Development and Preliminary Testing of the Perceived Benefit and Burden Scales for Cancer Clinical Trial Participation
Development and Preliminary Testing of the Perceived Benefit and Burden Scales for Cancer Clinical Trial Participation
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DOI：
10.1177/1556264618764730
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发表时间：
2018-07-01
影响因子：
1.3
通讯作者：
Grady, Christine
中科院分区：
文献类型：
--
作者：
Ulrich, Connie M.;Zhou, Qiuping (Pearl);Grady, Christine
我们使用顺序混合方法设计，对癌症临床试验参与者的定性（n = 32）和定量样本（n = 110）制定了参与癌症临床试验研究的收益和负担的衡量标准。随后通过认知访谈制定和评估福利负担项目（22 个福利，23 个负担），以了解内容、清晰度和含义。初步心理测量分析支持效益 (alpha = .90) 和负担 (alpha = .87) 研究参与量表的内部一致性可靠性和结构效度。项目反应理论模型支持量表上项目的辨别能力。与那些没有退出想法的参与者相比，有退出想法的参与者的效益量表分数较低 (p < .001)，负担分数较高 (p < .001)，这支持了结构有效性。通过进一步的心理测量测试，该量表可用于制定适当的干预措施，以解决临床研究中人类参与者的招募和保留问题。
We developed measures of benefits and burdens of research participation in cancer clinical trials using a sequential mixed methods design with a qualitative (n = 32) and quantitative sample (n = 110) of cancer clinical trial participants. Benefit-burden items (22 for benefits, 23 for burdens) were subsequently developed and assessed through cognitive interviewing for content, clarity, and meaning. Preliminary psychometric analyses support the internal consistency reliability and construct validity of Benefit (alpha = .90) and Burden (alpha = .87) research participation scales. Item response theory models supported the discrimination ability of the items on the scales. Participants who had thoughts of dropping out had lower Benefit scale scores (p < .001) and higher Burden scores (p < .001) than those who had no thoughts of dropping out, supporting construct validity. With further psychometric testing, the scale can be used to develop appropriate interventions to address recruitment and retention of human participants in clinical research.