Medical abortion reporting of efficacy: the MARE guidelines

Abstract

Contraception 94 (2016) 97 – 103 Commentary Medical abortion reporting of efficacy: the MARE guidelines ☆,☆☆ Mitchell D. Creinin ⁎ , Melissa J. Chen Department of Obstetrics and Gynecology, University of California, Davis, Sacramento, CA, USA Received 20 April 2016; accepted 22 April 2016 1. Introduction This commentary introduces the Medical Abortion Reporting of Efficacy (MARE) guidelines as a supplement to CONSORT [1] and STROBE [2]. The goal of the recommendations is to standardize early medical abortion efficacy reporting to facilitate comparison of outcomes between studies and to enrich the ability for data synthesis from different studies to create evidence-based guidelines. Although the term medical abortion had most commonly referred to the use of abortion-inducing medication for early pregnancy termination without primary surgical intervention, more recently, the phrase has been used to refer to labor induction abortions as well [3,4]. Accordingly, we consider early medical abortion to refer to procedures in the first trimester. Reports of using medical agents to cause early abortion first appeared in the 1950s [5], but the modern era of medical abortion research started in the early 1980s with the discovery of test agents that were ultimately developed into mifepristone. Over the past 30 years, research has evolved, with the use of various drugs including mifepristone, methotrexate, tamoxifen, letrozole and various prostaglandin analogs to induce early abortion [6]. The first drug with a labeled indication for medical abortion, mifepristone, was initially approved in China and France more than two decades ago. The United States Food and Drug Administration approved mifepristone in 2000 for use in combination with the prostaglandin analog misoprostol for abortion through 49 days gestation. Funding: none. Conflicts of Interest: Dr. Chen has no conflicts of interest. Dr. Creinin is a consultant to Danco. ⁎ Corresponding author. Tel.: +1-916-734-6670. E-mail address: mdcreinin@ucdavis.edu (M.D. Creinin). http://dx.doi.org/10.1016/j.contraception.2016.04.013 0010-7824/© 2016 Elsevier Inc. All rights reserved. Over the more than 25 years since mifepristone first became available for women to obtain a medical abortion, researchers have continued to evaluate alternative regimens to improve efficacy and the patient experience. Professional and national organizations now lead the way in promoting the best science by providing evidence-based recommendations for the preferred medical abortion treatment options [6–8]. Although many individual studies are methodologically strong, the heterogeneity of design, conduct and reporting hinders synthesis of data from multiple studies. Importantly, many studies do not stratify outcomes by week of gestation. These issues became evident during data collation for creation of the 2014 Medical Management of First Trimester Abortion Practice Bulletin written collaboratively by the American College of Obstetricians and Gynecologists and the Society of Family Planning [6,7]. More recently, a systematic review including approximately 30,000 patients who received mifepristone and buccal misoprostol found that only 57% had data identifying week of gestation for a stratified evaluation of overall efficacy; only 51% had such information for evaluation of continuing pregnancy [9]. Well-performed and reported research trials provide the basis for evidence-based guidelines and do more than simply inform providers and patients about more cost-effective or therapeutically effective options — they also affect access to care. Methodologically strong research can counter ideologi- cally motivated arguments for legal restrictions on medical abortion regimens and gestational age limits. The medical community can use this evidence to oppose such legislation. Future synthesis of the large body of available data to inform patient care and regulatory policy can be facilitated with the use of guidelines to ensure that publications of original data are presented in a standardized way. We herein present reporting recommendations for early medical abortion as a supplement to the CONSORT guidelines (for