Learning Objectives: On successful completion of this activity, participants should be able to (1) understand the requirements for first-inhuman radiopharmaceutical applications for the United States, European Union, and Canada; (2) realize the overall need for reduction of the human-use requirements due to lack of toxicity and the need to facilitate patient access; and (3) recognize that harmonization efforts between the U.S. Food and Drug Administration, Health Canada, and the European Medical Authority would streamline efforts in moving new radiopharmaceuticals forward for clinical care.
Background: Mood and anxiety issues are the main mental health complaints of women during pregnancy and the postpartum period. Services targeting such women can reduce perinatal complications related to psychiatric difficulties. This quality assurance project aimed to examine changes in mood and anxiety symptoms in pregnant and postpartum women referred to the Women's Health Concerns Clinic (WHCC), a specialized outpatient women's mental health program. Methods: We extracted patient characteristics and service utilization from electronic medical records of women referred between 2015 and 2016. We also extracted admission and discharge scores on the Edinburgh Postnatal Depression Scale (EPDS) and the Generalized Anxiety Disorder-7 (GAD-7) scale. Results: Most patients accessed the WHCC during pregnancy (54%), had a diagnosis of major depressive disorder (54.9%), were prescribed a change in their medication or dose (61.9%), and accessed psychotherapy for perinatal anxiety (30.1%). There was a significant decrease in EPDS scores between admission and discharge (t(214) = 11.57; p = .000; effect size d = .86), as well as in GAD-7 scores (t(51) = 3.63; p = .001; effect size d = .61). A secondary analysis showed that patients with more severe depression and anxiety symptoms demonstrated even greater effect sizes. Conclusions: Changes in EPDS and GAD-7 scores indicate that the WHCC is effective in reducing mood and anxiety symptoms associated with the perinatal period. This project highlights the importance of quality assurance methods in evaluating the effectiveness of clinical services targeting perinatal mental health, in order to inform policy and funding strategies.
IntroductionChronic Myeloid Leukaemia (CML) constitutes 15% of new adult leukaemia cases as well as 2%–3% of leukaemia in children under 15% and 9% of leukaemias in adolescents 15–19 years of age annually. The introduction of Tyrosine Kinase Inhibitors (TKI) therapy has dramatically improved survival in these patients, yet the off-target effects of this treatment may have long-term health impacts on CML survivors. The risk of adverse health outcomes is especially important in children, where TKI exposure may occur during critical windows of growth and puberty, and patients require treatment for prolonged periods of time. The aim of this systematic review protocol is to report on the methods used to conduct a systematic review to investigate the endometabolic and bone health effects of TKI therapy in CML.Methods and analysisSearches will be conducted in the Cochrane Central Register of Controlled Trials, EMBASE and MEDLINE from inception on August 1st, 2019. Searches may be updated while performing the systematic review to ensure new evidence is included if applicable. Grey literature search will include ClinicalTrials.gov and ProQuest Dissertations and Theses A&I. We will perform a meta-analysis if there are at least two studies reporting similar populations, interventions, methods and tracking the same outcome measures. The studies should also have similar age and sex distributions.Ethics and disseminationAs this is a systematic review protocol, it does not include patient data; therefore, Research Ethics Board approval is not indicated. The systematic review will be published in a peer-reviewed journal and presented at international conferences.PROSPERO registration numberCRD42018091175.
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