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Hypothesis: Complications are common in hospitalized surgical patients. Provider error contributes to a significant proportion of these complications., Design: Surgical patients were concurrently observed for the development of explicit complications. All complications were reviewed by the attending surgeon and other members of the service and evaluated for the severity of sequelae (major or minor) and for whether the complication resulted from medical error (avoidable) or not., Setting: University teaching hospital with a level I trauma designation., Patients: All inpatients (operative or nonoperative) from 4 different surgical services: general surgery, combined general surgery and trauma, vascular surgery, and cardiothoracic surgery., Main Outcome Measures: Total complication rate (number of complications divided by the number of patients) and the number of patients with complications. Complications were separated into those with major or minor sequelae and the proportion of each type that were due to medical error (avoidable). Rates of complications in a recent Institute of Medicine report were used as a criterion standard., Results: The data for the respective groups (general surgery, vascular surgery, combined general surgery and trauma, and cardiothoracic surgery) are as follows. The number of patients was 1363, 978, 914, and 1403; number of complications, 413, 409, 295, and 378; total complication rate, 30.3%, 42.4%, 32.3%, and 26.9%; minor complication rate, 13.3%, 19.9%, 13.5%, and 13.0% (percentage of minor complications that were avoidable, 37.4%, 59.0%, 51.2%, and 49.5%); major complication rate, 16.2%, 21.1%, 18.1%, and 12.9% (percentage of major complications that were avoidable, 53.4%, 60.7%, 38.8%, and 38.7%); and mortality rate, 1.83%, 3.33%, 2.28%, and 3.34% (percentage of mortality that was avoidable, 28.0%, 44.1%, 19.0%, and 25.0%)., Conclusions: Despite mortality rates that compare favorably with national benchmarks, a prospective examination of surgical patients reveals complication rates that are 2 to 4 times higher than those identified in an Institute of Medicine report. Almost half of these adverse events were judged contemporaneously by peers to be due to provider error (avoidable). Errors in care contributed to 38 (30%) of 128 deaths. Recognition that provider error contributes significantly to adverse events presents significant opportunities for improving patient outcomes.

Objective: Recent experiments have shown that dietary soy isoflavones such as genistein can significantly suppress invasiveness and growth of a number of human malignancies. This study examined whether genistein, at a concentration typical of plasma levels following soy diet intake, in combination with 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU, carmustine) exhibited an additive or synergistic inhibitory effect on the growth of glioma cells., Methods: The human glioblastoma multiforme (GBM) cell line U87 and the rodent C6 glioma were treated with genistein at 4 microM, combined with BCNU (0-50 microM). Monolayer cell growth and cytotoxicity, as measured by colonigenic survival in soft agarose, were then compared in control and drug-treated cultures. Presence of apoptosis, using the DNA ladder assay and laser scanning cytometry (LSC), was investigated in all cell lines at those concentrations where an enhancement of antiproliferative effect of BCNU in presence of genistein was observed., Results: A 32-41% increase in monolayer growth inhibition and a 28-42% increase in colony cytotoxicity in the U87 cell line were observed when genistein (4 microM) was added to BCNU in the 0-10 microM dose range. In the C6 cell line, a 30-36% increase in monolayer growth inhibition and a 39-54% increase in colony cytotoxicity were observed with the BCNU dose range of 0-50 microM. All experiments showed a significant increase in growth inhibition and a decrease in colonogenic survival (P < 0.05). We were unable to detect apoptosis in any of the lines when genistein was combined with BCNU., Conclusion: These results indicate that genistein at typical adult dietary plasma levels can significantly enhance the antiproliferative and cytotoxic action of BCNU. The implication for treatment of GBM may be a reduction in the chemotherapeutic dose recommendations of these agents and subsequently a decrease in the risk of treatment sequelae for these patients.

Purpose: The purpose of this study was to use the Fecal Incontinence Severity Index to assess fecal incontinence after fistulotomy and to correlate the Fecal Incontinence Severity Index score with quality-of-life measures., Methods: A retrospective chart review was performed on consecutive patients undergoing fistulotomy by a single colon and rectal surgeon at a university hospital from 1991 to 1999. Demographics, fistula anatomy, surgical technique, and length of follow-up were recorded. Mailed questionnaires and telephone interviews were conducted to determine the Fecal Incontinence Severity Index score, pad usage, lifestyle restriction, and psychosocial factors. A linear regression model was used to determine the relationship of clinical factors with Fecal Incontinence Severity Index. One-way ANOVA was used to correlate Fecal Incontinence Severity Index with quality-of-life measures., Results: Of 110 patients who underwent fistulotomy, 96 (88 percent) had complete follow-up. Mean age was 48 (range, 17-84) years, and 68 percent were male. Follow-up was less than two years in 26 percent, two to five years in 39 percent, and more than five years in 35 percent. Of these patients, 41 percent had intersphincteric fistulas, whereas 59 percent had transsphincteric fistulas. Median Fecal Incontinence Severity Index score was 6, with a mean of 13 (maximum Fecal Incontinence Severity Index = 61); 36 percent had a Fecal Incontinence Severity Index score of zero. Linear regression revealed that only the amount of external sphincter divided correlated with Fecal Incontinence Severity Index score (P = 0.05). Quality-of-life measures strongly correlated with Fecal Incontinence Severity Index by analysis of variance (P < 0.01 for pad usage, lifestyle restriction, depression, and embarrassment), with substantial quality-of-life drop-off documented with Fecal Incontinence Severity Index >30., Conclusion: The Fecal Incontinence Severity Index is an excellent tool to gauge quality of life after fistulotomy. Fecal Incontinence Severity Index scores >30 predict a detrimental effect on quality of life.