Human Factors Validation of the AeroForm Tissue Expander System for Breast Reconstruction.

The tissue expansion process using traditional saline expanders is lengthy and uncomfortable. A new technology has been developed, providing a needle-free option implanted after a mastectomy, and is activated by a handheld remote control releasing small amounts (10 cc) of carbon dioxide from an internal reservoir. The expander is gradually filled with CO2 resulting in mechanical stretching of the overlying tissue. The AeroForm System has been evaluated in a series of clinical trials including a randomized, controlled U.S. study comparing the AeroForm System with saline expanders. Results demonstrated patients can safely and reliably dose and complete their expansions in half the time compared to saline expanders. A human factors validation study was conducted in 8 patients to evaluate whether patients could correctly use the device to complete their expansion at home. The sessions were recorded and data on performance, behavioral, and subjective measures were collected and analyzed and submitted to the FDA as part of the U.S. marketing approval. All 8 participants were successful in using the controller to deliver a simulated dose. Participants found the device easy to use and the training material provided adequate to understand use of the controller. For women who choose 2-stage breast reconstruction, a new safe and effective option is available for tissue expansion, offering a convenient and empowering alternative. The human factors validation study conducted confirmed the simplicity of the device and further validated that the device can be used safely and effectively for breast tissue expansion.

A 2-year progress report of the AACAP-Harvard Macy Teaching Scholars Program.

OBJECTIVE: The American Academy of Child and Adolescent Psychiatry (AACAP) has partnered with the Harvard Macy Program for Healthcare Educators so that selected child and adolescent psychiatry academic faculty might enhance their teaching expertise in order to possibly enhance recruitment of medical students into child and adolescent psychiatry. METHODS: Thirteen child psychiatry faculty have graduated from the AACAP-Harvard Macy Teaching Scholars Program (HMTSP). There are 10 additional child and adolescent psychiatry faculty members in the process of completing the program. A survey was created to broadly assess the effect of the AACAP-HMTSP training on the first 13 graduates of the program as a pilot to guide future study of the program. Three teaching scholars who are the first authors of this article (JH, DS, MH) conducted this survey and the data interpretation for this study. RESULTS: Thirteen of the scholars submitted responses to the survey. All participants indicated a high degree of satisfaction with the HMTSP and with the overall usefulness of the concepts learned. All but one of the scholars reported that the program enhanced their teaching effectiveness. The scholars reported increased teaching of medical students (9 of 13) and psychiatry residents (6 of 13) after the HMTSP. CONCLUSION: The AACAP-Harvard Macy Teaching Scholars reported high levels of satisfaction with the overall program. Whether the reported increase in medical student and psychiatry resident mentoring and teaching will eventually lead to increased medical student recruitment into child and adolescent psychiatry remains to be determined.

Prognosis 30 years after temporal lobectomy.

To assess the long-term outcome after temporal lobectomy, the authors obtained information from 48 patients and families traced though the NIH Medical Records Department, Social Security, National Death Indices, and other sources. Preoperative evaluation, limited by current standards, was based mainly on interictal surface EEG. After a mean 29.9-year follow-up, 24 were seizure free, and 10 had died. Early seizure recurrence and invasive EEG studies predicted worse long-term outcome.

Ophtec iris reconstruction lens United States clinical trial phase I.

PURPOSE: To determine the safety and efficacy of the Ophtec model 311 iris reconstruction lens for treatment of visual disturbances, such as glare or photophobia, related to partial or total absence of the human iris. DESIGN: Phase I multicenter, nonrandomized, investigational device study. PARTICIPANTS: Ten iris reconstruction lenses were placed in 10 subjects at 6 sites. METHODS: Iris reconstruction lenses were placed in 9 patients who had lost all or part of their iris from trauma and in 1 patient who lacked iris pigmentation due to congenital albinism. Patients were examined preoperatively, intraoperatively, and postoperatively at day 1; week 1; and months 1, 3, 6, and 12. MAIN OUTCOME MEASURES: Efficacy measures were uncorrected visual acuity (UCVA), glare, starbursts, and photophobia. Safety measures were best-corrected visual acuity (VA), surgical complications, and adverse events. RESULTS: Uncorrected VA improved in all eyes after implantation of the iris reconstruction lens. Best-corrected VA did not change significantly (P = 0.24). Postoperative photophobia was reduced in all 9 eyes that experienced moderate to severe preoperative photophobia. Likewise, postoperative glare was reduced in all 6 eyes with moderate to severe preoperative glare. There were no surgical complications. Adverse events included 2 cases of iritis and 1 case of macular edema. CONCLUSIONS: Preliminary results suggest that the Ophtec model 311 iris reconstruction lens can improve UCVA and reduce glare and photophobia in patients with partial or total absence of the iris or iris pigmentation.

Environmental sampling for spores of Bacillus anthracis.

On November 11, 2001, following the bioterrorism-related anthrax attacks, the U.S. Postal Service collected samples at the Southern Connecticut Processing and Distribution Center; all samples were negative for Bacillus anthracis. After a patient in Connecticut died from inhalational anthrax on November 19, the center was sampled again on November 21 and 25 by using dry and wet swabs. All samples were again negative for B. anthracis. On November 28, guided by information from epidemiologic investigation, we sampled the site extensively with wet wipes and surface vacuum sock samples (using HEPA vacuum). Of 212 samples, 6 (3%) were positive, including one from a highly contaminated sorter. Subsequently B. anthracis was also detected in mail-sorting bins used for the patient's carrier route. These results suggest cross-contaminated mail as a possible source of anthrax for the inhalational anthrax patient in Connecticut. In future such investigations, extensive sampling guided by epidemiologic data is imperative.