AlignMap

As he is wont to do, Dr. House asks the right diagnostic question; in this case, the diagnosis is unintentional noncompliance:

Credit Due Department: My friend and colleague, Lord of Leisure, alerted me to this video.

Shortly after publishing Patient Compliance And The F Word, my post about Jonathan Richman’s essay, The Only Way Pharma Can Improve Compliance: Fun, I serendipitously heard from Katrina Firlik, MD, who introduces herself as a neurosurgeon-turned-entrepreneur, now founder and chief medical officer of a new start-up in the medication adherence space: www.healthprize.net.

On checking that site, I found the above graphic (click on image to enlarge) which held out the promise of, as the title of this entry notes, “more adherence fun.”

Once is happenstance, twice is a trend, … one more linkage between compliance and fun and we’ll have ourselves a movement.¹

HealthPrize Technologies – Motivating Treatment Adherence With Incentives

I must admit that my immediate, automatic reaction to the HealthPrize Technologies site was a flinch.  Like most healthcare professionals, I am unaccustomed to seeing treatment adherence linked to winning prizes.

From the HealthPrize Technologies site:

It’s all based on the simple idea that people respond to two things: money and fun. So we’ve developed a system that links adherence-tracking technologies to a series of financial incentives, like points, prizes, and cash. And the better consumers are about taking their medication, the more chances they have to win and the more fun they’ll have.

Differing opinions about the appropriateness of offering incentives for compliance with healthcare regimens is hardly a new topic. A partial list of AlignMap posts on this issue includes

• Cash For Compliance & Other Ethical Dilemmas
• Cash For Compliance – Benefit or Bribe?
• Shopping Discounts As Incentives For HIV Screening Compliance
• Incentives To Enhance Compliance With Addiction Treatment
• Automated Incentives For Medication Adherence
• Monetary Incentives To Decrease Obesity
• Another Case Of Cash For Compliance
• Recurrent Themes: Health Literacy & Incentives

The contentiousness triggered by this methodology has more to do with cultural, philosophical, and ethical concerns than pragmatic results. There is an impressive amount of evidence that supports the notion that fiscally based incentives (e.g., cash, coupons, and merchandise) can increase rates of treatment adherence.

Currently, an odd dichotomy of opinions on the matter exists. There is relatively little criticism heard, for example, about  corporate wellness programs offering  prizes and other incentives to obese participants who lose weight or to tobacco-using participants who are able to stop smoking. Offering those same prizes or similar incentives, however, to participants for following a prescribed medication regimen or undergoing indicated medical screenings is likely to result in charges of unethical behavior, mind control, and disreputable motives.

Given that some bioethicists insist that only an absolutely neutral presentation of treatment options to patients is acceptable, the idea of offering prizes for executing a course of treatment is sure to result in controversy.

For my part, incentives seem one more tactic that has been shown to enhance treatment adherence in some patients. In that sense, it falls in the same category as reminders, the use of pill boxes or automated medication dispensers, regimen simplification, adding a second medication to ameliorate the primary drug’s side, educating the patient about the workings of the medication, …

The key ethical issue would seem to be distinguishing the use of incentives to drive the behaviors necessary to execute a prescribed treatment from the use of incentives to drive the mindless ingestion of one pill or another.

My (slightly paraphrased) summary from  Patient Compliance And The F Word about the importance of fun as a motivator  fits the aggressive incentivisation practiced by HealthPrize Technologies as well:

1. It’s important because incentives have been shown to be effective for a significant number of patients (albeit not all)
2. 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 that has only been used on a limited scale, such as incentives, is astutely logical.
3. 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.

I cannot predict how effective this particular take on using incentives to improve treatment adherence will be clinically, and I certainly have no idea if  HealthPrize Technologies will prove a commercial success. It does seem, however, that adding a potentially useful, currently unavailable weapon to combat certain kinds of unintentional noncompliance to our clinical armamentarium could be – well, fun.

1. Actually, we may already have more than three such instances linking compliance to fun. See Celebrating Compliance and Compliance Enhancement: Party, Pedicure, and Potables↩

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 fourth 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.

Previous Steps follow:

1. Always provide context-pertinent definitions of Patient Compliance terminology
2. Differentiate between unintentional and intentional noncompliance
3. Support compliance claims

Don’t say “Adherence” when you mean “Brand Loyalty”

“Compliance,”¹ if it is to have useful significance as a term, cannot be used as code for “selling more medication X.”²

A helpful rule of thumb follows:

If an alleged Medication Compliance Program applies to only one drug  or one small group of drugs, all produced by the same manufacturer,  what you’ve got yourself there is not a Medication Compliance Program but a Brand Loyalty Program.

A Medication Compliance Program is concerned with all the medications in a patient’s regimen; eliminating or replacing a given medications from a patient’s regimen does not disqualify a patient from participation in a Medication Compliance Program.³

Again, I am enough of a believer in free market theory that I don’t seek to ban Brand Loyalty Programs for pharmaceuticals as long as the programs do not promote the inappropriate prescription or continuation of the medications on which they focus – and the intent of the Program (i.e., to sell more doses of Medication X) is made transparent to doctors and patients.

That one can certainly devise a lexicographical rationale for using “compliance,” “adherence,” and similar terms in association with Brand Loyalty Programs does not mitigate the ongoing confusion about the concept of compliance.

It’s simply a matter of clarity and trust.

1. In this post, “Compliance” and “Adherence” are used interchangeably↩
2. I hasten to add that I have no problem with the notion of selling more medication X. It’s one of my favorite pharmaceutical agents, useful for any number of ailments and almost devoid of side-effects. I object only to its marketing being confused with medication compliance.↩
3. The exception, of course, is a single-agent Medication Compliance Program that concerns treatment deemed so essential that its proper execution warrants special adherence protocols (e.g., DOT in the case of tuberculosis treatment).  One supposes that a Medication Compliance Program could also legitimately focus on a single given medication with inherent qualities, such as a particularly complex dosing schedule or overwhelmingly noxious side-effects, that rendered adherence especially difficult. I have, however, yet to find a Medication Compliance Program for a single drug that described its intent in that manner or its drug of focus in those terms↩

The How To Fix Patient Compliance Now Series

This is the third 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.

Previous Steps follow:

1. Always provide context-pertinent definitions of Patient Compliance terminology
2. Differentiate between unintentional and intentional noncompliance

Step #3. Support compliance claims

AKA Back it up or shut it up
AKA Don’t claim it if you can’t name it

Claims that, for example, medication compliance will be or has been improved by a new drug or the use of an automated reminder service has achieved X% adherence rate for participation in a disease screening program exam, must be accompanied by evidence.

Not doing so could mislead a naive audience; even worse, claims made without evidence to a more knowledgeable (or more cynical) audience may well play a role in making the entire field dealing with treatment adherence suspect. After all, if  retailers of compliance enhancements, developers of a specific compliance model,  and adherence promotions run by third party payers, pharmaceutical manufacturers, and independent firms boast of compliance rates so high they would mark a major breakthrough in the field but provide no support or only allude to vaguely defined “studies” that, if existent, can’t be found, readers and viewers will (and should) be suspicious of compliance claims in general.

An Example From Real Life

When a medication adherence program  administered under the imprimatur of a major health insurer claims a 95% compliance rate for treatments that typically carry a significantly lower rate of adherence, their press releases, especially those directed to clinicians, are, I contend, obligated to show the evidence. Was there a blind study with a control group? How was the rate calculated? If there was a study, was it run by an independent party or was it done internally?  Without that basic information, the claim of a 95% compliance rate is little more than puffery.

That my repeated emails to the program director asking for this information receive no response is, unfortunately, all too typical and tends to abet my suspicions that something is being hidden.

Proprietary Is Not A Magic Word

I’ve been involved in enough business matters to understand the value of trade secrets and necessity of not revealing proprietary information.

On the other hand, I also know the difference between abracadabra and proprietary.  And, I know there is something fundamentally wrong about declaring that the substance of a proprietary study must be kept secret while simultaneously claiming the alleged findings from that same study as evidence that a given compliance intervention or program is successful.

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↩

According to the Wall Street Journal article, UnitedHealth To Give Discounts For Adhering To Prescriptions,¹ UnitedHealth will offer

$20 discounts off monthly co-pays for members who refill certain prescriptions within about 30 days after the last prescription runs out – essentially rewarding patients for adhering to treatment plans,

The pilot program applies to only certain medications for asthma and depression and cannot be used for the initial prescription.

While the article speculates that program is triggered by “the weak economy has caused consumers to put off filling prescriptions or switch to cheaper generics,” the decrease or elimination of co-pays in return for high adherence made sense long before the current fiscal crisis erupted and is, in fact, a recommendation I have made for years.

Aligning the mutual interests of the patient, the payer, the pharmaceutical companies, and the clinicians is the key to enhanced compliance rates. Using a discount on medication costs as a financial incentive to effect this alignment is a great start.

I’ll be eager to see the results.

1. Peter Loftus, UnitedHealth To Give Discounts For Adhering To Prescriptions, Wall Street Journal. August 27, 2009↩

My most recent post, dealing with  profiling (segmentation) as it is used in the credit card industry and its potential applications to treatment implementation, can be found on the eyeforpharma.com site at The Potential Power Of Patient Profiling

Epiphany Du Jour – Training To Be An Effective Patient That Begins Post-Diagnosis Begins Too Late¹

Question #1: What is the likelihood that an individual reaching  adulthood in the US will eventually find himself or herself in the role of a patient?
Answer #1: Almost certain, according to my calculations.²

Question #2: When and how does one typically learn to how to operate effectively in the patient role?
Answer #2: While  learning to operate in the patient role theoretically takes place whenever one visits a clinician for any reason, that process, which could charitably be called “learning by doing,” is a hit or miss affair that routinely receives little attention until one is concerned about the possibility of or diagnosed with an anxiety-provoking disorder.³

Question #3: What is the worst possible way and the worst possible time to learn to operate effectively in the patient role?
Answer #3: See Answer #2.

A Illustrative Scenario

Consider this example: An asymptomatic,  intelligent 34 year old woman with only minor interactions previously with organized medicine is diagnosed with breast cancer during a routine exam.  Her doctor informs her (accurately) that any delay in treatment increases her risk. She is immediately faced with the decision of whether or not to follow the primary recommendation for surgical intervention and, if she agrees, which of the 2-4 possible procedures she wishes.  If she declines  the surgical procedures, she must decide which, if any, of the alternative treatments she will undergo. She also has to deal with the impact the diagnosis and treatment will have on her spouse, her children,  her job, her friends, and her extended family.

This is, I submit, a suboptimal situation for learning to be an effective patient, the intensity of ones motivation notwithstanding.

The Solution – Teaching How To Be An Effective Patient In The K-12 Curriculum

An explicit goal of elementary, middle, and high schools is preparing children to undertake  adult tasks. Thus, in addition to  learning basic math, writing methodology, and reading comprehension, students also take courses in sex  education, nutrition, consumer skills, and managing relationships.

Learning the skills necessary to be an effective patient, such as what to expect from, how to communicate with, and when to seek help from healthcare professionals, how to understand medical reports, pharmaceutical ads, and other pertinent printed and online literature, … , is at least as important as learning about the risks of unprotected sex or the need to save a portion of ones paycheck against future needs.

Making “How To Be An Effective Patient”  part of the K-12 school Health curriculum is no panacea, but it seems a rational and promising alternative that is likely to substantially improve the current “just too late” methodology.⁴

Credit Due Department: The photo portrait atop this post was taken by Bhernandez. The schoolroom photo was taken by Rob Shenk

1. Author’s Note: Patient Effectiveness Training is part and parcel of the system I (ambiguously) envision as a replacement for the current, non-functioning patient compliance model. The focus of this piece, that such training should take be part of the public education curriculum, is, admittedly, a tangent, and I am willing to stipulate that I am devoting a post to the notion less because of its impact on treatment adherence rates (although that impact could be significant) than because I think it’s a clever, useful idea. … and, it’s my blog.↩
2. Almost all of us who make it to adulthood in the US (or Canada or Britain or Germany or Scandinavia, …) will sooner or later be a patient. The exceptions are at most a tiny fraction of the population: those who consciously and conscientiously  avoid doctors because of reasoned principles, irrational fears, religious beliefs, cultural mores, or psychological disorders and also manage to avoid membership in organizations such as the armed forces that insist on involvement by clinicians and remain  healthy enough that they are not forced into healthcare (e.g., taken in an unconscious state secondary to a cardiovascular accident  into an emergency department) until they die.↩
3. In addition, there are educational processes that are even more sporadic and variable in quality: individuals may, for example, read articles about “how to be a good patient,” attend a workshop at the local hospital about “how to communicate with your doctor,” or receive information through various ad campaigns recommending that viewers ask their doctor about using one or another medication.↩
4. This is one of those ideas that seems so obvious that one assumes it is being done already. And maybe it is, but I can’t find any discussion of it.↩

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.↩