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http://dx.doi.org/10.7189/jogh.10.0203106 | DOI Listing |
Biom J
October 2025
Novella Clinical Full Service, IQVIA, Melbourne, Australia.
Phase I dose escalation trials in oncology generally aim to find the maximum tolerated dose. However, with the advent of molecular-targeted therapies and antibody drug conjugates, dose-limiting toxicities are less frequently observed, giving rise to the concept of optimal biological dose (OBD), which considers both efficacy and toxicity. The estimand framework presented in the addendum of the ICH E9(R1) guidelines strengthens the dialogue between different stakeholders by bringing in greater clarity in the clinical trial objectives and by providing alignment between the targeted estimand under consideration and the statistical analysis methods.
View Article and Find Full Text PDFWounds
August 2025
Solventum, Maplewood, MN, USA.
Background: Initially limited to inpatient use, negative pressure wound therapy (NPWT) is now frequently used in community settings. However, complexities in wound management step-down strategies in the United Kingdom, including regional variations in referral processes, lack of consensus on funding criteria, and limited availability of NPWT units, have led to extended hospital length of stay (LOS) for patients ready for discharge but still needing NPWT. Single-use NPWT (sNPWT) can serve as a bridge between hospital and community NPWT.
View Article and Find Full Text PDFKnee Surg Relat Res
September 2025
Florida Orthopaedic Institute, Gainesville, FL, 32607, USA.
Background: A clear understanding of minimal clinically important difference (MCID) and substantial clinical benefit (SCB) is essential for effectively implementing patient-reported outcome measurements (PROMs) as a performance measure for total knee arthroplasty (TKA). Since not achieving MCID and SCB may reflect suboptimal surgical benefit, the primary aim of this study was to use machine learning to predict patients who may not achieve the threshold-based outcomes (i.e.
View Article and Find Full Text PDFBJOG
September 2025
Department of Obstetrics and Gynaecology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
Objective: To estimate the effect on healthcare resource use after introducing the World Health Organization diagnostic criteria (WHO-2013) for gestational diabetes mellitus (GDM) compared to former criteria in Sweden (SWE-GDM).
Design: A cost-analysis alongside the Changing Diagnostic Criteria for Gestational Diabetes (CDC4G) randomised controlled trial.
Setting: Sweden, with risk-factor based screening for GDM.