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开发一种由观察者报告的结局指标,以捕捉婴幼儿发热不适症状的体征及影响。

Development of an observer-reported outcome measure to capture the signs and impact of fever distress symptoms in infants and young children.

作者信息

Smith Adam B, Tselenti Evi, Kanabar Dipak, Miles Lisa

机构信息

Health Outcomes, Reckitt Benckiser Healthcare, Dansom Lane, Hull, HU8 7DS, UK.

Guy's and St Thomas' NHS Foundation Trust, London, UK.

出版信息

Qual Life Res. 2022 May;31(5):1573-1585. doi: 10.1007/s11136-021-03049-z. Epub 2022 Jan 7.

DOI:10.1007/s11136-021-03049-z
PMID:34993744
Abstract

PURPOSE

This qualitative study aimed to construct an observer-reported outcome measure (ObsRO) to evaluate fever distress in young children.

METHODS

A literature review was conducted to identify fever-related concepts. Clinical experts were interviewed for feedback on these concepts. Parents of young children were interviewed to identify behaviours the child exhibited during a recent fever episode. Fever sign and behaviour concepts endorsed by ≥ 20% parents were used to create items for the draft ObsRO. Parents of young children who recently had fever completed the ObsRO and gave feedback during two successive rounds of cognitive interviews.

RESULTS

Twenty-five parents participated in the concept elicitation. Mean child age was 2.7 years (range: 0.6-5.8 years). Fever sign and behaviour concepts endorsed by ≥ 20% participants were high temperature (80%), skin hot to touch (32%), skin redness/flushing (32%), reduced appetite/drink (96%), needy/clingy/irritable (48-92%), less active/interactive (68-84%) and lethargic (64-88%). Eighteen items, four in the Fever Signs Module and 14 in the Fever Behaviours Module, were developed for the draft ObsRO. Chosen recall period was 24 h. Thirty participants (Round 1: n = 17; Round 2: n = 13), participated in cognitive interviews. Mean child age was 2.4 years (range 0.3-5.8). Round 1 feedback resulted in two Fever Signs items being combined. Three Fever Behaviour items were deleted, six revised and four unchanged. No changes were made following Round 2 feedback. Most participants understood all aspects of the ObsRO and found it user-friendly.

CONCLUSION

The ObsRO will undergo further development in validation studies testing measurement properties of each item.

摘要

目的

本定性研究旨在构建一种由观察者报告的结局指标(ObsRO),以评估幼儿的发热不适。

方法

进行文献综述以确定与发热相关的概念。就这些概念采访临床专家以获取反馈。采访幼儿家长以确定孩子在最近一次发热期间表现出的行为。≥20%家长认可的发热体征和行为概念被用于创建ObsRO草案的条目。近期发热的幼儿家长完成ObsRO,并在两轮连续的认知访谈中提供反馈。

结果

25名家长参与了概念引出。孩子的平均年龄为2.7岁(范围:0.6 - 5.8岁)。≥20%参与者认可的发热体征和行为概念包括体温高(80%)、皮肤触摸发热(32%)、皮肤发红/潮红(32%)、食欲/饮水量减少(96%)、有需求/黏人/易怒(48 - 92%)、活动/互动减少(68 - 84%)和嗜睡(64 - 88%)。为ObsRO草案制定了18个条目,其中发热体征模块4个,发热行为模块14个。选择的回忆期为24小时。30名参与者(第一轮:n = 17;第二轮:n = 13)参与了认知访谈。孩子的平均年龄为2.4岁(范围0.3 - 5.8岁)。第一轮反馈导致两个发热体征条目合并。删除了三个发热行为条目,六个进行了修订,四个未改变。第二轮反馈后未做更改。大多数参与者理解ObsRO的各个方面,并认为其使用方便。

结论

ObsRO将在验证研究中进一步开发,以测试每个条目的测量属性。

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