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Limitations of the BREAST-Q as an Outcomes Measure for Evaluation of Breast Augmentation Patients

Swanson, Eric M.D.

Plastic and Reconstructive Surgery: December 2014 - Volume 134 - Issue 6 - p 986e–988e
doi: 10.1097/PRS.0000000000000685
Letters

Swanson Center, 11413 Ash Street, Leawood, Kan. 66211, eswanson@swansoncenter.com

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Sir:

Drs. Alderman et al.1 dismiss previous outcome studies,2,3 calling them “ad hoc questionnaires, which have limited reliability and validity.”1 Does the BREAST-Q represent a higher level measurement device? Should all plastic surgeons adopt it? These questions take on increased importance as the FACE-Q,4 BODY-Q, and CLEFT-Q are introduced.5

The most serious problem with the BREAST-Q (and FACE-Q) is lack of disclosure of the actual study questions and scales, compromising the value of any publication based on it. Users are charged for access to this device6 and the senior author receives royalties.1 This financial conflict is not always disclosed.7,8 The BREAST-Q is a proverbial black box, so complicated that the licensee must rely on the owners to receive a “QScore.”5 The user must sign an 11-page licensing agreement6 mandating that the licensee include two BREAST-Q references in any publication, publish contact and copyright information for the BREAST-Q, not disclose the questionnaire itself, and provide a copy of the last version of the proposed publication before distribution for approval. Any disagreements are to be adjudicated by a court in Lyon, France.6 Patenting medical inventions is a disturbing trend.9 Two of the authors are also consultants for the implant manufacturer.1 It is unclear why additional funds are needed for a survey that is distributed to patients who were not compensated. Corporate sponsorship invites bias.9

Over half of the patients (329 women) did not return for a 6-month follow-up survey.1 The authors believe these missing patients are likely to be highly satisfied patients,1 which may be true in many cases, and might account for the slightly lower physical satisfaction scores if patients with problems are more likely to keep follow-up appointments. However, nonresponders may also include dissatisfied patients who elect to follow up elsewhere. It is impossible to know whether the experience of a minority of patients is representative of the whole, compromising reliability.10 The benchmark inclusion rate for evidence-based medicine is 80 percent.10 Previous studies11–13 using the BREAST-Q have also suffered from inadequate inclusion rates, as low as 38 percent.13 The BREAST-Q contains a sexual well-being module.1,7,11 Some patients may object to such highly personal questions. Privacy concerns may contribute to poor patient compliance. Concise (single-page) in-person interviews,3 as opposed to mailed surveys,7,8,11,12 reward the researcher with greater patient compliance and more thoughtful and complete responses. Patients fatigue easily; brevity is a virtue.

The BREAST-Q developers emphasize the importance of patient interviews and focus groups.7,11 Surprisingly, in developing the BREAST-Q, only 12 breast augmentation patients were interviewed, 10 of whom were later contacted by phone.11 Surveys were mailed to both preoperative and postoperative patients.11 Responsiveness cannot be determined by comparing two different patient groups. The present study1 also evaluated different patient groups. Only data for those patients completing surveys at all three time points should be compared.

Data inconsistencies in the original BREAST-Q study include differences in the reported numbers of preoperative (either 174 or 222) and postoperative patients (either 227 or 179)7,11 In this study,1 the sample size is reported as 611 patients in the Abstract and 639 patients in Table 1. Data appear to be missing. Adding the age subgroups produces only 554 total patients. Summing the body mass index subgroups produces 483 patients. Implant volumes are missing for 48 women. The present study1 does not specify whether augmentation/mastopexy patients were included. Surprisingly, women who underwent a simultaneous mastopexy were included in developing the breast augmentation module.7 Recruited patients in the original study were nonconsecutive and chosen from multiple centers,7,11 allowing selection bias and numerous confounders (e.g., different surgeons, protocols, techniques, and even operations).

Pusic et al.7,11 refer to U.S. Food and Drug Administration guidelines14 for outcomes measures used to evaluate a medical product with respect to labeling claims. The medical product in this case would be a breast implant. Product evaluation is much too complex to be undertaken by plastic surgeons. Our job is to evaluate our operations, not medical products. That responsibility is left to the implant manufacturer. Notably, the U.S. Food and Drug Administration recommends public access to outcomes measures and cautions against losing patients to follow-up and missing data.14 Pusic et al. suggest that the U.S. Food and Drug Administration will use “psychometric performance” to judge outcomes measures.7 In fact, psychometric methods and Rasch analysis are not recommended or even mentioned in the U.S. Food and Drug Administration guidelines.14 Although the developers claim that their method is the only one that not only meets but exceeds U.S. Food and Drug Administration standards,7,11 the BREAST-Q has not been evaluated or approved by the U.S. Food and Drug Administration. Tests of scale correlations are offered as evidence of validity.11 These comparisons are made at the authors’ discretion and do not in themselves establish validity, which is not a test property.15 Validity is simply the ability of a test to measure what it intends to measure.14,15

Preoperative breast satisfaction scores are not presented.1 Older women with breast ptosis may be less satisfied with their breasts to start with; it is not surprising that their postoperative scores are lower. Another problem with the BREAST-Q is the generality of the 0 to 100 scores. Such overall indices are needed in psychometric tests of intelligence (intelligence quotient) or scholastic ability; their usefulness in plastic surgery is unclear.15 The value of breast augmentation has been well documented in previous studies.2,3,8,13 In fact, the BREAST-Q has now done it three times.1,8,13 It is hard to imagine what is left for this product to do other than confirm what we already knew.

The authors1 claim that the BREAST-Q is validated by “a series of in-depth patient interviews, focus groups, expert panels, and literature review.” These are not methodologic criteria.16 A lengthy development process that includes field testing (i.e., mailing surveys to patients) and expert panels does not in itself confer validity.15 Validity is best determined by independent (and nonconflicted) users.15 Psychometric modeling is misapplied to plastic surgery questionnaires, which are intended to be surveys assessing surgical techniques, not psychological tests.15 Such applications add unnecessary complexity and introduce incomprehensible psychometric jargon.15 The Rasch model is a black box within a black box. Ironically, the authors dismiss other studies for “methodologic limitations.”1 When evaluating methodology, we cannot ignore basic scientific considerations16 such as consecutive patients, inclusion rate, eligibility criteria, selection bias, confounders, commercial bias, and, most importantly, transparency.

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DISCLOSURE

The author has no financial interest in any of the products or devices mentioned in this communication. The author has no conflicts of interest to disclose. There was no outside funding for this study.

Eric Swanson, M.D.

Swanson Center

11413 Ash Street

Leawood, Kan. 66211

eswanson@swansoncenter.com

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REFERENCES

1. Alderman AK, Bauer J, Fardo D, Abrahamse P, Pusic A. Understanding the effect of breast augmentation on quality of life: Prospective analysis using the BREAST-Q. Plast Reconstr Surg. 2014;133:787–795
2. Cash TF, Duel LA, Perkins LL. Women’s psychosocial outcomes of breast augmentation with silicone gel-filled implants: A 2-year prospective study. Plast Reconstr Surg. 2002;109:2112–2121; discussion 2122
3. Swanson E. Prospective outcome study of 225 cases of breast augmentation. Plast Reconstr Surg. 2013;131:1158–1166
4. Klassen AF, Cano SJ, Scott AM, Pusic AL. Measuring outcomes that matter to face-lift patients: Development and validation of FACE-Q appearance appraisal scales and adverse effects checklist for the lower face and neck. Plast Reconstr Surg. 2014;133:21–30
5. BREAST-Q (Web site). Available at: https://webcore.mskcc.org/breastq/index.html. Accessed April 5, 2014
6. BREAST-Q User Agreement. Available at: https://webcore.mskcc.org/breastq/docs/bq-user-agreement.pdf. Accessed April 5, 2014
7. Pusic AL, Reavey PL, Klassen AF, Scott A, McCarthy C, Cano SJ. Measuring outcomes in breast augmentation: Introducing the BREAST-Q augmentation module. Clin Plast Surg. 2009;36:23–32
8. McCarthy CM, Cano SJ, Klassen AF, et al. The magnitude of effect of cosmetic breast augmentation on patient satisfaction and health-related quality of life. Plast Reconstr Surg. 2012;130:218–223
9. Swanson E. The commercialization of plastic surgery. Aesthet Surg J. 2013;33:1065–1068
10. Sackett DL, Straus SE, Richardson WS, Rosenberg W, Haynes RB. Therapy. In: Evidence-Based Medicine. 20002nd ed. Toronto Churchill Livingstone:105–154
11. Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: The BREAST-Q. Plast Reconstr Surg. 2009;124:345–353
12. Cano SJ, Klassen AF, Scott AM, Cordeiro PG, Pusic AL. The BREAST-Q: Further validation in independent clinical samples. Plast Reconstr Surg. 2012;129:293–302
13. Coriddi M, Angelos T, Nadeau M, Bennett M, Taylor A. Analysis of satisfaction and well-being in the short follow-up from breast augmentation using the BREAST-Q, a validated survey instrument. Aesthet Surg J. 2013;33:245–251
14. U.S. Food and Drug Administration. Guidelines for industry patient-reported outcome measures: Use in medical product development to support labeling claims. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf. Accessed April 7, 2014
15. Swanson E. Validity, reliability, and the questionable role of psychometrics in plastic surgery. Plast Reconstr Surg Glob Open. 2014;2:e161
16. Swanson E. Levels of evidence in cosmetic surgery: Analysis and recommendations using a new CLEAR classification. Plast Reconstr Surg Glob Open. 2013;1:e66
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