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在一项关于骨髓瘤的北欧多中心研究中,医生对临床试验的态度及其与患者入组情况的关系。

Physicians' attitudes toward clinical trials and their relationship to patient accrual in a Nordic multicenter study on myeloma.

作者信息

Hjorth M, Holmberg E, Rödjer S, Taube A, Westin J

机构信息

Department of Medicine, Lidköping Hospital, Sweden.

出版信息

Control Clin Trials. 1996 Oct;17(5):372-86. doi: 10.1016/s0197-2456(96)00022-0.

DOI:10.1016/s0197-2456(96)00022-0
PMID:8932971
Abstract

Ninety-nine physicians participating in a Nordic multicenter trial on myeloma in 1990-1994 were surveyed, by means of a mailed questionnaire, with respect to their attitudes toward clinical trials and their opinions regarding the importance of certain factors influencing patient accrual. The inclusion rate of each participating clinic was recorded. Questions related to attitudes of presumed importance for patient accrual were analyzed for associations between the response distribution and the inclusion rate for the corresponding clinics. Ninety-three of the surveyed physicians responded to the questionnaire. The survey indicated that the physicians considered the scientific purpose of a trial to be the most important factor for patient accrual, followed by the simplicity of study protocol, the rightness of ethical aspects, the quality of communication with the study organization, and the degree of participation in investigators' meetings. A positive correlation to patient accrual was found for several attitudes held by the participating physicians, including their perception of the importance of a quality-of-life study in the protocol, their conception of the simplicity of the study protocol, their frequency of participation in investigators' meetings, and their awareness of cost and reimbursement levels for entered patients.

摘要

1990年至1994年期间,对参与一项北欧骨髓瘤多中心试验的99名医生进行了调查,通过邮寄问卷的方式,了解他们对临床试验的态度以及他们对影响患者入组的某些因素重要性的看法。记录了每个参与诊所的入组率。分析了与假定对患者入组重要的态度相关的问题,以探讨回答分布与相应诊所入组率之间的关联。99名接受调查的医生中有93人回复了问卷。调查表明,医生们认为试验的科学目的是患者入组的最重要因素,其次是研究方案的简易性、伦理方面的合理性、与研究机构沟通的质量以及参与研究者会议的程度。参与研究的医生所持的几种态度与患者入组呈正相关,包括他们对方案中生活质量研究重要性的认知、对研究方案简易性的看法、参与研究者会议的频率以及对入组患者费用和报销水平的了解。

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