21 August 2017
EVENT Study: HTA Feedback
I am a 'lay' reviewer but my interest lies in pre-term birth and neonatal care as both my children were born pre-term (28 weeks and 35 weeks). Both were 'spontaneous' and came without any warning whatsoever. From my point of view I think this proposal is clear and well thought out and as thus I have no issues to raise for you for consideration.
All I can say is that, in reading this particular proposal I was struck by the consideration the proposer has placed upon ensuring that participants emotional well being, as well as physical, is sufficiently met. This for me is huge positive.
What are the key strengths of this proposal?
Although it is essential that research is done into care pathways that can seek to delay pre-term
labour, it comes with ethical considerations regarding how this is handled given the people you need to participate in such a trial need to be approached at a point where they are at their most stressed and most emotionally vulnerable.
The real strength in this proposal, for me, is that I have a real sense that the applicant has fully
sought PPI and engaged with the what the patient groups have shared. The PPI for this application
is clear and comprehensive. Views have been sought and considered from people who have direct
experience of pre-term birth. My concerns, which are around the anxiety, stress and emotional
vulnerability of the participants and how this would impact on decision making in an emergency
situation, have been addressed by the applicant seeking views from relevant patient groups. The
way in which this proposal will conduct this trial, 'stepped wedge', has taken their view into account
and no undue burden will be placed. This is further supported by the applicant being supported by
units across the county that already would offer rescue cerclage if it were appropriate.
There is here a clear intention to use PPI to support the team's approach with participants by using a co-applicant that has set up their own support group and forum, who will also lead, in this trial, the
support and care of the participants involved. This also intends to ensure that the views of the
participants are sought and included. For me this has huge merit.
Another area of strength is the focus on outcomes, which are for positive outcomes by 1) baby being alive on discharge 2) being healthy and wise 2 years after birth. This I feel recognises all outcomes that result in a pre term birth. In addition there is an intention to record and monitor other indirect outcomes.
The applicant has said clearly why it was felt that 'randomised' testing would not be appropriate and I fully agree with the PPI which gave the view that in such stress and emergency situations it is hard
for patients to make true informed choices. I still can remember how I was on the day my 28 week
baby was born and I know how physically drained and emotionally vulnerable I was. I would have
said yes to any intervention offered.
I feel strongly, as someone who would have been a potential participant in a clinical trial, that this
proposal has clearly looked at the virtues of a 'ramdomised trial' vs ' stepped wedge' and in doing so
has chosen a route that can more fully support the be mindful of the people they need to participate.
Other strengths is the proposal to offer all 'at risk' women the vaginal swab to identify vaginal
Also the applicant has clearly expressed how the benefits and risks will be managed and measured.
This, for me, is a clearly written proposal.
What are the key weaknesses of this proposal?
I feel that there are no weaknesses in this proposal. I feel confident that this has been well
considered and thought out.
Does the plain English summary give a clear explanation of the research?
I have read a number of proposals for NIHR and I can say that this proposal has given me the best
'plain English' version so far!
The plain English summary is clear but gives enough detail to ensure the lay person has understood what the proposal intends.
There is a clear summary of what the issue is and what the rescue clerclage is and the risks involved.
The clinical trial is also clearly explained and details the PPI that has been used and will continue to
be involved. It is clear on how the trial will impact upon participants.
As a lay reviewer I feel confident, from reading this proposal, what the applicant is seeking through
the clinical trail.
This is an important area and currently under researched and largely not widely discussed in the
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