October 15, 2012

Vizzini's View of Diabetes Data Standards

One of the earliest YDMV posts stated out my view on diabetes data:
Type 1 isn’t all about the numbers. It is about kids living their lives. That said there are one hell of a lot of numbers. We gotta deal with the numbers, so we can love the kids as kids. Nobody need love the numbers. 
There are a ton of little electronic machines that produce billions and billions of numbers (and about as many strips on the floor). At times it seems we are floundering in a sea of data points (and strips on the floor). Unfortunately each machine speaks its own language. What we need is the UN. United Numbers.
It seems that I am not the part of the diabetes universe that sees data standards as a problem.  I recently read two articles that make the case for researchers to have a common diabetes data set. Data Standards in Diabetes Patient Registries (Journal of Diabetes Science and Technology May 2011) and A Strategy of Defining Common Data Elements to Support Clinical Care and Secondary Use in Clinical Research, (AMIA Clinical Research Informatics Summit 2010) both make the case that research would be better off with standards to facilitate data that researches, “collect once, use many times.”

As I understand the issue, research reinvents the diabetes data wheel with virtually every study. Each study collects what they are interested in but since it is not a common data set few studies have data that can be combined and used to further additional investigation.

One paper even has this lovely little graphic that helps demonstrate the overlap of parties that could benefit from common data. 

The second paper goes on to talk about these stakeholders in detail:
“There were no defined data standards for primary or secondary use in T1D at the start of this project, and so it is likely that the elements we have compiled will be subject to debate and revision when vetted in a broader T1D stakeholder community, which should include perspectives from diabetes care, research, population monitoring, and quality measurement.”
Notice anybody missing from that? 

I did. 

People with Diabetes.

It is their data.

In short if researchers want people to share their health information, there should be a value for participating. The ethical term is beneficence, that the research does some good for the participants.

I think that for diabetes research to find solutions that improve the lives of people living with diabetes those researchers need to ask the right questions. Starting with: Who is a stakeholder? As the risk of sounding like Vizzini, it seems inconceivable to effectively improve patient outcomes without seeing people with diabetes as a stakeholder in the process. 



  1. Wow.

    It stuns me that we, the patients, the people LIVING WITH DIABETES, are not thought of as stakeholders.

    Just wow.

    Thanks Bennet.

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  3. This is a pretty common theme that the broader e-patient community has seen.

    It is not just a diabetes issue, it actually an issue with how research (design, trial execution, and results) is perceived within the community of researchers themselves

  4. Scott

    Good point. I would suggest that patients be seen as having a stake in all research but that seems much more significant in chronic conditions where patents are responsible for self care, particularly where patients, based on education from their care team, adjust medication levels.

  5. Bennet,

    Another thing I forgot to mention is the various conferences that occur in medicine are often exactly the same way.

    I've heard patients talking about being invited to a conference to actually speak but not being offered any compensation for their expenses or time while a "professional" would be fully compensated... tho this is beginning to change somewhat

    It really seems to be a truly systemic issue through out the entire healthcare industry

  6. I question the argument the argument that "Each study collects what they are interested in but since it is not a common data set few studies have data that can be combined and used to further additional investigation. In reality, they may examine different elements, but they've all been brainwashed into believing that the "surrogate endpoint" of HbA1c reduction is the only factor that matters. This sounds like an effort to try and repurpose the data for uses other than what the original researchers intended, but realistically what would that do for us as patients? Reduce our costs? Fat chance on that? Reduce the burden of regular care ... I'll believe it when I see it? Finally, while meta-analyses are done all the time, I'm still troubled by the idea of repurposing the data when the participants were willing to be a part of the research knowing what they were looking for. Do the trial participants get a say in whether they want to be excluded from any repurposing of the data? Again, this is because people with diabetes have been excluded from the definition of "stakeholder". Good luck recruiting when you hand them an 80-page disclosure to read.

  7. I tried to get into the Aspire study (MM LGS study) a few months ago. To address Scott's point, I did have to sign a release about whether or not I was willing to let my information be repurposed into later studies should the information relate. I'm not sure how often that question is raised however.

  8. Yes I agree that this is a huge problem. We as medical professionals and researchers perform clinical research that could not be happen without the patients, yet we keep the results embargoed until publication, we publish usually in journals that are not available to the public, and results are communicated back indirectly to in the form of a press release when the article comes out, but not directly to the patient participants. So much of the process has to change, particularly in the era of the internet, online patient communities, and the epatient movement. I am interested in thinking about how to change this model with Glu (myglu.org) but there are developments happening across the national front. PCORI, is the new Patient Centered Outcomes Research Institute (http://www.pcori.org/about/). If you look at this recent blog post, http://healthaffairs.org/blog/2012/10/19/getting-specific-selecting-patient-and-stakeholder-initiated-topics-for-pcori-funding/
    it describes the PCORI’s Patient- And Stakeholder-Initiated Path. This is a new concept for the research funding world, and I am interested in seeing what happens with it. I would love know your comments and ideas on this concept and what type of feedback we can provide as a type 1 diabetes community to move this agenda forward. You can find me on twitter at @GluJoyceMD or email me at joycelee@T1DExchange.org to further the conversation.

  9. Thanks Joyce.

    Good link. I like this part, "It is a more time-consuming approach because it involves reaching out to the community to solicit questions, vetting questions to ensure that they constitute true research gaps, and constituting and preparing the multi-stakeholder Advisory Panels that will help us in prioritization. But this effort is necessary if we wish to avoid funding research that doesn’t find its way into practice."

    I particularly like the idea of investing in understanding patient communities so that research outcomes lead real world practices.