Addiction treatment trials: how gender, race/ethnicity, and age relate to ongoing participation and retention in clinical trials

Jeffrey E Korte1, Carmen L Rosa2, Paul G Wakim2, Harold I Perl21Division of Biostatistics and Epidemiology, Medical University of South Carolina, Charleston, SC, 2Center for the Clinical Trials Network, National Institute on Drug Abuse, Bethesda, MD, USAIntroduction: Historically, racial and ethnic minority populations have been underrepresented in clinical research, and the recruitment and retention of women and ethnic minorities in clinical trials has been a significant challenge for investigators. The National Drug Abuse Treatment Clinical Trials Network (CTN) conducts clinical trials in real-life settings and regularly monitors a number of variables critical to clinical trial implementation, including the retention and demographics of participants.Purpose: The examination of gender, race/ethnicity, and age group differences with respect to retention characteristics in CTN trials.Methods: Reports for 24 completed trials that recruited over 11,000 participants were reviewed, and associations of gender, race/ethnicity, and age group characteristics were examined along with the rate of treatment exposure, the proportion of follow-up assessments obtained, and the availability of primary outcome measure(s).Results: Analysis of the CTN data did not indicate statistical differences in retention across gender or race/ethnicity groups; however, retention rates increased for older participants.Conclusion: These results are based on a large sample of patients with substance use disorders recruited from a treatment-seeking population. The findings demonstrate that younger participants are less likely than older adults to be retained in clinical trials.Keywords: addiction treatment, age, ethnic minorities, gender difference, substance use disorders, race, recruitment, retention, clinical trial

Weak interactions and gauge theories

The status of the electroweak gauge theory, also known as quantum asthenodynamics (QAD), is examined. The major result is that the standard WS-GIM model describes the data well, although one should still look for signs of further complexity and better tests of its gauge theory aspect. A second important result is that the measured values of the three basic coupling constants of present-energy physics, g/sub s/, g, and ..sqrt..(5/3)g' of SU(3)/sub c/ x SU(2)/sub 2/ x U(1), are compatible with the idea that these interactions are unified at high energies. Much of the paper deals with open questions, and it takes up the following topics: the status of QAD, the scalar meson spectrum, the fermion spectrum, CP violation, and decay dynamics. 118 references, 20 figures. (RWR

613 cases of splenic rupture without risk factors or previously diagnosed disease: a systematic review

Background Rupture of the spleen in the absence of trauma or previously diagnosed disease is largely ignored in the emergency literature and is often not documented as such in journals from other fields. We have conducted a systematic review of the literature to highlight the surprisingly frequent occurrence of this phenomenon and to document the diversity of diseases that can present in this fashion. Methods Systematic review of English and French language publications catalogued in Pubmed, Embase and CINAHL between 1950 and 2011. Results We found 613 cases of splenic rupture meeting the criteria above, 327 of which occurred as the presenting complaint of an underlying disease and 112 of which occurred following a medical procedure. Rupture appeared to occur spontaneously in histologically normal (but not necessarily normal size) spleens in 35 cases and after minor trauma in 23 cases. Medications were implicated in 47 cases, a splenic or adjacent anatomical abnormality in 31 cases and pregnancy or its complications in 38 cases. The most common associated diseases were infectious (n = 143), haematologic (n = 84) and non-haematologic neoplasms (n = 48). Amyloidosis (n = 24), internal trauma such as cough or vomiting (n = 17) and rheumatologic diseases (n = 10) are less frequently reported. Colonoscopy (n = 87) was the procedure reported most frequently as a cause of rupture. The anatomic abnormalities associated with rupture include splenic cysts (n = 6), infarction (n = 6) and hamartomata (n = 5). Medications associated with rupture include anticoagulants (n = 21), thrombolytics (n = 13) and recombinant G-CSF (n = 10). Other causes or associations reported very infrequently include other endoscopy, pulmonary, cardiac or abdominal surgery, hysterectomy, peliosis, empyema, remote pancreato-renal transplant, thrombosed splenic vein, hemangiomata, pancreatic pseudocysts, splenic artery aneurysm, cholesterol embolism, splenic granuloma, congenital diaphragmatic hernia, rib exostosis, pancreatitis, Gaucher's disease, Wilson's disease, pheochromocytoma, afibrinogenemia and ruptured ectopic pregnancy. Conclusions Emergency physicians should be attuned to the fact that rupture of the spleen can occur in the absence of major trauma or previously diagnosed splenic disease. The occurrence of such a rupture is likely to be the manifesting complaint of an underlying disease. Furthermore, colonoscopy should be more widely documented as a cause of splenic rupture