Practitioner reporting of birth defects in children born following assisted reproductive technology: Does it still have a role in surveillance of birth defects?

BACKGROUND: National assisted reproductive technology (ART) data collections that rely on practitioners' reports of birth defects have consistently reported lower proportions of children with birth defects than record linkage studies that link ART infants to birth and malformation registers. METHODS: We compared the birth defect data reported to the national Australian Assisted Conception Data Collection (ACDC) by practitioners at three Western Australian ART clinics with the birth defect data identified on the Western Australian Birth Defects Registry (WABDR) through record linkage of all the pregnancies conceived at these clinics to the WABDR. Cases are reported to the WABDR by multiple statutory and voluntary sources. RESULTS: We found that the national ACDC significantly underestimated the prevalence of birth defects in WA-born ART infants. Less than one-third of ART children identified with a major birth defect on the WABDR were reported to the ACDC. CONCLUSIONS: Although national ART data collections provide valuable information on pregnancy rates and short-term pregnancy outcomes such as multiple birth and birth weight, we strongly recommend that birth defect information used for patient counselling is preferentially drawn from large studies that have used record linkage to high-quality birth defect registers.     

‘Oh my God,I can't handle this!’: trainees’ emotional responses to complex situations

Context

Dealing with emotions is critical for medical trainees’ professional development. Taking a sociocultural and narrative approach to understanding emotions, we studied complex clinical situations as a specific context in which emotions are evoked and influenced by the social environment. We sought to understand how medical trainees respond to emotions that arise in those situations.

Methods

In an international constructivist grounded theory study, 29 trainees drew two rich pictures of complex clinical situations, one exciting and one frustrating. Rich pictures are visual representations that capture participants’ perceptions about the people, situations and factors that create clinical complexity. These pictures were used to guide semi‐structured, individual interviews. We analysed visual materials and interviews in an integrated way, starting with looking at the drawings, doing a ‘gallery walk’, and using the interviews to inform the aesthetic analysis.

Results

Participants’ drawings depicted a range of personal emotions in response to complexity, and disclosed unsettling feelings and behaviours that might be considered unprofessional. When trainees felt confident, they were actively participating, engaged in creative problem‐solving strategies, and emphasised their personal involvement. When trainees felt the situation was beyond their control, they described how they were running away from the situation, hiding themselves behind others or distancing themselves from patients or families.

Conclusions

A sense of control seems to be a key factor influencing trainees’ emotional and behavioural responses to complexity. This is problematic, as complex situations are by their nature emergent and dynamic, which limits possibilities for control. Following a social performative approach to emotions, we should help students understand that feeling out of control is an inherent property of participating in complex clinical situations, and, by extension, that it is not something they will ‘grow out of’ with expertise.

     

Recommendations and Best Practices for Reference Standards and Reagents Used in Bioanalytical Method Validation

The continued globalization of pharmaceutics has increased the demand for companies to know and understand the regulations that exist across the globe. One hurdle facing pharmaceutical and biotechnology companies developing new drug candidates is interpreting the current regulatory guidance documents and industry publications associated with bioanalytical method validation (BMV) from each of the different agencies throughout the world. The objective of this commentary is to provide our opinions on the best practices for reference standards and key reagents, such as metabolites and internal standards used in the support of regulated bioanalysis based on a review of current regulatory guidance documents and industry white papers for BMV.     

Local excision and treatment of early node-negative anal squamous cell carcinomas in a highly HIV prevalent population

Techniques in Coloproctology - Anal squamous cell carcinoma (ASCC) is an uncommon cancer associated with human immunodeficiency virus (HIV) infection. There has been increasing interest in...     

2018 Focused Update of the Canadian Cardiovascular Society Guidelines for the Management of Atrial Fibrillation

The Canadian Cardiovascular Society (CCS) Atrial Fibrillation Guidelines Committee provides periodic reviews of new data to produce focused updates that address clinically important advances in atrial fibrillation (AF) management. This 2018 Focused Update addresses: (1) anticoagulation in the context of cardioversion of AF; (2) the management of antithrombotic therapy for patients with AF in the context of coronary artery disease; (3) investigation and management of subclinical AF; (4) the use of antidotes for the reversal of non-vitamin K antagonist oral anticoagulants; (5) acute pharmacological cardioversion of AF; (6) catheter ablation for AF, including patients with concomitant AF and heart failure; and (7) an integrated approach to the patient with AF and modifiable cardiovascular risk factors. The recommendations were developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) standards. Individual studies and literature were reviewed for quality and bias; the literature review process and evidence tables are included as Supplementary Material and are available on the CCS Web site. Details of the updated recommendations are presented, along with their background and rationale. This document is linked to an updated summary of all CCS AF guidelines recommendations, from 2010 to the present 2018 Focused Update, which is provided in the Supplementary Material.     

Changes in acquired immunodeficiency syndrome-related lymphoma since the introduction of highly active antiretroviral therapy

Clinical data on 7840 HIV-positive patients, representing 43 745 patient-years of follow-up, has been collected. All patients with ARL since 1986 (n = 150) were assessed at presentation for prognostic factors and outcomes recorded. Comparisons are made between cases in the pre-HAART era (1988-1995), and the HAART era (1996-1999). Statistical models are used to calculate the incidence of ARL and factors predicting its development. The incidence of ARL has not changed over time (3 to 7 of 1000 patients per year, P = .933), but contributes to a greater percentage of first AIDS-defining illnesses (ADI) in the HAART era (P < or = .0001). Older age, nadir CD4 count, and no prior HAART use, predict the development of ARL. There has been no change in stage at presentation, presence of B symptoms, performance status, or marrow involvement between the 2 time cohorts or between patients with or without prior HAART exposure. Similarly, there is no difference in survival duration between the pre-HAART and HAART era (log rank P = .15) or specifically in patients treated with HAART before ARL diagnosis (log rank P = .12). The use of HAART has not yet been shown to influence the incidence or survival of ARL. However, because nadir CD4 count and use of HAART are independent predictors of ARL development, this may translate into a future fall in new cases. (Blood. 2000;96:2730-2734)