III: Design considerations
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HEAT, SAID
This area for consideration consolidated reflections by obstetricians and women on the most appropriate trial design, and details of this kind of trial that might need to be considered.Obstetricians had mixed views on which trial design is preferable. Six expressed a direct preference, with 2 preferring design one (2-arm trial of push technique versus fetal pillow) and 4 preferring design two (3-arm trial of prophylactic use of push technique, fetal pillow, and waiting). Obstetricians recognised that the two designs address slightly different questions.If the question you’re asking is… ‘how do we prevent impacted fetal head?’ you want design two. If it’s ‘how do we deal with impacted fetal head?’ it’s design one. (HCP04)Actually the two different arms do represent two different approaches, a prophylactic approach and a treatment approach, which would be [difficult to] compare in themselves… I think clinicians who thought like I did would be more likely to take part in a trial where they could actually diagnose… the condition rather than acting prophylactically. (HCP07).Which design obstetricians preferred varied for several reasons. Those who preferred design one tended to do so because it was in keeping with their current practice and/or addressed the question directly (rather than prophylactically).I mean yeah, personally I would say the design one is more comfortable for me because it's like clear and straightforward, which is I am, I've been doing now. (HCP10)I wouldn’t be as keen on design two because I think that’s looking at prophylactics, how you reduce the impact of impacted fetal head, which … seems to be a different question of how do we deal with impacted fetal head and caesarean section. (HCP04).Those who preferred design two said it was because it gave them more options in terms of clinical management and/or was in keeping with their current practice.I'd rather go with the second one because you've got more options, so including more possible outcomes in your trial data. And if you think about it, the wait is you know, more in line with first do no harm, than the other two. (HCP02).Women also had mixed views on which trial design is preferable. Fifteen expressed a direct preference, with 8 preferring design one (2-arm trial of push technique versus fetal pillow) and 7 preferring design two (3-arm trial of prophylactic use of push technique, fetal pillow, and waiting).Women’s preference for design one was chosen as it as many felt it would prevent the situation progressing to impacted fetal head.The idea of waiting doesn’t fill me with confidence, because again if you’ve got a qualified person suspecting it, that is almost enough for me to go okay, well do something about it (laughs), and to start with the two techniques whereas waiting just feels like you’re increasing the risk of something horrible happening to the baby’s head. I don’t know, I might just be incorrect, but that’s sort of my feeling with it. (ECS W003).If that was me, I think I’d go for the [design] one because you’ve got, you're sort of thinking ahead of time…So, to me, it’s like you're trying to prevent a problem from happening, rather than deal with the problem when it occurs. (ECS W011).Whereas, design two was favoured by some women as it allowed for the inclusion of a wait arm which would rely on obstetrician discretion.Yeah. I … I personally feel more comfortable with the second option, I think that my instinct is to trust the obstetrician's instinct, and with that being an option, that they then would continue with whichever technique they're most comfortable with. (Primiparous W017).However, the concept of waiting caused much discussion with women, with worry that this would impact the safety of the baby and would waste time resolving the issue.From what I am assuming, that [design two] could create more consequences, medical consequence and psychological consequences to the baby. And probably more traumatic, you know, experience for mum and the partner, you know, the partner being in the room, I’m assuming during the C-Section, probably would be pretty, pretty in, in distress too. So, you know, when, forget about the partner and the mum, thinking about the baby and the baby’s damage, probably for psychological and, and physical health, I’d, I’d rather not wait. (Primiparous W016).Obstetricians reflected on the conflict between research protocols versus safety in what they knew. This is similar to the earlier theme of ‘Conflict between the trial and individual/site practice’ where obstetricians questioned whether they would stick to the protocol in emergency situations or revert to what they usually would do.When you’re doing something surgically I think you have to really believe in what you’re doing. And so… what’s going to be a really important thing in your trial design is whether or not you allow people to deviate and if you do, do they then come off the trial completely or do you still say that in itself is kind of an interesting thing to measure? (HCP01).Absolutely yeah, you want to do something … you want to rely on something at a critical time which you are most comfortable with isn't it, not something which you have hardly ever used. But then where it says like in the middle of the column, push technique and fetal pillow, have some sort of asterisk and say however if the clinician feels uncomfortable, or if the delivery is extremely difficult or whatever, they can switch to the other method they are more comfortable with, or something like that. (HCP06).If I was very concerned that time was of the essence, to deliver a baby safely, I would be more concerned about doing a technique that isn’t my known best, efficient technique for me. (HCP08).Obstetricians reflected on how this and other factors might affect the authenticity of results. Variation in how obstetricians carry out techniques and whether they deviate from the protocol would be really important in whether the results of a trial are robust and relevant to practice so these aspects need to be recorded as part of a trial.What part of their wrist or arm or muscles are they using to do the pull, are they using the flexion of their wrist to create a pull, are they using the triceps by having an ergonomic straight arm, but all of these things will also affect your outcomes and so you will get some variability between practitioners. (HCP08).Obstetricians thought another key issue for consideration was when to randomise and whether this is best to do before or during CS. A key concern was the time taken to randomise a woman in an emergency situation.So my main worry about this was randomising a woman, the time taken to randomise and the discussion with the woman in the heat of the moment. (HCP03)I’d want to know how you randomise, and making sure that that’s robust and all of your practitioners are truly comfortable using both, otherwise, you get skewing. (HCP04)Because of the potential delay obstetricians thought it was preferable to randomise women before the CS and either know about this before going into the operating theatre or in the theatre as soon as they were aware the fetal head was impacted.I think you’d need to go to theatre knowing what you were going to do. (HCP01)So you're going to have to randomise before that, so that's going to tweak it a bit, because some of those won't have had an impacted head. Or you randomise … before you go into theatre, but then you don't open the answer until you've got the impacted head. But you don't want to delay. (HCP02).Some obstetricians suggested consent to be in the trial should be taken at the same time as women consenting to an emergency CS.We always consent them for Caesarean Section. So, our consent form has trial of forceps plus or minus Caesarean Section. So, it’s at that point that I think you should take consent and randomise them. (HCP05).Women supported obstetrician views that in emergency situations they would want the obstetrician to abandon the trial and perform the technique they thought was best suited.I mean you could have someone going down for a c-section and you going down design one, but then when you get in there within a minute you could think no, we just need to get this baby out now and then I suppose, you know, they are going to do what they feel most comfortable with if it's, if it's safer for the baby. Erm, if you’ve got the time then by all means it’s safe for mum and baby to take that little bit more time to pick which technique they're going to use then I think fine, as long as obviously the mums have of course consented to it, but if it is an emergency then, you know, it needs to be acted on there and then, then they just need to do what they need to do to get the baby out. (ECS W012).Women also discussed their views on being randomised to one of the techniques, raising a concern as to whether or not the technique they were allocated to was suitable for them and would be the preferred technique in the obstetricians opinion.I guess if it was me on the table, and some, somebody, well not somebody, the computer says “This procedure should be done”, I would think about, well you know, is this procedure most, most sensible for me at this time or did the clinician think about, you know, perhaps the other procedure would be more suitable for me, and for the person next door, it would be more suitable another procedure. But I think that there might be an unacceptable one for me, you know, or somebody else. (Primiparous W016).