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

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

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

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

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

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

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

Back To The Tupperware Party

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

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

The Reciprocity Effect

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

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

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

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

Quoting Cialdini,

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

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

The Ethics Of Persuasion In Clinical Care

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

Patient Compliance And Tupperware Parties

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

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

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

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

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

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

Nocebo-Effect Noncompliance: When Telling The Patient Enough May Be Too Much

Power of Suggestion: When Drug Labels Make You Sick¹ is an article on  placebo and nocebo effects,² the sort of piece that appears regularly in the popular press,with little to surprise anyone familiar with clinical practice.  It is, however, a useful stepping-off point for a consideration of the impact a clinician’s manner of imparting information about treatment to a patient has on that patient’s response to the treatment and, inevitably, that patient’s adherence to the prescribed treatment regimen.

The following excerpts contain the core issues:

Research has shown that expecting to feel ill can bring illness on in some instances, particularly when stress is involved. The technical term is the “nocebo effect,” and it’s placebo’s evil twin. “It’s not a psychiatric disorder — it’s the way the mind works,” says Arthur Barsky, director of Psychiatric Research at Brigham and Women’s Hospital in Boston.

… in one 1960s test, when hospital patients were given sugar water and told it would make them vomit, 80% of them did. Studies have also shown that patients forewarned about possible side effects are more likely to encounter them. In a study last year at the University of Turin, Italy, men taking finesteride for enlarged prostates who were informed that it could cause erectile dysfunction and decreased libido were three times as likely to experience such side effects as men who weren’t told.

… Doctors may unwittingly foster placebo or nocebo effects by how enthusiastically or warily they discuss medication. “Physician communication with patients is the closest thing to magic. It gets communicated in incredibly subtle ways—a flash in the eye, a smile, a spring in the step,” says Daniel Moerman, an emeritus professor of anthropology at the University of Michigan-Dearborn. Doctors may also subconsciously transmit an expectation of pain. In a double-blind study of 60 patients who had wisdom teeth extracted, when clinicians thought they might be administering a medication that could heighten the pain instead of lessen it, the patients reported much more pain—even though they were really receiving placebos.

Should doctors discuss all those risks with patients, or can they be a self-fulfilling prophecy? It depends on the patient and the drug. “Patients should be made aware of anything that could be dangerous, so they don’t keel over on the street,” says Flavia Golden, an internist in New York City. “But if it’s minor like a headache, I don’t mention it. It’s better to keep the channels of communication open and say, ‘Call me if you have any problems.’ “

Patient-Clinician Interaction, Treatment Recommendations, Nocebo Effect, and Adherence

For the purposes of this exercise, I ask readers to stipulate that (1) the placebo and nocebo effects operate as described in the excerpts and can cause some patients to suffer significantly negative symptoms and (2) a significant number of patients will not follow a recommended treatment regimen if they suffer those significantly negative symptoms.

Now, you’re the physician recommending medication XYZ to your patient (as long as we’re stipulating, let’s also stipulate that this is the optimal medication for this patient, who will be 5 times more likely to recover from the affliction being treated than would be the case if a placebo were taken). Like most medications, there is a reasonable chance XYZ will cause some minor side-effects in a large fraction of patients and a relatively small chance it will cause a severe side-effects in a few patients.

The question is what you tell the patient and how you tell the patient about about (1) the likelihood of a favorable outcome and (2) the side-effects, including which side-effects (all, none, some) and the likelihood of those side-effects.

Keep in mind that, because of the placebo and nocebo effects, an optimistic appraisal of the outcome delivered enthusiastically is likely to cause some patients to achieve that outcome and encourage the patient to pursue the recommended treatment. Similarly, every side-effect you list for some patients will increase the likelihood they will suffer that side-effect and, as a result, increase the risk they will terminate the treatment. Of course, you can modulate that effect by how you describe the chances the side-effect will occur or how severe it may be.

It’s important to understand that the information you offer is not benign. The choice you make to tell your 100 patients taking drug XYZ that it can cause debilitating fatigue means, taking the nocebo effect into account, that some of those patients who would not have suffered debilitating fatigue will do so only because you chose to tell them about this potential side-effect. Further, some of those affected by this side-effect may well refuse to continue drug XYZ because they may think debilitating fatigue is worse than their original ailment, i.e. some patients will drop out of their optimal treatment plan only because you chose to tell them about this potential side-effect.

Are you proud of yourself?

Of course, you could decide not to tell any of them about the risk of debilitating fatigue. That’s fine – if you don’t mind hiding potentially important information from your patients and, in the process, perhaps violating ethical canons. Heck, if there is a hot shot plaintiff’s lawyer involved, you may find a jury of 12 of your peers have decided you’ve committed malpractice by not providing informed consent.

Naturally, you believe the patient must always be a partner on the clinical team so you can’t revert to the paternalistic Dr. Welby methodology of telling each patient only what you think that particular patient needs to know. And, to be fair, even if you were into retro-medical practice, unless you’re a TV doctor with good scriptwriters you won’t have more than a hunch which patients you should tell what.

Incidentally, that bit in the excerpt, “But if it’s minor like a headache, I don’t mention it. It’s better to keep the channels of communication open and say, ‘Call me if you have any problems,’ ” works better as a sound bite than as a general practice. It turns out that lots of patients are seriously miffed when they discover from the doctor taking call for you over the weekend that the headache that kept them from going to Thanksgiving dinner was a side-effect you knew could happen but chose not to tell them.³

Notice that the decision about how to inform a patient about the side-effects of a prescribed medication resolves rather straightforwardly into a forced choice about how you will manipulate the patient. Because of the placebo-nocebo effects, the reaction of some patients (and, no, you can’t tell which ones) to data, even when its transmission is seemingly neutral, is dramatically distorted. Consequently, what the clinician chooses to tell – or chooses not to tell – a patient about the side-effects of a single medication has a necessarily exaggerated impact (at least for a large number of patients), making that task, that may take place a dozen times in a morning clinic, incredibly challenging. Discussing a complex, comprehensive treatment plan for a disorder like diabetes is exponentially more difficult.

The Answer

Hey, don’t look at me – I’ve been trying to figure this out for 25 years.

The only answer I’ve come up with so far is the same declaration that opens this post:

Clinicians can choose how, not if,
they influence patient compliance

1. Power of Suggestion: When Drug Labels Make You Sick  by Melinda Beck. WSJ November 18, 2008.↩
2. A convincing argument can be made that the terms, “placebo effect” and “nocebo effect,” as they are used in the referenced article and in this post are ambiguous and counterproductive, but this is beyond the scope of today’s effort. See Stewart-Williams, S. & Podd, J., “The Placebo Effect: Dissolving the Expectancy Versus Conditioning Debate”, Psychological Bulletin, Vol.130, No.2, (March 2004), pp.324-340.↩
3. I suspect the doctor quoted would agree that this is not a one size fits all sort of tactic. Quotes for articles in the lay press are seldom complete and typically are lifted out of context.↩

Source:
Integrity outranks patient compliance
By Howard Brody. Galveston Daily News. September 11, 2007

Dr Brody’s Judgment Of Other Physicians

This article is Dr. Howard Brody’s jeremiad on the lack of ethical integrity among physicians – despite his own efforts to imbue the profession with sound moral values.¹ As the sole evidence of this lamentable state of affairs, Dr. Brody points to a survey of physicians and patients attitudes undertaken by Consumer Reports earlier this year. The essence of his argument is summarized in this excerpt from the beginning of his essay:

For many years, folks like me have been teaching ethics courses in medical school. Lesson One is usually the concept of “patient autonomy.” That idea is captured in the common phrase: “Whose life (or body) is it anyway?” So long as the patient is reasonably sane and competent, it should be her choice whether to have surgery or to undergo any medical treatment. As much as we might believe that the patient is making a serious mistake, we docs should not be able to order a patient to take a treatment.

It seems that no one has been listening. The February issue of Consumer Reports had a survey of 39,000 patients and 335 docs. Each was asked what they liked, and didn’t like, about the other. The docs’ biggest gripe (59 percent) was noncompliant patients — those who wouldn’t take their medicines as prescribed.

Now, if “patient autonomy” is a core ethical value in medicine, it follows logically that there cannot be any such thing as a “noncompliant” patient. “Compliance” assumes that the patient ought to do what the doctor says. But we teach in ethics class that it should be the patient’s free choice.

My Judgment of Dr. Brody’s Judgment

Dr. Brody’s contention, as I understand it, is that the concept of a noncompliant patient and the belief in patient autonomy as a fundamental element of the philosophy of medicine are mutually exclusive because “patient autonomy” (Dr. Brody’s quotation marks) means that “it [presumably, what a patient ought to do] should be the patient’s free choice.”

This line of reasoning presupposes that every instance of a patient’s healthcare behavior that is incongruent with the recommended behavior is the result of a patient’s conscious decision not to follow that recommendation. That is certainly not explicit or implicit in the definition of noncompliance routinely used in the medical literature or, at least in my experience, in formal or informal conversations between clinical personnel.

The discussion of the meaning of compliance in Interventions to Enhance Patient Adherence to Medication Prescriptions, a review by McDonald and colleagues published in JAMA in 2002,² is instructive. I’ve chosen this article from a plethora of pieces containing nearly identical definitions of patient compliance because its use of “compliance” and similar terms is characteristic of scores of other articles, it is extensively referenced, and the entire article is available online without cost. The following excerpt³ is relevant:

Adherence may be defined as the extent to which a patient’s behavior (in terms of taking medication, following a diet, modifying habits, or attending clinics) coincides with medical or health advice. If a patient is prescribed an antibiotic for an infection to be taken as 1 tablet 4 times a day for a week but takes only 2 tablets a day for 5 days, the adherence would be 36% (10/28). The term adherence is intended to be nonjudgmental, a statement of fact rather than of blame of the prescriber, patient, or treatment. Compliance and concordance are synonyms for adherence. [emphasis mine]

This simple definition of adherence belies the difficulties that many medical regimens present for patients. For example, the regimen described for type 2 diabetes mellitus in a previous article includes a special diet, increased exercise, smoking cessation, oral hypoglycemic drugs, and risk factor management, usually involving additional drugs. Such regimens fulfill theoretical, physiological, and empirical considerations about optimal care, while ignoring practical patient-centered concerns, such as the nature, nurture, culture, and stereotyping of the patient, and the inconvenience, cost, and adverse effects of the treatment. Indeed, low adherence with prescribed treatments is very common. Typical adherence rates for prescribed medications are about 50% with a range of 0% to more than 100%.

At a theoretical level, the nature and determinants of noncompliant behavior are complex and not well understood, although there are interesting models. The following generalizations stem from numerous studies of the determinants of adherence. Compliance has little relation to sociodemographic factors such as age, sex, race, intelligence, and education. Also, although low adherence is a problem with self-administered treatments for all disorders, patients with psychiatric problems are less likely to comply and those with physical disabilities caused by the disease are more likely to comply. In addition, patients tend to miss appointments and drop out of care when there are long waiting times at clinics or long time lapses between appointments. Finally, adherence decreases as the complexity, cost, and duration of the regimen increase.

In more informal terms, noncompliance, as the term is commonly used, takes place when the patient’s actual behavior differs significantly from the prescribed treatment plan – regardless of the reason.

A patient deciding, after pondering the doctor’s advice and weighing the pros and cons, to follow a course other than that recommended by his clinician is not uncommon but it is also not the only cause of noncompliance⁴ – nor is it even one of the most frequent causes. Noncompliance also takes place when the patient agrees with the doctor and intends, for example, to take the prescribed medication but forgets to do so, misunderstands the instructions (or is given unclear instructions), cannot afford the pills, … . It seems apparent that a patient who wants to follow the treatment recommendations but unintentionally falters in the execution of that intent is both autonomous and noncompliant, the exact combination that Dr. Brody claims cannot logically exist.

And there’s more.

The patients polled in the Consumer Reports survey did not, as one might predict from Dr. Brody’s article, complain in overwhelming numbers about being coerced by their doctors into following treatment orders. It appears, in fact, that none spontaneously raised this issue. Instead, the patients almost unanimously reported that they (the patients themselves) “completely” or “mostly” followed their doctor’s advice.

That the patients felt they were following instructions appropriately does not itself rule out the possibility that they were being somehow forced to do so but if the physicians observed that the patients did not follow instructions while the patients simultaneously thought they were following instructions, that disparity arose from some cause other than the patient’s explicit, conscious wish not to comply.

In short, Dr. Brody may (or may not) be correct about the lack of ethical integrity among healthcare professionals, but the frustration over noncompliance indicated by doctors on a marketing survey from Consumer Reports falls far short of proof of that assessment.

How Much Persuasion Is Enough But Not Too Much?

Later in the article, Dr. Brody writes

If the patient, for whatever reason, has chosen not to do what the doctor suggests, it shows that the advice, however scientifically accurate and well-intended, failed to fit the patient’s life in some key way. Should the doc then simply shrug his shoulders? Or is it then time to sit down and talk about Plan B or Plan C?

Isn’t figuring out what could work best — or seeing why the problem is simply not a priority for the patient at this time — more important than dithering about “compliance”?

This brings up two issues.

First, I am curious about the source of Dr. Brody’s knowledge that these physicians did not already “sit down and talk about Plan B or Plan C” – or Plan D, E, F, and G, for that matter. Perhaps an alternative interpretation would be that the doctors are frustrated over noncompliance in part because they went to the effort of offering several alternative treatment recommendations, none of which were successful. I certainly don’t know that such is the case, but I suspect Dr. Brody doesn’t know that these doctors offered, as he suggests, only one set of recommendations on a take it or leave it basis.

Or what if part of the frustration is based on the clinical knowledge that noncompliant patients are, as a group, experience higher morbidity and mortality than compliant patients? A physician who believes in a patient’s right to choose a course of action that is likely to have negative results (e.g., continuing to smoke in the face of worsening emphysema) could, it seems to me, feel frustrated without renouncing a belief in patient autonomy.

Second, some schools of bioethics argue that doctors who do more than lay out alternative treatment plans, their likely benefits, and their possible risks are violating patient autonomy by explicitly or implicitly, overtly or covertly influencing the patient to follow the recommendations. Some, indeed, would hold that a doctor who indicates a preference for one plan over another is infringing on the patient’s prerogatives – even if the patient requests the doctor’s opinion and advice.

Dr. Brody, however, seems to be suggesting that a doctor who does not respond to a patient’s noncompliance with alternatives is not doing his or her job even though continuing to push treatment options at a patient who initially refuses them could be seen as coercive (albeit not by me).

It is unclear to me how a clinician, even one with integrity out the wazoo, can invariably and precisely hit the mark of encouraging the patient without coercing the patient.

Time and Money

I find myself more in tune with Dr. Brody’s final concern:

The physicians’ complaints about noncompliant patients might have hidden another survey finding, which I believe raises compliance issues of a more serious sort.

About half of the docs said that they had been forced in recent years to speed up their practices and to cram in more patients every day to meet their target incomes. And half said that this means that they see too many patients each day to give effective treatment.

Hello? Since when did meeting a “target” income become more important than giving the patient effective treatment? No one is holding a gun to these docs’ heads, forcing them to schedule too many patients each day to do a good job. Only their professional integrity would require them not to do that.

I am, however, somewhat less confident of the interpretation of these survey findings than is Dr. Brody.

I do not know the phrasing used in the questionnaire the doctors completed for Consumers Reports,⁵ but I suspect the wording of the pertinent questions did not include anything on the lines of Dr. Brody’s felicitously chosen terms, such as “speed up their practices and to cram in more patients.” The Washington Post report phrases it “As for patient face time, more than half of the surveyed doctors said that had been shortened in the past five years, during which time they had had to expand their practices to meet their target income. And more than half also said they saw too many patients in one day to give effective treatment.” I happen to know that my own primary care doctor, for example, expanded his practice by increasing the number of hours he saw patient each week. The term “target income” also seems a tad vague. Seeing more patients in order to make enough money to buy that second private jet is one thing; maintaining an income adequate to pay the clinic’s staff and take care of ones family seems quite another. I would observe as well that while half expanded their practices to maintain the same income and half felt they saw too many patients in one day to give effective treatment, those two groups may not be identical. Some doctors, for example, might be salaried employees required by their employer to see X number of patients.

Those qualms notwithstanding, I agree that routinely seeing too many patients in a given time to give effective treatment is an ethical lapse that could be explained away only by the most extraordinary circumstances.

As for the article’s concluding shot, “What happened to compliance with professional integrity?” I believe Dr. Brody’s attempt to link the first issue he raises, the conflict he perceives between patient compliance and patient autonomy, with his later, more striking point, the potential impairment in physician integrity that he believes is indicated by the phenomenon of doctors knowingly seeing too many patients, through the use of the term “compliance” in two different senses only confuses and ultimately weakens his case.

Those Darn Semantics

Now, I would agree that the common definitions of compliance and noncompliance are flawed to the point that they are counterproductive. I have, in fact, previously argued that patients who decide not to adhere to a treatment recommendation and so inform the doctor should be considered compliant because they are acting in concert with the clinician.⁶ But I recognize that I lack the authority to change the meaning of compliance as it is routinely used simply by wishing it so.

The ethical distinction between a doctor laying out treatment options for a patient and persuading that patient to follow a specific recommendation is one deserving of exploration. I would argue, however that the compliance contretemps Dr. Brody describes is one that exists only in a rarefied universe of philosophical hypotheses rather than the day to day clinical world where noncompliance is all too often the result of cognitive errors, subtle psychological forces, or even lethargy rather than conscious decisions.

1. This article lacks only an explicit plea to God to smite the physicians who have fallen from obedience to meet full criteria for fitting into the Books of the Minor Prophets of the Old Testament. I think that, with the addition of that appeal to a wrathful God, this story of a prophet ignored by the heathen he is trying to save could serve well positioned, say, between Habakkuk and Haggai↩
2. Interventions to Enhance Patient Adherence to Medication Prescriptions, Heather P. McDonald, BSc; Amit X. Garg, MD, MA; R. Brian Haynes, MD, PhD. JAMA. 2002;288:2868-2879.↩
3. Because of format conflicts, I have stripped the citations from this excerpt. The references are, of course, available in the online article, available at Interventions to Enhance Patient Adherence to Medication Prescriptions↩
4. I have neither the time or energy to adequately discuss the implications of unrecognized psychological and sociological influences on decisions the patient believes were made on the basis of pure, cold logic; suffice it to say that our reasons for any decision are often not clear to us until long after the fact.↩
5. I am not a subscriber to Consumer Reports. My information about the survey comes for several articles written about the report, especially Tell Me Where It Hurts By Buzz McClain. The Washington Post. February 6, 2007↩
6. See How To (Correctly) Not Take Medications As Prescribed↩

Thoughtful Commentary On Core Issues

Source: Dealing with non-compliance
The Pharmaceutical Journal Vol 263 No 7074 p922-923, December 4, 1999 Forum

While the majority of AlignMap posts deal with research, the topic today is an editorial emanating from a Drug and Therapeutics Bulletin seminar on “How to look after patients who fail to care for themselves.”

Although this seminar was held in 1999, its content, the economic, ethical, and clinical aspects of treating noncompliant patients, remains pertinent today. This brief (less than 2000 words) article consists entirely of a series of comments from seminar participants that are insightful, thoughtful, and sometimes provocative and is well worth reading.

This editorial can be found at ~ Dealing with non-compliance ~

The News Release

Source: A Mother’s Day Tip: Encourage Mom to Take Her Medicine as Prescribed

Because I monitor patient compliance issues, I picked up a May 8, 2007 press release from AstraZeneca Pharmaceuticals LP that begins

There follows a description of medication noncompliance, including possible causes and consequences, followed by

References in footnotes complete the press release.

Commentary

Perhaps my discomfort with this message is exacerbated by my own penchant for bringing up the issue of patient compliance at – almost – every opportunity. After all, the facts about compliance in the press release are accurate (and referenced, for that matter). And I love my mother, who takes significant amounts of medication with varying degrees of adherence to her prescribed regimen.

Still, I am relatively certain that my mother would not consider a lecture on patient compliance to be “the best present that [I] could give her this Mother’s Day” – even if I included my all-star, hot shot PowerPoint presentation, replete with bells & whistles.

Further, I am even more certain that this tie-in with Mother’s Day ventures beyond awkwardness and that it, in fact, trivializes rather than promotes patient compliance.

I was annoyed enough to search for other information about this campaign. I didn’t find much about the compliance angle, but did discover a post by Dr. Peter Rost about another Mother’s Day promotion by AstraZeneca. This excerpt summarizes the issue and should prove an enticement to read Dr. Rost’s entire post:

Dr. Rost thoughtfully included AstraZeneca’s selling plans, labeled for “for internal use only,” which are self-explanatory. [Click on thumbnails to view larger images]

I have nothing to add.

Finding hope in South Africa is a posting about Ian Schwartz, a medical student in Winnipeg, who returns each summer to South Africa, the country of his birth, to to work as a volunteer at an AIDS clinic located 30 minutes from Durban in KwaZulu-Natal, South Africa, one of the hardest hit areas on the continent.

The entire post is worth reading, but two sections that deal with patient compliance, both disturbing in different ways, are excerpted here:

Commentary

While I was aware that some patients discontinue needed medication on the advice of practitioners opposed to traditional Western medicine, the notion of withholding ARV treatment until seriously ill patients successfully undergo a three month antibiotic trial to prove their willingness and capacity to comply was new to me and has motivated me to re-assess some of the processes we routinely use to determine whether, for example, a liver transplant candidate meets an ambiguously defined capacity to adhere to treatment before performing the life-saving procedure.

Little Traveller Dolls

According to the post, Ian Schwartz, in addition to volunteering his time at the clinic, also raises money for its support by selling “Little Travellers”—South African-made dolls of pins. The dolls are made by women who are caregivers at the clinic and whose families and friends have been affected by AIDS. Thus far, Schwartz, with the help of colleagues and friends, has raised more than $50,000 through the sale of the $5 dolls. The money, Schwartz says, helps Hillcrest maintain its programs and provides economic empowerment to the women who make the dolls.

Anyone interested in supporting this effort can purchase the “Little Traveller Dolls at Dolls For Sale.¹

Footnotes

1. AlignMap has no affiliation with, fiscal interest in, or information about the “Little Traveller Dolls” project beyond that provided by the referenced post↩

Source: ‘Tough Love’ Lessons From a Deadly Epidemic Barron H. Lerner, M.D. New York Times June 27, 2006
____________________

This article focuses on directly observed therapy (DOT), in which healthcare workers monitor the administration of medications, its role in quelling the increase in tuberculosis cases in New York in the 1990s, and its proposed use in the treatment of HIV. It also deals with the conundrum of determining the proper course of action when the rights of the individual clash with the public good, all in all an appropriate topic as we approach this country’s Independence Day.

Public Health & The Treatment Of Tuberculosis in the 1990s

While there were other causative factors, noncompliance was a significant problem in the rise in tuberculosis in the 1990s, especially among patients who used injection drugs or had psychiatric problems. The author notes, “In one often-cited study, 89 percent of tuberculosis patients at Harlem Hospital were lost before completing treatment.”

Not only did those patients fare poorly and possibly infect others, but their incomplete compliance led to the drug-resistant forms of tuberculosis.

With federal financing, New York aggressively expanded the use of DOT, with outreach workers administering anti-tuberculosis medications special clinics, the patients’ homes, or wherever patients could be found.

Further, those who didn’t fare well on DOT were placed under forcible detention, either at Bellevue Hospital or at Goldwater Hospital. According to Dr. Lerner, “More than 250 patients were detained between 1993 and 1998, some for as long as two years.”

From 1992 to 2001, new cases of tuberculosis dropped from 3,811 to 1,261.

HIV Treatment Monitoring

The New York health department has now proposed a similarly aggressive program for treating HIV. Specifically, these regulatory changes would include

• Simplifying consent for H.I.V. testing to encourage clinicians to screen more patients
• Tracking H.I.V. in a manner similar to tuberculosis
• Monitoring patients to ensure that they take their medications properly

Commentary

Dr. Lerner has done a laudable job of illustrating and summarizing the strengths of DOT and its effectiveness in managing tuberculosis within the confines of newspaper column. And, he points out the clinical issue that differentiates tuberculosis from HIV as a public health issue – the tuberculosis, unlike HIV, can be spread through casual contact.

Dr. Lerner’s primary argument is, indeed, primarily clinical in scope: Given that DOT is effective in reducing morbidity and mortality caused by noncompliance, thereby saving lives and decreasing the risk of epidemics to the public, public health officials should be legislatively allowed to use this tool.

If this perspective becomes the exclusive approach, of course, it begs the ethical question of how one determines at what point the danger to the public at large outweighs the rights of the individual to the extent that treatment can be legitimately coerced to the point of imprisonment, whatever nomenclature is used to designate forced detention and however humane the conditions.

It seems intuitively clear to me that at some point, public safety demands, even in a democracy, the restriction of the rights of those who endanger it – even if the individual is innocent of wrong doing and the danger is unintentional. It seems equally clear, however, that government cannot rationalize draconian measures simply because they work.

Do Patients Treated With Dignity Report Higher Satisfaction, Adherence, and Receipt of Preventive Care?

Beach MC, Sugarman J, Johnson RL, Arbelaez JJ, Duggan PS, Cooper LA. Ann Fam Med. 2005 Jul-Aug;3(4):331-8.

Introduction

I confess that, upon reading the title, Do Patients Treated With Dignity Report Higher Satisfaction, Adherence, and Receipt of Preventive Care?,  my cynicism automatically went on full alert as I sardonically calculated the likelihood that a negative finding to that kind of set-up question would be published or even submitted for publication.¹

While I hereby declare myself unreservedly in favor of treating patients with dignity, I also suspect that in a tiny, dark, staunchly adolescent corner of my soul, I  would not have been displeased if the research had demonstrated that treating patients with dignity had a negative correlation with reported satisfaction, adherence, and receipt of preventive care, thereby forcing doctors everywhere to disrespect and humiliate their patients in order to provide optimal care.²

Well, I shan’t keep you in suspense; the official conclusions follow:

Being treated with dignity and being involved in decisions are independently associated with positive outcomes. Although involving patients in decisions is an important part of respecting patient autonomy, it is also important to respect patients more broadly by treating them with dignity.

The Study

The path by which the researchers got to their desired destination starts with a 2001 survey (a questionnaire of multiple choice items) of 5,514 adults living in the United States designed to examine the independent correlations of (1) patients being treated with dignity and (2) patients being involved in decisions to the three titular outcomes (satisfaction, adherence, and receipt of preventive health care). The study also analyzed the results for differences across racial and ethnic groups.

Consideration Of Dignity

The authors point out, at length, that dignity is not synonymous with patient autonomy:

… the broader ethical principle of respect for persons, from which the principle of respect for autonomy is conceptually derived. Respect for persons has been broadly defined as the recognition that all persons have dignity or inherent worth. Thus, involving patients in decisions (respect for autonomy) is one important, but not exhaustive, expression of respect for persons.

This explanation is followed by a somewhat redundant Venn diagram of the relationship between Respect For Persons and Respect For Autonomy.
In gathering the data, the researchers cut through the Gordian knot of defining the complex ethical concept of dignity by the simple expedient of placing that onus on the respondent:

The primary independent variables were 2 items inquiring about different expressions of respect during the patient’s last encounter with a doctor: “Did the doctor involve you in decisions about your care (as much as you wanted, almost as much, less than you wanted, a lot less than you wanted)?” and “Did the doctor treat you with (a great deal of) respect and dignity (a fair amount, not too much, none at all)?”

Later, as part of the Discussion section, the authors offer their suggestion “that treating someone with dignity primarily involves recognizing inherent value in that person.” To their credit, the authors straightforwardly, if belatedly, affirm that the questionnaire and the data collected from it do not associate specific behaviors with being treated with dignity, explicate how the respondents arrived at their evaluation of dignity, or distinguish being treated with dignity from being treated kindly. As they note,

… such concepts as respect for persons and respect for autonomy are not perfectly measured by survey items, particularly from single items.

The Results

The authors summarize their results in this excerpt from the paper:

Overall, 76% of respondents reported being treated with a great deal of respect and dignity, and 77% reported being involved in decisions to the extent that they wished. There were no differences in the percentage of respondents reporting either type of respect by sex or education, yet there were differences in reports of involvement in decisions and treatment with dignity across age, race/ethnicity, and income.³ … Most respondents (62%) reported both being treated with dignity and being involved in decisions, although there were 12% who reported being treated with dignity only (without being involved in decisions), 12% who reported being involved in decisions only (without being treated with dignity), and 14% who reported neither.

The Conclusions

The authors hold that these results

have several important implications for practicing clinicians, medical educators, researchers, and medical ethicists. Practicing clinicians ought to consider how to foster their own attitudes of respectfulness toward patients by engaging in self-reflection or participating in educational or training programs in communication skills and professionalism. Medical educators ought to teach students about the principle of respect for autonomy, as well as foster environments in which patients are regarded as valuable and treated with dignity. After all, the most egregious cases of student-reported physician misconduct no longer seem to be in the realm of paternalism, but in the systematic devaluing of patients. Researchers ought to investigate which behaviors are interpreted by patients as an indication of treatment with dignity and, if our findings are replicated in other studies, to design and evaluate the impact of programs aimed at increasing levels of respect within health care systems.

They to on to report that

For ethicists, these data lend support to conceptual arguments for honoring the broader principle of respect for persons that incorporates treating patients with dignity in addition to the narrower responsibility of respecting autonomy. Although respect for persons is conceptualized as the broader principle, our data suggest that patients do not always experience being involved in decisions as an indication of respect more broadly. This finding may be because involving patients in decisions is only one part of respecting autonomy, but it may also be because respect for autonomy is not the full expression of respect, insofar as there are aspects of persons in addition to their autonomy (such as their dignity) that require attention morally.

Commentary

Perhaps I’m missing something because it seems to me that a data set generated by asking patients if they were treated with dignity, an ambiguous and intricately complex quality that was not defined for those surveyed and which the authors themselves note can’t be measured by the instruments used in this paper, is inherently suspect and perhaps fatally flawed. By reducing the multidimensional concept of “respect,” with all its implications and social, historical, and emotional baggage, to two questions, one of which seems to have a political agenda (see below), the study creates a self-selected  group of satisfied patients that has been too easily and too confidently  labeled “treated with respect” (i.e., patients who report being treated with respect may well be responding to a generally positive treatment experience). Nifty statistical manipulations of invalidly interpreted data does not yield compelling results that convince me to reassess or change anything about the way I operate clinically.

Further, one could, it seems to me, make a case that the other of the two major expressions of respect designated by the authors, involving the patient in the decision-making process, may be an important issue but does not necessarily correlate with respect.  In any case, the point smacks of false egalitarianism enlisted to support a specific sociological perspective. This bias is revealed in the manner in which the question is asked:

Did the doctor involve you in decisions about your care (as much as you wanted, almost as much, less than you wanted, a lot less than you wanted)?

One of the first differences I noticed between the textbook descriptions of patients and real patients  was that not every patient wanted the be empowered as a co-member of their treatment team. Some patients, in fact, all but panicked  at the prospect of assuming that role. Setting aside for now the questionable proposition that patient empowerment is a universal benefit, one notes that the question put to the patients in this study does not include all the pertinent options.  To present the issue to the subjects in a neutral manner, the question have been (additional options printed in bold),

Did the doctor involve you in decisions about your care (as much as you wanted, almost as much, less than you wanted, a lot less than you wanted, more than you wanted, much more than you wanted)?

I would  argue, that coercing a patient to be more involved than he or she wishes is an ethically untenable position for the doctor.

On the other hand, I do agree with the authors that

Further research is needed to understand what clinician behaviors are interpreted by patients as an indication of treatment with dignity.

Only after that is accomplished, should a study be done to determine if being treated with dignity has an impact on adherence to treatment.

1. The answer, by the way, falls into the proverbial range of slim to none↩
2. Because of this cynical slant on my part, I have excerpted somewhat larger chunks of the article than I might have otherwise to lessen the possibility of taking the authors’ words out of context↩
3. Shown in a table but not relevant to this discussion↩

Well-Intentioned Food Police May Create Havoc With Children’s Diets
By Harriet Brown

This essay in the May 30, 2006 New York Times raises concerns about the extent to which schools intervene in the lives of their students in hopes of improving health.

In the past, such efforts have included discrete and intermittent interventions (e.g., vaccinations and immunizations, either provided by or required by the schools), ongoing programs integrated into the school structure (exercise programs and health education), and auxiliary programs that had an impact on the students’ general health (e.g., hot lunches). Today, these elements seem to be accepted by all except religious sects that disallow certain medical measures, some conservative political groups alarmed by the intrusiveness of government, and a few others with concerns about the safety of specific medical procedures.

Ms Brown’s essay addresses the currently popular battle on obesity which is being carried out in the schools, by local initiatives and via legislation, such as the Child Nutrition Promotion and School Lunch Protection Act now before Congress, which would, in effect, set standards on food served at school cafeterias and vending machines.

While the article focuses on the wisdom of taking such actions based on unproven or oversimplified correlations between obesity and specific disease states, the ethical issues of using public authority, in this case the schools and legislation affecting schools, to intervene in the lives of individuals in hopes of improving health are even messier. Reading news stories, for example, of Arkansas Governor Mike Huckabee’s personal 100 pound weight loss and his consequent enthusiasm for enacting regulations to halt obesity causes one to wonder about the justification for those who are in positions of power pushing their own passions, however well-intended, onto others. Motives are even less clear in other situations since coming out in favor of improved school nutrition would seem a particularly safe, politically advantageous position.

Similar ethical conflicts (e.g., physicians advising Vs. coercing patients to follow a medication regimen) are not, of course, unusual in the field of medical compliance, but the school arena does merit special attention given that children are affected and the reasoning behind these decisions is unclear.