AlignMap

From Wired’s list of 10  Top Technology Breakthroughs of 2008

9. Edible Chips

Grandma’s pillbox with the days of the week neatly marked is set to go high tech. Tiny edible chips will replace the organizer, tracking when patients take their pills (or don’t) and monitoring the effects of the drugs they’re taking. Proteus, a Redwood City, California, company, has created tiny chips out of silicon grains that, once swallowed, activate in the stomach. The chips send a signal to an external patch that monitors vital parameters such as heart rate, temperature, state of wakefulness or body angle.

The data is then sent to an online repository or a cellphone for the physician and the patient to track. Proteus says its chips can keep score of how patients are responding to the medication. That may be just the beginning, as the chips could improve drug delivery and even insert other kinds of health monitors inside the body. Now doctors may have a better answer to a common patient complaint — they will know exactly how it feels.

Outlook: If proven in clinical trials, edible chips could let physicians look into a patient’s system in a way that could change how medicine is prescribed and how we take the drugs.

Commentary

While I am less confident than the denizens of Wired that the edible chips will automatically mark a revolution in health care, I do believe they could be a key tool in researching and confirming patient compliance.

At the least, they should be the new gold standard for tracking medication adherence.

Credit Due Department: Image from Businessweek

I came across the Rumpelstiltskin Phenomenon, a concept that is pertinent to my contention that the focus on renaming the phenomenon now most commonly known as patient compliance or treatment adherence is unlikely to prove an advantage, even if the renaming is accomplished.

The Rumpelstiltskin Phenomenon

From: A Dictionary of Psychology  (2001).  Author: Andrew M. Colman.

Rumpelstiltskin Phenomenon The tendency for the naming of something to create the impression of imparting an understanding of it. It applies, for example, to the naming of mental disorders: a person who tells implausible lies may be said to be suffering from pseudologia fantastica, but that term is nothing more than a name for implausible lying, and any impression that it imparts an understanding of the phenomenon is a cognitive illusion. [Named after Rumpelstiltskin in a famous fairly tale, called Rumpelstilzchen in the German version collected by the brothers Grimm, a strange dwarf who exerts a baleful influence over a miller's daughter until she eventually gains power over him by learning his name]

I confess to feeling gratified to discover that someone has articulated the ambiguous  notion I had  developed in thinking about the renaming of patient compliance.  It is, of course, a tad ironic that I’m happy about finding  the phenomenon I grasped instinctively – that naming something doesn’t necessarily improve ones understanding of it -  has a name

In a comment to Study Questions Advantages of Newer Antipsychotics for Early Schizophrenia,¹ Peter Buckley notes

Although readers, particularly policy makers, will inevitably be drawn to the “Should I choose an FGA [First Generation Antipsychotic]  or SGA [Second Generation Antipsychotic]” content of this study, it seems to me that the most striking finding is (yet again) how frequently patients stop their medications. The 72 percent overall “All Cause” Discontinuation rate bears an uncanny resemblance to the 74 percent in CATIE and to the similar rate in the one-year CAFE first-episode study. Thus, medication non-adherence is a major treatment  issue right from the onset of treatment. Set in that light, the differences observed in the study between agents are relatively modest. The data do not endorse the preferential “lead off” with any particular agent. Indeed, much like the discussion that followed the publication of the CATIE study, these data make the case for wide availability and choice of antipsychotic medications, rather than confining to a selective FGA first or X drug before trying Y among the SGAs.

Commentary

For those viewers who may be unfamiliar with the pharmacologic content of this text or the writing style used in the medical literature, I offer – with apologies to Dr. Buckley – this unauthorized translation of his comment into the vernacular:

As Dr. Buckley points out, nuanced distinctions between classes of antipsychotics tend to wash out in the tsunami of of a 70% discontinuance rate.

At the risk of oversimplifying his argument, I submit that the rate-limiting step in the improvement of treatment with antipsychotics (and many other areas of treatment as well) is the understanding and management of patient compliance rather than the discovery of the next generation of pharmaceutical agents.

1. While Dr. Buckley’s comment can stand on its own for our purposes,  I’ve excerpted a portion of Study Questions Advantages of Newer Antipsychotics for Early Schizophrenia to provide context. The full article, which summarizes the original study, is available at the link, as is Dr. Buckley’s full comment.

   An open-label study comparing first- and second-generation antipsychotic drugs in first-episode psychosis finds that patients continued to take the newer drugs for significantly longer, even though psychopathological symptoms, as measured by a standard rating scale, indicated no differences between drugs. The report, published in the March 29 Lancet, notes that extrapyramidal symptoms were more common with the first-generation drug haloperidol, but also raises the question of whether physician bias against the older drug may be at play.

   ↩

Would someone with a thermometer check whether hell has frozen over?

I just finished posting More Patient Compliance Myths Debunked, in which I endorse points made by  the chief scientist of the Aardex Group. Last week, or goodness sake, I published The Post Is Not Brought To You By Pfizer – It Just Seems That Way.  If that title alone isn’t enough data for a diagnosis, consider this excerpt:

Gosh, this is difficult.  Well, I may as well just come out with it – at the risk of appearing to be a shill for Pfizer, I must admit that the points made by European brand manager, Chris Venn, at eyeforpharma’s recent Patient Compliance Europe 2008 conference, as reported in Patient compliance programs: Learnings from the trenches, are valid, insightful, and useful.

That’s right – Mr. Venn is pushing ideas that are congruent with my own.

I know, what are the odds?

Now, I’ve happened  onto Dose Of Digital, a  blog produced Jonathan Richman, who previously “led some of the compliance initiatives for Arimidex, a breast cancer treatment, at AstraZeneca, a card-carrying member of Big Pharma.

The blog is dedicated to “help[ing] figure out how healthcare can leverage some of the digital technologies available today.”

Well, that’s nice.  What impresses  me, however, is Richman’s willingness to point out the glaringly obvious – such as compliance is a complex and complicated issue.  And Mission Accomplished claims for a single compliance methodology should be held suspect. Does that sound familiar?

Check out the content and, especially, the tone of this excerpt from Glorified Alarm Clocks:

So, if Mr. Rose says it isn’t a “reminder problem” and that most devices are “glorified alarm clocks,” how is his device which includes services such as “reminder calls” and “weekly emails” not a reminder device that’s a “glorified alarm clock?” The answer is that it is. This device is a glorified alarm clock. Just because it doesn’t ring and sends an email instead doesn’t change this fact. Using digital, such as email, doesn’t inherently make your product better or change it’s basic function.

If reminders worked, then simple beeping alarms would have solved the compliance problem long ago. The way I look at this is for a serious disease like breast cancer, isn’t opening your eyes each morning enough of a reminder that you have a disease that could kill you at any point? I’d think that might remind you about your medication. If reminders worked, wouldn’t the fact that you could die be reminder enough?

The reality is that compliance isn’t a reminder issue. It’s a complex psychological issue. People don’t take their medications for a number of reasons many of which include the patient’s decision that the drug isn’t helping them or isn’t necessary. Very few patients are informed enough to truly make this decision (they’re called doctors though) and yet it happens every day. People aren’t convince themselves that the risks outweigh the benefits or that they are feeling fine, so they must be “cured.” Point is, it’s something different for everyone. Very few people actually stop because they simply can’t remember.

Now, zip over to Dose of Digital to read the rest of Glorified Alarm Clocks.  Yes, now. Just hustle back here after you finish.  While I await your return, I’ll be humming the Jeopardy tune that played while each contestant scrawled his or her “Final Jeopardy” answer, in the form of a question.

Da, da, da , da da, da, daaa, da, da, da, da, dah!, da, da da da da, da da, da, da da, da, …

Is that post cool or what?   If I published those paragraphs here under my name, I’m willing to wager it would fit so well that no one would think it anything but one more of my politely phrased rants. As far as I know, Mr Richman and I were not separated at birth, he is not my evil twin (which leaves the possibility that I’m his evil twin), there has been no mind meld. I think  we may be kinda like those identical cousins in the Patty Duke Show.¹

One parallel post can,  of course, be an aberration, but this is a blog that I’m going to watch closely. In any case, I am excited about the notion that a blogger, especially one with a heavy duty corporate background, seems to be pushing a patient compliance agenda that mirrors some of the ideas I promote at AlignMap. Heck, if a few more bloggers and corporate types come into (ahem) alignment, we could have us a movement.

1. Mr. Richman may not, by the way, agree with my assessment of our similarities. And, even if he does see our  points of view as congruent, he may not necessarily view that as a positive.↩

Because so many misunderstandings and misconceptions about patient compliance are considered common sense and consequently go unchallenged, presenting them as “myths” can be an effective, if perhaps hackneyed, means of correcting misperceptions.

At least I hope so. One of the most popular pages on the AlignMap.com site has long been the discussion of my own pet compliance myths.

I recently found another set of myths.  Dispelling The Myths Of Patient Adherence, Lisa Roner’s summary of a presentation made by Bernard Vrijens, chief scientist with Aardex Group, at eyeforpharma’s Patient Compliance Europe 2008 conference is a succinct, clearly explained debunking of  widespread beliefs about compliance that are dangerously wrong.

Dr. Vrijens discusses these myths:

1. Caregivers assure adequate adherence.
2. The circumstances of clinical trials assure satisfactory adherence.
3. Adherence can be expressed as a percentage of prescribed doses or as a dichotomy.
4. Patient adherence improvement programs can rely solely on motivating.
5. Electronic monitoring is expensive.

The entire article is just over 1000 words and easily read, representing one of the best benefit to effort ratios you’re likely to come across today.  It can be found at Dispelling The Myths Of Patient Adherence

The So Re-name It Already Persistence Campaign

This post is part of my ongoing strategy to persist in writing about the re-naming of patient compliance until it annoys folks enough that a consensus on one name or another is reached, if for no other reason than to stop me blogging about it.

Today’s question: What are the likely consequences of a suboptimal or a distinctly inappropriate name?¹

When Good Children Have Bad Names

Who worries more about the catastrophes of a bad name more than parents? Well, the kids with those weird names, of course, but my point is people take the naming of their progeny seriously.  That the results are sometimes peculiar should perhaps be the first lesson in this parable. Taking naming too seriously means somebody gets named “Ima Hogg.”

Anyway, based on the premise that bad names are even more worrisome when applied to people than to phenomenon such as patient compliance, I thought a look at what happens when children are saddled with goofy  names might be enlightening.

Today’s source of sane thinking is A Boy Named Sue, and a Theory of Names by J. Marion Tierney from the  March 11, 2008 New York Times.  I’ve excerpted the pertinent portions but the entire piece is short, accessible, and a worthwhile read.

During his 1969 concert at San Quentin prison, Johnny Cash proposed a paradigm shift in the field of developmental psychology. He used “A Boy Named Sue” to present two hypotheses:

1. A child with an awful name might grow up to be a relatively normal adult.

2. The parent who inflicted the name does not deserve to be executed.

… Studies showed that children with odd names got worse grades and were less popular than other classmates in elementary school. In college they were more likely to flunk out or become “psychoneurotic.” Prospective bosses spurned their résumés. They were overrepresented among emotionally disturbed children and psychiatric patients.

… Today, though, the case for Mr. Cash’s theory looks much stronger, and I say this even after learning about Emma Royd and Post Office in a new book, “Bad Baby Names,” by Michael Sherrod and Matthew Rayback.

By scouring census records from 1790 to 1930, Mr. Sherrod and Mr. Rayback discovered Garage Empty, Hysteria Johnson, King Arthur, Infinity Hubbard, Please Cope, Major Slaughter, Helen Troy, several Satans and a host of colleagues to the famed Ima Hogg (including Ima Pigg, Ima Muskrat, Ima Nut and Ima Hooker).

The authors also interviewed adults today who had survived names like Candy Stohr, Cash Guy, Mary Christmas, River Jordan and Rasp Berry. All of them, even Happy Day, seemed untraumatized.

“They were very proud of their names, almost overly proud,” Mr. Sherrod said. “We asked if that was a reaction to getting pummeled when they were little, but they said they didn’t get that much ribbing. They did get a little tired of hearing the same jokes, but they liked having an unusual name because it made them stand out.”

…  But after I looked at experiments in the post-Sue era by revisionists like Kenneth Steele and Wayne Hensley, it seemed names weren’t so important after all.

When people were asked to rate the physical attractiveness and character of someone in a photograph, it didn’t matter much if that someone was assigned an “undesirable” name. Once people could see a face, they rated an Oswald, Myron, Harriet or Hazel about the same as a face with a “desirable” name like David, Gregory, Jennifer or Christine.

Other researchers found that children with unusual names were more likely to have poorer and less educated parents, handicaps that explained their problems in school. Martin Ford and other psychologists reported, after controlling for race and ethnicity, that children with unusual names did as well as others in school. The economists Roland Fryer and Steven Levitt reached a similar conclusion after controlling for socioeconomic variables in a study of black children with distinctive names.

“Names only have a significant influence when that is the only thing you know about the person,” said Dr. Ford, a developmental psychologist at George Mason University. “Add a picture, and the impact of the name recedes. Add information about personality, motivation and ability, and the impact of the name shrinks to minimal significance.”

… I sought an answer from Cleveland Kent Evans — not because he might have gotten into fights defending Cleveland, but because he’s a psychologist and past president of the American Names Society. Dr. Evans, a professor at Bellevue University in Nebraska, said there is evidence for the character-building theory from psychologists like Richard Zweigenhaft, but it doesn’t work exactly as Sue’s father imagined it.

“Researchers have studied men with cross-gender names like Leslie,” Dr. Evans explained. “They haven’t found anything negative — no psychological or social problems — or any correlations with either masculinity or effeminacy. But they have found one major positive factor: a better sense of self-control. It’s not that you fight more, but that you learn how to let stuff roll off your back.”  …

Commentary

OK, I’m willing to stipulate that human beings and other phenomena are different and therefore the whatever principles govern the impact of a bad name for humans may not be applicable to names of other phenomenon.

On the other hand, there is little evidence that the field of patient compliance would look differently today if it had been called “adherence,” “concordance,” or “Jimmy Bob.”

And, certain principles, such as Dr. Ford’s notion that

names only have a significant influence when that is the only thing you know about the person. Add a picture, and the impact of the name recedes. Add information about personality, motivation and ability, and the impact of the name shrinks to minimal significance,

ring true and seem as though they might fit the naming of ideas as well as they do the naming of children.

In any case, there are enough similarities and parallels that it would seem that we should at least consider the possibility that even being stuck with a name with some possible negative aspects may not make all that much difference and get on with improving compliance (or whatever) already.

1. For the purposes of this exercise, we’ll assume that “compliance” is a bad name, or that “compliance” has been replaced by “adherence” which is later discovered to be a bad name, or whatever term selected to designate the new compliance is revealed as bad.↩

Some of the recent entries at AlignMap In Cites warrant special attention.

• Always vigilant for any glimmer of humor associated with patient compliance, I was delighted to discover this short, funny video promoting adherence to ARVs as essential regardless of whatever else may be going on – including a gunfight. The scenario shown may not pass muster as politically correct, but I have showcased it here in the belief that this kind of public service announcement is more likely than the typical ponderous didactic presentation or scared-straight derivatives to attract an audience and have an impact on the the treatment adherence of those viewers.
• “Cancer-Related Fatigue Awareness Month” is not a name that flows trippingly from the tongue but the concept behind it is profoundly pertinent to compliance. “Between 70 and 100 percent of cancer patients receiving treatment have fatigue … . Up to one-half of all survivors have reported fatigue lasting months or even years after treatment.”  (From personal experience and my own reading, I would add that the fatigue factor is likely as high for the caretakers as well.)
• Etiquette-based medicine is a supplement to rather than a substitute for evidence-based medicine and could well enhance compliance with the latter.
• The flip side to etiquette-based medicine is the subject of the New York Times article, Arrogant, Abusive and Disruptive — and a Doctor.
• A new study pushes personalizing the often detached, dehumanized  exercise of reading x-rays by routinely adding patient photographs to the digital file of all radiographic examinations.
• A monograph on smart pillboxes and gizmos to magnify the fine print on pill bottles¹ contain photos of the latest compliance-enhancing devices on the market.
• The results of a national survey of compliance among Canadian women under treatment for osteoporosis demonstrate the usual surprising severity and pervasiveness of nonadherence,² even among patients who have experienced first hand the consequences of the unchecked disease. For example, “Only 56% of those who have fractured a bone are more careful about taking their osteoporosis medication as prescribed since their fracture.”
• A study backing the clinical wisdom that alcohol misuse predicts poor medication adherence, another study examining the relationship between blood pressure levels and adherence to medication in patients with chronic heart failure, and an advance look at a study that will systematically explore  medication compliance by children.

As always, the 10 most recent posts at AlignMap In Cites are listed at the bottom of the right sidebar of this page under the clever title, AlignMap In Cites Recent Posts.

1. See Check The Fine Print For Noncompliance, Part 1 and Part 2.↩
2. I will be starting a pool to allow wagers on how many of these studies will be necessary before the same dreadful results are described as surprising. The smart money – trust me on this one – will be on the high numbers.↩

Again With The Names?

Yep, and here’s why – I read a lot of the contemporary lay and professional literature dealing with what is commonly known as   patient compliance or treatment adherence or something similar – i.e., the variation between a prescribed treatment regimen and a patient’s implementation of that treatment regimen.

Based on that reading, my unproven but sincerely and confidently held contention¹ is that the most frequently and most vehemently addressed issue in that corpus of material is the re-naming of the phenomenon (i.e., compliance, adherence, concordance, … ) itself.

There’s more. I suspect that much of the sturm und drang associated with this effort has less to do with advancing adherence to treatment than with labeling who is right and who is wrong.

A significant number of folks consider the name, compliance, to be not only a suboptimal term but an abomination² in general and a roadblock specifically to progress in the field to be formerly known – if the re-namers are indeed successful – as compliance.³

Further, they are also certain that the correct, not-a-roadblock label is adherence

… except in the U.K., where the preferred appellation appears to be concordance

… except for those who lump adherence and concordance together with compliance as equally nefarious elements of the same Satanic vocabulary used to sustain the pjower of the healthcare  establishment and suppress the rights and independence of patients.⁴

There’s Still More – Naming Becomes Name Calling

Some re-naming diatribes clearly posit compliance Vs adherence⁵ as a litmus test. As far as I can determine, compliance is associated with a paternalistic, condescending, and uncaring style of medicine while adherence is an indicator of medicine practiced such that the patient is co-equal with clinicians, the inevitable consequences of which include mutual respect and caring between the patient and clinicians, enhanced treatment outcomes, and quite possibly humankind’s last best chance for peace on Earth, good will to men.⁶

The compliance Vs adherence battle has another unusual quality; adherence adherents and other anti-compliance groups are vocal and thus easily identified, but I have yet to track down the leaders of the compliance crusade. These days, the most adamant pro-compliance stance may, in fact, be something along the lines of my own laissez-faire recommendation found elsewhere on this web site:

Lacking compelling advantages favoring the use of any of the suggested terms and given the institutionalized encoding of “patient compliance” and “patient noncompliance” into the National Library of Medicine database’s official Medical Subject Headings, it makes sense — until something better comes along — to continue using this familiar phrase to designate the extent to which individuals follow an agreed upon treatment plan, and, unless specified otherwise, assume that adherence, compliance, and concordance refer to the same phenomenon.

It’s not going to replace The Ride of the Valkyries in those battle scenes, is it?

An (Apparently) Little-known Fact

Reading this re-naming material gives one the idea that, sometime in the 1970s, the Grand Vizier of Medical Literature decided it was time to name this process by which patients follow, don’t follow, or partially follow treatment recommended to them. He (in the 1970s all Grand Viziers of Medical Literature were white men; at least 67%, in fact, were dead white men) looked about and malignantly/inexplicably (choose one) selected, from the hundreds of thousands of words in the English language,⁷ the despicable compliance even though the far better adherence was right there, probably giving off a wholesome inner glow, available under “A,” near the front of the dictionary. Thus was healthcare progress stymied  for half a century.

What was he thinking?

As it turns out, reality is less dramatic but far more significant than my How The Grand Vizier of Medical Literature Named Compliance tale.

Compliance and noncompliance were first used in the healthcare literature in the 1950s but were popularized in the 1970s when Sackett and Haynes wrote and edited books, symposia, and articles about these phenomena.

The term compliance was, in fact, consciously chosen as a nonjudgmental alternative to earlier descriptions, such as “untrustworthy,” “uncooperative,” “unreliable,” or, my personal favorite, “faithless.” Compliance and noncompliance were specified as declarations of fact rather than indications of blame.⁸

Put another way, compliance was the 1970s version of adherence.

Well, I bet we get it right this time, by golly.

My Dirty Little Secret

I don’t much care which term – compliance, adherence, concordance, persistence, or any combination or permutation of these words or any other existent or yet to be coined word – is used to indicate the variation between a prescribed treatment regimen and a patient’s implementation of that treatment regimen. As long as everyone knows what that term is and what it means, and I can use it as an effective search term in the medical databases and Google, it’s OK with me.

The New Compliance

So, here’s my offer. You guys for whom this re-naming is a big deal – and you know who you are – get together and decide on a name for the new compliance. Heck, new compliance has a nice ring to it. Use it if you like  – gratis. Anyway, debate, vote, fight a duel, use a Ouija Board, draw straws, whatever. Once you have reached a decision, convinced the administrators of databases and search engines to enter a few fudge factors into their codes to make the new term work for old data, and spread the word among clinicians, researchers, patients, and, of course, all other stakeholders (don’t forget to translate the new term into every language used by organized healthcare), just e-mail me and I’ll adapt.

And yet, some folks think I’m argumentative.

1. If “unproven … contention” causes you to effect that  well-practiced sneer of contempt that you tragically believe passes for a bemused, classy, sardonic viewpoint and automatically dismiss whatever notion follows, just pony up the bucks and a couple of grad students to process the literature and I’ll produce the statistical proof. Otherwise, you’ll have to take my word for it.↩
2. I kid you not. “Abomination” is by no means the worst accusation hurled at compliance. One comment on a post, for example, condemned both adherence and compliance as “some of the worst terms in the health care industry!”↩
3. My apologies to the artist previously – and now once again – known as Prince↩
4. To complicate matters, certain subgroups, prominently but not exclusively in the pharmaceutical industry, have begun to stridently insist on the distinction between compliance, adherence, and persistence. Roughly, compliance is the extent to which a recommended treatment is followed within a designated timeframe while persistence addresses how long a patient follows the treatment plan. In oversimplified form, compliance + persistence = adherence. The good news is that I haven’t found any complaints that persistence furthers the Dr. Darth Vader agenda – yet. ↩
5. There are also cases in which compliance, adherence, and even concordance are all targeted as the vocabulary of a conspiracy against the rights and dignity of individual patients. For now, I will focus on the compliance Vs adherence model for the sake of simplicity.↩
6. For the record, I experienced the same kind of  pseudo-epiphany when I first became interested in patient compliance. It went a little something like this

   Doctors are just too paternalistic, too narcissistic, and too out of touch with their patients. As a result, they just tell patients to take X pills Y times a day, without explaining why the medicine is necessary, what the side-effects are, etc. If only all doctors were empathic, perceptive, and sensitive  – well, like me, for example – we could whip this noncompliance thing in a couple of weeks. Why hasn’t anyone else figured this out? It’s so simple. …

   It seems  I fancied myself the Luke Skywalker of adherence in this particular battle of the forces of good against the evil empire.

   Then I saw the sequel to the first epiphany. It turns out that the arrogant doctor thesis may explain some cases of noncompliance but by no means does it account for even a majority of patients who who don’t adequately follow their treatment plans to an adequate degree. So much for the Force being with me.↩

7. The second edition of the Oxford English Dictionary, for example, includes over 600,000 definitions according to Wikipedia.↩
8. See, among others, Haynes RB, Taylor DW, Sackett DL, eds. Compliance in Health Care. Baltimore, MD: The Johns Hopkins University Press; 1979 and Sackett DL, Haynes RB, eds. Compliance With Therapeutic Regimens. Baltimore, MD: The Johns Hopkins University Press; 1976.↩