Archive for: April 2011

Are We The Source of Knowledge?

Apr 26, 2011, 3:01 AM, Posted by Paul Tarini

Are We The Source of Knowledge?

We started hearing about it a couple years ago: an ALS member of Patients Like Me had seen (and translated—it was in Italian) a medical conference poster with results showing lithium carbonate could slow the disease’s progression.  That study was a single-blind trial of 16 treated patients and 28 controls.  The results spread through the ALS community and soon, patients began talking their physicians into prescribing lithium carbonate off-label. PLM soon had 348 members reporting on the effects of their use of the drug.

 PLM realized they had an opportunity to study the experience of their members who were—effectively—experimenting with the drug.  PLM couldn’t randomize, so they developed an algorithm and matched 149 treated patients to 447 controls based on the progression of their disease course.

 On Sunday, the journal Nature Biotechnology published PLM’s findings showing after 12 months of treatment, lithium carbonate had no effect on disease progression.  PLM reports that subsequent clinical trials reached similar conclusions.

 What’s important here is to recognize the potential to conduct research using patient self-reported data from an online social community.  PLM’s sweet spot is social communities for ambiguous diseases (that is, diseases we’re still learning about, diseases that don’t have clear, effective treatment protocols) where the patient does a lot of care at home.  To be sure, PLM is a pretty sophisticated community, but it’s intriguing to think about where we might be in 10-15 years.

A couple of us met last week with PLM’s Jamie Heywood and Dave Clifford.  We had a ranging discussion—hard to avoid with Heywood—that included linking patient self-reported data with clinicians, conducting research with this data, and business models.  A fundamental question Heywood is exploring is “whether it’s faster to get to learning health system through the current confines of the health system or through something like PLM.”

Given the growing ability and inclination of patients to capture and share details on their own experiences, how powerful a role is there for the analysis of this sort of data in our efforts to accelerate the discovery of new treatments for disease?

Up next? Oral Health.

Apr 22, 2011, 1:06 AM, Posted by Mike Painter

“Can you imagine a time when we fully incorporate mental and dental health into our thinking about health?  What is it about problems above the neck that seems to exclude them so often from policy about health care?”  That’s what Institute of Medicine President Harvey Fineberg asked in 2009.  On April 8th the IOM released a new consensus committee report, “Advancing Oral Health in America”. That committee’s 2011 response to Dr. Fineberg was essentially—“not this time—change starts here.”  I had the great privilege of participating on that committee along with 14 others from a variety of backgrounds and expertise.  Certainly, we were daunted by the enormity of the nation’s oral health challenge but also hopeful that there are, in fact, tools and approaches that could begin to make a difference. 

The IOM convened this committee based on a 2009 HRSA request for recommendations on a potential HHS oral health initiative.  The committee deliberated for almost a year while the long and contentious health care reform debate reverberated.  The specific charge for this committee was relatively narrow:  to provide strategic recommendations to HHS, specifically, regarding a department-wide oral health initiative.  Nevertheless, the national health care reform debate only served to highlight the concurrent need for reform in both oral health as well as health care, overall. 

And there were a few ghosts in the mix, so to speak—namely past reports, statements, actions, initiatives in oral health—good faith efforts all—juxtaposed against the harsh fact that the problems remain.  More than 10 years prior, the surgeon general issued a landmark report entitled, “Oral Health in America”.  It described the poor state of oral health as a “silent epidemic”.  Unfortunately and in spite of that warning, that epidemic remained altogether too silent.  In fact, arguably, nothing fundamentally has changed in those 10 years.  Entirely preventable oral diseases remain prevalent.  Oral health is part and parcel of overall health care—but the professions treat them as distinct and separate.  Vulnerable groups continue to suffer from disparate oral health outcomes. 

Even potentially more disturbing—we now recognize we’re essentially “flying blind” when it comes to the quality of oral health care.  Literally, we simply do not know much about the quality of oral health care for a variety of technical and policy reasons.  We don’t have great data sources for oral health care measures.  Even if we did, we do not have quality metrics to assess the quality of oral health care.  That’s fairly worrisome if one extrapolates from the overall health care experience in quality measurement and improvement.  In overall health care, once we started measuring the quality of that care, that’s when the scope of safety and quality problems—not to mention cost and value issues—really began to surface.  In oral health care right now, we don’t even know what we don’t know. More to the point, there’s no reason to think oral health care will be different than overall health care—and it could be worse—much worse.  In any event, it’s not acceptable to assume high quality in oral health care.  The public and our dedicated health professionals deserve to know.

So, the stakes are high—this report on improving oral health absolutely must be different than past efforts—but how?

The committee reviewed mountains of evidence, testimony, and specially commissioned reports.  From that evidence, the committee provided seven recommendations to the Secretary outlining specific steps to change the way the department approaches oral health as a governmental agency—and the way the department helps promote and lead improvement in the nation’s oral health.  Those recommendations ranged from (1) specific things the department should do to prioritize efforts—including an explicit challenge to open the initiative to patient and consumer participation, oversight and leadership; (2) an emphasis on strengthening prevention, promoting health literacy, and dramatically improving the ability and capacity of the health professions to address and improve oral health; (3) a focus on developing innovative new delivery system and payment strategies to support high value oral health care; (4) concerted efforts to use an ever expanding array of data for research—and, importantly, to develop and construct a range of oral health quality measures on performance, cost, efficiency and outcomes—and then make that information transparent and useful; and finally (5) an explicit challenge to HHS to hold itself publicly accountable year after year for action and improvement.

Of course, only time will tell if some new group 10 years hence looks back on this report as a turning point in improving the nation’s oral health—or says nice try, back to the drawing board.  We on that committee sure hope that the answer is—and the nation critically needs it to be—the former.

[These comments are the personal views of Dr. Painter and do not represent a statement by the IOM.]

Examining Innovation Through a Different Lens

Apr 21, 2011, 1:32 AM, Posted by Al Shar

Last week I had the opportunity to participate in the International Business Forum’s first Digital Healthcare Innovation Summit, which was held in New York City (Pioneer was a sponsor of the event). The sessions were good and had valuable content, but rather than rehash them, I will focus on those things that I learned about how some leaders in fields outside of health and health care think and work. Unlike many of the meetings we attend, this one was “created for all private equity investors and healthcare professionals to capitalize on the transformation of the healthcare industry.” This focus seemed offer a potentially different approach to technologies that can effectively support healthcare.

And while, superficially, the meeting was quite a bit like many others I’ve attended, there are a number of subtleties that are important and might help us in our work here.

  1. Finding a niche in which one can make inroads is more likely to succeed than a full on confrontation. A successful business strategy must be pragmatic.
  2. While high tech and wiz-bang solutions may excite, looking at good, stable and proven technologies used innovatively stands a better chance of adoption.
  3. Fail early; be prepared to walk away before considering multiple alternatives that might work. Don’t become too committed to either the idea or the constituency that might benefit.
  4. Be adaptable; be prepared to grow a small and peripheral kernel of a much bigger project. Major successes can grow from components that begin as ancillary to the main concept.
  5. Make sure that the right people are involved.

I think we in Pioneer do a fair amount of thinking along these same lines, but sometimes with what are likely to be different outcomes. For example, with regard to number one above, while we understand the value of finding a safer place to begin innovation, we seem to be more willing to directly confront conventional wisdom. With regard to number two, I think we’re more ready to look to a more unproven and less well vetted technology, with the belief that the technology will mature and become more stable. As for the third point, because the good that could come from success is so compelling, we sometimes are more unwilling to just walk away. While I can cite some major projects (most notably Project Echo and Changemakers) that have come somewhat unexpectedly from others, we don’t tend to look at the small opportunities that may emerge from grander visions. Finally, while we certainly want the right people involved, we’re unlikely to take the innovators and, as a condition of funding, make them turn over the enterprise to another.

Are these changes that we should make? I don’t think so. We are different and our measures of success need to be different as well. However, understanding the world and the way innovation can be supported by early and mid stage investors can help inform us in seeking breakthroughs with the potential to generate significant health and social impact.

Whose ODLs Are They Anyway?

Apr 19, 2011, 12:54 PM, Posted by Steve Downs

When it comes to deciding which “observations of daily living” should be collected, stored and reviewed, clinicians and patients have (surprise, surprise) different views.  And the overlap isn’t always that large.  This insight was a recurring them at last week’s meeting of Project HealthDesign teams.  So what’s to be done about that?

If you’re coming from a patient power or quantified self perspective, you might say that it doesn’t matter – people should track whatever they want, right?  Of course, but on the other hand, suppose you have limited patience for self-tracking and you really want your ODL data to influence how your clinical team understands your condition and how they make treatment decisions, then you probably want to make sure that some of your energy is devoted to collecting ODLs to which they might actually pay attention.  At the same time, it’s an opportunity for the patient to explain that ODLs she believes are relevant to her condition – either as triggers/exacerbators, or as symptoms of how her condition is manifesting itself in her life – are important to how she understands and manages her conditions.  So, for example, while a clinician might not be interested in a particular patient’s sleep pattern, that patient might feel strongly that sleep is inextricably linked to her health.

All this suggests a negotiation between person/patient and provider, which is the solution that the Crohnology.MD team is proposing.  They’ve mocked up an ODL prescription, which is, in effect, the outcome of the negotiation.  The prescription specifies the ODLs to be collected and the periods or durations during which they are to be collected.

We’re also discovering that there is a third party to the negotiation – the system developer.  In exploratory research project like the Project HealthDesign grants, this participation is explicit:  the developer talks with patients, talks with providers and ultimately builds a system around their requirements.  The developer’s design choices – from which ODLs to include to how they are defined to when they are collected – shape the patient’s participation in collecting them.  For example, the developers of FitBaby, a Project HealthDesign grant to investigate the use of ODLs to assist in the care of prematurely born infants coming home from the hospital, learned that understandably anxious parents in this situation often feel compelled to weigh the infants frequently.  However, weighing the baby too frequently not only lacks clinical value (as fluctuations are natural), but it’s also not healthy for the parents – particularly if the weighing becomes obsessive.  So the system developers set up the weight tracking routine to accept only one measurement of weight per week.  You can agree or disagree with that choice, but the point is that the developers shape the negotiation.  Outside of the research context, as developers build products for the marketplace, they are unwitting participants in the negotiation insofar as they are defining the solution space within which the negotiation between patient and clinician takes place.

From a policy perspective, this discrepancy between patient and clinician perspective on which ODLs matter has the effect of complicating the concept of “patient-generated” data, which appears in both the HIT Policy Committee’s proposed Stage 3 Meaningful Use criteria and the ONC’s recently released strategic plan. There are at least three types of “patient-generated” data: 

-          Data, such as blood pressure readings, already collected in a health care setting and typically found in a medical record.  The only difference is that the patient is collecting the reading.

-          Data, such as those found in a food diary, that are self-reported by the patient, but are not typically collected in a health care setting or documented in a medical record

-          Data, such as sensor data – or interpretations of sensor data, that are not self-reported by the patient but that are typically not found in the medical record.

As we go down the road of integrating “patient-generated” data – both traditional medical data and observations of daily living – into electronic medical records, then we’ll need to understand what types of data are really meant and which, under what circumstances, should be incorporated into one’s medical record.  To these questions, we hope to have more to say as the Project HealthDesign teams conduct their studies and experiment with different ways of providing all three of these data types to clinicians.

ResistanceMap Shows Rise in Dangerous Bacterial Infection

Apr 11, 2011, 1:24 AM, Posted by RWJF Blog Team

This guest post was submitted to Pioneering Ideas by Extending the Cure Research Analyst Nikolay Braykov. Extending the Cure researches policy solutions to prolong the useful life of antibiotics, an approach to fighting the rising trend of antibiotic resistant bacteria that was discussed by several prominent news outlets (The Guardian, Christian Science Monitor, Health Affairs) during last week's World Health Day.

The online tool ResistanceMap has released a new video that shows the spread of a deadly microbe able to survive treatment with the newest and most potent antibiotics in the current arsenal.

That microorganism, called carbapenem-resistant Klebsiella pneumoniae (CRKP), can cause potentially fatal pneumonia, bloodstream, or wound infections among elderly hospital patients. The featured video offers a first-of-its kind geographic retrospective of the pathogen’s emergence using nationally-representative data.

ResistanceMap, is developed by Extending the Cure – a nonprofit project sponsored by the Robert Wood Johnson Foundation’s Pioneer Portfolio that researches policy solutions to prolong the useful life of antibiotics. This online tool, which visualizes changes in resistance levels across regions of the U.S. from 2000 – 2009, summarizes data from microbiological labs across the country that measure bacterial drug resistance – the ability of microbes to survive treatment with antibiotics.

Whereas previous ResistanceMap videos highlighted the geography of established threats like Methicillin-resistant Staphylococcus aureus (MRSA), the new video tracks CRKP since its emergence in the early 2000s and adds to existing evidence that health authorities may be up against a new epidemic unless urgent steps are taken.

As the subject of this year’s World Health Day on April 7, drug resistance has drawn substantial attention from media like The Economist or MSNBC. In many reports, CRKP is heralded as the next “superbug”, particularly following reports on its growing prevalence in Southern California. One reason is the lack of proven treatment options – when last-resort drugs like carbapenems don’t work anymore, physicians can only experiment with combinations of antibiotics, often older drugs that have been shelved because of serious side effects. Another is that, as pointed out by a report in Scientific American, gram-negative bacteria like K. pneumoniae are very common, easily share resistance genes, and have been neglected by pharmaceutical researchers.

ResistanceMap helps us put the media coverage in more context.  In comparison with MRSA or other resistant bacteria, CRKP is still a rare, localized phenomenon - fewer than 3% of K. pneumoniae showed carbapenem resistance in 2009 and the bacteria was exclusively found in hospitals and nursing homes.

Still, the maps show how an outbreak initially confined to few New York hospitals can spread to facilities nationwide in a very short time. First emerging in the Mid-Atlantic with just a few occurrences in other regions, CRKP can now be found in 36 states.

K. pneumoniae are part of the normal microbial flora in humans and like all bacteria, their populations inevitably develop resistance mechanisms as organisms adapt to survive treatment. In order stay ahead in the race between bacterial evolution and drug research, public health officials have to act now – active surveillance and adherence to the latest CDC prevention and control guidelines can curtail the spread of CRKP before it spreads even further.

Enacting sensible, timely policies depends on our ability to inform constituents about emerging threats and to analyze existing ones. Thanks in part to initiatives like Extending the Cure, there is more public awareness and scientific knowledge available to help prevent a major crisis from unfolding and letting CRKP become the next MRSA.