Search

During September to October, 2006, state and local health departments and the Centers for Disease Control and Prevention investigated a large, multistate outbreak of Escherichia coli 0157:H7 infections. Case patients were interviewed regarding specific foods consumed and other possible exposures. E. coli 0157:H7 strains isolated from human and food specimens were subtyped using pulsed-field gel electrophoresis and multiple-locus variable-number tandem repeat analyses (MLVA). Two hundred twenty-five cases (191 confirmed and 34 probable) were identified in 27 states; 116 (56%) case patients were hospitalized, 39 (19%) developed hemolytic uremic syndrome, and 5 (2%) died. Among 176 case patients from whom E. coli 0157:H7 with the outbreak genotype (MLVA outbreak strain) was isolated and who provided details regarding spinach exposure, 161 (91%) reported fresh spinach consumption during the 10 days before illness began. Among 116 patients who provided spinach brand information, 106 (91%) consumed bagged brand A. E. coli 0157:H7 strains were isolated from 13 bags of brand A spinach collected from patients' homes; isolates from 12 bags had the same MLVA pattern. Comprehensive epidemiologic and laboratory investigations associated this large multistate outbreak of E. coli 0157:H7 infections with consumption of fresh bagged spinach. MLVA, as a supplement to pulsed-field gel electrophoresis genotyping of case patient isolates, was important to discern outbreak-related cases. This outbreak resulted in enhanced federal and industry guidance to improve the safety of leafy green vegetables and launched an independent collaborative approach to produce safety research in 2007. [ABSTRACT FROM AUTHOR]

Objective To assess the clinical spectrum of postdiarrheal hemolytic uremic syndrome (D+HUS) hospitalizations and sought predictors of in-hospital death to help identify children at risk of poor outcomes. Study design We assessed clinical variables collected through population-based surveillance of D+HUS in children <18 years old hospitalized in 10 states during 1997-2012 as predictors of in-hospital death by using tree modeling. Results We identified 770 cases. Of children with information available, 56.5% (430 of 761) required dialysis, 92.6% (698 of 754) required a transfusion, and 2.9% (22 of 770) died; few had a persistent dialysis requirement (52 [7.3%] of 716) at discharge. The tree model partitioned children into 5 groups on the basis of 3 predictors (highest leukocyte count and lowest hematocrit value during the 7 days before to 3 days after the diagnosis of hemolytic uremic syndrome, and presence of respiratory tract infection [RTI] within 3 weeks before diagnosis). Patients with greater leukocyte or hematocrit values or a recent RTI had a greater probability of in-hospital death. The largest group identified (n = 533) had none of these factors and had the lowest odds of death. Many children with RTI had recent antibiotic treatment for nondiarrheal indications. Conclusion Most children with D+HUS have good hospitalization outcomes. Our findings support previous reports of increased leukocyte count and hematocrit as predictors of death. Recent RTI could be an additional predictor, or a marker of other factors such as antibiotic exposure, that may warrant further study. [ABSTRACT FROM AUTHOR]

We examined the efficacy of recall notification and advertising in informing the public about a nationwide recall of hot dogs and deli meats. As part of an ongoing random population telephone survey, residents of seven states were interviewed. Data from the survey were weighted to account for the multistage sampling design. Overall. 307 (45%) of 633 knew about the recall. Knowledge was higher among persons older than 40 years (odds ratio = 2.1, 95% confidence interval 1.4 to 3.3) and persons interviewed after major newspaper notices about the recall. Among those who knew about the recall, 5% believed the products were safe to eat; 23% were not sure. Seventy percent learned about the recall through television. Our findings indicate that routine recall notifications failed to reach a large portion of the population and were not well understood. Messages to the public about recalled products should clearly describe the risks of consuming the recalled product. Supplemental advertising by manufacturers can be beneficial if the risks of consuming the recalled product and recommendations to consumers are clearly described. These policies, coupled with broader distribution through the television and print media, may help increase the proportion of the persons who receive the information they need from future product recalls. [ABSTRACT FROM AUTHOR]

From October 1997 through March 1998, three outbreaks of gastrointestinal illness among school children were linked to company A burritos. In September 1998, a similar outbreak occurred in three North Dakota schools following lunches that included company B burritos. We conducted an investigation to determine the source of the North Dakota outbreak, identify other similar outbreaks, characterize the illness, and gather evidence about the cause. The investigation included epidemiologic analyses, environmental investigation, and laboratory analyses. In North Dakota, a case was defined as nausea, headache, abdominal cramps, vomiting, or diarrhea after lunch on 16 September 1998. Case definitions varied in the other states. In North Dakota, 504 students and staff met the case definition; predominant symptoms were nausea (72%), headache (68%), abdominal cramps (54%), vomiting (24%), and diarrhea (16%). The median incubation period was 35 mm and median duration of illness was 6 h. Eating burritos was significantly associated with illness (odds ratio, 2.6; 95% confidence interval, 1.6 to 4.2). We identified 16 outbreaks that occurred in seven states from October 1997 through October 1998, affecting more than 1,900 people who ate burritos from two unrelated companies. All tortillas were made with wheat flour, but the fillings differed, suggesting that tortillas contained the etiologic agent. Results of plant inspections, tracebacks, and laboratory investigations were unrevealing. More than two million pounds of burritos were recalled or held from distribution. The short incubation period, symptoms, and laboratory data suggest that these outbreaks were caused by an undetected toxin or an agent not previously associated with this clinical syndrome. Mass psychogenic illness is an unlikely explanation because of the large number of sites where outbreaks occurred over a short period, the similarity of symptoms, the common food item, the lack of publicity, and the link to only two companies. A network of laboratories that can rapidly identify known and screen for unknown agents in food is a critical part of protecting the food supply against natural and intentional contamination. [ABSTRACT FROM AUTHOR]

Purpose: Considerable interobserver variability exists among providers and between providers and patients when measuring subjective symptoms. In the recently published Phase III N06C4 trial of mometasone cream vs. placebo to prevent radiation dermatitis, the primary provider–assessed (PA) endpoint, using the Common Toxicity Criteria for Adverse Events (CTCAE), was negative. However, prospectively planned secondary analyses of patient-reported outcomes (PROs), using the Skindex-16 and Skin Toxicity Assessment Tool (STAT), were positive. This study assesses the relationship between PA outcomes and PROs. Methods and Materials: Pearson correlation coefficients were calculated to compare the three tools. Statistical correlations were defined as follows: <0.5, mild; 0.5–0.7, moderate; and >0.7, strong. Results: CTCAE dermatitis moderately correlated with STAT erythema, and CTCAE pruritus strongly correlated with STAT itching. CTCAE pruritus had a moderate correlation with Skindex-16 itching. Comparing the 2 PRO tools, Skindex-16 itching correlated moderately with STAT itching. Skindex-16 burning, hurting, irritation, and persistence all showed the strongest correlation with STAT burning; they showed moderate correlations with STAT itching and tenderness. Conclusions: The PRO Skindex-16 correlated well with the PRO portions of STAT, but neither tool correlated well with CTCAE. PROs delineated a wider spectrum of toxicity than PA measures and provided more information on rash, redness, pruritus, and annoyance measures compared with CTCAE findings of rash and pruritus. PROs may provide a more complete measure of patient experience than single-symptom, PA endpoints in clinical trials assessing radiation skin toxicity. [ABSTRACT FROM AUTHOR]

Purpose: A two-arm, double-blind, randomized trial was performed to evaluate the effect of 0.1% mometasone furoate (MMF) on acute skin-related toxicity in patients undergoing breast or chest wall radiotherapy. Methods and Materials: Patients with ductal carcinoma in situ or invasive breast carcinoma who were undergoing external beam radiotherapy to the breast or chest wall were randomly assigned to apply 0.1% MMF or placebo cream daily. The primary study endpoint was the provider-assessed maximal grade of Common Terminology Criteria for Adverse Events, version 3.0, radiation dermatitis. The secondary endpoints included provider-assessed Common Terminology Criteria for Adverse Events Grade 3 or greater radiation dermatitis and adverse event monitoring. The patient-reported outcome measures included the Skindex-16, the Skin Toxicity Assessment Tool, a Symptom Experience Diary, and a quality-of-life self-assessment. An assessment was performed at baseline, weekly during radiotherapy, and for 2 weeks after radiotherapy. Results: A total of 176 patients were enrolled between September 21, 2007, and December 7, 2007. The provider-assessed primary endpoint showed no difference in the mean maximum grade of radiation dermatitis by treatment arm (1.2 for MMF vs. 1.3 for placebo; p = .18). Common Terminology Criteria for Adverse Events toxicity was greater in the placebo group (p = .04), primarily from pruritus. For the patient-reported outcome measures, the maximum Skindex-16 score for the MMF group showed less itching (p = .008), less irritation (p = .01), less symptom persistence or recurrence (p = .02), and less annoyance with skin problems (p = .04). The group''s maximal Skin Toxicity Assessment Tool score showed less burning sensation (p = .02) and less itching (p = .002). Conclusion: Patients receiving daily MMF during radiotherapy might experience reduced acute skin toxicity compared with patients receiving placebo. [Copyright &y& Elsevier]

Purpose: The quality of life (QOL) and neurocognitive function of patients with brain tumors are negatively affected by the symptoms of their disease and brain radiation therapy (RT). We assessed the effect of prophylactic d-threo-methylphenidate HCl (d-MPH), a central nervous system (CNS) stimulant on QOL and cognitive function in patients undergoing RT. Methods and Materials: Sixty-eight patients with primary or metastatic brain tumors were randomly assigned to receive d-MPH or placebo. The starting dose of d-MPH was 5 mg twice daily (b.i.d.) and was escalated by 5 mg b.i.d. to a maximum of 15 mg b.i.d. The placebo was administered as one pill b.i.d. escalating three pills b.i.d. The primary outcome was fatigue. Patients were assessed at baseline, the end of radiation therapy, and 4, 8, and 12 weeks after brain RT using the Functional Assessment of Cancer Therapy with brain and fatigue (FACIT-F) subscales, as well as the Center for Epidemiologic Studies Scale and Mini-Mental Status Exam. Results: The Mean Fatigue Subscale Score at baseline was 34.7 for the d-MPH arm and 33.3 for the placebo arm (p = 0.61). At 8 weeks after the completion of brain RT, there was no difference in fatigue between patient groups. The adjusted least squares estimate of the Mean Fatigue Subscale Score was 33.7 for the d-MPH and 35.6 for the placebo arm (p = 0.64). Secondary outcomes were not different between the two treatment arms. Conclusions: Prophylactic use of d-MPH in brain tumor patients undergoing RT did not result in an improvement in QOL. [Copyright &y& Elsevier]