Edwin G. Wilkins

Complications in postmastectomy breast reconstruction: two-year results of the Michigan Breast Reconstruction Outcome Study.

&NA; In this study, the effects of procedure type, timing, and other clinical variables on complication rates in mastectomy reconstruction were prospectively evaluated. Using a prospective cohort design, women undergoing firsttime, immediate or delayed breast reconstruction were recruited from 12 centers and 23 plastic surgeons. Complication data for expander/implant, pedicle transverse rectus abdominis musculocutaneous (TRAM) flap, and free TRAM flap procedures were evaluated 2 years after surgery in 326 patients. For each patient, the total number of complications was recorded and the complication data were dichotomized in two ways: (1) total complications and (2) major complications (those requiring reoperation, rehospitalization, or nonperioperative intravenous antibiotic treatment). The effects of procedure type, timing, radiotherapy, chemotherapy, age, smoking, and body mass index on complication rates were analyzed using logistic regression. Immediate reconstructions had significantly higher total as well as major complication rates, compared with delayed procedures (p = 0.011 and 0.005, respectively). Furthermore, higher body mass indexes were associated with significantly higher total and major complication rates (p = 0.005 and p < 0.001, respectively). No significant effects on complication rates were noted for procedure type or for the other independent variables, although there was evidence of trends for higher total and major complication rates in implant patients who received radiotherapy and a trend for higher major complication rates in TRAM flap patients who received chemotherapy. It was concluded that (1) immediate reconstructions were associated with significantly higher complication rates than delayed procedures, and (2) procedure type had no significant effect on complication rates. (Plast. Reconstr. Surg. 109: 2265, 2002.)

Prospective analysis of psychosocial outcomes in breast reconstruction: one-year postoperative results from the Michigan Breast Reconstruction Outcome Study.

In the past decade, changing attitudes toward breast reconstruction among both patients and providers have led a growing number of women to seek breast reconstruction after mastectomy. Although investigators have documented the psychological, social, emotional, and functional benefits of breast reconstruction, little research has evaluated the effects of procedure choice on these outcomes. The current study prospectively evaluated and compared psychosocial outcomes for three common options for mastectomy reconstruction: tissue expander/implant, pedicle TRAM, and free TRAM techniques. In a prospective cohort design, patients undergoing postmastectomy reconstruction for the first time with expander/implant, pedicle TRAM, or free TRAM procedures were recruited from 12 centers and 23 plastic surgeons in the United States and Canada. Before reconstruction and at 1 year after reconstruction, patients were evaluated by a battery of questionnaires consisting of both generic and condition-specific surveys. Outcomes assessed included emotional well-being, vitality, general mental health, social functioning, functional well-being, social well-being, and body image. Baseline (preoperative) scores and the change in scores (the difference between postoperative and preoperative scores) were compared across procedure types using t tests and analysis of covariance. Preoperative and 1-year postoperative surveys were obtained from 273 patients. Procedure type was reported in 250 patients, of whom 56 received implant reconstructions, 128 pedicle TRAM flaps, and 66 free TRAM flaps. A total of 161 immediate and 89 delayed reconstructions were performed. Among women receiving immediate reconstruction, significant improvements were observed in all psychosocial variables except body image. However, no significant effects of procedure type on these changes over time existed. Similarly, delayed reconstruction patients had significant increases in emotional well-being, vitality, general mental health, functional well-being, and body image. Although the choice of reconstructive technique did not significantly impact most of these outcomes, significant differences existed among procedure types for three psychosocial subscales. Patients undergoing delayed expander/implant reconstructions reported greater improvements in vitality and social well-being relative to women receiving delayed TRAM procedures. By contrast, delayed TRAM patients noted significantly greater gains in body image compared with women choosing delayed expander-implant reconstruction. The authors conclude that both immediate and delayed breast reconstructions provide substantial psychosocial benefits for mastectomy patients. Although the choice of reconstructive procedure does not seem to significantly affect improvements in psychosocial status with immediate reconstruction, our data suggest that procedure type does have a significant effect on gains in vitality and body image for women undergoing delayed reconstruction.

Determinants of patient satisfaction in postmastectomy breast reconstruction

In today’s increasingly competitive health care marketplace, consumer satisfaction has become an important measure of quality. Furthermore, measures of satisfaction with treatment interventions are influential factors in determining patients’ and payers’ choices of health care. This study sought to evaluate satisfaction with postmastectomy breast reconstruction and to assess the effects of procedure type and timing on patient satisfaction. As part of the Michigan Breast Reconstruction Outcome Study, patients undergoing first-time mastectomy reconstruction were prospectively evaluated, including cohorts of women choosing expander/implant, pedicle TRAM flap, and free TRAM flap procedures. Preoperatively and 1 year postoperatively, participants completed a questionnaire that collected a variety of health status information. The postoperative questionnaire had an additional seven items assessing both general satisfaction with reconstruction (five items) and aesthetic satisfaction (two items) as separate subscales. Patients were asked to respond to each item using a five-point Likert scale. Item responses ranged from 1, indicating high satisfaction, to 5, reflecting low satisfaction. In the data analysis, only patients responding with a 1 or 2 for all of the items within a subscale were classified as “satisfied” for the subscale. To assess the effects of procedure type (implant, pedicle TRAM flap, and free TRAM flap) and timing (immediate versus delayed) on satisfaction and to control for possible confounding effects from other independent variables, multiple logistic regression was employed. In our analysis, odds ratios and associated 95 percent confidence intervals were calculated for each independent variable in the regression. Statistical significance was designated at the p ≤ 0.05 level. A total of 212 patients were followed during the period of 1994 to 1997, including 141 immediate and 71 delayed reconstructions. The study population consisted of 49 expander/implant, 102 pedicle TRAM flap, and 61 free TRAM flap reconstruction patients. The analysis showed a significant association between procedure type and patient satisfaction. TRAM flap patients (both free and pedicle) appeared to have significantly greater general and aesthetic satisfaction compared with expander/implant patients (p = 0.03 and 0.001, respectively). Furthermore, pedicle TRAM flap patients were more aesthetically satisfied than those with free TRAM flaps (p = 0.072). The other independent variables of age and procedure timing did not appear to significantly affect either general or aesthetic satisfaction. However, preoperative physical activity was positively correlated with general satisfaction at the p = 0.034 level. The choice of procedure seems to have a significant effect on both aesthetic and general patient satisfaction with breast reconstruction. In this study, autogenous tissue reconstructions produced higher levels of patient aesthetic and general satisfaction compared with implant techniques. Pedicle and free TRAM flap patients do not seem to differ significantly in general satisfaction. However, women receiving pedicle TRAM flaps reported greater aesthetic satisfaction compared with patients undergoing free TRAM flaps. Furthermore, patient age and procedure timing may not have an effect on patient satisfaction with breast reconstruction.

Identifying and avoiding bias in research.

Summary: This narrative review provides an overview on the topic of bias as part of a series of articles in Plastic and Reconstructive Surgery on evidence-based medicine. Bias can occur in the planning, data collection, analysis, and publication phases of research. Understanding research bias allows readers to critically and independently review the scientific literature and avoid treatments that are suboptimal or potentially harmful. A thorough understanding of bias and how it affects study results is essential for the practice of evidence-based medicine.

Validation of the Caprini Risk Assessment Model in Plastic and Reconstructive Surgery Patients

BACKGROUND The Venous Thromboembolism Prevention Study (VTEPS) Network is a consortium of 5 tertiary referral centers established to examine venous thromboembolism (VTE) in plastic surgery patients. We report our midterm analyses of the studys control group to evaluate the incidence of VTE in patients who receive no chemoprophylaxis, and validate the Caprini Risk Assessment Model (RAM) in plastic surgery patients. STUDY DESIGN Medical record review was performed at VTEPS centers for all eligible plastic surgery patients between March 2006 and June 2009. Inclusion criteria were Caprini score ≥3, surgery under general anesthesia, and postoperative hospital admission. Patients who received chemoprophylaxis were excluded. Dependent variables included symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) within the first 60 postoperative days and time to DVT or PE. RESULTS We identified 1,126 historic control patients. The overall VTE incidence was 1.69%. Approximately 1 in 9 (11.3%) patients with Caprini score >8 had a VTE event. Patients with Caprini score >8 were significantly more likely to develop VTE when compared with patients with Caprini score of 3 to 4 (odds ratio [OR] 20.9, p < 0.001), 5 to 6 (OR 9.9, p < 0.001), or 7 to 8 (OR 4.6, p = 0.015). Among patients with Caprini score 7 to 8 or Caprini score >8, VTE risk was not limited to the immediate postoperative period (postoperative days 1-14). In these high-risk patients, more than 50% of VTE events were diagnosed in the late (days 15-60) postoperative period. CONCLUSIONS The Caprini RAM effectively risk-stratifies plastic and reconstructive surgery patients for VTE risk. Among patients with Caprini score >8, 11.3% have a postoperative VTE when chemoprophylaxis is not provided. In higher risk patients, there was no evidence that VTE risk is limited to the immediate postoperative period.

Prospective Analysis of Long-term Psychosocial Outcomes in Breast Reconstruction : Two-year Postoperative Results From the Michigan Breast Reconstruction Outcomes Study

Objective:To prospectively evaluate the psychosocial outcomes and body image of patients 2 years postmastectomy reconstruction using a multicenter, multisurgeon approach. Background:Although breast reconstruction has been shown to confer significant psychosocial benefits in breast cancer patients at year 1 postreconstruction, we considered the possibility that psychosocial outcomes may remain in a state of flux for years after surgery. Methods:Patients were recruited as part of the Michigan Breast Reconstruction Outcome Study, a 12 center, 23 surgeon prospective cohort study of mastectomy reconstruction patients. Two-sided paired sample t tests were used to compare change scores for the various psychosocial subscales. Multiple regression analysis was used to determine whether the magnitude of the change score varied by procedure type. Results:Preoperative and postoperative year 2 surveys were received from 173 patients; 116 with immediate and 57 with delayed reconstruction. For the immediate reconstruction cohort, significant improvements were observed in all psychosocial subscales except for body image. This occurred essentially independent of procedure type. In the cohort with delayed reconstruction, significant change scores were observed only in body image. Women with transverse rectus abdominis musculocutaneous flaps had significantly greater gains in body image scores (P = 0.003 and P = 0.034, respectively) when compared with expander/implants. Conclusions:General psychosocial benefits and body image gains continued to manifest at 2 years postmastectomy reconstruction. In addition, procedure type had a surprisingly limited effect on psychosocial well being. With outcomes evolving beyond year 1, these data support the need for additional longitudinal breast reconstruction outcome studies.

The effectiveness of surgical and nonsurgical interventions in relieving the symptoms of macromastia

&NA; In this report, the authors evaluate the effectiveness of breast reduction in alleviating the symptoms of macromastia by comparing baseline and postoperative health status using a series of well‐validated self‐report instruments. The study had a prospective design with a surgical intervention group and two control groups: a hypertrophy control group with bra cup sizes D or larger and a normal control group with bra cup sizes less than D. The effectiveness of nonsurgical interventions in relieving the symptoms of macromastia was also evaluated, both in the operative subjects and in the control groups. Surgical candidates and controls completed a self‐administered baseline survey that consisted of the following validated and standardized instruments commonly used to evaluate outcomes: SF‐36, EuroQol, Multidimensional Body‐Self Relations Questionnaire (MBSRQ), and the McGill Pain Questionnaire (MPQ). A specially designed and validated instrument, the Breast‐Related Symptoms (BRS), was also used. There were also questions about prior nonsurgical treatments, comorbid conditions, bra size, and a physical assessment. Additional information obtained on the operative subjects included surgical procedure data, resection weight, and complications. Approximately 6 to 9 months postoperatively, surgical subjects completed the same questionnaire as described above, and a final physical assessment was performed. The cohort included 179 operative subjects with matched preoperative and postoperative data sets, 96 normal controls and 88 hypertrophy controls. The women were predominantly Caucasian, middle‐aged, well educated, and employed. Fifty percent of the operative subjects reported breast‐related pain all or most of the time in the upper back, shoulders, neck, and lower back preoperatively compared with less than 10 percent postoperatively. Operative subjects and hypertrophy controls tried a number of conservative treatments, including weight loss, but none provided adequate permanent relief. Compared with population norms, the preoperative subjects had significantly lower scores (p < 0.05) in all eight health domains of the SF‐36, and in the mental and physical component summary scores. After surgery, the operative subjects had higher means (better health) than national norms in seven of the eight domains and improved significantly from presurgical means in all eight domains (p< 0.05). Before surgery, the operative subjects reported high levels of pain with a Pain Rating Index (PRI) score from the MPQ of 26.6. After surgery, pain was significantly lower with a mean PRI score of 11.7, similar to that of our controls (mean PRI score, 11.2). Regression analysis was used to control for covariate effects on the main study outcomes. Among the operative subjects, benefits from breast reduction were not associated with body weight, bra cup size, or weight of resection, with essentially all patients benefiting from surgery. Breast hypertrophy has a significant impact on womens health status and quality of life as measured by validated and widely used self‐report instruments including the SF‐36, MPQ, and EuroQol. Pain is a significant symptom in this disease, and both pain and overall health status are markedly improved by breast reduction. In this population, conservative measures such as weight loss, physical therapy, special brassieres, and medications did not provide effective permanent relief of symptoms. (Plast. Reconstr. Surg. 109: 1556, 2002.)

Postoperative enoxaparin prevents symptomatic venous thromboembolism in high-risk plastic surgery patients.

Background: Venous thromboembolism is a major patient safety issue. The Plastic Surgery Foundation–sponsored Venous Thromboembolism Prevention Study examined whether postoperative enoxaparin prevents symptomatic venous thromboembolism in adult plastic surgery patients. Methods: In 2009, four sites uniformly adopted a clinical protocol. Patients with a Caprini score of 3 or higher received postoperative enoxaparin prophylaxis for the duration of inpatient stay. Venous Thromboembolism Prevention Study historical control patients had an operation between 2006 and 2008 but received no chemoprophylaxis for 60 days after surgery. The primary study outcome was symptomatic 60-day venous thromboembolism. Results: Three thousand three hundred thirty-four patients (1876 controls and 1458 enoxaparin patients) were included. Notable risk reduction was present in patients with a Caprini score greater than 8 (8.54 percent versus 4.07 percent; p = 0.182) and a Caprini score of 7 to 8 (2.55 percent versus 1.15 percent; p = 0.230) who received postoperative enoxaparin. Logistic regression was limited to highest risk patients (Caprini score ≥7) and demonstrated that length of stay greater than or equal to 4 days (adjusted odds ratio, 4.63; p = 0.007) and Caprini score greater than 8 (odds ratio, 2.71; p = 0.027) were independent predictors of venous thromboembolism. When controlling for length of stay and Caprini score, receipt of postoperative enoxaparin was protective against venous thromboembolism (odds ratio, 0.39; p = 0.042). Conclusions: In high-risk plastic surgery patients, postoperative enoxaparin prophylaxis is protective against 60-day venous thromboembolism when controlling for baseline risk and length of stay. Hospitalization for 4 or more days is an independent risk factor for venous thromboembolism. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Quality of life and affective distress in women seeking immediate versus delayed breast reconstruction after mastectomy for breast cancer

Background: This study compared the presurgical psychosocial and functional status of 238 women seeking breast reconstruction, either at the time of their mastectomy (immediate) (n = 151) or after prior mastectomy (delayed) (n = 87). Delayed subjects were further categorized in groups of time-since-mastectomy to examine the effects of time on postmastectomy psychosocial adjustment. Methods: Presurgical measures of quality of life, psychological distress, and somatic anxiety were obtained. Results: The results revealed relative impairment of quality of life and psychosocial functioning for immediate compared with delayed subjects. Immediate subjects reported greater disturbance in general mental health functioning, more severe impairment in emotional well being related to their cancer diagnosis, and higher levels of anxiety. Immediate subjects also reported a trend toward greater disturbance in work and daily activities, more frequent interference in social activities, and less vitality. Similarly, it was noted that the immediate group reported greater impairment in physical and functional well being related to their cancer adjustment. On psychological assessment, immediate subjects were more likely to report higher levels of affective distress, depressive symptoms, and obsessive-compulsive traits. For the delayed group, no statistically significant differences in the dependent measures were obtained when comparing subjects at 1 year, 2 years, and more than 2 years after mastectomy. Conclusions: Women seeking immediate reconstruction at the time of mastectomy show a relatively higher incidence of psychosocial impairment and functional disability. Women who undergo mastectomy demonstrate early restoration of psychosocial health within the first year after surgery. Patient preoperative psychosocial distress may have important implications for clinical decision-making and surgical outcome for women seeking combined mastectomy and breast reconstruction.

Evaluations of aesthetic results in breast reconstruction: an analysis of reliability.

This study evaluated the reliability of three commonly used measures of aesthetic outcomes of breast surgery: a four-point ordinal scale of overall aesthetics, five four-point subscales, and a visual analogue scale. Fifty patients were randomly selected from women who underwent breast reconstruction surgery at University of Michigan hospitals between July 1989 and May 1993. Postoperative photographs of these patients were provided to three plastic surgeons, who were asked to rate the photographs using the three methods. The same process was repeated 4 weeks later. Intrarater and interrater reliability ranged from poor to good for the three methods, with the subscales showing the highest reliability. The lowest reliability occurred for those scales with the least-explicit rating criteria. Without explicit criteria, raters must develop and use their own criteria, which are likely to differ for each rater. Separating the various components of the aesthetic results of breast surgery into different subscales helps make the rating criteria more explicit. Scales with demonstrated reliability are critical for ensuring comparability of results across studies.