I am heading out to a private conference on patient data access (that is apparently embargoed until conference close!). In preparation, I thought I would share my own patient journey and challenges in data access, and then (in a subsequent post) propose some ideas for better approaches to providing patient data.

I was on a long trip through Europe when I discovered a large tumour in my inguinal lymph node (between the leg and groin) that had appeared from nowhere in a few weeks. I also had nausea and gastrointestinal distress at the time. I went to a French doctor in Nice. The doctor gave me some medicine for the cramps but refused to discuss the tumour and said “you need to go right back home to Scotland now and see your GP”. Once I got back to Scotland I called up my local NHS and, once I mentioned that I had some gastrointestinal distress as well, said “well you need to wait for that to resolve, call us in 10 days”. SoI went to a private GP who agreed that the tumour was quite concerning but also said that she could not order an MRI for the tumour until the intestinal problems went away. Incidentally (it will be important later), she was not able to do anything but with blood tests I took in Nice. After a couple weeks I finally convinced her to give me an MRI for the tumour. It turned out to be malignant (and it seemed larger to me by this time).

In Scotland. cancer care is pretty much exclusively handled by NHS. So I was referred to an NHS oncologist who ordered a CT scan, followed by a PET-CT scan. This reconfirmed the cancer and a biopsy was scheduled. Because of the fast growing nature I assumed that it was Diffuse Large B-Cell Lymphoma (DLBCL): aggressive but considered “curable” in early stages. The biopsy then showed it was in fact follicular lymphoma (FL), usually indolent (slow-growing) but in my case apparently not.

I was offered two options: watch and wait (which did not appeal to me given the size of the tumour and its rate of growth) and radiotherapy. These are the UK NICE guidelines for stage 1 FL. In the US and elsewhere there are better standard of care options (NCCN guidelines) for bulky stage 1 FL. Radiotherapy plus immunotherapy would have been in the mix of options. I made a case for radiotherapy plus rituximab because there are many studies showing much better 5 year progression-free survival of that treatment versus radiotherapy alone (above 90% versus 75%). My doctor disagreed but refused to articulate why and emphasised he was following the NICE standard of care guidelines.

I thought getting onto a clinical trial of some kind of radiation plus immunotherapy (rituximab or something else) might be a solution to getting better care in the face of this bulky fast-growing tumor. My doctor would not engage with me on this process and indicated he was not in support of getting me onto a trial. This eliminated any possibility of a trial in the UK or Europe as both regions insist on doctor involvement in trials. This left me with finding a US trial where I would not need my doctor to be involved. I spent weeks going through trials on clinicaltrials.gov. I have talked quite a bit about the difficulty of finding eligible trials in general. And of course it is what spurred me to create the technology behind CancerBot. I discuss the difficulty of finding truly eligible clinical trial here.

Finally, I did manage to find a clinical trial in the US at MD Anderson in Houston. The PI for the study responded to my inquiry immediately and said she would be very interested in having me participate. But that I needed to go through MD Anderson’s intake process. They told me that I needed to get all of my health records to them in electronic form. Failing that I would need to fly to Houston and start the process from the beginning (CT scan, PET-CT, biopsy) and then I would be considered for the study. They wouldn’t give me a timeline for getting all the diagnostics redone. They also said that I need US health insurance for all of the care beyond the drug itself (self pay was not an option).

Getting My Data

So I did an NHS Subject Access Request (SAR) for my patient data. NHS Scotland sent me a DVD with my tumour images. They were whole body scans so they were virtually impossible to interpret. There was no electronic form of the actual labs, diagnostics and biomarkers. Instead I was given the paper “yellow sheets” that all NHS patients get. None of the the tests that my private provider (Spire) had done were available in the NHS record, even though Spire had done the referral. MD Anderson said that neither of these were suitable.

I then requested my patient records from my private care provider. I assumed that they would be able to provide some more modern electronic format. Several phone calls and an email received no response.

I did manage to get US health insurance during this time. But, since I failed to get the data from my UK providers, and MD Anderson was not able to commit to a timeline to redo all the tests, the delay in getting treatment was starting to concern me. Plus there was a control arm of the study that would receive radiotherapy alone. I faced the prospect of living in Houston for a month or two and possibly getting nothing better than the radiotherapy I would get in the UK.

Specifically the tumour seemed to still be growing and I experienced symptoms of deep exhaustion that I assumed (as did my doctor) were associated with the FL. So I eventually agreed to the radiotherapy in the UK to try to do something about the tumour. In the end, the tumour was gone after two weeks of the one month of month treatment. Subsequent scans show no evidence of disease.

This experience showed me that there is a big problem in patient data access here in the UK (there are similar problems in the US, but the details vary a bit). Although I had a good outcome, fast access to truly complete and usable electronic data would have opened up better options for me. In the next post I will discuss what some potential options could be to allow easier access, processing, harmonization and aggregation of data by patients, that do not need to wait for regulatory changes to effect them. The approaches and methods should be driven by patient agency and choice in gathering, collating, and sharing their data.

What’s Needed

In my scenario, from French doctor to private doctor in UK to NHS Oncology, there were was no data handoff and no interoperability between any of the institutions. Any and all tests had to be repeated. This is by design: there was no incentive for any of them to share information. So I was left repeating diagnostics. If I had chosen a US trial I would have repeated all the diagnostics yet again. So I would have had as many as four different repetitions of the same test to get a planned optimal first line of treatment .

What is needed is an interoperable but persistent, long-term data store across institutions, state and country boundaries and patients. FHIR is a great interop framework. OMOP is a great way to spin up a structured data instance for a single study. With enough detail of data for all studies to work.

In next post, we will discuss ways that such a specifically managed distributed database system, governed appropriately by a “white-hat” organization, could provide a system to make a difference for patients.