Abstract The U.S. health care system is currently experiencing profound change. Pressure to improve the quality of patient care and control costs have caused a rapid shift from traditional ...volume-driven fee-for-service reimbursement to value-based payment models. Under the 2015 Medicare Access and Children’s Health Insurance Program Reauthorization Act, providers will be evaluated on the basis of quality and cost efficiency and ultimately receive adjusted reimbursement as per their performance. Although current performance metrics do not incorporate patient-reported outcome measures (PROMs), many wonder whether and how PROMs will eventually fit into value-based payment reform. On November 17, 2016, the second annual Patient-Reported Outcomes in Healthcare Conference brought together international stakeholders across all health care disciplines to discuss the potential role of PROs in value-based health care reform. The purpose of this article was to summarize the findings from this conference in the context of recent literature and guidelines to inform implementation of PROs in value-based payment models. Recommendations for evaluating key perspectives and measurement goals are made to facilitate appropriate use of PROMs to best benefit and amplify the voice of our patients.
IMPORTANCE: Previous outcome studies comparing implant and autologous breast reconstruction techniques have been limited by short-term follow-up, single-center design, and a lack of rigorous ...patient-reported outcome data. An understanding of the expected satisfaction and breast-related quality of life associated with each type of procedure is central to the decision-making process. OBJECTIVE: To determine outcomes reported by patients undergoing postmastectomy breast reconstruction using implant or autologous techniques 2 years after surgery. DESIGN, SETTING, AND PARTICIPANTS: Patients were recruited from 11 centers (57 plastic surgeons) across North America for the Mastectomy Reconstruction Outcomes Consortium study, a prospective, multicenter trial, from February 1, 2012, to July 31, 2015. Women undergoing immediate breast reconstruction using implant or autologous tissue reconstruction after mastectomy for cancer treatment or prophylaxis were eligible. Overall, 2013 women (1490 implant and 523 autologous tissue reconstruction) met the inclusion criteria. All patients included in this analysis had 2 years of follow-up. EXPOSURES: Procedure type (ie, implant vs autologous tissue reconstruction). MAIN OUTCOMES AND MEASURES: The primary outcomes of interest were scores on the BREAST-Q, a validated, condition-specific, patient-reported outcome instrument, which were collected prior to and at 2 years after surgery. The following 4 domains of the BREAST-Q reconstruction module were evaluated: satisfaction with breasts, psychosocial well-being, physical well-being, and sexual well-being. Responses from each scale were summed and transformed on a 0 to 100 scale, with higher numbers representing greater satisfaction or quality of life. RESULTS: Of the 2013 women in the study (mean SD age, 48.1 10.5 years for the group that underwent implant-based reconstruction and 51.6 8.7 years for the group that underwent autologous reconstruction), 1217 (60.5%) completed questionnaires at 2 years after reconstruction. After controlling for baseline patient characteristics, patients who underwent autologous reconstruction had greater satisfaction with their breasts (difference, 7.94; 95% CI, 5.68-10.20; P < .001), psychosocial well-being (difference, 3.27; 95% CI, 1.25-5.29; P = .002), and sexual well-being (difference, 5.53; 95% CI, 2.95-8.11; P < .001) at 2 years compared with patients who underwent implant reconstruction. CONCLUSIONS AND RELEVANCE: 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.
The BREAST-Q is a patient-reported outcome instrument used to evaluate outcomes in patients undergoing breast cancer surgery and reconstruction. Normative values for the BREAST-Q breast cancer ...modules have not been established, limiting data interpretation.
Participants were recruited by means of the Army of Women, an online community of women (with and without breast cancer), to complete Mastectomy, Breast Conserving Therapy, and Reconstruction preoperative BREAST-Q scales. Inclusion criteria were women aged 18 years or older without a history of breast surgery or breast cancer. Analysis included descriptive statistics, a linear multivariate regression, and a comparison of the generated normative data to previously published BREAST-Q findings.
The BREAST-Q was completed by 1201 women. The mean patient age was 54 ± 13 years, mean body mass index 26 ± 6 kg/m, and 38 percent (n = 455) had a bra cup size of D or greater. Mean ± SD scores for BREAST-Q scales were as follows: Satisfaction with Breasts (58 ± 18), Psychosocial Well-being (71 ± 18), Sexual Well-being (56 ± 18), Physical Well-being-Chest (93 ± 11), and Physical Well-being Abdomen (78 ± 20). Women with a body mass index of 30 kg/m or greater, cup size of D or greater, age younger than 40 years, and annual income less than $40,000 reported lower scores. Comparing normative scores to published data in breast cancer patients, Satisfaction with Breasts scores were higher after autologous reconstruction and lower after mastectomy; Sexual Well-being scores were lower after mastectomy and breast conserving therapy; and Physical Well-being Chest scores were lower after mastectomy, breast conserving therapy, and reconstruction.
These are the first published normative scores for the BREAST-Q breast cancer modules and provide a clinical reference point for the interpretation of data.
Patients considering postmastectomy radiation and reconstruction require information regarding expected outcomes to make preference-concordant decisions.
A prospective multicenter cohort study of ...women diagnosed with breast cancer at 11 centers between 2012 and 2015 compared complications and patient-reported outcomes of 622 irradiated and 1625 unirradiated patients who received reconstruction. Patient characteristics and outcomes between irradiated and unirradiated patients were analyzed using ttests for continuous variables and chi-square tests for categorical variables. Multivariable mixed-effects regression modelsassessed the impact of reconstruction type and radiotherapy on outcomes after adjusting for relevant covariates. All statistical tests were two-sided.
Autologous reconstruction was more commonly received by irradiated patients (37.9% vs 25.0%, P < .001). Immediate reconstruction was less common in irradiated patients (83.0% vs 95.7%, P < .001). At least one breast complication had occurred by two years in 38.9% of irradiated patients with implant reconstruction, 25.6% of irradiated patients with autologous reconstruction, 21.8% of unirradiated patients with implant reconstruction, and 28.3% of unirradiated patients with autologous reconstruction. Multivariable analysis showed bilateral treatment and higher body mass index to be predictive of developing a complication, with a statistically significant interaction between radiotherapy receipt and reconstruction type. Among irradiated patients, autologous reconstruction was associated with a lower risk of complications than implant-based reconstruction at two years (odds ratio OR = 0.47, 95% confidence interval CI = 0.27 to 0.82, P = .007); no between-procedure difference was found in unirradiated patients. The interaction was also statistically significant for satisfaction with breasts at two years (P = .002), with larger adjusted difference in satisfaction between autologous vs implant approaches (63.5, 95% CI = 55.9 to 71.1, vs 47.7, 95% CI = 40.2 to 55.2, respectively) in irradiated patients than between autologous vs implant approaches (67.6, 95% CI = 60.3 to 74.9, vs 60.5, 95% CI = 53.6 to 67.4) in unirradiated patients.
Autologous reconstruction appears to yield superior patient-reported satisfaction and lower risk of complications than implant-based approaches among patients receiving postmastectomy radiotherapy.
IMPORTANCE: In breast reconstruction, it is critical for patients and surgeons to have comprehensive information on the relative risks of the available options. However, previous studies that ...evaluated complications were limited by single-center designs, inadequate follow-up, and confounding. OBJECTIVE: To assess 2-year complication rates across common techniques for postmastectomy reconstruction in a multicenter patient population. DESIGN, SETTING, AND PARTICIPANTS: This longitudinal, multicenter, prospective cohort study conducted from February 1, 2012, through July 31, 2015, took place at the 11 study sites associated with the Mastectomy Reconstruction Outcomes Consortium study. Eligible patients included women 18 years and older presenting for first-time breast reconstruction with at least 2 years of follow-up. Procedures evaluated included direct-to-implant (DTI) technique, expander-implant (EI) technique, latissimus dorsi (LD) flap, pedicled transverse rectus abdominis myocutaneous (pTRAM) flap, free transverse rectus abdominis myocutaneous (fTRAM) flap, deep inferior epigastric perforator (DIEP) flap, and superficial inferior epigastric artery (SIEA) flap. INTERVENTIONS: Postmastectomy breast reconstruction. MAIN OUTCOMES AND MEASURES: Development of complications, reoperative complications, and wound infections during 2-year follow-up. Mixed-effects logistic regression analysis controlled for variability among centers and for demographic and clinical variables. RESULTS: A total of 2343 patients (mean SD age, 49.5 10.1 years; mean SD body mass index, 26.6 5.7) met the inclusion criteria. A total of 1525 patients (65.1%) underwent EI reconstruction, with 112 (4.8%) receiving DTI reconstruction, 85 (3.6%) pTRAM flaps, 95 (4.1%) fTRAM flaps, 390 (16.6%) DIEP flaps, 71 (3.0%) LD flaps, and 65 (2.8%) SIEA flaps. Overall, complications were noted in 771 (32.9%), with reoperative complications in 453 (19.3%) and wound infections in 230 (9.8%). Two years postoperatively, patients undergoing any autologous reconstruction type had significantly higher odds of developing any complication compared with those undergoing EI reconstruction (pTRAM flap: odds ratio OR, 1.91; 95% CI, 1.10-3.31; P = .02; fTRAM flap: OR, 2.05; 95% CI, 1.24-3.40; P = .005; DIEP flap: OR, 1.97; 95% CI, 1.41-2.76; P < .001; LD flaps: OR, 1.87; 95% CI, 1.03-3.40; P = .04; SIEA flap: OR, 4.71; 95% CI, 2.32-9.54; P < .001). With the exception of LD flap reconstructions, all flap procedures were associated with higher odds of reoperative complications (pTRAM flap: OR, 2.48; 95% CI, 1.33-4.64; P = .005; fTRAM flap: OR, 3.02; 95% CI, 1.73-5.29; P < .001; DIEP flap: OR, 2.76; 95% CI, 1.87-4.07; P < .001; SIEA flap: OR, 2.62; 95% CI, 1.24-5.53; P = .01) compared with EI techniques. Of the autologous reconstructions, only patients undergoing DIEP flaps had significantly lower odds of infection compared with those undergoing EI procedures (OR, 0.45; 95% CI, 0.25-0.29; P = .006). However, DTI and EI procedures had higher failure rates (EI and DTI techniques, 7.1%; pTRAM flap, 1.2%; fTRAM flap, 2.1%; DIEP flap, 1.3%; LD flap, 2.8%; and SIEA flap, 0%; P < .001). CONCLUSIONS AND RELEVANCE: Significant differences were noted across reconstructive procedure types for overall and reoperative complications, which is critically important information for women and surgeons making breast reconstruction decisions.
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 study's 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.
OBJECTIVE:In postmastectomy reconstruction, procedure choice is heavily influenced by the relative risks of the various options. This study sought to evaluate complications in a large, multicenter ...patient population.
SUMMARY OF BACKGROUND DATA:Previous studies have reported widely varying complication rates, but have been limited by their single center designs and inadequate controlling for confounders in their analyses.
METHODS:Eleven sites enrolled women undergoing first time, immediate, or delayed reconstruction following mastectomy for cancer treatment or prophylaxis. Procedures included expander/implant, latissimus dorsi (LD), pedicle transverse rectus abdominis musculocutaneous (PTRAM), free TRAM (FTRAM), and deep inferior epigastric perforator (DIEP) techniques. Data were gathered pre- and postoperatively from medical records. Separate logistic regressions were conducted for all complications and major complications (those requiring rehospitalization and/or reoperation) within 1 year. Odds ratios (ORs) were calculated for procedure type, controlling for site, demographic, and clinical variables.
RESULTS:Complication rates for 2234 patients were analyzed. Compared with expander/implant reconstructions, LD (OR) 1.95, P = 0.026), PTRAM (OR 1.89, P = 0.025), FTRAM (OR 1.94, P = 0.011), and DIEP (OR 2.22, P < 0.001) procedures were associated with higher risks of complications. Significantly higher risks were also associated with older age, higher body mass index (BMI), immediate reconstruction, bilateral procedures, and radiation. For major complications, regression showed significantly greater risks for PTRAM (OR 1.86, P = 0.044) and DIEP (OR 1.75, P = 0.004), than expander/implant reconstructions. Failure rates were relatively low, ranging from 0% for PTRAM to 5.9% for expander/implant reconstructions.
CONCLUSION:In this multicenter analysis, procedure choice and other patient variables were significant predictors of 1-year complications in breast reconstruction. These findings should be considered in counseling patients on reconstructive options.
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