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Parenteral and enteral nutrition support are key components of care for various medical and physiological conditions in infants, children, and adults. Nutrition support practices have advanced over time, driven by the goals of safe and sufficient delivery of needed nutrients and improved patient outcomes. These advances have been, and continue to be, dependent on research and development studies. Such studies address aspects of enteral and parenteral nutrition support: formulations, delivery devices, health outcomes, cost-effectiveness, and related metabolism. The studies are supported by public funding from the government and by private funding from foundations and from the nutrition support industry. To build public trust in nutrition support research findings, it is important to underscore ethical research conduct and reporting of results for all studies, including those with industry sponsors. In 2019, American Society for Parenteral and Enteral Nutrition's (ASPEN's) Board of Directors established a task force to ensure integrity in nutrition support research that is done as collaborative partnerships between the public (government and individuals) and private groups (foundations, academia, and industry). In this ASPEN Position Paper, the Task Force presents principles of ethical research to guide administrators, researchers, and funders. The Task Force identifies ways to curtail bias and to minimize actual or perceived conflict of interests, as related to funding sources and research conduct. Notably, this paper includes a Position Statement to describe the Task Force's guidance on Public-Private Partnerships for research and funding. This paper has been approved by the ASPEN Board of Directors., (© 2021 American Society for Parenteral and Enteral Nutrition.)

Background: The authors performed reexcision lumpectomy on patients with breast cancer with tumor at or close to the resection margin or if the margin status was unknown. Frozen section analysis (FSA) of reexcision lumpectomy margins was performed to allow additional excision of margins or mastectomy, saving the patient another operation or an additional radiation boost., Methods: The authors reviewed the accuracy of FSA of margins in 107 patients undergoing reexcision lumpectomy between 1987 and 1992. There were 359 frozen sections performed on 156 specimens. Sensitivity and specificity of FSA for each frozen section margin, specimen, and patient were evaluated, as was gross inspection of tumor involvement at the resection margins. The accuracy of each pathologist's use of FSA also was evaluated., Results: FSA sensitivity per frozen section margin, specimen, and patient was 0.90, 0.89, and 0.85, respectively. The specificity of gross inspection was 0.97, 0.96, and 0.96 (sensitivity, 0.44), which was significantly less accurate than that of FSA (P = 0.0015) or permanent section (P = 0.019). There was no significant discordance between FSA and permanent section. Of 19 pathologists doing FSA, 6 evaluated 10 or more specimens. The error rate ranged from 4% to 10% among pathologists with 10 or more readings, whereas 12 of 13 pathologists with fewer readings had no errors. The final pathologist had a 100% error rate, significantly worse (range, P = 0.0085-0.02) than any experienced pathologist. Thirty-four (32%) patients underwent additional excision (24 patients) or mastectomy (10 patients) based on the results of FSA, which saved the patients from undergoing another operation. No one required an additional operation or a mastectomy because of a false FSA result., Conclusion: FSA is safe and accurate in evaluating reexcision lumpectomy margins. Gross inspection is not reliable in margin evaluation. FSA saved an additional operation 32% of the time. Obtaining clear margins during one procedure eliminates the necessity of an additional radiation boost and probably will improve cosmesis.

Neoadjuvant therapy for locally advanced breast cancer improves disease control, but the complications of treatment are not well established. The aim of this study was to assess the operative morbidity in 20 consecutive patients with locally advanced, noninflammatory breast cancer treated with preoperative chemotherapy and radiation. Patients received preoperative cyclophosphamide, methotrexate, 5-fluorouracil, prednisone, and tamoxifen (CMFPT) to maximum response followed by concurrent chemotherapy and radiation to the involved breast and regional lymph nodes. Following modified radical mastectomy, chemotherapy was continued for a total of 10 cycles. Disease progressed in 3 of 20 patients (15%). Seventeen patients underwent mastectomy, 4 (24%) of whom demonstrated a pathologic complete response to chemoradiotherapy. Seven patients (41%) developed wound infections, 2 (12%) necrosis, 5 (29%) delayed healing, 2 (12%) upper extremity lymphedema, and 8 (47%) seromas. Postoperative chemotherapy was delayed in 4 (24%) patients. There was no mortality, and hospitalization was for less than 1 week. Only one patient required readmission. Although this treatment regimen is aggressive with attendant morbidity, complications are easily managed and generally do not delay therapy. Treatment modification to further reduce complications may be indicated.

Transrectal resection of rectal cancers with the use of the urologic resectoscope is a safe, controlled technique that allows good visualization with defined limits of excision. Twenty-three patients have undergone 50 transrectal resections, with a median survival of 10.8 months. Only 1 of 22 patients required subsequent colostomy before death. Patients, followed as long as 29 months, have had good local control of tumor and excellent palliation of symptoms.