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Large simple randomized controlled trials-from drugs to medical devices: lessons from recent experience.
Trials
January 2025
Department of Cardiology, University Hospital of Wales, Cardiff, UK.
Randomized controlled trials (RCTs) are the cornerstone of modern evidence-based medicine. They are considered essential to establish definitive evidence of efficacy and safety for new drugs, and whenever possible they should also be the preferred method for investigating new high-risk medical devices. Well-designed studies robustly inform clinical practice guidelines and decision-making, but administrative obstacles have made it increasingly difficult to conduct informative RCTs.
View Article and Find Full Text PDFMachine learning-based models for prediction of innovative medicine reimbursement decisions in Scotland.
J Epidemiol Popul Health
January 2025
Aix-Marseille University, CEReSS-Health Service Research and Quality of Life Center: UR3279, Marseille, France.
Objective: This study aimed to investigate the critical factors for reimbursement decisions of innovative medicines in Scotland and to explore the feasibility of machine learning models for predicting decisions.
Method: All appraisals for innovative medicines issued by the Scottish Medicines Consortium (SMC) from 2016 to 2020 were screened to extract decision outcomes and 24 explanatory factors. SelectKBest with chi-square test was used for factor selection.
From union clout to corporate couture: Unveiling the impact of trade unions on corporate social responsibility.
PLoS One
January 2025
Economics Area, Indian Institute of Management Indore, Indore, Madhya Pradesh, India.
Trade unions and corporate social responsibility (CSR) are important institutional mechanisms through which corporations undertake responsibility for their for-profit as well as not-for-profit actions. This study explores the roles of trade unions, management, and shareholders in influencing environmental, social, and governance (ESG) controversies and CSR reporting. Drawing on instrumental stakeholder theory, we argue that while management and shareholders typically focus on governance, profitability, and operational efficiency, trade unions act as critical relational stakeholders advocating for employee welfare and social sustainability.
View Article and Find Full Text PDFHelping people with psychosis with a low-cost intervention DIALOG+: protocol for the economic evaluation in a randomised control trial in India and Pakistan.
BMJ Open
January 2025
Unit for Social and Community Psychiatry, Queen Mary University of London Faculty of Medicine and Dentistry, London, UK.
Background: Approximately 69%-89% of people with severe mental illnesses, particularly psychosis, experience a treatment gap in low- and middle-income countries (LMICs) due to factors such as low public spending on health and weak healthcare systems. The PIECEs project aims to assess the effectiveness and cost-effectiveness of a solution-focused resource-oriented approach (DIALOG+) for improving the quality of life and mental well-being of people with psychosis in India and Pakistan.
Methods: The research design of this analysis is an economic evaluation piggybacked on the PIECEs randomised control trial to test the feasibility of DIALOG+ in India and Pakistan.
Willingness to pay for exercise oncology services: a mixed methods study.
Support Care Cancer
January 2025
Department of Health Services Research, Peter MacCallum Cancer Centre, Victoria, Australia.
Purpose: To evaluate cancer patients' willingness to pay for exercise services and oncology health professionals' perception of patients' willingness to pay.
Methods: A mixed-methods design was used. Online questionnaires and semi-structured interviews were administered to people with any type of cancer and oncology health professionals delivering clinical care.
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