Nonrandomized studies of interventions - complementary or just convenient?

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Date
2025-07-18
Authors
Dahly, Darren L.
Wilkinson, Jack
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Publisher
Elsevier Ltd.
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Abstract
Schwarze et al. present recommendations to improve the quality of nonrandomized studies of interventions (NRSIs). Given the methodological errors we regularly encounter when reading and reviewing NRSIs in assisted reproductive technologies (ART), we support the need for such recommendations to help researchers better design, analyze, and interpret these studies. That said, we are concerned that those who require such guidance will, almost by definition, not understand when the use of NRSIs is warranted, or mistake them as viable alternatives to randomized controlled trials (RCTs), despite reassurances from Schwarze et al. that NRSIs should be viewed as complementary. Our concerns are particularly relevant for ART, where regulation is limited, commercial conflicts of interest are common, and interventions are regularly adopted before they are evaluated using RCTs. To be clear, we do not see these as points of disagreement with Schwarze et al., but rather as additional points for consideration.
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Refers to: Schwarze, J. E., Tennant, P. W., Barnhart, K., Platt, R. W., Gupta, S., Venetis, C., D'Hooghe, T. and Schisterman, E.F. (2025) 'Recommendation to improve the rigor and impact of non-randomized studies of interventions in fertility treatment research', Fertility and Sterility. https://doi.org/10.1016/j.fertnstert.2025.05.168
Keywords
Nonrandomized studies of interventions (NRSIs) , Assisted reproductive technologies (ART) , Randomized controlled trials (RCTs)
Citation
Dahly, D. L. and Wilkinson, J. (2025) 'Nonrandomized studies of interventions - complementary or just convenient?', Fertility and Sterility. https://doi.org/10.1016/j.fertnstert.2025.07.019
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