Anne F Klassen1, Stefan J Cano2, Jonathan A Schwitzer3, Stephen B Baker4, Alastair Carruthers5, Jean Carruthers6, Anne Chapas7, Andrea L Pusic8. 1. Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada. 2. Modus Outcomes, Boston, Massachusetts. 3. Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York4Department of Plastic Surgery, Georgetown University Hospital, Washington, DC. 4. Department of Plastic Surgery, Georgetown University Hospital, Washington, DC. 5. Department of Dermatology, University of British Columbia, Vancouver, British Columbia, Canada. 6. Department of Ophthalmology, University of British Columbia, Vancouver, British Columbia, Canada. 7. Department of Dermatology, New York University School of Medicine, New York, New York. 8. Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
Abstract
IMPORTANCE: Patient-reported outcomes data are needed to determine the efficacy of cosmetic procedures. OBJECTIVE: 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). MAIN OUTCOMES AND MEASURES: 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. RESULTS: 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). CONCLUSIONS AND RELEVANCE: 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.
RCT Entities:
IMPORTANCE: Patient-reported outcomes data are needed to determine the efficacy of cosmetic procedures. OBJECTIVE: 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). MAIN OUTCOMES AND MEASURES: 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. RESULTS: 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). CONCLUSIONS AND RELEVANCE: 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.
Authors: Neil Aaronson; Jordi Alonso; Audrey Burnam; Kathleen N Lohr; Donald L Patrick; Edward Perrin; Ruth E Stein Journal: Qual Life Res Date: 2002-05 Impact factor: 4.147
Authors: Donald L Patrick; Laurie B Burke; Chad J Gwaltney; Nancy Kline Leidy; Mona L Martin; Elizabeth Molsen; Lena Ring Journal: Value Health Date: 2011-10-10 Impact factor: 5.725
Authors: Donald L Patrick; Laurie B Burke; Chad J Gwaltney; Nancy Kline Leidy; Mona L Martin; Elizabeth Molsen; Lena Ring Journal: Value Health Date: 2011-10-13 Impact factor: 5.725
Authors: Kathryn Eilene Lasch; Patrick Marquis; Marc Vigneux; Linda Abetz; Benoit Arnould; Martha Bayliss; Bruce Crawford; Kathleen Rosa Journal: Qual Life Res Date: 2010-05-30 Impact factor: 4.147
Authors: Andrea L Pusic; Anne F Klassen; Amie M Scott; Jennifer A Klok; Peter G Cordeiro; Stefan J Cano Journal: Plast Reconstr Surg Date: 2009-08 Impact factor: 4.730
Authors: Tomasz R Kosowski; Colleen McCarthy; Patrick L Reavey; Amie M Scott; Edwin G Wilkins; Stefan J Cano; Anne F Klassen; Nicholas Carr; Peter G Cordeiro; Andrea L Pusic Journal: Plast Reconstr Surg Date: 2009-06 Impact factor: 4.730
Authors: Martin J Carney; Kate E Golden; Jason M Weissler; Michael A Lanni; Andrew R Bauder; Brigid Cakouros; Fabiola Enriquez; Robyn Broach; Frances K Barg; Marilyn M Schapira; John P Fischer Journal: Patient Date: 2018-04 Impact factor: 3.883
Authors: Anne F Klassen; Stefan J Cano; James C Grotting; Stephen B Baker; Jean Carruthers; Alastair Carruthers; Nancy Van Laeken; Jonathan M Sykes; Jonathan A Schwitzer; Andrea L Pusic Journal: JAMA Facial Plast Surg Date: 2017-01-01 Impact factor: 4.611
Authors: Mirte Langeveld; Lara S van de Lande; Eimear O' Sullivan; Berend van der Lei; Joris A van Dongen Journal: Skin Res Technol Date: 2021-11-09 Impact factor: 2.240
Authors: Jean Carruthers; Lisa Donofrio; Bhushan Hardas; Diane K Murphy; Derek Jones; Alastair Carruthers; Jonathan M Sykes; Lela Creutz; Ann Marx; Sara Dill Journal: Dermatol Surg Date: 2016-10 Impact factor: 3.398
Authors: Su Keng Tan; Wai Keung Leung; Alexander Tin Hong Tang; Edward Chi Man Tse; Roger Arthur Zwahlen Journal: Plast Reconstr Surg Glob Open Date: 2017-12-28
Authors: Lisa Donofrio; Alastair Carruthers; Bhushan Hardas; Diane K Murphy; Jean Carruthers; Derek Jones; Jonathan M Sykes; Lela Creutz; Ann Marx; Sara Dill Journal: Dermatol Surg Date: 2016-10 Impact factor: 3.398