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author:("music, Andrea")
1.  Systematic Review of Quality of Life and Patient Reported Outcomes in Patients with Oncologic Related Lower Extremity Lymphedema 
Lymphatic Research and Biology  2013;11(1):14-19.
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.
PMCID: PMC3654818  PMID: 23531180
2.  Quality of life among breast cancer patients with lymphedema: a systematic review of patient-reported outcome instruments and outcomes 
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.
PMCID: PMC3683656  PMID: 23212603
Lymphedema; Breast cancer; Quality of life
3.  Preventative measures for lymphedema: Separating fact from fiction 
PMCID: PMC3652571  PMID: 21802319
Lymphedema; Prevention; evidence based medicine; venipuncture; weight loss; exercise; air travel; heat
4.  The effect of post-operative enoxaparin on risk for re-operative hematoma 
Plastic and reconstructive surgery  2012;129(1):160-168.
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.
Clinical Question
Level of Evidence
III (retrospective cohort study)
PMCID: PMC3246075  PMID: 21915085
5.  A Randomized Controlled Trial of Skin Care Protocols for Facial Resurfacing: Lessons Learned from the Plastic Surgery Educational Foundation’s Skin Products Assessment Research Study 
Plastic and reconstructive surgery  2011;127(3):1334-1342.
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.
PMCID: PMC3079206  PMID: 21364435
6.  Validation of the Caprini Risk Assessment Model in Plastic and Reconstructive Surgery Patients 
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.
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.
PMCID: PMC3052944  PMID: 21093314
7.  The Efficacy of Artecoll Injections for the Augmentation of Nipple Projection in Breast Reconstruction 
Eplasty  2010;10:e7.
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.
PMCID: PMC2848402  PMID: 20360871
8.  Satisfaction and quality of life in women who undergo breast surgery: A qualitative study 
BMC Women's Health  2009;9:11.
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.
PMCID: PMC2685365  PMID: 19409078
9.  Up regulation in gene expression of chromatin remodelling factors in cervical intraepithelial neoplasia 
BMC Genomics  2008;9:64.
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.
PMCID: PMC2277413  PMID: 18248679
10.  Microvascular Reconstruction of the Skull Base: A Clinical Approach to Surgical Defect Classification and Flap Selection 
Skull Base  2007;17(1):5-15.
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.
PMCID: PMC1852578  PMID: 17603640
Skull base; reconstruction; microvascular free flaps; classification
11.  Breast Reconstruction with Tissue Expanders and Implants: A Practical Guide to Immediate and Delayed Reconstruction 
Seminars in Plastic Surgery  2004;18(2):71-77.
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.
PMCID: PMC2884731  PMID: 20574485
Breast reconstruction; tissue expanders; breast implants; breast cancer

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