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A Consistent Lack of Consistency: Definitions, Evidentiary Expectations and Potential Use of Meaningful Change Data in Clinical Outcome Assessments Across Stakeholders. Results from a DIA Working Group Literature Review and Survey.
Ther Innov Regul Sci
January 2025
Bayer US LLC, Whippany, NJ, USA.
Background: Clinical outcome assessments (COAs) measure how patients feel or function and can be used to understand which patients experience benefits of treatment and which do not. Interpretation of COA data is influenced by how meaningful change is defined. We aimed to compare how different stakeholders define, assess, and use meaningful change for decisions that impact patients.
View Article and Find Full Text PDFClinical Pharmacokinetics of Antitubercular Drugs in the Overweight and Obese Population: Implications for Dosage Adjustments.
Clin Pharmacokinet
January 2025
Department of Clinical Pharmacology, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.
The rise in global obesity prevalence has increased the need to understand the pharmacokinetics of drugs in overweight and obese individuals. Tuberculosis remains a significant health challenge, and its treatment outcomes can be influenced by the pharmacokinetic profiles of antitubercular agents. This literature review aims to point out the clinical pharmacokinetics of antitubercular drugs in the overweight and obese patient population, highlighting considerations for potential dosage adjustments.
View Article and Find Full Text PDFWhat is the Surgical Burden of Treatment for High-Energy Lower Extremity Trauma? A Secondary Analysis of the OUTLET Study.
J Orthop Trauma
January 2025
Department of Orthopaedic Surgery, University of California, San Francisco, San Francisco, CA.
Objectives: To describe and enumerate surgeries for patients who underwent reconstruction or amputation after severe distal tibia, ankle, and mid to hindfoot injuries.
Methods: Design: Secondary analysis of a multicenter prospective observational study.
Setting: 31 U.
Understanding Interpersonal Influences on Maternal Health Service Utilization at Community Health Centers: A Mixed-Methods Study in Indonesia.
Healthcare (Basel)
December 2024
Institute of History and Ethics of Police and Public Administration (IGE), University of Applied Sciences for Police and Public Administration, 52068 Aachen, Germany.
: The utilization of maternal health services at the primary healthcare level is still considered an effective approach despite the critical role in improving maternal health outcomes. The study aimed to assess the influence of sociodemographic characteristics and interpersonal support on the use of maternal health services in three regions of the Province of Jambi, Indonesia. : Using a mixed-methods sequential explanatory design, a quantitative survey of 432 women and qualitative focus group discussions with nine families were conducted.
View Article and Find Full Text PDFWhat Is Truly Informed Consent in Medical Practice and What Has the Perception of Risk Got to Do with It?
Healthcare (Basel)
December 2024
SHARE-Centre for Resilience in Healthcare, Faculty of Health Sciences, University of Stavanger, N-4036 Stavanger, Norway.
Making decisions about risk, describing and appropriately explaining risk in medical practice is complex for patients and professionals. In this paper, we investigate how the concept of consent is practiced differently in the UK and Norway and discuss pros and cons of the chosen approaches from a patient safety culture perspective. We argue that consent is a fundamental part of the safety culture and influence on health system functioning and patient and staff safety.
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