Does true patient consent exists? – NO

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In a recent MS Journal Club, my colleague Heather Mah  presented an article about patient involvement in research. This then prompted the discussion about research bureaucracy, patient information sheets, and the standard of consent. Patient information sheets (PIS) are often long, text heavy documents that are impossible to understand. They are intended to provide all the information about a study to patients (risks/benefits/how your data is managed/how to withdraw, etc.) – but this isn’t the case. Researchers must complete these forms to meet regulator, legal and ethical requirements. Forms that were developed decades ago, have never been updated with strict sections and headings that can’t be altered, or they won’t be approved. 

This raised a lot of questions: Does the information contained in a PIS matter? How many patients read (and understand) an entire PIS before consenting to research? How can we make PISs more understandable and accessible for patients? Does having a simple PIS co-produced with patients mean that people are more likely to join research studies? What does full consent look like, and is a degree of consent sufficient? 

https://www.toolshero.nl/leiderschap/abcd-trust-model/

Does true consent exists – NO, it’s a matter of trust and novelty

Over the years, I have asked many pwMS and other individuals for their consent to participate in research studies. This has been for a wide range of studies with entirely different aims: 

1. No benefit for the participant. 

This type of study involves mere “databanking” or “biobanking”, and thus storing of blood or cerebrospinal fluid for scientific purposes. This could mean that the remainder of a blood sample which has been drawn based on clinical grounds would be used for research purposes. Other studies involved drawing blood or performing a lumbar puncture for the mere purpose of research. Along this line, some studies ask for permission to access your clinical data and brain MRI for research purposes (ie. comparing MRI features of people with similar characteristics).  

2. Unclear benefit for the participant

Some studies involved testing a new drug in pwMS which had a similar mode of action than an already available drug. The trial comparing ofatumumab versus ocrelizumab is a good example. This study compared an established intravenous anti-CD20 infusion versus an untested, novel subcutaneous anti-CD20 formulation. 

3. Clear benefit for the participant

An even smaller minority of the studies would involve potentially life-altering/extending interventions, such as new drugs for amyotrophic lateral sclerosis or ALS. This is a progressive neurological disease which is lethal in two to three years from now and for which no treatment – not even chemotherapy – exists. 

In MS, the third category of studies is rare. These are the trials that would involve stem cell transplantation or remyelination/neuroprotective drugs. As we currently have more than ten disease-modifying treatments available, the majority of the studies will, however, have no or an uncertain benefit. Irrespective of category 1/2/3, the associated consent forms do always include a vast number of side effects related to study participation. A lumbar puncture for example might lead to post-puncture headache, and even more daunting a ‘sagging brain’. Anti-CD20 formulations lead to B cell depletion (= mode of action); increase susceptibility to infection, and reduce response to vaccination. Giving access to your data for research means they will end up in a database on an external hard drive outside of the hospital. Potentially, this would make your data more susceptible to data breaches.  

Although none of these side effects are lethal; they do convey into small but existing safety risks that you would not be exposed to when not participating. Why do pwMS participate? Is this the equivalent of scientific altruism? 

Although I truly believe in patient empowerment and pwMS taking better decisions when being fully informed, I do feel the most important factor weighing on the decision-making process is trust between clinician’s and their patients. Do pwMS believe you have their best interest at heart? If you as a clinician show evidence of good intentions and empathy (there’s no manual for this, but some clinicians are definitely better at it than others) and if you are convinced about the necessity to perform the research, side effects will inevitably get a silver lining. 

Moreover, I honestly don’t think consent forms are currently drafted in a meaningful way for pwMS. How would unexperienced pwMS judge how awful a “progressive multifocal leukoencephalopathy” would be?  In a very specialised setting like this, words are not always meaningful. You can only understand the impact of such a side effect when you happen to have seen someone suffering from it. This is by the way one of the main reasons why patient support groups are so valuable. Some pwMS are better at grasping risks than others, but understanding risks that you have not been exposed to yourself and that are not part of day-to-day logic (e.g. getting hurt when using a knife) is something very very difficult and prone to interpretation bias. 

Based on my experience, obtaining true patient consent will always remain an illusion. No matter how accurate and accessible patient information sheets are, people most often do not read them before deciding or do not fully understand what they read. The likelihood of people participating will be influenced by the feeling of having had the possibility to be fully informed and a mutual appreciation between the clinician and the consentee. Nonetheless, this does not mean we should not try to inform our pwMS with the best and most accurate information. Offering the information is a question of moral duty. 

Have you ever been asked for consent? And which factors were decisive in this process?

Twitter: @SmetsIde

Disclaimer: Please note that the opinions expressed here are those of dr. Ide Smets and do not necessarily reflect the position of the Barts and The London School of Medicine and Dentistry nor Barts Health NHS Trust.

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Ide Smets

22 comments

  • I usually only skim patient consent forms as they tend to be generic. They’re long, portentously written and off putting. Fine if all a research project consists of is data harvesting but were it a trial involving, say CSF or a treatment, I would probably read more carefully. They really need a rewrite. As you point out Ide, if a treatment involves side effects (and most do) they might be severe, such asPML, which some pwMS might well have no knowledge of. That means the participant is entering a trial blind. So it’s an obligation to inform but may not inform the participant at all.

    • Then someone needs to tell the ethics committees this, because every time I have tried to simplify an ethics for the ethics committee has told me that I need to make them long and boring.

          • I applied to be on a REC, got to observe a REC and never heard another peep from NIHR, though my application showed evidence ofa lot of patient participation in research, fundraising for MS research etc.
            I was told there should be about 15 people on a REC of which a third should be lay members and that there were vacancies for the region my REC serves. Hope that answers your question.

    • Side effects really need contextualistion. People read something horrendous – and maybe it is but I have never see it put into any sort of context.

      Contextualising risk for people is something that is very well researched yet the learnings are never implemented.

      Prof Sir David Spiegelhalter who runs the Cambridge based Winton Centre For the Public Understanding Of Risk has written at length on this topic. His book ‘Norm’ is a good start.

      Strüngman Forum Reports published Better Doctors, Better Patients, Better Decisions – Envisioning Healthcare 2020, edited by Muir & Gigerenzer, which, IMHO, ought to be required reading for every medic who deals with patients and needs to communicate information to them.

      ISBN 978-0-262-01603-3

  • If md wrote this I am sure the heading would have been ‘Taking the PIS’ 🙂
    I would be more willing to take risks for useful research that could help future generations.

  • Thanks for writing this, it needs to related often, I feel.

    And there is such a data grab around consent forms now in my country. You agree to take part in a study, but they want permission to track every aspect of your life, things that have nothing to do with the study. There’s a general attitude “get everything, just in case we need it”. And there’s no expiry on the agreement either. I think all the information should be destroyed once the study is complete.

    The last time I was in my clinic, they asked me to take part in a longitudinal cognitive study. There were 2 consent forms, more than 10 pages of reading in total. With my cognitive issues that would take me at least a day to read (never mind if I actually understand it). When I asked if I could take them home to read, they said ‘no’ and ‘let’s just forget about the study then’.

  • I´m one who reads the whole document and annotates for questions. I have signed some for research studies that were non-drug and one for the CHORDS trial for Ocrevus. I refused to sign one that would have been a data grab of ALL my medical records and NOT hold them to HIPPA guidelines. When I realized that and declined, the person representing the “study” got pissy with me. I have also refused drug assistance for Gilenya when I realized that they too would have access to all my medical records and not be beholden to HIPPA. I guess they see us as a 2 for 1- $ for the drug and $ for the data.

  • I don’t read data collection forms, I just sign. If someone comes up with something out of the data, good. If not, tough luck.

    I’d be more careful if it involves additional procedures or meds.

  • Agreed. Have been consented many times. The forms are all the same. Ultimately: if things go wrong you can’t blame anyone. On your head be it. You can simplify it and pretty it up but it is all aiming towards the same conclusion. No amount of patient input can change the overall goal of the form.

    So one takes part because they trust the person asking them regardless of whether it is biobanking one’s blood or trying an entirely novel treatment.

    I understand that MS patients have a particularly high-risk threshold if looking at medications that stand to offer some improvement from the inevitable grind of the disease. Personally, I have far less to lose than just surrendering to an inevitable decline without pushing back every way and everywhere.

  • I do not think people take proper note of the information on possible risks and take a mature attitude.
    The categorisation of the benefits to the person needs to be set against the risk. I am donating my brain (when I die!) to the MS Tissue bank. I am certain that there will be no benefit to me, nor damage my health!
    People taking a DMT should balance the possible benefits against possible side effects. Each of us chooses with our own bias.
    For people considering taking part in a trial they are either being altruistic or hoping to receive a more effective treatment. Obviously I believe in research but not everyone does.
    The forms are a real turn off. I skim and try to spot the needle in hay stack. There is a lot of boilerplate with little density of information.
    Perhaps we need to look at why people do come forward or not and why they fail to complete.

    • From my experience, the little things do count when agreeing to participate in a trial Such as:

      Will there be any extra visits to the hospital required?
      Will I get a refund on hospital parking and travel expenses?

      Stating at the beginning of the PIS – Thank you for considering this study. Or Thank you for reading this information sheet. Helps a participant feel valued.

      Offering refreshments and fruit is nice too, before the patient leaves, if appropriate.

      Other things to consider are:
      Will it hurt me?
      What are the benefits and risks to me.
      How will this benefit the next patient like me?

  • I’ve been the lay member of my Trusts Research panel since 2016. Giving feedback on trial and study design and feedback on PIS, consent forms and posters for recruiting participants.

    I was warned early on in the role, that some HCP’s see patient involvement in research is tokenism.

  • Late to the thread, but this one’s worth sharing.

    Nine years ago I sat down with my neurologist to discuss whether to continue natalizumab after a year of treatment. Bad news, she said — my JCV blood test had come back positive. Then she explained that new published studies of pwMS on natalizumab showed that the incidence of PML, while still minuscule, was higher than previously believed.

    At the time it was my last DMT option. MS had worsened while I was on glatimer acetate. We’d ruled out fingolimod because of eye and infection risks. Still, she was uncomfortable continuing.

    “With PML, your life is basically over,” she said.

    I doubt those seven words have ever passed under the gaze of an ethics committee. But they told this patient all he needed to know.

    • Thanks for sharing Paul. This is indeed the language that people get, and is impossible to include in consent forms.

      • I am about to commence alemtuzumab in just over a month. I had the great idea that I’d pop over to Canada and see family (various lockdowns are being reimposed in areas) and my Doc just observed, rather drily, whether or not I thought it was a good idea?

        That was enough for even a dunce like me to get their drift and when I tried to turn to round and ask what they thought the reply was akin to ‘I’m not so sure it is.’ That was easily enough to stop me in my tracks. Even though it wasn’t as direct as the message Paul received, it was crystal clear.

        Playing the Devil’s Advocate:

        I really value direct communication. Consent forms are so complicated usually I just sign them in the knowledge that most things are deemed my fault. As a Personal Injury lawyer once said to me, if it is someone else’s fault/negligence then it doesn’t matter as long as it is provable so don’t feel too bad about signing these sorts of documents.

        I interpret that as the burden falling on the clinician(s) being able to ensure to themselves that the patient, regardless of how complicit they seem in the process, really does understand what they are signing up to. Could the person who managed the approvals process stand up in court, if necessary, and swear that they are happy that the signatory fully understood what they were consenting to? A wrinkle with MS is that the lawyer may try and run a strategy of transient diminished mental capacity.

        Dom

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