Cross design analysis of randomized and observational data – application to continuation rates for a contraceptive intra uterine device containing Levonorgestrel in adolescents and adults

Abstract

Abstract Background To combine results from a randomized controlled study (RCT) and an observational study (OS) to evaluate discontinuation rate of a levonorgestrel-containing intrauterine contraceptive device (LNG IUD) in a real-life setting. Methods We included 253 parous and nulliparous women aged 21–40 years from our own phase II RCT. A total of 1607 women of all ages (including adolescents, < 20 years) were recruited from an OS. We applied the cross design synthesis (CDS) method recommended by the United States General Accounting Office. This method combines the different strengths of RCTs and OSs into one single estimate. Results Combined continuation rates for parous vs nulliparous women could be estimated more precisely as well as overall continuation rates after one (86.6%) and two years (78.5%), irrespective of age and parity. Conclusion Cross design synthesis allowed more precise estimation of continuation rates of an intrauterine device.

Keywords

• Cross design syntheses
• Continuation rates
• Intra-uterine device