Volume 133, Number 1 • Letters Randomized Controlled Trial Comparing H ealthRelated Quality of Life in Patients Undergoing Vertical Scar versus Inverted T-Shaped Reduction Mammaplasty Sir:
D
rs. Thoma et al.1 conclude that vertical and inverted-T breast reductions are equivalent in their beneficial effects on quality of life. The purpose of their trial was to investigate the cost-effectiveness of these two procedures with a view to reducing the “unnecessary consumption of scarce health care resources.”2 Their study does not evaluate the aesthetic outcome. The government health plan is decidedly not concerned about appearance. Nevertheless, the majority of breast reduction patients are (quite understandably) concerned about both physical symptoms and the appearance of their breasts.3 Common patient concerns include the extent of scarring, breast shape and size, symmetry, nipple level, areola size, and nipple sensation.3 Equipoise is open to question here. Existing studies consistently show that patients prefer the vertical “lollipop” scar over the inverted-T “anchor” scar.4–7 Breast shape parameters favor the vertical technique.8,9 Clinical advantages include shorter operating times,1,10,11 less blood loss,10,11 greater nipple sensation,3 and a lower risk of nipple loss11 than inverted-T reductions. Most patients may be treated as outpatients,3,11 avoiding the need for hospital admission. Randomization is performed late, allowing an opportunity for selective patient exclusion from enrollment. All of the patients had already been preapproved for coverage under the government health insurance plan, eliminating private-pay patients. Over half of these preselected patients were excluded before randomization, including patients having cosmetic surgery on other body areas (n = 78) and those with a treatment preference (n = 41).1 A patient could be directed away from randomization simply by having simultaneous breast liposuction.1,2 The leftover “noncosmetic” clinic patients were enrolled in the study. These patients, who were kept unaware of what type of scars they would have until 1 hour before surgery,1 constitute a less discriminating patient group that cannot be considered generalizable to plastic surgery patients in the community. There are some unsettling ethical considerations. Patients were recruited at their preoperative appointment 1 week before surgery,1 not at their initial consultation. At this point, patients have already been approved for surgery, scheduled their operations, and made arrangements. They may feel that they have no alternatives, particularly in a single-payer government health care system. The ethical bottom-line question is whether the investigators would be willing to submit to such last-minute randomization of their own surgery. Patients and surgeons dislike randomization because they lose their freedom of choice. In surgery, that choice is likely to have permanent consequences.
Not surprisingly, patient recruitment and external validity are well-known problems associated with randomized trials.12 Their presumed superiority over observational studies has been challenged in recent years.13 Ironically, randomized trials often replace one set of methodologic problems—selection bias and confounders—with another. Although they are referenced as “validated” instruments, none of the four scales used in this study was designed specifically for evaluating surgical changes from breast surgery. The Health Utilities Index Mark 3 (which has been used to evaluate osteoporosis) assesses vision, hearing, speech, dexterity, emotion, cognition, and pain. The Breast-Related Symptoms Questionnaire is concerned only with physical symptoms caused by large breasts. Although the authors dismiss ad hoc questionnaires, such patient surveys are very responsive to specific surgical questions, including patient satisfaction,3,6 a key indicator that is missing in this study, despite its recognition by the senior author as the most important determinant of surgical success.14 The 70 percent response rate falls below the 80 percent benchmark for evidence-based medicine.15 The authors comment that all scales favored the inverted-T group over the vertical reduction group, albeit nonsignificantly.1 However, the data obtained using the Short Form-36 Physical Component Summary, presented in the authors’ Table 6 and Figure 4, show a greater improvement for vertical reduction patients at all follow-up times. (The change in Health Utilities Index Mark 3 Pain Attribute scores are slightly higher for the vertical group, according to Table 6, but the treatment groups may have been inadvertently flipped in this table.) There are important confounders to consider. The mean breast tissue resection weight was greater (left breast, 4.5 percent; right breast, 8.8 percent) for the inverted-T group than for the vertical group, although the differences did not reach significance. At the same time, the mean body mass index for the inverted-T patients was lower than for the vertical group. The combination of these factors makes the mean breast tissue resection weight relative to body mass index higher for the inverted-T group, now reaching significance on the right side (independent two-tailed t test: left, p = 0.08; right, p < 0.01). Because physical benefits are related to the reduction in breast weight, the inverted-T group has an advantage. An analysis of covariance adjusting for this difference in relative resection weights would be expected to increase the difference in scores on the Short Form-36 Physical Component Summary (unadjusted value of p = 0.148). This issue is not just a statistical nuance; a significant difference might change the study’s conclusions in favor of the vertical technique. Another uncontrolled confounder is operator experience. Learning curve issues must be considered when some of the investigators have performed as few as 10 successful vertical mammaplasties at the outset of the study after watching a video of the technique.1 There is little information to be learned from the
59e
Plastic and Reconstructive Surgery • January 2014 minimal complications data presented here. Evidently, postoperative concerns about appearance do not constitute complications. The authors believe the next logical step is a cost-effectiveness analysis.1 Is such a study necessary? Hall-Findlay reported a one-third reduction in operating time after adopting the vertical technique.10 Lista and Ahmad perform a vertical breast reduction in 62 minutes, on average.11 The authors themselves found a significant reduction in operating time for the vertical reduction, despite less experience. This difference alone would be expected to reduce costs. There is no reason to consider the two areas of concern to breast reduction patients—physical symptoms and appearance—as mutually exclusive. The functional and quality-of-life benefits of breast reduction are well documented now.1,3 Even small breast reductions and mastopexies can relieve physical symptoms and improve the quality of life for women.3 It is not clear that additional documentation regarding health benefits is needed. We cannot lose sight of the importance of appearance in evaluating breast reduction outcomes, regardless of the medical indications used to (appropriately) justify the operation. The frontier for plastic surgeons is clear: to improve the quality of the aesthetic result. DOI: 10.1097/01.prs.0000436417.99081.54
Eric Swanson, M.D. Swanson Center 11413 Ash Street Leawood, Kan. 66211 [email protected]
DISCLOSURE The author has no conflicts of interest to disclose. There was no outside funding for this study. REFERENCES 1. Thoma A, Ignacy TA, Duku EK, et al. Randomized controlled trial comparing health-related quality of life in patients undergoing vertical scar versus inverted T-shaped reduction mammaplasty. Plast Reconstr Surg. 2013;132:48e–60e. 2. Vertical Scar Versus Inferior Pedicle Reduction Mammoplasty. ClinicalTrials.gov identification number NCT00149344. Available at: http://clinicaltrials.gov/show/ NCT00149344. Accessed July 5, 2013. 3. Swanson E. Prospective outcome study of 106 cases of vertical mastopexy, augmentation/mastopexy, and breast reduction. J Plast Reconstr Aesthet Surg. 2013;66:937–949. 4. Godwin Y, Wood SH, O’Neill TJ. A comparison of the patient and surgeon opinion on the long-term aesthetic outcome of reduction mammaplasty. Br J Plast Surg. 1998;51:444–449. 5. Ferreira MC. Evaluation of results in aesthetic plastic surgery: Preliminary observations on mammaplasty. Plast Reconstr Surg. 2000;106:1630–1635; discussion 1636. 6. Cruz-Korchin N, Korchin L. Vertical versus Wise pattern breast reduction: Patient satisfaction, revision rates, and complications. Plast Reconstr Surg. 2003;112:1573–1578; discussion 1579.
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7. Sprole AM, Adepoju I, Ascherman J, Gayle LB, Grant RT, Talmor M. Horizontal or vertical? An evaluation of patient preferences for reduction mammaplasty scars. Aesthet Surg J. 2007;27:257–262. 8. Swanson E. Changes in breast shape after cosmetic surgery: A photometric study of 147 patients. Paper presented at: Plastic Surgery 2008: 77th Annual Scientific Meeting of the American Society of Plastic Surgeons; October 31–November 5, 2008; Chicago, Ill. 9. Swanson E. A retrospective photometric study of 82 published reports of mastopexy and breast reduction. Plast Reconstr Surg. 2011;128:1282–1301. 10. Hall-Findlay EJ. A simplified vertical reduction mammaplasty: Shortening the learning curve. Plast Reconstr Surg. 1999;104:748–759; discussion 760. 11. Lista F, Ahmad J. Vertical scar reduction mammaplasty: A 15-year experience including a review of 250 consecutive cases. Plast Reconstr Surg. 2006;117:2152–2165; discussion 2166. 12. Chung KC, Ram AN. Evidence-based medicine: The fourth revolution in American medicine? Plast Reconstr Surg. 2009;123:389–398. 13. Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000;342:1887–1892. 14. 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. 15. Sackett DL, Straus SE, Richardson WS, Rosenberg W, Haynes RB. Therapy. In: Evidence-Based Medicine: How to Practice and Teach EBM. 2nd ed. New York: Churchill Livingstone; 2000:105–153.
Preoperative Symptoms of Body Dysmorphic Disorder Determine Postoperative Satisfaction and Quality of Life in Aesthetic Rhinoplasty Sir:
P
icavet et al.1 conclude that “the severity of preoperative body dysmorphic disorder symptoms has a negative effect on patient satisfaction and quality of life, regardless of the objective nasal deformity.” The definition of body dysmorphic disorder includes a preoccupation with a slight or imagined defect in appearance causing clinically significant distress.2 Despite the (inaccurate) title of their study, the authors concede that only 2 percent of their patients fit this definition,1 similar to the prevalence of this disorder in the general population3 and even among secondary rhinoplasty patients.4 The authors believe that the definition of body dysmorphic disorder should be expanded, forgoing the requirement for only a slight physical defect, and effectively raising the prevalence of this disorder among rhinoplasty patients to 35 percent—the proportion of patients with at least moderate obsessive-compulsive scores. The authors believe that a “disturbed body perception” in rhinoplasty patients adversely influences their perception of nasal shape. However, their data support the reverse argument. The prevalence of moderate obsessive-compulsive symptoms among their control patients was only 5 percent,1 suggesting a connection between the presence of a nasal deformity and obsessive
D
rs. Thoma et al.1 conclude that vertical and inverted-T breast reductions are equivalent in their beneficial effects on quality of life. The purpose of their trial was to investigate the cost-effectiveness of these two procedures with a view to reducing the “unnecessary consumption of scarce health care resources.”2 Their study does not evaluate the aesthetic outcome. The government health plan is decidedly not concerned about appearance. Nevertheless, the majority of breast reduction patients are (quite understandably) concerned about both physical symptoms and the appearance of their breasts.3 Common patient concerns include the extent of scarring, breast shape and size, symmetry, nipple level, areola size, and nipple sensation.3 Equipoise is open to question here. Existing studies consistently show that patients prefer the vertical “lollipop” scar over the inverted-T “anchor” scar.4–7 Breast shape parameters favor the vertical technique.8,9 Clinical advantages include shorter operating times,1,10,11 less blood loss,10,11 greater nipple sensation,3 and a lower risk of nipple loss11 than inverted-T reductions. Most patients may be treated as outpatients,3,11 avoiding the need for hospital admission. Randomization is performed late, allowing an opportunity for selective patient exclusion from enrollment. All of the patients had already been preapproved for coverage under the government health insurance plan, eliminating private-pay patients. Over half of these preselected patients were excluded before randomization, including patients having cosmetic surgery on other body areas (n = 78) and those with a treatment preference (n = 41).1 A patient could be directed away from randomization simply by having simultaneous breast liposuction.1,2 The leftover “noncosmetic” clinic patients were enrolled in the study. These patients, who were kept unaware of what type of scars they would have until 1 hour before surgery,1 constitute a less discriminating patient group that cannot be considered generalizable to plastic surgery patients in the community. There are some unsettling ethical considerations. Patients were recruited at their preoperative appointment 1 week before surgery,1 not at their initial consultation. At this point, patients have already been approved for surgery, scheduled their operations, and made arrangements. They may feel that they have no alternatives, particularly in a single-payer government health care system. The ethical bottom-line question is whether the investigators would be willing to submit to such last-minute randomization of their own surgery. Patients and surgeons dislike randomization because they lose their freedom of choice. In surgery, that choice is likely to have permanent consequences.
Not surprisingly, patient recruitment and external validity are well-known problems associated with randomized trials.12 Their presumed superiority over observational studies has been challenged in recent years.13 Ironically, randomized trials often replace one set of methodologic problems—selection bias and confounders—with another. Although they are referenced as “validated” instruments, none of the four scales used in this study was designed specifically for evaluating surgical changes from breast surgery. The Health Utilities Index Mark 3 (which has been used to evaluate osteoporosis) assesses vision, hearing, speech, dexterity, emotion, cognition, and pain. The Breast-Related Symptoms Questionnaire is concerned only with physical symptoms caused by large breasts. Although the authors dismiss ad hoc questionnaires, such patient surveys are very responsive to specific surgical questions, including patient satisfaction,3,6 a key indicator that is missing in this study, despite its recognition by the senior author as the most important determinant of surgical success.14 The 70 percent response rate falls below the 80 percent benchmark for evidence-based medicine.15 The authors comment that all scales favored the inverted-T group over the vertical reduction group, albeit nonsignificantly.1 However, the data obtained using the Short Form-36 Physical Component Summary, presented in the authors’ Table 6 and Figure 4, show a greater improvement for vertical reduction patients at all follow-up times. (The change in Health Utilities Index Mark 3 Pain Attribute scores are slightly higher for the vertical group, according to Table 6, but the treatment groups may have been inadvertently flipped in this table.) There are important confounders to consider. The mean breast tissue resection weight was greater (left breast, 4.5 percent; right breast, 8.8 percent) for the inverted-T group than for the vertical group, although the differences did not reach significance. At the same time, the mean body mass index for the inverted-T patients was lower than for the vertical group. The combination of these factors makes the mean breast tissue resection weight relative to body mass index higher for the inverted-T group, now reaching significance on the right side (independent two-tailed t test: left, p = 0.08; right, p < 0.01). Because physical benefits are related to the reduction in breast weight, the inverted-T group has an advantage. An analysis of covariance adjusting for this difference in relative resection weights would be expected to increase the difference in scores on the Short Form-36 Physical Component Summary (unadjusted value of p = 0.148). This issue is not just a statistical nuance; a significant difference might change the study’s conclusions in favor of the vertical technique. Another uncontrolled confounder is operator experience. Learning curve issues must be considered when some of the investigators have performed as few as 10 successful vertical mammaplasties at the outset of the study after watching a video of the technique.1 There is little information to be learned from the
59e
Plastic and Reconstructive Surgery • January 2014 minimal complications data presented here. Evidently, postoperative concerns about appearance do not constitute complications. The authors believe the next logical step is a cost-effectiveness analysis.1 Is such a study necessary? Hall-Findlay reported a one-third reduction in operating time after adopting the vertical technique.10 Lista and Ahmad perform a vertical breast reduction in 62 minutes, on average.11 The authors themselves found a significant reduction in operating time for the vertical reduction, despite less experience. This difference alone would be expected to reduce costs. There is no reason to consider the two areas of concern to breast reduction patients—physical symptoms and appearance—as mutually exclusive. The functional and quality-of-life benefits of breast reduction are well documented now.1,3 Even small breast reductions and mastopexies can relieve physical symptoms and improve the quality of life for women.3 It is not clear that additional documentation regarding health benefits is needed. We cannot lose sight of the importance of appearance in evaluating breast reduction outcomes, regardless of the medical indications used to (appropriately) justify the operation. The frontier for plastic surgeons is clear: to improve the quality of the aesthetic result. DOI: 10.1097/01.prs.0000436417.99081.54
Eric Swanson, M.D. Swanson Center 11413 Ash Street Leawood, Kan. 66211 [email protected]
DISCLOSURE The author has no conflicts of interest to disclose. There was no outside funding for this study. REFERENCES 1. Thoma A, Ignacy TA, Duku EK, et al. Randomized controlled trial comparing health-related quality of life in patients undergoing vertical scar versus inverted T-shaped reduction mammaplasty. Plast Reconstr Surg. 2013;132:48e–60e. 2. Vertical Scar Versus Inferior Pedicle Reduction Mammoplasty. ClinicalTrials.gov identification number NCT00149344. Available at: http://clinicaltrials.gov/show/ NCT00149344. Accessed July 5, 2013. 3. Swanson E. Prospective outcome study of 106 cases of vertical mastopexy, augmentation/mastopexy, and breast reduction. J Plast Reconstr Aesthet Surg. 2013;66:937–949. 4. Godwin Y, Wood SH, O’Neill TJ. A comparison of the patient and surgeon opinion on the long-term aesthetic outcome of reduction mammaplasty. Br J Plast Surg. 1998;51:444–449. 5. Ferreira MC. Evaluation of results in aesthetic plastic surgery: Preliminary observations on mammaplasty. Plast Reconstr Surg. 2000;106:1630–1635; discussion 1636. 6. Cruz-Korchin N, Korchin L. Vertical versus Wise pattern breast reduction: Patient satisfaction, revision rates, and complications. Plast Reconstr Surg. 2003;112:1573–1578; discussion 1579.
60e
7. Sprole AM, Adepoju I, Ascherman J, Gayle LB, Grant RT, Talmor M. Horizontal or vertical? An evaluation of patient preferences for reduction mammaplasty scars. Aesthet Surg J. 2007;27:257–262. 8. Swanson E. Changes in breast shape after cosmetic surgery: A photometric study of 147 patients. Paper presented at: Plastic Surgery 2008: 77th Annual Scientific Meeting of the American Society of Plastic Surgeons; October 31–November 5, 2008; Chicago, Ill. 9. Swanson E. A retrospective photometric study of 82 published reports of mastopexy and breast reduction. Plast Reconstr Surg. 2011;128:1282–1301. 10. Hall-Findlay EJ. A simplified vertical reduction mammaplasty: Shortening the learning curve. Plast Reconstr Surg. 1999;104:748–759; discussion 760. 11. Lista F, Ahmad J. Vertical scar reduction mammaplasty: A 15-year experience including a review of 250 consecutive cases. Plast Reconstr Surg. 2006;117:2152–2165; discussion 2166. 12. Chung KC, Ram AN. Evidence-based medicine: The fourth revolution in American medicine? Plast Reconstr Surg. 2009;123:389–398. 13. Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med. 2000;342:1887–1892. 14. 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. 15. Sackett DL, Straus SE, Richardson WS, Rosenberg W, Haynes RB. Therapy. In: Evidence-Based Medicine: How to Practice and Teach EBM. 2nd ed. New York: Churchill Livingstone; 2000:105–153.
Preoperative Symptoms of Body Dysmorphic Disorder Determine Postoperative Satisfaction and Quality of Life in Aesthetic Rhinoplasty Sir:
P
icavet et al.1 conclude that “the severity of preoperative body dysmorphic disorder symptoms has a negative effect on patient satisfaction and quality of life, regardless of the objective nasal deformity.” The definition of body dysmorphic disorder includes a preoccupation with a slight or imagined defect in appearance causing clinically significant distress.2 Despite the (inaccurate) title of their study, the authors concede that only 2 percent of their patients fit this definition,1 similar to the prevalence of this disorder in the general population3 and even among secondary rhinoplasty patients.4 The authors believe that the definition of body dysmorphic disorder should be expanded, forgoing the requirement for only a slight physical defect, and effectively raising the prevalence of this disorder among rhinoplasty patients to 35 percent—the proportion of patients with at least moderate obsessive-compulsive scores. The authors believe that a “disturbed body perception” in rhinoplasty patients adversely influences their perception of nasal shape. However, their data support the reverse argument. The prevalence of moderate obsessive-compulsive symptoms among their control patients was only 5 percent,1 suggesting a connection between the presence of a nasal deformity and obsessive
