AIMS AND OBJECTIVES: An integrative literature review was undertaken to determine what type II diabetes prevention programmes have been evaluated, what type of programme is the most effective and how adherent to lifestyle changes adults are after participating in a prevention programme. BACKGROUND: Type II diabetes is important because the disease is affecting millions of people worldwide. Obesity and sedentary lifestyles are preventable risk factors for type II diabetes, leading many researchers from around the world to examine different programmes that are focussed on prevention of the disease. DESIGN: Integrative literature review. METHOD: Search of electronic databases. RESULTS: Diet, exercise, counselling and diet plus exercise were the types of prevention programmes, with the diet plus exercise being the most efficacious. Although many studies demonstrated excellent results initially, maintaining the effects of the lifestyle behaviour change proved to be difficult for participants, with only one study demonstrating the persistence of results after six years. CONCLUSION: Future research should focus on long-term maintenance programmes, rather than just short-term prevention programmes to determine the need for booster interventions or other means to ultimately decrease the incidence of type II diabetes. RELEVANCE TO CLINICAL PRACTICE: As front-line healthcare providers working across a broad array of settings, nurses are particularly well-suited to play an integral part in future applications of diabetes prevention programmes. Lifestyle interventions are being delivered in a variety of settings and venues such as the workplace, the Internet and places of worship. In addition, at-risk populations also can be targeted, particularly overweight and obese persons, with at least one parent having type II diabetes or persons with gestational diabetes.
 
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BACKGROUND: Oxidative stress may cause gastrointestinal cancers. The evidence on whether antioxidant supplements are effective in preventing gastrointestinal cancers is contradictory. OBJECTIVES: To assess the beneficial and harmful effects of antioxidant supplements in preventing gastrointestinal cancers. SEARCH STRATEGY: We identified trials through the trials registers of the four Cochrane Review Groups on gastrointestinal diseases, The Cochrane Central Register of Controlled Trials in The Cochrane Library (Issue 2, 2007), MEDLINE, EMBASE, LILACS, SCI-EXPANDED, and The Chinese Biomedical Database from inception to October 2007. We scanned reference lists and contacted pharmaceutical companies. SELECTION CRITERIA: Randomised trials comparing antioxidant supplements to placebo/no intervention examining occurrence of gastrointestinal cancers. DATA COLLECTION AND ANALYSIS: Two authors (GB and DN) independently selected trials for inclusion and extracted data. Outcome measures were gastrointestinal cancers, overall mortality, and adverse effects. Outcomes were reported as relative risks (RR) with 95% confidence interval (CI) based on random-effects and fixed-effect model meta-analysis. Meta-regression assessed the effect of covariates across the trials. MAIN RESULTS: We identified 20 randomised trials (211,818 participants), assessing beta-carotene (12 trials), vitamin A (4 trials), vitamin C (8 trials), vitamin E (10 trials), and selenium (9 trials). Trials quality was generally high. Heterogeneity was low to moderate. Antioxidant supplements were without significant effects on gastrointestinal cancers (RR 0.94, 95% CI 0.83 to 1.06). However, there was significant heterogeneity (I(2) = 54.0%, P = 0.003). The heterogeneity may have been explained by bias risk (low-bias risk trials RR 1.04, 95% CI 0.96 to 1.13 compared to high-bias risk trials RR 0.59, 95% CI 0.43 to 0.80; test of interaction P < 0.0005), and type of antioxidant supplement (beta-carotene potentially increasing and selenium potentially decreasing cancer risk). The antioxidant supplements had no significant effects on mortality in a random-effects model meta-analysis (RR 1.02, 95% CI 0.97 to 1.07, I(2) = 53.5%), but significantly increased mortality in a fixed-effect model meta-analysis (RR 1.04, 95% CI 1.02 to 1.07). Beta-carotene in combination with vitamin A (RR 1.16, 95% CI 1.09 to 1.23) and vitamin E (RR 1.06, 95% CI 1.02 to 1.11) significantly increased mortality. Increased yellowing of the skin and belching were non-serious adverse effects of beta-carotene. In five trials (four with high risk of bias), selenium seemed to show significant beneficial effect on gastrointestinal cancer occurrence (RR 0.59, 95% CI 0.46 to 0.75, I(2) = 0%). AUTHORS` CONCLUSIONS: We could not find convincing evidence that antioxidant supplements prevent gastrointestinal cancers. On the contrary, antioxidant supplements seem to increase overall mortality. The potential cancer preventive effect of selenium should be tested in adequately conducted randomised trials.
 
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CONTEXT: In 1999, the US Congress directed the Centers for Disease Control and Prevention to conduct a pivotal safety and efficacy study of anthrax vaccine adsorbed (AVA). OBJECTIVE: To determine the effects on serological responses and injection site adverse events (AEs) resulting from changing the route of administration of AVA from subcutaneous (s.q.) to intramuscular (i.m.) and omitting the week 2 dose from the licensed schedule. DESIGN, SETTING, AND PARTICIPANTS: Assessment of the first 1005 enrollees in a multisite, randomized, double-blind, noninferiority, phase 4 human clinical trial (ongoing from May 2002). INTERVENTION: Healthy adults received AVA by the s.q. (reference group) or i.m. route at 0, 2, and 4 weeks and 6 months (4-SQ or 4-IM; n = 165-170 per group) or at a reduced 3-dose schedule (3-IM; n = 501). A control group (n = 169) received saline injections at the same time intervals. MAIN OUTCOME MEASURES: Noninferiority at week 8 and month 7 of anti-protective antigen IgG geometric mean concentration (GMC), geometric mean titer (GMT), and proportion of responders with a 4-fold rise in titer (%4 x R). Reactogenicity outcomes were proportions of injection site and systemic AEs. RESULTS: At week 8, the 4-IM group (GMC, 90.8 microg/mL; GMT, 1114.8; %4 x R, 97.7) was noninferior to the 4-SQ group (GMC, 105.1 microg/mL; GMT, 1315.4; %4 x R, 98.8) for all 3 primary end points. The 3-IM group was noninferior for only the %4 x R (GMC, 52.2 microg/mL; GMT, 650.6; %4 x R, 94.4). At month 7, all groups were noninferior to the licensed regimen for all end points. Solicited injection site AEs assessed during examinations occurred at lower proportions in the 4-IM group compared with 4-SQ. The odds ratio for ordinal end point pain reported immediately after injection was reduced by 50% for the 4-IM vs 4-SQ groups (P < .001). Route of administration did not significantly influence the occurrence of systemic AEs. CONCLUSIONS: The 4-IM and 3-IM regimens of AVA provided noninferior immunological priming by month 7 when compared with the 4-SQ licensed regimen. Intramuscular administration significantly reduced the occurrence of injection site AEs. Trial Registration clinicaltrials.gov Identifier: NCT00119067.
 
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Objective:The primary purposes of our study were to establish age- and gender-specific BMIs in terms of lowest mortality (risk nadir BMIs) for the Japanese population, and to then compare those to (i) BMIs for whites as determined by similar studies and to (ii) the official BMI guidelines.Methods and Procedures:A total of 32,060 men and 61,916 women aged 40-79 years underwent health check-ups in Ibaraki prefecture, Japan, in 1993 and were followed through 2003. To determine the age- and gender-specific risk nadir BMIs, coefficients and the lowest point from a quadratic model with transformed BMI were calculated by a Cox proportional hazard model. This included the quadratic term of 1/BMI and adjusted values (age, alcohol intake, and smoking status).Results:For both age and both gender categories, the relationship between all-cause mortality risk and BMI categories are illustrated as U-shaped curves. The risk nadir BMIs for men in the age groups of 40-59 and 60-79 years were 23.4 and 25.3 kg/m(2), respectively. Similarly, in women, the risk nadir BMIs were 21.6 and 23.4 kg/m(2), respectively.Discussion:Among the general Japanese population, the risk nadir BMI for the age group of 60-79 years was higher compared to the age group of 40-59 years, which was similar to the study for whites, and the age-dependent risk nadir BMI differed from the official guidelines criteria. Our findings underscore the importance of weight control following appropriate indicators of body weight according to age.Obesity (2008) doi:10.1038/oby.2008.342.
 
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OBJECTIVES: To evaluate the safety and immunogenicity of an additional birth dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP). STUDY DESIGN: Fifty infants between 2 to 14 days of age were randomly assigned to receive either DTaP and hepatitis B vaccines (experimental) or hepatitis B alone (control) at birth. At 2, 4, 6, and 17 months of age, DTaP and routine vaccines were administered to both groups. Safety data were collected after each dose, and sera were obtained at birth, 6, 7, 17, and 18 months. Immune responses to pertussis toxin, filamentous hemagglutinin, pertactin, and fimbriae were measured by enzyme-linked immunosorbent assay; responses to other vaccines were assessed. RESULTS: No differences were seen between the 2 groups in either local or systemic reactions; all vaccines were well tolerated. Compared with the control group, infants in the experimental group demonstrated significantly lower geometric mean antibody concentrations for pertussis toxin and pertactin 6, 7, and 18 months, for fimbrae at 6, 7, 17, and 18 months, and for FHA at 18 months, and lower geometric mean antibody concentrations for diphtheria at 7 months. Immune responses to all other vaccine antigens were comparable. CONCLUSION: Administration of an additional dose of DTaP at birth was safe but was associated with a significantly lower response to diphtheria and 3 of 4 pertussis antigens compared with controls.
 
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BACKGROUND: Despite advances in prevention and treatment, sexually transmitted infections (STIs) remain an important cause of morbidity and mortality in the United States. PURPOSE: To systematically review the evidence for behavioral counseling interventions to prevent STIs in adolescents and adults (nonpregnant and pregnant). DATA SOURCES: English-language articles in MEDLINE, PsycINFO, the Centers for Disease Control and Prevention`s Prevention Synthesis Research Project database, and Cochrane databases (1988 through December 2007), supplemented with expert recommendations and the bibliographies of previous systematic reviews. STUDY SELECTION: Reviewers included 21 articles representing 15 fair- or good-quality randomized, controlled trials that evaluated behavioral counseling interventions feasible in primary care and 1 fair-quality and 1 good-quality controlled trial with study samples representative of primary care populations in English-speaking countries. Comparative effectiveness trials that did not include a true control group were excluded. DATA EXTRACTION: Investigators abstracted, critically appraised, and synthesized 21 articles that met inclusion criteria. DATA SYNTHESIS: Most evidence suggests a modest reduction in STIs at 12 months among high-risk adults receiving multiple intervention sessions and among sexually active adolescents. Evidence also suggested that these interventions increase adherence to treatment recommendations for women in STI clinics and general contraceptive use in male adolescents and decrease nonsexual risky behavior and pregnancy in sexually active female adolescents. No evidence of substantial behavioral or biological harms for risk reduction counseling was found. LIMITATION: Significant clinical heterogeneity in study populations, interventions, and measurement of outcomes limited the reviewers` ability to meta-analyze trial results and to suggest important intervention components. CONCLUSION: Good-quality evidence suggests that behavioral counseling interventions with multiple sessions conducted in STI clinics and primary care effectively reduces STI incidence in "at-risk" adult and adolescent populations. Additional trial evidence is needed for both lower-intensity behavioral counseling interventions and lower-risk patient populations.
 
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BACKGROUND: The benefits and harms of hepatitis B vaccination in persons not previously exposed to hepatitis B infection or with unknown exposure status have not been established. OBJECTIVES: To assess the benefits and harms of hepatitis B vaccination in people not previously exposed to hepatitis B infection or with unknown exposure status. SEARCH STRATEGY: Trials were identified from The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, LILACS,Science Citation Index Expanded (last search, March 2007). Additionally, we contacted experts and vaccine manufacturers, and read through reference lists for eligible trials. SELECTION CRITERIA: Randomised clinical trials comparing hepatitis B vaccine versus placebo, no intervention, or another vaccine in persons not previously exposed to hepatitis B (HBsAg negative) or with unknown exposure status. DATA COLLECTION AND ANALYSIS: The primary outcome was hepatitis B infection (detecting HBsAg, HBeAg, HBV DNA, or anti-HBc). Secondary outcomes were lack of sero-protection, antibody titre, clinical complications, adverse events, lack of compliance, and cost-effectiveness. Dichotomous outcomes were reported as relative risk (RR) with 95% confidence interval (CI), using intention-to-treat analysis assuming an unfavourable event for missing data. Sensitivity analyses based on methodological quality (risk of bias), available data analysis, intention-to-treat analysis assuming a favourable event for missing data, best-case scenario, and worst-case scenario were conducted. MAIN RESULTS: Twelve trials were eligible. All had high risk of bias and reporting was inconsistent. Hepatitis B vaccine did not show a clear effect on the risk of developing HBsAg (RR 0.96, 95% CI 0.89 to 1.03, 4 trials, 1230 participants) and anti-HBc (RR 0.81, 95% CI 0.61 to 1.07; 4 trials, 1230 participants, random-effects) when data were analysed using intention-to-treat analysis assuming an unfavourable event for missing data. Analysis based on data of available participants showed reduced risk of developing HBsAg (RR 0.12, 95% CI 0.03 to 0.44, 4 trials, 576 participants) and anti-HBc (RR 0.36, 95% CI 0.17 to 0.76, 4 trials, 576 participants, random-effects). Intention-to-treat analysis assuming favourable outcome for missing data showed similar reduction in risk. Hepatitis B vaccination had an unclear effect on the risk of lacking protective antibody levels (RR 0.57, 95% CI 0.26 to 1.27, 3 trials, 1210 participants, random-effects). Development of adverse events was sparsely reported. AUTHORS` CONCLUSIONS: In people not previously exposed to hepatitis B, vaccination has unclear effect on the risk of developing infection, as compared to no vaccination. The risk of lacking protective antibody levels as well as serious and non-serious adverse events appear comparable among recipients and non-recipients of hepatitis B vaccine.
 
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OBJECTIVE: To follow 61 participants (7-11 years old) from a study that compared three school-based interventions for anxious children: group cognitive-behavioral therapy (CBT) for children, group CBT for children plus parent training, and no-treatment control to determine whether posttreatment benefits are sustained longitudinally. METHOD: Parent, child, and clinician report measures of child anxiety were completed at 3, 6, and 12 months posttreatment. Semistructured diagnostic interviews were administered at 6- and 12-month follow-ups. For initial analyses, the group CBT and group CBT plus parent training conditions were collapsed into one group and compared to control. When significant results were found, each active treatment group was compared to control. RESULTS: Across several measures, the collapsed CBT group sustained significant improvement in anxiety severity and impairment across a 12-month period compared to control. There were no significant differences between the three groups on remission of baseline anxiety disorders or incidence of new anxiety disorders during the follow-up. Several parent-report measures at 3 and 6 months posttreatment suggested that group CBT for children plus parent training provided additional benefit over the group CBT for children when each was compared to the control group. CONCLUSIONS: School-based CBT appears effective in decreasing anxiety symptoms up to 12 months posttreatment for anxious children.
 
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OBJECTIVE: To examine the influence of continued smoking and previous pregnancy outcomes on subsequent pregnancy outcomes. DESIGN: Retrospective descriptive epidemiological study. SETTING: New South Wales, Australia, 1994-2004. POPULATION: Mothers who delivered two consecutive singleton births. METHODS: Bivariate and multiple logistic regression analyses were used to explore the influence of continued smoking on subsequent pregnancy outcomes. MAIN OUTCOME MEASURES: Subsequent preterm birth (PTB), low birthweight (LBW) and perinatal deaths. RESULTS: The findings showed that in addition to maternal and neonatal characteristics, birth outcomes in subsequent pregnancies were affected by poor birth outcomes in previous pregnancy. Previous PTB, short birth interval, antenatal care, gestational diabetes and smoking habits in two successive pregnancies had relatively strong association with a subsequent PTB and LBW. Mothers who continued to smoke in subsequent pregnancies were more likely to have adverse pregnancy outcomes compared with others. A change from smoking in first pregnancy to not smoking in next pregnancy had reduced the chance of a subsequent PTB and LBW. The risk of a subsequent preterm and LBW delivery increased with the amount of smoking during the second pregnancy. For mothers who remain as moderate smokers in subsequent pregnancies, the odds ratios for a PTB and LBW delivery were significantly lower than those who remain as heavy smokers. CONCLUSIONS: Effective interventions to help women to stop smoking during pregnancy could reduce the risk of adverse obstetric and pregnancy outcomes. Strategies to reduce the prevalence of smoking during pregnancy may include intense intervention for women who have had smoking-related adverse outcomes in a previous pregnancy.
 
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AIMS: Obesity has been shown to be a risk factor for first atrial fibrillation (AF), but whether it is associated with progression from paroxysmal to permanent AF is unknown. METHODS AND RESULTS: In this longitudinal cohort study, Olmsted County, MN residents confirmed to have developed paroxysmal AF during 1980-2000 were identified and followed passively to 2006. The interrelationships of body mass index (BMI), left atrial (LA) size, and progression to permanent AF were analysed. Of a total of 3248 patients (mean age 71 +/- 15 years; 54% men) diagnosed with paroxysmal AF, 557 (17%) progressed to permanent AF (unadjusted incidence, 36/1000 person-years) over a median follow-up period of 5.1 years (interquartile range 1.2-9.4). Adjusting for age and sex, BMI independently predicted the progression to permanent AF (hazard ratio, HR 1.04, CI 1.03-1.06; P < 0.0001). Compared with normal BMI (18.5-24.9 kg/m(2)), obesity (30-34.9 kg/m(2)) and severe obesity (>or=35 kg/m(2)) were associated with increased risk for progression [HR 1.54 (CI 1.2-2.0; P = 0.0004) and 1.87 (CI 1.4-2.5; P < 0.0001, respectively)]. BMI remained highly significant even after multiple adjustments. In the subgroup with echocardiographic assessment (n = 744), LA volume was incremental to BMI for independent prediction of progression after multiple adjustments, and did not weaken the association between BMI and progression to permanent AF (HR 1.04; CI 1.02-1.05; P < 0.0001). CONCLUSION: There was a graded risk relationship between BMI and progression from paroxysmal to permanent AF. This relationship was not weakened by LA volume, which was independent of and incremental to BMI for the prediction of progression to permanent AF.
 
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