Arbuckle Rob, Marshall Chris, Grant Laura, Burrows Kate, Albrecht Helmut H, Shea Tim
Adelphi Values Patient-Centered Outcomes, Bollington, UK.
Adelphi Values Patient-Centered Outcomes (at the time research was conducted), Bollington, UK.
J Patient Rep Outcomes. 2022 May 28;6(1):56. doi: 10.1186/s41687-022-00465-8.
This article describes qualitative interviews conducted with children (aged 6-11), adolescents (aged 12-17), and adults with the common cold as well as parents/caregivers of the 6-8-year-old children. The aim was to support the refinement and content validity testing of patient-reported outcome (PRO) items assessing chest congestion that could be used as pediatric clinical trial endpoints. Feasibility and acceptability of administering the PRO items electronically on a hand-held touch-screen device were also evaluated. The sample included children aged 6-8 years (n = 14), 9-11 years (n = 13), adolescents aged 12-17 years (n = 12), and adults (n = 10), all of who had current (n = 38) or recent (n = 11) cold. Both concept elicitation (CE) and cognitive debriefing (CD) interviews were conducted with all of these participants, conducted over in two rounds. Ten parents/caregivers of participants aged 6-8 years were also interviewed (separately from their child) regarding how they thought their children would understand the items. The CE interviews explored the qualitative experience of having chest congestion and related symptoms of the common cold. Following their CE interview, participants completed draft items on an electronic patient-reported outcome (ePRO) device twice daily for 2-5 days prior to their CD interview. During the CD interview participants were asked about relevance, understanding and interpretation of the draft PRO items. Qualitative analysis of the interview data and descriptive analyses of the ePRO data were conducted following both rounds of interviews, with modifications to the items implemented following Round 1 and tested in Round 2.
Eight symptoms were reported by children during concept elicitation. Findings from the child, adolescent, and adult/parent interviews supported revisions to the items and enabled the selection of the best performing items. The results provided evidence that the final items were well understood by participants and relevant to their experiences of chest congestion as part of a common cold. Findings also provide support for using the same items across age groups.
The results of the CE and CD interviews provide evidence supporting the content validity of new PRO items assessing the experience of chest congestion symptoms associated with common cold experienced by children, adolescents, and adults.
本文描述了对患有普通感冒的儿童（6至11岁）、青少年（12至17岁）和成年人以及6至8岁儿童的父母/照顾者进行的定性访谈。目的是支持对评估胸部充血的患者报告结局（PRO）项目进行完善和内容效度测试，这些项目可作为儿科临床试验的终点。还评估了在手持触摸屏设备上以电子方式管理PRO项目的可行性和可接受性。样本包括6至8岁儿童（n = 14）、9至11岁儿童（n = 13）、12至17岁青少年（n = 12）和成年人（n = 10），他们均患有当前（n = 38）或近期（n = 11）感冒。对所有这些参与者进行了两轮概念激发（CE）和认知反馈（CD）访谈。还对10名6至8岁参与者的父母/照顾者（与他们的孩子分开）进行了访谈，询问他们认为自己的孩子会如何理解这些项目。CE访谈探讨了胸部充血以及普通感冒相关症状的定性体验。在CE访谈之后，参与者在CD访谈前2至5天每天两次在电子患者报告结局（ePRO）设备上完成项目草稿。在CD访谈期间，询问参与者关于PRO项目草稿的相关性、理解和解释。在两轮访谈之后对访谈数据进行定性分析，并对ePRO数据进行描述性分析，在第一轮之后对项目进行修改，并在第二轮中进行测试。
在概念激发期间，儿童报告了8种症状。儿童、青少年和成人/父母访谈的结果支持对项目进行修订，并有助于选择表现最佳的项目。结果提供了证据，表明最终项目被参与者很好地理解，并且与他们作为普通感冒一部分的胸部充血经历相关。研究结果还支持在不同年龄组中使用相同的项目。
CE和CD访谈的结果提供了证据，支持新的PRO项目的内容效度，这些项目评估了儿童、青少年和成年人患普通感冒时胸部充血症状的体验。
