Ulrich Connie M, Zhou Qiuping Pearl, Ratcliffe Sarah J, Knafl Kathleen, Wallen Gwenyth R, Richmond Therese S, Grady Christine
1 University of Pennsylvania, Philadelphia, PA, USA.
2 George Washington University, Ashburn, VA, USA.
J Empir Res Hum Res Ethics. 2018 Jul;13(3):230-238. doi: 10.1177/1556264618764730. Epub 2018 Apr 9.
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 (α = .90) and Burden (α = .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.
我们采用序贯混合方法设计，对癌症临床试验参与者进行了定性研究（n = 32）和定量研究（n = 110），从而制定了衡量参与癌症临床试验的益处和负担的方法。随后制定了益处-负担项目（益处22项，负担23项），并通过认知访谈对其内容、清晰度和意义进行了评估。初步的心理测量分析支持了益处（α = .90）和负担（α = .87）研究参与量表的内部一致性信度和结构效度。项目反应理论模型支持了量表上各项目的区分能力。有退出想法的参与者与没有退出想法的参与者相比，益处量表得分更低（p < .001），负担得分更高（p < .001），这支持了结构效度。经过进一步的心理测量测试后，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。
