Implications of Changing the Diagnostic Criteria for Gestational Diabetes Mellitus (CDC4G): A Healthcare Cost Analysis Alongside a Stepped Wedge Cluster Randomised Trial

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Abstract
Objective: To estimate the effect on healthcare resource use after introducing the World Health Organization diagnostic criteria (WHO‐2013) for gestational diabetes mellitus (GDM) compared to former criteria in Sweden (SWE‐GDM).Design: A cost‐analysis alongside the Changing Diagnostic Criteria for Gestational Diabetes (CDC4G) randomised controlled trial.Setting: Sweden, with risk‐factor based screening for GDM.Population: 47 080 pregnant women and their infants.Methods: A register‐based cost‐analysis from a healthcare perspective alongside a stepped‐wedge cluster RCT of switching from SWE‐GDM to WHO‐2013 criteria in 2018. Analyses were made on the population level and repeated in the subgroup affected by the intervention, that is, those with plasma glucose values between SWE‐GDM and WHO‐2013 criteria. Sensitivity analysis by bootstrapping was performed.Main Outcome Measures: Estimated costs for obstetric surveillance (including GDM‐management), delivery and neonatal healthcare until 28 days postpartum.Results: On a population level, the WHO‐2013 criteria were associated with increased costs of obstetric surveillance (adjusted mean [bootstrap confidence interval]) €94.0 [24.5–169.1], delivery care €20.4 [−33.5 to 75.4] and neonatal care €331.0 [75.1–589.0] per pregnancy, and in the affected subgroup €606.9 [377.7–872.4], €348.5 [126.0–542.0] and €129.3 [−559.0 to 980.9] respectively.Conclusions: Implementation of the WHO‐2013 criteria in Sweden was associated with increased costs for obstetric surveillance and delivery on a population level, driven by the affected subgroup. The increased costs for neonatal care were associated with large uncertainty. A detailed understanding of the changes in resource use can guide decisions to mitigate cost increases.
Funding Information
  • Vetenskapsrådet (2018‐00470)
  • Skånes universitetssjukhus (REGSKANE‐622891)

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