The conduct and reporting of randomized controlled trials (RCTs) are enhanced by being compliant with the CONsolidated Standards of Reporting Trials (CONSORT) statement. The statement was meant to be general and was aimed at most RCTs without any particular focus on specific groups of patients. However, research in pregnancy presents important unique issues and challenges that are not addressed in the CONSORT statement. Thus, we suggest that there is a need to amend the statement to address RCTs enrolling pregnant or postpartum women. We propose CONSORT-OB (OBstetrics), with more than 30 modifications to the current statement. We hope the CONSORT group would consider our proposal, and we respectfully suggest that investigators incorporate these additional data into their reporting of RCTs involving pregnant or postpartum women.
"r non - inferiority and equivalence trials ( Piaggio et al . , 2006 ) or interventions , for example non - pharmacologic treatments ( Boutron et al . , 2008 ) , herbals ( Gagnier et al . , 2006 ) or acu - puncture ( MacPherson et al . , 2010 ) . Other groups in obstetrics and gyne - cology have modified the CONSORT checklist for obstetric trials ( Chauhan et al . , 2013 ) ."
[Show abstract][Hide abstract] ABSTRACT: Infertility is a common disability, and is listed by theWorld Health Organization as the fifth leading serious disability among populations under the age of 60 years. Effective therapies exist, but evidence-based options are uncommon. Clinical trials in infertility treatment lack uniform guidelines for reporting methodology and results. Clinical trials in infertility are unique in that they usually involve, at minimum, two individuals who may receive or participate in treatment, i.e. a woman and a man, and if treatment is successful, a third individual is followed in the trial, i.e. an infant, who is also the desired outcome of the treatment. This tri-partite involvement of three unique humans in a clinical trial is unprecedented in other clinical trials and the CONSORT (Consolidated Standards Of Reporting Trials) guidelines leave several areas of uncertainty in what to report with multiple individuals involved. Two of the individuals, a woman seeking pregnancy and the infant, have been classified ethically as vulnerable populations requiring careful collection of all adverse events, including congenital anomaly rates. Participants may experience varied risk and benefit from the trial, for example multiple pregnancy may be desired by the father, feared by the mother, and fatal to the infant. The outcome of primary interest to participants, i.e. a live birth, is separated fromthe actual treatment by 9 months and subject to confounding influences from other factors. These myriad issues lead to incomplete and inconsistent reporting of results.We developed this modification to the CONSORT statement, which we describe and justify in this document, in order to report the items of vital interest to infertile couples, clinicians and the public that should be collected in an infertility trial.
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