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Background & aimsCombination of polyamine and prostaglandin E2 (PGE2)-synthesis inhibitors reduced the risk of colorectal adenoma (CRA) by 70% in patients who received polypectomies. We studied effects of the combination of difluoromethylornithine (DFMO) and sulindac on biomarkers and investigated factors that modify their efficacy.MethodsWe analyzed rectal mucosal levels of polyamines (spermidine, spermine, and putrescine) and PGE2, treatment regimens, and risk of CRA in 267 participants of a phase IIb/III chemoprevention trial of DFMO/sulindac.ResultsIn the group that received DFMO/sulindac, spermidine-to-spermine ratio (Spd:Spm) in rectal mucosa decreased between baseline and 12- and 36-month follow-up examinations (0.30, 0.23, and 0.24, respectively; P < .001 for both comparisons to baseline). Putrescine levels decreased between baseline and 12 months (0.46 vs 0.15 nmol/mg protein; P < .001) but rebounded between 12 and 36 months (0.15 vs 0.36 nmol/mg protein; P = .001). PGE2 levels did not change, although aspirin use was significantly associated with lower baseline levels of PGE2. No significant associations were observed between changes in biomarker levels and efficacy. However, drug efficacy was greatest in subjects with low Spd:Spm and high PGE2 at baseline; none of these subjects, versus 39% of those given placebo, developed CRA (P < .001). Efficacy was lowest in subjects with high Spd:Spm and low PGE2 at baseline; 28% developed CRA, compared with 36% of patients given placebo (P = .563).ConclusionsA combination of DFMO and sulindac significantly suppressed production of rectal mucosal polyamines but not PGE2. No relationship was found between changes in biomarker levels and response. However, baseline biomarker levels modified the effect of DFMO/sulindac for CRA prevention.

A resampling-based method of inference--permutation tests--is often used when distributional assumptions are questionable or unmet. Not only are these methods useful for obvious departures from parametric assumptions (e.g., normality) and small sample sizes, but they are also more robust than their parametric counterparts in the presences of outliers and missing data, problems that are often found in clinical child and adolescent psychology research. These methods are increasingly found in statistical software programs, making their use more feasible. In this article, we use an application-based approach to provide a brief tutorial on permutation testing. We present some historical perspectives, describe how the tests are formulated, and provide examples of common and specific situations under which the methods are most useful. Finally, we demonstrate the utility of these methods to clinical and adolescent psychology by examining four recent articles employing these methods. (Contains 6 tables.)

Examined social physique anxiety, upper body esteem, social anxiety, and body dissatisfaction as possible predictors of anabolic steroid (AS) use. Results based on 185 AS-using bodybuilders and various control groups indicated that the upper body strength subscale of two measures, along with age, were significant predictors of AS use. (RJM)

Objective. To determine the population impact of pneumococcal conjugate vaccine (PCV) on pneumococcal-related diseases, including pneumonia and otitis media. Methods. Using administrative data from Tennessee Medicaid and 3 commercial insurance plans in upstate New York, we measured annual rates of medical visits for pneumococcal-related diseases (pneumococcal and nonspecific pneumonia and invasive disease; otitis media) and pneumococcal-unrelated diseases (other acute respiratory illnesses). Disease rates before (1995-2000 in Tennessee; 1998-2000 in New York) and after (2000-2002) PCV licensure were calculated for children aged Results. In 2001-2002, there were 67 380 and 9485 child-years of observation for Tennessee and New York children aged Conclusions. Adding PCV to the childhood immunization schedule was associated with a 10-fold greater reduction in pneumonia and a 100-fold greater reduction in otitis media than the previously reported reduction in culture-confirmed invasive pneumococcal diseases of 1.3 episodes per 1000 children aged, ABBREVIATIONS. PCV, pneumococcal conjugate vaccine; CI, confidence interval; ICD-9, International Classification of Diseases, 9th Revision; ED, emergency department. Streptococcus pneumoniae is the leading bacterial cause of meningitis, bacteremia, pneumonia, and [...]

Restaurants in the United States are regularly inspected by health departments, but few data exist regarding the effect of restaurant inspections on food safety. We examined statewide inspection records from [...]

The smallpox vaccine can cause an inflammation of hair follicles, according to a study of 148 people who received the vaccine. Fifteen developed this condition. The vaccine is based on a live virus called vaccinia that causes cowpox. However, skin biopsies showed that the follicles did not contain the vaccinia virus. All 15 people recovered without scars.

Context. Medical errors are an important problem for hospitalized adult inpatients. However, medical errors in children remain comparatively understudied, and published research has been relatively limited. Objectives. To investigate the national rates of hospital-reported medical errors in pediatric inpatients over the period 1988-1997; and to determine the association of patient and hospital characteristics with the occurrence of hospital-reported medical errors in children. Design, Setting, and Patients. A nonconcurrent cohort study of hospitalized nonnewborn pediatric patients in the United States [less than or equal to] 18 years of age. Data from the Healthcare Cost and Utilization Project for the years 1988, 1991, 1994, and 1997 were used for these analyses. Main Outcome Measure. The occurrence of hospital-reported medical errors. Results. The national rate of hospital-reported medical errors in hospitalized children ranged from 1.81 to 2.96 per 100 discharges. These medical error rates were statistically lower in 1988, with the years 1991, 1994, and 1997 not being statistically different from each other. There were no consistent differences in the rates of medical errors when stratified by gender, race, payor status, or median household income of the patient&apos;s zip code across years. There was, however, a statistically significant relationship between higher median household income and increasing medical error rates; this trend was consistent across all 4 years. Similarly, children with special medical needs or dependence on a medical technology also had significantly higher rates of hospital-reported medical errors. Although hospital size did not seem to be related to the rate of medical errors, private for-profit hospitals consistently reported lower rates, whereas urban teaching hospitals in all years but 1997 reported higher rates of medical errors. Conclusions. These data highlight both the strengths and limitations of administrative data in the investigation of medical errors. Substantively, they suggest fruitful areas for additional and more detailed study, notably children with special medical needs. Pediatrics 2003;111: 617-621; medical errors, pediatrics, children, iatrogenic injury, complications, administrative data., ABBREVIATIONS. ICD, International Classification of Diseases; HCUP, Healthcare Cost and Utilization Project; LOS, length of stay. The Institute of Medicine's (1) recent report on patient safety identified medical errors as [...]