CROWN initiative and preterm birth prevention: researchers and editors commit to implement core outcome sets

The emphasis on research quality has taken great strides in recent years. Publication of clinical trial protocols (i.e. SPIRIT guideline), prospective registration (e.g. ClinicalTrials.gov, WHO registry), high standards in research conduct (i.e. ICH-Good Clinical Practice guidelines) and transparent reporting of the findings (i.e. CONSORT guideline) are all becoming features of clinical effectiveness research. However, many more gains are possible to further improve the efficiency of clinical research and therefore reduce waste in health research, a problem that is estimated to consume 85% of the global medical research budget each year.1 When addressing the issue of research waste, an area of concern is the use of different (incomparable) outcomes.1 In preterm birth research for example, 103 trials reported 72 different primary outcomes, while 33 Cochrane reviews reported 29 different outcomes.2 This lack of commonality in the outcomes has hampered meaningful data synthesis. If datasets cannot be combined, it is difficult to reach proper statistical power, subsequently limiting the impact research can have on clinical practice. An additional concern is that outcomes reported have not always been those that patients regard as relevant.3

Recognising that disease-specific international consensus on outcome measures is an important step towards addressing the above concerns, the CROWN (Core Outcomes in Women's and Newborn Health) initiative was launched in 2014.4 A unique, sizable consortium of 82 women's health journals in multiple languages, it promised to encourage researchers to develop disease-specific core outcome sets (i.e. the minimal sets of outcomes that relevant stakeholders consider critical for evaluation of interventions in specific health conditions and in different resource settings) using robust consensus methodology.4 Functioning as a stakeholder group, it contributed to and endorsed the first core outcome set for preterm birth studies published following peer-review in 2016, together with summary publications in several journals and languages.5 With this commentary, we wish to give an update on its dissemination.