Standardizing definitions and reporting guidelines for the infertility core outcome set: an international consensus development study

Study QuestionCan consensus definitions for the core outcome set infertility be identified in order to recommend a standardized approach reporting?Summary AnswerConsensus individual outcomes, contextual statements, and reporting table have been developed.What is Known AlreadyDifferent exist outcomes infertility. This variation increases opportunities researchers engage with selective reporting, which undermines secondary research compromises clinical practice guideline development.Study Design, Size, DurationPotential were by systematic review of definition development initiatives guidelines reviewing Cochrane Gynaecology Fertility Group guidelines. These discussed face-to-face meeting, agreed definitions. A was also developed as part process.Participants/Materials, Setting, MethodsHealthcare professionals, researchers, people fertility problems brought together an open transparent process using formal methods.Main Results Role ChanceForty-four potential inventoried across four initiatives, including Harbin Consensus Conference Workshop International Committee Monitoring Assisted Reproductive Technologies, 12 guidelines, Twenty-seven participants, from 11 countries, contributed meeting. successfully all outcomes. Specific recommendations made improve reporting.Limitations, Reasons CautionWe used methods, inherent limitations. There limited representation low- middle-income countries.Wider Implications FindingsA minimum data should assist populating protocols, case report forms, other collection tools. The generic provide clear guidance their results within journal publications conference presentations. Research funding bodies, Standard Protocol Items: Recommendations Interventional Trials statement, over 80 specialty journals committed implementing this set.Study Funding/Competing Interest(s)This funded Catalyst Fund, Royal Society New Zealand, Auckland Medical Maurice Phyllis Paykel Trust. Siladitya Bhattacharya reports being Editor-in-Chief Human Reproduction Open editor group. Hans Evers Editor Emeritus Reproduction. Richard Legro consultancy fees Abbvie, Bayer, Ferring, Fractyl, Insud Pharma Kindex sponsorship Guerbet Hass Avocado Board. Ben Mol Guerbet, iGenomix, Merck, Merck KGaA ObsEva. Craig Niederberger Sterility Section Journal Urology, financial interest NexHand. Ernest Ng Merck. Annika Strandell Guerbet. Jack Wilkinson statistical Andy Vail that he Statistical & Review His employing institution has received payment HFEA his advice on evidence inform ‘traffic light’ system treatment ‘add-ons'. Lan Vuong Sharp Dohme. remaining authors declare no competing interests relation work presented. All completed disclosure form.Trial Registration NumberCore Outcome Measures Effectiveness Initiative: 1023. Can reporting? developed. Different development. Potential process. Healthcare methods. Forty-four reporting. We countries. set.