Contribution of age and gender to outcome of blunt splenic injury in adults: multicenter study of the eastern association for the surgery of trauma.

BACKGROUND: The purpose of this study was to examine the contribution of age and gender to outcome after treatment of blunt splenic injury in adults. METHODS: Through the Multi-Institutional Trials Committee of the Eastern Association for the Surgery of Trauma (EAST), 1488 adult patients from 27 trauma centers who suffered blunt splenic injury in 1997 were examined retrospectively. RESULTS: Fifteen percent of patients were 55 years of age or older. A similar proportion of patients > or = 55 went directly to the operating room compared with patients < 55 (41% vs. 38%) but the mortality for patients > or = 55 was significantly greater than patients < 55 (43% vs. 23%). Patients > or = 55 failed nonoperative management (NOM) more frequently than patients < 55 (19% vs. 10%) and had increased mortality for both successful NOM (8% vs. 4%, p < 0.05) and failed NOM (29% vs. 12%, p = 0.054). There were no differences in immediate operative treatment, successful NOM, and failed NOM between men and women. However, women > or = 55 failed NOM more frequently than women < 55 (20% vs. 7%) and this was associated with increased mortality (36% vs. 5%) (both p < 0.05). CONCLUSION: Patients > or = 55 had a greater mortality for all forms of treatment of their blunt splenic injury and failed NOM more frequently than patients < 55. Women > or = 55 had significantly greater mortality and failure of NOM than women < 55.     

Endometrial morphology in asymptomatic postmenopausal women

Few data are available regarding endometrial histologic features in asymptomatic perimenopausal and postmenopausal women. This study encompasses endometrial biopsy specimens obtained from 801 such women before enrollment in a multicenter study of estrogen-progestin replacement. One endometrial cancer was found (0.13%); four additional biopsy specimens showed atypia (total 0.63%). The endometrium was atrophic in 373 (46.9%), proliferative in 133 (16.7%), secretory in 54 (6.8%), and hyperplastic in 41 (5.2%). Insufficient tissue for diagnosis was obtained in 195 (24.5%). We conclude that the yield for neoplasia is so low that screening endometrial biopsy is not justified in asymptomatic perimenopausal and postmenopausal women.     

Dose-related distribution of codeine, cocaine, and metabolites into human hair following controlled oral codeine and subcutaneous cocaine administration

Hair testing for the determination of drug exposure has many useful applications. Drug incorporated into hair can be found for extended periods following drug exposure. There are few controlled drug administration studies investigating drug distribution into human hair. Ten volunteers participated in a 10-week controlled cocaine and codeine administration study while residing in the secure research ward. Weekly hair samples were collected by electric razor. During the low-dose week (week 4), volunteers received 75 mg/70 kg cocaine subcutaneously and 60 mg/70 kg codeine orally on alternating days, a total of three doses for each drug. Similarly, during week 7, volunteers received three doses 150 mg/70 kg cocaine and 120 mg/70 kg codeine. Maximum hair concentrations (C(max)) were found 1 to 3 weeks after low and high doses. Dose-related C(max) values of cocaine, benzoylecgonine, ecgonine methyl ester, norcocaine, cocaethylene, and codeine were found following low and high doses. Hair analysis was performed using liquid chromatography tandem mass spectrometry. A positive linear relationship was found between total melanin content of hair and C(max) of codeine, cocaine, and metabolites following high dosing. This study demonstrated dose-related concentrations of cocaine and metabolites in human hair following controlled cocaine administration. These data are the first demonstrating melanin-related incorporation of cocaine and metabolites into human hair following controlled cocaine administration.     

Are US informed consent requirements driving resuscitation research overseas?

Following a 2-year federally imposed moratorium on acute resuscitation research due to concern regarding the inability of patients in cardiac arrest to provide prospective, informed consent to participate in such research, the United States federal government in 1996 released regulations with provisions for exemption of prospective informed consent in certain types of emergency research. While very few acute resuscitation research studies have been attempted in the United States since that time, such research has continued overseas. We discuss one large multi-center, out-of-hospital trial of a device intended to improve the hemodynamics of cardiopulmonary resuscitation. After pilot implementation overseas, this trial could not be conducted in the United States, largely due to the difficulties and costs involved in implementing the requirements of the 1996 regulations. A recent European Union directive on the conduct of clinical trials may halt European research on patients who are unable to provide prospective, informed consent. The directive contains no provisions for exceptions or waiver of informed consent, and may hinder acute resuscitation research in Europe to an even greater degree than the 1996 regulations have in the United States.     

Low-bandwidth telemedicine for pre- and postoperative evaluation in mobile surgical services

Low-bandwidth telemedicine was used for the pre- and postoperative evaluation of patients treated by a mobile surgery service in remote Ecuador. Realtime and store-and-forward telemedicine was employed, using PCs connected via the ordinary telephone network. Between February 2002 and July 2003, 144 patients were studied preoperatively and 50 postoperatively. It was possible to establish 20 satisfactory preoperative realtime connections, which allowed good-quality, simultaneous audiovisual transmission. Thus, there were 124 preoperative assessments done by store-and-forward telemedicine and 50 postoperative assessments. Diagnoses and management plans made by a surgeon using telemedicine were compared with those made independently by a second surgeon, who saw the patient face to face. Due to poor quality of the transmitted images, 43 patients were excluded from the preoperative study and 13 from the postoperative study. In the 101 preoperative evaluations, there was agreement in 78 cases (77%); in the 37 postoperative evaluations, there was agreement in 36 cases (97%). Telemedicine may reduce the time required on site for preoperative planning, and may provide reliable postoperative surveillance, thus improving the efficiency of mobile surgery services.