There is a need for data on children’s self-reported discomfort in clinical research, helping ethics committees to make their evaluation of discomfort described in study protocols evidence-based. Since there is no appropriate instrument to measure children’s discomfort during medical research procedures, we aimed to develop a generic, short and child-friendly instrument: the DISCO-RC questionnaire (DISCOmfort in Research with Children). This article describes the six steps of the development of the DISCO-RC. First, we updated a literature search on children’s self-reported discomfort in clinical research to get insight in what words are used to measure discomfort (step 1). Subsequently, we interviewed 46 children (6–18?years) participating in research to get insight into important forms of discomfort for children (step 2), and asked them about their preferred response option for measuring discomfort (step 3). Next, we consulted nine paediatric research professionals from various backgrounds for input on the content and feasibility of the DISCO-RC (step 4). Based on the previous steps, we developed a draft version of the DISCO-RC, which we discussed with the professionals. The DISCO-RC was then pretested in 25 children to ensure face-validity from the child’s perspective and feasibility (step 5). Finally, validity, reliability and internal consistency were tested (step 6). The search-update revealed several words used for measuring discomfort in research (e.g. ‘worries’, ‘unpleasantness’). The interviews gave insight into important forms of discomfort for children in research (e.g. ‘pain’, ‘boredom’). Children preferred a 5-point Likert scale as response option for the DISCO-RC. The experts recommended a short, digital instrument involving different forms of discomfort, and measuring discomfort of individual research procedures. Pretesting of the DISCO-RC resulted in a few layout changes, and feedback from the children confirmed the feasibility of the DISCO-RC. Convergent validity and test-retest reliability were acceptable. Internal consistency based on item-rest correlations and Cronbach’s alpha were low, as expected. The DISCO-RC is a generic, practical and psychometrically sound instrument for measuring children’s discomfort during research procedures. It contributes to make the evaluation of discomfort in paediatric research evidence-based. Therefore, we recommend including the DISCO-RC as standard component of paediatric research studies.
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机译：在临床研究中需要有关儿童自我报告的不适感的数据，以帮助伦理委员会对研究方案中描述的不适感进行循证评估。由于在医学研究过程中没有合适的工具来衡量儿童的不适感，因此我们旨在开发一种通用，简短且对儿童友好的工具：DISCO-RC问卷（DISCOmfort in Children with Children）。本文介绍了DISCO-RC的六个开发步骤。首先，我们更新了有关儿童在临床研究中自我报告的不适感的文献搜索，以了解使用哪些词语来衡量不适感（步骤1）。随后，我们采访了参与研究的46名儿童（6至18岁），以深入了解儿童的重要不适形式（步骤2），并询问他们关于测量不适感的首选应对方案（步骤3）。接下来，我们咨询了来自不同背景的九名儿科研究专业人员，以获取有关DISCO-RC内容和可行性的意见（步骤4）。在前面的步骤的基础上，我们开发了DISCO-RC的草案版本，并与专业人员进行了讨论。然后，对25名儿童进行了DISCO-RC的预测试，以确保从儿童的角度和可行性来看面部的有效性（第5步）。最后，测试了有效性，可靠性和内部一致性（步骤6）。搜索更新显示了几个用于衡量研究不适感的词（例如“担忧”，“不愉快”）。访谈深入了解了研究中儿童的重要不适形式（例如“疼痛”，“无聊”）。孩子们更喜欢5点Likert量表作为DISCO-RC的反应选择。专家建议使用一种简短的数字仪器，该仪器涉及不同形式的不适感，并测量各个研究程序的不适感。 DISCO-RC的预测试导致布局发生了一些变化，孩子们的反馈证实了DISCO-RC的可行性。收敛效度和重测信度是可以接受的。正如预期的那样，基于项目休息相关性和Cronbach的alpha值的内部一致性很低。 DISCO-RC是一种通用，实用且从心理上讲合理的仪器，用于测量研究过程中儿童的不适感。它有助于使以儿科研究为基础的不适评估为依据。因此，我们建议将DISCO-RC纳入儿童研究的标准组成部分。
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