson, Anne;Skoog, Ingmar
通讯作者：
Skoog, Ingmar
DOI：
10.1136/bmj.f6104
发表时间：
2013-10-29
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Jones CW;Handler L;Crowell KE;Keil LG;Weaver MA;Platts-Mills TF
通讯作者：
Platts-Mills TF
DOI：
10.1136/bmj.b2535
发表时间：
2009-07-21
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Moher D;Liberati A;Tetzlaff J;Altman DG;PRISMA Group
通讯作者：
PRISMA Group
影响因子：
2.4
作者：
Hsieh, Sharpley;Schubert, Samantha;Hodges, John R.
通讯作者：
Hodges, John R.
影响因子：
4.4
作者：
Hill, J;Fillit, H;Chang, SB
通讯作者：
Chang, SB