Introduction: Healthcare systems must use treatments that are effective and safe. Regulators licensed many currently used older medications before introducing the stringent evidential requirements imposed on modern treatments. Also, there has been little encouragement to carry out within-class, head-to-head comparisons of licensed medicines. For commonly prescribed drugs, even small differences in effectiveness or safety could have significant public health implications. However, conventional clinical trials that randomise individual subjects are costly and unwieldy. Such trials are also often criticised as having low external validity. We describe an approach to rapidly generate externally valid evidence of comparative safety and effectiveness using the example of two widely used diuretics for the management of hypertension.
Methods And Analysis: The EVIDENCE (Evaluating Diuretics in Normal Care) study has a prospective, cluster-randomised, open-label, blinded end-point design. By randomising prescribing policy in primary care practices, the study compares the safety and effectiveness of commonly used diuretics in treating hypertension. Participating practices are randomised 1:1 to a policy of prescribing either indapamide or bendroflumethiazide when clinically indicated. Suitable patients who are not already taking the policy diuretic are switched accordingly. All patients taking the study medications are written to explaining the rationale for changing the prescribing policy and notifying them they can opt-out of any switch. The prescribing policies' effectiveness and safety will be compared using rates of major adverse cardiovascular events (hospitalisation with myocardial infarction, heart failure or stroke or cardiovascular death), routinely collected in national healthcare administrative datasets. The study will seek to recruit 250 practices to provide a study population of approximately 50,000 individuals with a mean follow-up time of two years. A primary intention-to-treat time-to-event analysis will be used to estimate the relative effect of the two policies.
Ethics And Dissemination: EVIDENCE has been approved by the East of Scotland Research Ethics Service (17/ES/0016, current approved protocol version 5, 26 August 2021). The results will be disseminated widely in peer reviewed journals, guideline committees, National Health Service (NHS) organisations and patient groups.
Trial Registration: ISRCTN 46635087 . Registered on 11 August 2017 (pre-recruitment).
Download full-text PDF |
Source |
---|---|
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8596935 | PMC |
http://dx.doi.org/10.1186/s13063-021-05782-9 | DOI Listing |
PLoS One
January 2025
Veterinary Epidemiology, Economics and Public Health Group, Department of Pathobiology and Population Sciences, WOAH Collaborating Centre in Risk Analysis and Modelling, Royal Veterinary College, London, United Kingdom.
Chicken meat (broiler) production is a rapidly growing livestock sector in India, and one dominated by contract farming. Studies have reported high levels of antibiotic use in Indian broiler farms which is concerning given this is one of the driving forces for the development of antibiotic resistance. This study used the economic lens of agency theory to examine strategic decisions which occur during contract broiler production and their potential impact on antibiotic use, using West Bengal as a case study.
View Article and Find Full Text PDFClin Infect Dis
December 2024
Public Health Ontario; Dalla Lana School of Public Health, University of Toronto; Unity Health Toronto.
Background: Shorter courses of antibiotic therapy are increasingly recommended to reduce antibiotic exposure. However quantifying the real-world impact of duration of therapy is hindered by bias common in observational studies. We aimed to evaluate the harms and benefits of longer versus shorter duration of therapy in older adults.
View Article and Find Full Text PDFAlzheimers Dement
December 2024
University of New South Wales, Sydney, NSW, Australia.
Background: Behaviour support plans (BSPs) for people in residential aged care (RAC) were mandated nationally in 2019 for those who require, or may require, restrictive practices as part of their care. The legislation aims to reduce and potentially eliminate restrictive practices: long-standing problems of their inappropriate use were highlighted by the Royal Commission into Aged Care Quality and Safety (2018). Many people living with dementia will be impacted: up to 90% experience changed behaviours; 54% of people in RACs have dementia; and approximately 20% experience cognitive decline without a diagnosis.
View Article and Find Full Text PDFAlzheimers Dement
December 2024
University of Calgary, Calgary, AB, Canada.
Background: The overuse of antipsychotics in persons with dementia in long-term care (LTC) has been a source of clinical concern, public attention, and policy intervention for over 30 years. Targeted quality improvement, broader awareness of risks, and other initiatives have resulted in substantial reductions in antipsychotic use in LTC settings in North America and elsewhere. Limited evidence suggests that reductions in antipsychotic use may be resulting in unintended consequences, such as substitution with alternate, but similarly harmful, psychotropic medications.
View Article and Find Full Text PDFOpen Forum Infect Dis
January 2025
Department of Medicine, Sinai Health and University Health Network, Toronto, Ontario, Canada.
Antibiotic resistance is a global public health threat driven, in part, by antibiotic overprescription. Behavior change theories are increasingly used to try to modify prescriber behavior. A metasynthesis of 8 reviews was conducted to identify factors influencing antibiotic prescribing for adults in hospital settings and to analyze these factors using 4 behavior change frameworks.
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!