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http://dx.doi.org/10.1038/s41436-020-00961-6 | DOI Listing |
Trials
August 2025
MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, 90 High Holborn, 2 Floor, London, WC1V 6LJ, UK.
Background: The use of estimands in clinical trials was formalised with the adoption of the final International Conference on Harmonisation E9 Addendum on Estimands and Sensitivity Analysis in Clinical Trials (ICH E9(R1) Addendum) in November 2019. The declared objective of the ICH E9(R1) Addendum is to bring clarity and transparency to the research question of interest. For this to be achieved, the estimand must be described in accordance with the requirements of the ICH E9(R1) Addendum so that the target treatment effect is clear to all stakeholders.
View Article and Find Full Text PDFMol Diagn Ther
August 2025
Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.
Background And Objective: Human papillomavirus (HPV) is the cause of most cervical cancers and is released as circulating cell-free tumour HPV DNA (ctHPV DNA) into circulation. Earlier studies have indicated that ctHPV DNA is a promising biomarker for analysing treatment response and for recurrence surveillance. However, factors influencing the release of ctHPV DNA, including HPV type and HPV viral load, have not been extensively studied and additional biomarkers for prognosis are needed.
View Article and Find Full Text PDFImplement Sci
August 2025
VA Center for Healthcare Evaluation, Research, and Promotion, VA Pittsburgh Healthcare System, Pittsburgh, PA, USA.
Background: The Consolidated Framework for Implementation Research (CFIR) is a determinant framework that includes constructs from many implementation theories, models, and frameworks; it is used to predict or explain barriers and facilitators to implementation success. CFIR is among the most widely applied implementation science frameworks, and after 15 years of use in the field, the framework was updated based on user feedback obtained via literature review and survey. Dissemination of the updated CFIR and accompanying outcomes addendum resulted in hundreds of requests from users for further guidance in applying the framework.
View Article and Find Full Text PDFAust Crit Care
August 2025
Department of Critical Care, Melbourne Medical School, The University of Melbourne, Australia; Department of Intensive Care, Melbourne Health, Melbourne, Australia.
Background: Peer support is a candidate intervention to improve health-related quality of life in survivors of critical illness. This trial will evaluate the effect of a codesigned digital peer support intervention (expert-facilitated, web-based peer support) compared to usual care.
Design: This study is planned as a randomised, multicentre, two-arm, parallel-group (1:1) hybrid effectiveness implementation trial of a digital peer support model versus usual care.
Front Psychiatry
July 2025
JFK Partners, University of Colorado Anschutz Medical Campus, Aurora, CO, United States.
Background: Autistic youth are at higher risk of developing anxiety compared to their peers, with as many as 40% experiencing clinical anxiety. Emerging research suggests that these rates are an underestimate as distinct presentations of anxiety (e.g.
View Article and Find Full Text PDF