What's the Metholodology behind Clinical Guidelines?

00:00:00: Diabetes Insights, Breakthroughs and Innovators.

00:00:04: The EASD TV podcast

00:00:07: from the

00:00:07: annual meeting of the European Association for the Study.

00:00:25: How guidelines are developed?

00:00:28: Well, with me to tell how they're developed is Thomas Carriganis from Thessaloniki.

00:00:34: And you were... Am I right a methodologist?

00:00:38: You also of course an internal medicine specialist but methodology's your particular thing.

00:00:47: so What are the problems that you have in trying to develop a guideline?

00:00:53: I guess one of those things is, try and make sure they're free from external influence.

00:01:02: One important thing to highlight this initiative for developing guidelines with these new normal specific processes.

00:01:12: it's very important because previous guidance documents The key word here is that they were not based on a robust rigorous international accepted methodology.

00:01:23: So the keyword is methodology.

00:01:25: and why methodology so important?

00:01:28: because methodology reassures all recommendations.

00:01:33: everything that is produced related to a guidance document, it's free of bias or conflicts of interest and this always evidence-based and follow specific transparent and clear methodological steps and rules.

00:01:47: So my role as the Methodologist in this initiative is make sure these steps are followed and everything is free from bias.

00:01:59: Actually, we have documented this process by recently publishing in Debitologia a guidance document on how to develop these guidelines with these steps.

00:02:13: It's called an SOP which stands for Standard Operating Procedures For the ESD Guidance.

00:02:21: And that's really important, because I said you were saying about conflicts of interest.

00:02:25: and there are all sorts of potential conflicts of interests ranging from clinicians with a very fixed opinion about some particular procedure or intervention to for instance equipment or technology manufacturers drug farmer.

00:02:43: So they're all sorts people who could have an influence on it but categorically through this rigorous methodology, that it's not possible to influence the outcome.

00:02:57: That is going be done in a way and therefore can be absolutely trustworthy?

00:03:02: Correct!

00:03:03: Well... It isn't feasible or practical.

00:03:06: always find people with zero conflicts of interest.

00:03:09: Yes because you told me before we were chatting just now about the people who are involved.

00:03:17: At least fifty percent of them must have no conflicts of interest at all.

00:03:21: And the other ones just minor conflicts?

00:03:23: Correct, and in guideline development panels we do want people who are experts on the field to know research and clinical knowledge about a specific topic... ...and it's difficult for such people with no conflict of interest but they need to find a middle line here.

00:03:40: So, we do not want important significant conflicts of interest.

00:03:44: Some conflicts may be allowed but even so... They

00:03:47: have to be declared!

00:03:48: ...they always have been declared and at least once every year.

00:03:52: We've set rules for that Across all the members of a guideline development panel, we have another rule that will follow.

00:04:02: That at least more than fifty percent do not have any conflicts or finters.

00:04:07: This is particularly important for methodologists to have as possible no conflicts and finters at

00:04:14: all.".

00:04:15: So the ESD guidelines on diabetes distress are going to be presented aren't they?

00:04:22: Ah!

00:04:24: So we've actually got somebody else, so come and introduce yourself sir because you are the other part of this methodology team.

00:04:34: Introduce yourselves please!

00:04:35: Hi everyone hello.

00:04:37: I'm.

00:04:37: Francesco Zaccadia worked with Thomas as a methodologist for The First Ever Guidelines these guidelines about diabetes distress that were going to present tomorrow.

00:04:47: So now we've got both of you, but actually there are three I think guidelines under preparation.

00:04:54: Tell us about this, Francesca?

00:04:55: Yeah!

00:04:55: Actually

00:04:56: i'm just coming from the meeting above the second guideline that will be

00:04:59: presented... That's why it allowed him to be late.

00:05:04: We have discussed some key aspects, the meta-analysis underlying The second guidelines that we will present in Milan next year, and the topic is around continual course monitoring of individuals with type-to-diabetes.

00:05:19: And third one?

00:05:20: There's another one isn't there?

00:05:22: Yes!

00:05:22: That's correct.

00:05:23: Thomas was involved as well... What about

00:05:24: that one Tomas?

00:05:25: Well

00:05:26: I'm involved as a two methodologist for the third one and also important it's about prevention of type to diabetes people who are at risk developing

00:05:37: Diabetes.

00:05:38: So I've got to ask you both, what do you need to be a methodologist?

00:05:42: What makes you...

00:05:43: A good

00:05:43: point!

00:05:44: ...a methodologist is there are particular... Are your particular character types...?

00:05:49: Well i think

00:05:50: that as mentioned earlier it's lack of conflicts with interest.

00:05:55: So no conflicts or interests but..

00:05:58: Yeah so I think one key element is at least personally the passion for numbers.

00:06:06: So, you know loving numbers and seeing medicine also from a perspective of numbers how to collect numbers.

00:06:16: How to harmonize the studies when possible?

00:06:18: How to combine together in getting an overall on average effect which is essential.

00:06:23: element analysis just the key elements underpinning one step in the development of guidelines.

00:06:29: So yeah, having a strong interest numbers I think is important.

00:06:33: but probably for future there's another skill or element given the importance of AI in medicine and so you know being probably data scientists or again statisticians may be really really important maybe helpful when to prepare these guidelines combined, of course with clinical expertise.

00:06:56: And the North Thomas has mentioned already.

00:06:58: but there is also an interest from DSD about use of AI for guidelines.

00:07:07: so we are preparing some documents on that as well.

00:07:09: That's

00:07:09: interesting and presumably you hope this document don't just live in EASD Europe.

00:07:18: you can set them free, they can roam widely and inform other countries' jurisdictions.

00:07:25: Yeah definitely!

00:07:26: So there is one step at the end of the guidelines which are adoption in development of the guideline.

00:07:35: Adolopment... This creates a synthesis of these two words because what has been prepared by us then across the different nations of Europe and potentially also outside, if there are other countries which are interested.

00:07:51: Of course they may be necessary some steps to amend not amend but you know implement some of these changes than to adopt according to the country that specific country.

00:08:03: But it's not something that is just on website or ESD or published so can be used by an older national guidelines.

00:08:11: So is there a danger as Methodologist that you are so focused on your numbers and methodology, that In clinical practice?

00:08:25: and is that why for instance you have patient involved at end clinicians involved in the guidelines.

00:08:31: Well,

00:08:32: I would argue that it's not only about numbers while numbers is one part the statistical parts of making a guide lines but this note on Lee about numbers.

00:08:41: Actually, a good quality of the methodology is to be able to put all things together.

00:08:45: To actually take into account also their opinions on people with lived experience of diabetes and this an important aspect that we've also incorporated in these guidelines.

00:08:55: for example two of the guideline development panels are People With Lived Experience with Diabetes And We Also Want The Opinion In The Peer Review Process Of The Public And The People With Diabetes.

00:09:11: Also, this methodology that we are following by definition does not only follow strict statistical rules but also takes into account other parameters equally important in order to make recommendations such as equity issues resources use of resources etc.

00:09:30: So I would argue that this is a good quality or the qualities of methodologies.

00:09:37: put all these things together, all the parameters.

00:09:40: Of course this would ideally require some formal training which has also been taken into consideration.

00:09:47: All GDP members have received a formal training guideline methodologist with the methodologists receiving additional more advanced trainings in those aspects.

00:09:58: I'm sure that we're with audience and saying they never knew there was so much behind guidelines.

00:10:05: And my final question to you, does it give you both joy when finally you've given birth to your guidelines and then they're out there being used?

00:10:14: Is that maybe the reward…?

00:10:15: Yeah.

00:10:15: Definitely!

00:10:17: We started a couple of years ago so we had regular meetings... ...we have discussed with a variety people in our team like Thomas mentioned – with expertise from different angles.

00:10:29: To see the final product is what counts.

00:10:35: Also because then particularly this topic of diabetes distress, when you discuss with people it's very relevant.

00:10:43: So the fact that we have now a guideline about that is final product for lots works and hours spent.

00:10:53: but to say... Very nice process!

00:10:57: As I mentioned there are quite lot work behind it But yeah..very happy, very rewarding

00:11:05: Yes, of course.

00:11:05: The ultimate goal for all these is to improve the lives people with diabetes and if we see that this rigorous process helps towards one step toward this direction Of course it brings joy and satisfaction.

00:11:23: Fantastic!

00:11:23: Thank you both so

00:11:25: much.

00:11:26: And who knew there was so much behind guidelines?

00:11:30: Now you know about methodologists.

00:11:33: We'll be with you again

00:11:57: soon.