Is A Moratorium on Disease Management Company White Papers Warranted? If Not, Here Are 7 Guideline Rules

What’s up with disease management organizations and their ‘white papers?’ Typically paired with some inflated press release or a laudatory web site, these downloads (also labeled as ‘research,’) are typically engineered to convince the reader a novel and important advance is at hand. Capitalizing on the company’s supposed scientific ‘player’ status, we’re expected to believe that a ‘patented approach,’ or a ‘validated methodology’ or a ‘proprietary system’ backed by ‘industry leaders’ increases quality, saves money, attains physician buy-in and restores karma across the healthcare landscape. Alas, while there may be some exceptions, most of the time, those assertions are not supported by the data..

With the increasing visibility of the Disease Management Care Blog, it is fast becoming the target of company sponsored white papers, analyses, reviews and postings. It has generally avoided commenting on them because it has found many of the papers have astonishingly shallow research designs, truncated bibliographies and self-serving conclusions. Recall how disease management organizations published all that junk years ago? While the reviewers and editors finally caught up with them, like whack-a-moles, this pseudoscience still has a lingering safe zone on the web-pages of and spam-like email attachments from even some of the more reputable disease management companies.

Ah, you say, this is just the plain ol’ marketing, what’s the big deal and everyone does it? The big deal is that the disease management industry has a unique reputation for lousy analyses that have repeatedly violated multiple fundamental statistical and analytic rules. The audience of clinical leaders, policy makers, politicians’ aides, physicians and insurance executives has been sensitized to this and are likely to see these white papers for what they are: the same old garbage. As a result, these glossy faux articles paradoxically cause the industry to lose credibility. And since it’s not hard to find the old white papers out there, the arrival of even more makes the DMCB think there must be a manuscript zombies about, spreading their pestilence thanks to naïve marketing departments, poorly trained scientific writers and high level executives who are impatient with science and the pace of peer review.

The DMCB thinks the blow-back toxicity of the white papers run amok is enough to warrant a moratorium. The DMCB is humbly resigned, however, to the likelihood that the industry will not follow its recommendations. So, it offers up the DMCB Seven - If You Must - Rules to White Paper Management:

1. Think: is the scientific news that your company wants to share really so critically important that you can’t accommodate the peer review process? If it’s that important, many Journals will 'fast track' your findings. If it’s not that important, then it’s probably marketing, not a white paper. Treat it as such and don’t insult the intelligence of your customers by pretending otherwise.

2. There are some outstanding Journals that have an outstanding turn-around time with volunteer expert peer reviewers that can help sharpen the conclusions, spot inappropriate assertions and help you with a high acceptance rate. Your company won’t have to wait long to see its findings in print with all the advantages of a white paper with fewer gaffes.

3. If you must issue a white paper, strive to make it good enough to pass peer review anyway. In fact, it’s possible to submit it to a journal, skip the publication (though that’s very rude if they offer to take it) and use the reviewers’ comments to make the manuscript better.

4. The DMCB calls your bluff if you go with a white paper. Try using your readership as peer reviewers by open sourcing your (HIPAA compliant) data so that others can confirm your findings.

5. While you may believe your company is aided by claims of proprietary expertise, transparency is a stronger suit long term.

6. Minimize the involvement of sales and marketing until after the scientific writing is completed.

7. Think about getting involved with the PHI Institute. These guys have a process that helps companies assure that their in-house analyses follow the basic rules when it comes to correctly attributing causality between your program on one end that the observed outcomes at the other end.

The DMCB Responds to Dr. Marcia Angell's JAMA Editorial About Pharma Research & the Creation of an Institute: Open Source is Better

In the Sept 3 issue of JAMA, former New England Journal of Medicine (NEJM) Editor in Chief Marcia Angell editorialized about the effect of the pharmaceutical industry on U.S. medical care with a special emphasis on published research. After ticking off the usual litany of recent conflict-of-interest author sins including ghost-writing, stock options and speaker fees, Dr. Angells turned the spotlight on the published research itself, made faux thanks to spin, bias, and data suppression. She concluded that physicians can no longer trust peer review journals. Then she made a curious, if understandable, recommendation: the creation of an ‘institute for prescription drug trials.’

Hmm. The Disease Management Care Blog suspects this is akin to proposals for the Feds to establish a center for comparative effectiveness research. The DMCB knows many physicians are distrustful of blunt, oversized & unwieldy ‘solutions’ designed by otherwise well-meaning experts. Think FDA and you’ll understand the caution over the merits of more federally owned or sponsored institutes/centers.

The DMCB would like to offer a contrarian viewpoint on how to get from here (a broken system) to there (a higher likelihood of discerning the truth in clinical research trials).

Rather than ‘compact’ the storage, analysis, interpretation and reporting of data from drug trials, the DMCB recommends open sourcing it. In other words, following publication, post the original data from the trials in a downloadable flat file on the internet. Let anyone access it and let anyone offer up a similar or different interpretation.

Advantages include:

Far many more experts, both professional and amateur alike, will be able to openly and far more thoroughly vet the researchers’ original conclusions. The expertise of volunteer crowds has already been put to good use by Procter & Gamble, IBM and NASA. Think academics or amateur statisticians with down analytic time and little hope otherwise of getting into JAMA or the NEJM wont jump at the chance at being the one to find an otherwise missed clinically and statistically significant correlation? Think again.

This is a far more efficient – i.e., speedy, cheaper and reliable – approach than relying on an ‘institute.’ Given the track record of similarly contrived academic, governmental and bureaucratic central planning, the DMCB would rather rely on the increasing sophistication of today’s information markets to sort fact from spin. It’ll cost little and can start tomorrow. Make that today.

Allegations of flawed or biased conclusions, intentional or not, will be mitigated. This is a far better way for all parties, including the print journals, to promote transparency and demonstrate a commitment to getting to the truth. The DMCB suspects consumers will be more likely to trust the public domain than an FDA-clone institute. Think juries in New Jersey or Texas won’t pay attention? Well, maybe not, but it can’t hurt. As for the physician community, we’ve been accused of being saps when it comes to pharmas’ trickery. Open source the data and there are many of us that will show you otherwise.

Criticisms? There are some, but none seem insurmountable to the naïve DMCB:

Research participants’ privacy will be compromised by open source posting. The DMCB believes a) patient identifiers can be reasonably masked, b) bullet-proof privacy is less important to increasing numbers of persons in this age of YouTube, Facebook and MySpace, c) what, like other corners of health care offer bulletproof privacy? d) the remote possibility of a privacy breach can be included in the Informed Consent and e) for most potential research subjects, the pleasure of helping advance the advancement of scientific knowledge for the advancement of mankind will continue to outweigh the risks.

There is little evidence that open sourcing will perform better than the current system of closed peer review buttressed by an ‘institute.’ In fact, it may be worse. While open source Wikipedia has a reputation for critical lapses in accuracy, the DMCB believes a) repeated and independent analyses will eventually but always triangulate on the truth and b) experts – many of whom will be unexpected – will emerge as trusted third party super-vetters. And, like, given their track record, can we trust the current ‘expert-class’ of editors and academics to do a better job with their information monopoly? Their preference the status quo laced with some institute/center ‘steroids’ looks like an unseemly stab at job security. A quasi-governmental business model is simply out of touch with our distributed knowledge society. Last but not least, the editors’ dismay is undercut by the highly remunerative drug ads that appear in the same print journals that tut-tut editorialize about their underlying methods.

Research sponsors will never give their intellectual property away. Maybe that kind of attitude explains why much of their market capitalization has vaporized. In contrast, IBM and P&G, after struggling with the same issues of trade secrets, have witnessed an increase in the quality of their products and the price of their stock. Ironically, one solution is to ‘copyleft’ (vs. copyright) the data, which will impede competitors’ ability to take unfair advantage. While there’s a risk, perpetuation of the double-dog-secret closed information system has imploded too many times for too many otherwise pretty good drugs.

Print media will be undercut. These grand old dames may see circulation drop, especially if data posting and the original interpretation skips the hassle of publication altogether. The DMCB doesn’t think so because print journals have such a strong bullpen of reviewers.

The DMCB offers some possible wrinkles to think about:

This could be piloted. Compare open source vetting to closed system manuscript review to both and see which performs better.

What about the option posting the data with a preliminary introduction and summary of results without any interpretation and offering a prize for the ‘best’ analysis?

Treating High Cholesterol in Children? Think Again, But If We Must, Think Also About Disease Management

The condolences of the Disease Management Care Blog go out to all the primary care pediatricians whose phone lines will be lit up tomorrow, thanks to tonight’s news reports about treating high cholesterol in children. Moms will be calling and asking if their children need to start statins for high cholesterol. And why not? After all, chances are dad, mom, the aunts the uncles and all four grandparents are taking them also.

The reports were prompted by a July 1 ‘clinical report’ from the American Academy of Pediatrics (AAP). If you skip down to the summary at the end of the article, the good news is that unless the ‘bad’ cholesterol or LDL is extremely high, children 8 years or older who are just overweight or obese will never need to take a statin. However, if the child is obese and has an additional chronic condition such as high blood pressure, diabetes mellitus or tobacco abuse and diet is to no avail, drug treatment, depending on the LDL level, is recommended.

The notion of starting children on long-term statin therapy is not new. Other conditions including kidney disease, heart transplants, Kawasaki disease and surviving cancer treatment have been treated with statins for many years. The good news is that in these populations, the incidence of side effects has been very low.

On the other hand, the DMCB – who is the first to admit that it knows little about pediatrics – is wondering if the AAP is recommending an overly aggressive treatment approach. While it is true that even children are developing early signs of atherosclerotic vascular disease, the science here is one of primary prevention. Even among adults, the ‘yield’ from using statins to prevent disease in persons without a prior heart attack is quite low. Decreases cardiovascular events are measured in single percentage points over 5 years or single digits per 1000 patient years. Ironically, even though heart attack rates may go down, there are no data showing there is a decrease in mortality. Can we generalize the data from adults to children without the benefit of good evidence from long term prospective randomized clinical trials that go longer than just one year? What’s more, have enough children been exposed to statins over a long enough period of time to help us truly understand the long term health consequences? Last but not least, have we reached the point where our lifestyles have driven even our children into pills for all their ills?

But the DMCB isn’t about the harangue the pediatric community with rhetorical questions about the science. Instead, it is concerned that the AAP report has no mention of need for a dedicated long term drug safety registry in this age group. Lacking any insight from prospective clinical trials, we need this kind of database to assess the ongoing safety and value of statins in the pediatric population.

The DMCB also couldn’t help but notice that the AAP report did not list any potential conflicts of interests involving the authors – especially since the payoff to statin pharma manufacturers from this expansion in their market could be significant. Think there aren’t other bloggers digging into that potentially juicy possibility as I type this?

Last but not least, there is little mention of the contribution of disease management. The DMCB suggests a prescription for a statin should be accompanied by health coaching that not only engages patients in maximally managing diet and exercise, but helps assure medication adherence and is ready to help with potential side effects. And if the AAP isn’t going to lead the way, perhaps the disease management companies (or pharmacy benefit managers - who are getting into disease management) could use their considerable IT resources to help create the registries – adding even greater value to the services that could be provided in this area. If my colleagues in DM were particularly courageous, they could also open-source them.

Comments About the On-Line Chantix Study, the **Shocking** CBO HIT Report and More Insight on Why the Chicken....

From the front page of today’s USA Today: a report that varenicline (Chantix) is associated with mental status changes and that the Federal Aviation Administration no longer considers it safe for use by active-duty commercial pilots. But what’s interesting to the Disease Management Care Blog was that, according to USA Today, the study was posted on-line because…

‘co-author Curt Furberrg, a Wake Forest University medical epidemiologist said he and his co-authors felt ‘this was too important’ to submit first to a medical journal, which could take six months or more to publish [italics mine].’

Surprised by the changing relationship of medical science and print or web-based media? Don’t be. After all, you read the Disease Management Care Blog.

And the Congressional Budget Office continues its reputation as a parade raining, party-pooping sourpuss by releasing a report that sheds doubt on the financial assumptions of the habitués of the Health Information Technology cool-aid. The DMCB is shocked, shocked.

Last but not least, many readers of the Disease Management Care Blog have probably gotten the Ver. 2 updated ‘why did the chicken cross the road’ joke email from family or friends. It starts out:

BARACK OBAMA:
The chicken crossed the road because it was time for a CHANGE! The chicken wanted CHANGE!

JOHN MC CAIN:
My friends, that chicken crossed the road because he recognized the need to engage in cooperation and dialogue with all the chickens on the other side of the road.

HILLARY CLINTON:
When I was First Lady, I personally helped that little chicken to cross the road. This experience makes me uniquely qualified to ensure -- right from Day One! -- that every chicken in this country gets the chance it deserves to cross the road. But then, this really isn't about me.......

The DMCB thought it would expand on the theme:

HEALTHWAYS:

Numerous peer review studies have conclusively demonstrated that when chickens are ready to change, they can be coached by Healthways colleagues to cross the road with maximum outcomes. At baseline, the chicken was on one side of the road. At follow-up, it was on the other side of the road. We obviously caused that to happen with an ROI of 2 to 1.

HEALTH DIALOG

Our proven predictive modeling and patient engagement strategies help chickens decide how and when to cross the road. After we commenced our personalized intervention, road-crossing behavior measurably, consistently increased. The ROI was 2 to 1.

MEDICARE

Unless more chickens cross the road at lower cost budget neutrality compared to other chickens that didn’t cross the road, you can forget about Phase 2 in Medicare Health Support.

DMAA

It’s not chickens. We announced at our last annual meeting that they are barnyard feathered fowl.

PHYSICIANS

Stay away from our chickens.

ACTUARIES

The vector observed that describes chicken road crossing is typically associated with food seeking behavior, avoiding automobiles, avoiding predators, attraction to roosters, stupidity and random behavior. We can say with 64% confidence that it was one or more of these causes.

ALERE

Because a remote monitoring device ascertained the chicken should seek out the other side of the road. The recent acquisition of Matria brings even more value to that chicken, the road and our shareholders.

ECAREMANAGEMENT BLOG

Because only chickens would be dumb enough to do that for the .35 relative value units (RVUs) that the American Medical Association/Specialty Society RVS Update Committee thinks is enough for a Medical Home.

CATO INSTITUTE BLOG

To escape from the inane health policy recommendations of the Commonwealth Fund

DISEASE MANAGEMENT CARE BLOG

To avoid having to take the spouse to any movie starring Sarah Jessica Parker.

'Wikinomics' Sheds More Light on Open Source

And now for some interesting quotes from Wikinomics, How Mass Collaboration Changes Everything by Don Tapscott and Anthony Williams. Heady stuff, but the Disease Management Care Blog agrees that health services researchers will eventually discover they can reach a wider audience by bypassing the traditional peer-review journals. The trick is to harness the mass collaborative potential already evident in other business models. Once that tipping point is reached, one click of the mouse on an author's wiki/blog interpretation of an open source database will beat 5 prestigious publications interpreting a closed data base. As mentioned previously in this blog, the disease management industry could lead the way.

'...the new Web will forever change the way scientists publish, manage data and collaborate across institutional boundaries. The walls dividing institutions will crumble and open scientific networks will emerge in their place. All of the world's scientific data and research will at last be available to every single researcher - gratis - without prejudice or burden.'

'Unrealistic you say? No really when you consider that conventional scientific publishing is both slow and expensive.... Traditional journals aggregate academic papers by subject and deploy highly structured systems... Each paper is peer reviewed by two or more experts, and can go through numerous revisions before it is accepted... Frustrated authors can find their cutting edge discoveries less cutting edge after a lumbering review process has delayed final publications by up to a year.'

'Rapid iterative and open access publishing will engage a much greater proportion of the scientific community in the peer review process. Results will be vetted by hundreds of participants on the fly, not by a handful of anonymous referees, up to a year later.'

Open Sourcing - Help (and possibly make some money), Follow or Get Out of the Way

Regular readers may recall this blog’s prior posts on the option of ‘Open Sourcing’ by the disease management industry. Advantages include the good will generated by transparency and the likelihood that others will be able to glean additional insights from the data. I also pointed out that the asymmetric patient-physician information gap could dissipate, leading to emnuclear powered patient-amateur scientists and profound changes for the medical profession.

Here’s a glimpse of the open sourcing that is already possible, courtesy of the New York Times. The Disease Management Care Blog thinks this makes for astonishing reading. In truest web fashion, individuals are not just “self-aggregating” into an anecdote-sharing and support community, they’ve gone open source and are using their own subgroup analyses to come up with measures of central tendency that takes “translational research” to a whole new level. There is some needed discussion about managing the privacy trade-offs and the expected tut-tutting from physicians – none of which is insurmountable. What goes unmentioned is how users are also bypassing the traditional peer-review/scientific publication process.

How will health insurers, health/electronic medical record vendors, on-line personal health record “aggregators,” scientific journals and the disease management industry respond? The DMCB is only distantly aware of that science known as “marketing,” but it knows that where there is demand for disruptive technology, there is also opportunity.

Scientific Info and Policy Making: Print vs. the Web

The Disease Management Care Blog also recommends the Health Affairs Blog, where you’ll find top caliber thinking from the wisest of the healthcare Brahmins. Speaking of which, that’s where you’ll find an announcement that James Robinson is stepping down from the editor-in-chief post. In the interim, the highly regarded John Iglehart will return to his old post and look hard for a replacement.

Here’s an unsolicited opinion for Dr. Inglehart and his colleagues: the prognosis for scientific and policy web publishing using blog and wiki formats is much ultimately brighter than staid print journals like Health Affairs. Their exclusive web-based articles in addition to the paper-medium journal are a step in the right direction, but it’s not enough.

As someone who has had both peer-reviewed manuscripts make it to print and has also gotten a case of blog-fever, my impression is that blogging is a better deal for the writer and the reader.

Why is that you ask?

I'm still writing and submitting manuscripts to journals, but I've begun to notice that more and more of the useful references I quote are web-based.

In a blog, everything is really mine. In print, I have to assign copyright to the journal. It's theirs.

In a blog, I write, I post and *click!*, it’s up. In print, it typically takes months to make it through the peer reviewers and, if I’m lucky enough to get accepted, additional months before it’s published and mailed bulk rate. It’s not very satisfying to the writer and the topic can quickly turn obsolete.

In a blog, I’m completely responsible for the content. In print, I am at the mercy of space constraints and the peer reviewers. They are very smart, very dedicated and have helped me polish all my manuscripts, but I think they can also be biased with viewpoints that may not necessarily be perfectly aligned with the intended audience. Who knows, they know their readers but those biases can shape the final product that appears in print.

In a blog, the reader can comment immediately. In print, it’s a letter to the editor.

You may think the delay, process and peer review is worth it since that gives traditional journals the safeguards necessary to protect the reader from wrong information. While true, that assurance has become dented. Check out this review from the American Journal of Psychiatry that demonstrates how vulnerable the peer-review process is to intentionally and unintentionally contrived studies. Even the luster of New England Fortress of Medicine has been victimized by under-reporting of side effects, having its reviewers be vulnerable to allegations of misconduct and authors neglecting to report conflicts of interest.

This is why I predict some academic institutions and/or researchers will eventually start posting/blogging/wiki-ing their reports directly on the internet. Readers need to judge for themselves anyway and have the smarts to do it. No need for scientists and policy makers to worry about criteria for tenure, because their academic success will be measured not in the stature of the journal or the number of reprint requests, but by the number of “hits” or “comments” from members of the medical community. In the meantime, print will remain important but could fast become a medium that is used by fewer and fewer to write about less and less.

Remind you of the disintermediation going on in the music industry? It should.

Should the disease management industry take note? It should.

I’m sorry Health Affairs, but your business model is destined to change and soon. I’m sure you guys have already been thinking about this and may be already planning to have your blog eventually become the chief source of revenue. I hope Dr. Iglehart’s replacement finds a way to manage it, because I think it’s likely to happen soon.

Enough of Open Source already. What really convinces in disease management are anecdotes!

After re-reading prior entries on the topic, the Disease Management Care Blog has no doubts about the non-likelihood that any entity in the business of population-based health care will ever adopt Open Source. So, it's time to blow tanks and surface by ceasing further commentary on the topic (both for the readers’ sake as well as mine)….after one last important point.

The very erudite Thomas Wilson, PhD reminded me once that a key difference in the health care trade versus other types of business is that the former is based on the Hippocratic principle of 'Primum non nocere' (first, do no harm), while the latter, at least in its classic form, is founded upon the philosophy of 'caveat emptor' (buyer beware).

For me, that gets to the heart of the issue. While this is an admittedly overbroad distinction, the fact is that no health care intervention is truly risk free (including the possibility of wasting time and money). The medical community has always had a stake in explicitly measuring the value of its goods and services. In contrast, other sectors of business often leave it up to the customer to assess value. This distinction can be muddied by somewhat by common and contract law as well as other dimensions of business ethics, but I think you’ll agree that there is something to this point.

Add this fundamental Primun non nocere principle to the widely prevalent culture of social mission “research,” in medicine and it becomes clearer why the high standard “prove this works” evidence-based medicine ethos has butted heads with style of many commercial disease management programs. While there is plenty of guilt to go around in the various medical device manufacturers, hospital business lines, pharma, integrated delivery systems and medical schools, that doesn’t absolve the disease management community of also having a responsibility to thoroughly and transparently assess the good, the bad and the ugly of its otherwise proprietary processes and putative outcomes.

There must be ways to move to Open Source that relies on third parties with a viable business model that protects the interests of all involved. It’s happening in genomic medicine, should happen in pharma and is applicable to the science of epidemiology. It could have also provided some additional protection to the hapless hip protector researcher Dr. Kiel as well as the unlucky COX II New England Journal of Medicine reviewers who have apparently been subjected to a subpoena.

Feel free to post your thoughts (if posting works... I'm trying to fix this) or let me know what you think.

As for me, time to move onto a related but different topic:

It’s not research findings that win hearts and minds in the market, but anecdotes! Heart wrenching and tailored to support a pre-ordained conclusion, the DMCB thinks it was raised to an art form during the Reagan Presidency when he stacked the rhetorical decks during the State of the Union Addresses by recognizing examples of the righteousness of his cause in the Visitors’ Gallery.

And it’s spread to healthcare. Rather than debate policy based on just the facts, fans of Massachusetts’s style insurance, the Medical Home (see page 12) and Personal Health Records are buttressing their points of view with convincing anecdotes.

So, the DMCB took a quick walk-about of many of the disease management company web sites and is distressed to report there is a dearth of anecdotes supporting their notions of remote telephonic population based health care. Egads!

As a service to the industry, I’ve hastily created a turnkey, menu driven ‘population based care anecdote template’ below. If you are from a DM company and anecdotes are not liberally sprinkled in your web site and other marketing materials, I suggest you download this, edit freely, plug in the appropriate text and implement it ASAP.

[Name] was [surprised/flummoxed/ready to take a nap] when it was discovered that [he/she/they] had [diabetes/asthma/chronic heart failure/lumbago/other]. [Name]’s condition was [out of control/turning weird colors/becoming radioactive] until there was a life-transforming phone call from the [name of disease management company]’s [coach/sherpa/barista] named [Mary/Hulk Hogan/The Green Lantern]. After being [empowered/spammed/browbeat], [Name]’s [condition] got [better/was posted on YouTube/was found to be a misdiagnosis]! The co-morbidities [- use more than one - gout/writer’s cramp/halitosis/tinea unguum/oculomicturalgia/Pott’s Disease/sausage digits/conkus of the bonkus] was also [improved/cut out/triggered a county wide quarantine] by the [name of company]’s state of the art consumer engagement and activation. ‘If it weren’t for my [name of disease management company]’s [nurse, radiology technician/fruit vendor],’ said [Name], 'I would have never gotten [through this/such a nice tan/my car started]. Thank you [name of disease management company] and all your investors,' [he/she/they] added, 'and please don't let them cancel Medicare Health Support.'

Pfizer Health Solutions, Florida: A Healthy State & more on Open Source

In the last two Disease Management Care Blog (DMCB) entries, we impertinently suggested the industry jettison the short-term competitive advantage of their clinical/claims data bases and adopt an Open Source “business model.” The chief advantages are 1) increased credibility, thanks to inviting independent confirmation of any conclusions, 2) the likelihood of new discoveries, thanks to more scientists (and eventually amateur-scientist lay persons) “mining” the data and 3) achieving the fullest manifestation of what Kaiser Permanente is teaching us: that the advent of these colossal patient/enrollee/consumer data bases in the disease management industry are an incredibly valuable resource that exceeds the biggest baddest electronic health record. The potential benefit to the general knowledge of mankind is great. So, by the way, is the good will it would generate.

For a good example, first congratulate the folks at Pfizer Health Solutions (PHS) for getting some important clinical outcomes into the peer review literature. Most readers of the DMCB will recall PHS is providing disease management services to portions of the Florida Medicaid population. PHS funded a study on the impact of their “Florida: A Health State” Program on a number of outcomes including blood pressure, lipids, blood glucose and asthma control among persons with chronic illness who were enrolled in their program. Morisky and colleagues at the UCLA School of Public Health found there was a clinically and statistically significant improvement across multiple care domains.

The improvement was detected by comparing the study population (with available data) to an age, gender, ethnicity, poverty level and time-point matched National Health and Nutrition Examination Survey (NHANES) data set using odds ratios.

While that sounds pretty easy (not), it seems to the DMCB that it was the control population that was the critical factor in the reaching the study’s conclusions. In addition, odds ratios, compared to other approaches, can be difficult to fathom. Stakeholders not familiar with research techniques (for example, the human resource person in charge of a TPA, or a staffer in a politician’s office) may have difficulty understanding the more subtle dimensions of interpreting these findings. Last but not least, the study was honorably, but let’s face it, commercially funded.

You may say I’m a dreamer, but imagine for a moment if the data from the “Florida: A Healthy State” were available gratis to other researchers who were welcome to confirm the results using another control group or another comparative approach. The DMCB thinks that the conclusions would hold up, that the transparency would reassure stakeholders in academia and policy circles that the findings are for real and, who knows, other important insights about the needs or care of persons with chronic illness would be closer to discovery.

Florida and its citizens would be better off for it.

Disease Management & the Open Data Movement

In yesterday’s edition, the Disease Management Care Blog doffed a hat to Weng et. al and promised to tackle the implications of using disease management data bases for research. Here's a naive tackle for your consideration.

First off, note that biomedical “research” is any “systematic investigation designed to contribute to generalizable knowledge.” Pursuit of that knowledge is good. It makes life better for all of us and our children. What’s more, it doesn’t necessarily exclude a profit for the individuals assuming risk in sponsoring the research and taking the findings to market. That being said, the market does operate under a well described public interest that demands several attributes of research including 1) truth, 2) transparency 3) likelihood that the any benefit will become accessible by those who need it.

Even a cursory literature search using the terms “disease management” will yield up a host of studies with research findings that spell profit for the sponsoring companies. However, in my opinion, that’s a problem. While everyone knows classic not-for profit “academic” biomedical research is not free of its own problems, the published disease management literature has more than its fair share of incredulity from the market. The necessary attributes mentioned above are often lacking: many readers don’t believe the findings, criticize the underlying research methodologies and despair over its commercialized health insurer pedigree. There is an undeserved but real perception that pursuit of profits over populations is driving much of the conduct of disease management research.

So this blog has a partially thought-out proposal for the Disease Management Community :

Create or join the Open Data movement. Have courage and make the underlying important research data from any published studies or marketing materials freely available to everyone without restriction.

This is more than a doubling down of the NIH decision to “ask” its funded researchers to make their reports available on line. By becoming Open Data, the disease management industry would replicate and possibly exceed SHARe.

Naïve suggestion unlikely to ever see the light of day? You bet, but I offer up the following points that should mitigate some doubts about the wisdom of an Open Data paradigm:

• The doubts about the value of disease management are long standing and profound. This calls for a dramatic break-through approach.

• While the proprietary data have value, instances of that translating that value into a meaningful competitive advantage with a measurable ROI are few. Better to make the data available to researchers worldwide and build the next iterations of the industry on translational insights obtained in the public domain. The scientists out there are better at it anyway.
  

• The traditional research journals that have served as platforms for disseminating research findings have a short term problem and a long term problem:

• A) Over the short term, they have become part of the problem by allowing flawed research findings to get past their reviewers and editors. They are being out hustled by enterprising scientists who knowingly or unknowingly spin data and text. The market knows it.

• B) Over the long term, the arrival of change “Singularity” will not only make print media obsolete. In an online world, the authors’ interpretation of their research findings will no longer serve as the sole arbiter of truth. Instead it’ll only be the first. Given the ready availability of terrabyte data bases and easy to use analytic tools, the market is going to expect to take the data for its own test drive. I believe this will eventually include lay people but I note that SHARe is starting out by restricting access to qualified scientists. Better to anticipate this and start planning implementing now.

• Believe the mainstream academic journals are biased against disease management? See the point above.

• While disease management organizations and their share holders may fret over the possibility that their data could be used against them, a) the truth always seems to come out anyway and b) the industry is well established and is arguably not so vulnerable anymore. The "value chain" has become well established and will remain intact.

There may be implications for Regional Health Information Exchanges and on-line Personal Health Information platforms. Check out Vince Kuraitis’ astute discussions in his latest posts and feel free to add your thoughts about the fit of that piece in this big puzzle. The topic is also complicated by credentialing the scientists, protecting patient confidentiality, de-identifying the data, deciding which data to post, possibly getting an IRRB involved, being HIPAA compliant and extending legal protections to well-meaning researchers.

For your consideration. Kaiser didn’t necessary economically benefit on a short term basis from the study by Weng et al, but they got some great press. More importantly, they further established themselves as a public resource that exists to serve the interests of the common man thanks to their extensive data bases. The argument is true for Kaiser and more so for the disease management industry and is a real key to long term success.

Kaiser Permanente's Lesson for the Disease Management Community

The disease management care blog found this blog posting of an interesting letter from George Halvorson, CEO of Kaiser Permanente. In it, he celebrates Kaiser’s unique information systems that have “all of the data about the provision of care and about the cost of care.” He points out this capability was responsible for important research published in the American Journal of Obstetrics and Gynecology on the association between caffeine consumption and miscarriage. He takes not a small amount of pleasure in noting that the findings of that study were reported in many news outlets worldwide.

According to George (that’s how he signed the letter) just what is it about the Kaiser information systems that make them so special? He gushes that it is its comprehensiveness, thanks to patients getting all their care at Kaiser. This secret sauce contrasts with the “splintered” care in other settings, where patients are unnecessarily victimized by unconnected clinics and hospitals.

So, the ever curious disease management blog went to the published study (hats off to AJOG for making it fully available on-line) to give it a once-over. It turns out the study was not an exercise in culling and correlating extant caffeine and miscarriage data from the user-friendly KP information ether. The authors’ success was the result of hard work, done the old fashioned way, surveying volunteers (with a 43% refusal rate) about their caffeine intake one interview at a time. And yes, while the ready availability of a single clinical data repository aided the researchers, the statistically significant association between caffeine intake and miscarriage:

a) could have also been extracted from a splintered electronic health record and

b) depended not only on the databases and the medical records but on “contacting participants whose outcomes could not be determined by using the previous 2 methods.” Those would be the folks in the Kaiser System getting splintered care.

While it is the nature of health care CEOs to spin, the disease management blog thinks Dr. Halvorson (assuming the letter is completely reproduced) could have mentioned the lead author Xiaoping Weng and colleagues Roxana Odouli and De-Kun Li by name, congratulated them for their hard work and not implied that the information systems yielded up the association after the researchers keystroked Esc-F1.

That being said, George has a point. The study was significantly aided by the Kaiser registries. This has a huge lesson for the disease management community. I believe these companies’ multi-state multi-payor insurance claims and clinical data bases rival Kaiser’s. In fact, they probably exceed it. Toss in their IVR and telephonic-based access to millions of persons and the possibilities become astonishing. The Carl Saganesque access to billions and billions of 1s and 0s make it possible for them to discover hitherto unknown, important and possibly life-saving associations.

Want a small example? At a prior DMAA meeting, the disease management blog sat in on a presentation about the use of disease management data as well as other public information to better identify persons at risk for diabetes. A fascinating finding was the discovery of a strong association between diabetes and ownership of a minivan. Yup, a minivan. It makes sense when you think about it: exclude persons with an age and gender consistent being a soccer mom, and the remainder are older individuals with an abdominal girth that is best accommodated by the height and style of the “captain’s chair” typical of that style of automobile. Is this life saving? While it doesn’t rise to the level of miscarriages, asking patients about the presence of a minivan may be the next best thing if you can’t get BMI or waist circumference data, lead to a strong recommendation to see a doctor and….you get the picture.

The difference is that Weng, Odouli and Li did us a great service by getting their insight into the public domain. In contrast, the relative silence from the disease management companies is deafening. Either that or their work is not getting the attention it deserves.

More on the implications of this tomorrow.