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Introduction: In Quebec, Canada, receipt of the 2009 AS03-adjuvanted pandemic H1N1 vaccine was associated with increased risk of anaphylaxis and other allergic-like events (ALE), especially among women of childbearing age. In response to this safety signal, a case-control study was conducted to identify potential risk factors., Methods: A total of 435 ALE (50 anaphylaxis) occurring <24h following pandemic vaccination were compared to 849 age-gender matched controls randomly selected from the provincial Pandemic Influenza Vaccination Registry. More than 60 potential risk factors were evaluated through phone interviews and included demographic information, medical history, medication use or acute respiratory illnesses (ARI) concurrent with vaccination and other risk factors associated with general allergy. Odds ratios (ORs) with 95% confidence intervals were estimated with unconditional logistic regression., Results: Factors associated with increased risk of anaphylaxis included concurrent ARI (18% cases vs. 4% controls, ORadj 7.67, 95%CI: 3.04-13.37), food allergy (26% cases vs. 4% controls, ORadj 3.84, 95%CI: 1.51-9.74) and vaccination during the first four weeks of the campaign (66% cases vs. 50% controls, ORadj 2.16, 95%CI: 1.10-4.25) whereas alcohol exposure (≥1 drink/week) was associated with reduced risk (29% cases vs. 42% controls, ORadj 0.26, 95%CI: 0.13-0.57). These factors were also significantly associated with any ALE but the strength of association was weaker. Allergy to components found in the vaccine (e.g., egg, thimerosal) was infrequent and did not significantly differ between cases and controls., Conclusion: Increased anaphylaxis and other allergic-like events observed in association with AS03-adjuvanted pandemic H1N1 vaccine remain mostly unexplained despite extensive risk factor review. However, prior to mass vaccination with similar formulations this safety signal warrants further consideration and better understanding. In particular, the predominance among women of childbearing age may be a clue to underlying biological or hormonal influences on adverse immunological responses to vaccine., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Background: Anaphylaxis after trivalent influenza vaccination is typically reported at a rate of <1 per million doses. In Quebec, Canada, anaphylaxis following administration of the monovalent AS03-adjuvanted H1N1pdm09 vaccine was reported through passive surveillance at a rate of 8 per million doses administered. This was 20 times higher than the reporting rate for non-adjuvanted trivalent vaccines administered during the six previous seasons. However, adequate estimation of the incidence of anaphylaxis is hindered by wide variations in definitions and diagnosis., Methods: Using the Brighton collaboration case definition of anaphylaxis, all cases with allergic symptoms (AS) reported to public health were reviewed to estimate the incidence of anaphylaxis following AS03-adjuvanted H1N1pdm09 vaccine., Results: Among 752 reports of allergic symptoms, 33 were initially reported as anaphylaxis of which 20/33 (60%) met the Brighton definition (19/20 with certainty levels 1 or 2). A total of 38 additional cases with onset within 1h of vaccination also met the Brighton definition of anaphylaxis (27 (71%) with certainty levels 1 or 2). The 58 cases meeting Brighton Level 1 or 2 criteria for anaphylaxis represent a 75% increase over the 33 passively reported and an incidence of 13 per million doses administered., Conclusion: A substantial number of patients with early-onset allergic symptoms met the most specific levels of the Brighton case definition but were not reported as anaphylaxis. Based on this specific case definition, the incidence of anaphylaxis after AS03-adjuvanted H1N1pdm09 vaccine substantially exceeded that reported with seasonal influenza vaccines, a signal that warrants better understanding., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

The role of the anterior temporal lobe (ATL) in semantic memory is now firmly established. There is still controversy, however, regarding the specific role of this region in processing various types of concepts. There have been reports of patients suffering from semantic dementia (SD), a neurodegenerative condition in which the ATL is damaged bilaterally, who present with greater semantic impairment for concrete concepts than for abstract concepts, an effect known as reversal of the concreteness effect. This effect has previously been interpreted as reflecting degraded visual-perceptual features of objects due to damage to the inferior temporal lobes such as is observed in SD. Temporal lobe atrophy in SD, however, is bilateral even if it usually predominates to the left ATL, and it has been found to extend beyond the ATL, throughout the temporal lobes including medial and posterior temporal lobe regions. The question therefore remains whether greater impairment for concrete concepts results from damage to the ATL or from damage to the visual association cortex, and if unilateral damage can produce such a deficit. The aim of the present study was to investigate the processing of concrete and abstract words in rare patients who underwent a selective ATL surgical resection, and to compare their performance with that of patients with selective medial temporal lobe damage sparing the ATL region. Seven patients with a selective unilateral anterior temporal resection (ATL), 15 patients with a selective unilateral amygdalo-hippocampectomy (SeAH), and 15 healthy age- and education-matched controls underwent detailed neuropsychological assessment and carried out a semantic similarity judgment task evaluating their comprehension of concrete and abstract words. Results showed that both ATL and SeAH groups were significantly impaired on the semantic task relative to the control group. Within the patient groups, however, comprehension of concrete words was significantly more impaired than that of abstract words in the ATL group, while comprehension of abstract and concrete words was equally affected in the SeAH group. Results of this study suggest that the ATL region may play a critical role in processing concrete concepts, and that the reversal of the concreteness effect observed in ATL patients may result from damage to a categorical organization underlying the representation of concrete concepts., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

There is currently no evidence that treatment of unruptured aneurysms is beneficial. Confronted with the uncertainty, many clinicians are attracted by an individual calculus of risks using numbers extracted from subgroup statistics of observational studies or natural history data. The so-called natural history of unruptured aneurysms refers to a purely man-made ratio of events divided by the number of untreated patients identified by imaging, a ratio heavily influenced by referral patterns and arbitrary clinical decisions. Available studies lacked prespecified hypotheses, exposing all analyses to sampling error and bias, and sample sizes were too small to provide reliable subgroup statistics. Far from being "natural kinds" of aneurysms, subgroups were post-hoc creations. Resulting data-driven statistics can only be exploratory, the error too uncontrollable to serve for clinical decisions. A randomized trial is in order, but selection according to fixed size criteria is ill-advised, given the imprecision of imaging, the influence of other factors such as location, previous history, multiplicity of lesions, risks of treatment, age and the danger of arbitrarily excluding from a long trial a large segment of the population with aneurysms for whom the research question is most pertinent.

Background: With the widespread availability of non-invasive imaging of the brain in an aging population, we are increasingly confronted with the problem of the incidental discovery of unruptured aneurysms. The management of these patients remains controversial. Endovascular treatment can prevent rupture, but involves immediate risks. Furthermore, successful treatment does not eliminate all risk of rupture. The safety and efficacy of endovascular treatment of unruptured aneurysms remain undetermined. Hence the balance of the risks and benefits is uncertain. A randomized trial is needed to assess the potential benefits of endovascular management of unruptured aneurysms., The Trial: TEAM (Trial on Endovascular Aneurysm Management) is a randomized trial comparing endovascular treatment versus conservative management of unruptured aneurysms. TEAM aims to recruit 2002 patients in 60 centers throughout the world over a 3-year period and to follow all patients for 10 years. The primary outcome is to verify if the clinical outcome (morbidity/mortality (modified Rankin scale > 2) related to the aneurysm or its treatment) can be improved from 8% to 4%. The study is funded by the Canadian Institutes of Health Research.

Background: Little is known about how women who receive an inconclusive result from BRCA1/2 testing interpret their result. Clinical observations suggest that some of them may be falsely reassured and, consequently, may not adhere to recommended surveillance. The purpose of this study is to evaluate whether women with inconclusive BRCA1/2 test results are falsely reassured., Methods: Participants were adult women with a family history suggestive of a germ-line mutation in either the BRCA1 or the BRCA2 gene who underwent genetic testing in the context of the interdisciplinary research program INHERIT BRCAs. Data were collected using self-administered questionnaires at genetic counseling and 1 month after result disclosure. Reassurance was assessed through indicators of cancer risk perception, cancer worry, relief following result disclosure, painfulness of the test result, and its effect on quality of life., Results: Five-hundred women (105 carriers, 140 noncarriers, and 255 inconclusive) were included in this analysis. Compared to noncarriers, women with inconclusive results had higher cancer risk perception, were more worried about cancer, were less relieved by their test result, and perceived their quality of life as being more adversely affected by it., Conclusion: The differences observed between noncarriers and women who received an inconclusive result run counter to the hypothesis that the latter are falsely reassured following BRCA1/2 testing. For clinicians, our findings show the value of taking precautions to fully explain to women that inconclusive results do not rule out the possibility that they still may face a higher risk of developing breast and/or ovarian cancer.

Objective: To determine hormone replacement therapy (HRT)use among women at high risk for breast cancer and ovarian cancer, before genetic testing for the cancer susceptibility genes BRCA1 and BRCA2, and 1 year following disclosure of the test results., Methods: Participants were 209 French-Canadian women (from 67 high-risk families) who were tested for BRCA1/2 mutations as part of the multidisciplinary research program INHERIT BRCAs (INterdisciplinary HEalth Research International Team on BReast CAncer susceptibility). Use of HRT was recorded at the first genetic counselling session and through a self-administered questionnaire 1 year after result disclosure., Results: At the genetic counselling session, approximately 15% of women (31/209) reported using HRT, a proportion that is significantly lower than the 25% observed among similarly aged women from the general Quebec population (P < .001). Further analyses, based on the generalized estimating equations models, were carried out to evaluate variations in HRT use from the first genetic counselling session up to 1 year post-disclosure of BRCA1/2 test results. These analyses indicated a trend toward decreased HRT use among BRCA1/2 mutation carriers (P = .08)., Conclusions: Women at high risk for breast cancer and ovarian cancer tend to avoid HRT when BRCA1/2 mutations are either suspected or confirmed. Further studies are needed to assess the actual risk of HRT use among women at high risk of breast cancer, and to develop clinical guidelines regarding its use in this population of women.