CommentaryMedical abortion reporting of efficacy: the MARE guidelines☆,☆☆
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.
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], [7], [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 ideologically 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 randomized trials) and STROBE guidelines (for prospective and retrospective cohort studies), referred to as MARE, MARE-C and MARE-S, respectively. The goals of these guidelines align with the CROWN and COMET initiatives to promote core outcome data sets [10], [11].
Section snippets
The MARE supplement
The MARE supplement consists of 14 additional items that clarify the existing CONSORT (MARE-C, Table 1) and STROBE (MARE-S, Table 2) guidelines for early medical abortion trials. The aims of the statement are primarily to ensure standardized reporting of the regimen used, number of women treated, number who had follow-up (outcome) data available and efficacy outcomes by gestational age. Reporting outcomes in a standard manner will ensure that data are available for better synthesis into
Endorsement
The Society of Family Planning, an academic society dedicated to improving sexual and reproductive health, endorses these guidelines. We hope that abortion researchers as well as funders of abortion research will support the MARE supplements to CONSORT (MARE-C) and STROBE (MARE-S). We invite the editors of women's health scientific journals to include the MARE supplements in author guidelines. The supplements will be maintained and updated by the Society of Family Planning.
Acknowledgement
- 1.
Meeting participants for discussion of possible medical abortion efficacy reporting guidelines (October 7, 2015, Vancouver, BC, Canada).
Meeting attendees.
Paul Blumenthal, MD, MPH; Stanford University.
Mitchell Creinin, MD; University of California, Davis; Sacramento, CA.
Bela Ganatra, MD; World Health Organization.
Daniel Grossman, MD, MPH; University of California, San Francisco; IBIS Reproductive Health.
Susan Higginbotham; Executive Director, Society of Family Planning.
Elizabeth Raymond, MD,
References (11)
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CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials
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The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines or reporting observational studies
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(2008) Medical abortion regimens: historical context and overview
Am J Obstet Gynecol
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Clinical guidelines. Labor induction abortion in the second trimester
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(2011) Therapeutic abortions with a folic acid antagonist, 4-Aminopteroyglutamic acid (4-amino P.G.A.) administered by the oral route
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Cited by (30)
The Safety and Efficacy of a “No Touch” Abortion Program Implemented in the Greater Toronto Area During the COVID-19 Pandemic
2024, Journal of Obstetrics and Gynaecology CanadaSafety and effectiveness of self-managed medication abortion provided using online telemedicine in the United States: A population based study
2022, The Lancet Regional Health - AmericasStandardizing abortion research outcomes (STAR): Results from an international consensus development study
2021, ContraceptionCitation Excerpt :Robust, well-developed clinical trials and guidelines on abortion provide information that can enhance safety, effectiveness, and acceptability of these ubiquitous services. Thus far, researchers have reported on a variety of outcomes in abortion clinical trials, with some efforts to standardize medical abortion effectiveness and surgical abortion outcomes reporting [13,14]. The STAR project is a 3-stage international and interdisciplinary effort to identify the most relevant outcomes for abortion-related research [15].
Medical abortion at 13 or more weeks gestation provided through telemedicine: A retrospective review of services
2021, Contraception: XCitation Excerpt :The primary outcome of the analysis was pregnancy status after medical abortion drug administration, as measured via self-report, either in the post- medical abortion evaluation or online communication with Women on Web. Secondary outcomes were incidence of adverse events and seeking additional treatment from a health facility, including surgical uterine evacuation, to align with the Medical Abortion Reporting Efficacy (MARE-S) guidelines [28]. The MARE-S guidelines recommend defining a successful medical abortion as one in which the intrauterine pregnancy is expelled without need for surgical intervention [28].
Outcomes During Early Implementation of Mifepristone-Buccal Misoprostol Abortions up to 63 Days of Gestation in a Canadian Clinical Setting
2019, Journal of Obstetrics and Gynaecology Canada
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Funding: none.
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Conflicts of Interest: Dr. Chen has no conflicts of interest. Dr. Creinin is a consultant to Danco.