Core outcome set for induction of labour trials: what's the expectation?

Abstract

The induction of labour is one of the most common procedures performed in obstetrics. As such, many clinical trials have been undertaken to try to optimise induction strategies and interventions. Unfortunately, the wide variation in the measuring and reporting of outcomes across induction studies—as well as studies involving different topics—has hampered the process of data synthesis and effective translation into clinical practice. In an effort to mitigate these challenges, there has been a growing call for the development and use of core outcome sets in the field of obstetrics. Core outcome sets that are determined to be important to each clinical question would diminish the heterogeneity between studies and also minimise the risk for reporting bias. This study (Dos Santos et al. BJOG 2018; 125:1673–80) proposes a core outcome set to be used in future clinical trials of the induction of labour. Using the Delphi method (Sinha et al. PLoS Med 2011;8(1): e1000393), the investigators utilised a systematic approach to the collation of core outcomes considered most clinically pertinent for women undergoing induction of labour. The investigators are to be commended for their efforts to use a structured multi-staged methodology that was determined a priori, and to involve multiple relevant stakeholders, including patient representatives who had some personal experience with induction of labour, across several countries. The final developed core outcome set included 28 outcome measures. This may simply reflect the conundrum of the multifaceted process of an induction of labour, and the consideration of outcomes for both pregnant women and their offspring. Such a large number of outcomes will undoubtedly pose significant challenges to future researchers, however, as they may be expected to compile and report, at a minimum, this entire set of outcomes. Furthermore, there is no proposed guideline for how each of the components within the proposed outcome set should be defined and/or measured. Although this may be outside of the scope of their work, this is an essential next step as there is likely to be significant variation in the measurement of these outcomes, which will be problematic. In addition, participants from some large high-income countries, such as the USA, as well as from middle- and low-income areas, were not well represented, and so the generalisability may be limited and hinder the widespread adoption of the proposed core outcome set. There is a growing awareness that the use of agreed-upon standardised outcome sets in clinical trials would improve research into women's health. The establishment of initiatives like The Core Outcomes in Women's and Newborn Health Initiative (www.crown-initiative.org) is encouraging. Although the development of core outcome sets is a challenge, the greater challenge will be the ‘buy-in’: the actual commitment to widespread implementation within the research community. For this to occur, proposed core outcome sets will need to be comprehensive yet feasible, specific yet generalisable, standardised but flexible, and most importantly, transparent and replicable. It is a high bar, but it is necessary if we are to truly advance our field. Dos Santos et al. take an important initial step in this quest. None declared. Completed disclosure of interests form available to view online as supporting information. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.