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Background: There is increasing evidence that co-design can lead to more engaging, acceptable, relevant, feasible, and even effective interventions. However, no guidance is provided on the specific designs and associated methods or methodologies involved in the process. We propose the development of the Preferred Components for Co-design in Research (PRECISE) guideline to enhance the consistency, transparency, and quality of reporting co-design studies used to develop complex health interventions.
Objective: The aim is to develop the first iteration of the PRECISE guideline. The purpose of the PRECISE guideline is to improve the consistency, transparency, and quality of reporting on studies that use co-design to develop complex health interventions.
Methods: The aim will be achieved by addressing the following objectives: to review and synthesize the literature on the models, theories, and frameworks used in the co-design of complex health interventions to identify their common elements (components, values or principles, associated methods and methodologies, and outcomes); and by using the results of the scoping review, prioritize the co-design components, values or principles, associated methods and methodologies, and outcomes to be included in the PRECISE guideline.
Results: The project has been funded by the Canadian Institutes of Health Research.
Conclusions: The collective results of this project will lead to a ready-to-implement PRECISE guideline that outlines a minimum set of items to include when reporting the co-design of complex health interventions. The PRECISE guideline will improve the consistency, transparency, and quality of reports of studies. Additionally, it will include guidance on how to enact or enable the values or principles of co-design for meaningful and collaborative solutions (interventions). PRECISE might also be used by peer reviewers and editors to improve the review of manuscripts involving co-design. Ultimately, the PRECISE guideline will facilitate more efficient use of new results about complex health intervention development and bring better returns on research investments.
International Registered Report Identifier (irrid): PRR1-10.2196/50463.
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http://dx.doi.org/10.2196/50463 | DOI Listing |
JMIR Med Inform
September 2025
Department of Hepatobiliary and Vascular Surgery, First Affiliated Hospital of Chengdu Medical College, Chengdu, China.
Background: Primary liver cancer, particularly hepatocellular carcinoma (HCC), poses significant clinical challenges due to late-stage diagnosis, tumor heterogeneity, and rapidly evolving therapeutic strategies. While systematic reviews and meta-analyses are essential for updating clinical guidelines, their labor-intensive nature limits timely evidence synthesis.
Objective: This study proposes an automated literature screening workflow powered by large language models (LLMs) to accelerate evidence synthesis for HCC treatment guidelines.
Bioanalysis
September 2025
GSK, Precision Medicine Design Assurance, Stevenage, UK.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use M10 guideline provides a global framework for bioanalytical method validation in studies intended for regulatory submission. While its structure ensures consistency and data reliability, the guideline also acknowledges that not all studies require the same level of validation. This paper examines where full compliance is essential and where scientific judgment allows for leaner, context-driven validation, such as in early-stage development, for additional matrices, metabolites, nonstandard biological matrices or studies intended for internal decision-making.
View Article and Find Full Text PDFNat Prod Res
September 2025
Facultad de Ciencias Químicas, Universidad de Colima, Coquimatlán, Colima, Mexico.
bark is used in Mexican traditional medicine to treat chronic illnesses, including diabetes. For this reason, the purpose of this work was to evaluate the anti-hyperglycaemic effect of the aqueous extract from bark. Therefore, the aqueous extract at 40 mg/kg, administered orally and chronically, exhibited an anti-hyperglycaemic effect in a streptozotocin/nicotinamide model in Wistar rats.
View Article and Find Full Text PDFCancer
September 2025
Division of Urology, Department of Surgery, University of Toronto, Toronto, Ontario, Canada.
Introduction: Treatment intensification with androgen receptor signaling inhibitors and/or chemotherapy is guideline recommended for patients with de novo metastatic hormone-sensitive prostate cancer (mHSPC). However, most patients only receive androgen deprivation therapy monotherapy. The aim was to identify physician-, patient-, and tumor-related factors associated with the receipt of treatment intensification.
View Article and Find Full Text PDFBMJ
September 2025
Centre for Pain IMPACT, Neuroscience Research Australia, Sydney, Australia
Importance: When randomized trials are unavailable or not feasible, observational studies can be used to answer causal questions about the comparative effects of interventions by attempting to emulate a hypothetical pragmatic randomized trial (target trial). Published guidance to aid reporting of these studies is not available.
Objective: To develop consensus based guidance for reporting observational studies performed to estimate causal effects by explicitly emulating a target trial.