Clara N. Lee

Patient-reported outcomes of breast reconstruction after mastectomy: a systematic review.

Breast reconstruction is commonly utilized after mastectomy for breast cancer and is generally felt to improve women’s quality of life and well-being.1 However, most studies that have evaluated breast reconstruction have focused on outcomes that may not be relevant to patients or that are of interest primarily to surgeons (such as fat necrosis, symmetry without clothing),2–4 and many studies have not compared outcomes of breast reconstruction to outcomes of mastectomy only. In addition, recent findings of large geographic variations in rates of breast reconstruction have called into question the appropriateness of who gets breast reconstruction.5–8 Thus, our understanding of the impact of breast reconstruction on women’s lives remains somewhat limited. The purpose of this systematic review is to evaluate studies examining patient-reported outcomes of breast reconstruction after mastectomy for breast cancer, compared to mastectomy only.

The use of acellular dermal matrices in two-stage expander/implant reconstruction: a multicenter, blinded, randomized controlled trial.

Background: Current efficacy data supporting the routine use of acellular dermal matrices in postmastectomy tissue expander/implant reconstruction are limited. A multicenter, blinded, randomized controlled study was designed to evaluate the effectiveness of acellular dermal matrix in the setting of tissue expander/implant reconstruction. The primary objective of the study was to determine whether the use of matrix would decrease patient-reported postoperative pain. The secondary objective was to determine whether its use would accelerate the rate of postoperative expansion. Methods: The randomized controlled trial was conducted at two U.S. centers from 2008 to 2011. Immediately following mastectomy, all patients were randomized to one of two treatment arms: (1) acellular dermal matrix–assisted, tissue expander/implant reconstruction; and (2) submuscular tissue expander/implant placement. All patients were blinded to their treatment arm. Results: One hundred eight consented to participate; 38 were excluded prior to randomization. In total, 70 patients were randomized. There were no differences seen in immediate postoperative pain (p = 0.19) or pain during the expansion phase (p = 0.65) between treatment arms. There was similarly no difference in postoperative narcotic use (p = 0.38). The rate of postoperative expansion did not differ between groups (p = 0.83). Conclusions: The results suggest that the use of acellular dermal matrix in the setting of tissue expander/implant reconstruction neither reduces postoperative pain nor accelerates the rate of postoperative expansion. An examination of its efficacy in improving long-term outcomes following tissue expander/implant reconstruction is warranted. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

Decision Making about Surgery for Early Stage Breast Cancer

BACKGROUND Practice variation in breast cancer surgery has raised concerns about the quality of treatment decisions. We sought to evaluate the quality of decisions about surgery for early-stage breast cancer by measuring patient knowledge, concordance between goals and treatments, and involvement in decisions. STUDY DESIGN A mailed survey of stage I/II breast cancer survivors was conducted at 4 sites. The Decision Quality Instrument measured knowledge, goals, and involvement in decisions. A multivariable logistic regression model of treatment was developed. The model-predicted probability of mastectomy was compared with treatment received for each patient. Concordance was defined as having mastectomy and predicted probability >0.5 or partial mastectomy and predicted probability <0.5. Frequency of discussion about partial mastectomy was compared with discussion about mastectomy using chi-square tests. RESULTS Four hundred and forty patients participated (59% response rate). Mean overall knowledge was 52.7%; 45.9% knew that local recurrence risk is higher after breast conservation and 55.7% knew that survival is equivalent for the 2 options. Most participants (89.0%) had treatment concordant with their goals. Participants preferring mastectomy had lower concordance (80.5%) than those preferring partial mastectomy (92.6%; p = 0.001). Participants reported more frequent discussion of partial mastectomy and its advantages than of mastectomy, and 48.6% reported being asked their preference. CONCLUSIONS Breast cancer survivors had major knowledge deficits, and those preferring mastectomy were less likely to have treatment concordant with goals. Patients perceived that discussions focused on partial mastectomy, and many were not asked their preference. Improvements in the quality of decisions about breast cancer surgery are needed.

Development of instruments to measure the quality of breast cancer treatment decisions

Background  Women with early‐stage breast cancer face a multitude of decisions. The quality of a decision can be measured by the extent to which the treatment reflects what is most important to an informed patient. Reliable and valid measures of patients’ knowledge and their goals and concerns related to breast cancer treatments are needed to assess the decision quality.

Bilateral Mastectomy versus Breast-Conserving Surgery for Early-Stage Breast Cancer: The Role of Breast Reconstruction.

Background: Although breast-conserving surgery is oncologically safe for women with early-stage breast cancer, mastectomy rates are increasing. The objective of this study was to examine the role of breast reconstruction in the surgical management of unilateral early-stage breast cancer. Methods: A retrospective cohort study of women diagnosed with unilateral early-stage breast cancer (1998 to 2011) identified in the National Cancer Data Base was conducted. Rates of breast-conserving surgery, unilateral and bilateral mastectomy with contralateral prophylactic procedures (per 1000 early-stage breast cancer cases) were measured in relation to breast reconstruction. The association between breast reconstruction and surgical treatment was evaluated using a multinomial logistic regression, controlling for patient and disease characteristics. Results: A total of 1,856,702 patients were included. Mastectomy rates decreased from 459 to 360 per 1000 from 1998 to 2005 (p < 0.01), increasing to 403 per 1000 in 2011 (p < 0.01). The mastectomy rates rise after 2005 reflects a 14 percent annual increase in contralateral prophylactic mastectomies (p < 0.01), as unilateral mastectomy rates did not change significantly. Each percentage point of increase in reconstruction rates was associated with a 7 percent increase in the probability of contralateral prophylactic mastectomies, with the greatest variation explained by young age(32 percent), breast reconstruction (29 percent), and stage 0 (5 percent). Conclusions: Since 2005, an increasing proportion of early-stage breast cancer patients have chosen mastectomy instead of breast-conserving surgery. This trend reflects a shift toward bilateral mastectomy with contralateral prophylactic procedures that may be facilitated by breast reconstruction availability.

Shine on: Review of Laser- and Light-Based Therapies for the Treatment of Burn Scars

Restoration of form and function after burn injury remains challenging, but emerging laser and pulsed light technologies now offer hope for patients with hypertrophic scars, which may be associated with persistent hyperemia, chronic folliculitis, intense pruritis, and neuropathic pain. In addition to impairing body image, these scars may limit functional recovery, compromise activities of daily living, and prevent return to work. Three different platforms are now poised to alter our reconstructive algorithm: (1) vascular-specific pulsed dye laser (PDL) to reduce hyperemia, (2) ablative fractional CO2 laser to improve texture and pliability of the burn scar, and (3) intense pulsed light (IPL) to correct burn scar dyschromia and alleviate chronic folliculitis. In this paper, we will provide an overview of our work in this area, which includes a systematic review, a retrospective analysis of our preliminary experience, and interim data from our on-going, prospective, before-after cohort trial. We will demonstrate that laser- and light-based therapies can be combined with each other safely to yield superior results, often at lower cost, by reducing the need for reconstructive surgery. Modulating the burn scar, through minimally invasive modalities, may replace conventional methods of burn scar excision and yield outcomes not previously possible or conceivable.

Measuring decision quality: psychometric evaluation of a new instrument for breast cancer surgery

BackgroundThe purpose of this paper is to examine the acceptability, feasibility, reliability and validity of a new decision quality instrument that assesses the extent to which patients are informed and receive treatments that match their goals.MethodsCross-sectional mail survey of recent breast cancer survivors, providers and healthy controls and a retest survey of survivors. The decision quality instrument includes knowledge questions and a set of goals, and results in two scores: a breast cancer surgery knowledge score and a concordance score, which reflects the percentage of patients who received treatments that match their goals. Hypotheses related to acceptability, feasibility, discriminant validity, content validity, predictive validity and retest reliability of the survey instrument were examined.ResultsWe had responses from 440 eligible patients, 88 providers and 35 healthy controls. The decision quality instrument was feasible to implement in this study, with low missing data. The knowledge score had good retest reliability (intraclass correlation coefficient = 0.70) and discriminated between providers and patients (mean difference 35%, p < 0.001). The majority of providers felt that the knowledge items covered content that was essential for the decision. Five of the 6 treatment goals met targets for content validity. The five goals had moderate to strong retest reliability (0.64 to 0.87). The concordance score was 89%, indicating that a majority had treatments concordant with that predicted by their goals. Patients who had concordant treatment had similar levels of confidence and regret as those who did not.ConclusionsThe decision quality instrument met the criteria of feasibility, reliability, discriminant and content validity in this sample. Additional research to examine performance of the instrument in prospective studies and more diverse populations is needed.

Under-Reporting of Road Traffic Mortality in Developing Countries: Application of a Capture-Recapture Statistical Model to Refine Mortality Estimates

Road traffic injuries are a major cause of preventable death in sub-Saharan Africa. Accurate epidemiologic data are scarce and under-reporting from primary data sources is common. Our objectives were to estimate the incidence of road traffic deaths in Malawi using capture-recapture statistical analysis and determine what future efforts will best improve upon this estimate. Our capture-recapture model combined primary data from both police and hospital-based registries over a one year period (July 2008 to June 2009). The mortality incidences from the primary data sources were 0.075 and 0.051 deaths/1000 person-years, respectively. Using capture-recapture analysis, the combined incidence of road traffic deaths ranged 0.192–0.209 deaths/1000 person-years. Additionally, police data were more likely to include victims who were male, drivers or pedestrians, and victims from incidents with greater than one vehicle involved. We concluded that capture-recapture analysis is a good tool to estimate the incidence of road traffic deaths, and that capture-recapture analysis overcomes limitations of incomplete data sources. The World Health Organization estimated incidence of road traffic deaths for Malawi utilizing a binomial regression model and survey data and found a similar estimate despite strikingly different methods, suggesting both approaches are valid. Further research should seek to improve capture-recapture data through utilization of more than two data sources and improving accuracy of matches by minimizing missing data, application of geographic information systems, and use of names and civil registration numbers if available.

Surgery and Global Public Health: The UNC-Malawi Surgical Initiative as a Model for Sustainable Collaboration

Addressing global health disparities in the developing world gained prominence during the first decade of the twenty-first century. The HIV/AIDS epidemic triggered much interest in and funding for health improvement and mortality reduction in low- and middle-income nations, particularly in sub-Saharan Africa. Alliances between U.S. academic medical centers and African nations were created through the departments of internal medicine and infectious disease. However, the importance of addressing surgical disease as part of global public health is becoming recognized as part of international health development efforts. We propose a novel model to reduce the global burden of surgical diseases in resource poor settings by incorporating a sustained institutional surgical presence with our residency training experience by placing a senior surgical resident to provide continuity of care and facilitate training of local personnel. We present the experiences of the University of North Carolina (UNC) Department of Surgery as part of the UNC Project in Malawi as an example of this innovative approach.

Utility of the omentum in pelvic floor reconstruction following resection of anorectal malignancy: patient selection, technical caveats, and clinical outcomes.

This study assesses the usefulness of the omentum in the reconstruction of complex perineal defects, following abdominoperineal resection or pelvic exenteration, for anorectal malignancy.Between 2000 and 2008, 70 patients (mean age: 59 years) with anorectal malignancy underwent abdominoperineal resection (n = 57) or pelvic exenteration (n = 13) and were reconstructed by primary repair alone (n = 13), primary repair with omentum (n = 16), myocutaneous flap alone (n = 28), or myocutaneous flap with omentum (n = 13). Patients with and without omental flaps were compared by Student t test and &khgr;2 analysis. Omental flaps were based on a single pedicle, tunneled in the retrocolic plane lateral to the ligament of Treitz, and transposed across the sacrum to the pelvic floor.In total, 29 patients had pelvic floor and perineal reconstruction with the omentum, and 41 patients had reconstruction without the omentum. Incidence of major pelvic complications (abscess, urinoma, deep vein thrombosis, flap dehiscence, hernia, bowel obstruction, fistula) was greater in the “no omentum” group (25/41 patients, 61%), compared with the “omentum” group (6/29 patients, 21%) (P < 0.01). No differences were observed regarding age, stage, incidence of radiotherapy, blood loss, length of stay, or mortality.Use of the omentum as a primary flap, or in combination with a myocutaneous flap, in the reconstruction of complex perineal defects, is associated with a decreased incidence of postoperative complications, strongly supporting the use of the omentum in pelvic floor reconstruction.