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Rationale Essay

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.3 Why it is important to do this review -
The points below help to identify a rationale for this SR.
1.3.1 What is known already -?
From Guidelines-
RCOG - (Evidence from observational SRs, Cochrane, and some individual RCTs) They suggest single (max 2-3) dose regimes of MTX (50mg/m2) without folinic acid in selected patients. AEs listed are nausea, vomiting, flatulence and abnormal liver function tests. Elson 2016
ACOG - (Evidence from observational SRs) They suggest multiple/variable dose regimes of MTX with folinic acid. AEs listed are the same as shown in Table 1.Pfeifer 2013
NICE- (Evidence from observational SRs, individual RCTs and Cochrane) No AEs listed. NICE 2012
From SRs –
SRs of observational studies-
One SR 49 quote AEs of …show more content…

Many of these SRs 3, 5, 30 have not commented on the quality or the strength of their evidence. Neither were they done thoroughly – most of them (except the Cochrane SR)16 looked at one or two electronic databases. The Cochrane SR 16, have not commented clearly on any individual or total AEs.
One way of addressing this problem is to study MTX AEs (total and individual), reported in randomised, placebo-controlled trials and presenting an overall summary.
1.2.3 Aim of this SR -
This SR, aims to identify the total and individual rates of treatment associated AEs, (expected or not expected but collected) from systemic MTX use, in ectopic pregnancy (compared to placebo or any other one drug or different doses of MTX) through a systematic search of all available literature.

Chapter 2 Methods - 2.1 Inclusion and exclusion criteria-
To do a SR on drug AEs, it is best to compare this with a placebo 17,31. Initial scoping searches discovered, that there were only 3 RCTs comparing MTX with placebo. Some authors feel it may be even unethical to do an RCT, given the limited evidence for expectant management.17 Hence the research question was broadened to include-RCT's (of tubal and extra tubal pregnancies) comparing systemic MTX with other drugs. Additionally, various doses and different ways of giving the drug, were included in the comparator arm.

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