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. 2021 Nov 15;2021(11):CD009286. doi: 10.1002/14651858.CD009286.pub4
Date Event Description
14 March 2019 New citation required and conclusions have changed We include 2 new high‐quality trials. Meta‐analysis of all the high‐quality trials shows no effect on either of the co‐primary outcomes of independence and disability. Meta‐analysis of all trials irrespective of trial quality showed that SSRIs reduced disability at the end of treatment.
14 March 2019 New search has been performed We have clarified that there are 2 primary outcomes: independence and disability.
For modified Rankin Score (mRS) in advance of starting this update, we decided to report the proportion of independent participants compared with the proportion dead or dependent which is the usual convention in stroke trials. In the previous version we had reported the proportion dependent and had excluded the dead participants from the analysis.
We checked the total number of participants included in the 2012 review. We had stated that the trials included 4060 participants; there were errors in the arithmetic (due to counting number allocated rather than those recruited, and omitting to count data from 2 small trials). When we recalculated the figures, there were 4109 recruited. We excluded 7 of these trials (439 participants) which had combined an SSRI with another active intervention and compared it to the active treatment alone or where there was a non‐random component to sequence generation process (see list of excluded studies in text).
We added 14 new completed trials, recruiting 5498 participants.
There are now a total of 63 trials recruiting a total of 9168 participants.
We decided to restrict our primary analyses only to those trials at low risk of bias. We did this because we wished to provide a clear answer about the risks and benefits of SSRIs, which was not influenced by trial quality and because it would have been impractical, given the resources for this update, to perform analyses including all the low‐quality trials. We made this decision before we knew the results of the largest trial in this review (FOCUS). We have, however, performed a sensitivity analysis for dependence and disability (our primary outcomes) using data from all trials; as in the first version of the review, this sensitivity analysis showed that when low‐quality trials are included, results tend to be in favour of SSRIs.
We adhered to the MECIR standards for conduct and reporting.
We shortened our list of excluded studies in line with the Cochrane Handbook, by not listing those studies that obviously did not fulfil inclusion criteria, including those studies which clearly had an ineligible comparator, intervention or study design.
26 August 2013 Amended The review authors identified minor errors following publication of the previous version. These errors have now been corrected and have resulted in very minor changes in SMD for disability and some I2 values. The changes have not materially changed the results or conclusions of the review.
Changes made:
(1) the total number of participants has been changed from 4059 to 4060;
(2) Almeida 2006 recruited people without depression; this has been corrected in the 'Characteristics of included studies' table, and data have been moved to 'did not have to have depression' in the relevant subgroup analyses;
(3) disability data for Acler 2009 had been entered incorrectly; this has now been corrected.