Query about Hospital Notes

[Verbena17]

Hi, so I’m just wondering about a detail which wasn’t added to my hospital notes a few years ago. I can’t get it out of my head and hoped someone here might know.

If a person connected to the hospital but without any clinical remit, walks into your single hospital room (with ward staff obviously knowing), talks to you and questions you about going onto one of two drug trials and then tells you ‘you might die if you don’t’ (sign up), should any of all of that be in my hospital notes? At least the part where the person went into my room/what time etc?

I was trying to work out how firstly, nothing about them coming in is in my notes and secondly, how nobody medical came in with them or mentioned it to me before or after they came in.

Should something about them have been on my notes?

I know she wasn’t. She works for the Wellcome Trust

I didn’t know I could. Do you think they’ll be very different?

The strange thing was, she told me I could die if I didn’t sign up but she also said (when I asked her if I would definitely be getting a trial drug or a placebo) she couldn’t say if I would be getting a placebo!

I was like “right, so you are saying I could die but you’re also saying I might not even get the trial drug?” Then I told her I’d stick with what the hospital were doing because at least I knew I was definitely getting medication!

genuine question, why did you not query what they were giving you and refuse if you didn't want it? Or have you since decided you didn't want it?

I wouldn't say this would go in your notes unless requested by your clinical team and then they wrote that on as part of the plan and if you accepted then maybe out that in. But there's limited time to put in even the most important parts of a clinical plan so no not everything goes in.
Possibly in the nursing notes if you complained or were upset or something or if you were accepted into the trial?
I wouldn't overthink it.

Not sure why you think the ward staff would have documented anything - recruitment to trials would not normally be part of their role. If you're concerned about the process there will have been a clinical PI on site at the time and there will have been someone in the Trust research team involved - you could perhaps find out who either of them were and talk to them. The consultant who was looking after you at the time would also be able to shed more light as they would probably have been the one who identified you as being a potential trial candidate. If you've only got the notes for the 2 weeks you were in it's not impossible that the visit is just documented somewhere else in your records (either online or on paper). There are very clear protocols to be followed whenever patients are being approached/recruited to trials and not following them can have significant implications for the trial so it would be most unusual for nothing at all to have been documented.

When they gave me the Tocilizumab, I asked what they giving me to a nurse. She replied, “it’s an antiviral - we are giving it to everyone”.

However, later once home, when I called the ward and asked for the name of the drug, the nurse said it was a monoclonal antibody called Tocilizumab. I asked them to change my discharge notes stating its name and to send a letter with the change to my GP, in case I was poorly and nobody outside of hospital would have known I had been given it.

This wasn’t the trial drugs that I refused. This was an IV bag they gave me saying it was an antiviral when it wasn’t. I didn’t find out what it was until after leaving hospital.

Thank you @Greybeardy thats very useful. So my 2 weeks worth of paper notes might not have been my full notes?

Do you find it odd that no staff member asked me /told me if the trial lady could come and speak to me?

So you got the right drug with the wrong explanation… are you planning on complaining about this? Every drug you had will be visible to your GP via clinical portal

I’m a nurse. I don’t find it odd that no one told you about the trial lady coming. We don’t know ourselves until after they’ve came to speak to you and they speak to us.

I find the tone you describe of this woman bizarre and unprofessional though.

Can I ask why are you thinking of this 3 years later?

Which is a fair enough response. Not quite sure why your dwelling on it 3 years down the road though.

Write to the head of the R and D committee at the hospital. If you can't find the name on the hospital website, PALS will find it for you.
It sounds as if the person you met was not following correct prototols/ was untrained.
The only person in the hospital who can help you is the R and D lead.

I’m saying they said they were giving me an antiviral but actually they gave me an Emergency Use drug of monoclonal Antibodies.

They listed every medication I had been given during my 2 week stay but left out the Monoclonal Antibody. When I queried what the antiviral drug was, they said it wasn’t an antiviral drug and that it was a monoclonal antibody. They then wrote to my GP with an amended statement to then include the monoclonal antibody.

That though, wasn’t the Trial Drugs mentioned in my orignal post. That’s just an additional thing that happened.

I’ve been thinking about this in and off for 3 years….well it will be 3 years in October.

Thanks. You mean Research & Development?

Because hospital procedures & policies are there for a reason. I luckily got better, but the lady round the corner from me with a bowel obstruction at the same hospital suffered neglect (court case and the family won) and sadly passed away. If my information can help in the future when it comes to implementing better care and adherence to policy, why wouldn’t I try and sort it?

Also, having been trained to volunteer in hospital/medical settings with vulnerable mothers, I’m very aware that the woman in my room was acting very strangely and unprofessionally and so I feel that the hospital needs to be held to account.

Finally, in myself, I don’t feel right about it. I feel uneasy every time I think about it and whilst I know hospital notes are often incorrect, every other single part of the documented notes (as far as I can see) are correct.

Im not saying I’m suffering from PTSD however I do have a niggling feeling that won’t go away and feel that something wasn’t carried out correctly. If it’s in my digital notes, that’s fine. But I want to know and ask questions. And I want to make sure that if the lady is still there, the hospital know how her behaviour affected me that day. Her behaviour was cover ice and when I said no, she kept on at me and got cross/grumpy when I didn’t want to agree to it. Extremely unprofessional in my mind.

How do the clinical trials staff know which patients to approach though?

Yes exactly.

Yes. Sorry. I was typing as quick as possible while multi tasking.

Could this have been part of the RECOVERY trial which was offered in 2021 for hospital covid patients, both the drugs you mention were used for covid. It all sounds upsetting and I would have expected your consultant to gave been involved in the selection and suitability so it may be in your notes. We're you in hospital for covid pneumonia.

I’m assuming it was part of the Recovery Trial.
There is absolutely Zero mention of a trial/lady in my room.

They made me test for covid. The test said positive.
They then immediately treated me for covid rather than looking at any other possibility. But I’ve come to terms with that. In my notes I think it mentions ‘query covid pneumonia’ once. It states just ‘pneumonitis’ multiple times.

I’ve just thought of something else.
I was on a high dependency ward, isolated in a single room. The number of staff coming in to my room was kept at the very minimum (they told me) for obvious reasons during that time.

Why wouldn’t a ward doctor who was already working on the ward (think there were about 15 rooms) come and ask me about the trial options? Why would they put an extra person at risk, coming into my supposedly highly infectious room if they didn’t have to? Very strange.

They look through the electronic patient record for patients that meet their criteria.

It's not at all strange. To participate in trial recruitment a staff member has to have agreed to take on that role and completed the training in the recruitment process (GCP training and trial specific training). Not every doctor/nurse/other HCP has a particular interest in research and if they haven't completed the training, signed the delegation log etc then it would not be at all appropriate for them to be involved in the recruitment process.