Developing a core outcome set for future infertility research: an international consensus development study †‡

AbstractSTUDY QUESTIONCan a core outcome set to standardize outcome selection, collection and reporting across future infertility research be developed?SUMMARY ANSWERA minimum data set, known as a core outcome set, has been developed for randomized controlled trials (RCTs) and systematic reviews evaluating potential treatments for infertility.WHAT IS KNOWN ALREADYComplex issues, including a failure to consider the perspectives of people with fertility problems when selecting outcomes, variations in outcome definitions and the selective reporting of outcomes on the basis of statistical analysis, make the results of infertility research difficult to interpret.STUDY DESIGN, SIZE, DURATIONA three-round Delphi survey (372 participants from 41 countries) and consensus development workshop (30 participants from 27 countries).PARTICIPANTS/MATERIALS, SETTING, METHODSHealthcare professionals, researchers and people with fertility problems were brought together in an open and transparent process using formal consensus science methods.MAIN RESULTS AND THE ROLE OF CHANCEThe core outcome set consists of: viable intrauterine pregnancy confirmed by ultrasound (accounting for singleton, twin and higher multiple pregnancy); pregnancy loss (accounting for ectopic pregnancy, miscarriage, stillbirth and termination of pregnancy); live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital anomaly. Time to pregnancy leading to live birth should be reported when a...
Source: Human Reproduction - Category: Reproduction Medicine Source Type: research