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Beyond evidence hierarchies: Leveraging randomized controlled trials and real-world data to advance the value of

Yanan Hu1, Valerie Slavin2,3,4,5, Joanne Enticott1

  • 1Monash Centre for Health Research and Implementation, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.

Acta Obstetricia Et Gynecologica Scandinavica
|January 9, 2026
PubMed

While existing literature has compared the methodological strengths and limitations of randomized controlled trials (RCTs) and real-world data (RWD) in general medical research, two critical gaps remain unaddressed: (1) no prior communication papers have specifically examined this comparison in the context of maternity care where unique ethical and practical considerations exist, and (2) no studies have systematically compared cost-effectiveness analyses derived from RCTs versus RWD approaches-a crucial dimension for value-based maternity care decisions. This article examines how both approaches can strengthen the evidence base and support the delivery of value-based maternity care. We argue that neither RCTs nor RWD should be regarded as inherently superior in guiding decision-making. Each study design offers valuable insights, and their findings must be critically appraised in light of methodological rigor, context, and relevance, particularly when their results diverge.

Keywords:
costmaternitypregnancyreal‐world datatrialvalue‐based care

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