A recent study published in Acta Obstetricia et Gynecologica Scandinavica argues that both randomized controlled trials (RCTs) and real-world data (RWD) are valuable for guiding maternity care.
These findings are relevant for myriad patients and conditions, including fetal and neonatal alloimmune thrombocytopenia (FNAIT).
“We argue that neither RCTs nor RWD should be regarded as inherently superior in guiding decision-making,” the authors explained. “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.”
RCTs are conducted under highly monitored settings and are often regarded as the gold standard for clinical research. RWD, on the other hand, reflects everyday experiences in an uncontrolled environment.
While previous research has considered the strengths and weaknesses of RCTs and RWD, no communication papers have evaluated this relationship as it pertains to maternal care. Additionally, no systematic studies have assessed the cost-effectiveness analyses derived from each approach.
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Although RCTs are reliable for studying causal relationships, they suffer from pitfalls such as limited inclusion criteria and strict protocols. As a result, findings may not necessarily be generalizable to diverse maternal populations. Individuals who live in rural areas, are in lower income brackets and have migrant status are less likely to be represented in RCTs.
RWD, the authors argued, should be viewed as a complement to RCTs. Oftentimes, RWD is obtained from patient health records, registries and insurance claims. RWD better captures underserved populations and allows researchers to obtain a better picture of patient outcomes in the real world. Like RCTs, though, RWD have limitations of their own. It is more likely to be impacted by missing data and confounding factors.
One method of combining RCT and RWD that has been evaluated in obstetrics and gynecology is called target trial emulation. This approach uses RWD to construct a hypothetical RCT and is quicker and more cost-effective than a clinical trial.
In terms of cost analysis, RCTs generally consider only direct costs. RWD may contain more information on indirect costs and payer-specific information. However, this is dependent on data availability and linkage.
The researchers caution that both RCTs and RWD can succumb to quality issues like information suppression, data falsification and plagiarism.
“No single study, RCT or RWD, can be deemed definitive,” they concluded. “By harnessing the complementary evidence from RCTs and RWD, stakeholders including policymakers, health care professionals, and women and their families, are able to make better-informed decisions that promote higher value maternity care.”
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