Division of Neurological Surgery, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona;
J Neurosurg. 2013 Oct;119(4):1068-74. doi: 10.3171/2013.3.JNS122032. Epub 2013 May 10.
Patient-reported quality-of-life (QOL) end points are becoming increasingly important health care metrics. To date, no nasal morbidity instrument specifically designed for patients undergoing endonasal skull base surgery has been developed. In this study, the authors describe the development and validation of a site-specific nasal morbidity instrument to assess patient-reported rhinological outcomes following endonasal skull base surgery.
Eligible patients included those with planned endonasal transsphenoidal surgery for sellar pathology identified in outpatient neurosurgical clinics of 3 skull base centers from October 2011 to July 2012. An initial 23-question pool was developed by subject matter experts, review of the literature, and from the results of a previous validation study to assess for common rhinological complaints. Symptoms were ranked by patients from "No Problem" to "Severe Problem" on a 6-point Likert scale. Exploratory factor analysis, change scores, and importance rank were calculated to define the final instrument consisting of 12 items (The Anterior Skull Base Nasal Inventory-12, or ASK Nasal-12). Psychometric validation of the final instrument was performed using standard statistical techniques.
One hundred four patients enrolled in the study. All patients completed the preoperative survey and 100 patients (96%) completed the survey 2-4 weeks after surgery. Internal consistency of the final instrument was 0.88. Concurrent validity measures demonstrated a strong correlation between overall nasal functioning and total scores (p < 0.001). Test-retest reliability measures demonstrated a significant intraclass correlation between responses (p < 0.001). Effect size as calculated by standardized response mean suggested a large effect (0.84). Discriminant validity calculations demonstrated that the instrument was able to discriminate between preoperative and postoperative patients (p < 0.001).
This prospective study demonstrates that the ASK Nasal-12 is a validated, site-specific, unidimensional rhinological outcomes tool sensitive to clinical change. It can be used in conjunction with multidimensional QOL instruments to assess patient-reported nasal perceptions in endonasal skull base surgery. This instrument is being used as a primary outcome measure in an ongoing multicenter nasal morbidity study. Clinical trial registration no.: NCT01504399 (ClinicalTrials.gov).
患者报告的生活质量（QOL）终点越来越成为重要的医疗保健指标。迄今为止，尚无专门针对接受经鼻颅底手术患者的鼻腔发病率仪器。在这项研究中，作者描述了一种特定于部位的鼻腔发病率仪器的开发和验证，用于评估经鼻颅底手术后患者报告的鼻科学结果。
合格的患者包括在 2011 年 10 月至 2012 年 7 月的 3 个颅底中心的门诊神经外科诊所中计划接受经蝶鞍内经鼻手术治疗的患者。通过主题专家、文献回顾以及先前验证研究的结果，开发了最初的 23 个问题库，以评估常见的鼻科投诉。患者在 6 分李克特量表上将症状从“无问题”到“严重问题”进行排名。计算探索性因素分析、变化分数和重要性等级，以定义由 12 个项目组成的最终仪器（前颅底鼻清单-12 或 ASK 鼻-12）。使用标准统计技术对最终仪器进行心理测量学验证。
共有 104 名患者入组该研究。所有患者均完成了术前调查，100 名患者（96%）在术后 2-4 周完成了调查。最终仪器的内部一致性为 0.88。同时效度量表明整体鼻腔功能与总分之间存在很强的相关性（p < 0.001）。测试 - 重测可靠性测量表明，反应之间存在显著的组内相关性（p < 0.001）。根据标准化反应均值计算的效应大小表明，效应较大（0.84）。判别有效性计算表明，该仪器能够区分术前和术后患者（p < 0.001）。
这项前瞻性研究表明，ASK 鼻-12 是一种经过验证的、特定于部位的、一维的鼻科学结局工具，对临床变化敏感。它可以与多维生活质量仪器一起使用，以评估经鼻颅底手术患者报告的鼻腔感知。该仪器目前正在一项正在进行的多中心鼻腔发病率研究中用作主要结局测量指标。临床试验注册号：NCT01504399（ClinicalTrials.gov）。
