Constance M. Chen

Measuring quality of life in cosmetic and reconstructive breast surgery: a systematic review of patient-reported outcomes instruments.

Background: Patient-reported outcomes in cosmetic and reconstructive breast surgery are increasingly important for clinical research endeavors. Traditional surgical outcomes, centered on morbidity and mortality, remain important but are no longer sufficient on their own. Quality of life has become a crucial research topic augmenting traditional concerns focused on complications and survival. Given this, reliable and valid patient questionnaires are essential for aesthetic and reconstructive breast surgeons. Methods: The authors performed a systematic literature review to identify patient-reported outcome measures developed and validated for use in cosmetic and reconstructive breast surgery patients. Qualifying instruments were assessed for adherence to international guidelines for health outcomes instrument development and validation. Results: The authors identified 227 health outcomes questionnaires used in breast surgery studies. After 135 generic instruments, 65 ad hoc instruments, seven oncologic instruments, 11 education questionnaires, and two non-English-language questionnaires were excluded, seven measures remained. Detailed analysis revealed that six of the seven measures had undergone limited development and validation. Only one measure, the Breast-Related Symptoms Questionnaire, demonstrated adequate development and validation in its target population. It had, nevertheless, significant content limitations. Conclusions: Valid, reliable, and responsive instruments to measure patient-reported outcomes in cosmetic and reconstructive breast surgery are lacking. To demonstrate the benefits of aesthetic and reconstructive breast surgery, future research to rigorously develop and validate new cosmetic and reconstructive breast surgery-specific instruments is needed.

Measuring Quality of Life in Oncologic Breast Surgery: A Systematic Review of Patient‐Reported Outcome Measures

Abstract:  Multiple randomized trials demonstrate equivalent survival between BCT and mastectomy, but clinical outcomes research must also evaluate patient satisfaction and quality of life. This review analyzes existing patient‐reported outcome (PRO) measures in oncologic breast surgery to assess utility and make recommendations for future research. We performed a systematic literature review to identify PRO measures used in oncologic breast surgery patients. After applying inclusion and exclusion criteria, qualifying instruments were assessed for adherence to international guidelines for health outcomes instrument development and validation. Ten measures underwent development and psychometric evaluation in an oncologic breast surgery population. Five of ten measures (EORTC QLQ BR‐23, FACT‐B, HBIS, BIBCQ, and BREAST‐Q) reported an adequate development and validation process. Three of these 5 measures (EORTC QLQ BR‐23, FACT‐B, HBIS) focused on non‐surgical treatment issues. A fourth instrument (BIBCQ) did not address aesthetic concerns after breast reconstruction. The fifth instrument (BREAST‐Q) was developed for use in patients undergoing mastectomy ± reconstruction, but did not address breast‐conserving therapy. Overall, two key limitations were noted: 1) surgery‐specific issues of breast‐conserving surgery patients were not well represented and 2) measures were largely developed without the aid of newer psychometric methods that may improve their clinical utility. Reliable and valid PRO measures in breast cancer patients exist, but even the best instruments do not address all important surgery‐specific and psychometric issues of oncologic breast surgery patients. Newer psychometric methods would facilitate development of scales for use in individual patient care as well as group level comparisons.

Reconstruction of extremity long bone defects after sarcoma resection with vascularized fibula flaps: a 10-year review.

Background: Limb-sparing wide excision has become as effective as amputation in treating extremity sarcoma. Limb reconstruction has traditionally involved allografting. The authors evaluated reconstruction of extremity long bone defects after tumor resection using fibula free flaps. Methods: A retrospective chart review (1991 to 2002) was performed of 25 consecutive patients at Memorial Sloan-Kettering Cancer Center who underwent reconstruction with free fibula flaps after limb-sparing resection of extremity sarcomas. Timing of reconstruction, complications, metastasis, survival, bone union, and functional outcome were analyzed. Functional assessment was based on the 1987 Musculoskeletal Tumor Society Score/Enneking classification. Results: Twenty-five patients (14 male patients and 11 female patients) were treated. Osteosarcoma (n = 8), Ewing’s sarcoma (n = 8), and chondrosarcoma (n = 6) accounted for the majority of the cases. Reconstructed areas included tibia (n = 9), radius (n = 5), humerus (n = 6), femur (n = 4), and ulna (n = 1). All flaps survived (100 percent). One patient required emergent reexploration (4 percent), one suffered partial flap skin loss (4 percent), and three experienced postoperative infections (12 percent). In patients followed over 6 months, uncomplicated bony union was achieved in 11 of 14 patients (78 percent). After secondary procedures, bony union was ultimately achieved in 13 of 14 patients (93 percent), all of whom had good functional outcomes. Eight patients suffered local recurrences or metastases (32 percent); six died during the study period. Conclusions: The microvascular free fibula flap has a lower infection rate than traditional allograft reconstruction. There is a high rate of bone union, and functional outcome is good. Thus, the authors recommend the microvascular fibula transfer as the technique of choice for reconstructing large, complex long bone defects resulting from tumor extirpation.

The effect of postoperative anticoagulation on microvascular thrombosis.

Background:Numerous protocols exist to prevent thrombosis after free-tissue transfer. Many surgeons advocate using aspirin or other antiplatelet agents, but little objective evidence supports this practice. This study evaluates the rate of microvascular thrombosis in patients undergoing free-tissue transfer treated with or without antiplatelet agents. Methods:All consecutive free flaps from 2002–2005 at a single center were reviewed using a prospectively maintained database. Patients were in 2 groups based on postoperative anticoagulation administration. In group 1, 325 mg of aspirin was administered daily for 5 days postoperatively. In group 2, patients were treated with 5000 units of low-molecular-weight heparin (LMWH) per day until ambulating. Patient demographics, procedure type, diagnosis, adjuvant treatment, and procedure type were recorded. Outcome variables included microvascular thrombosis, partial or total flap loss, hematoma, bleeding, deep venous thrombosis (DVT), pulmonary embolism, and death. Results:Four hundred seventy patients underwent 505 microvascular free flaps to reconstruct oncologic defects. Two hundred sixty flaps (group A) received postoperative aspirin therapy; 245 flaps (group B) received LMWH therapy. Both groups were statistically similar in their composition. No statistically significant difference was noted between the 2 groups when comparing outcome variables including microvascular thrombosis, partial or total flap loss, hematoma, bleeding, DVT, pulmonary embolism, and death. Conclusions:Postoperative anticoagulation choice has no statistically significant effect on the incidence of free flap complications, including bleeding, thromboembolism, and flap loss. We conclude that aspirin or LMWH therapy demonstrates equivalent outcomes when used as single-agent postoperative anticoagulation in oncologic free flap reconstruction.

A 15-year review of midface reconstruction after total and subtotal maxillectomy: part I. Algorithm and outcomes.

Background: Reconstruction of complex midfacial defects is best approached with a clear algorithm. The goals of reconstruction are functional and aesthetic. Methods: Over a 15-year period (1992 to 2006), a single surgeon (P.G.C.) performed 100 flaps to reconstruct the following midfacial defects: type I, limited maxillectomy (n = 20); type IIA, subtotal maxillectomy with resection of less than 50 percent of the palate (n = 8); type IIB, subtotal maxillectomy with resection of greater than 50 percent of the palate (n = 8); type IIIA, total maxillectomy with preservation of the orbital contents (n = 22); type IIIB, total maxillectomy with orbital exenteration (n = 23); and type IV, orbitomaxillectomy (n = 19). Free flaps were used in 94 cases (94 percent), and pedicled flaps were used in six (6 percent). Results: One hundred flaps were performed in 96 patients (69 males, 72 percent; 27 females, 28 percent); four patients underwent a second flap reconstruction due to recurrent disease (n = 4, 4 percent). Average patient age was 49.2 years (range, 13 to 81 years). Free-flap survival was 100 percent, with one partial flap loss (1 percent). Five patients suffered systemic complications (5.2 percent), and four died within 30 days of hospitalization (4.2 percent). Over 50 percent of patients returned to normal diet and speech. Almost 60 percent were judged to have an excellent aesthetic result. Conclusions: Free-tissue transfer offers the most effective and reliable form of reconstruction for complex maxillectomy defects. Rectus abdominis and radial forearm free flaps in combination with immediate bone grafting or as osteocutaneous flaps consistently provide the best functional and aesthetic results. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

A systematic review of patient-reported outcome measures in head and neck cancer surgery.

Objective To identify, summarize, and evaluate patient-reported outcome questionnaires for use in head and neck cancer surgery with the view to making recommendations for future research. Data Sources A systematic review of the English-language literature, with the use of head-and-neck-surgery-specific keywords, was performed in the following databases: Medline, Embase, HAPI, CINAHL, Science/Social Sciences Citation Index, and PsycINFO from 1966 to March 2006. Data Extraction and Study Selection All English-language instruments identified as patient-reported outcome questionnaires that measure quality of life and/or satisfaction that had undergone development and validation in a head and neck cancer surgery population were included. Data Synthesis Twelve patient-reported outcome questionnaires fulfilled our inclusion criteria. Of these, four were developed from expert opinion alone or did not have a published development process and seven questionnaires lacked formal item reduction. Only three questionnaires (EORTC Head and Neck Module, University of Michigan Head and Neck Quality-of-life Questionnaire, and Head and Neck Cancer Inventory) fulfilled guidelines for instrument development and evaluation as outlined by the Medical Outcomes Trust. Conclusions Rigorous instrument development is important for creating valid, reliable, and responsive disease-specific questionnaires. As a direction for future instrument development, an increased focus on qualitative research to ensure patient input may help to better conceptualize and operationalize the variables most relevant to head and neck cancer surgery patients. In addition, the use of alternative methods of psychometric data analysis, such as Rasch, may improve the value of health measurement in clinical practice for individual patients.

Is the use of intraoperative heparin safe

Background: Despite the reliability of microvascular free tissue transfer, flap loss remains a significant concern. To improve outcome, various pharmacologic agents have been used to prevent microvascular thrombosis. The authors review their experience with intraoperative heparin therapy, specifically addressing the risks of hematoma, pedicle thrombosis, and flap loss rate. Methods: Results from consecutive free flaps performed over a 3-year period were reviewed using a prospectively maintained database. Patients were divided into two groups: group A received a bolus of 3000 units of intraoperative heparin 10 minutes before flap pedicle ligation; group B did not receive intraoperative heparin. Patient demographics, procedure type, diagnosis, adjuvant treatment, and complications were recorded. Outcome variables included microvascular thrombosis, total and partial flap loss, hematoma, seroma, pulmonary embolism, and death. Results: Four hundred seventy patients underwent 505 microvascular free flaps for reconstruction of oncologic defects. Reconstructed areas included head and neck (n = 288), trunk and breast (n = 151), upper extremity (n = 12), and lower extremity (n = 19). Of these, 260 flaps (group A) received an intraoperative heparin bolus, and 245 flaps (group B) received no intraoperative heparin bolus. There were no statistically significant differences in major and minor complications between the two groups (power = 0.85). Conclusions: Intraoperative systemic heparin use has no statistically significant effect on the incidence of microvascular thrombosis. In addition, administration of a single dose of intraoperative heparin does not increase the rate of hematoma formation or prevent microvascular thrombosis. Thus, critical factors for flap survival are likely independent of the use of intraoperative anticoagulation.

The incidence of venous thromboembolism after oncologic head and neck reconstruction.

This study evaluates the incidence of symptomatic deep venous thrombosis and pulmonary embolism after head and neck reconstruction at a single tertiary care cancer center. From 1997 to 2006, 6,759 surgical procedures were performed. There were 1,591 head and neck reconstructions (n = 1,591) and 5,168 non-head and neck reconstructions (n = 5,168). Free flaps, regional flaps, and other procedures were included. Although the incidence of venous thromboembolism (VTE) was less than 1% in both patient populations, there was a significantly greater incidence of VTE among patients undergoing head and neck reconstruction than non-head and neck reconstruction (P < 0.05). When compared with patients undergoing non-head and neck reconstruction, patients undergoing oncologic head and neck procedures were older, underwent longer anesthesia times, spent more days in the hospital, and were more likely to need free flaps. When possible, appropriate prophylaxis against VTE in cancer patients under going head and neck reconstruction is recommended.

Simplifying the vertical reduction mammaplasty.

The vertical reduction mammaplasty is an evolving technique. Its proponents report significantly decreased scarring, better breast shape, and more stable results compared with the standard inverted-T method, but the learning curve is long and cosmetic outcomes can be inconsistent. Many surgeons have experimented with the vertical closure before returning to methods more familiar to them. The authors present their modifications to the vertical reduction mammaplasty. Their changes simplify the preoperative markings and the intraoperative technique to shorten the learning curve while maintaining reliable aesthetic results. With the patient standing, only four preoperative marks are made: (1) the inframammary fold; (2) the breast axis; (3) the apex of the new nipple-areola complex; and (4) the medial and lateral limbs of the vertical incision. In the operating room, a medial or a superomedial pedicle is developed. Excess breast skin is resected with the inferior and lateral parenchyma as a C-shaped wedge. The lateral skin-adipose flap is redraped inferomedially and sutured to the chest wall. The inferior aspect of the breast is aggressively debulked and a gathering subcuticular stitch is started 2 cm below the nadir of the nipple-areola complex. Finally, a 38-mm to 42-mm nipple-areola complex marker is used to create a circular defect that is offset 0.5 cm medial to the vertical axis of the breast. In their series, 56 patients were treated and no major complications were noted. The median follow-up period was 17 months. The average reduction was 554.5 g per breast; however, the reduction was greater than 1000 g per breast in eight patients. The authors found that (1) chest wall anchoring improves lateral contour and minimizes axillary fullness; (2) aggressive debulking inferiorly avoids the persistent inferior bulge; and (3) starting the subcuticular gathering suture 2 cm below the nipple-areola complex followed by placement of a nipple-areola complex marker at the conclusion of the case prevents lateral deviation and corrects the nipple-areola complex teardrop deformity. These innovations accelerate the learning curve by simplifying the preoperative markings and lead to more consistent postoperative results and an improved cosmetic outcome. In conclusion, these modifications yield a simple, easily learned vertical reduction mammaplasty with aesthetically reliable results.

A 15-year review of midface reconstruction after total and subtotal maxillectomy: part II. Technical modifications to maximize aesthetic and functional outcomes.

Background: Midface reconstruction of oncologic defects is one of the most challenging problems in plastic surgery. Over time, the senior author (P.G.C.) has developed modifications in his technique for oncologic midface reconstruction to minimize complications and maximize outcomes. Methods: Over a 15-year period (1992 to 2006), 100 flaps for midface oncologic reconstruction were performed at Memorial Sloan-Kettering Cancer Center. The first 50 flaps were performed from 1992 to 2000, and the second 50 flaps were performed from 2001 to 2006. Over time, technical improvements were made in the following areas: palate, dental implants and prosthesis, orbital floor, eyelid, nasal sidewall, lips, cranial base and dura, and pedicle anastomosis. Using a prospectively maintained database, the authors compared the functional and aesthetic outcomes of the first 50 flaps and the second 50 flaps. Results: Improvements in palatal reconstruction increased the proportion of patients who achieved normal speech from 38.9 percent in the first half of the series (1992 to 2000) to 50 percent in the second half of the series (2001 to 2006). The percentage of patients who were able to tolerate an unrestricted diet increased from 44.4 to 52 percent. The use of new methods to reconstruct the orbital floor also lowered the ectropion rate from 71.4 to 47.6 percent. The percentage of patients whose aesthetic results were judged as “excellent” increased from 12 to 58.6 percent. Conclusions: Over the last 15 years, the senior author has refined methods of midface reconstruction that have improved functional and aesthetic outcomes. These technical advancements have made it possible to obtain better and more consistent results. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.