Gale Victoria, Powell Philip A, Carlton Jill
School of Medicine and Population Health, University of Sheffield, Sheffield, UK.
Qual Life Res. 2025 Jun;34(6):1633-1646. doi: 10.1007/s11136-025-03940-z. Epub 2025 Mar 5.
Establishing the comprehensibility of patient reported outcome measures (PROMs) in quality of life research is essential. Cognitive interviews are recommended as a 'gold standard' for evaluating comprehensibility among adult populations but are not routinely used with young children (≤ 7 years). The current study therefore aimed to evaluate the feasibility of cognitive interviewing using traditional and adapted methods with children aged 6-7 years to evaluate PROM item comprehensibility.
Fourteen children (6-7 years) with a range of diagnosed health conditions participated in individual cognitive interviews. Each child answered six mock PROM items (physical, psychological, and social health-related quality of life domains) and concurrent verbal probes were used to evaluate item comprehensibility. Interviews were audio recorded and transcribed verbatim. Transcripts were analysed using a novel Comprehensibility Continuum which coded the extent of alignment between children's explanations of items and intended meanings.
Cognitive interviews were successful; extent of comprehensibility could be determined for 83/84 (99%) item discussions. Most items were comprehensible, with children describing the intended item meaning for 74/84 (88%) items evidenced by contextual examples and/or de-contextual definitions in children's responses to verbal probes. Three items ('walk', 'sad', and 'made fun of') were identified as requiring further testing and/or refinement, where a lower percentage of discussions contained evidence of intended item meaning.
Despite previous uncertainty, this study demonstrates how methodological challenges can be addressed to enable young children's participation in cognitive interviews evaluating item comprehensibility, ultimately contributing to the accurate measurement of young children's health outcomes in healthcare and research.
确定患者报告结局量表(PROMs)在生活质量研究中的可理解性至关重要。认知访谈被推荐为评估成年人群可理解性的“金标准”,但在幼儿(≤7岁)中并非常规使用。因此,本研究旨在评估采用传统方法和改良方法对6至7岁儿童进行认知访谈以评估PROM项目可理解性的可行性。
14名患有一系列已确诊健康状况的6至7岁儿童参与了个体认知访谈。每个儿童回答6个模拟PROM项目(身体、心理和与社会健康相关的生活质量领域),并使用同步言语探查来评估项目的可理解性。访谈进行了录音并逐字转录。使用一种新颖的可理解性连续体对转录本进行分析,该连续体对儿童对项目的解释与预期含义之间的一致程度进行编码。
认知访谈取得成功;84个项目讨论中的83个(99%)可以确定可理解程度。大多数项目是可理解的,儿童对84个项目中的74个(88%)描述了预期的项目含义,这在儿童对言语探查的回答中的情境示例和/或脱离情境的定义中得到了证明。三个项目(“走路”、“悲伤”和“被取笑”)被确定需要进一步测试和/或完善,其中包含预期项目含义证据的讨论比例较低。
尽管之前存在不确定性,但本研究展示了如何应对方法学挑战,以使幼儿能够参与评估项目可理解性的认知访谈,最终有助于在医疗保健和研究中准确测量幼儿的健康结局。