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It’s Magic! “Resolution 710 – Identifying Abusive, Hostile Or Non-Compliant Patients” Changed To Procedural Code Issue

OK – Resolution 710, proposed at the 2009 Annual Meeting of the American Medical Association,¹ was always technically a procedural coding issue. Heck, it’s not even an unusual sort of procedural coding issue.

The Non-Compliant Patient Coding Resolution Isn’t Quite As Bad As Some Folks Are Making  It Out To Be

The Resolution would have caused certain data to be collected in order to formulate new modifier and/or add-on  Current Procedural Terminology codes² to identify services provided for “Abusive, Hostile Or Non-Compliant Patients.”

Those modifier and/or add-on CPT codes could have two possible consequences:

1. Clinicians could use the new codes to modify their usual charges for a treatment because of the special circumstances (i.e., that the patients being served are “Abusive, Hostile Or Non-Compliant”).

This is nothing new or nefarious. Psychiatrists, for example, may charge different rates for 30 minutes of psychotherapy, depending on the setting and whether medical evaluations are included:

• Psychotherapy, 20-30 minutes; office/outpatient setting (CPT 90804)
• Psychotherapy, 20-30 minutes; office/outpatient setting with medical evaluations and management services (CPT 90805)
• Psychotherapy, 20-30 minutes; inpatient hospital, partial hospitalization or residential care setting (CPT 90816)
• Psychotherapy, inpatient hospital, partial hospitalization or residential care setting with medical evaluations and management services (CPT 90817).³
  

And, surgeons may legitimately charge more for an operation if there factors present which require substantially more work.

For example, because no CPT code exists for a revision of an arthroscopic anterior cruciate ligament (ACL) reconstruction, a physician may report CPT code 29888 (arthroscopically aided anterior cruciate ligament repair/augmentation or reconstruction) with a modifier 22. The documentation must support substantially greater work for the revision, such as increased time and technical difficulty associated with approach through adhesions/scar tissue, removal of hardware, or tendon grafting. In box 19 on the claim form, add a note that the modifier 22 supports a revision ACL with increased complexity.⁴

Resolution 710 could conceivably have led to modifier codes associated with higher compensation based on the altogether credible notion that providing some direct clinical services for “Abusive, Hostile Or Non-Compliant Patients” is more difficult than providing those same services for patients who are cooperative.⁵

It’s a bit like United Airlines charging extra for passengers too overweight to fit comfortably into an airplane seat. It may not be compassionate or humanitarian, but it can be justified on an economic basis. (It’s also worth noting that the existence of a CPT code or modifier does not mean an insurer, government agency, or individual patient will automatically honor it by paying higher fees.)

2. The new codes could lessen the impact of negative outomes on a clinician’s performance record.

Even more important than the money, however, is the concern that patients in these categories could make their physicians look bad.  This is, at least from my own hypervigilant perspective, an understandable concern. With everyone from the government to third party payors to consumer groups to rate-your-doc web sites collecting data on clinical performance, it’s easy to see how someone in the healing professions would worry about a treatment failure showing up on his or her record, not because of an error in prescribing treatment but because the patient didn’t follow instructions.

But The Non-Compliant Patient Coding Resolution Is Still Pretty Bad

First, I would have lots of questions about how “Non-Compliant Patient” would be defined, given that I have yet to find an acceptable all-encompassing definition of the term. Is anyone who misses an appointment non-compliant?  How about missing six of the last eleven appointments?⁶

Come to think of it, I’m not sure I can come up with a functional definition of “Abusive Patient” or “Hostile Patient” either.

But even as fundamental an issue as how one identifies these patients is, I suggest, secondary to the real problem.

The Real Problem – Nasty, Insulting Language

The real problem is the language and tone of the Resolution. The significant text of Resolution 710 begins

Whereas, Many patients are becoming more abusive and hostile toward physicians for many reasons not limited to the economy, increasing co-pays and deductibles, unreasonable expectations and demands, a lack of instantaneous cure, arrogance and/or the belief that they “own” their physicians;

As I noted in an earlier post, it really doesn’t get much better after that.

While I did not expect a ringing denunciation of this insulting-to-patients, embarrassing-to-doctors Resolution, I had thought it possible that a delegate would comment on the implicit message (you know, the one about “we hate patients”) conveyed by the document as presented, perhaps using filtering the criticism through the classic code so that it becomes, “The way it’s written now, it could be misinterpreted by others as insulting to patients even though I am sure Dr. Jones, who authored this Resolution, cares deeply for all his patients.”

Nope, Reference Committee G opted to mumble something about “concerns in labeling patients” and then  pass the problem to somebody else by implementing the classic technicality ploy – This isn’t my problem – this is his problem.

Here’s what happened, as excerpted from Report of Reference Committee G

RESOLUTION 710 – IDENTIFYING ABUSIVE, HOSTILE OR NON-COMPLIANT PATIENTS

Mr. Speaker, your Reference Committee recommends that Resolutions 710 not be adopted.

Resolution 710 asks that our AMA ask its CPT Editorial Panel to investigate for data collection and report back at Annual 2010 meeting:

1) developing a modifier for the E&M codes to identify non-compliant patients and/or
2) develop an add-on code to E&M codes to identify non-compliant patients.

Your Reference Committee heard limited supportive testimony on Resolution 710. The author stated that the intent of this resolution is to identify non-compliant patients, especially as there is an increasing focus on physician performance and releasing of physician data. Testimony was empathetic to the difficulty in working with non-compliant patients, but expressed concerns in labeling patients and acknowledged a desire to be sensitive to the possible mental health issues of non-compliant patients.

Testimony provided by the CPT Editorial Board stated that the appropriate forum for addressing CPT issues is through the CPT Editorial Panel process, not the House of Delegates. In addition, while there are no codes that exist to identify someone as specifically non-compliant, there are existing modifiers to identify patients who do not comply. For example, Modifier 2P (Performance Measure Exclusion Modifier Due to Patient Reasons) is available to report non-compliant patients. The list of reasons for Modifier 2P include (1) “patient declined”, (2) “economic, social, or religious reasons”, and (3) “other patient reasons”. This modifier is intended to be used with performance measure Category II codes. CPT Category II Performance Measurement codes are intended to facilitate data collection about the quality of care rendered by coding certain services and test results that support nationally established performance measures and that have an evidence base as contributing to quality patient care. These codes describe clinical components that may be typically included in evaluation and management services or clinical services and, therefore, do not have a relative value associated with them. Given that there exists an appropriate avenue to code for non-compliant patients and that this issue should be directly addressed through the CPT Editorial Panel, your Reference Committee recommends that Resolution 710 not be adopted.

Got that?  My unofficial translation follows:

Everybody knows that there are some patients so difficult that they make their doctors (and nurses and physician assistants and respiratory therapists and … ) miserable and they are capable of screwing up their own treatment. Everybody sane knows you can’t go around calling these patients nasty names. Besides, some of them have psychiatric problems, and no one wants to open that bag of worms.

Besides, the Resolution is a CPT issue.  This is the House of Delegates, not  the CPT committee. We aren’t the ones to deal with new CPT codes. In any case, there are already some codes that address these issues; they just don’t use the term, “Non-Compliant Patient,” thank goodness.

So, let’s put an end to this foolishness right now.  If the people pushing this loser want to pursue it, they can take it up with the CPT Editorial Panel.

I think I understand why this went down as it did, and I’m sympathetic to the internal  political demands the AMA and most such institutions face.

And, the Resolution was, happily, not adopted, so that’s good.

I believe, however, the AMA missed an opportunity to make it clear that the language of Resolution 710 is aberrant and does not reflect the medical community’s characterization of patients.

1. For background, see AMA Resolution On Non-Compliant Patients – What’s Up With That?↩
2. CPT codes “describes medical, surgical, and diagnostic services and is designed to communicate uniform information about medical services and procedures among physicians, coders, patients, accreditation organizations, and payers for administrative, financial, and analytical purposes.” From Wikipedia↩
3. From Answers to Common Questions About New CPT Psychotherapy Codes↩
4. From Modifier changes for 2008↩
5. Of course, I suspect I could make an equally persuasive economic case for patients paying reduced rates if they have to deal with an abusive, hostile, or noncooperative doctor.↩
6. See  Patient Compliance – So Wrong For So Long for a list of hair-splitting examples that illustrate the problem of defining noncompliance.↩

AlignMap In Cites, the tumblelog companion to this blog, offers succinctly annotated links to web sites and online material pertinent to treatment adherence.

Typically, these are brief news stories, videos of compliance enhancement devices, and summaries of treatment studies that require little explication.  In addition, AlignMap In Cites posts frequently include information sources from outside the healthcare sciences mainstream.

Some of the most recent AlignMap In Cites posts follow:

• Poison information specialists concerned about callers who don’t adhere to their advice
• A new Research Chair in Patient Adherence to Drug Therapy at the University of Saskatchewan
• A discussion of the legal and ethical aspects of withholding state of the art AIDS drugs from non-compliant patients
• An educational and behavioral change focused game promoting Adherence

Excerpts from and links to the most recent AlignMap In Cites posts are listed in the right sidebar.

In the preceding AlignMap post, AMA Resolution On Non-Compliant Patients – What’s Up With That?, I was critical of a proposed Resolution coming before the American Medical Association House Of Delegates bearing the subject line, “Identifying Abusive, Hostile or Non-Compliant Patients” and beginning

Whereas, Many patients are becoming more abusive and hostile toward physicians for many reasons not limited to the economy, increasing co-pays and deductibles, unreasonable expectations and demands, a lack of instantaneous cure, arrogance and/or the belief that they “own” their physicians;¹

And, it really doesn’t get much better after that.²

Seized this morning by an altogether atypical compulsion to be fair to the AMA,³ I found A Responsible Patient,⁴ an article by Swathi Arekapudi published in Virtual Mentor, which is published by the American Medical Association Journal Of Ethics.

This thoughtful piece addresses the term “non-compliant” in language parallel to that I used in Compliance Versus Adherence and Beyond – The War Of The Words, definitively establishing the wisdom of the author:⁵

The move from overt paternalism towards increased patient autonomy is illustrated by the change in the adjectives used by medical authorities over the course of a century to describe patients who do not follow medical advice. The terms evolved from the “vicious” and “ignorant” TB patients of the early 1900s, the “recalcitrant” after World War II, to the “non-compliant” patient that emerged in the 1970s. Ironically the term non-compliant, which was developed specifically to be a non-judgmental phrase, has been criticized for its implication that patients should necessarily follow physician recommendations. “Non-adherent” is suggested as a better term because its lacks the implication that patients must necessarily follow their physicians’ advice. No doubt this new term will face a slew of criticisms in time.

Even more pertinent to the AMA Resolution is the concluding section:

The modern patient-physician relationship is grounded in the autonomy of the patient and the need for the patient to make informed decisions. As we move away from the paternalism that formerly characterized patient-physician relationship, we see that active communication between the physician and the patient is invaluable in the patient’s informed decision making. The goal of a physician, namely to improve or maintain the health of his or her patients when possible, can be accomplished by increasing the number of patients who adhere to recommended therapy. Though collaboration and cooperation are necessary they do not necessarily put the physician and the patient on equal footing in terms of medical knowledge. But through a patient-physician relationship built on a mutual understanding of what is expected of the other, patients will be able to understand their role in their own health care. Though physicians can no longer “order” patients to follow medical instructions they must now educate patients about the medical consequences of accepting or refusing treatment. The best method for achieving the goal of patient health is open communication between physician and patient. Labeling a patient “difficult” or “non-compliant” will weaken the bond of communication between doctor and patient.

Being Fair

Despite the risk of losing my credibility as a blogger, I must admit that, while the language used and the ideas set forth in A Responsible Patient are especially well-constructed, they are otherwise far more representative of the professional literature, symposia, and AMA publications dealing with noncompliance I’ve read over the past 30-40 years than is the “Identifying Abusive, Hostile or Non-Compliant Patients” Resolution.

Further, all I know for certain about the AMA’s stance on this issue is that somebody in the Michigan delegation to the American Medical Association House Of Delegates thought this was a good idea and managed to get it to a vote of the House.

Even if, however, this embarrassment is voted down, I fear the publicity it has churned up will have negated much of the work the medical community has done in improving doctor-patient communication, the tone of which is reflected in A Responsible Patient.

This short article, well worth reading by clinicians and non-clinicians alike, is available without charge at A Responsible Patient.

1. The entire Resolution can be found at AMA Resolution On Non-Compliant Patients – What’s Up With That?↩
2. I was hoping the final paragraph would be something along the lines of “Fooled you. You’ve been punk’d.”↩
3. Full disclosure: I once belonged to the AMA. I can’t find my records, but my most recent payment of AMA dues was at least 10 years and probably closer to 20 years ago.↩
4. A Responsible Patient by Swathi Arekapudi. Virtual Mentor. April 2003, Volume 5, Number 4.↩
5. I’ve omitted references from the following  excerpts. Those footnotes are, of course, available in the original article that is available online.↩

In one of those instances of serendipity about which one hears so much, the AMA and I have each been independently engaged in changing the current perspective and policies on management of non-compliant patients.

Our proposals, it turns out, are not identical.

The result of my efforts today can be found in the preceding post, Beyond Patient Compliance: Patients Who Lie, in which I hold that

optimal treatment is most efficaciously pursued by aligning the doctor, the patient, and other stakeholders to maximize mutual trust, a strategy which takes priority over the percentage of prescribed pills taken by the patient.

The AMA Resolution

After hitting the “publish” button for that post, I checked  the patient compliance news alerts I  follow, only to discover that the American Medical Association House Of Delegates was considering Resolution 710, “Identifying Abusive, Hostile or Non-Compliant Patients,” which comes up for a vote tomorrow (June 16, 2009). The text of the resolution, taken from http://www.ama-assn.org/ama1/pub/upload/mm/475/refcomg.pdf, follows:

Resolution: 710 (A-09)
Introduced by: Michigan Delegation
Subject: Identifying Abusive, Hostile or Non-Compliant Patients
Referred to: Reference Committee G, (J. Leonard Lichtenfeld, MD, Chair)

_____________________________________

Whereas, Many patients are becoming more abusive and hostile toward physicians for many reasons not limited to the economy, increasing co-pays and deductibles, unreasonable expectations and demands, a lack of instantaneous cure, arrogance and/or the belief that they “own” their physicians; and

Whereas, There are decreasing numbers of physicians both in primary care and specialties especially in terms of access; and

Whereas, Increasing noncompliance with treatment can reflect negatively on physicians during black box audits by insurance companies and oversight governmental agencies; and

Whereas, Abusive, hostile, and noncompliant patients result in increasing office resources, adding to office overhead and added stress on all of the office personnel, which can lead to potential ill health; and

Whereas, The stress of dealing with ungrateful patients is adding to the stress of physicians leading to decreased physician satisfaction; and

Whereas, Any complaint to any oversight investigative regulatory body leads to uncompensated expenditure of time, resources, and monies to defend physicians or the “guilty until proven innocent” principal; and

Whereas, Physicians need to own the data to simplify patient collection and identification to defend themselves as well as alert outside investigating agencies to the potential nature of the patient’s records; therefore be it

RESOLVED: That our American Medical Association ask its CPT Editorial Panel to investigate for data collection and report back at Annual 2010 meeting: 1) developing a modifier for the E&M codes to identify non-compliant patients and/or 2) develop an add-on code to E&M codes to identify non-compliant patients. (Directive to Take Action)

Fiscal Note: Staff cost estimated at less than $500 to implement.
Received: 05/06/09

The Implications

I have little to say about the AMA’s Resolution, which seems all too straightforward. From others, however, there has been an  (understandably)  vehement  response to the AMA resolution.  Googling “AMA non-compliant patients” displays a  batch of these venomous criticisms of arrogant doctors.

I, of course, believe my ideas on non-compliance are far superior to  those implicit in this Resolution the AMA is considering. I’ll be publishing further posts in the near future outlining this  new vision that goes beyond Patient Compliance.

Meanwhile, I’m desperately hoping that there is an explanation for the AMA even considering a resolution that threatens, by its very language, to alienate doctors and patients, exacerbating rather than alleviating non-compliance.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The potential consequences, however, may be less apparent.

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

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

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

A Case Of Routine & Tragic Patient Noncompliance

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

Already in this scenario, noncompliance has resulted in

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

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

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

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

Patient Compliance Is A Self Defeating  Strategy

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

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

This realization led to what I then modestly called …

The Incredibly Revolutionary Idea

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

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

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

Storming The Bastille

The New Order Of Things – Replacing Patient Compliance

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

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

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

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

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

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

One option for managing patients who may be lying

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

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

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

Intercosmic Journal Of Treatment Side-Effectology

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

Articles

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

Patient shown operating  Visual
Side-effect Detection Modulator

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

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

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

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

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

About That Fish, The Barrel, And The Smoking Guns

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

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

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

I’ve been invited to post on the eyeforpharma.com site. In hopes of extending my audience, I’m giving it a shot.

This is a trial and error process. We’ll see how it works out.

The initial post can be viewed at The Tragedy Of Patient Compliance.¹

1. Because of the differences in formatting and use of graphics at eyeforpharma.com and AlignMap, I’m also considering reposting similar material to that I enter at eyeforpharma.com at AlignMap at the same time or a short time later.↩

The Emperor Views His New Clothes

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

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

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

The Emperor’s New Clothes And Patient Compliance

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

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

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

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

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

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

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

A Tentative Response

How about this for a rule of thumb:

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

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

The Role Of AlignMap

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

Upcoming AlignMap Series:

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

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

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

   ↩

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

Las Vegas, 1983

About Giles Brindley – Extreme Show & Tell

Professor Giles Brindley and his amazing presentation were the topics of an article, originally published at this site November 6, 2006. Today’s offering is a significantly revised version with additional information not previously available to me and, as far as I can determine, not available elsewhere in print or on the Internet. The update is found at Giles Brindley – Extreme Show & Tell.

The question now becomes, who is Giles Brindley and what could be so “amazing” about his presentation to warrant clicking on one more link to access that post?

Anticipating that AlignMap readers are of the discriminating ilk that would pose such a query, I have prepared a response, in the form of …

5 Reasons To Read Giles Brindley – Extreme Show & Tell

1. The opening lines of the post are not without a certain intrigue:

Answer:
Displaying One’s Erection As Part Of A Lecture At A Scientific Meeting
Question:
What Happens In Vegas That Doesn’t Stay In Vegas?

2. The central event, which takes place in Las Vegas during a medical society annual meeting, features (1) a farcical episode in which physicians and their spouses, dressed in formal attire, are beset with shock and awe by the sight of an exposed penis, (2) an important advance in basic physiology and the treatment of erectile dysfunction, and (3) a contribution to a major cultural shift.

3. A “logical bassoon” plays a role in the discussion (and not as an euphemism) , as do pole-vaulting (also not an euphemism), orienteering, visual neuroprosthetics (in the 1960s), ironically rare photos, and – yep, you guessed it – Leonard Cohen.

4. A major thrust of this post (the one with the exposed penis, Las Vegas setting, pole-vaulting, etc.) is to counterbalance the sensationalism of other reports of this episode.

5. Dr Klotz, the author of the definitive first hand account of Professor Brindley’s presentation, has generously written a laudatory afterword recommending the piece that I immodestly reproduce here:

In April 1983, I was a senior resident in the last few months of my residency training, and heavily focused on preparing for my upcoming qualifying exams. To top up my knowledge, I vowed to attend every session at the annual meeting of the American Urological Association that I could. That was the only reason that I attended the evening session of the Urodynamics Society, since urodynamics was not my primary interest. At that lecture, I was witness to a unique and historic experience. The lecture, at which Giles Brindley announced to the world his historic self-experiments in penile injection therapy, and demonstrated its effectiveness in a highly convincing way, has remained very fresh in my mind. The lecture rapidly took on a mythic quality in urologic circles. There were 2 reasons for this: a) Dr. Brindley’s courage and idiosyncracy in demonstrating the effects of penile injection on himself in a public forum, and b) the importance of his discovery. Penile injection therapy revolutionized the management of erectile dysfunction, and is widely used around the world.

Allan Showalter has written an extraordinary description of this extraordinary and unique individual. Dr. Brindley is one of a kind and he deserves to be remembered. Dr. Showalter has made a major contribution by portraying his multi-dimensional qualities. His article is wonderful.

Laurence Klotz
President, Canadian Urological Association

Again, today’s post can be found at

Giles Brindley – Extreme Show & Tell

Same Old Functions But It Does Look Slick

The Capshell, featured at the  Yanko Design Blog, operates much like the other automated pill dispensers:

The device records when medication is taken, and shows the user the correct intervals programmed by the pharmacist. If not activated at the correct time, the device sends an alert to the users phone via text, or “SMS.” Once in the grip of the user, it opens easily by turning round, revealing the opening corresponding with the time of day. This way of opening is helpful to the elderly, as it eliminates hard-to-open caps. Each days replacement tube is labeled clearly with text and with Braille numbering.

The packaging is, however, unique. The steel and gray containers seem a 1990s update of the venerable pneumatic tubes, a design dating to the early 1800s.

Pneumatic Tube used in some US post offices

Even the opening latch mechanism seems familiar.

Capshell

I am keeping the Capshell in mind. It should look great in Mom’s Manhattan pied-a-tier.

The Presentation

Compliance With Capecitabine Therapy Very High Among Swiss Cancer Patients: Presented at ASCO-GI ¹  summarizes a presentation of study results² made on January 17 at the American Society of Clinical Oncology’s 6th Gastrointestinal Cancers Symposium (ASCO-GI), cosponsored by the American Gastrointestinal Association Foundation, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

The findings are encouraging – but there is a caveat. Pertinent excerpts follow:

Patients who were prescribed oral capecitabine for treatment of breast or gastrointestinal (GI) cancer appear to be highly compliant in taking the oral medication, according to a study conducted in Switzerland.

… For the study, patients receiving capecitabine either as monotherapy or in combination with other chemotherapeutic agents recorded their daily capecitabine intake and any adverse effects on a diary. After completion of therapy for a maximum of 8 cycles, the data were transferred to a questionnaire in which the reasons for discontinuation were also collected.

…  Of the overall cohort, 91% took capecitabine as prescribed for the entire course of treatment. Reasons for interrupting therapy included forgetting to take treatment (56%), adverse effects (25%), and misunderstanding instructions (19%).

… Dr. Winterhalder said that the 16 patients who did make compliance errors included 9 instances in which the patients forgot to take the medicine. He said that despite the impressive compliance figures seen in the study, there are ways to improve the compliance further.

“Patient management systems such as patient diaries may further improve compliance and adherence with treatment,” he said during his poster presentation. “Compliance may be further improved by educating patients about how to recognise and manage treatment toxicities.”

Commentary Or What’s Wrong With This Premise?

Maybe I’m missing something, but I think this study declares that using a medication diary enhances compliance – based on compliance rates measured by the patients’ entries in a medication diary.

And, as far as I can determine, there is no control group for comparison.

Either the summary of this study is incomplete or the quality of the evidence must be considered suspect.

1. Compliance With Capecitabine Therapy Very High Among Swiss Cancer Patients: Presented at ASCO-GI By Ed Susman. Doctor’s Guide. January 19, 2009↩
2. Presentation title: Compliance With Capecitabine: Findings From a Prospective Cohort Analysis. Abstract 420↩