The development of the DISCO-RC for measuring children's discomfort during research procedures.
The development of the DISCO-RC for measuring children's discomfort during research procedures.
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DOI：
10.1186/s12887-017-0949-y
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发表时间：
2017-11-29
期刊：
影响因子：
2.4
通讯作者：
Hunfeld JAM
中科院分区：
文献类型：
--
作者：
Staphorst MS;Timman R;Passchier J;Busschbach JJV;van Goudoever JB;Hunfeld JAM
临床研究中需要有关儿童自我报告的不适的数据，帮助伦理委员会对研究方案中描述的不适进行基于证据的评估。由于没有合适的工具来测量儿童在医学研究过程中的不适，我们的目标是开发一种通用、简短且适合儿童的工具：DISCO-RC 问卷（DISCOmfort in Research with Children）。本文介绍了 DISCO-RC 开发的六个步骤。首先，我们更新了临床研究中儿童自我报告不适的文献检索，以深入了解使用哪些词语来衡量不适（步骤 1）。随后，我们采访了参与研究的 46 名儿童（6-18 岁），以深入了解儿童不适的重要形式（步骤 2），并询问他们在测量不适时首选的反应选项（步骤 3）。接下来，我们咨询了九位来自不同背景的儿科研究专业人士，以了解 DISCO-RC 的内容和可行性（步骤 4）。基于前面的步骤，我们开发了DISCO-RC的草稿版本，并与专业人士进行了讨论。然后 DISCO-RC 在 25 名儿童中进行了预测试，以确保从儿童的角度来看的表面有效性和可行性（步骤 5）。最后，检验有效性、可靠性和内部一致性（步骤6）。搜索更新显示了用于衡量研究中不适感的几个词（例如“担忧”、“不愉快”）。这些访谈深入了解了研究中儿童不适的重要形式（例如“痛苦”、“无聊”）。孩子们更喜欢使用 5 点李克特量表作为 DISCO-RC 的回答选项。专家们推荐了一种简短的数字仪器，涉及不同形式的不适，并测量个人研究程序的不适。 DISCO-RC 的预测试导致了一些布局变化，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 α 的内部一致性较低。 DISCO-RC 是一种通用、实用且心理测量学上合理的仪器，用于测量儿童在研究过程中的不适感。它有助于使儿科研究中不适的评估基于证据。因此，我们建议将 DISCO-RC 作为儿科研究的标准组成部分。
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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