Pulmonology/innov WHC & Radiology, Bayer AG, Digital & Commercial Innovation, Pharmaceuticals, Berlin, Germany.
Patient-Centered Research, Evidera, London, UK.
J Patient Rep Outcomes. 2023 Jul 10;7(1):65. doi: 10.1186/s41687-023-00605-8.
Refractory chronic cough (RCC), a cough lasting longer than 8 weeks with an unexplained underlying etiology and unresponsive to conventional treatment, can have substantial effects on patients' quality of life. For assessment of the efficacy of antitussive medication in clinical trials in RCC, patient-reported outcome (PRO) instruments should be fit for purpose with appropriate content validity. Here we describe the qualitative testing of a newly developed PRO instrument: the Severity of Chronic Cough Diary (SCCD).
The SCCD was developed to assess patients' symptom experience of cough in patients with RCC. A preliminary version was tested and refined based on an iterative process in a qualitative study. In total, three rounds of interviews were conducted with adult participants diagnosed with RCC in the USA (n = 19) and UK (n = 10). Rounds 1-3 consisted of hybrid concept elicitation (CE) interviews and cognitive interviews (CIs), with Round 3 also including interviews in a subset of participants (n = 5) about the usability of the SCCD as administered on an electronic handheld device.
The CE interviews identified concepts important to patients' experiences related to RCC that were broadly in line with the concepts in the preliminary version of the SCCD. Participants provided positive feedback on the draft SCCD across all CI rounds, reporting the instrument to be relevant and straightforward to complete, and containing a comprehensive set of concepts to evaluate their symptom experience of RCC. Participants demonstrated a good understanding of proposed item wording, response options, and the 24-hour recall period, and thought completion of the SCCD on the electronic device was easy. Following revisions based on results from each interview round, the SCCD at the end of this qualitative research study had 14 items assessing the concepts of: cough symptoms (five items), symptoms related to cough (four items), disruption to activities due to cough (three items), and disruption to sleep due to cough (two items).
The results of this study provide qualitative evidence supporting the content validity of the SCCD as a PRO instrument for evaluating outcomes of therapies for RCC in clinical trials.
难治性慢性咳嗽（RCC）是一种持续时间超过 8 周的咳嗽，其潜在病因不明且对常规治疗无反应，会对患者的生活质量产生重大影响。为了评估临床试验中镇咳药物的疗效，患者报告的结局（PRO）工具应具有针对性，并具有适当的内容效度。在这里，我们描述了一种新开发的 PRO 工具——慢性咳嗽严重程度日记（SCCD）的定性测试。
SCCD 是为评估 RCC 患者咳嗽症状体验而开发的。初步版本经过迭代过程的定性研究进行了测试和改进。总共对 19 名在美国和 10 名在英国诊断为 RCC 的成年参与者进行了三轮访谈。第 1-3 轮访谈包括混合概念发掘（CE）访谈和认知访谈（CI），第 3 轮访谈还包括对 SCCD 电子手持设备的使用性的部分参与者（n=5）访谈。
CE 访谈确定了与 RCC 患者体验相关的重要概念，这些概念与 SCCD 初步版本中的概念大致相符。所有 CI 轮次的参与者对 SCCD 草案均给予了积极反馈，报告称该工具与完成相关且简单易懂，并包含一套全面的概念来评估他们的 RCC 症状体验。参与者对提议的项目措辞、响应选项和 24 小时回忆期有很好的理解，认为在电子设备上完成 SCCD 很容易。在根据每个访谈轮次的结果进行修订后，这项定性研究结束时的 SCCD 有 14 个项目评估以下概念：咳嗽症状（5 个项目）、与咳嗽相关的症状（4 个项目）、因咳嗽而导致的活动中断（3 个项目）和因咳嗽而导致的睡眠中断（2 个项目）。
这项研究的结果提供了定性证据，支持 SCCD 作为一种 PRO 工具用于评估临床试验中治疗 RCC 的疗法的结局具有内容效度。
