School of Psychology, University of Plymouth, Plymouth, PL4 8AA, UK.
Plymouth Hospital's NHS Trust, Plymouth, UK.
Health Qual Life Outcomes. 2018 Jan 27;16(1):24. doi: 10.1186/s12955-018-0851-9.
Previous research shows that existing asthma quality of life questionnaires fail to measure the burden of oral corticosteroids that can be used to treat severe asthma, and are therefore not fit for purpose for severe asthma according to the USA's Federal Drug Authority's (FDA) criteria for content validity. Patient input and documentation of that input is key to achieving content validity according to FDA guidelines. This paper describes the process of constructing a new questionnaire to measure the burden of asthma symptoms and burden of treatment in severe asthma, using criteria specified by the FDA.
A draft severe asthma questionnaire (SAQ) was constructed using qualitative input from severe asthma patients who took part in an earlier study. The aim of this study was to improve that draft questionnaire using a further group of patients. In four iterative focus groups, 16 people with severe asthma completed the draft questionnaire, discussed the wording and structure and suggested changes that were incorporated into the final version.
The original intention to ask patients to identify whether problems were caused by asthma symptoms or side effects of medication was abandoned as the attribution of cause was found to be difficult and inconsistent. The recall period of 2 weeks was acceptable but fails to reflect the patients' desire to express the variability of severe asthma. Patients suggested improvements to the wording of the draft questionnaire, including splitting some items in two, combining two items in one, and changes to some of the words in individual items and the response scale.
The final version of the questionnaire was substantially different from one constructed using only qualitative reports from patients about the quality of life deficits of severe asthma. Patients make a valuable contribution to the questionnaire if they are asked to comment and improve an initial draft and where patients are treated as partners in the process of questionnaire construction, rather than only as a source of information to experts who construct the questionnaire.
先前的研究表明，现有的哮喘生活质量问卷无法衡量口服皮质类固醇的负担，而皮质类固醇可用于治疗严重哮喘，因此根据美国联邦药物管理局（FDA）的内容有效性标准，这些问卷不适合严重哮喘。根据 FDA 指南，患者的意见和对这些意见的记录是实现内容有效性的关键。本文描述了使用 FDA 规定的标准构建新问卷来衡量严重哮喘患者症状负担和治疗负担的过程。
使用之前参与过一项研究的严重哮喘患者的定性意见来构建严重哮喘问卷（SAQ）草案。本研究的目的是使用另一组患者进一步改进该草案问卷。在四轮迭代焦点小组中，16 名严重哮喘患者完成了草案问卷，讨论了措辞和结构，并提出了一些建议，这些建议被纳入了最终版本。
最初的意图是让患者确定问题是由哮喘症状还是药物副作用引起的，但由于归因困难且不一致，因此放弃了这一意图。2 周的回顾期是可以接受的，但未能反映出患者表达严重哮喘变异性的愿望。患者建议改进草案问卷的措辞，包括将一些项目分成两个，将两个项目合并为一个，以及对个别项目和响应量表中的一些单词进行更改。
最终版本的问卷与仅使用患者对严重哮喘生活质量缺陷的定性报告构建的问卷有很大不同。如果患者被要求对初始草案进行评论和改进，并且将患者视为问卷构建过程中的合作伙伴，而不仅仅是专家的信息来源，那么患者会对问卷做出有价值的贡献。
