RTI Health Solutions, Manchester, UK.
Amgen Inc., Thousand Oaks, CA, 91320, USA.
Health Qual Life Outcomes. 2018 Aug 3;16(1):160. doi: 10.1186/s12955-018-0970-3.
The increasing emphasis on patient-reported outcomes in health care decision making has prompted greater rigor in the evidence to support the instruments used. Acceptability and content validity are important properties of any measure to ensure it assesses the relevant aspects of the target concept. The purpose of this study was to evaluate the acceptability and content validity of the EQ-5D 5-Level (EQ-5D-5L) to assess the impact of asthma on patients' lives.
Qualitative interviews were conducted with 40 adults with asthma in the United Kingdom. The first 25 interviews used cognitive-debriefing methods to assess the relevance and acceptability of the EQ-5D-5L and two asthma-specific measures for comparison: an asthma-specific, preference-based measure (the Asthma Quality of Life Utility Index-5 Dimensions) and an Asthma Symptom Diary. The final 15 interviews combined concept elicitation to identify patient-perceived asthma impact, and cognitive debriefing to assess relevance and acceptability of the EQ-5D-5L and the Asthma Symptom Diary. Cognitive-debriefing feedback on the content of the measures was collated and summarized descriptively. The concept-elicitation data were analyzed thematically.
Participants were aged 20 to 57 years and 62.5% were female. Although some participants expressed positive opinions on aspects of the EQ-5D-5L, only the usual activities dimension was consistently considered relevant to participants' asthma experiences. The mobility and self-care dimensions prompted strong negative reactions from some participants. Variations in interpretation of the mobility dimension and difficulties with multiple concepts in the pain/discomfort and anxiety/depression dimensions also were noted. Concepts reported by participants as missing included environmental triggers, asthma symptoms, emotions, and sleep. The EQ-5D-5L was the least preferred measure to describe the impact of asthma on participants' lives. Participants reported shortness of breath and impact on activities as especially salient issues.
The content of the EQ-5D-5L was poorly aligned with the patient-perceived impact of asthma, and the measure failed to meet basic standards for acceptability and content validity as a measure to assess the impact of asthma from the patient perspective. The shortcomings identified raise concerns regarding the appropriateness of the EQ-5D in asthma and further evaluation is warranted.
在医疗保健决策中越来越强调患者报告的结果,这促使人们更加重视支持使用的工具的证据的严谨性。可接受性和内容效度是任何衡量标准的重要属性,以确保其评估目标概念的相关方面。本研究的目的是评估 EQ-5D 5 级(EQ-5D-5L)评估哮喘对患者生活影响的可接受性和内容效度。
在英国对 40 名成年哮喘患者进行了定性访谈。前 25 次访谈使用认知剖析方法来评估 EQ-5D-5L 与两种哮喘专用措施(哮喘专用的偏好为基础的措施(哮喘生活质量效用指数-5 维度)和哮喘症状日记)的相关性和可接受性。最后 15 次访谈结合了概念提取,以确定患者感知的哮喘影响,并进行认知剖析,以评估 EQ-5D-5L 和哮喘症状日记的相关性和可接受性。对措施内容的认知剖析反馈进行了整理和描述性总结。对概念提取数据进行了主题分析。
参与者年龄在 20 至 57 岁之间,62.5%为女性。尽管一些参与者对 EQ-5D-5L 的某些方面表示了积极的看法,但只有通常的活动维度始终被认为与参与者的哮喘经历有关。移动性和自我护理维度引起了一些参与者的强烈负面反应。对移动性维度的解释存在差异,并且在疼痛/不适和焦虑/抑郁维度中存在多个概念的困难也引起了注意。参与者报告缺失的概念包括环境诱因、哮喘症状、情绪和睡眠。EQ-5D-5L 是最不受参与者欢迎的描述哮喘对其生活影响的措施。参与者报告呼吸急促和活动影响是特别突出的问题。
EQ-5D-5L 的内容与患者感知的哮喘影响不符,该措施在可接受性和内容效度方面均未达到基本标准,无法作为从患者角度评估哮喘影响的措施。确定的缺点引起了对 EQ-5D 在哮喘中的适当性的关注,需要进一步评估。