What were the discussions around feasibility if a site doesn’t have Clinical Research Nurse available for recruitment?

Although not having a research nurse may feel like a significant barrier to sites that currently have a research nurse, across our 100 sites we anticipate the majority will not have clinical research nurses.The good news is we know that from the TIRED UK study, sites that don’t have research nurses can still recruit exceptionally well.

Plan / Build a small study team

Organise for team members to take study leave (as per the study leave letter in the study pack)

Use study leave for site set-up and follow-up

The key is to informing doctors and nurses about the inclusion checklist and opt-out consent leaflet and empowering them to recruit patients using these documents

The inclusion checklist includes all poorly documented prospective data that we need

The process of completing the inclusion checklist and opt-out consent should take less than 2 minutes, therefore we anticipate it could be done 24/7, 7 days per week

All other data can be collected retrospectively

Study team organises time to complete REDCap data collection, using study leave at a later date

The local study team will be encouraged to ask their local R+Ds to second a research nurse to ED for the study period for the specific task of completing REDCap data collection during office hours (as per Research Nurse R+D Letter in the study pack).

28 day follow up – please confirm who does this? I think it will be us! – This is done by whoever is able to do it. If research nurses are available they would be a great asset. Otherwise Trainees will have some study leave time too.

Is there anyway on RedCaps to save the data and come back to continue inputting at a later stage?

REDCap saves automatically. When you open a new entry, it produces a new record which you can revisit and update at any stage later.

For the Hb question does this relate to the result of the Hb on a formal FBC sample taken on the day of attendance if there is one? Is the result on a VBG acceptable? Or are you looking for the most recent historical result?

We are looking for the result on the day of attendance. Formal lab Hb is best but a VBG is acceptable. The reason for this is, if a patient is significantly anaemic it is more difficult to identify blood on CT. Therefore, a SAH could be missed on brain CT due to anaemia and significantly affect our overall sensitivity.

I note CT scanners are to be labelled 1,2,or 3. I’m assuming we will need to send information regarding the configuration / type / slices / speed etc of each of our scanners in order for these to be identified prior to the trial starting. Is that correct?

Yes. There will be a CT questionnaire coming out prior to attendance. Locally you will have define which CT scanner is 1, 2 etc.

The data collection relates to data at least 28 days after attendance. Does all data have to be inputted at the same time – i.e. do we need to wait until all the information is available and hence wait at least 28 days to do this or will the system “save things as we go along” I.e. can we put the first bits in and then come back to it later?

REDCap autosaves as you go, so I would anticipate the data is collected on different occasions. REDCap will list all your local patients with the REDCap number plus the PIS number – this is how you will be able to identify the patients to re-enter their record. 

When we open the patients GP record it asks specifically if we have the patient’s consent to access their notes.

Good to raise this. We brought this up with ethics to ensure they were happy. In the Patient Information Sheet/opt out leaflet it explicitly states:

“we will check your hospital and GP medical records to check that you weren’t re-admitted to a hospital with headache for a 4-week period after today”

Ethics have approved this approach and I can confirm that we are covered by ethical approval to tick a box asking if we “approval” or “consent” to access GP or hospital records.

We estimate that around 60% of headaches present to the ED dept, and the remainder go via their GP into a day unit.  Would we still be able to take part in the SHED study as the inclusion criteria specifically mentions the ED dept?

Yes, you would still be able to take part.

As you know we are keen to recruit patients who present with “acute severe headache with maximal intensity within one hour”.

The growth of ambulatory care/medical day units or whatever your hospital calls them, is a UK system change over the last 5ish years. Prior to this all the patients who are managed here would have presented to ED.

If the patient presents to one of these units we would still be keen to recruit them if possible. We understand this may produce some logistical challenges. The department the patient is seen in, doesn’t really change their presenting complaint, our UK system has just “streamed” them to somewhere else.

So as long as the patient who presents to ambulatory care is >18 years old and has a severe headache with maximal intensity that peaks within one hour, we are keen to recruit them. It may be worth exploring with the medical day unit if these are the sort of patients they are seeing or are they seeing more chronic headaches?

Our research team are starting to question the feasibility of us joining in on this study.

I know you aim to recruit 90 in 3 months – as we are a small dept, we unlikely to get!

….is there a minimum number per site required?

Target recruitment is an interesting one. I understand its important to upload and prospectively declare your target recruitment. The truth is we don’t know the prevalence of acute severe headache in the UK, therefore its impossible for your to give an accurate target. I’m happy for you to state whatever you want!

Is there any funding available to support this study.  I seem to remember something about paying for stamps?

If you require stamps for the mailed opt-out consent then these can be provided.

These have not been included on any direct communication from the Sponsor as for something as small as stamps, it is not worth formulating official finance agreements between the 100 sites

What is the time period required by the sponsor for the retention of study documents post study closedown at site?

January 8^th Meeting

Attendance certificate

Available here:

Recording:

Available here:

Minutes:

See website document page