Please take your next topic. The next topic is very much related to Nettskjema integration. We are going to speak
about the second iteration of consent, and the second iteration of consent very similar to the survey
API was more against Focus towards consumers. The initial version of the consent system was aimed at
providing compliance with the GDPR, so our idea is that, yes, you do
deliver your forms with Nettskjema to TSD, and they are digitally signed so we get a consent reliably
and safely. The first version was of course aimed towards the patients so they could go online and
check their consent, and if they want to revoke it, but it was not aimed at clinicians and
administrators and this is what we wanted to change. There was much more demand in the
last years. Can we can we help and provide a more advanced forms of support for clinicians and
administrators of project for consent, and this is what the consent of version 2.0 is all about.
Of course, as everything in TSD, it started from a request. A couple months ago it came a request from one of
the projects to get processing
consents both from patients and clinicians for experimental Cancer Treatments. The idea is that the
patient consents after, they consult with a doctor about some kind of a treatment, and then
after the patient consents to the treatment, the clinician confirms the patient consent. So he says
that "yes, the patient is aware I have informed the patient about the treatment and risk and we can
proceed with the treatment". And as it is very experimental treatment it usually require
that hospital administrators follow the procedures, check the process and make sure that all the
consents were gathered correctly. So this was the request, and as I said, the
process is very simple. The clinicians refers a patient to a consent form,
the patient sign the consent form, the clinicians have to get a notification when the consent was delivered by
the patient, and the clinician will confirm the consent of the patient and carry on. This became the
consent version 2. The idea we overall to the consent system, making it faster and easier to use.
We put a lot of effort as well in putting a better UI.
Patrick has helped us a lot with building a faster, more responsive interface as well as we focus
a little bit on the problem detection. The old version of the consent system had some quirks as it
was one of the first APIs in TSD and we put a lot of effort in making it more stable. We want to
expand the consent system to be accessible as well from outside of TSD. You don't have to login
inside TSD
to check if your patients have delivered consent. Thus of course with the caveat
that you have to have certain group rights as Patrick mentioned. Viewing data and having access to
data is a responsibility so it should be controlled by a management that is controlled by access based on
proper group. It will be integrated with the new Nettskjema-delivery,
meaning that once consent is delivered
the consent will be loaded by the consent system automatically from the new survey API, as well as once
the consent is delivered we are now able, because of the notification service, to notify clinicians that
the patient have filled in a consent form and consented to their study. It will be
accessible to administrators, we provide functionality
for administrators. The project that can check all the consents again, as well as consents of the
commission for the referrals. The referrals is something that I'm going to speak about now.
This is the new consent portal. What you see is what the patient will see. It is very much what it
used to be, but in a better shape. If you can see the consent that you deliver for yourself, this is
your consents. As it is now, and as it was before, you can always see what you have consented to, and you
have actions if you want to remove your consent or to
give consent to some additional study. What is new though, are the referrals and the referrals
are aimed towards the clinicians. You can add a referral to a patient by simply sending the small link
to the patient with your personal ID and the patient can follow this link, go to Nettskjema, fill in
the consent form and after they fill in the consent form, you'll get notified that the
patient have consented. The consent of the patients that you have referred to are
appeared in the referrals-tab. What we see here is their patients, where each
patient have a field in a consent form and you can see here a special reference ID, but this
reference ID refers to
the doctor that asked the patient to fill in the consent form. So the patient
fill in the consent form so the doctor here can see the patient's consents, and in our example that I
mentioned before, the doctor can confirm the patient's consent by going to Nettskjema and
fill in his consent form again. In this case, in the previous slide,
this was a confirmation. The doctor have confirmed the patient's consent, and that's why he
sees his consent inside the personal consent of the doctor. And as the doctor confirms the
consent, you have a check mark on the consent saying "this consent from the patient
was confirmed by the doctor, thus the doctor knows that he can proceed with the treatment".
Referring a patient to the consent form, is even more easier than that. Here the doctor can send a
link with his personal ID to the patient. The personal ID is an internal ID inside TSD that the
doctor can use to refer patients to it, and the patient can, when they fill the form, the doctor
automatically get the consent of the patient into the referrals list. Notice that this, we are speaking
about doctors not in the form of members of the projects. In this case the doctors they are
associated members of the project. They do not have access to the data itself, all they get is an
access to their own projects, the people that they refer to to the consent forms.
So practically, which means that we can allow clinicians to use the consent system and refer patients
and collect consents without ever logging into TSD. The other administration of consent will be
done automatically by the project administrators that will have access to all the consents both from
the doctors and the clinicians.
This is more or less the new features of the new consent system. It will appear
online by the end of the month, as well integrated with the new survey API.
Questions about something?
So now it is possible to use the consent system to administrate outside of TSD?
Yes. So you never have to start the consent system portal inside TSD? Well you can
still do that. What we did was to add additional functionality outside TSD to address the needs
for the doctors to give consents, to see consents from patients that
they have referred to the consent form, as well as for the administrators we want to make the consent-
system easier and more accessible. Of course adding more functionality of the consent-system
outside of TSD will be limited to access based on the group. So the administrators of the
project will have control, while the individual members can see only the things that the
administrators will allow them to do.
It was a question about, is it possible to delete a given consent permanently? In the new survey API
it is. As we are storing data not anymore in files, but into a database, yes the deleting consents will
be easier, as well as the deleting answers will be easier in the new Nettskjema-delivery.
There should be a very good and special reason to delete a consent, because
then the participant has their copy in the digital postkasse, and
the researcher don't have a copy. It will be good when
we delete, no, when we add this functionality it will be very important that we also add
notification to the patient saying "Okey, your consent was deleted, and
your data is not any more processed by TSD". It will be useful for them to know.
The question we got here is, will this affect the old system or is it like the
same? You said it can still use the management of inside TSD. Yes, you can still use the
management system,
all consents declarations will be ported to the new system. So there is nothing that the users need
to do. They will continue to work as it is. Everything will continue to work. This is
valid also as well from the new Nettskjema-delivery, the new survey API delivery will be slowly
integrated, and mainly first on the new projects, and then we'll continue with the older projects in
TSD while we slow
move to a new solution for new forms. We do not want to create additional problems for the users, so
we will slowly integrate the system and we will start with new projects.
Will there be complications if a patient wants to withdraw from a study? If the patient wants to withdraw
from a study, currently they can fill the Nettskjema form, but.. and then you have to set up a Nettskjema
that "I want to withdraw" and then you can set up the Nettskjema "if you have chose "I want to withdraw"
send an email to this place.
Yes I think that could be a good solution. Yes I think that forms that are specific for withdrawal of
consents with the new survey API and notification, we cannot email to researchers any time that
somebody fill this form. It is important for us, as well as when it when they fill the consent, but
it's very important when they withdraw, even more.
Will there be a contact database-solution but where administrators can follow patients with survey?
I guess the question is more, I know that the large projects they have their
CSV files and they try to make a structure of like "this is my 200.000 consents", so will there
be other possibilities in this solution to administer? I think it's a valid point, once you start
getting the survey it's very good if you can say
"Okay I want to continue with this patient and send him a second survey". Yes, I think that in the
future we can think about a good solution about that. And we will see if there are some well preformed
projects that we can run these, and help them to see how we can connect these. But it's a very
interesting point. We really want to improve our
Nettskjema-delivery, and not stop the moment we deliver answers to TSD. we want to add more
features to the researchers to allow them to follow up their surveys. Our initial goal the last
two years was more to improve the service overall, and I think that with the new survey API we will
achieve this goal with integration with Nettskjema. We put a lot of effort in this, and now that we
have it we can move
forward to a better, faster
development.