Key standards and principles for developing evidence-based clinical guidelines: balancing health professional, patient, funder, and government needs.

Fertil Steril

Monash Centre for Health Research and Implementation, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia; Department of Diabetes and Vascular Medicine, Monash Health, Melbourne, Victoria, Australia. Electronic address:

Published: April 2025


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Article Abstract

Clinical practice guidelines are critical tools to inform healthcare decision-making, yet development faces significant challenges in ensuring rigorous, reliable, and globally applicable recommendations. This review examines the essential standards and evolving approaches for creating high-quality, evidence-based guidelines that can effectively support clinical practice across diverse healthcare settings. Key standards for high-quality clinical practice guideline development emerge from leading global health organizations, emphasizing several critical components-establishing a multidisciplinary development group, defining a clear and relevant scope, conducting systematic evidence reviews and meta-analyses, and ensuring transparency throughout the development process. Innovative principles address emerging challenges such as research integrity assessment, incorporation of patient-centered methodologies, promotion of global collaborative approaches, and development of strategic implementation strategies. These evolving principles recognize the complex landscape of modern healthcare, where guidelines should adhere to rigorous standards to genuinely improve patient outcomes and encourage best practice care across diverse healthcare settings.

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http://dx.doi.org/10.1016/j.fertnstert.2025.01.023DOI Listing

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