African-American women are significantly less likely to undergo postmastectomy breast reconstruction compared White women in the US. These observed differences have been interpreted as evidence of a healthcare disparity. The current study examines breast reconstruction decision-making among African-American women, locating reconstruction decisions in a context of culture, racial inequality, and biomedicalization. Semi-structured interviews were conducted with 27 African-American women who underwent mastectomy for breast cancer to add patient-centred perspectives to existing conceptualizations of racial/ethnic differences in reconstruction. Participants were socio-demographically diverse, and resided in the New York metropolitan area. Data analysis was informed by grounded theory. Spiritually and culturally-informed body ethics often guided surgery decisions. Participants expressed reservations about breast implants, preferring autologous procedures that use “what God has given.” For some, breast reconstruction restored a sense of normalcy after cancer; others challenged an imperative to reconstruct. Several participants redirected our focus on access to reconstruction toward access to alternatives, noting the low reimbursement for prostheses, or their unavailability in patients' skin tones. We suggest that a framework of “stratified biomedicalization” better addresses the complexities of race, class, and gender that inform preference, access, and recommendations for breast reconstruction, and focuses attention on access to high and lower-tech interventions.
breast cancer; reconstructive surgery; culture; qualitative methods; body image; health disparities
Patient-reported outcomes (PRO) data from randomised controlled trials (RCTs) are increasingly used to inform patient-centred care as well as clinical and health policy decisions.
The main objective of this study was to investigate the methodological quality of PRO assessment in RCTs of prostate cancer (PCa) and to estimate the likely impact of these studies on clinical decision making.
A systematic literature search of studies was undertaken on main electronic databases to retrieve articles published between January 2004 and March 2012. RCTs were evaluated on a predetermined extraction form, including (1) basic trial demographics and clinical and PRO characteristics; (2) level of PRO reporting based on the recently published recommendations by the International Society for Quality of Life Research; and (3) bias, assessed using the Cochrane Risk of Bias tool. Studies were systematically analysed to evaluate their relevance for supporting clinical decision making.
Sixty-five RCTs enrolling a total of 22 071 patients were evaluated, with 31 (48%) in patients with nonmetastatic disease. When a PRO difference between treatments was found, it related in most cases to symptoms only (n = 29, 58%). Although the extent of missing data was generally documented (72% of RCTs), few reported details on statistical handling of this data (18%) and reasons for dropout (35%). Improvements in key methodological aspects over time were found. Thirteen (20%) RCTs were judged as likely to be robust in informing clinical decision making. Higher-quality PRO studies were generally associated with those RCTs that had higher internal validity.
Including PRO in RCTs of PCa patients is critical for better evaluating the treatment effectiveness of new therapeutic approaches. Marked improvements in PRO quality reporting over time were found, and it is estimated that at least one-fifth of PRO RCTs have provided sufficient details to allow health policy makers and physicians to make critical appraisals of results.
In this report, we have investigated the methodological quality of PCa trials that have included a PRO assessment. We conclude that including PRO is critical to better evaluating the treatment effectiveness of new therapeutic approaches from the patient's perspective. Also, at least one-fifth of PRO RCTs in PCa have provided sufficient details to allow health policy makers and physicians to make a critical appraisal of results.
Prostate cancer; Patient-reported outcomes; Clinical trials; Quality of life; Clinical decision making
The goal of postmastectomy breast reconstruction is to restore a woman’s body image and to satisfy her personal expectations regarding the results of surgery. Studies in other surgical areas have shown that unrecognized or unfulfilled expectations may predict dissatisfaction more strongly than even the technical success of the surgery. Patient expectations play an especially critical role in elective procedures, such as cancer reconstruction, where the patient’s primary motivation is improved health-related quality of life. In breast reconstruction, assessment of patient expectations is therefore vital to optimal patient care. This report summarizes the existing literature on patient expectations regarding breast reconstruction, and provides a viewpoint on how this field can evolve. Specifically, we consider how systematic measurement and management of patient expectations may improve patient education, shared medical decision-making and patient perception of outcomes.
breast cancer; breast reconstruction; expectations; health-related quality of life; patient education; satisfaction
Current efficacy data supporting the routine use of acellular dermal matrices (ADM) in postmastectomy tissue expander/implant reconstruction is limited. A multi-center, blinded, randomized controlled study was designed to evaluate the effectiveness of ADM in the setting of TE/I reconstruction. The primary objective of the study was to determine whether the use of ADM would decrease patient-reported, post-operative pain. The secondary objective was to determine whether the use of ADM accelerated the rate of post-operative expansion. Tertiary objectives included an evaluation of long-term aesthetic results, capsular contracture rates and patient satisfaction.
The randomized controlled trial was conducted at two centers in the US from 2008 to 2011. Immediately following mastectomy, all patients were randomized to one of two treatment arms: i) ADM-assisted, TE/I reconstruction and ii) placement of an expander in a completely submuscular position. All patients were blinded to their treatment arm.
108 consented to participate, 38 of whom were excluded prior to randomization. Thus, in total, 70 patients were randomized. There were no differences between the two groups in pain in the immediate, post-operative period (p=0.19) and pain averaged during the expansion phase (p=0.65). There was similarly no difference in post-operative narcotic use between treatment arms (p=0.38). The rate of post-operative expansion did not differ between groups (p= 0.83). The evaluation of long-term outcomes is currently ongoing.
The results of this multicenter, blinded, randomized controlled trial suggest that the use of ADM in the setting of TE/I reconstruction neither reduces post-operative pain nor accelerates the rate of post-operative expansion. This data provides impartial evidence on the effectiveness of ADM in the early post-operative period. An examination of the efficacy of ADM in improving long-term outcomes following TE/I reconstruction is warranted.
acellular dermal matrix; AlloDerm; breast reconstruction; breast implants; tissue expander/implant reconstruction; randomized controlled trial
Every cancer treatment, irrespective of its clinical effectiveness, has an impact on patients’ quality of life (QoL). Even recently developed targeted therapies might have side effects and significantly impact patients’ QoL. Thus, understanding the advantages and disadvantages of different treatments from the patient’s standpoint has become a must in clinical research and is highly valued by major stakeholders. Thousands of cancer patients are enrolled into randomized controlled trials (RCTs) each year and many complete patient-reported outcome (PRO) instruments to obtain patient-centered information as part of the assessment of the overall effectiveness of the new therapy. Some of these RCTs have generated high quality PRO evidence forming the basis for approval (or support to approval) of drugs by the US Food and Drug Administration. However, a consistent strategy to determine the quality of patient centered evidence presented in RCTs has until recently been lacking. One of the fundamental questions when including PROs in clinical research revolves around methodological robustness and consistency of outcome reporting. Cancer patients, physicians and healthcare system stakeholders need to rely on solid information to make the best possible choice regarding treatment. Therefore generating high-quality findings from PRO assessment in cancer trials is of paramount importance. In an effort to improve quality of PRO assessment and reporting in the near future, the Patient-Reported Outcome Measurements Over Time In ONcology (PROMOTION) Registry was developed. The scope of this Registry is to identify, track, analyse, and store information on all cancer RCTs that have included PROs, and assess the quality of their PRO assessments.
Cancer; Patient-reported outcomes; Clinical trials; Quality of life; Clinical decision-making
Lower limb lymphedema (LLL) is a common complication of cancer treatment. The disease is chronic and progressive with no cure. Although a common and significant source of morbidity, the impact of this condition on health-related quality of life (HRQOL) has only recently been addressed. In effort to identify valid treatment strategies for LLL, we performed a systematic review, identifying studies describing HRQOL outcomes in patients with LLL secondary to cancer.
Methods and Results
Seven medical databases were searched to identify reports using validated Patient Reported Outcome (PRO) instruments on patients with cancer-related LLL. Studies were classified by levels of evidence set by the Agency for Healthcare Research and Quality (AHRQ) and evaluated using the Efficace criteria. 25 studies were identified, 6 met inclusion criteria. Levels of evidence included: no level I studies, level II (n=3), level III (n=1), and level 4 (n=2). 50% of studies were compliant with the Efficace criteria. 5 PRO HRQOL instruments were used, but only 1 was specific to cancer-related lymphedema. Treatment strategies assessed included complete decongestive physiotherapy (CDP), exercise, and compression bandaging. CDP yielded significant enhancements in HRQOL.
There is a deficit in high quality studies for HRQOL in patients with LLL secondary to cancer. Furthermore, of the studies present, most did not conform to guidelines set for assessment of HRQOL, nor did they use lymphedema condition specific PRO instruments. New measures specific to assessing LLL are necessary to gain more accurate evaluation of how this debilitating disorder affects HRQOL.
Lymphedema following breast cancer surgery remains a common and feared treatment complication. Accurate information on health-related quality of life (HRQOL) outcomes among patients with lymphedema is critically needed to inform shared medical decision making and evidence-based practice in oncologic breast surgery. Our systematic review aimed to (1) identify studies describing HRQOL outcomes in breast cancer-related lymphedema (BCRL) patients, (2) assess the quality of these studies, and (3) assess the quality and appropriateness of the patient-reported outcome (PRO) instruments used.
Using the PRISMA statement, we performed a systematic review including studies describing HRQOL outcomes among BCRL patients. Studies were classified by levels of evidence and fulfillment of the Efficace criteria. PRO instruments were assessed using the COSMIN criteria.
Thirty-nine studies met inclusion criteria, including 8 level I and 14 level II studies. Sixteen of 39 studies were compliant with the Efficace criteria. Seventeen HRQOL instruments were used, two specific to lymphedema patients. Exercise and complex decongestive therapy treatment interventions were associated with improved HRQOL.
High-quality data on HRQOL outcomes is required to inform surgical decisions for breast cancer management and survivors. Of the lymphedema-specific PRO instruments, the Upper Limb Lymphedema 27 (ULL-27) was found to have strong psychometric properties. Future studies should strive to use high-quality condition-specific PRO instruments, follow existing guidelines for HRQOL measurement and to consider economic burdens of BCRL.
Implications for Cancer Survivors
As lymphedema may develop many years after breast cancer surgery, the ULL-27 may offer greater content validity for use in survivorship research.
Lymphedema; Breast cancer; Quality of life
Lymphedema; Prevention; evidence based medicine; venipuncture; weight loss; exercise; air travel; heat
The risk of post-operative bleeding is the chief concern expressed by plastic surgeons who do not use pharmacologic prophylaxis against venous thromboembolism (VTE). The Plastic Surgery Foundation-funded Venous Thromboembolism Prevention Study (VTEPS) examined whether receipt of post-operative enoxaparin prophylaxis changed rates of 60-day re-operative hematoma.
In 2009, VTEPS Network sites uniformly adopted a “best practice” clinical protocol to provide post-operative enoxaparin prophylaxis to adult plastic surgery patients at risk for peri-operative VTE. VTEPS historic control patients (2006–2008) received no chemoprophylaxis for 60 days after surgery. Retrospective chart review identified demographic and surgery-specific risk factors that potentially contributed to bleeding risk. The primary study outcome was 60-day re-operative hematoma. Stratified analyses examined re-operative hematoma in the overall population and among high-risk patients. Multivariable logistic regression controlled for identified confounders.
Complete data were available for 3,681 patients (2,114 controls and 1,567 enoxaparin patients). Overall, post-operative enoxaparin did not change the rate of re-operative hematoma when compared to controls (3.38% vs. 2.65%, p=0.169). Similar results were seen in subgroup analyses for breast reconstruction (5.25% vs. 4.21%, p=0.737), breast reduction (7.04% vs. 8.29%, p=0.194), or non-breast plastic surgery (2.20% vs. 1.46%, p=0.465). In the regression model, independent predictors of re-operative hematoma included breast surgery, microsurgical procedure, and post-bariatric body contouring. Receipt of post-operative enoxaparin was not an independent predictor (OR 1.16, 95% CI 0.77–1.76).
Post-operative enoxaparin does not produce a clinically relevant or statistically significant increase in observed rates of re-operative hematoma. Independent predictors for re-operative hematoma include breast surgery, post-bariatric body contouring, and microsurgical procedure.
Level of Evidence
III (retrospective cohort study)
The Skin Products Assessment Research (SPAR) Committee was created by the Plastic Surgery Educational Foundation (PSEF) in 2006. SPAR study aims were to (1) develop an infrastructure for PSEF-conducted, industry sponsored research in facial aesthetic surgery and (2) test the research process by comparing outcomes of the Obagi Nu-Derm System (ONDS) versus conventional therapy as treatment adjuncts for facial resurfacing procedures.
The SPAR study was designed as a multi-center, double-blind, randomized controlled trial (RCT). The study was conducted in women with Fitzpatrick type I-IV skin, moderate to severe facial photo damage, and peri-ocular and/or peri-oral fine wrinkles. Patients underwent chemical peel or laser facial resurfacing and were randomized to ONDS or a standard care regimen. The study endpoints were time to re-epithelization, erythema, and pigmentation changes.
Fifty-six women were enrolled and 82% were followed beyond re-epithelization. There were no significant differences in mean time to re-epithelialization between ONDS and control groups. The ONDS group had a significantly higher median erythema score on day of surgery (after 4 weeks of product use) which did not persist after surgery. Test-retest photo evaluations demonstrated that both inter- and intra-rater reliability were adequate for primary study outcomes.
In a clinical RCT, we demonstrated no significant difference in time to re-epithelization between patients who used the ONDS or a standard care regimen as an adjunct to facial resurfacing procedures. The SPAR research team has also provided a discussion of future challenges for PSEF sponsored clinical research for readers of this article.
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.
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.
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.
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.
Introduction: Various techniques have been used in an attempt to achieve long-term nipple projection following nipple-areolar reconstruction. A common setback, however, is the diminution of projection overtime; this phenomenon is particularly evident following implant-based breast reconstruction. Artecoll may be suitable for injection into the nipple complex to maintain permanent, 3-dimensional projection. Artecoll is an injectable substance that is biocompatible and immunologically inert and resists degradation in vivo. The purpose of this study was thus to prospectively evaluate the efficacy of Artecoll (polymethylmethacrylate microspheres suspended in 3.5% denatured bovine collagen with 0.3% lidocaine) in obtaining and maintaining nipple projection following postmastectomy, nipple-areolar reconstruction. Methods: A prospective, clinical trial was performed. Consecutive patients deemed to have inadequate nipple projection at least 6 months following “C-V flap” or “modified-skate flap” reconstruction were identified. Only women who had postmastectomy reconstruction with tissue expanders and implants were considered eligible for participation. Artecoll was injected under the nipple at 2 time points: baseline and 3 months. Calipers were used to measure nipple projection preinjection and postinjection at baseline, 3, 6, and 9 months. Results: Thirty-three nipples were injected in 23 patients. There were no adverse events. Prior to injection, mean nipple projection was 1.33 ± 1.0 mm. The mean increase in projection over the 9-month study period was both clinically and statistically significant (1.60 ± 1.24 mm; P <.001). A history of prior irradiation was a significant negative predictor of final nipple projection (P = .012). Conclusion: Artecoll injection is both feasible and effective in increasing and maintaining nipple projection in the setting of implant-based breast reconstruction.
In cosmetic and reconstructive breast surgery, measurement of patient-reported outcomes has become increasingly important to research efforts and clinical care. We aimed to describe how breast conditions and breast surgery impact on patient satisfaction and quality of life.
We conducted qualitative, in-depth interviews with 48 women who had undergone either breast reduction (n = 15), breast augmentation (n = 12), or breast reconstruction (n = 21) surgery in order to begin to build a theoretical understanding of patient satisfaction and quality of life in breast surgery patients. Interviews were audio-taped, transcribed verbatim and analyzed thematically.
The patient interviews revealed that breast conditions and breast surgery impact women in the following six main areas: satisfaction with breasts; satisfaction with overall outcome; psychosocial well-being; sexual well-being; physical well-being; and satisfaction with the process of care. We used these six themes to form the basis of a conceptual framework of patient satisfaction and quality of life in women who undergo breast surgery.
Our conceptual framework establishes the main issues of concern for breast surgery patients. This new framework can be used to help develop local guidelines for future clinical assessment, management and measurement, establish the validity of the current management strategies, and develop evidence-based guidance for the development of new patient reported outcome measures for future outcomes research.
The highest rates of cervical cancer are found in developing countries. Frontline monitoring has reduced these rates in developed countries and present day screening programs primarily identify precancerous lesions termed cervical intraepithelial neoplasias (CIN). CIN lesions described as mild dysplasia (CIN I) are likely to spontaneously regress while CIN III lesions (severe dysplasia) are likely to progress if untreated. Thoughtful consideration of gene expression changes paralleling the progressive pre invasive neoplastic development will yield insight into the key casual events involved in cervical cancer development.
In this study, we have identified gene expression changes across 16 cervical cases (CIN I, CIN II, CIN III and normal cervical epithelium) using the unbiased long serial analysis of gene expression (L-SAGE) method. The 16 L-SAGE libraries were sequenced to the level of 2,481,387 tags, creating the largest SAGE data collection for cervical tissue worldwide. We have identified 222 genes differentially expressed between normal cervical tissue and CIN III. Many of these genes influence biological functions characteristic of cancer, such as cell death, cell growth/proliferation and cellular movement. Evaluation of these genes through network interactions identified multiple candidates that influence regulation of cellular transcription through chromatin remodelling (SMARCC1, NCOR1, MRFAP1 and MORF4L2). Further, these expression events are focused at the critical junction in disease development of moderate dysplasia (CIN II) indicating a role for chromatin remodelling as part of cervical cancer development.
We have created a valuable publically available resource for the study of gene expression in precancerous cervical lesions. Our results indicate deregulation of the chromatin remodelling complex components and its influencing factors occur in the development of CIN lesions. The increase in SWI/SNF stabilizing molecule SMARCC1 and other novel genes has not been previously illustrated as events in the early stages of dysplasia development and thus not only provides novel candidate markers for screening but a biological function for targeting treatment.
Skull-base tumor resection and reconstruction produce a major physiologic and anatomic impact on the patient. At our institution, the use of vascularized, free-tissue transfer has replaced pedicled flaps as the preferred modality for reconstructing complex cranial base defects involving resection of dura, brain, or multiple major structures adjacent to skull base, including the orbit, palate, mandible, skin, and other structures. The goals of reconstruction are to: (1) support the brain and orbit; (2) separate the CNS from the aerodigestive tract; (3) provide lining for the nasal cavity; (4) re-establish the nasal and oropharyngeal cavities; (5) provide volume to decrease dead space; and (6) restore the three-dimensional appearance of the face and head with bone and soft tissues. Surgical management requires a multidisciplinary effort with collaborating neurosurgical, head and neck, and plastic surgical teams. Successful reconstruction of skull base defects is predicated upon a careful appreciation of the specific region. Defects may be classified based on their anatomic location and loss of volume, support, and skin cover. Free flaps provide reliable, well-vascularized soft tissue to seal the dura, obliterate dead space, cover exposed cranial bone, and provide cutaneous coverage for skin or mucosa.
Skull base; reconstruction; microvascular free flaps; classification
Breast reconstruction with tissue expanders and implants offers patients satisfying aesthetic results with no donor site morbidity. This article provides a practical guide for successful reconstruction using current techniques and available devices. Preoperative planning is discussed, emphasizing close collaboration with medicial and surgical oncology colleagues. Special concerns regarding adjuvant radiation are also addressed. Intraoperative techniques that optimize the final result are presented, along with a reliable and reasoned approach to the management of complications. Following these guidelines, aesthetically pleasing results with few complications can be obtained consistently.
Breast reconstruction; tissue expanders; breast implants; breast cancer