Diagnostic and economic evaluation of new biomarkers for Alzheimer's disease: the research protocol of a prospective cohort study.
Diagnostic and economic evaluation of new biomarkers for Alzheimer's disease: the research protocol of a prospective cohort study.
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DOI：
10.1186/1471-2377-12-72
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发表时间：
2012-08-10
期刊：
影响因子：
2.6
通讯作者：
Verhey FR
中科院分区：
文献类型：
--
作者：
Handels RL;Aalten P;Wolfs CA;OldeRikkert M;Scheltens P;Visser PJ;Joore MA;Severens JL;Verhey FR
最近开发了诊断阿尔茨海默病(AD)的新的研究标准，通过依赖新兴的生物标记物来早期诊断AD的病理生理学。为了能够有效地分配卫生保健资源，需要证据来支持决策者在临床实践中采用新兴生物标记物。研究的目标是1)评估当前临床诊断工作和MRI、PET和CSF中新兴生物标志物的诊断测试准确性，2)进行成本-结果分析，3)通过经济模型评估长期成本-效果。在队列设计中，241名被怀疑患有原发神经退行性疾病的患者在四个学术记忆诊所接受了治疗，并进行了两年的跟踪调查。收集临床数据和有关生活质量、成本和新兴生物标记物的数据。诊断试验的准确性是通过将临床实践和新的研究标准诊断与参考诊断相联系来确定的。仅使用临床信息(没有生物标记物)的专家之间的共识程序反映了基线的临床实践诊断。基于新研究标准的诊断反映在结合临床和生物标记物信息的决策规则中。参考诊断是由专家根据两年时间内症状过程的临床信息通过协商一致的程序确定的。建立一个决策分析模型，结合来自不同来源的现有证据，其中(准确性)来自研究、文献和专家意见，以评估新兴生物标志物的长期成本效益。其他几个多中心试验研究了新的生物标记物对AD和相关疾病的早期评估的相对价值。这项研究的独特之处在于评估资源利用和生活质量，以便进行经济评估。这项研究结果可以推广到因记忆问题而转诊到记忆诊所的患者群体。NCT01450891
New research criteria for the diagnosis of Alzheimer’s disease (AD) have recently been developed to enable an early diagnosis of AD pathophysiology by relying on emerging biomarkers. To enable efficient allocation of health care resources, evidence is needed to support decision makers on the adoption of emerging biomarkers in clinical practice. The research goals are to 1) assess the diagnostic test accuracy of current clinical diagnostic work-up and emerging biomarkers in MRI, PET and CSF, 2) perform a cost-consequence analysis and 3) assess long-term cost-effectiveness by an economic model. In a cohort design 241 consecutive patients suspected of having a primary neurodegenerative disease are approached in four academic memory clinics and followed for two years. Clinical data and data on quality of life, costs and emerging biomarkers are gathered. Diagnostic test accuracy is determined by relating the clinical practice and new research criteria diagnoses to a reference diagnosis. The clinical practice diagnosis at baseline is reflected by a consensus procedure among experts using clinical information only (no biomarkers). The diagnosis based on the new research criteria is reflected by decision rules that combine clinical and biomarker information. The reference diagnosis is determined by a consensus procedure among experts based on clinical information on the course of symptoms over a two-year time period. A decision analytic model is built combining available evidence from different resources among which (accuracy) results from the study, literature and expert opinion to assess long-term cost-effectiveness of the emerging biomarkers. Several other multi-centre trials study the relative value of new biomarkers for early evaluation of AD and related disorders. The uniqueness of this study is the assessment of resource utilization and quality of life to enable an economic evaluation. The study results are generalizable to a population of patients who are referred to a memory clinic due to their memory problems. NCT01450891
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影响因子：
9.9
作者：
Cummings, JL
通讯作者：
Cummings, JL
DOI：
10.1016/j.jalz.2011.03.005
发表时间：
2011-05
期刊：
Alzheimer's & dementia : the journal of the Alzheimer's Association
影响因子：
--
作者：
McKhann GM;Knopman DS;Chertkow H;Hyman BT;Jack CR Jr;Kawas CH;Klunk WE;Koroshetz WJ;Manly JJ;Mayeux R;Mohs RC;Morris JC;Rossor MN;Scheltens P;Carrillo MC;Thies B;Weintraub S;Phelps CH
通讯作者：
Phelps CH
影响因子：
11
作者：
Lindeboom, J;Schmand, B;Jonker, C
通讯作者：
Jonker, C
影响因子：
3.3
作者：
Brooks, R
通讯作者：
Brooks, R
影响因子：
3.3
作者：
Logsdon, RG;Gibbons, LE;Teri, L
通讯作者：
Teri, L