AlignMap

This is the second post in this series on the inadequacy of the current treatment adherence paradigm. The link to the first post in this series follows: Why Today’s Treatment Adherence Paradigm Must Be Destroyed – Part 1.

The photo atop this post, “Instant Of Impact,” was taken by Jeff Lowe

Patient Compliance – The Concept That Wouldn’t Die

The status of Patient Compliance (AKA Treatment Adherence, AKA Concordance, … ) as an organized field of study is baffling.

On one hand,I find no convincing arguments refuting, entirely, in part, or in degree, the assessment of the effectiveness of patient compliance I published over three years ago:¹

After almost 2500 years of pondering, healthcare’s consensus is that compliance problems are complex, and the most promising solutions are also complex, as well as impractical and diverse, with no sure means of determining which interventions are most likely to work for a specific patient. And, few reviewers confidently endorse any specific tactic without extensive hedging.

Heck, the only reason I haven’t submitted Patient Compliance to one of those web sites that collect urban legends, online hoaxes, and the like is my inability to find folks who believe that the efforts expended in the name of treatment adherence have contributed much in the way of useful information or tactics. It’s not a legend, urban or otherwise, if no one believes in it.

On the other hand, I notice that  Pfizer Canada, AstraZeneca, and Merck Frosst Canada have each kicked in $400,000 and the Canadian  provincial government has contributed $500,000 to  fund a new Research Chair in Patient Adherence to Drug Therapy at the University of Saskatchewan,² leading one to assume somebody in those companies and in the Canadian government either has faith in the concept or too much money left in the budget at the end of the fiscal year.

This morning, I was excited to find, in a recently published (23 June 2009) article, Group kicks off effort to improve medication compliance, the information that

… a new initiative by the New England Healthcare Institute hopes to determine which strategies are most likely to control this problem. The Institute is forming work groups composed of key healthcare stakeholders, including payers, patients, providers, caregivers, health IT execs and employers, to examine strategies for combatting non-compliance with med regiments [sic].³

The next paragraph, however, transformed my excitement into discouragement:

Strategies under consideration include patient education, dosing schedules, packaging and financial incentives to comply with physicians’ recommendations.

The piece I originally found turned out to be a rewrite of another article, Initiative aiming for better medication adherence,⁴ which is no more forthcoming on this point:

The institute will establish work groups out of its participating stakeholders to identify strategies to combat nonadherence, including patient education, dose schedules, packaging and financial incentives.

After the most promising strategies are selected,

… the institute will create demonstration projects to test those strategies.

Let’s recapitulate:  The New England Healthcare Institute, an organization considered well grounded and admirably innovated  by some folks,⁵ is working with “key healthcare stakeholders, including payers, patients, providers, caregivers, health IT execs and employers,” many or most of whom are, one assumes, knowledgeable about patient compliance, to select strategies from candidates such as “patient education, dosing schedules, packaging and financial incentives” to for demonstration projects to “improve patients’ adherence to their medication.”

My question is:

What is the rationale for pursuing compliance enhancement within the framework of a system that has yet to show substantial results after decades of attempts, especially given that all of the strategies named have been subjected to a significant number of  clinical  trials already?

As follow-up, I also have the following  rhetorical questions which are, of course, no more than thinly disguised elements of my ongoing rant:

• Do they think they will generate different results from implementing the same methodologies?
• Do they think the problem is that the research groups who performed the previous studies didn’t do a good job?
• Are they going to implement these previously tested strategies in a unique way, and, if so, what do they have in mind?
• Are they going to consider only previously tested, mainstream approaches?
• How does one get in on a gig like this? Do they need a consultant with a moderately varying point of view?

Patient Compliance Accomplishments

Another dichotomy contributes to the befuddlement: my jeremiads on the the near absence of  effective compliance enhancements contrast with my astonishment over the amount of material produced under the aegis of treatment adherence.

Workers in the field have, for example, generated all manner of books, graduate theses, articles in the medical and sociological literature, newspapers, and periodicals from Parade to Tallahassee Magazine, government grants, marketing projects by pharmaceutical firms, books, medication reminder appliances that range from novelty items to sophisticated, state of the art electronics, salaried positions, workshops, panels, international conferences, and other boondoggles.

The presumption of improved adherence is also, of course, the rationale that launched a thousand new drug applications.

How many industries or scientific fields⁶ remain viable after spending 30-40 years producing libraries of  research papers, handbooks, and published articles, battalions  of machines and devices, and a plethora of PowerPoint presentations with only a handful of  achievements that actually produce the desired effect?

I Believe For Every Drop Of Rain That Falls, …

Notwithstanding the massive investments of money, time, and effort, when it comes to empirical results, the relative impotency of patient compliance enhancements  ranks among the worst kept secrets in healthcare.

Oh,  we try to be polite about  it.  For example, David E. Williams, in his recent  post,  The last lever for big pharma, noted

Meanwhile there is one other major lever: medication adherence. If big pharma can find a way to encourage existing patients to sustain their therapy, there is also a significant growth opportunity. That’s easier said than done, however, and pharma companies are still struggling to find cost effective approaches to this challenge. [emphasis mine]

I don’t know Mr. Williams, but I’ll bet he’s a nice guy – because instead of writing “… pharma companies are still struggling to find cost effective approaches to this challenge,” he could have, with equal accuracy, written “… pharma companies have repeatedly failed to find cost effective, comprehensive approaches to this catastrophic problem.”

Moreover, he could have, again with equal accuracy (and more thoroughness),  written,  “… pharma companies, academic researchers, healthcare organizations, clinicians, health insurers, governmental agencies, and other third party payors have repeatedly failed to find cost effective, comprehensive approaches to this catastrophic problem.”

The smart money, in fact, is on Diogenes finally stumbling across that honest man before a stakeholder in treatment adherence (who isn’t hawking the latest and greatest compliance enhancement product) championing the historical accomplishments of and future prospects for the field turns up.

Exceptions and Outliers

To save folks the trouble of emailing protestations that their program, gizmo, or incantation does so  improve patient compliance and, in fact,  returns $22,655  in health savings for every $1 investment in said program/gizmo/incantation, I am willing to stipulate that islands of success may indeed exist somewhere in the vast, uncharted seas of patient compliance enhancement failure.

The supposed examples of success I’ve examined thus far, however, have turned out to involve complex, labor-intensive sets of multiple interventions, special circumstances (e.g., self-selected populations of clients likely to be compliant with or without enhancements),  inaccessible, unvalidated evidence (e.g., favorable results from proprietary studies, the data of which are kept secret), or other magical assumptions (e.g., defining the removal of a medication from a dispenser as equivalent to appropriate ingestion of that medication).  This is a bit like a government agency charged with improving mine safety claiming success based on  a single, unpublished study, the data for which was gathered from the miners’ recall of accidents over the past year, showing a “low rate of significant preventable injuries directly attributable to mine engineering” in a single model mine in Idaho. I can’t determine what the so-called evidence means – other than I won’t be strolling through that mine.

So, If Patient Compliance Is Useless, Why Do We Keep Using It

Well, it sounds a bit like a shared delusion, but a delusion is an unshakable belief in something untrue. That “unshakable belief” criterion pretty much rules out this diagnosis since there exist  few hard-core supporters of the concept of patient compliance.  Perhaps that makes it the first case of  pseudo-folie à plusieurs (”false madness of many”).

Or maybe it’s a discipline-wide repetition compulsion.

Or, maybe there isn’t a name for the problem but I do know a joke that covers it:

A passerby walking home late at night sees a drunk on his knees under a streetlight, searching for something. The passerby asks the drunk, “What are you doing?” “Looking for my apartment key,” says the drunk. The passerby, trying to be helpful, walks to the area near the drunk and begins  looking for the key.  After 15 minutes, it becomes clear that the key is not in the vicinity.  The newcomer asks, “Are You sure you lost your key here?” “No, actually I first noticed it was missing when I was walking over there,” the drunk says, pointing to an area a half block away. The passerby, a bit perplexed, asks, “Then, why are  you looking here if you lost your key over there?” Responds the drunk, “Because the light is better here, under the streetlight.”

It’s time to do the merciful thing and pull the plug on this flat-lined concept.

Next Post: Alternatives To The Patient Compliance Paradigm

1. The Verdict From Patient Compliance Research↩
2. U of S adds research chair, Heanette Stewart, The Star Phoenix. June 16, 2009↩
3. Actually, I was a tad miffed as well since this is an idea I’ve been pushing for years with no success, but I suppose I should deal with that on my own time.↩
4. Initiative aiming for better medication adherence , by Jean DerGurahian. ModernHealthcare.com. Posted: June 22, 2009↩
5. Yes, including me.↩
6. To avoid unseemly arguments and bloodshed, let’s exclude faith-based areas of endeavor and activities taking place before 1900↩