Questionnaires included in the analysis were appraised for their adherence to international guidelines for the development and validation of health outcomes questionnaires as outlined by the Scientific Advisory Committee of the Medical Outcome Trust7 and the U.S. Food and Drug Administration.8 Psychometric properties, when available, were reported. Content domains included in each questionnaire were also summarized.
Results from our review indicate that few questionnaires have been formally developed and validated among patients undergoing facial cosmetic surgery or nonsurgical facial aesthetic procedures. A total of 442 articles were identified. From these, we identified 47 potentially relevant patient-reported outcome measures. On closer inspection, we excluded 12 generic health instruments,9–21 23 general psychiatric inventories,22–32 one visual analogue scoring system,33–36 and two nasal symptoms/functional assessments,37–40 as these measures were not developed or validated in a facial surgery/nonsurgical facial rejuvenation patient population (Fig. 1). Of the nine measures that remained (Table 2,31,41–54) three were targeted for use in a rhinoplasty population, three were for skin rejuvenation patients, one was for face-lift patients, one was for blepharoplasty recipients, and one was focused on general appearance after cosmetic surgery. Assessment of development and validation characteristics of each measure is summarized in Table 3. Evaluation of the content of each measure is presented in Table 4.
The Rhinoplasty Outcomes Evaluation, Facelift Outcomes Evaluation, Blepharoplasty Outcomes Evaluation, and Skin Rejuvenation Outcomes Evaluation are four separate questionnaires of six items (questions) each developed by Alsarraf et al.41,42 Each measure examines three major domains, including appearance, functional outcome, and social acceptance following the respective procedure. Although these measures have been validated, lack of published information on their development process hinders full evaluation of each measure. In particular, expert opinion appears to be the only method used for item generation purposes; patient interviews were not used in the development process.
The Facial Lines Treatment Satisfaction questionnaire is a 14-item measure intended to assess patient satisfaction with facial line treatment.43 It was developed in industry by professionals at Allergan (Irvine, Calif.) in a cosmetic skin rejuvenation patient population. Overall, the Facial Lines Treatment Satisfaction is a well-developed, validated measure. Although it is quick and easy to administer, the scope of the measure is limited to analysis of facial line appearance, procedure satisfaction (including side effects), and patient confidence.
The Glasgow Benefit Inventory is an 18-item, postinterventional questionnaire that measures general perception of well-being and psychological, social, and physical well-being.45 The questionnaire was originally developed within a patient population that included ear surgery, rhinoplasty, and tonsillectomy patients. Ninety-six traumatic and nontraumatic rhinoplasties were used subsequently for the validation studies. Formal psychometric analyses of acceptability, internal consistency reliability, and test-retest reliability were not performed. However, comparison with the Nasal Symptom Questionnaire demonstrated good convergent validity.
The Facial Appearance Sorting Test is a card-sorting test requiring patients seeking or treated by rhinoplasty to order 18 face profile caricatures from least attractive to most attractive.46 Patients are then asked to identify where they would rank their own personal appearance on this spectrum of attractiveness. Thus, this test solely examines patient self-perception of appearance. Although a prospective study of 22 patients accepted for rhinoplasty and their matched pairs demonstrated that the instrument was able to detect an improvement in appearance and psychiatric symptomatology after cosmetic surgery relative to controls, formal psychometric analysis of this instrument was not performed. Published data regarding development are similarly not available.
The Derriford Appearance Scale 59 and its parallel 24-item short form (Derriford Appearance Scale 24) are general appearance scales designed to objectively measure and evaluate patients with disfigurements and aesthetic problems of appearance.47,48 The Derriford Appearance Scale 59 generates six scores of psychological distress and dysfunction. Two additional items also address physical distress and dysfunction. The central difficulty with using this measure for facial aesthetic surgery patients is that the Derriford Appearance Scale is meant to be a generic measure that is relevant to a number of different surgical procedures. As such, there are items that would not be relevant to a facial cosmetic surgery patient (e.g., avoid communal dressing; avoid undressing with partner; distressed by clothing limitations).
In our review, we identified nine questionnaires developed and/or validated to assess satisfaction and quality of life after facial cosmetic surgery and nonsurgical facial rejuvenation. The quality of the questionnaires was variable with respect to their development and psychometric properties. Detailed analysis revealed that eight of the nine instruments (Rhinoplasty Outcomes Evaluation, Facelift Outcomes Evaluation, Blepharoplasty Outcomes Evaluation, Skin Rejuvenation Outcomes Evaluation, Facial Lines Outcomes Questionnaire, Glasgow Benefit Inventory, Facial Appearance Sorting Test, and Derriford Appearance Scale 59) had undergone limited development and validation. The remaining measure, the Facial Line Treatment Satisfaction questionnaire, demonstrated adequate psychometric properties yet had significant content limitations. From this review, we thus conclude that valid, reliable, and responsive instruments to measure patient-reported outcomes following facial aesthetic procedures are lacking.
Of the nine questionnaires in our review, five (Rhinoplasty Outcomes Evaluation, Facelift Outcomes Evaluation, Blepharoplasty Outcomes Evaluation, Skin Rejuvenation Outcomes Evaluation, Facial Appearance Sorting Test) were developed from expert opinion alone (i.e., patient interviews and/or focus groups were not performed as a component of item generation) or did not have a published development process. Although of great importance, expert opinion and literature review alone cannot be expected to identify all aspects of the treatment process and other quality-of-life issues that cosmetic facial rejuvenation patients may find relevant. Thus, in-depth patient interviews analyzed using careful qualitative research methods are necessary to help identify the overall issues and specific details that are important to patients but that may otherwise be overlooked by medical professionals.7
The final aspect of questionnaire development discussed is the use of new statistical methods for both development and analysis: specifically, Rasch item analysis and item response theory. The aforementioned questionnaires used classic test theory, the primary psychometric method used to develop quality-of-life questionnaires for the past 20 years.53,55 However, a significant shortcoming of questionnaires developed using classic test theory is that they are valid for population-based research but are not necessarily valid as clinical measurement tools for individual patients. With the advent of Rasch and item response theory, patient-reported outcome measures are more sophisticated, have improved accuracy, and allow surgeons to measure outcomes of individual patients.56,57 This will greatly improve the utility of patient-reported outcome measures for plastic surgeons in private practice, as they will be able to directly and reliably measure their patients' satisfaction with appearance before and after surgery at each follow-up visit. In addition, a surgeon may be able to determine that a dissatisfied patient is upset not about the actual outcome of their operation but about another aspect of their treatment experience (e.g., interactions with office staff). Thus, such a questionnaire may foster physician-patient communication, allowing the physician to be more effective in addressing the specific issues of a patient.
To summarize, there is a need for a new patient-reported outcome measure that is designed to measure satisfaction with facial appearance and quality of life following aesthetic procedures. The adoption of a broadly accepted, clinically relevant outcome measure would be important for the practice of individual plastic surgeons and that of the entire specialty. A well-developed patient-reported outcome measure would allow for the comparison of techniques, quantification of positive effects, and identification of patients most likely to benefit from the procedure. Such a patient-reported outcome measure would provide a follow-up standard and a reference point for clinical trials, regulatory efforts (e.g., U.S. Food and Drug Administration), and effectiveness studies. In addition to providing data for researchers, patient-reported outcome measure data may aid the individual plastic surgeon in his or her clinical practice. Using newer psychometric methods, a well-developed patient-reported outcome measure could provide valid assessment of individual patients over time. Increasingly, aesthetic patients are seeking meaningful data to help them better understand expected outcomes. When advising new patients, plastic surgeons who use such patient-reported outcome measures would be able to provide tangible evidence of prior patients' satisfaction with their outcome. In addition, patient-reported outcome measures may be used to evaluate how patients feel they are treated by their surgeon, nurses, and office staff. With appropriate use of patient-reported outcome measures, clinicians may thus receive feedback from patients about the entire treatment experience. Surgeons may then be able to tailor and improve specific aspects of their practice to optimize “customer satisfaction.” Finally, in the increasingly competitive environment of facial aesthetic surgery, it is imperative for the field of plastic surgery as a whole to demonstrate its superior outcomes for the wide array of aesthetic procedures. This can only be achieved with the use of a well-developed patient-reported outcome measure.
In developing such a questionnaire, the ultimate goal would be to better understand the impact of aesthetic procedures from the patient perspective and, with this knowledge, improve patient outcomes. As evidence-based medicine is rapidly setting a standard for clinical decision-making among aesthetic patients, such data regarding patient satisfaction and quality of life will be essential to aesthetic surgeons.
This study was funded by grant support from the Plastic Surgery Educational Foundation.
1. Ching S, Thoma A, McCabe RE, Antony MM. Measuring outcomes in aesthetic surgery: A comprehensive review of the literature. Plast Reconstr Surg.
2003;111:469–480; discussion 481–462.
2. Cano SJ, Browne JP, Lamping DL. Patient-based measures of outcome in plastic surgery: Current approaches and future directions. Br J Plast Surg.
3. Pusic A, Liu JC, Chen CM, et al. A systematic review of patient-reported outcome measures in head and neck cancer surgery. Otolaryngol Head Neck Surg.
4. Cano SJ, Browne JP, Lamping DL, Roberts AH, McGrouther DA, Black NA. The Patient Outcomes of Surgery-Head/Neck (POS-head/neck): A new patient-based outcome measure. J Plast Reconstr Aesthet Surg.
5. Cano SJ, Klassen A, Pusic AL. The science behind quality of life measurement: A primer for plastic surgeons. Plast Reconstr Surg.
6. Wilkins EG, Lowery JC, Smith DJ Jr. Outcomes research: A primer for plastic surgeons. Ann Plast Surg.
7. Assessing health status and quality-of-life instruments: Attributes and review criteria. Qual Life Res.
8. U.S. Food and Drug Administration. Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. FDA web site, 2006. Available at: http://www.fda.gov/cder/guidance/index.htm
. Accessed May 20, 2008.
9. Klassen A, Jenkinson C, Fitzpatrick R, Goodacre T. Patients' health related quality of life before and after aesthetic surgery. Br J Plast Surg.
10. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Med Care
11. Chren MM, Lasek RJ, Quinn LM, Mostow EN, Zyzanski SJ. Skindex, a quality-of-life measure for patients with skin disease: Reliability, validity, and responsiveness. J Invest Dermatol.
12. Augustin M, Reich C, Schaefer I, Zschocke I, Rustenbach SJ. Development and validation of a new instrument for the assessment of patient-defined benefit in the treatment of acne. J Dtsch Dermatol Ges.
13. Brown TA, Cash TF, Mikulka PJ. Attitudinal body-image assessment: Factor analysis of the Body-Self Relations Questionnaire. J Pers Assess.
14. Kind P, Gudex C. The HMQ: Measuring Health Status in the Community.
York: University of York Center for Health Economics; 1991.
15. Augustin M, Bross F, Foldi E, Vanscheidt W, Zschocke I. Development, validation and clinical use of the FLQA-I, a disease-specific quality of life questionnaire for patients with lymphedema. Vasa
16. Augustin M, Lange S, Wenninger K, Seidenglanz K, Amon U, Zschocke I. Validation of a comprehensive Freiburg Life Quality Assessment (FLQA) core questionnaire and development of a threshold system. Eur J Dermatol.
17. Augustin M, Zschocke I, Sommer B, Sattler G. Sociodemographic profile and satisfaction with treatment of patients undergoing liposuction in tumescent local anesthesia. Dermatol Surg.
18. Sommer B, Zschocke I, Bergfeld D, Sattler G, Augustin M. Satisfaction of patients after treatment with botulinum toxin for dynamic facial lines. Dermatol Surg.
19. Georgalas C, Paun S, Zainal A, Patel NN, Mochloulis G. Assessing day-case septorhinoplasty: Prospective audit study using patient-based indices. J Laryngol Otol.
20. Cole RP, Shakespeare V, Shakespeare P, Hobby JA. Measuring outcome in low-priority plastic surgery patients using Quality of Life indices. Br J Plast Surg.
21. Ware JE Jr. Effects of acquiescent response set on patient satisfaction ratings. Med Care
22. Dinis PB, Dinis M, Gomes A. Psychosocial consequences of nasal aesthetic and functional surgery: A controlled prospective study in an ENT setting. Rhinology
23. von Soest T, Kvalem IL, Skolleborg KC, Roald HE. Psychosocial factors predicting the motivation to undergo cosmetic surgery. Plast Reconstr Surg.
2006;117:51–62; discussion 63–64.
24. Beck AT, Ward CH, Mendelson M, Mock J, Erbaugh J. An inventory for measuring depression. Arch Gen Psychiatry
25. Derogatis LR, Rickels K, Rock AF. The SCL-90 and the MMPI: A step in the validation of a new self-report scale. Br J Psychiatry
26. Ercolani M, Baldaro B, Rossi N, Trombini E, Trombini G. Short-term outcome of rhinoplasty for medical or cosmetic indication. J Psychosom Res.
27. Ercolani M, Baldaro B, Rossi N, Trombini G. Five-year follow-up of cosmetic rhinoplasty. J Psychosom Res.
28. Goin MK, Rees TD. A prospective study of patients' psychological reactions to rhinoplasty. Ann Plast Surg.
29. Kisely S, Morkell D, Allbrook B, Briggs P, Jovanovic J. Factors associated with dysmorphic concern and psychiatric morbidity in plastic surgery outpatients. Aust N Z J Psychiatry
30. Marcus P. Psychological aspects of cosmetic rhinoplasty. Br J Plast Surg.
31. Robin AA, Copas JB, Jack AB, Kaeser AC, Thomas PJ. Reshaping the psyche: The concurrent improvement in appearance and mental state after rhinoplasty. Br J Psychiatry
32. Veale D, De Haro L, Lambrou C. Cosmetic rhinoplasty in body dysmorphic disorder. Br J Plast Surg.
33. Mahler D, Moses S, Last U. A measuring scale for objective evaluation of the nasal shape. Aesthetic Plast Surg.
34. Bonne OB, Wexler MR, De-Nour AK. Rhinoplasty patients' critical self-evaluations of their noses. Plast Reconstr Surg.
1996;98:436–439; discussion 440–441.
35. Last U, Moses S, Mahler D. Mental health correlates of valid perception of nasal deformity in female applicants for aesthetic rhinoplasty. Aesthetic Plast Surg.
36. Moses S, Last U, Mahler D. After aesthetic rhinoplasty: New looks and psychological outlooks on post-surgical satisfaction. Aesthetic Plast Surg.
37. Stewart MG, Smith TL, Weaver EM, et al. Outcomes after nasal septoplasty: Results from the Nasal Obstruction Septoplasty Effectiveness (NOSE) study. Otolaryngol Head Neck Surg.
38. Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg.
39. Most SP. Analysis of outcomes after functional rhinoplasty using a disease-specific quality-of-life instrument. Arch Facial Plast Surg.
40. Fairley JW, Durham LH, Ell SR. Correlation of subjective sensation of nasal patency with nasal inspiratory peak flow rate. Clin Otolaryngol Allied Sci.
41. Alsarraf R. Outcomes research in facial plastic surgery: A review and new directions. Aesthetic Plast Surg.
42. Alsarraf R, Larrabee WF Jr, Anderson S, Murakami CS, Johnson CM Jr. Measuring cosmetic facial plastic surgery outcomes: A pilot study. Arch Facial Plast Surg.
43. Cox SE, Finn JC, Stetler L, Mackowiak J, Kowalski JW. Development of the Facial Lines Treatment Satisfaction Questionnaire and initial results for botulinum toxin type A-treated patients. Dermatol Surg.
2003;29:444–449; discussion 449.
44. Fagien S, Cox SE, Finn JC, Werschler WP, Kowalski JW. Patient-reported outcomes with botulinum toxin type A treatment of glabellar rhytids: A double-blind, randomized, placebo-controlled study. Dermatol Surg.
45. Robinson K, Gatehouse S, Browning GG. Measuring patient benefit from otorhinolaryngological surgery and therapy. Ann Otol Rhinol Laryngol.
46. Copas JB, Robin AA. The Facial Appearance Sorting Test (FAST): An aid to the selection of patients for rhinoplasty. Br J Plast Surg.
47. Harris DL, Carr AT. The Derriford Appearance Scale (DAS59): A new psychometric scale for the evaluation of patients with disfigurements and aesthetic problems of appearance. Br J Plast Surg.
48. Carr T, Moss T, Harris D. The DAS24: A short form of the Derriford Appearance Scale DAS59 to measure individual responses to living with problems of appearance. Br J Health Psychol.
49. Hellings PW, Nolst Trenité GJ. Long-term patient satisfaction after revision rhinoplasty. Laryngoscope
50. Carruthers A, Carruthers J. Prospective, double-blind, randomized, parallel-group, dose-ranging study of botulinum toxin type A in men with glabellar rhytids. Dermatol Surg.
51. McKiernan DC, Banfield G, Kumar R, Hinton AE. Patient benefit from functional and cosmetic rhinoplasty. Clin Otolaryngol Allied Sci.
52. Konstantinidis I, Triaridis S, Printza A, Triaridis A, Noussios G, Karagiannidis K. Assessment of patient benefit from septo-rhinoplasty with the use of Glasgow Benefit Inventory (GBI) and Nasal Symptom Questionnaire (NSQ). Acta Otorhinolaryngol Belg.
53. Klassen A, Jenkinson C, Fitzpatrick R, Goodacre T. Measuring quality of life in cosmetic surgery patients with a condition-specific instrument: The Derriford Scale. Br J Plast Surg.
54. Litner JA, Rotenberg BW, Dennis M, Adamson PA. Impact of cosmetic facial surgery on satisfaction with appearance and quality of life. Arch Facial Plast Surg.
55. Traub R. Classical test theory in historical perspective. Educ Meas Issues Pract.
56. Rasch G. Probabilistic Models for Some Intelligence and Attainment Tests.
Copenhagen: Danish Institute for Education Research; 1960.
57. Lord FM, Novick MR. Statistical Theories of Mental Test Scores.
Reading, Mass.: Addison-Wesley; 1968.
APPENDIX: GLOSSARY OF TERMS*
- Construct validity: Evidence that the scale measures a single construct, that the items can be combined to form a summary score, and that the subscales measure distinct but related constructs. Assessed on the basis of internal consistency, item-total correlations, intercorrelations between scales, and tests of scaling assumptions.
- Content validity: The extent to which the content of a scale is representative of the conceptual domain it is intended to cover. Assessed qualitatively during questionnaire development.
- Convergent validity: Evidence that the scale is correlated with other measures of the same or similar constructs. Assessed on the basis of correlations between the new scale and measures of similar constructs.
- Discriminant validity: Evidence that the scale is not correlated with measures of different constructs. Assessed on the basis of correlations with age, sex, and social class.
- Internal consistency: A measure of reliability that examines the extent to which items in a scale measure the same construct. Assessed by Cronbach α and item-total correlations.
- Responsiveness: The ability of a scale to detect clinically significant change following a treatment of known efficacy. Assessed by examining scores before and after surgery/intervention and calculating an effect size statistic (mean change score divided by SD of before surgery/intervention scores).
- Test-retest reliability: The stability of a scale. Assessed on the basis of correlations between repeat administrations of the scale on two occasions.
- Validation: The process of assessing a patient-reported outcome measure's ability to measure a specific concept or collection of concepts. This ability is described in terms of the instrument's measurement properties that are derived during the validation process. At the conclusion of the process, a set of measurement properties is produced that are specific to the specific population and the specific form and format of the patient-reported outcome measure tested.
*Adapted from the U.S. Food and Drug Administration. Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. FDA web site, 2006. Available at: http://www.fda.gov/cder/guidance/index.htm. Accessed May 20, 20088; and Cano SJ, Klassen A, Pusic AL. The science behind quality of life measurement: A primer for plastic surgeons. Plast Reconstr Surg. 2009;123:98e–106e.5