2 posts tagged “Journal of Medical Internet Research”

How Patients Like You Use Your Treatments in the Real World: Two New Studies

Posted January 31st, 2011 by

Ever wonder how many patients like you are using drugs off-label?  Or how hard is it to take MS medications as prescribed?  You’re about to find out.

In January, the PatientsLikeMe R&D team published not one but two studies in the Journal of Medical Internet Research (JMIR) in an effort to provide answers about how patients like you are actually using your treatments.  We’ll highlight both studies here on the blog today and tomorrow.  (Note: Because JMIR is an open-access journal, the articles are free for you or anyone to read in full, without fees or subscriptions or a library card.)

Study One:  Off-Label Drug Usage

Our first study looked at the rates of off-label drug usage in our communities.  What do I mean by “off-label”?  When a drug is approved by the FDA (or outside of the US, by other regulators such as the EMEA), it is “indicated” for the treatment of a specific condition, which permits the manufacturer to market it to doctors who treat that condition and patients diagnosed with it.  This indication is described on the medication’s label.

Any physician may choose to prescribe a treatment for a purpose that has not been indicated, however.  This is known as “off-label” use.  Manufacturers are not allowed to promote such use, though, and because most research focuses on new drug development, there are few systematic ways to discover how common off-label drug use is or to quantify its effects.  Yet at PatientsLikeMe, thousands of patients like you are sharing data on this very practice.  So, the R&D team decided to take a closer look.

This led to our JMIR study entitled “Patient-reported Outcomes as a Source of Evidence in Off-Label Prescribing: Analysis of Data From PatientsLikeMe” (which I am proud to report was the winner of the inaugural Medicine 2.0 award).  We started by identifying two widely used drugs to study:  amitriptyline (a tricyclic antidepressant indicated for the treatment of depression) and modafinil (a wakefulness-promoting drug indicated for the treatment of narcolepsy).  Then, we examined how patients like you were using them used across five condition-based PatientsLikeMe communities: MS, fibromyalgia/chronic fatigue syndrome, ALS, mood disorders (depression, bipolar disorder, and anxiety disorders) and Parkinson’s disease.rd1

Our data revealed that less than 1% of almost 2,000 patients taking modafinil and only 9% of nearly 1,400 taking amitriptyline are taking each drug for its approved indication.  That means the vast majority of you are taking these drugs “off-label.” You also reported higher perceived efficacy for off-label uses than for approved indications, surprisingly. Another interesting discovery is that many of you cited what are normally considered the side effects of amitriptyline (e.g. dry mouth) as your purpose for taking the drug (e.g. to treat excessive saliva).

If researchers are only looking at clinical trial data, they’re missing the whole story because they don’t know what’s being prescribed off-label. To be clear, off-label prescribing is commonplace and standard practice in many conditions, with safety and efficacy established by clinicians’ experience rather than formal studies. However, whenever we can improve upon the status quo by unlocking a new data source (such as what you share via our site), we should seek to maximize that information.

Up next tomorrow…how you’ve helped develop patient-reported outcome instruments.

PatientsLikeMe member pwicks


It’s Official: Sharing Health Data Improves Outcomes

Posted June 21st, 2010 by

(Listen here to the PatientsLikeMeOnCallTM podcast on this topic)

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Last week the PatientsLikeMe R&D team published a study entitled “Sharing Health Data for Better Outcomes on PatientsLikeMe” in the Journal of Medical Internet Research (JMIR), the leading open access peer-reviewed journal on health care in the Internet age. The study aimed to find out direct from our users how they were using the site and whether the information they’d learned was helping to influence their interactions with healthcare providers, their decision-making, and ultimately their outcomes. Because JMIR is an open-access journal, you can download the whole paper for free here, but here are some of the highlights from the 1,323 patients that completed the survey:

  • Almost all of our patients (94%, N=1,249) were diagnosed when they joined the site; an important factor in joining a community of “patients like me”
  • The majority of members (72%, N=952) agreed that the site was helpful for learning about a symptom they have experienced (check out our symptom reports to see what they’re learning!)
  • Many respondents (57%, N=757) agreed that the site had helped them to understand side effects of their treatments (check out our treatment reports to find out more!) and 42% (N=559) found the site helpful in finding another patient with experience of taking a specific treatment for their condition
  • Patients who used the site more perceived more benefits. We gave each patient an “engagement score” from 0-4 based on how many features of the site they’d used; we found that the higher the participation, the higher the benefit. Correlation doesn’t necessarily mean causation though, so it could be patients who share more get more out of it, or it could be that patients who have already benefited from the site are more willing to participate. Interesting hypothesis for a follow-up perhaps?
  • Nearly a third of patients (29%, N=388) had printed out their profiles and shared them with their doctor; two thirds of users (66%, N=871) said their healthcare team were supportive of them using the site. More controversially, we were interested to find that overall, 12% (N=151) said they had changed their physician as a direct result of information received from PatientsLikeMe; that number was twice as high in fibromyalgia (21%)!
  • In the spirit of openness we also made available (in de-identified form) all of the open comments we received at the end of the survey on how we could improve the site, both positive and negative.

This was the first study to quantify the potential benefits that users of the site can experience; we hope to discover more about how these change over time and what benefits are perceived by users of our newer communities such as epilepsy and organ transplants.

PatientsLikeMe member pwicks