Reviewer's report
Title:Simplified Follow-up after Medical Abortion using a Low-sensitivity Urinary
Pregnancy Test and a Checklist in Rajasthan, India -Study Protocol and
Intervention adaptation of a Randomised Control Trial
Version:2Date:6 June 2014
Reviewer: Hillary Bracken
Reviewer's report:
MAJOR COMPULSORY
1. This paper describes a protocol testing the efficacy of home-based
self-assessment after a medical abortion and the acceptability and feasibility of
the intervention in a low-resource setting. Overall, the study is well-designed and
of interest to the reproductive health community. However, two issues may limit
the applicability and relevance of the study conclusions.
First, the primary outcome of the study is rate of complete abortion in both
groups. Yet, continuing pregnancy after medical abortion is the primary outcome
of interest in any follow-up scheme. The measures of “incomplete abortion”
described by the authors (i.e. percentage of surgical interventions or clinical
administration of additional misoprostol) may be dependent upon a provider’s
experience with medical abortion, access to diagnostic technologies (i.e.
ultrasound), and clinical judgment or preference rather than a clear expression of
clinical ‘need.’ Ongoing pregnancy offers a more objective and clinically relevant
primary outcome. Assuming an ongoing pregnancy rate of 1-2%, the study is
inadequately powered to test the efficacy of the self-assessment scheme for
identifying ongoing pregnancy after medical abortion. The authors should
recognize this limitation in their discussion section.
Second, the study is designed to test a system of “self-assessment.” However,
the woman will make the decision to refer for further follow-up after consultation
with a research assistant (Page 10). The interaction with the research assistant
may be central to the decision-making around referral. A study of
self-assessment would, arguably, allow the woman to complete the follow-up
steps at home and then decide herself (without consultation with the clinic)
whether or not follow-up is necessary. Thus, the study, as designed, may be
more accurately described as testing a system of follow-up employing a
non-clinician for follow-up by phone or home visit.
2. Adaptation Phase (Page 8, paragraph 2)
“Instead of routine follow-up at seven days post-abortion, the follow-up occurred
at 10-14 days post-initiation for the purpose of the study.” Why was this change
made? Please clarify. Was the change made to ensure that the follow-up occurs
at the same time in the two groups? Given that loss to follow-up appears to be a
problem, would the rates of follow-up be improved by allowing for earlier
follow-up (i.e. at 7-10 days post-mifepristone administration)? It may be helpful
for the authors to describe how the parameters of the low-sensitivity test inform
their choice of time of follow-up.
3. Randomization Procedure (Page 8, paragraph 1): Stating the block size in the
protocol may undermine concealment.
4. Study Protocol: The authors should include a list of the screening questions
included in the self-assessment tool in the protocol. Please confirm whether (or
how) the tool was validated.
5. Misoprostol provision on Day 3 (Page 9)
What proportion of women do you anticipate will elect clinic administration of
misoprostol? A high proportion of women who elect to take the misoprostol in the
clinic may pass the pregnancy at the clinic under medical supervision (and thus
may be more informed about their abortion status). Will these women still
complete the self-assessment at home? If so, is the sample size adequately
powered to exam differences in self-assessment outcome for these two groups?
This may be a potential limitation of the study and should be addressed in the
discussion.
6. Additional procedures or extra visits (Page 11) Why will the record of treatment
for complications or adverse events before follow-up be taken from a woman’s
report rather than the clinic records? I would anticipate that the clinical record of
the procedure performed (and indications for this procedure) would be more
complete and accurate than a woman’s account of what occurred at a given visit.
Will women who return to the clinic before follow-up still be asked to complete the
pregnancy test and checklist? It would be helpful if this was addressed in the
methods section.
7. Discussion (Page 13) Paragraph 2: Depending upon the proportion of women
who elect to take the misoprostol in the clinic, this may limit the generalizability of
the findings. Also, do the authors anticipate that the criteria limiting enrollment to
a specific catchment area and the employment of RAs to contact women may
influence the generalizability of the findings? This should be addressed in the
discussion.
8. The discussion section could be shortened.
MINOR DISCRETIONARY
1. Background (Page 3, Paragraph 2, Reference 6): Are there more recent
references on the rate of legal abortions performed in India?
2. Page 4, Paragraph 1: There are three recent publications on alternative
follow-up schemes that may be of interest.
A. Bracken H, Lohr PA, Taylor J, Morroni C, Winikoff B. RU OK? The
acceptability and feasibility of remote technologies for follow-up after early
medical abortion. Contraception. 2014 Jul;90(1):29-35.
doi:10.1016/j.contraception.2014.03.016. Epub 2014 Apr 13. PubMed PMID:
24815098.
B. Michie L, Cameron ST. Simplified follow-up after early medical
abortion:12-month experience of a telephone call and self-performed
low-sensitivity urine pregnancy test. Contraception. 2014 May;89(5):440-5.
doi:10.1016/j.contraception.2014.01.010. Epub 2014 Jan 21. PubMed PMID:
24560481.
C. Ngoc NT, Bracken H, Blum J, Nga NT, Minh NH, van Nhang N, Lynd K,
Winikoff B, Blumenthal PD. Acceptability and feasibility of phone follow-up after
early medical abortion in Vietnam: a randomized controlled trial. Obstet Gynecol.
2014 Jan;123(1):88-95. doi: 10.1097/AOG.0000000000000050. PubMed PMID:
24463668.
D. Clark W, Bracken H, Tanenhaus J, Schweikert S, Lichtenberg ES, Winikoff B.
Alternatives to a routine follow-up visit for early medical abortion. Obstet
Gynecol. 2010 Feb;115(2 Pt 1):264-72. doi: 10.1097/AOG.0b013e3181c996f3.
PubMed PMID: 20093898.
Level of interest: An article whose findings are important to those with closely
related research interests
Quality of written English: Acceptable
Statistical review: Yes, but I do not feel adequately qualified to assess the
statistics.
Declaration of competing interests:
I declare that I have no competing interests.