Tackling poorly selected, collected, and reported outcomes in obstetrics and gynecology research

Clinical research should ultimately improve patient care. To enable this, randomized controlled trials must select, collect, and report outcomes which are both relevant to clinical practice and genuinely reflect the perspectives of key stakeholders including healthcare professionals, researchers, and patients. Unfortunately, many randomized controlled trials fall short of this requirement. Complex issues, including a failure to take into account the perspectives of key stakeholders when selecting outcomes, variations in outcome definitions and measurement instruments, and outcome reporting bias make research evidence difficult to interpret, undermining the translation of research into clinical practice. Problems with poor outcome selection, measurement, and reporting can be addressed by developing, disseminating, and implementing core outcome sets. A core outcome set represents a minimum data set of outcomes developed using robust consensus science methods engaging diverse stakeholders including healthcare professionals, researchers, and patients. Core outcomes should be routinely utilized by researchers, collected in a standardized manner, and reported consistently in the final publication. They are currently being developed across our specialty including infertility, endometriosis, and preeclampsia. Recognizing poorly-selected, -collected, and -reported outcomes as serious hindrances to progress in our specialty, over 80 journals including the American Journal of Obstetrics and Gynecology, have come together to support the Core Outcomes in Women’s and Newborn Health (CROWN) initiative. The consortium supports researchers to develop, disseminate, and implement core outcome sets. Implementing core outcome sets could make a profound contribution to addressing poorly-selected, -collected, and -reported outcomes. Implementation should ensure future randomized controlled trials hold the necessary reach and relevance to inform clinical practice, enhance patient care, and improve patient outcomes