Pharmacoepidemiol Drug Saf
Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
Published: July 2020
Purpose: As more biosimilars become available in the United States, postapproval noninterventional studies describing biosimilar switching and comparing effectiveness and/or safety between switchers and nonswitchers will play a key role in generating real-world evidence to inform clinical practices and policy decisions. Ensuring sound methodology is critical for making valid inferences from these studies.
Methods: The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) convened a workgroup consisting of academic researchers, industry scientists, and practicing clinicians to establish best practice recommendations for the conduct of noninterventional studies of biosimilar and reference biologic switching. The workgroup members participated in eight teleconferences between August 2017 and February 2018 to discuss specific topics and build consensus.
Results: This report provides workgroup recommendations covering five main considerations relating to noninterventional studies describing reference biologic to biosimilar switching and comparing reference biologic to biosimilars for safety and effectiveness in the presence of switching at treatment initiation and during follow-up: (a) selecting appropriate data sources from a range of available options including insurance claims, electronic health records, and registries; (b) study designs; (c) outcomes of interest including health care utilization and clinical endpoints; (d) analytic approaches including propensity scores, disease risk scores, and instrumental variables; and (e) special considerations including avoiding designs that ignore history of biologic use, avoiding immortal time bias, exposure misclassification, and accounting for postindex switching.
Conclusion: Recommendations provided in this report provide a framework that may be helpful in designing and critically evaluating postapproval noninterventional studies involving reference biologic to biosimilar switching.
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http://dx.doi.org/10.1002/pds.4809 | DOI Listing |
BMC Public Health
January 2025
Department of Nutrition and Dietetics, Kutahya Health Sciences University School of Health Sciences, Kütahya, Turkey.
Background: This study was conducted to identify the impacts of the healthy plate model workshop on 4th-graders nutrition knowledge, behaviors, and habits.
Methods: The study was conducted from March to June 2023 in the Uskudar district of Istanbul, involving 102 children (50% girls) with a mean age of 10.2 ± 0.
J Dent
January 2025
Department of Restorative, Preventive and Pediatric Dentistry, zmk bern, University of Bern, Switzerland; Unit for Practice-based Research, School of Dental Medicine, University of Bern, Switzerland. Electronic address:
Objectives: The aim of this non-interventional, multi-center, prospective, practice-based study was, firstly, to evaluate the longevity of composite build-ups in endodontically treated teeth, treated with root canal therapy (ETT), without post placement and secondly, to identify and analyze factors influencing the success of these reconstructions.
Methods: Each of seven general dental practitioners placed up to 50 composite build-ups without additional posts in ETT. Teeth were restricted to incisors, canines and premolars.
PLOS Digit Health
January 2025
Centre Référent Maladies Rares Neuromusculaires, Service de Médecine Physique et de Réadaptation Pédiatrique des Hospices Civils de Lyon - Hôpital Femme Mère Enfant, Bron, France.
Unlabelled: Among the 32 items of the Motor Function Measure scale, 3 concern the assessment of hand function on a paper-based support. Their characteristics make it possible to envisage the use of a tablet instead of the original paper-based support for their completion. This would then make it possible to automate the score to reduce intra- and inter-individual variability.
View Article and Find Full Text PDFInvest Ophthalmol Vis Sci
January 2025
Department of Surgical Sciences, Eye Clinic Section, University of Turin, Turin, Italy.
Purpose: This study aimed to comprehensively assess visual performance in eyes with idiopathic epiretinal membrane (iERM). Additionally, it sought to explore the associations between optical coherence tomography (OCT) imaging biomarkers and visual performance in patients with iERM.
Methods: In this prospective, non-interventional study, 57 participants with treatment-naïve iERM from the University of Turin, between September 2023 and March 2024 were enrolled.
Sleep Breath
January 2025
Faculty of Medicine, Institute of Health Sciences, Department of Public Health, University of Hacettepe, Ankara, Türkiye.
Background: Fatigue, sleep disorders, and daytime sleepiness are interconnected, posing significant risks to occupational health and workplace safety. However, the literature on their relationships remains fragmented, with notable gaps, particularly concerning working populations. This descriptive cross-sectional study aimed to evaluate sleep quality (SQ), daily sleep time in hours (DST), daytime sleepiness, fatigue levels among employees in an automotive workplace, and their interrelationships.
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