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Beyond Compliance, Adherence, & Concordance – Supporting The Patient’s Implementation Of Optimal Treatment

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The Must-See Medication Reminder Video

April 22nd, 2010 at 5:56 pm · Allan Showalter, MD · Enhancements

The Context-Aware Pill Bottle and Medication Monitor Video – Great Without Glitz

There is nothing technologically unique about the Context-Aware Pill Bottle and Medication Monitor (an accurate but not  euphonious and decidedly not catchy name) from the University of Calgary, and there is certainly nothing slick in the production values of the video  about that appliance. Yet, it  is indeed a must-see presentation.

The first portion of the video, which explains the intent, positive effects,  and workings of the mechanism, will appear familiar to anyone who has seen promotions for medication dispensers/reminders, but the portion that follows the “Critique” heading enters uncharted territory to those who don’t routinely attend research meetings. It is during this critique, you see, that the same individual who presented all the benefits of the device discusses possible flaws in its design. The informative critique is not only enlightening but also heartening.

Of course, this is a video version of a research paper. One shouldn’t expect an ad agency to suggest the same sort of balanced presentation to a client trying to sell a product.

Still, one can dream.

The Context-Aware Pill Bottle and Medication Monitor1, May. Video and two page paper, duration 3:58. Also as Report 2004-752-17, May.))

Abstract: The video illustrates and critiques a context-aware pill bottle/stand that reminds the elderly when it is time to take their medication. A medication monitor situated in a caregiver’s home displays awareness information about the elderly user’s medication compliance.

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  1. Agarawala, A., Greenberg, S. and Ho, G. (2004). The Context-Aware Pill Bottle and Medication Monitor. In Video Proceedings / Proceedings Supplement of the UBICOMP 2004 Conference. ((September 7-10, Nottingham, England

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Where Do Babies Come From? Turns Out Quite A Few Come From Adherence Failure

April 21st, 2010 at 8:02 am · Allan Showalter, MD · Noncompliance, Public Health

Half Of US Pregnancies Unintended

An article in the  Health Journal portion of the 20 April 2010 Wall Street Journal, The Birth-Control Riddle by Melinda Beck, offers these impressive statistics regarding unintended pregnancies:

Almost half of all pregnancies in the U.S.—some 3.1 million a year—are unintended, according to the most recent government survey, from 2001.1 One out of every two American women aged 15 to 44 has at least one unplanned pregnancy in her lifetime. Among unmarried women in their 20s, seven out of 10 pregnancies are unplanned.

While the causes of the problem may be, as the article’s title indicates, a riddle, its mechanics  are not:

Almost half (48%) of unintended pregnancies involve contraceptive failures. In 52% of cases, couples used no birth control at all. Cost is a factor for some of them. Even though most insurers now cover contraceptives, co-pays and deductibles can still present obstacles.

And many young people are in “the fog zone” in which their beliefs about pregnancy don’t match their behaviors, according to a 2009 report by the National Campaign to End Teen and Unplanned Pregnancy. In a survey conducted by the Guttmacher Institute of 1,800 single men and women aged 18 to 29, more than 80% of both sexes said it was important to them to avoid pregnancy right now, yet 43% of those who are sexually active said they used no contraception or used it inconsistently.

The following chart from the CDC (not in the WSJ article) offers confirmation of the premise that most couple incidents of unintended pregnancy were the result of not using any contraceptives.

CDC Data

The CDC 2002 PRAMS Surveillance Report: Multistate Exhibits – Unintended Pregnancy and Contraceptive Use also provides these sobering indicators that the problem is not lessening:2

In 2002, among women who reported that their pregnancy was unintended, the prevalence of contraceptive (any method) use at the time of pregnancy ranged from 38.7% (Hawaii) to 53.3% (Vermont).

During 2000–2002, the prevalence of contraceptive (any method) use at the time of pregnancy among women with an unintended pregnancy decreased in 4 states (Florida, New Mexico, New York, and North Carolina).

Education And Technology As Solutions

After delineating the problem, the article  (The Birth-Control Riddle) notes,

Some population experts say the rates of unintended pregnancy would be far lower if more women used IUDs and implants that prevent pregnancy for years at a time. Only about 3% of American women currently do.

“There are terrible misperceptions about these methods— and about all forms of contraception,” says James Trussell, director of the Office of Population Research at Princeton University.

Many traditional forms of contraception have been updated in recent years. Here’s a look at the latest developments: …

A summary of the pros and cons of various contraceptive methodologies, under the headings, The New IUDs, The Implant , Hormone Pills, Patches And Rings,Condoms, Caps And Sponges, Emergency Contraception, Permanent Birth Control, and Vasectomy Variations, completes the piece.

The Problem With Education And Technology As Solutions To Noncompliance

The advancements in effectiveness, safety, and ease of use of contraceptive technology are important and may well trigger incremental improvements in the rate of use of these methods. Nonetheless, the emphasis on improved technology begs the question of why none of the previously available, well publicized contraceptive methods (e.g., birth control pills, abstinence, diaphragms) were used in half of all unintended pregnancies.

And, educating patients beyond the basics  (i.e., the instructions for safe and effective treatment implementation and a simple explanation of how the medication, diet, surgical procedure, etc. works) has rarely proved successful in significantly ameliorating noncompliance.

The most problematic aspect of the focus on education and technology, however, is that it distracts from other possible factors, including the cultural, socioeconomic, and psychological issues that may prevent a woman and her partner from using any contraceptive method regardless of their understanding or appreciation of the technology.

Given that unintended pregnancy has been shown to influence a woman’s behavior and experiences during pregnancy and in the post-natal period  to the detriment of  the health of her infant, this is a noncompliance problem that merits a more inclusive response than appeals for more education and tbetter technology, however worthy those  efforts may themselves be.

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  1. The same article goes on to note: “An updated version of those numbers from the 2006 National Survey of Family Growth is expected to be released next month. But population experts don’t anticipate much change; the rate of unplanned pregnancy was the same in 1994, and smaller studies have found that even newer birth control methods haven’t made much of a dent.”
  2. Note: PRAMS data is not collected in all states. In 1999, for example, data was collected in 17 states: Alabama, Alaska, Arkansas, Colorado, Florida, Illinois, Louisiana, Maine, New Mexico, New York, North Carolina, Ohio, Oklahoma, South Carolina, Utah, Washington, and West Virginia

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A Review Of Treatment Adherence 2010 – Final Section Now Online

April 20th, 2010 at 9:30 am · Allan Showalter, MD · Transforming Compliance

As promised in A Review Of Treatment Adherence – 2010, Part 2 of the summary review of patient noncompliance is now live on pharmaphorum at Rethinking patient noncompliance (Part 2).

As before, I am posting only the major headings from the piece here.

Patient noncompliance: Misunderstood concept – ineffective solutions

Development of an effective methodology for managing patient noncompliance remains unlikely as long as the strategies being investigated are limited to those already shown to be ineffective.
Key Point: Noncompliance is not exclusively a medical issue but a personality trait that manifests in many areas of life. Treating patient compliance as though it’s a straightforward, sui generis phenomenon independent of other human behavior all but eliminates the potential for significant advances in the field.

Employing a Copernican perspective to find compliance solutions that work

  1. Do away with the restrictions implicit in the contention that healthcare compliance is unique.
  2. Change the compliance game from clinician vs. patient to clinician & patient vs. problem being treated

Readers interested in the complete paper can find it at Rethinking patient noncompliance (Part 2).

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A Review Of Treatment Adherence – 2010

April 14th, 2010 at 7:10 am · Allan Showalter, MD · Transforming Compliance

Rethinking Patient Noncompliance – Again

Once more unto the breach, dear friends, once more1

Paul Tunnah, founder of pharmaphorum, an online pharma discussion and networking site, invited me to submit an overview of patient noncompliance. The first portion of that paper was published today at Rethinking patient noncompliance (Part 1).

While those who have followed my efforts on AlignMap will find little that is surprising, the article does, I think, offer a coherent, condensed summary of the current, problematic status of treatment adherence.  The main points, sans discussion, follow:

The Dysfunctional Concept Of Patient Compliance

1. Patient compliance, as described by its standard definition, is a useful statistical measure but an inadequate and often counterproductive explanatory concept.
Key Point: The term patient noncompliance, by definition, is no more than a descriptive label given to a phenomenon and indicates nothing about the cause of that phenomenon.

2. Noncompliance leads to inadequate implementation of treatment recommendations, which itself leads to devastating economic and personal consequences.
Key Point: Characterizing the financial, physiological, and social costs of patient noncompliance as catastrophic is neither hyperbole nor hysteria, just fact.

3. Patient noncompliance is, by any measure and from any perspective, pervasive and difficult to detect.
Key Point: While patient compliance varies, a reasonable expectation, absent evidence to the contrary, is an average compliance rate of 50%.

4. No practical methodology has been shown to significantly, reliably, and enduringly enhances compliance for a diverse patient population.
Key Point: Many methodologies designed to enhance compliance are effective – for some patients some of the time; none of these methodologies are effective for most patients most of the time. Further, no methodologies have been demonstrated to predict which patients will and will not follow treatment recommendations or which patients will respond to which compliance enhancement techniques.

Solutions, AKA Coming Attractions

A new perspective on treatment adherence that offers potential solutions is the focus of Part 2 of Rethinking Patient Noncompliance, which will be published at pharmaphorum next week.

Part 1 of this piece is available now, in its entirety, at Rethinking patient noncompliance (Part 1).

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  1. “King Henry V” by William Shakespeare: Act 3. Scene I

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House, MD Uncovers Patient Noncompliance

November 22nd, 2009 at 3:00 pm · Allan Showalter, MD · Bagatelles

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.

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More Adherence Fun – HealthPrize Technologies

October 29th, 2009 at 8:41 am · Allan Showalter, MD · Enhancements

healthprize2

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

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.

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  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

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Patient Compliance And The F Word

October 20th, 2009 at 8:31 am · Allan Showalter, MD · Transforming Compliance

adland

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

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  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

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How To Make The Patient Compliance Concept More Useful NOW – Step #4. Don't Say "Adherence" When You Mean "Brand Loyalty"

October 19th, 2009 at 10:42 am · Allan Showalter, MD · AlignMap Web

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.

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  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

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How To Make The Patient Compliance Concept More Useful NOW – Step #3. Support Compliance Claims

October 1st, 2009 at 10:37 am · Allan Showalter, MD · Transforming Compliance

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.


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How To Make The Patient Compliance Concept More Useful NOW – Step #2. Differentiate Between Unintentional And Intentional Noncompliance

September 28th, 2009 at 8:51 pm · Allan Showalter, MD · Transforming 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.

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How To Fix Patient Compliance Now – Practical Steps To Rehabilitate The Concept Of Adherence

September 22nd, 2009 at 9:09 pm · Allan Showalter, MD · Transforming Compliance

manifesto

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.

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  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.

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Patient Compliance And Behavioral Economics

September 3rd, 2009 at 11:52 am · Allan Showalter, MD · Basics, Decision-Making, Ethics

tup-party

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.

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  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

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