This narrative review provides an overview on the topic of bias as part of Plastic and Reconstructive Surgery's series of articles 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 which 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.

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 first-time, 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.

At 2 years, patients who underwent autologous reconstruction were more satisfied with their breasts and had greater psychosocial well-being and sexual well-being than did those who underwent implant reconstruction. These findings can inform patients and their clinicians about expected satisfaction and quality of life outcomes of autologous vs implant-based procedures and further support the adoption of shared decision making in clinical practice.

Limited concordance between patient preference and patient perception and between patient and physician perception in how the treatment decision was made suggests the need for better communication between patient and clinician during a critical treatment encounter for breast cancer patients.

Background The VTEPS Network is a consortium of five tertiary referral centers established to examine venous thromboembolism in plastic surgery patients. We report our mid-term analyses of the study’s control group to 1) evaluate the incidence of VTE in patients who receive no chemoprophylaxis and 2) 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 post-operative hospital admission. Patients who received chemoprophylaxis were excluded. Dependent variables included symptomatic DVT or PE within the first 60 post-operative days and time to DVT or PE. Results We identified 1126 historic control patients. The overall VTE incidence was 1.69%. Approximately one in nine (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 to patients with Caprini score of 3–4 (OR 20.9, p<0.001), 5–6 (OR 9.9, p<0.001), or 7–8 (OR 4.6, p=0.015). Among patients with Caprini score 7–8 or Caprini score >8, VTE risk was not limited to the immediate post-operative 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 post-operative VTE when chemoprophylaxis is not provided. In higher risk patients, there was no evidence that VTE risk is limited to the immediate post-operative period.

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.

Purpose The goals of immediate postmastectomy breast reconstruction are to minimize deformity and optimize quality of life as perceived by patients. We prospectively evaluated patient-reported outcomes (PROs) in women undergoing immediate implant-based or autologous reconstruction. Methods Women undergoing immediate postmastectomy reconstruction for invasive cancer and/or carcinoma in situ were enrolled at 11 sites. Women underwent implant-based or autologous tissue reconstruction. Patients completed the BREAST-Q, a condition-specific PRO measure for breast surgery patients, and Patient-Reported Outcomes Measurement Information System-29, a generic PRO measure, before and 1 year after surgery. Mean changes in PRO scores were summarized. Mixed-effects regression models were used to compare PRO scores across procedure types. Results In total, 1,632 patients (n = 1,139 implant, n = 493 autologous) were included; 1,183 (72.5%) responded to 1-year questionnaires. After analysis was controlled for baseline values, patients who underwent autologous reconstruction had greater satisfaction with their breasts than those who underwent implant-based reconstruction (difference, 6.3; P < .001), greater sexual well-being (difference, 4.5; P = .003), and greater psychosocial well-being (difference, 3.7; P = .02) at 1 year. Patients in the autologous reconstruction group had improved satisfaction with breasts (difference, 8.0; P = .002) and psychosocial well-being (difference, 4.6; P = .047) compared with preoperative baseline. Physical well-being of the chest was not fully restored in either the implant group (difference, -3.8; P = .001) or autologous group (-2.2; P = .04), nor was physical well-being of the abdomen in patients who underwent autologous reconstruction (-13.4; P < .001). Anxiety and depression were mitigated at 1 year in both groups. Compared with their baseline reports, patients who underwent implant reconstruction had decreased fatigue (difference, -1.4; P = .035), whereas patients who underwent autologous reconstruction had increased pain interference (difference, 2.0; P = .006). Conclusion At 1 year after mastectomy, patients who underwent autologous reconstruction were more satisfied with their breasts and had greater psychosocial and sexual well-being than those who underwent implant reconstruction. Although satisfaction with breasts was equal to or greater than baseline levels, physical well-being was not fully restored. This information can help patients better understand expected outcomes and may guide innovations to improve outcomes.

The purpose of this study was to identify important sociodemographic factors affecting the utilization of immediate and early delayed postmastectomy breast reconstruction in the United States. Using the Surveillance, Epidemiology, and End Results (SEER) program, all cases of mastectomy-treated breast cancer that were reported to a SEER registry in 1998 were identified. Data were limited to reconstructions within the first 4 months postmastectomy, and logistic regression was used to analyze the effects of sociodemographic variables on reconstruction rates. Of the 10,406 mastectomy-treated breast cancer patients, 1607 (15 percent) underwent reconstruction within the first 4 months postmastectomy. Compared with women 45 to 54 years old, those 35 to 44 years old were significantly more likely to have breast reconstruction (OR = 1.52, p < 0.001), but women 55 to 64, 65 to 74, and 75 years and older were significantly less likely to have reconstruction (OR = 0.42, p < 0.001; OR = 0.16, p < 0.001; OR = 0.04, p < 0.001, respectively). Compared with Caucasian women, African American, Hispanic, and Asian women were significantly less likely to have reconstruction (OR = 0.48, p < 0.001; OR = 0.45, p < 0.001; OR = 0.29, p < 0.001, respectively). In addition, a four-fold difference in reconstruction rates existed in high-use versus low-use regions. With regard to the type of reconstruction, patients younger than 35 and 65 to 74 years old were significantly less likely to receive autogenous tissue reconstruction compared with women 45 to 54 years old (OR = 0.47, p = 0.047; OR p = 0.61, p = 0.031, respectively). However, African Americans were significantly more likely to receive autogenous tissue reconstructions compared with Caucasians (OR = 2.03, p = 0.021). According to these data, the utilization of immediate and early delayed breast reconstruction in the United States is low and is significantly influenced by patients' age, race, and geographic location. Further research is needed to evaluate the impact of provider bias, patient preference, and barriers to care on the utilization of breast reconstruction in the United States.