Klassen Anne F, Cano Stefan J, Schwitzer Jonathan A, Baker Stephen B, Carruthers Alastair, Carruthers Jean, Chapas Anne, Pusic Andrea L
Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada.
Modus Outcomes, Boston, Massachusetts.
JAMA Dermatol. 2016 Apr;152(4):443-51. doi: 10.1001/jamadermatol.2016.0018.
Patient-reported outcomes data are needed to determine the efficacy of cosmetic procedures.
To describe the development and psychometric evaluation of 8 appearance scales and 2 adverse effect checklists for use in minimally invasive cosmetic procedures.
DESIGN, SETTING, AND PARTICIPANTS: We performed a psychometric study to select the most clinically sensitive items for inclusion in item-reduced scales and to examine reliability and validity with patients. Recruitment of the sample for this study took place from June 6, 2010, through July 28, 2014. Data analysis was performed from December 11, 2014, to December 22, 2015. Pretreatment and posttreatment patients 18 years and older who were consulting for any type of facial aesthetic treatment were studied. Patients were from plastic surgery and dermatology outpatient clinics in the United States and Canada (field-test sample) and a clinical trial of a minimally invasive lip treatment in the United Kingdom and France (clinical trial sample).
The FACE-Q scales that measure appearance of the skin, lips, and facial rhytids (ie, overall, forehead, glabella, lateral periorbital area, lips, and marionette lines), with scores ranging from 0 (lowest) to 100 (highest), and the FACE-Q adverse effects checklists for problems after skin and lip treatment.
Of 783 patients recruited, 503 field-test patients (response rate, 90%) and 280 clinical trial participants were studied. The mean (SD) age of the patients was 47.4 (14.0) years in the field-test sample and 47.7 (12.3) years in the clinical trial sample. Most of the patients were female (429 [85.3%] in the field-test sample and 274 [97.9%] in the clinical trial sample). Rasch Measurement Theory analyses led to the refinement of 8 appearance scales with 66 total items. All FACE-Q scale items had ordered thresholds and acceptable item fit. Reliability, measured with the Personal Separation Index (range, 0.88-0.95) and Cronbach α (range, 0.93-0.98), was high. Lower scores for appearance scales that measured the skin (r = -0.48, P < .001), lips (r = -0.21, P = .001), and lip rhytids (r = -0.32, P < .001) correlated with the reporting of more skin- and lip-related adverse effects. Higher scores for the 8 appearance scales correlated (range, 0.70-0.28; P < .001) with higher scores on the core 10-item FACE-Q satisfaction with facial appearance scale. In the pretreatment group, older age was significantly correlated with lower scores on 5 of the 6 rhytids scales (exception was forehead rhytids) (range, -0.28 to -0.65; P = .03 to <.001). Pretreatment patients reported significantly lower scores on 7 of the 8 appearance scales compared with posttreatment patients (exception was skin) (P < .001 to .005 on independent sample t tests).
The FACE-Q appearance scales and adverse effects checklists can be used in clinical practice, research, and quality improvement to incorporate cosmetic patients' perspective in outcome assessments.
需要患者报告的结果数据来确定美容手术的疗效。
描述8个外观量表和2个不良反应清单的开发及心理测量学评估，用于微创美容手术。
设计、地点和参与者：我们进行了一项心理测量学研究，以选择最具临床敏感性的项目纳入简化量表，并检验其在患者中的信度和效度。本研究的样本招募于2010年6月6日至2014年7月28日进行。数据分析于2014年12月11日至2015年12月22日进行。研究了18岁及以上因任何类型面部美容治疗前来咨询的治疗前和治疗后患者。患者来自美国和加拿大的整形外科和皮肤科门诊（现场测试样本）以及英国和法国一项微创唇部治疗的临床试验（临床试验样本）。
FACE-Q量表用于测量皮肤、嘴唇和面部皱纹（即整体、额头、眉间、眶周外侧区域、嘴唇和木偶纹）的外观，分数范围为0（最低）至100（最高），以及FACE-Q皮肤和唇部治疗后问题的不良反应清单。
在招募的783名患者中，研究了503名现场测试患者（应答率90%）和280名临床试验参与者。现场测试样本中患者的平均（标准差）年龄为47.4（14.0）岁，临床试验样本中为47.7（12.3）岁。大多数患者为女性（现场测试样本中429名[85.3%]，临床试验样本中274名[97.9%]）。拉施测量理论分析导致对8个外观量表进行了细化，共66个项目。所有FACE-Q量表项目都有有序的阈值和可接受的项目拟合度。用个人分离指数（范围0.88 - 0.95）和克朗巴哈α系数（范围0.93 - 0.98）测量的信度很高。测量皮肤（r = -0.48，P <.001）、嘴唇（r = -0.21，P =.001）和唇部皱纹（r = -0.32，P <.001）的外观量表得分较低与报告更多皮肤和唇部相关不良反应相关。8个外观量表得分较高与核心10项FACE-Q面部外观满意度量表得分较高相关（范围0.70 - 0.28；P <.001）。在治疗前组中，年龄较大与6个皱纹量表中的5个得分较低显著相关（额头皱纹除外）（范围-0.28至-0.65；P =.03至<.001）。与治疗后患者相比，治疗前患者在8个外观量表中的7个上报告的得分显著较低（皮肤除外）（独立样本t检验中P <.001至.005）。
FACE-Q外观量表和不良反应清单可用于临床实践、研究和质量改进，以便在结果评估中纳入美容患者的观点。
