Self reported outcomes and adverse events after medical abortion through online telemedicine: population based study in the Republic of Ireland and Northern Ireland
BMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j2011 (Published 16 May 2017) Cite this as: BMJ 2017;357:j2011
All rapid responses
We read with interest the Rapid Response by Jadeva Mehet and colleagues (1) to our paper on the safety and effectiveness of abortion telemedicine (2). Abortion guidelines in the United Kingdom, Ireland, and United States do indeed recommend Anti-D be administered to Rhesus negative women obtaining medical abortions. However, Dr. Mehet and colleagues' comment raises an important issue with these guidelines, namely, that there is no evidence for this recommendation. A review of Rh prophylaxis in early pregnancy by Fiala, Fux and Gemzell Danielsson (3) concludes: “An evaluation of the risk for Rh-immunization in Rh-negative women after medical abortion using mifepristone is still missing. The existing data are commonly derived from studies on surgical abortion or older methods of medically induced abortion (saline injection). Although these methods are different in many ways compared to the method used today for early induced abortion, they are used as references for guidelines.” Moreover, national abortion guidelines do not recommend anti-D for medical abortions up to 7 weeks in Canada (4) and the Netherlands (5), 8 weeks in Denmark (6), and 9 weeks in Sweden (7).
Further, Dr. Mehet and colleagues note that the Institute of Obstetricians and Gynaecologists: Royal College of Physicians of Ireland guidelines expressly state that women experiencing a spontaneous abortion within 12 weeks' gestation do not require anti-D. However, a recent Cochrane Review of this topic concludes that “there are insufficient data available to evaluate the practice of anti-D administration in an unsensitised Rh-negative mother after spontaneous miscarriage” (8).
Treating women differently after early spontaneous pregnancy loss and medical abortions makes little sense, since the two are clinically indistinguishable. Moreover, clinical guidelines that are not evidence-based or are based on data from outdated clinical practices have limited use. In the meantime, the issue is not whether Women on Web advises women in line with current guidelines, but whether they advise them according to the best available evidence.
References
(1) Mehet J et al. Anti-D and Tele-abortions. BMJ. 2017. May 20. http://www.bmj.com/search/Anti-d%20and%20tele-abortions?f%5B0%5D=bundle%...
(2) Aiken ARA, Digol I, Trussell J, Gomperts R. Self reported outcomes and adverse events after medical abortion through online telemedicine: population based study in the Republic of Ireland and Northern Ireland. BMJ. 2017 May 16;357:j2011
(3) Fiala C, Fux M, Gemzell Danielsson K: Rh profylaxis in early pregnancy-a review, Acta Obstet Gynecol Scand. 2003 Oct;82(10):892-903
(4) http://www.jogc.com/article/S1701-2163(16)00043-8/abstract?showall=true
(5) http://fiapac.org/static/media/docs/Guideline-Treatment.pdf
(6) http://www.dsog.dk/
(7) https://www.sfog.se/start/
(8) Karanth L, Jaafar SH, Kanagasabai S, Nair NS, Barua A. Anti-D administration after spontaneous miscarriage for preventing Rhesus alloimmunisation. Cochrane Database Syst Rev. 2013 Mar 28;(3)
Competing interests: Digol and Gomperts are employed by Women on Web; Trussell is on the board of directors of the Women on Web Foundation
It is vital that the outcomes of telemedicine abortions are made available. Clandestine practices can potentially be detrimental to health. Hence the seminal publication of Aiken et al. is to be welcomed(1). However a potentially important point is overlooked by the authors. The Women on Web organisation (WoW) counsel women against the need for anti-D immunoglobin to avert Rhesus D alloimmunisation. This is contrary to the position statements of the Institute of Obstetricians and Gynaecologists: Royal College of Physicians of Ireland(2), The UK Royal College of Obstetricians of Gynaecologists(3), The American College of Obstetrics and Gynecologists(4) and the Society of Obstetricians and Gynaecologists of Canada(5).
Further, certain practices of WoW do raise some concern. The telemedicine portal advises women, should they seek medical attention, to tell attending doctors that they have suffered a miscarriage rather than attempted a medical abortion (https://www.womenonweb.org/en/page/1683/in-collection/6902/what-if-you-h...). This raises specific issues in Ireland. The Institute of Obstetricians and Gynaecologists: Royal College of Physicians of Ireland guidelines expressly state that women who suffer a spontaneous abortion within 12 weeks' gestation do not require anti-D. However in all cases of medical abortion anti-D must be administered "as soon as possible" after the event(2). The advice given by WoW may place women and subsequent children at risk. Ireland has one of the highest prevalences of the Rhesus negative phenotype in the world at 15%(6,7). This makes the WoW guidance potentially particularly hazardous in this population. It may be premature to conclude that telemedicine abortions are safe in the short- or longterm.
(1)Aiken ARA, Digol I, Trussell J, Gomperts R. Self reported outcomes and adverse events after medical abortion through online telemedicine: population based study in the Republic of Ireland and Northern Ireland. BMJ. 2017 May 16;357:j2011
(2)https://rcpi-live-cdn.s3.amazonaws.com/wp-content/uploads/2016/05/10.-An...
(3)https://www.rcog.org.uk/globalassets/documents/guidelines/best-practice-...
(4)http://www.acog.org/Resources-And-Publications/Practice-Bulletins/Commit...
(5) http://www.jogc.com/article/S1701-2163(16)00043-8/abstract?showall=true
(6) https://www.giveblood.ie/All_About_Blood/Blood_Group_Basics/
(7)Bhutani VK, Zipursky A, Blencowe H, Khanna R, Sgro M, Ebbesen F, Bell J, Mori R, Slusher TM, Fahmy N, Paul VK, Du L, Okolo AA, de Almeida MF, Olusanya BO, Kumar P, Cousens S, Lawn JE.Neonatal hyperbilirubinemia and Rhesus disease of the newborn: incidence and impairment estimates for 2010 at regional and global levels. Pediatr Res. 2013 Dec;74 Suppl 1:86-100. doi: 10.1038/pr.2013.208. web appendix www.nature.com/pr/journal/v74/n1s/extref/pr2013208x1.doc
Competing interests: No competing interests
I am concerned that you claim your study shows telemedicine abortions are safe, and in particular you cite a zero death rate, all on self-reported data (self-reported deaths being rare). You cover for this by writing essentially that a death would have been big news and you would have heard about it somehow. This seems an untenable conclusion. You have no reasonable way of detecting deaths in your methodology, indeed there was no attempt to, and although deaths resulting from these drugs would be very unlikely, this conclusion is simply not warranted. It should be removed.
You go on to write that rates of adverse events, which thankfully could be self-reported, where women sought medical care for 'a symptom of a potentially serious complication' were low at 95.0%, which I assume was another error - but the actual figure of 9.5% does not sound low to me, especially in the context of telemedicine where I imagine there are limits on continuity of care.
Competing interests: No competing interests
Re: Self reported outcomes and adverse events after medical abortion through online telemedicine: population based study in the Republic of Ireland and Northern Ireland
We regret that Dr. Ross Kirkbride (1) did not take the time to read more carefully our paper on the safety and effectiveness of abortion telemedicine (2). He makes two incorrect assertions, which we explain below.
First, the paper does not state that no deaths occurred. We stated that “No deaths resulting from the intervention were reported by family, friends, the authorities, or the media.” As we explain in the paper, far from “covering” for anything, we draw a reasonable and transparent conclusion based on the best available information. Perhaps because Dr. Kirkbride does not practice in Ireland or Northern Ireland, he does not recognize the highly politicized environment surrounding abortion, or the fact that investigations would inevitably be launched if a woman were to die in circumstances resembling an abortion attempt.
Second, we did not state that “rates of adverse events…where women sought medical care for 'a symptom of a potentially serious complication' were low at 95.0%.” Here, Dr. Kirkbride confuses the concepts of adverse events and symptoms of potentially serious complications. As clearly stated in our results, not all women experiencing the symptoms of what could be a serious complication will actually be experiencing one. Only 3.1% of women (not 95%, as Dr. Kirkbride asserts) reported treatment for an adverse event. By contrast, 9.3% of women reported the symptom of a potentially serious complication, and among these, 95% sought medical care as advised.
References
(1) Kirkbride RA. BMJ. 2017. May 19. http://www.bmj.com/content/357/bmj.j2011/rr
(2) Aiken ARA, Digol I, Trussell J, Gomperts R. Self reported outcomes and adverse events after medical abortion through online telemedicine: population based study in the Republic of Ireland and Northern Ireland. BMJ. 2017 May 16;357:j2011
Competing interests: Gomperts and Digol are employed by Women on Web; Trussell is on the board of directors of Women on Web Foundation