The role of antibiotics in preventing totally implantable venous access device (TIVAD) infections; is there a population that would benefit?

PURPOSE: To assess the role for prophylactic antibiotics in preventing totally implantable venous access device (TIVAD) infections and identify populations that may benefit from antibiotics. METHODS: 1284 patients undergoing TIVAD placement were retrospectively reviewed to determine association between infection rate, prophylactic antibiotics, and clinical data including white blood cell (WBC) count, platelets, and coagulation profile. Patients were further sub-categorized based on hospital admission status and leukopenia. Patients who received antibiotics were compared to those who did not using chi-square test or Fisher's exact tests and Student's t-tests. Additionally, multivariable logistic regression analysis was used to determine factors associated with infections. RESULTS: A total of 7 infections were identified with an infection rate of 0.5%. 1010 patients received antibiotics (78.7%), and infection rate in these patients was 0.7% compared to 0% in patients who did not receive antibiotics. 21 patients were under the age of 18, eight of which received antibiotics. No infections occurred in the pediatric group. Upon multivariate analysis, developing TIVAD infection was significantly associated with inpatient placement (p < 0.0001, OR 29.1, 95% CI 3.1-272.1), while utilization of double lumen ports was not (OR 3.0, 95% CI 0.5-17.4). There were no significant associations between infections and antibiotic use (p = 0.36), leukopenia (p = 0.47), pediatric patients (p = 1) or other demographic or laboratory data. CONCLUSION: Routine use of prophylactic antibiotics with TIVAD placement should be avoided. Antibiotics may not benefit even those with greater risk for infection.

Population-Based Study of Attitudes toward BRCA Genetic Testing among Orthodox Jewish Women.

Given the high prevalence (1 in 40) of BRCA1 and BRCA2 mutations among Ashkenazi Jews, population-based BRCA genetic testing in this ethnic subgroup may detect more mutation carriers. We conducted a cross-sectional survey among Orthodox Jewish women in New York City to assess breast cancer risk, genetic testing knowledge, self-efficacy, perceived breast cancer risk and worry, religious and cultural factors affecting medical decision-making. We used descriptive statistics and multivariable logistic regression models to identify predictors of genetic testing intention/uptake. Among evaluable respondents (n = 243, 53% response rate), median age was 25 and nearly half (43%) had a family history of breast cancer. Only 49% of the women had adequate genetic testing knowledge and 46% had accurate breast cancer risk perceptions. Five percent had already undergone BRCA genetic testing, 20% stated that they probably/definitely will get tested, 28% stated that they probably/definitely will not get tested, and 46% had not thought about it. High decision self-efficacy, adequate genetic testing knowledge, higher breast cancer risk, and overestimation of risk were associated with genetic testing intention/uptake. Decision support tools that improve knowledge and self-efficacy about genetic testing may facilitate population-based BRCA testing among Orthodox Jews.

Comparison of serious adverse events posted at ClinicalTrials.gov and published in corresponding journal articles.

BACKGROUND: The reporting of serious adverse events (SAEs) in clinical trials is crucial to assess the balance between benefits and risks. For trials with serious adverse events posted at ClinicalTrials.gov, we assessed the consistency between SAEs posted at ClinicalTrials.gov and those published in corresponding journal articles. METHODS: All records from ClinicalTrials.gov up to February 2014 were automatically exported in XML format. Among these, we identified all phase III or IV randomized controlled trials with at least one SAE posted. For a random sample of 300 of these trials, we searched for corresponding publications using MEDLINE via PubMed and extracted safety results from the articles. RESULTS: Among the sample of 300 trials with SAEs posted at ClinicalTrials.gov, 78 (26%) did not have a corresponding publication, and 20 (7%) had a publication that did not match the ClinicalTrials.gov record. For the 202 remaining trials, 26 published articles (13%) did not mention SAEs, 4 (2%) reported no SAEs, and 33 (16%) did not report the total number of SAEs per treatment group. Among the remaining 139 trials, for 44 (32%), the number of SAEs per group published did not match those posted at ClinicalTrials.gov. For 31 trials, the number of SAEs was greater at ClinicalTrials.gov than in the published article, with a difference ≥30 % for at least one group for 21. Only 33 trials (11%) had a publication reporting matching numbers of SAE and describing the type of SAE. CONCLUSIONS: Many trials with SAEs posted at ClinicalTrials.gov are not yet published, omit the reporting of these SAEs in corresponding publications, or report a discrepant number of SAEs as compared with ClinicalTrials.gov. These results underline the need to consult ClinicalTrials.gov for more information on serious harms.