On August 12, the Council of Medical Specialty Societies hosted the fifth webinar in their series focused on COVID-19 and clinical registries.
If you missed it — or want to watch it again — here’s the video:
Here, also, are the panelists’ slides and a collection of tweets posted in advance of and during the event.
As moderator, it was my job to frame the discussion and, later, choose from the many questions posed by the audience.
To begin, I quoted Subha Madhavan, who, in a prior webinar, called for data science education and training in advance of a crisis like a pandemic. I invited people to think: How might we raise and train a citizens brigade or Cajun Navy of personal scientists? People ready to help measure, test, and report symptoms, just like the people with sewing machines were ready when we needed thousands of cloth masks.
David Glazer made a point during a prior webinar about how the massive data necessary for genomics and radiology forced those two fields of study to adopt cloud technology early. I asked the audience to consider: What fields of study need to be early to patient-generated data and patient-led research? How might we tackle not only the current mystery of COVID-19 but also build up our skills and tool sets to be ready for the next one, and the next one?
Heather Hogan, who is in week 20 of living with longcovid, wrote, when she realized her clinicians had no experience with her challenges: “I was the science.” How might we diversify our response to be more ready for patient input to situations like this? How might we tap into existing peer-to-peer networks of patients to fill in the missing puzzle pieces?
Below are all the questions and comments shared by audience members during our webinar. I was able to ask a few of them, but thought it would be useful to post the full list, in case panelists and others would like to weigh in now.
Audience questions and comments:
- Could the panel please elaborate a bit on how they define patient-led research? Who “qualifies” as a patient (and who does not)? And what qualifies as “leading research”?
- Some registries combine self directed and clinical approaches – like Evidation.
- Re choosing the IRB route for the second survey: What are the main benefits and downsides?
- Have you thought about recruiting people who recovered quickly or even people who did not get covid as comparison groups?
- The comment from Gina on “proper researchers think that researchers shouldn’t use themselves as research subjects” really resonates with me. Could you talk about how you have handled/managed/addressed comments like that?
- Do we need to change how we make science to include expertise outside academia? What are the main obstacles to achieving this? What’s the problem with not [seeing] patients as promising knowledge makers?
- A fundamental tenet of clinical research is identity verification, have any of the these studies included online methods for identity verification? Note the identities don’t need to be reported, but the responders need to be “real”.
- For Gina and Hannah, have you personally or in your data learned about the rehab needs of patients? Would research on that be helpful?
- For Emily, what PROs are you using in your research?
- Patient/public follow through problems
- Given that women are traditionally under represented in clinical research, does it mean something special to you that – from the gate – women are more fully represented in these initial studies?
- Can such a C19 (possibly a chronic illness) be a for profit platform
- Please repeat the URL for Hannah & Gina’s study. Thanks. [SF: Sorry I didn’t get a chance to answer during the panel! Their site is patientresearchcovid19.org — here’s the link.]
- I am in in awe of the work Gina and Hannah have done while feeling so unwell.
- Gary mentioned getting further away from serving the research community and being separated from the medical community. What suggestions do you and panelists have to bring these pieces together?
- Long-term patient engagement is the biggest hurdle. Lot of money needed to invest in new ways to engage for the long term.
- What you’re doing is great! Washington University in St Louis has a COVID biobank sample. It would be good to have a partner to store blood or other biological samples to compare changes over time. Any effort in this direction?
- How to bring DNA sequencing into the fray–why do different people respond differently to C19.
- How did you screen out people who may not actually have had covid? So meaning, do you think a percentage of your respondents were really just looking for community?
- Amazing panel!!! Thank you!!!
- Excellent discussion. Congrats on all your work! Thank you for sharing in this webinar.
If you were able to attend (or catch up to watch) the webinar, what did you think? What questions, nightmares, hopes, or dreams did we inspire? Comments are open.
Image: “Puzzling,” by Jolene Faber on Flickr.
This was such a mind-blowing discussion this week to hear from the CMSS panelists. But now I wonder, how can we integrate this patient-generated data into broader research? How do we legitimize data collected and produced by patients?
Yes! It’s a huge question, so I’m hoping we can break it down into manageable pieces. For example: Which fields of study or medical specialties would benefit most from patient-generated data?
Thank you to everybody who listened and asked questions; and, thank you especially to Susannah for organizing and Gina, Hannah, and Emily for the conversation during the preparation meeting. I’ve learned a lot from what you are doing and expect to continue to learn. I tried to capture my main lessons from the webinar in a blog post here:
Self-Registration: A person-centered approach to recording symptoms, observations, and outcomes: https://quantifiedself.com/blog/self-registration-a-person-centered-approach-to-recording-symptoms-observations-and-outcomes/
Gina made a point during the webinar that is extremely important when thinking about how to take some of these ideas into practice, so that our discussion doesn’t become just another “hmmm, interesting” moment. That is, patients who have had to take charge of their own community building and data gathering efforts often do so because they are sick and therefore very motivated to make and contribute to discoveries. This is a source of innovation and leadership, but without institutional support most of these projects will not realize their potential over the long term.
By institutional support I’m very much not referring to volunteer councils and consultations. What’s needed is a serious, long term funding commitment to support patient leadership and build the institutional capacity to engage traditional biomedical research on a more equal basis. This need is not a bright shiny object, so it’s probably only going to appeal to people whose been scorched by the flames of a few bright shiny objects failing in mid-flight and burning those of us on the ground. But I want to state the need as clearly and directly as possible, because until we build some institutional infrastructure all the burden is going to remain on relatively unsupported patient leaders pulled into these efforts by acute personal need. Their unstinting work can do a lot, but every time we allow them to burn out on their own, or in severely under resourced “collaboration” with academic partners, we lose ground.
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Wonderfully said Gary !
As you know I have been co-creating this community with my Project Apollo patients.
For those interested here is link of this patient community:
https://projectapollo.me
Finding the “institutional support” is paramount for long term success. The workload always lands on the patients themselves. They have to be motivated to track their own wellness journey. They have to self assimilate as well and form their own community.
To me, this is NOT fair to the patients. They are all suffering from their own chronic conditions. Plus they are fighting the ‘system’ the whole way. Their resources are ALREADY limited and adding another burden on top of things is not a sustainable model.
“Taking charge” of your own health should be part of the infrastructure.
Empowering each patient to do so should be part of the ‘system’.
I’m all in on building this infrastructure.
Happy to help out from the physician / provider and clinical point of view.
And empowering patients.
But yes, finding the support and institutions to ‘plug’ into is the key here.
Thanks for commenting Michael. I know about Project Apollo of course, and I know you have faced challenges similar to those faced by many other participatory care projects. I recently visited the Project Apollo web site, and spent some time on this page: https://projectapollo.me/collaborate-with-us.php#organizations and thinking about your list of affiliated organizations. It’s an impressive list (see below), and I hope I’m not revealing any secrets to guess that most of these organizations do NOT contribute financially to your work. In general, I doubt the problem of sustainable effort can be solved by every small patient organization spinning itself up into a fully staffed non-profit foundation with the capacity to do the kind of development that keeps them going for the long term. I almost feel impolite talking frankly about this in public; but only “almost.” If it doesn’t get said and discussed, we can’t fix it.
I note that you chose the name Project Apollo. I remember some years ago when you first told me about it and we were all at the Quantified Self Public Health Meeting that Dr. Smarr hosted. Soon after, I was at a conference including many patient scientists in Europe and at the bar after the conference we discussed the popularity of the concept of the “moon shot.” Thomas Blomseth Christiansen pointed out that the Apollo program built upon decades of work by the pioneers of rocketry and space flight. It did not start from scratch in 1961. A question I’ve since put to people who think about moon shots is the same one Thomas put to me that night: What if we aren’t yet at the Apollo stage? What if we are far, far earlier? It’s obvious that at this stage of participatory research and personal science, there are a relatively small number of people convinced that our approach is not an interesting special case, but potentially the main engine of health discovery.
I’m seeing some patterns in how peer-to-peer and personal science communities are getting stuck at a certain stage of development.
At the risk of repeating myself, but because I think it could be useful, here’s how I see the COVID-19 Patient Research Group’s progress through the first few stages of peer-to-peer health care:
1) Isolation. You not only feel alone but you are also told you are an extremely rare case. As Heather Hogan wrote: “I was the science.” (This is what I call Stage Zero of peer-to-peer health care.)
2) Connection. The moment when you hear about, read about, or even connect directly with someone else who shares your symptoms, diagnosis, life stage, or whatever characterizes your health status. This is what Brene Brown might call the “knowing laughter” stage, when shame falls away. Those who are in the know can start to crack open their facades and laugh with each other. (Stage One of peer-to-peer health care.)
3) Organization. Innovation in small groups. People who have banded together start sharing ideas about how to solve problems they all face. For some COVID-19 long-haulers, that meant joining a group like Body Politic and contributing to their study. For someone learning about personal science, this is when you join a Quantified Self chapter or start going to meetings. There are LOTS of groups stuck at this stage of development. (Stage Two)
4) Resource infusion. Mainstream institutions take notice and start helping. Ed Yong’s article about long-haulers in The Atlantic was one turning point – the infusion of media attention is a powerful boost to any social movement. The U.S. Centers for Disease Control acknowledging that 35% of people are not back to normal after the suggested “recovery” period is another example of a mainstream institution adding fuel to the peer network’s fire. The National Institutes of Health’s All of Us program’s heavy use of community partnerships is an example of mainstream attention and energy pulling groups into this stage. Count Me In is another example of serious money and resources being infused into patient-partnered research effort. (Stage Three of peer-to-peer health care.)
A “moon shot” is the right label for an ambitious project that originates inside a big organization like NASA. What’s a term for one that originates OUTSIDE a big organization but is recognized as needing to be nurtured and given resources by powerful, mainstream institutions?
I’m going to continue this conversation as if we’re all together in a room! (I know that people who haven’t been active in this space may question some of the assumptions here – if that’s you, feel free to pipe up.)
Susannah, I think there’s a big barrier between stages 3 and 4. The barrier is not just one of getting noticed. If that were the case, the Quantified Self community would have had way more impact than it has had so far. I wrote a cover story for the New York Times magazine, had a TED talk with more than 1 million views, and I remember there were two years in a row where the big consumer tech show in Las Vegas (CES) was said to be “The Year of the Quantified Self.” (Being the “year of something” two years in a row is illogical, but OK we’ll take it.) But in the end, as we reported in our Robert Wood Johnson Foundation white paper during the first QS Public Health meeting, five years ago, mainstream biomedicine continued to see person generated data as merely a “production input.” That is: give us your data, and we will make knowledge from it, and turn the product back to you for your benefit, eventually. That’s really not what people in our community wanted. We were interested in advancing our own agency as participants, empowering ourselves to formulate the questions that were most relevant to us in our own lives; questions that might not ever make it onto the agenda of biomedicine, which has a focus on “one-size fits many” outputs that are either healthcare products or new standards of care. We want to collaborate with each other and the research community, and build reliable ways to share data and discoveries, but we don’t want this to be a one-way street. Especially when all the work we do is volunteer effort on our own time, while every single academic and clinical researcher, without exception, is doing this professionally and supported institutionally. We know their work is not easy! They are our friends and allies! But there is a giant power disparity, and a real clash of approaches, and even though our allies were loved by us and we needed their help, the actual institutional agendas, publish-or-perish, and scientist/enterprise oriented workflows and priorities often prevented progress.
OK, so maybe it was just us? There could be many reasons why our community wasn’t able to get as much benefit from biomedical collaboration as we hoped. (We certainly tried. Martijn de Groot and I even edited a special section of Methods of Information in Medicine on “N-of-1” research, but that’s another story.) But fine, maybe we didn’t have what it takes. The counter-argument to this is to look at ALL THE OTHER EFFORTS. Even the most successful, such as Patients Like Me, in the end had to basically transform themselves into biomedical and scientist/healthcare admin projects to survive. Submit, or vanish. My conclusion is that even with discounting for bias on my part, it’s rational to look for systematic barriers between stages 3 and 4.
For homework, let’s look at the data return policy of one of the flagship projects you mention, Count Me In. Here’s what Count Me In promises to do with the data we contribute:
“Our research teams will process this data and will remove all readily-identifiable information before uploading it to the research databases that scientists around the world use to study cancer. Keep in mind, we do not return any individual research results to patients and cannot offer clinical advice to guide your treatment—that’s always best provided by your own physician.”
Think hard about this policy. From a biomedical perspective it makes perfect sense. How can an academic/clinical researcher take responsibility for the medical care of thousands of anonymous contributors. It would be irresponsible to attempt and impossible in practice. However, the de-identification of data and failure to return results to participants guarantees a “one-way street.” A foundation with the courage to go upstream a few steps would find that there are alternative approaches to data gathering and participant management that have evolved in open culture projects; for instance, trusted 3rd party, community-managed data stewardship that allows revokable continuous access to data; and, I2D (infrastructure to data) approaches that allow analytical operations on data that is never copied to the researcher’s data store. These may seem bizarre or futuristic to biomedical researchers who are used to workflows designed to serve them, but they are neither bizarre nor futuristic within the domain of participatory culture generally.
To take this route would be to, if not give up on the concept of the moonshot approach exemplified by the All of Us initiative, at least to supplement with some different approaches to collaborative knowledge making based on realizing the potential for genuine large scale participation in discovery.
As a reward to anybody who made this this far, I give you the full text of Sherry Arnstein’s classic paper: “A Ladder of Citizen Participation.” If you have seen the image of the ladder of citizen participation in this paper reproduced in one of the countless citizen science articles that cite it, but have never read the paper itself, now is your chance. Note Arnstein’s important concern about manipulation and tokenism. These issues are salient for our discussion!
https://lithgow-schmidt.dk/sherry-arnstein/ladder-of-citizen-participation.html
A really nice mini-bio of Arnstein in here: https://www.aacom.org/become-a-doctor/financial-aid-and-scholarships/sherry-r-arnstein-minority-scholarship/sherry-arnstein-biography
Thank you — this discussion is vital and although I do wish we could all be in one room to hash it out, it’s useful for me, personally, to be able to read & chew over these ideas asynchronously.
You are absolutely right: The transition from “small-group innovation” to “resource infusion” is ENORMOUSLY difficult. There are massive barriers and getting attention (such as from the media, big conferences, etc) do not dissolve them. Sometimes they can exacerbate them, as when people hear so much about a trend or innovation that they think it’s solved already.
We’ve been talking on this thread about clinical data registries, but we can widen the lens now to hear from people with other projects, other expertise, if anyone wants to weigh in.
I really appreciate this robust discussion, Gary, Michael, Susannah. We have over 13,000 in our patient registry, MyLymeData–which is a patient led research effort, and, yes, we have had to raise money to do this as a non-profit. We do act as a trusted third party intermediary. We are working on our second, third, and fourth studies from the registry –with one peer reviewed published and 2 very close. I do think that research disadvantaged diseases (no one is incentivized but the patients) have had to lift this extraordinarily difficult burden without funding or support from the government. And we are doing bleeding edge research that can be culture transformative. Anytime you look to a sustainable model that is not non-profit fundraising–they involve trade-offs as Gary mentioned.
Even PCORI with its patient powered research networks ultimately required data sharing at a level our community was not comfortable with. With stigma and research bias issues in Lyme disease, our role as third party data stewards involves vetting researchers, vetting projects, and managing data use/reuse. That means we don’t simply post data for any researcher to use for any project. Also, we do give back to our community by continually sharing data analysis and what we know now. For the most part that means something that looks a lot like community based participatory research with patients at the lead and funding coming from patients. Our research is conducted through long term partnerships primarily.
I’ve read Arnstein’s ladder and cited it in a college text book chapter I wrote with Jay Bea Smalley from PCORI (then)–NIH editors. It is the core of all of this. I recreated a graphic of that ladder for the text chapter. (Johnson, L.B.; Smalley, J.B. Engaging the Patient: Patient-Centered Research. In Strategies for Team Science Success: Handbook of Evidence-Based Principles for Cross-Disciplinary Science and Practical Lessons Learned from Health Researchers, Hall, K.L., Vogel, A.L., Croyle, R.T., Eds. Springer International Publishing: Cham, 2019; 10.1007/978-3-030-20992-6_10pp. 135-147.) I still work with the PCORnet groups as a subject matter expert through NORC at the University of Chicago. One topic? The Challenges of Sustainability.
Also note the Chicago Beyond graphic of research equity and how we create “truth”–who has authority, who is accountable, who claims authorship, who owns the data/results, who determines value and validity. Very powerful concepts. https://chicagobeyond.org/researchequity/
Thank you Susannah for providing the space for this conversation!
I have separated this comment out–
Any idea why so many females in the Patient-Led Research for COVID-19 survey (77%) ? Is this who gets long hauler effects (immune system response etc) or is it a survey response self selection issue? Susannah your research on internet use shows a 10-15% spread between males and females in term of diagnostic internet research. (That could reflect women as caregivers taking the lead or survey selection bias–any ideas?) https://www.pewresearch.org/internet/2013/01/15/information-triage/ I would be interested in the groups thoughts here. We are working on a gender bias study presently and trying to sort this all out.
https://cmss.org/wp-content/uploads/2020/08/CMSS-Webinar-8.12.2020-FINAL.pdf
Patient-Led Research for COVID-19 Gina Assaf and Hannah Davispatientresearchcovid19.com
Majority of respondents are white76.5%
and identified as cisgender female76.6%
Since this blog is my outboard memory, I’m adding some articles and links related to the theme of patient-led research:
How and Why Patients Made Long Covid, by Felicity Callard and Elisa Perego in Social Science & Medicine.
Patient researchers — the missing link? Patients’ contributions to biomedical research have quickly been shifting from passive participant to active contributor. But what happens when the person with lived experience of the disease becomes the clinical researcher? by Sara Riggare in Nature Medicine.
Brain Tumor Discussions on Twitter (#BTSM): Social Network Analysis, by Josemari Feliciano, Liz Salmi, Charlie Blotner, Adam Hayden, Edjah Nduom, Bethany Kwan, Matthew Katz, Elizabeth Claus in Journal of Medical Internet Research.
If you see other examples, please share them!