How do you define a disruptive hero? Here is Hacking Work’s three-pronged filter:
Disruptive because they are proving conventional wisdom wrong.
Heroes because they are changing the rules of the game, for the better.
Great because they helped to change us all for the better.
Given these demanding criteria, we are pleased to announce that Hacking Work has recognized PatientsLikeMe Co-Founder and Chairman Jamie Heywood for disrupting the accepted rules of the medical world. How did his upbringing encourage him to ask questions? Why does he believe it’s possible to both challenge and respect the healthcare system at the same time?
Find out that and much more in this thought-provoking interview:
Earlier this month, we told you about a new study showing that ALS patients reporting their health status over the Internet (using a rating scale known as the ALSFRS-R) is just as reliable as a trained nurse rating the patient’s score. Now, we’d like to share our interview with lead study author Dr. Thomas Meyer, a neurologist at Charité University Hospital in Berlin, Germany. What role did PatientsLikeMe play in this research? And what are the study’s implications for the future of clinical trials? Find out that and more in our interview with Dr. Meyer below.
1. When did you become interested in patient-reported outcomes?
In 2005, we first used tablet PCs in our outpatient department to capture patient-reported outcomes (PROs). To us neurologists, PROs play a crucial role. Many neurological conditions can be captured by means of PROs only – I am thinking of pain in neuropathies, spasticity in multiple sclerosis (MS), the subjective perception of movement ability in Parkinson’s syndrome and dyspnoea (breathing difficulty) in neuromuscular conditions, including ALS. Given this fact, we neurologists have always listened to our patients a little more carefully so that we can do a good job. Therefore, the systematic capturing of PROs is a natural process to us, and we are most happy to be able to support any advancement and positive development thereof.
2. Your study showed remarkable agreement between the two ALSFRS-R reporting methods. Were you surprised that they were so similar?
You are absolutely correct. Correlation here looks like a textbook example of medical statistics. We were indeed very surprised to find that the data were so unequivocal. Notwithstanding, our previous experience with the offline electronic capturing of ALSFRS-R had taught us that the data captured in a personal interview are very close to those captured in computer-based self-assessments.
Then we took the next step and progressed from offline to online assessment. Other work groups had already shown good correlation between the face-to-face capturing of the score on the one hand, and data capturing over the phone on the other. That was very useful upfront information for us. Insofar, the success of our study didn’t come as a complete surprise to us.
3. How did Dr. Paul Wicks, PatientsLikeMe’s Director of Research & Development, contribute to this research project?
Our great interest in the issue of PROs in ALS goes back a long time. Nevertheless, we were very much aware of the fact that PatientsLikeMe is by far the most experienced organization with regard to PROs worldwide and also the one that identifies with this topic most. So, a small group of four of us flew from Berlin to Boston to introduce our clinical trial to PatientsLikeMe and to learn from their experience. Once we had concluded the study, we flew to Boston once again to see Paul and to prepare the paper. We profited immensely from Paul’s input, and he gave the manuscript a superordinate perspective.
So it is for a good reason that he is listed as co-author of this publication. Overall, this scientific research project was a collaboration between the Charité University Hospital and PatientsLikeMe. I believe it is also an important, gratifying and affirming experience for PatientsLikeMe to see that in terms of methodology the online capturing of PROs is at least equal to an interview conducted face-to-face. I can even imagine situations where the online mode of capturing PROs is actually better than a personal interview, especially where rather complicated and very private issues are addressed. This is just one of the many points we discussed vividly with Paul.
4. Do you believe online patient reporting will become an acceptable practice for clinical trials? What are the ramifications if it does?
I can very well imagine that the online capturing of PROs will one day become an integral part of clinical trials. It is quite an obvious thing; however, owing to regulatory requirements, it will be quite some time before it will actually be possible to implement this. The bottom line is that clinical trials will have to be conducted for each score demonstrating equivalence between paper-based and web-based capturing. Not all of the scores have actually been evaluated for online capturing. Another critical point surely is Internet access.
Having said that, it certainly also depends on the patient group and the actual medical condition under examination. I suppose that from a medical-ethical point of view it is problematic to exclude patients from a trial simply because they are unable to realize an online completion of the score. In this regard, I believe the first step to be taken must be to demonstrate equivalence between online and offline capturing of the score. Then one could give patients the option of using online assessment in the context of participating in a clinical trial and see what they would prefer to do.
The benefits would be immense. This method could highly enhance the quality of the data, the efficiency of data capturing and, not least of all, it would help reduce the costs of a clinical trial. I believe that online assessment will be a matter of course in the future, but not immediately.
Earlier this month, corporate research firm Lead411 announced its 2012 “Hottest Companies in Boston” awards, which recognize the fastest growing technology companies in the Boston area. The award selection process started with over 1,776 companies and was narrowed down to the top 62. We were one of them.
Headquartered in Cambridge, Massachusetts, PatientsLikeMe is honored to have been recognized, and we congratulate all of our fellow award recipients. Check out the press release to see the full list of honorees and learn about the award criteria. And in case you’re wondering, yes, we’ve had to turn up the A/C since becoming a “hot company.”
Our executive team travels the world speaking at conferences for healthcare, technology, research, and more. Here are some highlights of where we’ll be presenting in the coming months. Will we see you there? Drop us a line or leave a comment.
At PatientsLikeMe we’ve been collecting self-reported data about patients with ALS (PALS) since 2006 – over 5,000 PALS to be exact! ALS is a disease that causes muscle wasting in the arms, legs, head and chest, which leads to problems walking, eating, and even communicating. However, unlike a disease like diabetes where there’s a blood test to tell you exactly how patients are doing, the main outcome measure used to record how PALS are doing is an instrument called the ALS Functional Rating Scale – Revised (ALSFRS-R).
It’s a short, 12-item questionnaire that is the “gold standard” tool for clinical trials, but it has one important caveat: it’s normally only completed by clinicians (doctors, nurses, research assistants, etc.). When PALS take part in clinical research studies the questions are read out loud to them and patients are not normally allowed to see their ALSFRS-R scores. When we launched PatientsLikeMe, the concept that we would give patients their very own copy of the ALSFRS-R scale and let PALS see their scores was controversial, and although we’ve gone on to publish a number of studies using the ALSFRS-R and even expanded it for highly impaired patients, the question has always remained: is a patient’s self report of their own ALSFRS-R scores “valid”? In other words, if a patient scored her walking as “3 out of 4” on the scale, would her clinician rate it the same?
Fortunately, our research partners at the Charité Hospital in Berlin, Germany, wanted to know the answer to this too! They’ve been piloting an exciting new project to encourage patients to share progress reports on their ALS with their doctors electronically, using the Internet and other tools including the ALSFRS-R. To support this, they conducted a study where 127 ALS patients were invited to rate their severity of illness over the web, and then were invited to clinic to have their ALSFRS-R score rated in the traditional way by a trained nurse.
As the chart above shows, the results were unequivocal: “Agreement between both data-capture methods was very high…there was no systematic directional bias to any differences…more than 95% of all pairs of measurement were within the limits of agreement.” Even better, 95% of patients found there was no significant time burden, nor physical or emotional strain from completing such reports over time.
So far this all might seem rather academic, so why is this important? As the authors go on to say, “Completing patient-reported outcomes online could be a way to complement face-to-face visits and manage care in a more personalized and needs-based way, rather than relying upon regular time-intervals such as three- or six-month follow-up appointments. Online patient-reported outcomes could also be used to improve the convenience and thereby participation in clinical trials that use the ALSFRS-R as an endpoint.”
The published study is now available open-access and so is free for all to read in its entirety. We’ll also have an interview with lead study author Dr. Thomas Meyer soon, so stay tuned.
(This post has been repurposed from an article written by PatientsLikeMe’s Paul Wicks for the scientific journal Clinical Investigation.)
But when it comes to clinical trials, can we afford to let it be?
“Information (or data) wants to be free” – so goes the mantra of hackers and data activists. In the past this meant computer geeks hacking into secure private networks to fulfill their own curiosity or liberate secret knowledge. Today, voluntary “data liberation,” as practiced by governments and corporations, is relatively commonplace and semiorganized groups with data freedom agendas, such as Wikileaks and Anonymous, have entered the mainstream consciousness.
For me, it feels increasingly challenging to delineate the margins where free data is good or bad. A highly networked, mobile-enabled popular uprising is considered a “revolution” when it’s against an oppressive regime, but considered a “menace” when it is a disenfranchised mob rioting in a western democracy. Bravely recorded videos of civilians attacked by autocratic regime military forces are essential in prosecuting crimes against humanity, but videos leaked from within a democratic military are a “threat to national security.” So while data itself may want to be free, we don’t always want it to be. And so, to clinical trials.
From a societal perspective, the requirement for any trials conducted in the USA to register on ClinicalTrials.gov can only be a good thing in preventing past sins, such as suppressing negative trials or changing end points. As the US government makes this data open, it also allows repurposing. For instance, PatientsLikeMe imports the complete dataset from ClinicalTrials.gov every night to let our membership know (free of charge) about the 30,000+ active trials for which they may be eligible. So far, so good. But what if even more clinical trial data were free?
Last November, we attended TEDx Cambridge, a one-day event featuring 30+ speakers and lots of Ideas Worth Spreading (TED’s mission). The theme for this particular gathering was “Thrive.” How can we as individuals – and communities – not just survive but thrive?
One of the speakers to take a crack at that question was PatientsLikeMe Co-Founder and President Ben Heywood, who talked about the story behind PatientsLikeMe. In addition to sharing how it all began with his brother Stephen’s diagnosis with ALS, and what PatientsLikeMe is trying to do (“a revolution of openness”), Ben focused on how we can thrive as a company against big expectations – both external and internal.
Tune in to the video below to find out just that. Congrats to Ben on an inspiring talk – not to mention his standing ovation!
Last week, PatientsLikeMe Co-Founder Jamie Heywood had the honor of speaking at the Personalized Medicine World Conference (PMWC), a two-day event held at the Computer History Museum in Silicon Valley. His presentation was entitled “Patient Driven Convergence of Clinical Discovery and Care.” In recognition of the conference’s venue as well as the role that technology plays in personalized medicine, we decided to share some of the “tweets” that Jamie’s talk generated on Twitter.
Ruby Gadelrab(@DivaBiotech) tweeted: “James Heywood, PatientsLikeMe, starts presentation with very poignant picture of his brother suffering from ALS.”
Ron Ribitzky, MD(@RonRibitzkyMD) tweeted: “James Heywood of PatientsLikeMe at PMWC: Industry develops systems that can impact if people live or die, but not giving it to them.”
Shirley Wu(@shwu) tweeted: “Heywood of PatientsLikeMe: At events like this, I often see tech searching 4 problems, not well-defined problems searching 4 solutions.”
Ribozyme(@ribozyme) tweeted: “JH PatientsLikeMe: If they (were to) add genotype data it would be a huge phenotype-genotype correlation study.”
Daniel Kraft, MD(@daniel_kraft) tweeted: “Talk from @PatientsLikeMe. Reduced ER visits by 18%. ‘Predict the future so we can change it.’”
Are you part of the Twitterverse too? Follow us @PatientsLikeMe today. We’re just 25 people shy of reaching 5,000 followers!
I love the conveniences that come from having my data moved around online (with my permission, of course). For example, TurboTax will pull all my information from my investment bank and the IRS, and then calculate how much I owe. With me doing hardly anything, I’m done in about 20 minutes! Similarly, Mint.com can pull in my bank and credit card transactions to scold me about how much I’m over-spending on Amazon and restaurants.
Sadly, my healthcare data is not nearly as portable or accessible as my financial data. It’s a shame, because there are many talented people in health start-ups who want to build tools to help people make sense of their health data. It’s been 15 years since HIPAA was passed to promote this accessibility and portability of data, but many obstacles have gotten in the way of implementation: debates about data standards, the cost of updating information systems, debates about whether patients should really own their data and more.
This is exactly why the U.S. Department of Veterans Affairs (VA) should be commended. The VA cut through these obstacles and implemented data download for all the veterans using their “My HealtheVet” online health services portal. With the click of a single button, users can now download appointment information, medication histories, lab results and more. To date, nearly a half million veterans have already downloaded their data. What’s more, the VA is encouraging other health providers to follow their lead: they would love to see every health portal have a big, blue button that allows users to download their data with a single click. They are calling this the “Blue Button” initiative.
Blue Button is an ambitious undertaking, and we’re just beginning to understand its potential. However, Blue Button doesn’t necessarily make it easier for a patient to move data to other services. In fact, there are no data formatting standards for Blue Button, a decision meant to motivate providers to participate because they wouldn’t get bogged down in an argument about which standard is best (for example, Continuity of Care Document (CCD) vs. Continuity of Care Record (CCR).) This lack of standardized data output means it will be more work for any third-party services that want to import it.
Moreover, the VA’s implementation of Blue Button for My HealtheVet poses some additional challenges for data portability. The sample data export from My HealtheVet is just a free-text file with very little structure to it. While it is easily read by humans, it is not in a format that can easily be parsed by computer programs, such as XML or comma-separated-value (CSV) files.
To help facilitate the portability of the VA’s Blue Button download data, PatientsLikeMe is releasing an open-source Blue Button parser, which translates the free-text data file into structured data. Our goal is to make it easier for programmers to use this data for their own applications, or even for building tools to translate the data into a more established health data standard like CCD or CCR. Because the parser is open-source, it is not only free, but improvements made by any developers can be contributed back so that others may benefit. We believe sharing is a good thing.
There actually have been a couple prior attempts at parsing the My HealtheVet records to date. One person made a great start at an online tool for parsing My HealtheVet files. Also, Microsoft’s HealthVault service will read Blue Button VA files, but, as far as we can tell, the parser they use for this is not available as open source yet.
The lack of a defined data format “standard” for BlueButton frees us from endless debating over nuances of one standard versus another, but at the cost of data portability. PatientsLikeMe believes Blue Button can be even more powerful if patients have more options for what they can do with that data. By releasing a standard open-source parser, PatientsLikeMe hopes to give providers and other services a way to participate in Blue Button without worrying about the lack of definition.
What does this mean for patients? Hopefully we’re a little bit closer to all having a Mint.com for our health.
Last April, we had the honor of presenting the results of our epilepsy survey at the American Academy of Neurology (AAN) Annual Meeting. In some of the key takeaways, we shared that 55% of respondents consider PatientsLikeMe “moderately or very” helpful in learning about the type of seizures they experience. 45% found it useful for charting seizures, and 30% felt they received better healthcare as a result. In addition, 27% each said that PatientsLikeMe was useful for managing side effects and for improving treatment adherence. (Check out our press release for more on this survey, which we conducted with our partner UCB. PatientsLikeMe and UCB launched the epilepsy community in 2010.)
Now, we’re pleased to announce that our full survey results have been published as an open access article in the scientific journal Epilepsy & Behavior. This gives you and anyone interested in epilepsy the opportunity to dig deeper into our findings. For example, another interesting discovery is that one in three epilepsy patients surveyed did not know a single other person with their condition. That is – until they joined PatientsLikeMe. Survey respondents reported the benefits of using an online community to find other patients like them, and strikingly, the more friends with epilepsy that users had in the online community, the more benefits they experienced from using the site.
Do you agree that having friends with the same condition – either online or offline – has affected your experience for the better? Share your thoughts in the comments section.
