AlignMap

The How To Fix Patient Compliance Now Series

This is the second in a series of posts offering steps to improve the study of and communication about patient compliance.

These recommendations are simple and inexpensive; their implementation, in fact, is solely a function of motivation on the part of those working in the field.

Finally, the benefits of these recommendations are magnificently  self-apparent.

These traits are demonstrated by the first step, which was discussed in the previous post, How To Fix Patient Compliance Now – Practical Steps To Rehabilitate The Concept Of Adherence:

1. Always provide context-pertinent definitions of Patient Compliance terminology

Step #1 is, again, simple, inexpensive, and obviously beneficial.  After all, since there are no standard, universally applicable definitions of the most basic terms, including “compliance” and “adherence,” it seems clear that using those words in professional literature or commercial promotions obligates the  author to provide definitions.

Step #2. Differentiate between unintentional and intentional noncompliance

One can slice and dice noncompliance in a myriad of ways (e.g., according to the type of treatment with which a patient is noncompliant, whether the patient is completely or partially noncompliant, the cause of the noncompliance, etc.). Depending on the situation, certain classifications will  be useful or even vital.

In any clinical discussion of noncompliance, however, it is always essential to  identify whether noncompliance is intentional or unintentional. (The exceptions are cases in which noncompliance is discussed exclusively as a global concept rather than a clinical event)

If both intentional and unintentional noncompliance are present, those groups must be broken out and described separately.

It’s essential to differentiate between unintentional and intentional noncompliance because intentional and unintentional compliance are fundamentally different events – much as, say, a death due to murder committed for hire by a mob hit man is different from a death caused by pancreatic cancer.

Drawing conclusions, comparing results, or developing patient care methodologies is a hopeless task if unintentional and intentional  noncompliance cannot be specifically identified.

Of course, there may be instances in which information distinguishing between intentional and unintentional noncompliance  is not available (e.g., reporting on a study that didn’t include that parameter). Happily, there is an simple solution. Studies in which  unintentional and intentional noncompliance cannot be differentiated are simply eliminated from consideration.

Revolutionary Overthrow Of Compliance¹ Concept Delayed

Bringing down the current concept of  patient compliance and replacing it with a functional set of principles is taking for-freaking-ever.

The current hangup is the manifesto. Any revolution worth its salt has to have a manifesto. Since it’s not the sort of thing  one can knock off on a Saturday afternoon while watching college football on TV, it’s hardly a surprise that composing a manifesto requires time and effort.

But, it turns out that just designing and printing a manifesto in a format that bespeaks authority yet is simultaneously cool in that ironically subversive way, the stylistic goal to which the really hip manifestos aspire, is no small task.  The bids for engraving the final product on stone tablets came back way over budget so I have to rework the publication process, substituting simulated calligraphy on recycled parchment for chiseled granite. That should reduce costs considerably, but it all takes time.

While awaiting the completion of the manifesto and the beginning of the revolution, however, much can be done to (partially) rehabilitate patient compliance into a concept that is, if not an efficacious construct, at least one that is more useful, less likely to result in mistakes and misunderstandings, and – well, less embarrassing.

Things To Do Until The Manifesto Is Finished

Starting with this entry and continuing for the next several posts, I will introduce, one at a time, principles which are simple and inexpensive to implement in any context yet can massively improve the field of treatment adherence.

Moreover, these axioms are  so self-apparent – and should, in fact, have been in use for years – that the failure to implement them should be a res ipsa loquitur case of fundamental miscommunication, whether intentional or unintentional,  and/or profoundly flawed scientific method.

Step #1: Always provide context-pertinent definitions of Patient Compliance terminology

The choice of Patient Compliance terminology (e.g, “compliance,” “adherence,” “concordance,” etc.) is a matter of taste.  Provision of context-pertinent definitions of those terms in every case in which they are published is invariably an obligation.

This is, as advertised, a simple proposition: because there are no standard definitions of “compliance,” “adherence,” “concordance,” etc.,  that apply universally, using one or more of these terms (or their negatives) in any formal or informal publication (including but not limited to articles,  press releases, abstracts, advertisements, white papers, editorials, dissertations, studies, feature stories in the lay press, and poster sessions), obligates the author to define those words pertinent to their context.

A key feature of this step is the bypassing of the inevitably interminable debates over the “correct” definitions and the inevitably unsuccessful efforts to coerce everyone in the field to follow the mandated official Glossary Of  Patient Compliance Terminology.  Authors, researchers, marketers, clinicians, professors, and anyone else dealing with the field can use terms to mean whatever they prefer – as long as those meanings are clearly explained.

“Context-pertinent” means the definition must be sufficient to allow a reader to understand precisely what behavior qualifies as “adherence” or “non-adherence” in the circumstances described by the article or advertisement.

A press release, for example, claiming a medication program results in “95% Adherence” would necessarily  include an explanation of “adherence” as used in the copy (e.g, “For the purposes of this report, adherence is the percentage of patients who reported taking at least 80% of their medications every week over a period of 6 months”).²

This is fundamental and essential information, yet by my casual count, it is absent from more than 75% of the press releases and promotional pieces that include claims of high or improved compliance. And, that fundamental and essential information is absent in a discouragingly large fraction of the scientific literature I peruse.³

One of the advantages of always providing definitions of adherence terminology is that nonspecific (or vague or  nebulous or vacuous)  applications of these words are acceptable as long as it’s made clear that the usage is nonspecific (or vague or nebulous or vacuous). Those four-color brochures about the  6th format of a medication can still boast that “Medication X is now available in once a day dose for better compliance,” simply by adding, “‘Better compliance’  in this case means we think, based on some studies, none of which involved Medication X, patients will, one way or another, be more likely to take the right dose at the right time  with the once a day dose as compared to patients taking the same medication two or more times a day.”⁴

The definitions can be within the text, in a footnote, part of a glossary on a sidebar, … as long as they are obvious and, most importantly, available in every publication format. The abstracts of scientific papers, for example, must include the definitions since they may be published independently of the paper itself. And no fair writing that “definitions are available on request.”

Advantages Of Implementing Step #1 – Inclusion Of Definitions

Being certain about what a study or a press release means by the words “improved adherence” seems, from my perspective, itself sufficient  justification for implementing this step. Studies can be compared, anomalies understood, and the significance of findings determined. (I would also have fewer emails to write, asking for missing data.)

But there are other potential gains.

With luck, for example, the automatic inclusion of definitions might detoxify some of  the terminology and might even decrease the noise level of the arguments about which synonym of adherence is most coercive and condescending.

Perhaps best of all, the altogether reasonable expectation that publications about compliance include definitions of the pertinent terminology would go far toward eliminating much of the confusion and conflicting claims that plague the clinical, research, and commercial aspects of the treatment adherence concept and preclude most unintentional miscommunication about compliance and at least render the creation of  intentionally misleading claims more difficult.

1. Compliance, as used in this post, denotes the concept rather than a specific case of patient compliance, i.e., the study of why patients do or do not follow their prescribed treatment regimen. Further, in this post, “compliance,” “adherence,” and “concordance” are used synonymously.↩
2. There is substantially more information that is required to justify this claim. That will be covered in future posts.↩
3. I should note that writing to the authors of the scientific papers nearly always yields the missing definitions although it does not excuse the failure to provide those definitions in the paper itself.   Email requesting missing definitions sent to those responsible for the press releases, regardless of that person’s profession, title, or academic appointment typically goes unanswered and most of the replies that are received boil down to “That’s proprietary information.”↩
4. I happen to believe in the fewer doses = better compliance equation. I also happen to believe that readers deserve to know which claims are scientifically proven, which are extrapolations from other work that conveniently leave out conflicting evidence, and which are the hopes, dreams, and fantasies of a someone writing copy for an ad.↩

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↩

Because The Survival Of The Current Patient Compliance Concept Endangers Patients

But more about that later.

Understanding both the catastrophic risk and the seemingly inexplicable persistence of the patient compliance model¹ is facilitated by first considering a parallel case of another incorrect medical hypothesis.

There Will Be Blood: Bloodletting As A Model For Adherence

While mistaken beliefs in many fields of knowledge can impair or imperil  individuals, the calculus of  the danger represented by erroneous medical concepts can be especially evident. Prescribing an ineffective  treatment, for example, can be a death sentence to a patient with a serious disorder. Some  treatments that were once widely accepted, in fact, are now known to be toxic  even to  otherwise healthy individuals.

Nonetheless, detecting and rooting out such errors has frequently proved to  be an  extraordinarily arduous and prolonged task.

Medical theories and practices that now appear blatantly  fallacious and even ludicrous were often founded on logical premises, were seemingly congruent with the available evidence, and were supported and used by competent, careful, and conscientious practitioners.  Many treatments that we now know were disastrous wrong were not the work of quacks, greedy producers and sellers of worthless or poisonous potions, charismatic charlatans, sociopaths, or religious fanatics. In fact, the most widespread and enduring – and therefore the most dangerous – mistaken medical methodologies were those formed and held by clinicians acting thoughtfully and in good faith.

Consider bloodletting, as described in Wikipedia:²

Bloodletting (or blood-letting) is the withdrawal of often considerable quantities of blood from a patient in the belief that this would cure or prevent a great many illnesses and diseases. It was a tremendously popular medical practice from antiquity up to the late 19th century, a time span of almost 2,000 years. The practice has been abandoned for all except a few very specific conditions. It is conceivable that historically, in the absence of other treatments for hypertension, bloodletting could sometimes have had a beneficial effect in temporarily reducing blood pressure by a reduction in blood volume. However, since hypertension is very often asymptomatic and thus undiagnosable without modern methods, this effect was unintentional. In the overwhelming majority of cases, the historical use of bloodletting was harmful to patients.

Bloodletting was founded on a logical, albeit inaccurate, notion:

“Bleeding” a patient to health was modeled on the process of menstruation. Hippocrates believed that menstruation functioned to “purge women of bad humors”. Galen of Rome, a student of Hippocrates, began physician-initiated bloodletting.³

And, scientific discoveries supported it.

The popularity of bloodletting in Greece was reinforced by the ideas of Galen, after he discovered that veins and arteries were filled with blood, not air as was commonly believed at the time.

Bloodletting was not cavalierly formulated. Rather the associated theoretical explanations became increasingly sophisticated.

Galen created a complex system of how much blood should be removed based on the patient’s age, constitution, the season, the weather and the place. Symptoms of plethora were believed to include fever, apoplexy, and headache. The blood to be let was of a specific nature determined by the disease: either arterial or venous, and distant or close to the area of the body affected. He linked different blood vessels with different organs, according to their supposed drainage. For example, the vein in the right hand would be let for liver problems and the vein in the left hand for problems with the spleen. The more severe the disease, the more blood would be let. Fevers required copious amounts of bloodletting.

Bloodletting was widespread, and became one of of those principles so obviously true that it was integrated into common sense.

The Talmud recommended a specific day of the week and days of the month for bloodletting, and similar rules, though less codified, can be found among Christian writings advising which saints’ days were favourable for bloodletting. Islamic medical authors too advised bloodletting, particularly for fevers. The practice was probably passed to them by the Greeks; when Islamic theories became known in the Latin-speaking countries of Europe, bloodletting became more widespread. Together with cautery, it was central to Arabic surgery; the key texts Kitab al-Qanun and especially Al-Tasrif li-man ‘ajaza ‘an al-ta’lif both recommended it. It was also known in Ayurvedic medicine, described in the Susruta Samhita.

Bloodletting Machine Mechanism

Not everyone, however, bought into the idea. Some, in fact, began demonstrating that, at least in some classes of cases, bloodletting was valueless.

William Harvey disproved the basis of the practice in 1628, and the introduction of scientific medicine, la méthode numérique, allowed Pierre Charles Alexandre Louis to demonstrate that phlebotomy was entirely ineffective in the treatment of pneumonia and various fevers in the 1830s.

By the mid-1800s, there was substantial empirical evidence this method didn’t work in a number of specific cases. These findings not only  failed to stop the practice but likewise failed to slow its growth.  Indeed, bloodletting enjoyed a surge of popularity during this period with it being touted as a potential treatment for almost every imaginable ailment.

…  in 1840, a lecturer at the Royal College of Physicians would still state that “blood-letting is a remedy which, when judiciously employed, it is hardly possible to estimate too highly”, and Louis was dogged by the sanguinary Broussais, who could recommend leeches fifty at a time.

Bloodletting was used to treat almost every disease. One British medical text recommended bloodletting for acne, asthma, cancer, cholera, coma, convulsions, diabetes, epilepsy, gangrene, gout, herpes, indigestion, insanity, jaundice, leprosy, ophthalmia, plague, pneumonia, scurvy, smallpox, stroke, tetanus, tuberculosis, and for some one hundred other diseases. Bloodletting was even used to treat most forms of hemorrhaging such as nosebleed, excessive menstruation, or hemorrhoidal bleeding. Before surgery or at the onset of childbirth, blood was removed to prevent inflammation. Before amputation, it was customary to remove a quantity of blood equal to the amount believed to circulate in the limb that was to be removed.

Leeches became especially popular in the early nineteenth century. In the 1830s, the French imported about forty million leeches a year for medical purposes, and in the next decade, England imported six million leeches a year from France alone. Through the early decades of the century, hundreds of millions of leeches were used by physicians throughout Europe.

Bloodletting persisted into the 20th century and was even recommended by Sir William Osler in the 1923 edition of his textbook The Principles and Practice of Medicine

The question becomes, why did bloodletting  persist for 2,000 years even though for all but a handful of cases it provided no physiological advantage in the fight against disease? As it turns out, one need not invoke conspiracy theories about nefarious plots carried out by the Leech-sellers Guild and the physicians to fool the public to explain the longevity of bloodletting.

One reason for the continued popularity of bloodletting (and purging) was that, while anatomical knowledge, surgical and diagnostic skills increased tremendously in Europe from the 17th century, the key to curing disease remained elusive, and the underlying belief was that it was better to give any treatment than nothing at all. The psychological benefit of bloodletting to the patient (a placebo effect) may sometimes have outweighed the physiological problems it caused. Bloodletting slowly lost favour during the 19th century, but a number of other ineffective or harmful treatments were available as placebos—mesmerism, various processes involving the new technology of electricity, many potions, tonics, and elixirs. [Emphasis mine]

And, there are a limited number of cases in which bloodletting is helpful:

In the absence of other treatments, bloodletting actually is beneficial in some circumstances, including the fluid overload of heart failure, and possibly simply to reduce blood pressure. In other cases, such as those involving agitation, the reduction in blood pressure might appear beneficial due to the sedative effect.

Summary: Comparing Bloodletting And Patient Compliance

Let’s review:

Bloodletting is a practice dating back to Hippocrates which was, until 200 years ago when it began to fall out of favor, the standard of care for a wide scope of disorders throughout the civilized world. A multitude of explanatory theories and methodologies of implementation were devised. Skilled physicians, surgeons, and barbers, aided by cleverly designed mechanical devices and leeches (biological machines), became ever more efficient in performing the procedure. That the process could not be shown to result in positive outcomes in the overwhelming majority of cases was explained away or ignored, as was the scientific evidence that the process was therapeutically ineffective in given disorders, perhaps in the belief that it was better to give any treatment than nothing at all.

Treatment adherence is a model dating back to Hippocrates which continues to be the standard of care throughout the civilized world. A multitude of explanatory theories and methodologies of implementation have been devised. Skilled physicians, other clinicians, and researchers, aided by cleverly designed mechanical devices, have become ever more efficient in performing a set of compliance enhancement procedures (such as reminding the patient to take a pill, educating the patient, packaging all of a patient’s medication in dose packs, etc.). That the process has not been shown to result in significant improvements in the overwhelming majority of cases has been explained away or ignored, as has the scientific evidence that certain specific procedures are ineffective, perhaps in the belief that it is better to try to improve compliance by any means available than do nothing at all.

On the other hand, I can find no evidence that anyone has suggested that patient compliance can be enhanced by the use of leeches.

The Potential Risk Of Bloodletting And Patient Compliance

The danger of bloodletting was not, except in a small number of cases, death by exsanguination. Instead, the harm done to centuries of patients was in the form of what economists call opportunity cost.  If, for example, one purchases a car for $30,000, the opportunity to invest that  $30,000 in ones next best choice, say starting ones own business, is lost.

During the time that bloodletting was in favor, it was the dominant investment target for available intellectual, financial, and medical professional capital. Consequently, the opportunity to use those resources to develop and implement other, perhaps more effective, therapies was lost. Every day that the practice of bloodletting slowed the development of more effective therapies was a day treatment outcomes were worse than they could have been – that means some patients died, suffered incapacities, recovered more slowly, and, at best, endured the pain and cost of treatment needlessly.

Similarly, as long as intellectual, financial, and medical professional capital are devoted to the current patient compliance paradigm, developing and implementing other, perhaps more effective, alternatives is unlikely. And, every day that the current patient compliance paradigm slows the development of more effective enhancement of treatment implementation is a day treatment outcomes are  worse than they could have been – that means some patients die, suffer incapacities, recover more slowly, and, at best, endure the discomfort, inconvenience, and cost of treatment needlessly.

Incorrect, ineffective patient compliance theory is not  trivial  – it is literally a matter of life and death.

And that is why I  resort to posts like this with accurate but  admittedly sensationalist titles like “Why Today’s Treatment Adherence Paradigm Must Be Destroyed.”

Coming In Part 2

• A brief exposition on my contention that the patient compliance paradigm is ineffective and wastes resources yet doesn’t have the good grace to die on its own.
• The  lack of enthusiasm for the contemporary concept of patient compliance  paradoxically coupled with continuing use of that system as a basis for research and interventions.
• The Showdown: My dismissal of treatment adherence compliance as a system capable of generating effective compliance enhancements could be wrong, but I’ve found almost no support for the opposing view. I maintain that, at this point, those continuing to pursue research, offer programs, invest in a Chair in Patient Adherence to Drug Therapy, … have the intellectual responsibility to present their arguments for staying the course or indicate the changes they  intend to institute.
• Possible alternatives to patient compliance.

Credit Due Department:
The photo atop this post, ”4 Seasons Hotel Implosion,” was taken by Mozambique – Moments.

1. For the purposes of this post, “patient compliance model,” “treatment adherence paradigm,” and similar terms refer to any  ideas explicitly set forth by or implicit to patient compliance as  a system of thought rather than a simple statistic.  For example, the calculation of number of doses taken as prescribed divided by the total number of doses prescribed is a patient compliance statistic; the idea that noncompliance is an entity that causes patients to fail to take their medications as prescribed (not unlike miasma was thought to cause the Black Death) and that can be addressed by a simple response such as patient education is part of the “treatment adherence paradigm.”↩
2. All references, unless otherwise specified, are from Wikipedia↩
3. Those who scoff at the “logic” employed by  Hippocrates and his followers to derive this premise are urged to consider that in 2009, many and perhaps most adults still believe in the disproved idea that sweat rids the body of toxins.↩

If the same principles currently prevalent in the field of patient compliance were applied to the study and management of side-effects, …

Intercosmic Journal Of Treatment Side-Effectology

Searching for the cause  of treatment side-effects & its cure

Articles

Patients  equipped with new  side-effect reduction device report  disappearance of  rashes caused by medication

Patient shown operating  Visual
Side-effect Detection Modulator

An AlignMap.com Publication – Allan Showalter, MD, Editor

The Emperor Views His New Clothes

Unicorns, Atlantis, Easter Bunny, Hooker With Heart Of Gold, World Champion Chicago Cubs In Runners-Up Spots

To illuminate the flaws  inherent in  the  contemporary notion of patient compliance, I have, in previous posts, invoked such cultural references as the Ptolemaic cosmological model,  Rumpelstiltskin, Johnny Cash’s classic  “A Boy Named Sue,” The War of the Worlds, Lincoln’s riddle about how many legs a dog would have if one called the dog’s tail a leg,¹ and the artist formerly known as “the artist formerly known as Prince.”

But, it is the Hans Christian Andersen fairy tale, The Emperor’s New Clothes,² that provides  the most rewarding comparison to  and the clearest understanding of the problems with the concept of adherence to treatment and the need for a comprehensive reorientation of our perspective on this issue rather than a refinement of nuances.

The Emperor’s New Clothes And Patient Compliance

The  congruity between the Emperor’s New Clothes fairy tale and the Myth of Patient Compliance ain’t subtle – or pretty:³

The Emperor’s New Clothes: No one can see the non-existent apparel ostensibly worn by the King, yet the King and everyone else, except one child, behave as though they not only see but admire  those clothes.

The Myth Of Patient Compliance: No one can see non-existent evidence that the current ideas about treatment adherence are conceptually or pragmatically valid, yet the healthcare community behaves  as though these theories are not only well supported but have also proved to be useful means of  improving the proportion of treatments effectively completed as prescribed.⁴

In the fairy tale, the King parades in his “new clothes” that exist  only in the fantasy woven by the corrupt tailors because he has too much invested in his self-image to admit he sees nothing (which would also be confessing, as explained by those same crooked clothiers, that he is too stupid to see the outfit). The crowd of  subjects cheering their Monarch only ostensibly dressed in his finest attire may have shared the Emperor’s narcissism, been intimidated by the Royal Guard, been influenced by the others in the crowd claiming to see the wonderful clothes, or simply succumbed to  the lure of the path of least resistance.

Similarly, few authoritative individuals, healthcare organizations, professional societies, institutions, commercial firms, pharmaceutical companies, or third party payers  identify themselves as passionate disciples of the dominant point of view re treatment adherence.  In fact, the clinician  willing to  unequivocally endorse the utility of the current notion of adherence to treatment may be no more common than the afore mentioned unicorn. Yet, the topic continues to generate ever increasing numbers  workshops, conferences, electronic gizmos, web sites, advertising programs, claims of effectiveness, declarations, sub-theories, and, especially, research papers. The capacity of those in the field to run the same compliance studies and enhancement programs to obtain the same unsubstantial results for the past 30+ years in the face of minuscule, if any, progress is, as the kids used to say, awesome, dude.

At this point a hypothetical reader⁵ may be (conveniently) asking, “Why haven’t we tried other approaches?” Well, as far as I can determine, the healthcare industry persists in treating patient compliance as though it is a pragmatically effective idea (or, at worst, a concept that requires only that one final study to provide definitive proof) because of *1) confusion between patient compliance as a statistic (e.g., the percentage of medication doses taken as prescribed) and patient compliance as a conceptual perspective and (2) simple intellectual inertia.

We in the healthcare community are a persistent fort, albeit perhaps not quite as bright as our mothers might have hoped.

A Tentative Response

How about this for a rule of thumb:

If, after 30 years of extensive and intensive effort based on a given theory, the clinical, scientific, and commercial sectors of  healthcare cannot develop effective solutions to a problem that massively reduces the effectiveness of medical treatment, then  (1) trying the same studies for another 30 years or refining the jargon isn’t likely to be  the optimal course of action, (2) maybe – just maybe -  it’s  the theory rather than the research that is faulty, and (3) approaching the issue from a new perspective could be the way to go.

Yeah, it’s a wacky idea, but it’s so crazy so crazy it might just work.

The Role Of AlignMap

As for me, I’m auditioning for the role of the  conveniently non-self-censoring little brat boy who points out the obvious.  It smacks a bit of typecasting, but still, …

Upcoming AlignMap Series:

Transforming Adherence Into A Useful Concept
Things To Do Until The Manifesto Is Finished

1. Solution: The dog still has four legs because – here it comes – calling a dog’s tail a leg doesn’t make it a leg.↩
2. Wikipedia provides a serviceable  synopsis of the story line:

   An emperor of a prosperous city who cares more about clothes than military pursuits or entertainment hires two swindlers who promise him the finest suit of clothes from the most beautiful cloth. This cloth, they tell him, is invisible to anyone who was either stupid or unfit for his position. The Emperor cannot see the (non-existent) cloth, but pretends that he can for fear of appearing stupid; his ministers do the same. When the swindlers report that the suit is finished, they dress him in mime. The Emperor then goes on a procession through the capital showing off his new “clothes”. During the course of the procession, a small child cries out, “But he has nothing on!” The crowd realizes the child is telling the truth. The Emperor, however, holds his head high and continues the procession.

   ↩

3. The fairy tale and the issues involved in adherence to treatment do not fit perfectly in one area.  Unlike the con men hired as the Emperor’s tailors, the clinician-researchers who formulated our current vocabulary and models of patient compliance were attempting to discover underlying truths rather than pull off a scam  for their personal gain.  On the other hand, it does appear  likely  that some  self-serving claims about certain compliance enhancing technologies have employed especially  creative interpretations of  already ambiguous  terminology.↩
4. Evidence for and an elaboration of these contentions can be found at The State of the Art.↩
5. Or, alternatively, a unicorn↩

Coming across two blogs relating especially poignant and insightful  personal experiences with medication compliance defeated my plan to abstain from  posting while I develop a new project (more about that at a later date).

My repeated criticisms of contentions made about treatment adherence without evidence notwithstanding, I’ve long held the belief, based on my interpretation of my own clinical experience (at best, a particularly shaky n=1),  that (1) healthcare practitioners who have an empathic understanding of their patients’ struggles with compliance can better assist those individuals in that effort than the equally competent but unempathic colleagues and (2) one way of gaining and deepening such empathy is through reading personal account by patients – like these.¹

Patient Compliance Overlaps Parent-Child Compliance

Bending, not Breaking at  Chez Perky describes a special subcategory of  medication adherence, a child’s resistance to medication. This excerpt evokes the sense of the mother’s dilemma  and indicates how much energy, thought, and time she has invested before calling the pediatrician for help:

Getting him to take his medication has always been a struggle, as you may remember. That’s why the Daytrana Patch was such a lifesaver. But it had too many downsides for his profile to be the optimal answer. It didn’t work as well for him as the Focalin does. But getting him to take a medicine orally is next to impossible. We have two good weeks, and then two weeks of hell, then two good weeks, then two weeks of pure hell, and so on. We are currently in hell, and I’m not sure it’s only going to last two weeks.

His latest trick is that he won’t open his mouth to take the medicine, but even once he does, he gets the medicine (which was mixed into mango sorbet – don’t ask… he has a discriminating palate) in his mouth and then won’t swallow it. He stands there and cries and refuses to swallow for what seems like forever, but is really somewhere between 5 and 15 minutes, and then either spits it out or forces himself to throw up (no, I’m not exaggerating). Occasionally he’ll swallow it under threat of not getting potato chips in his lunchbox, but that threat doesn’t hold a lot of weight anymore.

From Mandated To Self-Motivated Treatment Adherence

Two posts, Why I Take My Medicine and  Recovery: What Helped Me to Recover from Schizophrenia, at Overcoming Schizophrenia focus on compliance. The latter examines the importance of  legally mandated treatment (often known as “Assisted Outpatient Treatment” or “outpatient commitment”) in the writer’s case while the first entry describes the catastrophic consequences of the writer’s past nonadherence and the rationale the writer has found most useful in maintaining compliance. This excerpt summarizes that reasoning:

Medication compliance is a life-long routine because there is no cure schizophrenia, however, there is treatment. If I stop taking the medication I have an increased risk for a relapse, another psychotic break, and symptoms will return. My chances of a relapse increase each day I do not take my medication; so far I have accidentally skipped two days total over a span of one year on Abilify. I take pride in the responsibility I carry out every day of my life.

Each of these posts is worthwhile reading for clinicians who want to understand and help their patients in the realm of medication compliance and for patients and the family and friends of patients involved in those struggles.

1. I know – my concept is not scientifically supported; there are few studies that address this point and the results of those are open to varying interpretations. I do have two defenses: (1) I point out that I have no proof of this hypothesis so at least readers are not being misled and (2) My blog, my rules.↩

Because so many misunderstandings and misconceptions about patient compliance are considered common sense and consequently go unchallenged, presenting them as “myths” can be an effective, if perhaps hackneyed, means of correcting misperceptions.

At least I hope so. One of the most popular pages on the AlignMap.com site has long been the discussion of my own pet compliance myths.

I recently found another set of myths.  Dispelling The Myths Of Patient Adherence, Lisa Roner’s summary of a presentation made by Bernard Vrijens, chief scientist with Aardex Group, at eyeforpharma’s Patient Compliance Europe 2008 conference is a succinct, clearly explained debunking of  widespread beliefs about compliance that are dangerously wrong.

Dr. Vrijens discusses these myths:

1. Caregivers assure adequate adherence.
2. The circumstances of clinical trials assure satisfactory adherence.
3. Adherence can be expressed as a percentage of prescribed doses or as a dichotomy.
4. Patient adherence improvement programs can rely solely on motivating.
5. Electronic monitoring is expensive.

The entire article is just over 1000 words and easily read, representing one of the best benefit to effort ratios you’re likely to come across today.  It can be found at Dispelling The Myths Of Patient Adherence

Again With The Names?

Yep, and here’s why – I read a lot of the contemporary lay and professional literature dealing with what is commonly known as   patient compliance or treatment adherence or something similar – i.e., the variation between a prescribed treatment regimen and a patient’s implementation of that treatment regimen.

Based on that reading, my unproven but sincerely and confidently held contention¹ is that the most frequently and most vehemently addressed issue in that corpus of material is the re-naming of the phenomenon (i.e., compliance, adherence, concordance, … ) itself.

There’s more. I suspect that much of the sturm und drang associated with this effort has less to do with advancing adherence to treatment than with labeling who is right and who is wrong.

A significant number of folks consider the name, compliance, to be not only a suboptimal term but an abomination² in general and a roadblock specifically to progress in the field to be formerly known – if the re-namers are indeed successful – as compliance.³

Further, they are also certain that the correct, not-a-roadblock label is adherence

… except in the U.K., where the preferred appellation appears to be concordance

… except for those who lump adherence and concordance together with compliance as equally nefarious elements of the same Satanic vocabulary used to sustain the pjower of the healthcare  establishment and suppress the rights and independence of patients.⁴

There’s Still More – Naming Becomes Name Calling

Some re-naming diatribes clearly posit compliance Vs adherence⁵ as a litmus test. As far as I can determine, compliance is associated with a paternalistic, condescending, and uncaring style of medicine while adherence is an indicator of medicine practiced such that the patient is co-equal with clinicians, the inevitable consequences of which include mutual respect and caring between the patient and clinicians, enhanced treatment outcomes, and quite possibly humankind’s last best chance for peace on Earth, good will to men.⁶

The compliance Vs adherence battle has another unusual quality; adherence adherents and other anti-compliance groups are vocal and thus easily identified, but I have yet to track down the leaders of the compliance crusade. These days, the most adamant pro-compliance stance may, in fact, be something along the lines of my own laissez-faire recommendation found elsewhere on this web site:

Lacking compelling advantages favoring the use of any of the suggested terms and given the institutionalized encoding of “patient compliance” and “patient noncompliance” into the National Library of Medicine database’s official Medical Subject Headings, it makes sense — until something better comes along — to continue using this familiar phrase to designate the extent to which individuals follow an agreed upon treatment plan, and, unless specified otherwise, assume that adherence, compliance, and concordance refer to the same phenomenon.

It’s not going to replace The Ride of the Valkyries in those battle scenes, is it?

An (Apparently) Little-known Fact

Reading this re-naming material gives one the idea that, sometime in the 1970s, the Grand Vizier of Medical Literature decided it was time to name this process by which patients follow, don’t follow, or partially follow treatment recommended to them. He (in the 1970s all Grand Viziers of Medical Literature were white men; at least 67%, in fact, were dead white men) looked about and malignantly/inexplicably (choose one) selected, from the hundreds of thousands of words in the English language,⁷ the despicable compliance even though the far better adherence was right there, probably giving off a wholesome inner glow, available under “A,” near the front of the dictionary. Thus was healthcare progress stymied  for half a century.

What was he thinking?

As it turns out, reality is less dramatic but far more significant than my How The Grand Vizier of Medical Literature Named Compliance tale.

Compliance and noncompliance were first used in the healthcare literature in the 1950s but were popularized in the 1970s when Sackett and Haynes wrote and edited books, symposia, and articles about these phenomena.

The term compliance was, in fact, consciously chosen as a nonjudgmental alternative to earlier descriptions, such as “untrustworthy,” “uncooperative,” “unreliable,” or, my personal favorite, “faithless.” Compliance and noncompliance were specified as declarations of fact rather than indications of blame.⁸

Put another way, compliance was the 1970s version of adherence.

Well, I bet we get it right this time, by golly.

My Dirty Little Secret

I don’t much care which term – compliance, adherence, concordance, persistence, or any combination or permutation of these words or any other existent or yet to be coined word – is used to indicate the variation between a prescribed treatment regimen and a patient’s implementation of that treatment regimen. As long as everyone knows what that term is and what it means, and I can use it as an effective search term in the medical databases and Google, it’s OK with me.

The New Compliance

So, here’s my offer. You guys for whom this re-naming is a big deal – and you know who you are – get together and decide on a name for the new compliance. Heck, new compliance has a nice ring to it. Use it if you like  – gratis. Anyway, debate, vote, fight a duel, use a Ouija Board, draw straws, whatever. Once you have reached a decision, convinced the administrators of databases and search engines to enter a few fudge factors into their codes to make the new term work for old data, and spread the word among clinicians, researchers, patients, and, of course, all other stakeholders (don’t forget to translate the new term into every language used by organized healthcare), just e-mail me and I’ll adapt.

And yet, some folks think I’m argumentative.

1. If “unproven … contention” causes you to effect that  well-practiced sneer of contempt that you tragically believe passes for a bemused, classy, sardonic viewpoint and automatically dismiss whatever notion follows, just pony up the bucks and a couple of grad students to process the literature and I’ll produce the statistical proof. Otherwise, you’ll have to take my word for it.↩
2. I kid you not. “Abomination” is by no means the worst accusation hurled at compliance. One comment on a post, for example, condemned both adherence and compliance as “some of the worst terms in the health care industry!”↩
3. My apologies to the artist previously – and now once again – known as Prince↩
4. To complicate matters, certain subgroups, prominently but not exclusively in the pharmaceutical industry, have begun to stridently insist on the distinction between compliance, adherence, and persistence. Roughly, compliance is the extent to which a recommended treatment is followed within a designated timeframe while persistence addresses how long a patient follows the treatment plan. In oversimplified form, compliance + persistence = adherence. The good news is that I haven’t found any complaints that persistence furthers the Dr. Darth Vader agenda – yet. ↩
5. There are also cases in which compliance, adherence, and even concordance are all targeted as the vocabulary of a conspiracy against the rights and dignity of individual patients. For now, I will focus on the compliance Vs adherence model for the sake of simplicity.↩
6. For the record, I experienced the same kind of  pseudo-epiphany when I first became interested in patient compliance. It went a little something like this

   Doctors are just too paternalistic, too narcissistic, and too out of touch with their patients. As a result, they just tell patients to take X pills Y times a day, without explaining why the medicine is necessary, what the side-effects are, etc. If only all doctors were empathic, perceptive, and sensitive  – well, like me, for example – we could whip this noncompliance thing in a couple of weeks. Why hasn’t anyone else figured this out? It’s so simple. …

   It seems  I fancied myself the Luke Skywalker of adherence in this particular battle of the forces of good against the evil empire.

   Then I saw the sequel to the first epiphany. It turns out that the arrogant doctor thesis may explain some cases of noncompliance but by no means does it account for even a majority of patients who who don’t adequately follow their treatment plans to an adequate degree. So much for the Force being with me.↩

7. The second edition of the Oxford English Dictionary, for example, includes over 600,000 definitions according to Wikipedia.↩
8. See, among others, Haynes RB, Taylor DW, Sackett DL, eds. Compliance in Health Care. Baltimore, MD: The Johns Hopkins University Press; 1979 and Sackett DL, Haynes RB, eds. Compliance With Therapeutic Regimens. Baltimore, MD: The Johns Hopkins University Press; 1976.↩

Michelangelo's Temptation and Fall - from Sistine Chapel Ceiling

Increasing Ones Knowledgebase Is Not Without Risk

Treatment Adherence Data From Fields Beyond Healthcare

While I’ve previously written AlignMap posts about the value of alternative perspectives on patient compliance, most of the entries here focus on pertinent studies and review articles from the familiar genre of medical literature.

Readers interested in extending their thinking beyond the standard party line may find some of the material covered at AlignMap In Cites, the tumblelog companion to this blog, helpful.  The succinctly annotated links comprising AlignMap In Cites tend to be more catholic in content than AlignMap.com and often include information sources from outside the mainstream.

Moreover, thanks to the recent change in the AlignMap.com structure it now  easier for viewers on this site to follow AlignMap In Cites.¹ The section labeled “AlignMap In Cites Recent Posts” at the bottom of the column to the reader’s right is a list of links to the 10 latest posts at AlignMap In Cites.

The two most recent AlignMap In Cites posts  today, in fact, are examples of non-medical resources:² the first links to a review of Buyology By Martin Lindstrom, which examines how marketers, using magnetic resonance imaging scanners, record brain activity in minute detail, measuring how the products they are selling affect the brain’s pleasure centers while the second is a reference to Emerging Lessons, a WSJ article on “understanding the needs of poorer consumers,” which includes, by my reading at least, useful concepts for conveying information to patients with low healthcare literacy. Both of these have obvious implications that could affect how we understand treatment adherence.

Posting at AlignMap In Cites tends to happen in batches separated by fallow periods so I recommend following the titles here and checking out those that look helpful.

I’ll also be listing other nontraditional sources of information about patient compliance here at AlignMap.com in the future.

Bonus #1: Other AlignMap In Cites Posts

I’ll take this opportunity to explain that the content of AlignMap In Cites includes references such as those discussed above, connections to AlignMap.com posts,³ and many entries into what might charitably be called “Miscellaneous.” Among today’s recent posts group, for example, is a quote lifted from a medical student’s publically published blog, which evidences that political correctness has not completely eliminated the blatently obnoxious declaration and which reminds those of us grown perhaps a tad jaded to the basics of patient compliance that teaching the fundamentals to medical students remains an essential task.

Bonus #2: Heck Of A Guy Posts

Near the bottom of the column on the left is a list of links to the ten most recent posts at Heck Of A Guy, my personal blog, which has almost nothing to do with patient compliance other than the occasional post alerting readers there to AlignMap posts of general interest. The tag line at Heck Of A Guy is “A pastiche of posts, featuring song, dance, snappy chatter plus notes on prose, poesy, love, lust, life, and beyond,”⁴  which should clue in any blog reader that I have no idea, day to day, about the content of the posts I’ll publish. I recently published my 1000th Heck Of A Guy post, which included a list of random topics covered there:

• Leonard Cohen
• Anjani
• Ketchup decantation
• Recommendations for additional subtypes of quotation marks:Quid Pro Quotation Marks And 2 More Specialty Quotation Marks and Misquotation Marks & Quasi-Quotation Punctuation
• Love story Julie and I shared
• George Washington Carver 6 Posts (Link goes to first in series)
• The reaction of my hometown to the Gay Games Rowing Event being held here 5 Posts (Link goes to first in series)
• Broomcorn 2 Posts (Link goes to first in series)
• The proposed revision of The Seal Of McHenry County Illinois More Than 10 Posts (Link goes to first in series)
• Mom’s inventory  of Ozark tchotchkes Multiple Posts (Link goes to summary)

I know – I don’t understand why it’s popular either.

1. AlignMap In Cites has also transformed its look into one more easily read and one that is, well, way cool.↩
2. Quelle coincidence, eh?↩
3. The graphics featured in Robot Enhancement of Treatment Adherence, for example, were first displayed on AlignMap In Cites,↩
4. Until recently, the tag line was “If this has made just 1 person spew Pinot Noir through his or her nose, then it’s all been worth it … ,” which may be more indicative of the Heck Of A Guy tone.↩

Source: Psychotropic Medications for Patients With Bipolar Disorder in the United States: Polytherapy and Adherence Ross Baldessarini, Henry Henk, Ami Sklar, Jane Chang, and Leslie Leahy, Psychiatr Serv 2008 59: 1175-1183

Medication Regimen Adherence And The Bipolar Disorder Polytherapy Trend

In the 1970s when I began my residency in psychiatry, a movement denouncing the scourge of polypharmacy in the treatment of psychiatric disorders was being mounted in the literature. Not long afterward, those physicians who tended to use only one medication for the treatment of these same disorders were similarly criticized.  This is not necessarily a matter of clinicians succumbing to fads (although medical professionals are as susceptible as others to unscientific influences, including peer pressure); advances in research, changes in the concepts of a given pathology or the criteria of successful treatment, and the development of new biological agents may cause shifts in the recommended course of treatment.

In any case, the use of a combination of medications in the treatment of bipolar disorder is currently in favor.

In addition, the popularity of the diagnosis of bipolar disorder has steadily increased. Over the past 10 years, according to Moreno and colleagues,((Moreno C, Laje G, Blanco C, Jiang H, Schmidt AB, Olfson M. National trends in the outpatient diagnosis and treatment of bipolar disorder in youth. Arch Gen Psychiatry. 2007 Sep;64(9).)) clinic visits by adults that resulted in a diagnosis of bipolar disorder doubled and visits by children and adolescents that resulted in that diagnosis increased by a factor of 40.

Consequently, the widespread – but not universally held – contention that adherence to medication regimens decreases  as the complexity of a dosage schedule increases makes the examination of compliance by this group of patients especially important.

The Study

Baldessarini and colleagues studied national health plan claims data (2000–2004) of 7,406 patients with bipolar disorder (bipolar I: 55%, bipolar II: 15%, bipolar disorder not otherwise specified: 30%).

I have excerpted some of the findings pertinent to compliance:

Treatment adherence
Additional new findings included identification of factors independently and significantly associated with long-term adherence to an initial mood-stabilizing treatment. Perhaps not surprisingly, only a minority (30%) of U.S. patients diagnosed as having bipolar disorder were nominally continued for a year on an initial mood stabilizer, and only 28% of this subsample were considered to be treatment adherent, on the basis of an MPR =80% averaged over 12 months.¹  Factors associated with greater treatment adherence included being older, use of lamotrigine or lithium, lack of substance abuse, and treatment by a psychiatrist rather than a primary care physician. Inferior adherence was associated with use of valproate (the most commonly prescribed anticonvulsant mood stabilizer), use of carbamazepine or oxcarbazepine, use of supplemental anticonvulsants that lack FDA-approval for use in bipolar disorder, alcohol or drug abuse, and greater illness complexity.

… However, no significant association were found between MPR and co treatment with antidepressants or antipsychotics, nor with sex, diagnostic subtype, comorbidity index, or geographical region.

… Finally, we found complex associations between treatment adherence and utilization of health services. Office, and especially emergency service, visits for bipolar disorder–related care were more frequent in association with greater treatment adherence, whereas emergency service utilization for other indications and days per year of hospitalization for any reason were lower with greater adherence to mood stabilizer treatment). The lesser utilization of emergency and inpatient services suggests potential cost savings with greater adherence to mood-stabilizing treatments. On the other hand, greater use of ambulatory and emergency services for bipolar disorder–related indications suggests that greater treatment adherence may reflect relatively close monitoring, with more frequent clinician contacts. However, the available data do not permit clarification of cause-effect relationships between treatment adherence and utilization of clinical services.

Conclusions
… Adherence to long- term mood stabilizer treatment, although uncommon, was associated with several plausible clinical factors. Our findings of heavy reliance on antidepressants and polytherapy, low mood stabilizer utilization and adherence rates, and high rates of dropout from long-term mood-stabilizing treatment strongly suggest that more effective and better-tolerated mood – stabilizing treatments are required for patients with bipolar disorders, along with redoubled educational efforts to underscore the importance of sustained, longterm prophylactic treatment of such patients, even through periods of relative euthymia.

Commentary: Sadly, No Surprises

It is important to keep in mind that, as indicated in the article, the study used claims data as the information source and, congruently, defined adequate adherence as a medication possession ratio (MPR = the percentage of the past 365 days with apparent access to the medication) of at least 80%. This methodology is a rational research approach but is subject to limitations, one of which is that access to medication tends to define the maximum number of patients who may actually take sufficient amounts of their medication (i.e., patients cannot take their medications if they don’t have access to them, but  having access to medication does not necessarily mean those medications were administered appropriately).

The most significant finding is also the least surprising: Of the 30% of patients diagnosed as having bipolar disorder that were, on paper at least, continued for a year on an initial mood stabilizer, only 28% were found to be adherent.

The associations between treatment adherence and utilization of health services is, as the authors note, “complex.” The connection between better adherence and decreased use of emergency service utilization for indications other than those related to bipolar disorder  and days per year of hospitalization are heartening.  But, as the article points out, one cannot establish a cause-effect relationship. It may be, for example, that, as other studies have suggested, patients who tend to be adherent to treatment are also healthier, independently of the effects of their treatment.

I am also hesitant to subscribe to the authors’ positive spin on the data reflected in their speculation that “…  greater use of ambulatory and emergency services for bipolar disorder–related indications suggests that greater treatment adherence may reflect relatively close monitoring, with more frequent clinician contacts.”

Other explanations are possible. One alternative hypothesis, for example, is that a subgroup of noncompliant patients whose family or friends assure that doctors’ appointments are kept and that the patients are taken to the ER during exacerbations of their disorders might also be more likely to have prescriptions filled, again because of the insistence and assistance  of  friends and family. Those patients, who might rarely take the medications, would be accounted adherent because the medications are  accessible to them.

Of course, the difference in those interpretations may have less to do with a cognitive assessment of the data than with the difference between the research team’s world view  and my own perspective.

Those differences could also explain my lack of enthusiasm for the paper’s recommendations that “more effective and better-tolerated mood – stabilizing treatments are required for patients with bipolar disorders, along with redoubled educational efforts to underscore the importance of sustained, longterm prophylactic treatment of such patients, even through periods of relative euthymia.”

Before I start getting nasty emails, I will point out that I’m not against “more effective and better-tolerated mood – stabilizing treatment” or “redoubled educational efforts.”

I am, in fact, 110% in favor of producing treatments that are more effective for every disease, that are better tolerated by patients, that taste like cherry pie, and that render those patients more attractive, all of which could enhance compliance.  I am also in favor of clean streets, lower taxes, an end to world hunger, and a World Series championship for the Cubs.

And, I’ll call your  “redoubled educational efforts” and raise you a  retripled educational  effort. Heck, I’m willing to go as high as an exponentially increased educational effort.  I just don’t find much evidence that quantum leaps in educational effort beyond a competent communication of information have a significant positive effect on compliance.

As explained in my introduction, adherence to polytherapy of bipolar disorder is an especially significant area and Dr. Baldessarini et al have provided an important confirmation of the catastrophically low proportion of bipolar patients who are receiving an adequate course of treatment.

I suggest, however, that the appropriate primary response to these findings is not better drugs and more patient education but further research that would explain  why these results, that less than 30% of bipolar patients even have access to sufficient medication during the 12 months studied, isn’t on the front page of today’s New York Times and Chicago Tribune and broadcast as the lead story on CNN and the ABC Evening News.

Footnotes

1. The research group measured adherence to mood stabilizers by using a medication possession ratio (MPR).  MPR is the percentage of the past 365 days with apparent access to an initial mood stabilizer.↩

At the risk of diminishing my reputation for cynicism modulated only by profound pessimism, I feel compelled to recommend to clinicians, patients, and families and friends of patients Never Give Up! Don’t Let Statistics Rob Your Hope And Joy, a thoughtful and exuberant (adjectives altogether too rarely found in tandem) post found at Jay’s Family Health Neighborhood.

The tactic recommended, in oversimplified form, is reframing the statistical correlation between treatment adherence and clinical outcome from an obligation backed up by the threat of physical deterioration and shortened life span into an opportunity associated with realistic rewards.

That tactic is impressively clever, but, even more significantly, it is incredibly empathic.

An excerpt follows, but I urge viewers to read the entire piece.

With many medical conditions, there is a strong correlation between good self-care and longevity. Parents can use statistics to inspire hope and spark an “I can beat this” attitude. Parents who give off positive, “we can beat this” vibes generally raise kids with the same determined spirit. We have met many CF parents and their children who demonstrate this indomitable and inspiring attitude.

In summary, wise parents handle statistics and medical predictions by:

• Emphasizing that significant medical progress is being made in almost all areas, and that health and longevity are increasing for almost all illnesses.• Realizing that for all individuals, the future is unknown. Many lives are shortened by unexpected illness and traumatic events.
• Encouraging their children to believe that they have every chance of being one of those children “who fall on the high side of the bell curve because you take such good care of yourself.”• Understanding that the quality of a life is measured not by its length, but by the amount of love, accomplishment, and giving that fills it.
• Understanding that worrying about the future and chewing on the mistakes of yesterday rob both today and tomorrow. The resulting hopelessness, negativity, and worry can shorten lives and certainly diminish the quality of life.
• Believing that those who bravely face life’s obstacles build a character that not only leads them to be more capable people and leaders, but sets an example that enhances the lives of all with whom they come in contact.

The more characteristically sardonic tone I’ve established for this blog over the past couple of years will return with the publication of the next post.