Many prescribers are knowledgeable about randomized controlled trials (RCT), but are less familiar with pharmacoepidemiology studies; that is, observational studies in which a pharmacologic agent is the exposure of interest. To date, few clinical trials include pregnant women. With the absence of RCT data, prescribers must largely rely on the pharmacoepidemiology literature to guide prescribing decisions for pregnant patients. We describe different types of pharmacoepidemiology studies and present a flowchart and table checklist to support clinicians to assess the quality of, and thus the validity of conclusions from, pharmacoepidemiology studies. We provide illustrative examples of published observational studies examining antidepressant treatment during pregnancy and fetal and infant outcomes.
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http://dx.doi.org/10.1016/j.semperi.2020.151225 | DOI Listing |
Dialogues Clin Neurosci
December 2025
University Bordeaux, Inserm, Bordeaux Population Health Research Center, Team Pharmacoepidemiology, UMR 1219, Bordeaux, France.
Soon after the introduction of second-generation antipsychotics, antipsychotic off-label use (OLU) progressively became a common prescribing practice. This evolving practice should be regularly monitored considering the growing number of persons exposed to the adverse effects of antipsychotics. The aim of the present review was to synthesise the literature published over the last 15 years on antipsychotic OLU for mental health symptoms.
View Article and Find Full Text PDFAnn Thorac Surg Short Rep
September 2024
Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan.
Background: Suitable tracheostomy timing after cardiac operation remains controversial; hence, this study compared the effectiveness of early and late tracheostomy after cardiac operation.
Methods: By using the nationwide administrative claims database in Japan, patients who underwent cardiac operation between April 2010 and March 2020 were identified and included in this study. In-hospital mortality, incidence of deep sternal wound infection, and ventilator-free days were analyzed and compared by dividing patients into 2 groups: an early group (patients who underwent tracheostomy 1-14 days postoperatively) and a late group (patients who underwent tracheostomy 15-30 days postoperatively).
Eur Psychiatry
January 2025
Mental Health Services Noord-Holland-Noord, Alkmaar, the Netherlands; Dutch Clozapine Collaboration Group, Alkmaar, the Netherlands.
JAMA Intern Med
December 2024
Section of Health Policy and Equity, Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.
Clin Kidney J
January 2025
MP3CV Laboratory, Jules Verne University of Picardie, Amiens, France.
Background: The serum calcification propensity test (or T50 test) might become a standard tool for the assessment of vascular calcification risk and T50 might be a valuable biomarker in clinical trials of treatments intended to slow the progression of vascular calcification. Literature data suggest that non-calcium-containing phosphate binders can influence T50 in chronic dialysed patients. However, it is not clear whether similar interventions are effective in patients at earlier stages of chronic kidney disease (CKD).
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