Department of Otolaryngology-Head and Neck Surgery, Northwestern University, Feinberg School of Medicine, Chicago, Ill.
Department of Medical Social Sciences, Northwestern University, Feinberg School of Medicine, Chicago, Ill.
J Allergy Clin Immunol Pract. 2020 Jul-Aug;8(7):2341-2350.e1. doi: 10.1016/j.jaip.2020.04.048. Epub 2020 May 4.
Patient-reported outcome (PRO) measures developed and validated on patients with the currently defined phenotypes of chronic rhinosinusitis (CRS) are needed to support clinical trials in CRS.
This study developed and examined the initial reliability and validity of the CRS-PRO, a new PRO measure of CRS.
Instrument development was performed through structured interviews and focus groups with clinical experts and 45 patients with CRS meeting current definitions of disease, 21 patients with CRS without nasal polyps (CRSsNP), and 24 patients with CRS with nasal polyps (CRSwNP) to identify items important to patients. Then another 50 patients (32 with CRSsNP and 18 with CRSwNP) with stable CRS symptoms were enrolled to evaluate the reliability of the instrument. Each patient completed the CRS-PRO, Sinonasal Outcome Test-22 (SNOT-22), and 4 Patient-Reported Outcome Measurement Information System short forms at the baseline visit and then at least 7 days later.
After the development process, 21 items were identified from the conceptual domains of physical symptoms, sensory impairment, psychosocial effects, and life impact. Using the responses of the 50 patients with CRS, 21 draft items were further refined to 12 items by eliminating conceptually similar or highly correlated items or those with low mean symptom severity. The 12-item questionnaire was shown to have excellent internal consistency (Cronbach α, 0.86) and test-retest reliability with a high intraclass correlation coefficient (0.89) and Pearson's correlation (r = 0.82, P < .0001). The 12-item CRS-PRO correlated highly with the longer SNOT-22 (r = 0.83, P < .0001) demonstrating its concurrent validity. We also demonstrated validity and reliability in a separate analysis for patients with CRSsNP and CRSwNP.
The CRS-PRO is a concise, valid, and reliable measure that was developed with extensive input from patients with CRS with current disease definitions.
需要针对目前定义的慢性鼻-鼻窦炎（CRS）表型患者开发和验证患者报告结局（PRO）测量工具，以支持 CRS 的临床试验。
本研究开发并检验了 CRS-PRO 的初步可靠性和有效性，这是一种新的 CRS PRO 测量工具。
通过与临床专家和 45 名符合当前疾病定义的 CRS 患者、21 名无鼻息肉的 CRS（CRSsNP）患者和 24 名有鼻息肉的 CRS（CRSwNP）患者进行结构化访谈和焦点小组，识别对患者重要的项目，来进行工具开发。然后，招募了另外 50 名（32 名 CRSsNP 和 18 名 CRSwNP）有稳定 CRS 症状的患者，以评估该工具的可靠性。每位患者在基线就诊时完成 CRS-PRO、鼻-鼻窦炎结局测试-22（SNOT-22）和 4 项患者报告结局测量信息系统简表，然后至少在 7 天后再次完成。
在开发过程中，从身体症状、感觉障碍、心理社会影响和生活影响等概念领域确定了 21 个项目。使用 50 名 CRS 患者的反应，通过消除概念上相似或高度相关的项目或那些具有低平均症状严重程度的项目，进一步将 21 个草案项目细化为 12 个项目。12 项问卷表现出极好的内部一致性（Cronbach α，0.86）和测试-重测可靠性，具有较高的组内相关系数（0.89）和 Pearson 相关系数（r=0.82，P<0.0001）。12 项 CRS-PRO 与较长的 SNOT-22 高度相关（r=0.83，P<0.0001），表明其具有同时有效性。我们还在对 CRSsNP 和 CRSwNP 患者的单独分析中证明了有效性和可靠性。
CRS-PRO 是一种简洁、有效、可靠的测量工具，是在当前疾病定义的 CRS 患者的广泛投入下开发的。
