Kostenen effecten van doelmatigheidsonderzoek in de obstetrie: Een budget-impactanalyse van 8 obstetrische doelmatigheidsstudies

Objective: To estimate the expected impact of nationwide effectiveness studies in obstetrics on health outcome and costs at national level. Objective: To estimate the expected impact of nationwide effectiveness studies in obstetrics on health outcome and costs at national level. Design: Budget impact analysis. Method: We searched for all completed multicenter obstetrical evaluation research completed in The Netherlands between 2008 and 2012. We used the website of the Dutch 'consortium for women's health and reproductive studies' giving an overview of all evaluation research performed at multicenter level. We also consulted gynaecologist in order to find out if other evaluation research performed in this period was missed. To be included, study results had to be published in MEDLINE or EMBASE database or available in a final report to the (governmental) funder ZonMw. Moreover, either an economical analysis had to be available, or a reliable cost-difference calculation could be performed from the available data. We extrapolated the study findings to the national situation, according to the total numbers of patients in The Netherlands on whom the study results could be applied, and performed a budget impact analysis. In this analysis, we estimated the health-improvements for mother and child, as well as potential cost-savings assuming a reasonable implementation of care after the study results had been published. The robustness of calculations was evaluated in sensitivity analyses varying assumptions on implementation after the study, difference in costs of interventions performed, difference in study-related costs and difference in incidence of studied obstetrical condition. Results: We detected 19 obstetrical evaluation studies of which 11 studies did not have a final report on their outcomes yet, while eight multicenter randomized controlled trials (RCTs) randomizing 10.980 patients met the inclusion criteria. The results of these trials had been published between 2009 and 2010 in the Lancet, JAMA, New England Journal of Medicine, Obstetrics and Gynecology, BMJ and Plos Medicine. The studies evaluated include: (1) induction of labour versus expectant monitoring for gestational hypertension or mild pre-eclampsia (GH/PE) at term (HYPITAT trial); (2) induction of labour versus expectant monitoring for intrauterine growth restriction at term (DIGITAT trial); (3) induction of labour versus expectant management in women with preterm prelabour rupture of membranes between 34 and 37 weeks (PPROMEXIL trial); (4) induction of labour with foley catheter versus vaginal prostaglandin E2 gel at term (PROBAAT trial); (5) internal versus external tocodynamometry for monitoring labour (IUPC trial); (6) 17α-Hydroxyprogesteron Caproate for the prevention of adverse neonatal outcome in multiple pregnancies (AMPHIA trial); and (7) effect of maintenance tocolysis with nifedipine in threatened preterm labour (APOSTEL II trial). A potential benefit on the health of mothers and children could be observed in women suffering from pregnancy induced hypertension and mild pre-eclampsia, women with an unripe cervix in whom labour was induced; and women undergoing fetal monitoring. Within women with hypertensive disease at term, for example, an increase in labour induction from 50% to 80% in women suffering GH/PE at term, can potentially reduce a severe maternal morbidity with 10%. Intravenous antihypertensive medication is no longer needed for 32% and 20% of their neonates will not be born with an arterial pH of less than 7.05. Furthermore, de-implementation of non-effective practices such as prolonged tocolysis and induction of labour in preterm prelabour ruptured membranes or not implementing a strategy such as progestagens for the prevention of preterm delivery in twins generates substantial cost savings. The potential cost reduction of these eight studies was found to be €9,6 million per year, on basis of a one-time investment of €3,1 million for the conduction of the evaluation projects. Conclusion: Evaluation of the effectiveness and the health care efficiency of obstetrical care can potentially result in considerable health-gains and cost-reduction when compared to continuation of non-evaluated treatment. The potential reduction of health costs at national level found in this study is 3 times the trial costs. Adequate implementation and de-implementation of the results of effectiveness studies is essential. This economical analysis can be extended toward other medical fields and might be extrapolated to a global level.