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AdherenceLand - Where Compliance is FUN

Adherence Enhancement – Fun vs Futility

Yesterday, Jonathan Richman at Dose Of Digital, published The Only Way Pharma Can Improve Compliance: Fun, a post with three commendable aspects:

1. The  perspicacious  identification of AlignMap as the  “ultimate in compliance resources”
2. The equally perspicacious and arguably more significant  observation that “…  the reason we haven’t made an impact is because we test and use one intervention at a time.  …  What we need to offer is a wide choice of different compliance programs with each individual enrolled in the programs that are going to impact them.”
3. The proposition that fun might well be a motivator for adherence behaviors

Why Fun Is Important In Transforming Compliance

The argument made for fun is convincing and – well, fun.

It’s also important.

It’s important because the Adherence Can Be Fun hypothesis looks like it might work.¹  Rather than repeat the argument Jonathon Richmond makes, I suggest you read his post and see for yourself.  I think you’ll be impressed.

It’s important because, as I have pointed out on occasion, ² repeating the same processes tends to produce the same results.  In the case of patient compliance, that means trying the same adherence enhancement that didn’t work the first 821 times probably won’t work the 822nd time.  Trying something new (not just another version of the same tired idea),  is essential; trying something new, such as fun, which has proven successful in changing behaviors in other fields is astutely logical.

Finally, it’s important because we need to be looking for methodologies that enhance compliance by enhancing the alliance of the patient with those involved in his or her healthcare, including clinicians, Pharma, third party payers, and other stakeholders.  Fun would be a potent force to effect that alignment.

Now, hit that link and read  Jonathan Richman’s piece – heck, have fun with it: The Only Way Pharma Can Improve Compliance: Fun

1. Admittedly, I have no credentials as an expert on fun; still, …↩
2. See, for example, Why Today’s Treatment Adherence Paradigm Must Be Destroyed – Part 2, Patient Compliance – So Wrong For So Long, and The Tragedy Of Patient Compliance↩

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.↩

Where Is The Quintessential American Compliance Setting?
Hint: It’s Not The Doctor’s Office

According to Robert Cialdini, writing in Influence: The Psychology of Persuasion, the quintessential American compliance setting is the Tupperware Party.¹ We’ll get to the “why” behind that claim and what the medical community might learn from get-togethers in suburban living rooms dedicated to retailing plastic food containers  in a moment; first we need to look at …

Psychology Of Persuasion, Decision-making, Influence, Motivation, Consumer Choices, … And Behavioral Economics

A widely varied group, including philosophers, economists, academicians, salesmen, psychologists, sociologists, retailers, manufacturers, marketing and advertising professionals, and others, has, for the past several years, invested much time and effort into understanding the psychological machinations which determine how an individual reaches a decision to take one or another action, such as determining the brand of blue jeans to buy, whether or not to buckle ones seat belt, which political candidate to support, who to marry, when to trade in the family car for a newer model, whether to attend religious services and, if so, which religious services,  … .

Of paramount significance in these efforts is the  focus on how these decisions are  actually – not theoretically – made.

The primary victim of this obsessively pragmatic process has been the paradigm of the Rational Man – the notion that individuals make decisions by calculating the advantages, disadvantages, costs, uses, risks, and similar factors pertaining to possible courses of actions and then choosing the option that best facilitates that individual reaching specific, predetermined goals at the least cost. ²

Decades of experiments, studies, observations, and sales data convincingly demonstrate that, instead, we routinely make decisions based on unfounded beliefs, unconscious  associations, buyer-seller dynamics, and illogical reasoning. In short, in the matter of decision-making, our confidence far exceeds our capacities.³

Back To The Tupperware Party

The Rational Man would, for example, presumably go about meeting his food storage needs by considering the price, warranties, size, sturdiness, experiences of others, and so on for implements available in the marketplace, comparing the findings with his personal preferences and then only then purchasing the items that best match his requirements.

In reality, as shown in a 1990 study by Jonathan Frenzen and Harry Davis, published in the Journal of Consumer Research, Tupperware parties were successful in merchandising the product because those attending liked the hostess, not the Tupperware. Fondness for the hostess was twice as important as whether they liked, wanted, or needed the product.

The Reciprocity Effect

Reciprocity, one element of “liking” someone selling an item or an idea, serves as a useful example of the principles underlying everyday decision-making.

The Reciprocity Effect describes the sense of indebtedness felt when someone does something for us or gives us something and our need to reciprocate in order to relieve that sense of obligation.

In a classic, much quoted experiment by Regan,⁴ subjects are instructed to rate, along with another person (the other person is actually a confederate of the researcher), the quality of a work of art. During a rest period, the confederate leaves the room. When he returns, he is carrying a Coke for himself and one for the subject. There was also a control condition in which the confederate leaves the room and comes back with no Coke for himself or the subject. So subjects in the experimental group receive an unsolicited act of kindness while those in the control group do not.

At the end of the ostensible art-rating experiment, the confederate informally tells the subject that he’s selling raffle tickets and is eligible to win a prize if sells the most tickets. He then asks the subject to help by buying some tickets. Subjects who receive the gift of a Coke buy far more tickets subjects who receive no such gift. Subjects receiving the 10 cent Coke (it’s 1974) buy at least two more raffle tickets at 25 cents each. In fact, the positive effect of the gift (buying more lottery tickets) maintains even if the confederate makes it clear that the Cokes are supplied by the research project so that there is no cost to the giver of the gift.⁵

Quoting Cialdini,

If what you give to somebody is meaningful, tailored and unexpected, that’s really the best you can do. All the evidence shows you will be repaid.

Which is why it is important that games were played and prizes awarded at Tupperware parties, why surveys come with a dollar attached, why the Disabled American Veterans organization sends personalized address labels. with its form letter asking for support (the DAV credits the inclusion of the labels with increasing their response rate from 18 percent to 35 percent), and why an especially smart business partner gave me an extensive collection of music he (correctly) guessed I would enjoy before we even began discussing working together.

The Ethics Of Persuasion In Clinical Care

The use of tactics associated with the principles of persuasion does carry with it significant ethical and moral implications that are beyond the scope of this single posting. While I will elaborate on this in a later entry, suffice it for now to note (1) the concepts of behavioral economics, not unlike the technologies of medicine, are intrinsically amoral; it is how they are put into use that is an ethical concern, and (2) casual observation at any clinic demonstrates that patients making decisions about treatment, one of the first steps in determining adherence, do not behave congruently with the Rational Man theory and are, intentionally or unintentionally, subjected to as many influences as the guest at the Tupperware party; the difference is that those influences were effectively applied to reach a goal at the Tupperware party.

Patient Compliance And Tupperware Parties

Non-rational motivations are, incidentally, equally important in the purchase of a car, the choice of pharmacies, and the election of a Senator as they are in buying Tupperware. While I lack the specific data to prove it, I am willing to wager a significant sum (say, all the money I can lay my hands on) that the same is true in the case of patient compliance.

At the least, clinicians should be aware of and be able to address those influencing forces in the context of patient compliance. I also believe a compelling argument can be made (and I will be making that argument in another post) that clinicians not only have the ethical authority to use certain tactics of persuasion in the service of enhancing the chances that a treatment regimen will be successfully implemented but that they have a responsibility to do so.

I’ve long railed against the concept of the Rational Man as it applies to theories of patient compliance. (See, for example, Patient Behavior, Current Patient Compliance Models, Neuroeconomics, The Rational Man, & Noncompliance, and Decision-Making Processes Of Prostate Cancer Patients)) Ongoing readers could well accuse me of beating a dead horse were it not for evidence found everyday in the literature, conversations, studies, and clinical practice that this particular horse is alive and well.

The concept of the Rational Man continues to dominate – and misdirect – thinking in the field of patient compliance.

And that’s a damned shame – because we should know better by now.

1. It may be helpful to keep in mind that Influence: The Psychology of Persuasion was first published in 1984.↩
2. Rational Man and Economic Man are terms used in economics, law, and other settings to stipulate a hypothetical individual that uniformly and inevitably acts logically to achieve the highest possible well-being for himself using whatever pertinent information is available. More formally, The Washington University Economic Geography Glossary defines Economic Man as the “Highly abstract model of human economic behavior based on simplifying but extreme assumptions of perfect information and perfect ability to use such information in a rational way (i.e. to achieve optimal ends)” ↩
3. For details, descriptions, and data pertaining to behavioral economics, one can turn to a number of recent books written for the lay public. My personal favorite is “Predictably Irrational: The Hidden Forces That Shape Our Decisions” by Dan Ariely. HarperCollins. 2008↩
4. Regan, R.T., 1971, “Effects of a favor and liking on compliance,” Journal of Experimental Social Psychology, 7, 627-639.↩
5. Peter A. Ubel, Free Market Madness: Why Human Nature is at Odds with Economics–and Why it Matters↩

How We Got Here: The Failure Of  Patient Compliance

The currently used Patient Compliance paradigm, as I’ve subtly suggested in previous posts,¹ has not yielded a positive return on the time, money, and effort spent in its pursuit.

The consensus of experience and research in and experience with these efforts to improve adherence to treatment can be succinctly and accurately characterized by these three points:

1. Many of the currently used individual compliance-enhancement interventions benefit some of the patients under some conditions some of the time.
2. None of the currently used individual compliance-enhancement interventions benefit most patients in most conditions.
3. Reliably predicting if a specific compliance-enhancement intervention will benefit a specific patient in a specific situation is an unachieved goal.

From these principles, one can infer that offering several different interventions at once might well  be beneficial.  And, in fact, there is evidence that a package of several, multi-layered compliance-enhancement interventions can be effective across the patient population. As one would suspect, however,  such shotgun approaches are neither efficient or economic. This extract from a Cochrane Review of medication compliance enhancements elegantly summarizes the current state of affairs:

Several complex strategies, including combinations of more thorough patient instructions and counseling, reminders, close follow-up, supervised self-monitoring, and rewards for success can improve adherence and treatment outcomes. However, these complex strategies for improving adherence with long-term medication prescriptions are not very effective despite the amount of effort and resources they consume.²

My conviction is that the failure to develop pragmatic solutions for noncompliance is due to the concept of medical noncompliance itself, manifested in a widespread misunderstanding of that concept, a denial of its complexity, and an obsessive drive to find a panacea for a problem that is more ideological than pathological.

Medical Noncompliance has ultimately become no more than a label we’ve assigned to an extraordinarily wide and varied category of non-optimal behaviors patients exhibit in response to their clinicians’ treatment recommendations. Instances of noncompliance, as already noted, can appear in an infinite variety of forms and be caused by an infinite number of causes. And to flip the late Justice Potter Stewart’s famous statement about pornography,

We can define medical noncompliance
but we often don’t know it when we see it

Why Now: Money – And Saving A Life Or Two

Remarkably, there has been so much emphasis placed on the potential cost-saving to be wrung from increased treatment adherence rates that it seems incumbent to note that the primary goal in improving the effectiveness of medical treatments is to maintain and improve the health of individuals, thus reducing suffering and the loss of life.

That improving the effectiveness of medical treatment by increasing treatment adherence rates will decrease primary healthcare expenses and secondary costs due (e.g., losses due to absenteeism from work) is a pleasant  bonus (OK, make that an incredibly wonderful bonus).

That point duly documented, the economic cataclysm created by spiraling healthcare costs during a period of general economic chaos is the tipping point precipitating long overdue changes in how healthcare is managed, politically, professionally, and administratively.  Healthcare expenses in some industries are the  most expensive budget category other than salaries.³   A 2004 McKinsey Quarterly presciently opened an article on controlling healthcare benefits with the observation that “In a few years, the average Fortune 500 company may be spending as much on health benefits as it earns in profits.”⁴  Further, responsibility for healthcare costs  have arguably become the primary conflict between management and labor. In these circumstances, the inability to efficiently improve medical compliance rates, the most significant cause of unnecessasry healthcare costs has escalated from painful and frustrating to catastrophic.

The healthcare community has a responsibility to find a solution. We should start by  looking for that solution in the most likely places.

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.”

I’ve used that joke before,⁵ but it fits too well here to pass it up.  The point, of course, is that we can’t afford to keep looking for solutions in areas that have repeatedly been shown to be bereft of answers even if those areas are more familiar.

What Has To Change: New Solutions To Noncompliance

One  might hypothesize⁶ that the current system has been perpetuated simply because no alternatives have been found.

In this instance, one would, however, be wrong.

Heck, not only are there promising alternatives but those alternatives are well known and in place – in other fields

Compliance and noncompliance are issues in many areas  of human endeavor other than healthcare.  The legal system is, in fact, built around the notion of citizens complying with laws. Politicians work to bring us into compliance with their ideas. Adherence is an essential element in educational institutions, military units, and professional communities. And, of course, marketing is all about getting potential buyers to comply with recommendations to buy a particular product or set of goods.

Here’s the key:

Noncompliance is not exclusively a medical issue.
It’s a personality trait that manifests in many areas of life.

Consequently, a reasonable source of  potential tactics for managing noncompliance is that set of strategies that have been successful in these other fields.

For today, I’ll ask the reader to be content with one example with the promise (i.e., threat) of several other possibilities to follow in the future.

What Next: Population Segmentation – One Promising Option To Improve Treatment Effectiveness

In keeping with the principles of full disclosure, I want to alert readers to the fact that I am  involved with EnrichMap, which offers a system of interventions based on population segmentation (also called patient profiling).

Marketing research uses population segmentation to identify the likely users of a product or service and the specific appeals to which those users are most likely to respond. Within that definition, however, are several varieties of segmentation. Large groups may be broken down into subgroups based on age, ethnic background, economic status, cultural mores, psychological traits, … .

Ironically, Big Pharma is one of many industry sectors that use population segmentation extensively. Most commonly, however, pharmaceutical manufacturers use patient segmentation only for determining the characteristics of the patient group whose needs best match  a given product.

Today, sophisticated statistical techniques are used to divide the pharmaceutical marketplace into distinct segments of patients, based on their clinical profiles and the type of medical care they receive. When done well, patient segmentation reveals the size of the market, which  segments hold the most value for a brand, and which product attributes will appeal to each patient sector.⁷

And, population segmentation is used extensively in health care planning, i.e., anticipating future needs, allotting resources, and constructing delivery systems.

To create a valid, reliable, and useful segmentation is not a trivial task; the specific methodology required is, thankfully, beyond the scope of this post. On the other hand, the potential utility of such groupings is intuitively apparent.

If, for example, market segmentation shows that 85-90% of your product, a digital caliper with built-in GPS, is purchased by 45-55 year old Asian women with postgraduate engineering degrees, you can probably turn down that commercial time on SpongeBob SquarePants the ad company is pushing you to buy, regardless of how low the ad rates or how huge the show’s audience (unless there is convincing evidence that the program’s viewership skews to 45-55 year old Asian women with postgraduate engineering degrees).

Similarly, if population segmentation shows that 94% of a working mothers of school-age children strongly believe keeping their kids’ immunizations up to date is essential but find it difficult to keep track of current recommendations, document which immunizations their children have already had, and arrange the logistics of getting their offspring immunized, public health officials might consider (1) decreasing the monies spent on educating mothers about the importance of  immunizations (2) developing an automated means of alerting parents to changes in immunization recommendations, and (3)  constructing a system, perhaps in cooperation with the schools or other community institutions, to conveniently provide and document the immunizations.

And, on a doctor-patient level, if a physician knows that a patient is part of a population segment that typically becomes ill at ease, uncertain, and confused when dealing with healthcare decisions or treatment instructions, the doctor might decide to institute special measures  for that patient that might not be used for others with the same diagnosis. After the explanation of a treatment plan, for example, the patient might be asked to describe the recommendations in his own words or to complete a simple  test about the treatment to check his understanding of the plan. The clinician might also  provide that patient with auxiliary calendars indicating dosing times and dates, arrange for the patient to enroll in a system of automated reminders or, if the risk from the disorder is high, use an automated medication dispenser that alerts care-givers and the clinical staff if the medication is not dispensed, schedule more frequent follow-up appointments, and request that staff call the patient the next day to assure that the treatment is being correctly implemented.

How Segmentation Differentiates Compliance Interventions

Patient Segmentation matches the specific patient with the interventions most likely to succeed in improving treatment implementation  rather than searching for one panacea for all noncompliance. While one might argue that all the measures listed in the case described in the preceding paragraph  could be beneficial to every patient, patient segmentation shows that a significant percentage of patients will implement treatment correctly without these aids, another significant percentage of patients will be unlikely to correctly follow any treatment whether or not they are provided these aids, and still another significant percentage of patients will demonstrate a meager improvement with the described assistance but will show a more robust response to other interventions.

Further, segmentation techniques can identify patients that are comparatively more responsive  to incentives, personal interventions by the physician, comprehensive explanations, peer support groups, and a myriad of other interventions now applied to a population on an all or nothing basis.

Patient Segmentation focuses on the realistic goal of managing noncompliance rather than the incredibly difficult if possible at all goal of curing noncompliance.

And, given  that (1) improving communications between physician and patient can improve patient behaviors  (including implementation of prescribed treatment) and (2) communications with patients can be managed more efficaciously  than attempting to directly manage behaviors of patients, reaching the ultimate goal – improved treatment effectiveness – is more likely to be accomplished by shifting from the current efforts to coerce higher compliance rates to using Patient Segmentation to enhance the doctor-patient communication systems.

What’s The Catch?

Patient Segmentation sounds pretty good, doesn’t it?

So, why isn’t  this kind of tool in use everywhere now?⁸

The reflexive response is that there is no definitive proof that interventions based on segmentation effectively improves the successful implementation of treatment – which only transforms the question to why  a patient segmentation approach to treatment adherence isn’t being vigorously explored.

Why are clinical organizations, academics, the government,  pharmaceutical companies, and other  healthcare stakeholders  far more willing to fund studies of traditional compliance tactics which have  been repeatedly shown to be unsuccessful  than segmentation strategies, which have been demonstrated effective in other fields?

It’s a puzzlement.

Future posts will address other alternatives (i.e., in addition to population segmentation) to the conventional patient compliance model.

1. See, for example, The Tragedy Of Patient Compliance, Patient Compliance – So Wrong For So Long,  Why Today’s Treatment Adherence Paradigm Must Be Destroyed – Part 1, Why Today’s Treatment Adherence Paradigm Must Be Destroyed – Part 2, Ending The Damage Caused By The Treatment Adherence Paradigm.↩
2. Haynes RB, McDonald H, Garg AX, Montague P. Interventions for helping patients to follow prescriptions for medications. (Reprint of a Cochrane review 2003, Issue 4) Update Software Ltd, Summertown Pavilion, Middle Way, Oxford OX2 7LG, UK. 9↩
3. Sick and Getting Sicker, By Simona Covel. WSJ. July 13, 2009.↩
4. How To Control Health Benefit Costs, Lynn Dorsey Bleil, James Kalamas, and Rayman K. Mathoda. McKinsey Quarterly. February 2004.↩
5. See Why Today’s Treatment Adherence Paradigm Must Be Destroyed – Part 2↩
6. I’m assuming this is the same “one” who, in the first section of this post, correctly inferred that offering several different compliance-enhancement interventions at once might well  be beneficial and now feeling on a roll, has thus been rendered a tad overconfident and perhaps even foolhardy when it comes to reaching suppositions.↩
7. A New Measure for Segmenting Patients by Their Total Health Care Experience By John Iacoviello, PhD, and Jim Carroll. Product Management Today. Vol 18, No 3. March 2007↩
8. To be fair, segmentation is used here and there.↩

My post, It’s Time To Stop The Damage Caused By Today’s Patient Compliance Paradigm, went online at the eyeforpharma.com site today.

While fundamentally a summary of the preceding posts on this blog, ¹ It’s Time To Stop The Damage Caused By Today’s Patient Compliance Paradigm can claim an original introduction, which, I think, is worth sharing here:

Imagine that, say,  a well known Fortune 500 manufacturer of state of the art medical devices and the Feds co-funded a $14.2 million multi–center  study at four prestigious universities to determine the  effectiveness of a newly designed stereotactic laser bloodletting* machine (with optional Facebook connection)  in treating diabetes.

Doesn’t it seem likely that a whistle-blower – or, failing that, a Senator coming up for re-election, an investigative reporter desperate for a story, a publicity-seeking Attorney General of one state or another, a gadfly shareholder, a do-gooder looking for a cause, or a Ralph Nader wannabe – would be loudly decrying the use of public and shareholder monies on a clinical trial of a treatment never shown to be of benefit to patients with this disease despite many, many years of use? One would, in fact, think that  congressional committees would be convened, newspaper stories written, blog posts posted, accusations leveled and denied, indictments brought, damage control instituted, scapegoats designated, and heads rolled.

At the least, the medical device company,  the Federal agency that handed over the bucks, and the academic institutions involved would be called upon to justify their choice of investments, i.e., explain why the limited amount of money and skilled researchers were designated to be expended on this project instead of a potentially effective therapy – or at least one that has not already proven useless.

I contend that  the now dominant  paradigm of adherence to treatment, has,  like bloodletting,  been so unsuccessful for so long (see previous posts: The Tragedy Of Patient Compliance and Patient Compliance – So Wrong For So Long)  that continuing to explore the same familiar primrose paths  of the patient compliance model  entails an intellectual responsibility to provide an explicit rationale for taking this tack.

Next: Alternatives To the Current Patient Compliance Model

The posts in this sequence have thus far focused on the why the treatment adherence paradigm is ineffective and the danger of its continued use.

As noted already, the next entries will begin a discussion of possible alternatives to the current model.

1. See Why The Treatment Adherence Paradigm Must Be Destroyed:  Part 1 and Part 2↩

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.↩

Flag of the Surgeon General Of The U.S.

Why President Obama Should Appoint Me Surgeon General

1. It would make my mother feel better if I had a salaried job with the government.
2. I would have the opportunity to give back something to medicine and society, improve public health, embrace humanity, end world hunger, save the whales, be all that I can be, reach out and touch someone, get ‘er done, boldly go where no man has gone before, bla bla bla bla … .
3. I could really use that Federal health insurance.
4. My campaign to transform patient Compliance into a useful concept producing effective results is the only means of fulfilling President Obama’s promise to  improve the medical system and extend coverage  to significantly more people while decreasing healthcare costs other than paying doctors and hospitals in Confederate money.
5. Chicks dig a guy in uniform.

Surgeon General J.K. Barnes - Appointed by President Lincoln

Keep a watch also on the faults of the patients, which often make them lie about the taking of things prescribed.
- Hippocrates¹

Launching A Guerrilla Attack On Patient Compliance – The Battle Of Patients With Pants On Fire

The publication of  Lots Of Patients Fib, Sometimes By Accident, a  nicely done article by Karen Ravn in the June 8, 2009 LA Times about patients who  lie to their physicians  provides a circumscribed clinical scenario that  demonstrates  both the problems with the current patient compliance paradigm and the rationale for the kinds of changes necessary to transform it into a useful concept.

An excerpt from the Lots Of Patients Fib, Sometimes By Accident follows:

It’s well-known that patients don’t always do a perfect job of following — or “adhering to” — the treatment plans their doctors lay out for them. A paper published in 2004 in the journal Medical Care analyzed more than 500 studies on that matter and found that, on average, about 75% of patients met the adherence standards researchers had set.

But these figures may overestimate adherence because some patients are probably fudging. “Patients who say they always take their meds may not be,” says Dr. Steven Hahn, professor of clinical medicine at Albert Einstein College and an internist at Jacobi Medical Center in New York City.

“Patients who say they don’t always take them are likely to be missing significant amounts.”

One indication of how much people fib is how things change when they know they’re being watched.

In a 2001 study in the Journal of Hypertension, scientists followed 41 patients who had been unsuccessful in lowering their blood pressure with three prescribed drugs. Patients continued taking the same three drugs during the study, but they now knew they were being monitored electronically: The drugs came in special packages that recorded the date and time whenever they were opened.

After two months of being monitored, about one-third of the patients had lowered their blood pressure to the normal range. Chances were good, the researchers concluded, that those patients had not been taking the drugs properly before.

A number of other studies have found that patients in clinical trials sometimes “dump” their medication — i.e., simply dispose of it — so it will look as if they’ve been using it as prescribed even though they haven’t.

Also, in the above-mentioned 2000 study published in Chest, 236 patients used inhalers to take medication intended to help them breathe. The inhalers were fitted with electronic monitors that could record the date and time whenever patients used them. Not all of the patients knew about the monitoring feature.

During one year of the study, 30 of the 101 patients who did not know they were being monitored — about 30% — dumped at least once. (Dumping was defined as activating the inhaler more than 100 times within a three-hour period.)

Of the 135 patients who did know they were being monitored, only one dumped.

Most of the dumping incidents occurred just before a clinic visit, and researchers concluded that patients dumped in order to give the impression that they had used their inhalers more often than they had.

No experienced clinicians, I suspect, will be surprised by this information. And, I’ve found few non-clinicians, who, on reflection, fail to recognize that misleading a doctor about treatment adherence, whether by omission or commission, is common.

The potential consequences, however, may be less apparent.

I examined the difficulties created by patients misleading their doctors about their compliance with the prescribed treatment in an earlier post, Treatment Adherent Refusal Of Prescribed Medications.  There I pointed out the risk that the patient would undergo unnecessarily aggressive treatment:

Clinicians cannot efficaciously deal with treatment failure caused by noncompliance if they do not know that the patient did not follow the treatment plan. At best, physicians will be less efficient in providing appropriate care; at worst, they may modify the treatment with disastrous results.

Moreover, the dangers to the patient’s health and the financial cost to the patient and society can increase exponentially. Consider this example from Noncompliance Costs of a nonadherent patient who hides the noncompliance from his doctor:

A Case Of Routine & Tragic Patient Noncompliance

A patient with an respiratory infection does not complete the full course of the antibiotic prescribed by his physician. When symptoms persist, the patient returns to his doctor but fails to report the noncompliance. The physician consequently believes that the original medication was somehow inadequate (e.g., the pathogen was resistant to the medication or not covered within the therapeutic range of the medication) and prescribes a different agent, one that is more costly and more prone to side-effects.

Already in this scenario, noncompliance has resulted in

• At least one unnecessary clinic visit
• Two medications in a situation in which one might have sufficed
• A potentially erroneous shift in ongoing treatment
• An increased risk of adverse medication effects, both because the second drug causes more side-effects than the first and because the patient is exposed to two medications instead of one
• A deviation, based on misinformation, from the initial treatment plan which, by design, should provide the optimal combination of safety, affordability, and effectiveness for that patient. At best, the new treatment plan will be similar to but somehow less advantageous than the original therapy. At worst, the noncompliance-caused treatment failure will cause the clinician to mistakenly alter the diagnosis and treatment such that the actual problem is not addressed.

This example is, admittedly, oversimplified. Some disorders improve despite noncompliance with treatment. Some clinicians might have suspected noncompliance when the patient did not improve. Some patients do confess their failure to follow the treatment plan. Nonetheless, a plethora of evidence demonstrates that noncompliance clearly increases the risk of treatment failure, that clinicians rarely recognize or even suspect noncompliance, and that patients even more rarely reveal nonadherence to treatment. This example is, in fact, statistically condensed but conceptually accurate, and countless analogous cases occur every day throughout the healthcare system. …²

Because of the complexity and interdependent nature of the contemporary healthcare system, the impact of patient noncompliance is rarely limited to wasting one medical treatment that would have been successful if implemented. Instead, any treatment failure caused by noncompliance is subject to an array of multipliers, some obvious and some invisible, that can easily increase the potential fiscal, physiological, and social cost exponentially and connections, both direct and indirect, that distribute a similar range of losses to others. Moreover, the extraordinarily high value western culture places on both the individual and health heightens the stakes and further drives the process.

Not only is this a common problem and one with serious consequences but it is also one nurtured by the contemporary patient compliance model.

Patient Compliance Is A Self Defeating  Strategy

In Treatment Adherent Refusal Of Prescribed Medications, I also pointed out that the conflict between patient and clinician that is part and parcel of our perspective on patient compliance motivates the patient to lie to the doctor:

The currently prevalent models of noncompliance management have a final common pathway: their objective, their only measure of success, is the patient following the medication regimen as prescribed – whether this goal is attained by coercion, persuasion, incentives, moral appeals to responsibility or concern for ones family, patient education, or other methods. Even so-called “patient empowerment” can be accurately translated in this context as “the patient is empowered to choose to take the medication as prescribed.” Consequently, patients who do not take their medications as prescribed are powerfully but covertly encouraged to actively or passively mislead clinicians about the noncompliance, perpetuating this vicious cycle.

This realization led to what I then modestly called …

The Incredibly Revolutionary Idea

1. We quit pretending that noncompliance will disappear if patients are properly educated, persuaded, empowered, informed, motivated, coerced, bribed, threatened, influenced, or reminded. We acknowledge the obvious – that except in a few cases,³ the patient makes the final choice about following a prescribed treatment.

2. Rather than continue the unrequited efforts to eradicate noncompliance, we try, as a first step in breaking the vicious cycle, fixing that part of the healthcare system that multiplies the damage caused by noncompliance: the miscommunication between clinician and patient about noncompliance.

I went on to suggest how the reader might address this issue directly with his or her clinician, but precise tactics are, in this case, less important than the big picture, i.e., the afore mentioned Incredibly Revolutionary Idea.

Storming The Bastille

The New Order Of Things – Replacing Patient Compliance

While only one aspect of the healthcare process, the problem of patients lying about adherence does spotlight the need for and the type of change in patient compliance I am promoting.

Continuing to emphasize the requirement of adhering to a prescribed treatment regimen also continues the conflict between patient and clinician, which, in turn, encourages the patient to lie to the doctor about following treatment. Because every doctor has had the experience of patients lying to him or her, the mistrust has become pervasive. Wary doctors may well mistrust all patients since discerning who is and isn’t telling the truth is difficult and often impossible.   Consequently the entire system has become corrupted.

My contentions are (1) the goal is not good compliance by a specific patient but instead optimal treatment for each patient and (2) optimal treatment is most efficaciously pursued by aligning the doctor, the patient, and other stakeholders to maximize mutual trust, a strategy which takes priority over the percentage of prescribed pills taken by the patient.

To dismantle the patient compliance apparatus that has hindered improvements in treatment outcomes, a systemic shift in perspective is necessary.

As an integral element of that shift, the doctor must convincingly transmit to the patient that valid and reliable communication between them supersedes a compliance scorecard.

Or, I suppose we can invest in electronic compliance monitoring devices, lie detectors, and a spy network.

One option for managing patients who may be lying

By the way, we might want to consider changing the name from “lie detector” to something like “trust enhancement processor.”

1. I know – I’m tired of seeing this quotation too. It just fit so well, I felt compelled to use it.↩
2. This scene is extended beyond this point in the original example at Noncompliance Costs, . I recommend reading it in its entirety to gain a perspective on how  impressively simple it is to conjure up plausible scenarios in which initial noncompliance which is compounded by lying  about it leads to severe incapacity or death and, by extrapolation, how likely it is that this sort of thing happens with some frequency.↩
3. E.g., cases involving children or adult patients incompetent to handle their own healthcare and cases in which forced compliance with treatment is legally sanctioned and is pragmatically feasible↩

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

I’ve published a second post, Patient Compliance – So Wrong For So Long, at the eyeforpharma.com site.

For ongoing AlignMap readers, this will be a new perspective on an old theme – the failure of the concept of patient compliance to provide reliable or valid information about a patient’s response to treatment recommendations.

Specifically, I compare the meager accomplishments in treatment adherence to the civilization-changing benefits produced in the field of epidemiology.

I also offer examples in which minor situational variations may – or may not – change ones assessment whether a given patient is compliant or noncompliant. The implicit question, of course, is how useful can the concept of compliance itself be if the significance of a patient being identified as compliant or noncompliant is nebulous.

About That Fish, The Barrel, And The Smoking Guns

Yeah, I know it seems like overkill, and it is, I admit,  a tad too easy to be enjoyable as a sport, but, after all, the current ideas about patient compliance have so far  been able to dodge bullets for decades and still survive.

More to the point,  this elaboration of the problems with patient compliance is necessary as explanation of and motivation for the changes essential for creating a functional alternative to the current thinking.

In the meantime, take a look at Patient Compliance – So Wrong For So Long if for no other reason than garnering inspiration from epidemiology’s successes and imagine what could be accomplished if we could make similar advances in patient compliance.