The Anti-Clot Treatment Scale (ACTS) in clinical trials: cross-cultural validation in venous thromboembolism patients.
The Anti-Clot Treatment Scale (ACTS) in clinical trials: cross-cultural validation in venous thromboembolism patients.
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DOI：
10.1186/1477-7525-10-120
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发表时间：
2012-09-26
影响因子：
3.6
通讯作者：
Smith S
中科院分区：
文献类型：
--
作者：
Cano SJ;Lamping DL;Bamber L;Smith S
抗血凝治疗量表（Anti-Clot Treatment Scale，缩写为CET）是一个由15项患者报告的抗凝治疗满意度量表。它包括一个12项的负担量表和一个3项的福利量表。它在临床试验和其他环境中的作用应该得到证据的支持，证明它既有临床意义，又有科学依据。本研究的目的是基于传统的心理测量方法，评价在静脉血栓栓塞症患者中使用的测量性能（荷兰语、意大利语、法语、德语和英语版本）。ACTS在规模和项目层面分析了一项大型临床试验（EINSTEIN DVT）的负担和益处规模数据，该试验涉及1336名静脉血栓栓塞患者。五个关键的心理测量学特性进行了检查，使用传统的心理测量学方法：可接受性，缩放假设，可靠性（包括内部一致性信度，重测重现性），有效性（包括已知的群体和判别效度）和反应。这些检查方法支持美国食品和药物管理局对患者报告结局工具评价的建议。总的来说，12项负担量表和3项益处量表在项目和量表水平上均符合心理测量标准，但荷兰语版本中的一些相对较小的问题除外，这些问题略低于可靠性标准（即α = 0.72，重测组内相关性= 0.79）。一个一致的发现，从项目级的评价，总认可频率和偏度表明，响应规模可能会得到改善，减少响应选项的数量从五个到四个。在多语言数据集中，患者负担和患者获益量表始终符合传统的可靠性和有效性标准，支持其作为临床试验中抗凝治疗满意度的临床有用的患者报告工具。NCT00440193
The Anti-Clot Treatment Scale (ACTS) is a 15-item patient-reported instrument of satisfaction with anticoagulant treatment. It includes a 12-item ACTS Burdens scale and a 3-item ACTS Benefits scale. Its role in clinical trials and other settings should be supported by evidence that it is both clinically meaningful and scientifically sound. The aim of the study was to evaluate the measurement performance of the ACTS (Dutch, Italian, French, German and English language versions) in patients with venous thromboembolism based on traditional psychometric methods. ACTS Burdens and Benefits scale data from a large clinical trial (EINSTEIN DVT) involving 1336 people with venous thromboembolism were analysed at both the scale and item level. Five key psychometric properties were examined using traditional psychometric methods: acceptability, scaling assumptions, reliability (including internal consistency reliability, test-retest reproducibility); validity (including known groups and discriminant validity); and responsiveness. These methods of examination underpin the US Food and Drug Administration recommendations for patient-reported outcome instrument evaluation. Overall, the 12-item ACTS Burdens scale and 3-item ACTS Benefits scale met the psychometric criteria evaluated at both item and scale levels, with the exception of some relatively minor issues in the Dutch language version, which were just below reliability criteria (i.e. alpha = 0.72, test-retest intraclass correlation = 0.79). A consistent finding from item-level evaluations of aggregate endorsement frequencies and skewness suggested that response scales may be improved by reducing the number of response options from five to four. Both the ACTS Burdens and ACTS Benefits scales consistently satisfied traditional reliability and validity criteria across multiple language datasets, supporting it as a clinically useful patient-reported instrument of satisfaction with anticoagulant treatment in clinical trials. NCT00440193
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影响因子：
11
作者：
Hobart, Jeremy C.;Cano, Stefan J.;Thompson, Alan J.
通讯作者：
Thompson, Alan J.
DOI：
10.1016/j.jhsb.2004.06.002
发表时间：
2004-10-01
期刊：
JOURNAL OF HAND SURGERY-BRITISH AND EUROPEAN VOLUME
影响因子：
--
作者：
Cano, SJ;Browne, JP;Black, NA
通讯作者：
Black, NA
影响因子：
3
作者：
KAZIS, LE;ANDERSON, JJ;MEENAN, RF
通讯作者：
MEENAN, RF
DOI：
10.1136/qhc.9.3.146
发表时间：
2000-09-01
期刊：
QUALITY IN HEALTH CARE
影响因子：
--
作者：
Fitzpatrick, R;Morris, R;Gregg, P
通讯作者：
Gregg, P
影响因子：
10.4
作者：
Heit, JA
通讯作者：
Heit, JA