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临床试验的行为学方面。来自行为理论的综合框架。

Behavioral aspects of clinical trials. An integrated framework from behavior theory.

作者信息

Morrow G R, Hickok J T, Burish T G

机构信息

Cancer Center, University of Rochester School of Medicine and Dentistry, New York 14642.

出版信息

Cancer. 1994 Nov 1;74(9 Suppl):2676-82. doi: 10.1002/cncr.1994.2820740918.

DOI:10.1002/cncr.1994.2820740918
PMID:7954285
Abstract

A less-than-optimal proportion of patients with cancer are entered into National Cancer Institute-sponsored clinical trials. This article reviews the literature on accrual in oncology clinical trials to characterize the extent of the problem, identify reasons for low accrual, and suggest ways to promote accrual. Four well known theories of health behavior (the Health Belief Model, Subjective Expected Utility Theory, Protection Motivation Theory, and the Theory of Reasoned Action) point to central concepts involved in understanding patient health-related behavior: (1) the probability that an unwelcomed health event will happen to a patient, (2) the severity of that event if it does occur, (3) the effectiveness of a particular behavior (such as taking part in a clinical trial) to modify the severity, and (4) the cost of adopting that behavior. These concepts form a framework for integrating the available information about accrual to clinical oncology trials. Patient and physician factors previously related to clinical trials suggest specific recommendations for increasing accrual to clinical oncology trials.

摘要

参与美国国立癌症研究所资助的临床试验的癌症患者比例并不理想。本文回顾了肿瘤学临床试验中关于患者入组情况的文献,以描述该问题的严重程度,找出入组率低的原因,并提出提高入组率的方法。四种著名的健康行为理论(健康信念模型、主观期望效用理论、保护动机理论和理性行动理论)指出了理解患者健康相关行为所涉及的核心概念:(1)不良健康事件发生在患者身上的概率;(2)如果该事件发生,其严重程度;(3)特定行为(如参加临床试验)改变严重程度的有效性;(4)采取该行为的成本。这些概念构成了一个框架,用于整合有关肿瘤学临床试验入组情况的现有信息。先前与临床试验相关的患者和医生因素为提高肿瘤学临床试验入组率提出了具体建议。

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Behavioral aspects of clinical trials. An integrated framework from behavior theory.临床试验的行为学方面。来自行为理论的综合框架。
Cancer. 1994 Nov 1;74(9 Suppl):2676-82. doi: 10.1002/cncr.1994.2820740918.
2
How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials.社会人口统计学、肿瘤专科医生的配备以及医院癌症项目如何影响癌症治疗试验的入组情况。
J Clin Oncol. 2002 Apr 15;20(8):2109-17. doi: 10.1200/JCO.2002.08.056.
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Improving accrual of older persons to cancer treatment trials: a randomized trial comparing an educational intervention with standard information: CALGB 360001.提高老年人参与癌症治疗试验的入组率:一项比较教育干预与标准信息的随机试验:CALGB 360001
J Clin Oncol. 2005 Apr 1;23(10):2201-7. doi: 10.1200/JCO.2005.01.222.
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Predicting accrual achievement: monitoring accrual milestones of NCI-CTEP-sponsored clinical trials.预测入组完成情况:监测 NCI-CTEP 资助的临床试验的入组里程碑。
Clin Cancer Res. 2011 Apr 1;17(7):1947-55. doi: 10.1158/1078-0432.CCR-10-1730. Epub 2011 Mar 29.
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Communication, accrual to clinical trials, and the physician-patient relationship: implications for training programs.沟通、参与临床试验以及医患关系:对培训项目的影响。
J Cancer Educ. 1996 Summer;11(2):73-9. doi: 10.1080/08858199609528399.
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Who's Eligible Anyway? Risk Modeling for Clinical Trial Accrual.谁有资格呢?临床试验入组的风险建模。
Clin Cancer Res. 2016 Nov 15;22(22):5397-5399. doi: 10.1158/1078-0432.CCR-16-1710. Epub 2016 Sep 6.
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A report on accrual rates for elderly and minority-ethnicity cancer patients to clinical trials of the American College of Surgeons Oncology Group.美国外科医师学会肿瘤学组针对老年和少数族裔癌症患者参与临床试验的入组率报告。
J Am Coll Surg. 2004 Oct;199(4):644-51. doi: 10.1016/j.jamcollsurg.2004.05.282.
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Assuring access to state-of-the-art care for U.S. minority populations: the first 2 years of the Minority-Based Community Clinical Oncology Program.确保美国少数族裔人群能够获得最先进的医疗服务:基于少数族裔的社区临床肿瘤项目的头两年。
J Natl Cancer Inst. 1993 Dec 1;85(23):1945-50. doi: 10.1093/jnci/85.23.1945.
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Insights From Building a New National Cancer Institute Community Oncology Research Program Site.建设新的国立癌症研究所社区肿瘤学研究项目站点的见解。
WMJ. 2016 Aug;115(4):191-5.
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Accrual in supportive care trials in pediatric oncology, a challenge!儿科肿瘤支持性护理试验中的累积,是一个挑战!
Support Care Cancer. 2012 Dec;20(12):3149-53. doi: 10.1007/s00520-012-1447-2. Epub 2012 Apr 4.

引用本文的文献

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Willingness to participate in health research: Tunisian survey.参与健康研究的意愿:突尼斯调查。
BMC Med Ethics. 2016 Aug 4;17(1):47. doi: 10.1186/s12910-016-0131-3.
2
Accrual in supportive care trials in pediatric oncology, a challenge!儿科肿瘤支持性护理试验中的累积,是一个挑战!
Support Care Cancer. 2012 Dec;20(12):3149-53. doi: 10.1007/s00520-012-1447-2. Epub 2012 Apr 4.
3
Recruitment and retention of patients into emergency medicine clinical trials.招募和保留急诊医学临床试验中的患者。
Acad Emerg Med. 2010 Oct;17(10):1104-12. doi: 10.1111/j.1553-2712.2010.00866.x.
4
An extended model of reasoned action to understand the influence of individual- and network-level factors on African Americans' participation in HIV vaccine research.扩展理性行为模型,以了解个体和网络层面因素对非裔美国人参与 HIV 疫苗研究的影响。
Prev Sci. 2010 Jun;11(2):207-18. doi: 10.1007/s11121-009-0162-9.
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Preference assessment of recruitment into a randomized trial for adolescent idiopathic scoliosis.青少年特发性脊柱侧凸随机试验招募的偏好评估
J Bone Joint Surg Am. 2008 Dec;90(12):2594-605. doi: 10.2106/JBJS.G.01460.
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An Internet-based cancer clinical trials matching resource.一个基于互联网的癌症临床试验匹配资源。
J Med Internet Res. 2005 Jul 1;7(3):e24. doi: 10.2196/jmir.7.3.e24.
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The promise of empirical research in the study of informed consent theory and practice.实证研究在知情同意理论与实践研究中的前景。
HEC Forum. 2004 Mar;16(1):53-71. doi: 10.1023/b:hecf.0000031780.66472.f4.