Development of Patient Reported Outcome Scale and Items Screening in Traditional Chinese Medicine for Patients with Recurrent Oral Ulcer

YANG Zhaoshuo; JI Weiping; CHEN Peipei; CHEN Yan; XU Liaoyu; WANG Yong; SHI Meiqin

doi:10.13288/j.11-2166/r.2019.08.005

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Development of Patient Reported Outcome Scale and Items Screening in Traditional Chinese Medicine for Patients with Recurrent Oral Ulcer

更新时间：2021-11-10

- Development of Patient Reported Outcome Scale and Items Screening in Traditional Chinese Medicine for Patients with Recurrent Oral Ulcer
- Journal of Traditional Chinese Medicine Vol. 60, Issue 8, Pages: 648-652(2019)
- 作者机构：
  
  1. 复旦大学附属中山医院
  2. 上海市中医文献馆
  3. 复旦大学附属眼耳鼻喉科医院
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2019.08.005
  CLC： R276.8
- Published：2019
- 稿件说明：
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[1]杨兆硕,季伟苹,陈沛沛,陈燕,徐燎宇,王勇,石美琴.中医复发性口腔溃疡患者报告结局量表的研制及条目筛选[J].中医杂志,2019,60(08):648-652.

YANG Zhaoshuo, JI Weiping, CHEN Peipei, et al. Development of Patient Reported Outcome Scale and Items Screening in Traditional Chinese Medicine for Patients with Recurrent Oral Ulcer[J]. Journal of Traditional Chinese Medicine2019, 60(8): 648-652.
[1]杨兆硕,季伟苹,陈沛沛,陈燕,徐燎宇,王勇,石美琴.中医复发性口腔溃疡患者报告结局量表的研制及条目筛选[J].中医杂志,2019,60(08):648-652. DOI： 10.13288/j.11-2166/r.2019.08.005.

YANG Zhaoshuo, JI Weiping, CHEN Peipei, et al. Development of Patient Reported Outcome Scale and Items Screening in Traditional Chinese Medicine for Patients with Recurrent Oral Ulcer[J]. Journal of Traditional Chinese Medicine2019, 60(8): 648-652. DOI： 10.13288/j.11-2166/r.2019.08.005.

摘要

目的在中医理论指导下研制中医复发性口腔溃疡患者报告结局（PRO）量表。方法按照PRO量表制作原则与流程

结合中医相关理论

建立复发性口腔溃疡PRO量表的理论框架。通过访谈法、文献法等方式建立条目池

根据专家Delphi法及Likert评定法进行条目筛选和优化

并通过文化适应性调查等形成预调查量表。临床调查复发性口腔溃疡患者

运用离散趋势法、相关系数法、因子分析法、t检验法、克朗巴赫α系数法、专家重要性评分6种统计方法进行条目筛选。结果形成条目池78条症状

经优化得到复发性口腔溃疡PRO预调查量表条目27条。发放量表175份调查表

共回收169份

通过离散趋势法删除标准差<0.7的条目2条

因子分析法除去与其他因子接近的条目1条

克朗巴赫α系数法删除Cronbach’sα系数<0.7的条目1条

专家重要性评分删除评分<8分的条目6条（其中2条与离散趋势法相同）

最终筛选出19个条目

形成中医复发性口腔溃疡PRO量表。分为生理、心理、社会、独立性领域4个领域

包括疼痛及不适、体力、睡眠、二便、饮食、出汗、寒热、积极感受、消极感受、日常生活、个人能力、社会关系、社会环境12个方面。结论中医复发性口腔溃疡PRO量表研制流程规范

能够体现中医复发性口腔溃疡发病特色

反映复发性口腔溃疡患者生存质量

尚需对量表的信度、效度及反应度实施进一步的科学性考评。

Abstract

Objective To develop a patient reported outcome（ PRO） scale for patients with recurrent oral ulcer under the guidance of traditional Chinese medicine（ TCM） theory. Methods According to the principle and process of PRO scale development

combined with the relevant theory of TCM

the theoretical framework of the recurrent oral ulcer PRO scale was established. The item pool was established through interviews and literature methods.The items were screened and optimized according to the expert Delphi method and the Likert evaluation method

and the pre-survey scale was formed through the cultural adaptability survey. Clinical investigation was conducted in patients with recurrent oral ulcers. The item screening was performed using discrete trend method

correlation coefficient method

factor analysis method

t test method

Cronbach α coefficient method

and expert importance score.Results Totally 78 symptoms of the pool of items were formed

and 27 items of the PRO pre-survey scale for recurrent oral ulcers were obtained after optimization. A total of 175 questionnaires were issued

and 169 copies were collected. Two items with standard deviation < 0. 7 were deleted by discrete trend method. Factor analysis method was used to remove one item close to other factors

and by Cronbach α coefficient method one item with Cronbach αcoefficient < 0. 7 was deleted. Six items with expert importance score < 8 points（ 2 of which were the same as discrete trend method） were deleted

and finally 19 items were selected to form the PRO scale of TCM recurrent oral ulcer. They were divided into 4 areas of physical

psychological

social

and independent fields

including 12 aspects of pain and discomfort

physical strength

sleep

urine and stool

diet

sweating

cold

positive feelings

negative feelings

daily life

personal ability

social relations

social environment. Conclusion The development process of TCM recurrent oral ulcer PRO scale can reflect the characteristics of the occurrence of TCM recurrent oral ulcer

reflect the quality of life of patients with recurrent oral ulcer

and further scientific assessment is needed to ensure the reliability

validity and response of the scale.

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