Aspirin for primary thrombosis prevention in the antiphospholipid syndrome: a randomized, double-blind, placebo-controlled trial in asymptomatic antiphospholipid antibody-positive individuals

OBJECTIVE: To determine the efficacy of a daily dose of 81 mg aspirin in primary thrombosis prevention in asymptomatic, persistently antiphospholipid antibody (aPL)-positive individuals (those with positive aPL but no vascular and/or pregnancy events). METHODS: The Antiphospholipid Antibody Acetylsalicylic Acid (APLASA) study was a multicenter, randomized, double-blind, placebo-controlled clinical trial in which asymptomatic, persistently aPL-positive individuals were randomized to receive a daily dose of 81 mg of aspirin or placebo. In a separate observational and parallel study, asymptomatic, persistently aPL-positive individuals who were taking aspirin or declined randomization were followed up prospectively. RESULTS: In the APLASA study, 98 individuals were randomized to receive aspirin or placebo (mean +/- SD followup period 2.30 +/- 0.95 years), of whom 48 received aspirin and 50 received placebo. In the observational study, 74 nonrandomized individuals were followed up prospectively (mean +/- SD followup period 2.46 +/- 0.76 years); 61 received aspirin and 13 did not. In the APLASA study, the acute thrombosis incidence rates were 2.75 per 100 patient-years for aspirin-treated subjects and 0 per 100 patient-years for the placebo-treated subjects (hazard ratio 1.04, 95% confidence interval 0.69-1.56) (P = 0.83). Similarly, in the observational study, the acute thrombosis incidence rates were 2.70 per 100 patient-years for aspirin-treated subjects and 0 per 100 patient-years for those not treated with aspirin. All but 1 patient with thrombosis in either study had concomitant thrombosis risk factors and/or systemic autoimmune disease at the time of thrombosis. CONCLUSION: Our results suggest that asymptomatic, persistently aPL-positive individuals do not benefit from low-dose aspirin for primary thrombosis prophylaxis, have a low overall annual incidence rate of acute thrombosis, and develop vascular events when additional thrombosis risk factors are present.     

A critical assessment of the quality of reporting of randomized, controlled trials in the urology literature

PURPOSE: Randomized, controlled trials are the gold standard for evidence based assessment of therapeutic interventions. In 1996 the Consolidated Standards of Reporting Trials statement was published in an effort to standardize the reporting of clinical trials. To our knowledge we report the first systematic assessment of randomized, controlled trial quality in the urology literature by Consolidated Standards of Reporting Trials standards. MATERIALS AND METHODS: All human subject randomized, controlled trials published in 4 leading urology journals in 1996 and 2004 were identified for formal review. A standardized evaluation form was developed based on the Consolidated Standards of Reporting Trials statement. Each article was evaluated by 2 independent reviewers and discrepancies were settled by consensus. A Consolidated Standards of Reporting Trials criteria summary score was calculated on a scale of 0 to 22. RESULTS: A total of 152 randomized, controlled trials met inclusion criteria. The mean+/-SEM Consolidated Standards of Reporting Trials summary score was 10.2+/-0.3 (median 10.3) and 12.0+/-0.3 (median 12.2) in 1996 and 2004, respectively, with a mean difference of 1.8 (95% CI 1.0, 2.6; p=0.001). Reporting of important methodological criteria, eg sample size justification and randomization implementation, improved from 1996 to 2004. Improvement notwithstanding, reporting of key methodological criteria remained consistently below 50% in 2004. CONCLUSIONS: This formal review suggests that randomized, controlled trial reporting in the urology literature has improved since the publication of the Consolidated Standards of Reporting Trials statement in 1996. Certain areas, such as reporting of trial methods, continue to meet Consolidated Standards of Reporting Trials criteria in fewer than half of publications. Ongoing graduate and postgraduate education in trial design and evidence based practice may result in further improvement in randomized, controlled trial reporting.     

Embolic protection in infrainguinal interventions

The benefits of the use of embolic protection devices (EPDs) in saphenous vein coronary artery bypass grafts and carotid arteries have been shown, but the utility of their application during infrainguinal endovascular interventions is somewhat unclear. Patients with specific anatomical features or lesion characteristics, or patients undergoing specific types of endovascular interventions may benefit from the off-label use of EPDs, but this has yet to be determined. This report will examine the current literature related to the use of EPDs in infrainguinal endovascular interventions and attempt to identify the patients who would most likely benefit from their use. In addition, the setting in which EPDs have been used at one institution is briefly described. This discussion will serve as a general guideline for the use of EPDs and act as an impetus for the development of future clinical trials to help elucidate the patients who will truly benefit from EPDs use when undergoing lower extremity endovascular revascularization procedures.     

MR imaging of the diabetic foot

MR imaging can be quite useful in the evaluation of pathologic processes related to the diabetic foot. The diagnosis of soft tissue processes such as callus formation, ulceration, foreign body granuloma, cellulitis, abscess, and gangrene can be made with the assistance of MR imaging. Osseous deformities such as hammertoe, rocker-bottom foot, neuropathic osteoarthropathy, and osteomyelitis can be detected and defined with MR imaging. Finally, although there are some overlapping features of neuropathic osteoarthropathy and osteomyelitis, the differentiation between the two entities is possible in most instances with the aid of MR imaging.     

Reflecting peer-support groups in the prevention of stress and burnout: randomized controlled trial

Title.  Reflecting peer-support groups in the prevention of stress and burnout: randomized controlled trial.
Aim.  This paper is a report of a study to test the effect of participating in a reflecting peer-support group on self-reported health, burnout and on perceived changes in work conditions.
Background.  Stress-related conditions are one of the most common causes for long-term sick-leave. There is limited evidence for the effectiveness of person-directed interventions aimed at reducing stress levels in healthcare workers. Prior research in the relationship between support and burnout show somewhat inconsistent results.
Method.  A randomized controlled trial with peer-support groups as the intervention was conducted with 660 healthcare workers scoring above the 75th percentile on the exhaustion dimension of the Oldenburg Burnout Inventory. One hundred and fifty-one (22·9%) agreed to participate. The intervention started in 2002 with 51 participants (96·1% were women), 80 of whom constituted the control group. Potential differences in outcome measures 12 months after the intervention were compared using ancova , and data collected was completed in 2004. Qualitative content analyses were used to analyse reported experiences from group participation.
Results.  Statistically significant intervention effects were found for general health, perceived quantitative demands at work, participation and development opportunities at work and in support at work. Seven categories of experiences from participating were identified: talking to others in a similar situation, knowledge, sense of belonging, self-confidence, structure, relief of symptoms and behavioural change.
Conclusion.  Peer-support groups using a problem-based method could be a useful and comparatively inexpensive tool in alleviating work-related stress and burnout.     

Home or Nursing Home: Does Place of Residence Affect Longevity in Patients With Alzheimer's Disease? The Experience of CERAD Patients

ABSTRACT There is concern that life is curtailed when patients with Alzheimer's disease (AD) are institutionalized. To determine whether placement in a nursing home reduces their remaining years of life, we examined the experience of White patients with AD ( n =890) enrolled in the Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Proportional hazards survival analysis using the landmark approach (with the landmark set to 12 months after CERAD entry and reevaluated at succeeding 6-month time intervals through 5 years) indicated that longevity at home and in the nursing home was comparable. Thus, in these patients enrolled at tertiary care medical centers, living at home or in a nursing home did not affect time to death. These data suggest that when home care is no longer feasible, families and nurses counseling them should not feel that they are curtailing life by placing an AD patient in a nursing home.     

Aneuploid mosaicism in the developing and adult cerebellar cortex

Neuroprogenitor cells (NPCs) in several telencephalic proliferative regions of the mammalian brain, including the embryonic cerebral cortex and postnatal subventricular zone (SVZ), display cell division "defects" in normal cells that result in aneuploid adult progeny. Here, we identify the developing cerebellum as a major, nontelencephalic proliferative region of the vertebrate central nervous system (CNS) that also produces aneuploid NPCs and nonmitotic cells. Mitotic NPCs assessed by metaphase chromosome analyses revealed that 15.3% and 20.8% of cerebellar NPCs are aneuploid at P0 and P7, respectively. By using immunofluorescent analysis of cerebellar NPCs, we show that chromosome segregation defects contribute to the generation of cells with an aneuploid genomic complement. Nonmitotic cells were assessed by fluorescence-activated cell sorting (FACS) coupled with fluorescence in situ hybridization (FISH), which revealed neuronal and nonneuronal aneuploid populations in both the adult mouse and human cerebellum. Taken together, these results demonstrate that the prevalence of neural aneuploidy includes nontelencephalic portions of the neuraxis and suggest that the generation and maintenance of aneuploid cells is a widespread, if not universal, property of central nervous system development and organization.