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.”
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.
On October 24-25th, PatientsLikeMe attended the 8th Annual Patient Adherence, Communication and Engagement (PACE) Conference in Philadelphia. The event focused on how the healthcare industry can deliver measurable improvements in patient adherence (i.e., taking medications as prescribed by your doctor). Put simply, how can we help patients like you take the correct dosages at the correct times?
Why does this topic merit its own conference? Well, as we learned at PACE, medication non-adherence costs more than $300 billion every year in the US alone. You read that right. And this staggering amount is comprised of more than just hospitalization and emergency room costs. It also includes things like lost employee productivity and the cost for less optimal patient outcomes. Essentially, think of it as $300 billion the US could be saving each year – but currently is spending – in the midst of an economic downturn.
A key factor in non-adherence is that patients may frequently have an incorrect understanding or an unrealistic expectation from their doctor of what their medications will do for them.
Recently passed US legislation is attempting to change the way doctors are paid. The new law provides financial incentives for health plans to implement quality measures that hold doctors accountable for impacting patient outcomes.
Many new solutions, such as telemedicine and the patient-centered medical home, are being piloted and studied. The goal is to learn how technology can impact patient outcomes via medication adherence services and remote medical care.
To remain relevant to patients, biopharmaceutical companies now recognize that they must incorporate the voice and experience of the patient into their decision-making processes.
Last but not least, our very own Chief Marketing Officer and Head of Business Development David S. Williams III spoke about the work PatientsLikeMe is doing around medication adherence. Specifically, he focused on patient-to-patient interaction as an influential driver of medication adherence and how we can give patients the tools they need to (1) understand how their medication is working for them and (2) hold each other accountable for following their doctors’ instructions.
Do you believe connecting with – and learning from – other patients is critical to adherence? Share your thoughts in the comments section.
MS PATIENTS PERCEIVE COPAXONE EFFICACY AND TOLERABILITY AS COMPARABLE TO REBIF AND AVONEX PatientsLikeMe Continues Report Series on Real-World Patient Experiences with Multiple Sclerosis Medications
CAMBRIDGE, MA—November 3, 2011—In the second report of a series on Multiple Sclerosis (MS) disease modifying therapies (DMTs), PatientsLikeMe reveals that MS patients perceive Copaxone as having comparable efficacy and tolerability profiles to the interferon therapies Avonex and Rebif. However, all three medications are perceived as trailing in efficacy and tolerability to Gilenya, Tysabri and Betaseron. In the report’s analysis of 3,200+ patient conversations about MS DMTs from January-June this year, PatientsLikeMe also finds that Copaxone is perceived as safer than other MS DMTs.
“Patients’ sharing of their Copaxone experience may adversely affect its demand as a first line therapy since patients are becoming more influential in their treatment decisions,” says David S. Williams III, Chief Marketing Officer at PatientsLikeMe. “What has become clear through these reports is that real-world evidence will have a major impact on relative pricing for MS DMTs and play an increasingly important role in access decisions.”
This 46-page report—entitled “Does Copaxone patient experience in the real world justify its value?”—quantitatively and qualitatively analyzes 4,100+ MS patients with experience using Copaxone. Other report sections include:
The Patient Voice in Treatment Discussions: Copaxone was discussed in 25% of all patient conversations about MS DMTs.
Copaxone Efficacy and Side Effects: Of the 1,100+ MS patient evaluations on Copaxone’s efficacy and side effects, 30% reported experiencing “moderate” to “major” efficacy, while 26% reported “moderate” to “severe” side effects.
Copaxone Price vs. Value: Is this medication appropriately priced compared to other MS DMTs given real-world evidence regarding efficacy and side effects?
Note to Editor: All data cited from this report must be sourced as originating from PatientsLikeMe®
PatientsLikeMe® (www.patientslikeme.com) is the world’s leading online health data sharing platform. PatientsLikeMe® creates new knowledge by charting the real-world course of disease through the shared experiences of patients. While patients interact to help improve their outcomes, the data they provide helps researchers learn how these diseases act in the real world and accelerate the discovery of new, more effective treatments. [Follow company news on www.twitter.com/PatientsLikeMe andhttp://blog.patientslikeme.com]
(This piece was written for eyeforpharma’s PatientWeek 2011 and originally posted here September 23, 2011)
Real-world, patient-reported data is becoming more important to everyone in healthcare. One source of that data is patient registries.
According to the US Department of Health & Human Services’ Agency for Healthcare Research and Quality (AHRQ), a patient registry is “a database of confidential patient information that can be analyzed to understand and compare the outcomes and safety of health care.” Ultimately, the goal of capturing and analyzing this data (shared by multiple sources like hospitals, pharmacies, physicians and patients) is to learn from one another and improve healthcare. Like registries, PatientsLikeMe understands the importance of capturing data in a meaningful, computable and quantifiable way.
However, behind every piece of data is a patient.
So, in the spirit of putting patients first, we began thinking about the next generation of a patient registry where patients benefit in real-time from what they share. It would need to be where patients could openly share longitudinal demographic and clinical data about their disease while using online tools to improve their outcomes. It couldn’t be just silos of health data focused on one disease at a time; it would need to encompass data on all diseases and inspire patients to share information about those co-morbidities. Finally, it would need to motivate and engage patients to share more, share better.
If this next generation of a “registry” could ensure long-term data sharing, can you imagine how much meaningful insight would be available for patients and industry alike? We could … and that’s what we’ve been building at PatientsLikeMe for the last five years. We’re excited about what that means for our members each day, as well as what it means for the future of medicine.
Our members believe in community—a one-for-all mindset where they can share what they experience and see the same for every other patient like them; a mindset where they expect us to then pass on those experiences to researchers, companies and others who want to learn together and improve healthcare. When we tell members how we make money (by sharing their de-identified data with our trusted partners), many of those patients say, “Great. Share! Share! Share!”
We, as a community, have no doubt that sharing is the essential ingredient in accelerating research, ensuring patient safety and making better treatments.
As we look beyond the chat room and beyond the traditional patient registry, we see a world where patients are openly sharing meaningful, computable and quantifiable data with each other to make their lives better … and, in turn, making all of medicine that much better too.
TWO OUT OF THREE PATIENTS REPORT DISCONTINUING TYSABRI WITHOUT DOCTORS’ ADVICE
PatientsLikeMe Releases First in Series of Reports on Real-World Patient
Experiences with Top Multiple Sclerosis Drugs
CAMBRIDGE, MA—September 22, 2011—In the first report of a series on Multiple Sclerosis (MS) disease modifying therapies (DMTs), PatientsLikeMe reveals that nearly two-thirds (64%) of patients who report discontinuing the use of Tysabri (n=323) did not cite “doctor’s advice” as a reason. “Side effects too severe” and “did not seem to work” topped the other reasons cited by patients. The report goes on to reveal that patients stop Tysabri due to side effect severity less frequently than patients who discontinue other DMTs for that same reason. The PatientsLikeMe report is the first of five in a series focusing on how patients are experiencing and evaluating DMTs in the real world.
“People with MS and other conditions have become much more than just consumers of prescription medications, they are now customers who wield a high level of influence on treatment decisions,” says David S. Williams III, Chief Marketing Officer at PatientsLikeMe. “The goal is maximizing health outcomes for patients. Clinicians can use the real-world insights from this report to collaborate better with patients in treatment planning while manufacturers can use them to better design adherence programs to reduce inappropriate discontinuation.”
This 40-page report—titled “Does Tysabri patient experience in the real world justify its value?”—analyzes the experiences of more than 12,000 MS patients who are taking, or have taken, Tysabri or other DMTs. In the report, PatientsLikeMe evaluates:
Tysabri Price vs. Value: Is this drug appropriately priced given real-world evidence regarding efficacy and side effects?
The Patient Voice in Treatment Discussions: Of the 4,083 patient conversations mentioning one or more MS DMTs from January-June this year, Tysabri commanded 27% share of patient voice. What percentage of Tysabri-related discussions were focused on progressive multifocal leukoencephalopathy (PML) or JCV (John Cunningham virus) antibodies?
Efficacy and Side Effects: More than half (55%) of the 500 Multiple Sclerosis patients who have taken and evaluated Tysabri experienced “moderate” to “major” efficacy compared to interferon therapies which average 33% moderate to major efficacy.
Note to Editor: All data cited from this report must be sourced as originating from PatientsLikeMe®
About PatientsLikeMe PatientsLikeMe® (www.patientslikeme.com) is the world’s leading online health data sharing platform. PatientsLikeMe® creates new knowledge by charting the real-world course of disease through the shared experiences of patients. While patients interact to help improve their outcomes, the data they provide helps researchers learn how these diseases act in the real world and accelerate the discovery of new, more effective treatments. [Follow company news on www.twitter.com/PatientsLikeMe and http://blog.patientslikeme.com]