DeConde Adam S, Bodner Todd E, Mace Jess C, Smith Timothy L
Division of Rhinology and Sinus Surgery, Oregon Sinus Center, Department of Otolaryngology-Head and Neck Surgery, Oregon Health & Science University, Portland.
Department of Psychology, Portland State University, Portland, Oregon.
JAMA Otolaryngol Head Neck Surg. 2014 Aug;140(8):712-9. doi: 10.1001/jamaoto.2014.1045.
Patient-reported measures are designed to detect a true change in outcome, but they are also subject to change from biases inherent to self-reporting: changing internal standards, changing priorities, and changing interpretations of a given instrument. These biases are collectively known as "response shifts" and can obscure true change after medical interventions.
To determine the presence of response shifts in patients with chronic rhinosinusitis (CRS) after endoscopic sinus surgery.
DESIGN, SETTING, AND PARTICIPANTS: Multisite, prospective, observational cohort study conducted at academic tertiary care centers between February 2011 and May 2013. Study participants comprised a population-based sample of 514 adults (age ≥18 years) with CRS, who elected surgical intervention for continuing medically refractory symptoms.
Endoscopic sinus surgery.
Preoperative and postoperative data from the 22-item Sinonasal Outcome Test (SNOT-22) survey instrument was characterized using exploratory factor analysis. Subsequent longitudinal structural equation models were estimated to test structure, potential response shifts, and true change in the SNOT-22 scores.
A total of 339 participants (66.0%) provided survey evaluations at baseline and 6-month follow-up. Factor analysis of the SNOT-22 revealed 5 correlated, yet distinguishable, underlying factors. Endoscopic sinus surgery had a differential impact across these factors, with the largest effect size in rhinologic symptoms (mean [SD] SNOT-22 scores before and after surgery, 13.18 [5.11] and 7.37 [5.48], respectively; d = -1.13 [P < .001]) and extranasal rhinologic symptoms (8.31 [3.46] and 4.83 [3.68], respectively; d = -1.00 [P < .05]) (d is an effect size measure defined as the difference in means divided by the presurgery SD). Endoscopic sinus surgery had a smaller, yet significant, effect size on the remaining 3 factors: ear/facial symptoms (7.32 [4.6]) and 3.90 [4.07], respectively; d = -0.74 [P < .001]), psychological dysfunction (11.90 [7.21] and 6.50 [6.69], respectively; d = -0.75 [P < .05]), and sleep dysfunction (10.12 [5.59] and 5.88 [5.37], respectively; d = -0.76 [P < .001]). Participants were found to undergo recalibration, reprioritization, and reconceptualization of symptoms after intervention; however, the magnitude of these response shifts was small and not clinically significant.
The SNOT-22 measures 5 distinct factors, not a single construct. Reporting of individual subscale scores may improve sensitivity of this instrument in future studies. Participants undergoing endoscopic sinus surgery experience only clinically insignificant response shifts, validating assessment of change through use of presurgery and postsurgery SNOT-22 responses.
clinicaltrials.gov Identifier: NCT01332136.
患者报告的测量方法旨在检测结果的真实变化,但它们也会因自我报告固有的偏差而发生变化:内部标准的改变、优先级的改变以及对特定工具的解释的改变。这些偏差统称为“反应转移”,可能会掩盖医疗干预后的真实变化。
确定慢性鼻-鼻窦炎(CRS)患者在内镜鼻窦手术后是否存在反应转移。
设计、设置和参与者:2011年2月至2013年5月在学术三级医疗中心进行的多中心、前瞻性、观察性队列研究。研究参与者包括514名年龄≥18岁的CRS成年患者,他们因持续存在药物难治性症状而选择手术干预。
内镜鼻窦手术。
使用探索性因素分析对22项鼻鼻窦结局测试(SNOT-22)调查问卷工具的术前和术后数据进行特征分析。随后估计纵向结构方程模型,以测试SNOT-22评分的结构、潜在反应转移和真实变化。
共有339名参与者(66.0%)在基线和6个月随访时提供了调查评估。对SNOT-22的因素分析揭示了5个相关但可区分的潜在因素。内镜鼻窦手术对这些因素有不同的影响,在鼻科症状方面效应量最大(手术前后SNOT-22评分的平均值[标准差]分别为13.18[5.11]和7.37[5.48];d=-1.13[P<.001])以及鼻外鼻科症状(分别为8.31[3.46]和4.83[3.68];d=-1.00[P<.05])(d是效应量指标,定义为平均值之差除以术前标准差)。内镜鼻窦手术对其余三个因素的效应量较小但具有统计学意义:耳部/面部症状(分别为7.32[4.6]和3.90[4.07];d=-0.74[P<.001])、心理功能障碍(分别为11.90[7.21]和6.50[6.69];d=-0.75[P<.05])以及睡眠功能障碍(分别为10.12[5.59]和5.88[5.37];d=-0.76[P<.001])。发现参与者在干预后对症状进行了重新校准、重新排序和重新概念化;然而,这些反应转移的程度较小且无临床意义。
SNOT-22测量5个不同的因素,而非单一结构。在未来研究中报告各个子量表得分可能会提高该工具的敏感性。接受内镜鼻窦手术的参与者仅经历了无临床意义的反应转移,这验证了通过术前和术后SNOT-22反应来评估变化的有效性。
clinicaltrials.gov标识符:NCT01332