Adrenaline or salt water. Changes to the way heart attack patients are treated.

[Darkesteyes]

Just seen a report on Newsnight. Instead of injecting with adrenaline some patients (but we wont know which ones until afterwards) will be injected with saltwater as a placebo. It is to see if adrenaline causes more harm than good.
DH has heart disease. He called this an experiment. And i certainly see his point. He says its obviously to "kill some people off" He got quite upset. What do MNers think of this?

Lonecat - people are being recruited into this study without their knowledge, so how can consent be gained?

And like I said - to who are the Ethics Committees answerable to? Are they looking after MY interests? The only way to make this even slightly ethical is to ask patients (or next of kin should they not survive) after the event. No consent, the data should not be included. It seems that with care.data, and this, and no doubt other studies, we are all part of one big study to see how far they can abuse the population of this country before we rebel. Because that is what this is - approved abuse. An ethics committee could justify what went on in Staffordshire if they claimed it was in the name of research....

An ethics committee should only be allowed to approve studies where informed, explicit consent is involved. Anything else should require an individual Act of Parliament, which would be discussed on behalf of the people, by those voted in by the people. Not by those acting in their own interest.

And if you read that Telegraph article, it states that the reasons for the decisions are withheld owing to commercial confidentiality. So, nice and transparent there, then, isn't it? What about the NHS constitution and all that? Or is that just forgotten about when ethics committees have had a meeting behind closed doors?

And any doctor, nurse, paramedic worth their salt should refuse to take any part of a study where people are treated without dignity or respect like this, and only treat people as part of a study where consent has been gained.

And if it is the ambulance services taking part, surely there are data protection issues as well, as the patients data will have to follow them between various different organisations? Or are ethics committees justifying themselves ignoring that as well?

Well, I've just read the website. It would seem that they will be seeking consent to continue in the study after the emergency has passed. Presumably this will be from a NoK should the patient not survive. Here:

{{http://www2.warwick.ac.uk/fac/med/research/hscience/ctu/trials/critical/paramedic2/faqs/]]

The whole story, yet again, not being told by the media. And causing people like me (and the OP) distress...

www2.warwick.ac.uk/fac/med/research/hscience/ctu/trials/critical/paramedic2/faqs/

Well, reading it further, only survivors will be approached for consent. Those who die will not, and nor will their relatives. I now stand by my original comments. Scum.

"Scum" ?????

Pseudonym, you clearly don't understand how clinical research happens and that's okay but calling people who are trying to save lives "scum" is just unreasonable.

"people are being recruited into this study without their knowledge, so how can consent be gained? "

This study is being done in patients who are in cardiac arrest. Their heart has STOPPED. They are clinically DEAD. Attempted resuscitation is an attempt to bring them back to life, to save their lives. Without it, they are DEAD. How do you get consent from a dead person?

"to who are the Ethics Committees answerable to? Are they looking after MY interests?"

From the link, you've helpfully found:

All research studies run in the NHS are conducted in accordance with the Research Governance Framework and relevant legislation. The Health Research Authority provides robust, ethical review of proposed research via independent Research Ethics Committees (RECs) who scrutinise applications and put the rights, safety, dignity and well-being of research participants at the centre of their decision making.

NHS Research Ethics Committees consist of up to 18 members, a third of whom are lay (broadly, this means their main professional interest is not in a research area, nor are they a registered healthcare professional).

They safeguard the rights, safety, dignity and well-being of research participants, independently of research sponsors. They review applications for research and give an opinion about the proposed participant involvement and whether the research is ethical. RECs are entirely independent of research sponsors (that is, the organisations which are responsible for the management and conduct of the research), funders and investigators.

Yes, they are looking YOUR interests because they don't want potentially harmful treatments (as in the CRASH study) to be used that might kill, rather than save people.

"only survivors will be approached for consent. Those who die will not, and nor will their relatives. I now stand by my original comments. "

So looking at the trial protocol (see from page 19 of www2.warwick.ac.uk/fac/med/research/hscience/ctu/trials/critical/paramedic2/documents/protocol_1.0_3rd_march_2014.pdf), they are not asking dead people for consent because they will be dead and no more data will be collected because they are dead.

If someone survives the initial cardiac arrest (less than 10% of those who have out of hospital arrests), then they will be asked if they agree to have data collected at 30 days, 3 months, 6 months and 12 months. If not, that is the end of their data collection.

Pseudonym, would you consider becoming a member of an ethics committee?

More details about applying for a role like this; Research Ethics Committee

What is odd, is how much media hype this is getting (without any real emphasis on the fact that NONE of the treatment of cardiac arrest has any direct evidence of benefit, except for defibrillation and CPR).

When atropine was dropped from the Advanced Life Support guidelines in 2010 there was no trial, it was a literature review and professional consensus, and I don't remember there being any reporting at all outside of the medical / allied health press.

I wonder if there have been lots of press releases about this so that the people in the counties affected know about it and can opt out if needed. I imagine their ethics approval is dependent on them publicising it well, given that consent can't be gained at the time.

Pseudonym you've obviously never done any research involving human subjects, otherwise you'd know what a hard process it is to get approval, especially if it is clinical research like this.

There are some medical situations where to get scientifically sound evidence in order to improve outcomes you have to do research without initial consent. This is one of them.

And like I said - to who are the Ethics Committees answerable to? Are they looking after MY interests? In a nutshell, yes. The NHS has its own Health Research Authority which was established by the government, is part of the DoH and is accountable to Parliament.

Iam an ACLS provider. I have atteneded a lot of cardiac arrests, In ACLS training we are taught that it is not the drugs that save lives in cardiac arrest but good cpr and early defibrillation. It has long been of question how useful a role adenaline plays in this scenario. This study aims to help to give us a definitive answer.

Research in the UK is regulated by Research Ethics Committees. Proposals have to pass peer review, a process that confirms that the proposed research has scientific merit, and then ethics review by the RECs. RECs are public bodies regulated by law and made up by a variety of medical professionals and lay representatives.

Where trials involve competent adults consent is generally required. This is compatible with randomised controlled trials as participants are informed at the start that they will be randomly assigned to different arms of the trial which may include placebo or no treatment. Having said that in some cases the requirement for consent may be waived, for example, in emergency medicine where there is no time or possibility to obtain consent. It's up to the REC to look at the particulars of the trial and decide.

Hospitals have Clinical Ethics Committees who usually look at larger policy issues e.g. organ donor allocation policy.

Universities also have research ethics committees that deal with a variety of issues arising from research. This is an area where you are most likely to come across research that has to be carried out without consent as seeking consent may distort the results of the trial (e.g. if you tell people you are interested in how often they eat salad they may eat more salad for the duration of the trial or positively misrepresent their eating habits so it's better for the trial to ask a more general and neutral question), but then again the risks for participants also tend to be minor.

Pseudonym, assuming that there is a deep concern that medical professionals are currently causing unnecessary brain damage to survivors of cardiac arrest and it would be unethical to continue to administer it without some research, how would you suggest they proceed?

I can't see how they can move things on without a trial like this, it's better than them changing things on a whim or never making progress. It does sound scary if you read a headline though, it's understandable that at first glance people may worry.

Anyone interested in Ethics Committee stuff may enjoy this BBC Radio 4 programme.

Goldmandra - I would suggest they proceed by asking for consent. If the patient is dead, ask their NoK. Even patients who refuse consent will still have data gathered up until that point included. How can that be ethical? How can it even be legal . Its disgusting, and these researchers and medical staff involved are SCUM.

How do you ask for consent from someone who is in cardiac arrest?

How can they delay treatment long enough to explain the process sufficiently for the next of kin to give informed consent if they were even present (which they may very well not be)?

Would you prefer that we did not try to improve outcomes for cardiac arrest patients?

Tbh in most cardiac arrests it will be a moot point anyway as adrenaline is not given anyway.

Gold - you ask for consent afterwards. Either from the patient if they survive, or their NoK if they don't. Simples. Causing distress by informing a relative of a deceased person should not be used as an excuse by researchers to shirk their duty to seek proper consent. Likewise, if a patient does not consent, their data should not be included. Why can't these ethics committees see that?

NCIS - I am not against the research. What I am against is the attack on individual autonomy my the medical and research 'professions'.

So saving someone's life is a attack on their individual autonomy ? REALLY ????????? You sound batshit crazy pseudonym , a conspiracy theorist of the worst kind . Please do give me your take on end of life care whilst you have worked yourself up into a frenzy !

Unfortunately gaining consent for information to be used from next of kin is not really allowing 'individual autonomy' as they are not the individuals concerned. Gaining consent at scene is impossible, people will be able to opt out in advance and that information will be held by control centres.

Ethically it is a difficult study but only by facing these difficult issues can post arrest outcomes be improved. The use of adrenaline was never subject to any sort of trials in the first place. Perhaps it would be better to just withdraw it altogether until it can be proved that it is beneficial. After all the use of atropine in cardiac arrest patients was withdrawn without these sort of trials taking place.

Asking NoK is better than strangers making decisions. NoK is far more likely to know the patient's wishes.

frumpet - it is not about saving someone's life. My argument is about consent to take part in a medical trial. Yes, you cannot seek consent to have to administer saline in an emergency, but you can seek consent afterwards to include that data in the study. These people have decided they do not want to do that.

Lots of people have legal nok that they are not in contact with. I think that if people cared enough about the issue they would opt out in advance.