瘙痒患者报告结局工具测量属性的系统评价

焦姝婷; 赵亚利

doi:10.16766/j.cnki.issn.1674-4152.003979

瘙痒患者报告结局工具测量属性的系统评价

doi: 10.16766/j.cnki.issn.1674-4152.003979

焦姝婷,
赵亚利^,

首都医科大学全科医学与继续教育学院，北京 100069

基金项目:

首都卫生发展科研专项资助重点项目首发2023-1Y-001

详细信息

通讯作者:
赵亚利，E-mail：zylnmtb@ccmu.edu.cn

中图分类号: R758.3
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出版历程
- 收稿日期: 2024-07-21
- 网络出版日期: 2025-06-30

Systematic review of patient-reported outcome measures for pruritus

JIAO Shuting,
ZHAO Yali^,

School of General Practice and Continuing Education, Capital Medical University, Beijing 100069, China

摘要

摘要: 目的系统评价瘙痒相关患者报告结局工具(PROMs)的质量，为合理选择相关工具提供参考。方法检索PubMed、Embase、web of science、中国知网、万方、维普及中国生物医学文献服务数据库，获取国内外公开发表的瘙痒PROMs研究，由2名研究者分别使用基于共识选择健康测量工具的标准(COSMIN)对纳入研究展开方法学质量和测量学属性评价。结果共纳入27项研究，涉及24个瘙痒PROMs。对13个PROMs给出推荐等级，在多维度瘙痒评估工具中，SIIS(英语)、ICQ(英语)为A类推荐，FIIQ(中文)、EIQ(繁体中文)、BIQ(中文)、瘙痒评估量表(中文)为B类推荐，12-PSS(中文)为C类推荐; 瘙痒相关生活质量工具中，TweenItchyQoL(英语)为A类推荐，UP-Dial(中文11项)、SRISS(英语)、ItchyQoL(中文)为B类推荐，UP-Dial(中文14项)、KIQoL(英语)为C类推荐。结论 SIIS(英语)、ICQ(英语)、TweenItchyQoL(英语)需汉化后应用。ItchyQoL(中文)测量属性评价相对全面，可暂时作为中文推荐工具使用。
- 瘙痒 /
- 患者报告结局工具 /
- 系统评价 /
- 健康测量工具的标准
Abstract: Objective To systematically assess the quality of pruritus-related patient-reported outcome measures (PROMs) and provide a guidance for selecting appropriate tools. Methods PubMed, Embase, web of science, CNKI, Wanfang, Whipple, and Chinese Biomedical Literature databases were searched to identify publicly available studies on pruritus-related PROMs both domestically and internationally. Two researchers evaluated the methodological quality and measurement attributes of the included studies using the consensus-based standards for the selection of health measurement instruments (COSMIN). Results A total of 27 studies involving 24 pruritus-related PROMs were included. Thirteen PROMs were given a recommendation rating. Among the multidimensional pruritus tools, SIIS (English) and ICQ (English) were rated level A, while FIIQ (Chinese), EIQ (Traditional Chinese), BIQ (Chinese), and Pruritus Evaluation Scale (Chinese) were recommended as level B, and 12-PSS (Chinese) was related level C. Among pruritus-related quality of life tools, the TweenItchyQoL (English) was related level A, while the UP-Dial (11 items in Chinese), SRISS (English), and ItchyQoL (Chinese) were related level B, and the UP-Dial (14 items in Chinese) and KIQoL (English) were related level C. Conclusion SIIS (English), ICQ (English), and TweenItchyQoL (English) need to be translated into Chinese before application. ItchyQoL (Chinese) measurement has a relatively comprehensive measurement attribute evaluation and can be used as a Chinese tool for use at present.
- Pruritus /
- Patient-reported outcome measures /
- Systematic review /
- Consensus-based selection of health measurement instruments

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表 1 纳入PROMs基本信息

Table 1. Basic characteristics of included PROMs

分类	量表名称(语言)	发表时间 (年)	研制方	目标人群患病类型	样本量	条目/维度
单维工具	NRS-11 worst itch(英语)^[7-10]	2021/2023	美国	AD、结节性荨麻疹	2 696	1/1
	pruritus NRS(英语)^[11]	2024	美国	AD	301	1/1
多维工具	FIIQ(中文)^[12]	2015	中国	尿毒症	120	4/4
	SIIS(英语)^[13]	2020	美国	AD、银屑病	137	13/2
	ICQ(英语)^[14]	2020	美国	AD、银屑病	137	20/2
	12-PSS(中文)^[15]	2019	中国	皮肤病	143	12/5
	12-PSS(波斯语)^[16]	2021	伊朗	血液透析	195	12/5
	EIQ(繁体中文)^[17]	2021	中国台湾	皮肤病	103	132/6
	5-D IS(巴西葡萄牙语)^[18]	2019	巴西	烧伤	30	8/5
	5-D IS(波斯语)^[19]	2021	伊朗	血液透析	90	8/5
	5-D IS(泰语)^[20]	2022	泰国	湿疹、慢性荨麻疹	130	8/5
	5-D IS (西班牙语)^[21]	2022	智利	烧伤	10	9/6
	BIQ(中文)^[22]	2022	中国	烧伤后瘙痒	110	17/3
	PRUCISION ObsRO(英语)^[23-24]	2022	美国	8岁以下胆淤患儿照护者	52	8/4
	瘙痒评估量表(中文)^[25]	2022	中国	皮肤病	143	9/4
瘙痒相关生活质量工具	UP-Dial(中文14项)^[26]	2019	中国	血液/腹膜透析	270	14/3
	UP-Dial(中文11项)^[27]	2022	中国	血液透析	132	11/3
	UP-Dial(波兰语)^[28]	2022	波兰	血液透析	30	14/3
	SRISS(英语)^[13]	2020	美国	AD、银屑病	137	16/1
	ItchyQoL(中文)^[29]	2020	中国	皮肤病	220	22/3
	ItchyQoL(多语言修订)^[30]	2021	PruNet	慢性瘙痒	551	22/3
	KIQoL(英语)^[31]	2021	美国	6~7岁患皮肤病	100	14/3
	TweenItchyQoL(英语)^[32]	2021	美国	8~17岁患皮肤病	175	35/3
	CIB(法语)^[33]	2022	法国	皮肤病	300	20/2
注：NRS-11 worst itch为the worst itch numerical rating scale; AD为特应性皮炎(atopic dermatitis); FIIQ为四项目瘙痒量表(four-item itch questionnaire); SIIS为the scratch intensity and impact scale; ICQ为the itch cognitions questionnaire; 12-PSS为十二项目瘙痒量表(12-item pruritus severity scale); EIQ为the Chinese eppendorf itch questionnaire; 5-D IS为5-D瘙痒量表(5-D itch scale); BIQ为烧伤瘙痒问卷(burns itch questionnaire); UP-Dial为维持性血液透析患者皮肤瘙痒评估量表(uremic pruritus in dialysis patients scale); SRISS为the sleep-related itch and scratch scale; ItchyQoL为瘙痒患者生活质量问卷(the pruritus-specific quality of life instrument); KIQoL为kids itchy QoL; CIB为the chronic itch burden scale; PruNet为欧洲瘙痒症严重程度和负担评估网络(the European network on assessment of severity and burden of pruritus)。

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表 2 纳入PROMs测量属性评价结果汇总及推荐意见

Table 2. Synthesis of measurement properties of included PROMs and recommendation formulation

分类	量表	内容效度	结构效度	内部一致性	跨文化效度	稳定性	假设检验	反应度	推荐等级
单维工具	NRS-11 worst itch(英语)	±/极低	NR	NR	NR	+/低	-/极低	+/高	/
	pruritus NRS(英语)	±/低	NR	NR	NR	+/高	+/低	+/高	/
多维工具	FIIQ(中文)	±/极度	+/低	+/低	NR	？/低	-/低	NR	B
	SIIS(英语)	+/低	+/中	+/中	NR	？/低	+/中	NR	A
	ICQ(英语)	+/极低	+/中	+/中	NR	？/低	+/高	-/低	A
	12-PSS(中文)	±/低	-/高	+/高	NR	？/极低	-/高	NR	C
	EIQ(繁体中文)	±/低	-/极低	？/极低	NR	NR	-/低	+/中	B
	5-D IS(巴西葡萄牙语)	NR	NR	+/低	NR	NR	NR	NR	/
	5-D IS(波斯语)	NR	+/中	+/低	NR	+/极低	-/低	NR	/
	5-D IS(泰语)	NR	NR	NR	NR	+/低	-/极低	+/极低	/
	BIQ(中文)	±/低	+/中	+/中	NR	？/极低	NR	NR	B
	PRUCISION ObsRO(英语)	+/极低	NR	NR	NR	+/低	-/极低	+/极低	/
	瘙痒评估量表	±/低	+/中	NR	NR	？/极低	-/低	+/低	B
瘙痒相关生活质量工具	UP-Dial(中文14项)	？/极低	+/中	+/中	NR	？/极低	-/低	NR	C^a
	UP-Dial(中文11项)	？/极低	+/中	NR	NR	？/极低	-/低	NR	B
	UP-Dail(波兰语)	NR	NR	+/低	NR	+/极低	-/极低	NR	/
	SRISS(英语)	+/低	+/极低	？/极低	NR	？/低	+/中	NR	B
	ItchyQoL(中文)	？/低	-/低	+/高	NR	NR	+/高	+/低	B
	ItchyQoL(多语言修订)	NR	+/高	NR	+/中	NR	NR	NR	/
	KIQoL(英语)	+/极低	-/高	-/高	NR	-/低	NR	-/高	C
	TweenItchyQoL(英语)	+/低	+/中	+/中	NR	+/低	NR	+/低	A
	CIB(法语)	NR	+/中	+/中	NR	NR	+/高	NR	/
注：+为充分，-为不足，±为不一致，？为不确定。NR为因研究未报告或实施相关内容而无法评价(波斯语12-PSS和西班牙语5-D IS因未评价任何测量属性而略去)。/为无法划分推荐强度。^a为考虑到UP-Dial(中文14项)开发过程不良，给予C级推荐。

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