Measuring Quality of Life and Patient Satisfaction After Body Contouring: A Systematic Review of Patient-Reported Outcome Measures

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1 Body Contouring Measuring Quality of Life and Patient Satisfaction After Body Contouring: A Systematic Review of Patient-Reported Outcome Measures Aesthetic Surgery Journal 31(7) The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journalspermissions.nav DOI: / X Patrick L. Reavey, MD, MS; Anne F. Klassen, DPhil; Stefan J. Cano, PhD; Colleen McCarthy, MD, MS; Amie Scott, MS; J. Peter Rubin, MD; Michele Shermak, MD; and Andrea L. Pusic, MD, MHS Abstract Evidence-Based Background: In both cosmetic and postbariatric body contouring populations, the primary determinants of success are patient satisfaction and quality of life (QOL). These patient-reported outcomes (PRO) are ideally measured with specially-designed, procedure- or conditionspecific questionnaires.. Objective: The authors identify and appraise all patient-reported outcome (PRO) measures (questionnaires) developed for patients undergoing body contouring surgery. Methods: MEDLINE, EMBASE, PsychINFO, Ebase, CINAHL, HAPI, Science Citation Index/Social Sciences Citation Index, Ovid Evidence Based Medicine databases were searched from the inception of each database through August Articles included in the study described the development and/or psychometric evaluation of a PRO measure developed for body contouring patients. Each measure was then appraised for adherence to internationallyrecommended guidelines for item generation, item reduction, and psychometric evaluation. Results: The following five PRO questionnaires were identified by our search: one liposuction (the Freiburg Questionnaire on Aesthetic Dermatology and Cosmetic Surgery, FQAD), one general plastic surgery (Derriford Appearance Scale, DAS-59/24), and three breast reduction measures (the Breast Reduction Assessed Severity Scale Questionnaire, BRASSQ; Breast Related Symptoms questionnaire, BRS; and the BREAST-Q reduction module. Detailed examination of these measures revealed that the FQAD, DAS-59, and BRS are limited by both their content range and psychometric properties. The BRASSQ and BREAST-Q both have strong psychometric properties, and the BREAST-Q is unique in its inclusion of items covering specific postoperative issues such as scarring. Conclusions: While instruments are available for measuring outcomes in breast reduction patients, reliable, valid, and responsive PRO measures are lacking for the majority of body contouring procedures. To demonstrate the unique outcomes of body contouring surgery, future research to rigorously develop and validate new PRO measures in this population is necessary. Keywords abdominoplasty, body contouring, brachioplasty, breast reduction, dermatolipectomy, liposuction, massive weight loss, obesity, thighplasty Body contouring is the most rapidly growing field in plastic surgery. This field encompasses a range of procedures, including liposuction, brachioplasty, breast reduction, abdominoplasty, and thighlift. According to 2010 statistics from the American Society for Aesthetic Plastic Surgery (ASAPS), abdominoplasty procedures have increased 362.2% since The significant media coverage of cosmetic plastic surgery procedures has likely played a role in the increasing number of patients seeking cosmetic body contouring surgery. Additionally, growing numbers of patients are undergoing bariatric surgery, with more than 200,000 weight loss procedures performed in Many of these patients lose significant amounts of weight, which may result in excesses of skin that can be unsightly and cause chafing, rashes, and fungal infections. 3-6 As these issues motivate approximately one-quarter of bariatric surgery patients to undergo body contouring surgery, 6,7 it is no surprise that body contouring procedures benefiting Dr. Reavey is a fellow at the Institute of Reconstructive Plastic Surgery, New York University Medical Center, New York, New York. Dr. Klassen is Associate Professor at McMaster University, Hamilton, Ontario, Canada. Dr. Cano is Chartered Psychologist and Lecturer at the Peninsula College of Medicine and Dentistry, Plymouth, England. Dr. McCarthy is Assistant Professor, Ms. Scott is a Research Project Coordinator, and Dr. Pusic is Assistant Professor at the Memorial Sloan-Kettering Cancer Center, New York, New York. Dr. Rubin is Associate Professor at the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. Dr. Shermak is Assistant Professor at the Johns Hopkins Medical Center, Baltimore, Maryland. This paper was presented on May 29th at the 2008 Annual Meeting of the Plastic Surgery Research Council in Springfield, Illinois. Corresponding Author: Dr. Andrea L. Pusic, Division of Plastic and Reconstructive Surgery, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY USA. pusica@mskcc.org

2 808 Aesthetic Surgery Journal 31(7) this patient population (eg, upper armlift, lower bodylift) have increased more than 4000% since In cosmetic and postbariatric body contouring populations, the primary determinants of success are patient satisfaction and quality of life (QOL). These patientreported outcomes are ideally measured with specially designed procedure- or condition-specific questionnaires called patient-reported outcome (PRO) measures. PRO measures generally come in two forms: generic and disease/condition specific. Generic questionnaires such as the Short Form-36 9 measure a variety of psychosocial issues, such as QOL, body image, or sexual function. However, they are developed in, and intended to be used among, broad and diverse patient groups (including healthy people). Given the more general (or generic) nature of their questions, they are unlikely to address all important concerns of a specific surgical patient population (eg, scarring). Additionally, these questionnaires may not be sensitive enough to measure changes as a result of a surgical intervention. Condition- or disease-specific measures, however, are designed to measure QOL outcomes in specific patient groups. When developed properly, these PRO measures have the potential to provide sensitive, reliable, and valid data on procedural QOL outcomes. As the field of body contouring continues to grow, it is imperative that the benefits of these procedures be examined from the patient s perspective. This evaluation requires PRO measures that are specially designed to capture the concerns of this particular patient population. Application of such instruments in research and clinical practice may inform the advancement of surgical techniques, improve evidence-based practice, and facilitate the process of shared medical decision-making between patients and surgeons. To identify currently available and appropriate instruments to measure PRO in body contouring patients, we conducted a systematic literature review. The objectives of this review were to (1) identify PRO measures designed to measure patient satisfaction, body image, and/or QOL concerns in patients who have undergone body contouring surgery and (2) evaluate these measures with respect to their development process, content, and psychometric performance. Methods An electronic bibliographic database search was conducted in multiple databases MEDLINE, EMBASE, PsychINFO, Ebase, CINAHL, HAPI, Science Citation Index/ Social Sciences Citation Index, and Ovid Evidence-Based Medicine from their inception through August In each database, a similar search strategy was utilized. Search terms were grouped into three general categories terms pertaining to obesity or overall body image, terms pertaining to plastic surgery in general or specific body contouring surgical procedures, and terms pertaining to QOL outcomes in general or questionnaires (Table 1). Each Table 1. Literature Search Terms Category Body image Body contouring procedure Outcome measure term was searched as a text word and mapped to appropriate subject headings when available. Terms within each search category were grouped by the Boolean operator OR, and summed results from each category were combined with the Boolean operator AND to retrieve articles that contained at least one keyword in each category. Non- English language articles were excluded. Two reviewers (PLR, CM) independently examined the abstracts of all identified articles and the full text of potentially relevant papers. Articles that did not include the description or use of a PRO measure were excluded. Articles that utilized only ad hoc questionnaires were additionally excluded. Disagreement was settled by consensus and review by the senior author (ALP). Citations for included articles were examined to identify additional articles and measures. Identified PRO measures were each then independently researched to obtain information on the development and validation process. Authors were contacted when information was lacking in the literature. Generic questionnaires were excluded. Remaining PRO measures were then appraised for adherence to guidelines of the Scientific Advisory Committee of the Medical Outcomes Trust 10 and the US Food and Drug Administration. 11 Additionally, all questionnaires were analyzed for content on an itemwise basis to determine whether they covered all preoperative and postoperative issues likely to be relevant to the body contouring population. At each stage, any discrepancies between the two primary reviewers were resolved by the senior author (ALP). Results Terms appearance, body image, overweight, obese, obesity, morbidly obese, bariatric, weight-loss, lipodystrophy, skin redundancy plastic surgery, abdominoplasty, circumferential abdominoplasty, body contouring, bodylift, panniculectomy, liposuction, dermolipectomy, thighlift, buttock lift, brachioplasty, reduction mammaplasty, mastopexy, torsoplasty, belt lipectomy treatment-outcome, outcome-assessment, measure, questionnaire, scale, score, instrument, research instrument, inventory, health-related quality of life, quality of life, satisfaction The database search identified 1504 articles. Of those, 132 met our initial inclusion criteria and were examined in detail. Figure 1 shows the number of publications by type of instrument (ad hoc, generic, or procedure-specific) that measured patient QOL or satisfaction in body contouring over the past decade ( ). As illustrated, many articles utilized only ad hoc questionnaires and were thus

3 Reavey et al # of Papers Specific Generic Ad Hoc Figure 1. Publications assessing patient-reported outcomes in body contouring patients, excluded. A review of the remaining 76 articles identified 54 PRO measures, five of which were developed to measure procedure-specific outcomes: one liposuction (the Freiburg Questionnaire on Aesthetic Dermatology and Cosmetic Surgery [FQAD]), one general plastic surgery (the 59-item Derriford Appearance Scale [DAS-59]), and three breast reduction measures (the Breast Reduction Assessed Severity Scale Questionnaire [BRASSQ], Breast Related Symptoms questionnaire [BRS], and the BREAST-Q reduction module). Table 2 shows detailed information about the content of each questionnaire. Table 3 summarizes procedures adhered to by authors in the development and validation of each instrument. Here we provide key information pertaining to each instrument, including how well the criteria were met for item generation and psychometric testing. Freiburg Questionnaire on Aesthetic Dermatology and Cosmetic Surgery The FQAD 12 is a 64-item multiscale questionnaire developed for liposuction patients. Questionnaire items were generated from open surveys of patients who underwent liposuction of the arms, abdomen, waist, legs, chin, and/ or neck. No information about the psychometric properties of the instrument is available in the literature. Following its initial development, application of this questionnaire has been limited to a study measuring patient satisfaction with facial appearance following botulinum toxin treatment. 13 Additionally, only a general description of the measure s content is available in the literature. Attempts to contact the authors and retrieve a copy of the instrument were unsuccessful. Derriford Appearance Scale The DAS-59 14,15 (and a 24-item shortened version 16 ) is a questionnaire developed for plastic surgery patients who have undergone a number of surgical procedures (eg, abdominoplasty, breast surgery). Questionnaire content was generated from in-depth interviews with plastic surgery patients and a review of the literature. The questionnaire items focus on patients psychosocial distress or dysfunction related to aspects of their appearance. This measure is designed to be versatile in that it does not ask questions about specific body areas but instead asks patients to focus on a particular feature of concern to them when responding to questions. This questionnaire has undergone substantial psychometric evaluation. 14,15,17 However, there is evidence to suggest that the generic design of the questionnaire may limit its responsiveness and may not allow for accurate postoperative follow-up assessment. 18,19

4 810 Aesthetic Surgery Journal 31(7) Table 2. Content Evaluation of PRO Measures for Body Contouring Patients General Plastic Surgery Breast Reduction Liposuction Domains DAS-59 BRASSQ BRS BREAST-Q FQAD a Appearance Arms Breasts Abdomen Thighs Gluteal Overall Surgery-specific issues Scars Sensation/numbness Postoperative pain Recovery process Satisfaction with treatment Process of care Preoperative information Surgeon/medical team Office staff Body symptoms Pain Pulling Itching/rash Other Body image Area specific Overall General QOL Physical/functional/sexual well-being Social well-being Overall QOL Life satisfaction Psychosocial Self-esteem Self-consciousness Confidence Distress Mood General psychology a Specific information on all questionnaire items not available.

5 Reavey et al 811 Table 3. Development and Psychometric Evaluation of PRO Measures for Body Contouring Patients General Plastic Surgery Breast Reduction Liposuction Method/Evaluation DAS-59 BRASSQ BRS BREAST-Q FQAD Item generation Patient interviews/focus groups Literature Expert opinion Develop conceptual model Item reduction Expert opinion Item redundancy Endorsement frequencies Missing data Factor analysis Tests of scaling assumptions Psychometric analyses Acceptability Internal consistency reliability Item-total correlations Interrater reliability Test-retest reliability Validity within scale Validity comparison with other measures Validity hypothesis testing Responsiveness Breast Related Symptoms Questionnaire The BRS 20 is a 13-item scale developed to measure physical symptoms related to breast hypertrophy. Items for this measure were generated from focus groups with patients and input from an expert panel. The focus of the scale is on physical symptoms and/or physical limitations related to breast hypertrophy. Other broader QOL issues are not covered, nor is patient satisfaction with breast appearance following surgery. The BRS is reported to have good testretest reliability and face validity. Breast Reduction Assessed Severity Scale Questionnaire The BRASSQ 21 is a 39-item questionnaire composed of five subscales. Items for this questionnaire were developed through focus groups with breast reduction patients and input from expert panels. This questionnaire s validation and evaluation process are documented in the literature 21,22 and it has good reliability. However, the items included in the BRASSQ are limited to physical symptoms and psychological issues related to breast hypertrophy. There are no items or scales that measure postoperative issues (eg, scarring, pain, and recovery process); therefore, it may not be appropriate for comparing different operative techniques for breast reduction. BREAST-Q The BREAST-Q has a procedure-specific modular structure. The Reduction Module 23 is composed of 91 items that measure aspects of patient satisfaction/qol across multiple domains. Items were generated from interviews with breast

6 812 Aesthetic Surgery Journal 31(7) reduction patients, input from expert panels, and a systematic review of other relevant breast surgery measures. Item reduction and scale generation for the measure was performed with new psychometric methods (Rasch analysis). The BREAST-Q covers a range of content domains important to the breast reduction patient across seven subscales. In addition to investigating QOL with issues such as sexual and physical functioning, the scales evaluate patient satisfaction with breast appearance (including scarring), satisfaction with outcome, nipple sensation, and satisfaction with overall care. Validation studies have confirmed high validity, reliability, and responsiveness. 24 Discussion In this systematic review of the plastic surgery literature, we identified five PRO measures that have been developed to measure patient satisfaction and QOL concerns among body contouring surgery patients. Evaluation of the content and psychometric properties of these questionnaires revealed limitations as well as strengths. The FQAD, DAS-59, and BRS are all limited by their content range and psychometric properties. Thus, we cannot recommend application of these questionnaires in rigorous QOL outcomes studies. Conversely, the BRASSQ and BREAST-Q both demonstrate good psychometric performance and have been appropriately validated in breast reduction patients. The primary differences between the BRASSQ and BREAST-Q are that the latter includes items related to specific postoperative issues and was developed with modern psychometric methods (eg, Rasch measurement methods). The inclusion of postoperative items related to scarring, for example, make the BREAST-Q a better choice to evaluate specific patient satisfaction outcomes. The use of Rasch analysis in the development of the BREAST-Q provides additional advantages This new psychometric method allows for the construction of questionnaires that are more accurate and sensitive to clinical change. Therefore, the BREAST-Q may be better suited for studies evaluating subtle differences in outcomes between breast reduction techniques. Rasch analysis also results in questionnaires that can be applied in clinical practice, enabling plastic surgeons to follow each patient independently. While the BREAST-Q and BRASSQ are two measures that could be used with breast reduction patients, there is clearly a lack of adequately-developed PRO measures for other body contouring procedures. Importantly, no measure has been designed for the postbariatric surgery population. Given the preoperative physical and psychological differences that exist between postbariatric patients and the cosmetic body contouring population, 8,29 it is likely that specific concerns and QOL issues will differ. Studies to evaluate the validity of the BREAST-Q and BRASSQ in postbariatric surgery patients are necessary before routine application of these measures in this population. Similarly, as new PRO measures are developed to measure outcomes following other body contouring procedures, separate instruments for the cosmetic and postbariatric populations may be needed. There appears to be growing interest in PRO measures among plastic surgeons, which is likely due in part to increasing numbers of body contouring procedures being performed but also to the recognition that patient satisfaction and QOL are central to the success or failure of these operations. Currently, interest in these outcomes has outpaced the understanding of the tools available to measure them. As seen in Figure 1, the number of studies that evaluated patient-reported outcomes in body contouring patients more than doubled from 2008 to However, the proportion of these studies that utilized ad hoc questionnaires also increased (ie, those neither formally developed nor validated). Unfortunately, administering an ad hoc questionnaire can be likened to measuring a breast with a surgeon s hand span because a tape measure is not available. Our current healthcare environment demands high-quality data to guide surgical decision making, patient education, and negotiations with payers; given this, the use of ad hoc questionnaires is simply no longer acceptable. Therefore, research is needed to develop reliable PRO measures for the full variety of body contouring procedures. Once developed, these measures should be evaluated and appropriately utilized in subsequent clinical studies. It is our hope that the incorporation of reliable patient-reported outcomes data with traditional complications data will guide an informed outcomes discussion and, in so doing, help to advance surgical techniques, evidence-based practice, and patient education. Conclusions As the field of body contouring continues to grow and advance, it is imperative that the process be guided by high-level evidence. Thus, the development and application of scientifically-strong PRO measures to assess QOL outcomes following body contouring procedures is essential. The BREAST-Q and BRASSQ are two such questionnaires for breast reduction patients. Physicians investigating PRO and QOL outcomes in this patient population are encouraged to utilize either of these surgery-specific measures in future studies. Unfortunately, reliable PRO measures for other body contouring procedures are lacking. In lieu of an appropriate body contouring PRO, investigators should be cautioned about drawing major conclusions from studies utilizing generic questionnaires to measure surgery-specific outcomes. Disclosures The BREAST-Q is jointly owned by Memorial Sloan-Kettering Cancer Center and the University of British Columbia. Drs. Pusic, Klassen, and Cano are codevelopers of the BREAST-Q and, as such, receive a share of any license revenues based on the inventor sharing policies of these two institutions.

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