AlignMap

Happy Holidays

We’re doing the over hill and over dale to grandmother’s house thing so I do not anticipate publishing more AlignMap blog posts until after the New Year — although that is always subject to emendation.

For this final pre-Yuletide post, I offer the classic Christmas Compliance Song:

I hope your Holidays are especially wonderful.

The Inspiration

In the movie, Miracle On 34th Street, Kris Kringle is hired to be the Santa for Macy’s store on 34th Street in New York City. He causes a storm of reactions of all sorts when he sends one woman shopper to another store, Schoenfeld’s, for a fire engine for her son and tells another mother that Macy’s rival, Gimbel’s, has better skates for her daughter.

And the result?

Kris Kringle’s unorthodox practice of recommending rival stores when they have better bargains generates so much good publicity and customer goodwill for Macy’s that Mr. R.H. Macy himself proffers bonuses to the executives who hired Santa and, in a show of cooperation, shakes hands with his biggest competitor, Mr. Gimbel (Herbert H. Heyes), owner of Gimbels Department Store.

And What Does That Have To Do With Patient Compliance?

Well, perhaps it’s time for pharma to acknowledge that running patient compliance programs that focus on only one medication the sponsoring company manufactures has resulted in neither improved compliance or good will from the public or healthcare professionals and consider the potential benefits of cooperating with their competitors to create a patient compliance strategy that is widely supported and targets a wide range of diseases and treatments.

Nor should pharma be the only group involved. Improvements in patient compliance would primarily benefit two industries financially: pharmaceuticals and healthcare insurance. From this admittedly oversimplified perspective, it follows that these two groups would have the most to gain by funding such a project.

To avoid both regulatory problems and divisiveness within the leadership, this consortium would fund a third party organized for the purpose from experts in the scientific or medical community to develop and administer the program with the funders and other stakeholders serving as a board of directors. To assure transparency, full and detailed reports of the activities of this patient adherence supergroup would made not only to the directorship and all funders, but also to clinicians and the public.

For their part, organizations representing healthcare professionals and healthcare organizations, such as hospital and outpatient groups would have a seat on the oversight committee in return for their support in urging their members to follow the guidelines produced.

Likewise patient support organizations would have an official role exchanging information and insights with the project leadership in return for their support of and cooperation with the programs.

Finally, the other major stakeholder, the government, also a major fiscal beneficiary, would coordinate the multiple regulatory agencies to streamline the program implementation and provide tax advantages for those funding the project.

That doesn’t seem very realistic

As Fred Gaily, who successfully represented Kris Kringle at the hearing to determine if he were actually Santa Claus, puts it,

Besides, there’s this Who’s Been Naughty & Nice List thing.

Adherence to Treatment Among Economically Disadvantaged Patients With Panic Disorder Mukherjee S, Sullivan G, Perry D, Verdugo B, Means-Christensen A, Schraufnagel T, Sherbourne CD, Stein MB, Craske MG, Roy-Byrne PP. Psychiatr Serv. 2006 Dec;57(12):1745-50.

This article is featured in today’s post not only because of the information it offers but also the comparison it provides to the newspaper story discussed in yesterday’s post, ADD Medication Adherence: Cultural Changes & Individual Attitudinal Shifts.

Study Parameters

This excerpt from the abstract of “Adherence to Treatment Among Economically Disadvantaged Patients With Panic Disorder” describes the basis of the study:

And, the study’s finding that is most pertinent to patient compliance is “barriers to adherence were predominantly logistical.”

Commentary

I agree with the authors that the logistical hurdles these patients faced in attending CBT and the consequent recommendations for clinicians are significant and helpful. For example,

I am less convinced, however, that the complete set of causes of noncompliance in these cases is predominantly logistical. Rather, I suspect that the research methodology used, semistructured interviews subsequently coded for patterns, lends itself to patients listing such rationales rather than reasons that might be uncomfortable or embarrassing to voice (e.g., forgetfulness, dislike of the clinician, substance abuse) or might be unavailable to the patient’s consciousness (e.g., psychological conflicts).

Comparison & Contrast Of Scientific Vs Lay Press Articles

It is instructive to compare the presentation of this study, “Adherence to Treatment Among Economically Disadvantaged Patients With Panic Disorder” with the Las Angeles Times story, “Many of the ‘ADD generation’ say no to meds,” from yesterday’s post.

Both today’s study and the newspaper story are based largely on interviews, and, the null hypothesis of scientific studies, notwithstanding, both display a bias on the part of the authors.

The vital difference, however, is that while the newspaper story provides no details of methodology (e.g., how subjects were selected, how many were interviewed) let alone potential problems in the techniques used, the authors of “Adherence to Treatment Among Economically Disadvantaged Patients With Panic Disorder” take pains to point out the limitations, both apparent and potential, on the conclusions one can draw from their work. The following excerpt is typical:

Further, the study’s authors straightforwardly acknowledge that the statements of the interviewees reflect those subjects’ perceptions, which may be difficult to interpret. Consequently, they suggest, “Additional research is needed to better understand patients’ definitions of well-being and the levels of symptoms and functioning that denote ‘equilibrium,’ especially because this equilibrium appears to be related to decisions about adherence.” In contradistinction, the newspaper story appeared to accept the interviewees’ declarations as unadulterated reflections of reality (i.e., if a subject reported discontinuation of a medication resulted in feeling happier, that statement as unquestionably accepted as fact).

Finally, the researchers distinguished between patients’ feelings and clinical results. A patient’s anxiety about taking medication, for example, was acknowledged and respected but did not lead to the conclusion that such patients would not benefit from medication. The point of the newspaper story appears to have been that patients didn’t want to take the medication so they shouldn’t, with no thought given to the possibility that the medication could have been helpful. Of course, neither I or the newspaper reporter has any way of knowing if the medication’s benefits (if any) outweighed its problems (if any); and, that’s precisely the point. I hold that the author has a responsibility to point out such pertinent negatives.

That scientific papers are implicitly and, in the majority of medical journals at least, explicitly expected to include this kind of self-critique to alert the reader and demonstrate the authors’ own awareness of the possible misinterpretations of their work is especially significant in an era in which even hard news stories on TV are skewed by the simple process of editing out video footage that doesn’t support the program’s own agenda.

Perhaps the lay media owe their audiences at least a disclaimer that, while conclusions drawn from stories such as “Many of the ‘ADD generation’ say no to meds,” may or may not turn out to be accurate, those reports cannot be taken as complete, unbiased, or scientifically valid and actions taken based on them may prove more dangerous than one would assume from the article itself.

Many of the ‘ADD generation’ say no to meds; Newly minted grown-ups are carrying out a massive natural experiment by choosing to do without the drugs that profoundly affected their experience of childhood. By Melissa Healy, Las Angeles Times December 18, 2006¹

This article focuses primarily on a number of young adults who, diagnosed with and treated with medication for Attention Deficit Disorder in childhood, have chosen to discontinue those stimulants.

Commentary

This article exemplifies one of the most problematic aspects of the lay press reporting on healthcare issues by promoting a point of view that could influence readers.

There is no indication that any aspect of the story is inaccurate or intentionally misleading. On the other hand, each of the individuals who decided to stop taking their ADD medications is reported to have done well. Further, support for the discontinuation of medication is presented uncritically while doubt is cast upon theories and studies favoring the ongoing use of these medications.

And, consider the tone of these excerpts:

The penultimate portion of the article is devoted to Dr. Lawrence Diller, the author of “The Last Normal Child,” in which he “raises concerns about the effect on society and children when parents, schools and the medical establishment reach too easily for such medication [for ADD].”

The issues raised, whether ADHD medications should be taken indefinitely and, if not, how the decision to continue or discontinue the medication is determined, is both legitimate and important. A reporter’s responsibilities in presenting the story are less clear. In this case, a newspaper story that features reports of interesting individuals who seem to have made the right decision going off a medication, breezy summaries of research and ideas about the disease, and a clear air of approbation for independence-minded young adults who defy their parents and doctors by discontinuing their medications is, it would seem, more likely to influence those facing this decision than pages of grey print reporting findings of scientific studies.


Footnotes

1. Also see Related Stories “in their own words”↩

Survey Reveals Significant Noncompliance With Medication

ccording to a national medication adherence survey¹ just released by the National Community Pharmacists Association (NCPA) and Pharmacists for the Protection of Patient Care (P3C), “nearly three out of every four consumers admit they don’t always take their prescription medications as directed.”

Interestingly, 64 percent of respondents said they follow their physician’s instructions “extremely closely,” but 74 percent also admit to non-adherent behavior.

Other findings follow:

• 49 percent said they had forgotten to take a prescribed medication.
• 31 percent had not filled a prescription they were given.
• 24 percent had taken less than the recommended dosage.
• 11 percent had substituted an over- the-counter medication instead of filling the prescription they were given.

The survey’s press release goes on, “The good news out of the survey was that consumers appeared open to tapping into the unique expertise of their pharmacist in order to improve medication adherence.”

Source: Take As Directed: A Prescription Not Followed; New Survey Shows Improper Medication Use Reaching Crisis Proportions 12/15/2006

Commentary

While the noncompliance results are hardly surprising, they are useful numbers and reinforce or complement earlier findings. Cynic that I am, I am less impressed with the findings of a survey sponsored by two groups of pharmacists that those surveyed had positive responses to queries about their confidence in pharmacists. Watching market research being carried out over a span of several years, I am acutely aware of the effect the phrasing of a survey’s queries has in prompting a wished-for response. On the other hand, I do believe pharmacists may have a unique, potentially effective role to play as compliance enhancement agents.

1. The telephone survey of 1,000 adults was conducted by the Polling Company, Inc. between Oct. 25-29. The margin of error for the survey is 3.1 percent at the 95 percent confidence level.↩

‘Cognitive Dissonance’ Became a Milestone In 1950s Psychology By Cynthia Crossen Wall Street Journal December 4, 2006

As the title of this article suggests, it is an historical look at Leon Festinger’s development of the concept of cognitive dissonance. I’ve written about it today because (1) it’s interesting on its own merits and (2) it serves as a reminder that the phenomena underlying patient compliance are not unique to healthcare and that theoretical work in non-healthcare fields, including but not limited to cognitive dissonance, may be directly applicable to the problems of nonadherence to treatment.

This excerpt makes the same point:

Why, for example, do people who know cigarettes are bad for their health continue to smoke? This is classic cognitive dissonance: They know one thing and feel another. Mr. Festinger believed this incongruity is as uncomfortable to the human organism as hunger. One way or another, the anxiety must be assuaged. So the smoker builds a bridge — a rationalization — from feeling to fact: If he stopped smoking, he’d gain weight, which would also be unhealthy; some risks are worth taking to have a full life; the risks of smoking have been exaggerated. Indeed, in a 1954 survey asking people if they felt the link between lung cancer and cigarettes had been proven, 86% of heavy smokers thought it wasn’t proven, while only 55% of nonsmokers doubted the connection.

And, the examples are fascinating. For example,

But where Mr. Festinger found the richest raw material for his theory was in a cult that developed in Chicago in 1954. A woman Mr. Festinger called Marion Keech claimed she was receiving messages from another planet, Clarion. The messages predicted that on a given date, a cataclysmic flood would engulf most of the continent. Those who joined Mrs. Keech’s sect would be picked up by flying saucers and evacuated from the planet. … Before the dates of the expected flood, the cult was mostly averse to publicity and had no interest in attracting other believers. On the day before the flood, the group was told that at midnight a man would appear at Mrs. Keech’s house and take them to a flying saucer. But no knock came at her door, and the group struggled to find an explanation for why there would be no flying saucer or flood. At 4:45 a.m., the group said, a message arrived from God saying He had stayed the flood because of their strength. What interested Mr. Festinger was not so much this face-saving explanation as what the cult members did in the following weeks. Rather than shunning public attention as they had before, they began zealously proselytizing. “There were almost no lengths to which these people would not go now to get publicity and to attract potential believers,” Mr. Festinger wrote. “If more converts could be found, then the dissonance between their belief and the knowledge that the prediction hadn’t been correct could be reduced.”

Commentary: Cognitive Dissonance And Noncompliance

Among other insights it offers, cognitive dissonance goes a long way toward explaining why starkly presenting patients with facts, regardless of how valid the data and how elegant the research, is insufficient to improve compliance. In fact, as the example of the doomsday cult excerpted above points out, those individuals whose beliefs are proven inaccurate in the most definite and most public manner are most likely to react by intensifying their commitment to those erroneous beliefs. It further follows that perhaps aggressive, dramatically confrontational approaches to patient education are not only ineffective but counterproductive.

I Want It Now! The curious economics of temptation By Tim Harford Slate.com Nov. 25, 2006

While this brief article at Slate.com, an entry in that online publication’s “Undercover Economist” column, does not mention healthcare or compliance, the applicability of its message to those areas is apparent. That message is set forth in these two excerpts:

The author goes on to point out the utility of this insight, describing, as an example, a plan called:

Commentary

Every clinician has dealt with the patient who will follow his blood sugars assiduously, take her pills precisely as prescribed, or adhere to his diet – tomorrow. The idea raised in this article should, at least, remind physicians that it’s likely that the patient’s explanations are manifestations of the value he or she places on immediacy rather than a failure of will power or an excuse offered in hopes of avoiding compliance.

And, perhaps lifestyle shifts (e.g., terminating smoking) are more likely to be effected if the clinician recommending the change suggests that the commitment to change be made now with the actual behavioral alteration taking place in the future.

Cultivating Compliance By Peter Carkeek, Pharmaceutical Executive Europe. May 1, 2006

This article, composed of discussions with senior executives from some of Europe’s biggest pharmaceutical companies, speaks directly to the problems and potential solutions of phama’s involvement with compliance programs, issues raised in this blog in the post, Making Pharma-supported Compliance Programs Independent Of Marketing. I’ve listed some of the major ideas in excerpts or condensed form below, but the entire piece deserves reading.

Len Starnes, Head of e-business at Schering AG (Germany), points out that there “is a disconnect between the short-term focus of most marketing teams and the long-term commitment required to ensure the success of patient compliance programmes, particularly in long-term and chronic health conditions.”

The challenge, according to Di Stafford, head of patient relationship marketing for Pfizer UK, is obtaining the “cross-functional buy-in” necessary for success of patient compliance programs by these groups: medical, marketing, information technology, and sales.

Only high-value brands that are prescribed long-term offer sufficient financial returns for compliance programs. One solution recommended is involving other stakeholders, such as third party payers, to help finance more programs. Another is to view compliance programs as an integral part of the product itself rather than a value-added offering.

While compliance programs have the potential of benefiting multiple brands and business areas, most companies operate at the brand level with regard to planning and budgets.

Some pharma companies have had some success, establishing sophisticated programs that “integrate a variety of patient touch points such as dedicated professional nurses, contact centres, websites, and direct mail” and segment patients according to their risk of noncompliance.

Some companies are using behavioral specialists to garner an empathic understanding of patient issues.

David-Romain Bertholon, public health project manager at Schering Plough in France, reports “forming partnerships with patient organizations throughout France to better understand how to produce informational brochures that are both convenient and easy for patients to read.”

Bertholon goes on to say that the biggest challenge is to convince other non-pharma stakeholders that patient compliance issues and the pharma-supported compliance programs are important.

Yvonne van der Schouw, patient relations manager for Abbott in the Netherlands, also works with patient organizations, specifically to discover “how to improve information flows through print channels, such as magazines and newspaper articles, offering disease information on rheumatoid arthritis — an area of therapeutic importance to Abbott.” She also reports on Abbott’s use of third parties to communicate with consumer to avoid running afoul of restrictions on working directly with patients.

Commentary

This is a thoughtful reconsideration of pharma-sponsored medication compliance programs, which provides a valuable service by pointing out the complexities and intrinsic organizational conflicts that have limited the success of such efforts in the past. While some of the potential solutions vary, these fundamental concerns are parallels to the issues I’ve raised on this site and John Mack elaborated in his post, Compliance, Math, and Marketers. Clearly, the over-simplified notion of a time-limited adherence enhancement program that uses unproven methodology to promote one brand, an idea that has long been the standard approach in the industry, is insufficient. While it is disheartening that this trend has flourished and opportunities have been lost, that it is being challenged now is most encouraging.

Even more exciting (OK, it’s exciting mostly to patient adherence geeks like me, but still, … ) are the concepts raised in response to these problem. If manifest into reality, such ideas (e.g., expanding the scope of those involved in supporting the programs, bringing in other stakeholders, using behavioral specialists to identify important patient traits, and working with patient groups) hold the potential to make a quantum leap in compliance enhancement.

The Eyes Of Honesty by Clive Thompson New York Times December 10, 2006

This brief brief article in the New York Times Sunday Magazine describes an experiment based on the premise that individuals are more likely to behave honestly if they know they are being watched.

In the psychology department at Newcastle University, some patrons were not making their contributions at a self-serve, self-pay coffee station.

After reading about this, a British police department in Birmingham is placing posters of eyes as part of a campaign called “We’ve Got Our Eyes on Criminals.” Researchers will analyze the results to determine if there is a similar effect on street crime.

Watching Compliance

While patient compliance is clearly not identical to honesty, adherence is higher when patients know they will are being observed, just as office workers are more likely to pay for coffee on the honor system if they know they are being watched. It seems worth considering whether compliance would improve if a similar psychological cue were provided.

Compliance, Math, and Marketers John Mack; December 01, 2006

John Mack provides an upfront description of hs blog, which is useful in placing his comments in context:

The specific posting that referenced here is based on Mr. Mack’s observations of the goings-on at eyeforpharma’s 3rd Annual Patient Compliance and Adherence Congress in Philadelphia. While the entire entry is worth reading,¹ the portion most pertinent to my point follows:

Mr. Mack goes on to describe ideas raised about using social networking to reach patients and concludes,

I’m taken by this recommendation, especially coming as it does from someone intimately familiar with the pharmaceutical industry. When I’ve corresponded with marketers about compliance projects, those individuals were, almost without exception, bright, personable, and significantly more forthcoming than I would have anticipated. Still, they all thought of compliance, congruent with Mr. Mack’s assessment, in terms of short-term projects limited to one medication (one produced, of course, by their corporation) or, at most, one disease (for which their corporation produced a heavily-used medication). As Mr. Mack puts it, “How can they be otherwise?”

And, I agree that “Patient Opinion Leader” (Mack’s term for patients already on medication who would serve as outreach agents to other patients) is a grand notion (OK, I think it’s grand because I’ve been pushing it myself for a while now) as part of the solution. But, that idea, from my perspective, is a sidelight to the post’s main point:

From Mr. Mack’s lips to God’s ear.


Footnotes

1. One somewhat puzzling note is the distinction between “compliance” and “adherence” Mr. Mack reports was made at the conference:

   Compliance concerns following the dosing regime of a drug. You can measure it as the percent of doses of a drug taken as prescribed while the patient is actively taking drug.

   Adherence, on the other hand, concerns refilling the prescription. As time goes on, patients refill less and less often and many drop the medication altogether. It has been estimated that in developed countries only 50% of patients who suffer from chronic diseases adhere to treatment recommendations. This is measured with ‘persistence’ curves.

   I am unfamiliar with these distinctions, and these definitions are not routinely used by clinicians or in the medical literature. There has been a movement advocating the use of “adherence” as less patronizing than “compliance,” but despite years of this effort, the majority of clinicians continue to use “compliance” and “adherence” interchangeably.↩

Creating Compliance Pharmaceutical Executive Europe Oct 1, 2006

This interview with Christian Husegaard, the head of sales and marketing for Bang & Olufsen Medicom, contains little, if any, new information but does nicely summarize the basic noncompliance issues and provides some insight into commercial development of compliance enhancements, especially electronic devices to remind patients of their medication regimens.

This excerpt is Mr. Husegaard’s response to the query, “How are approaches to patient non-compliance changing?”

Commentary

Given that this article is, after all, on some level, a puff piece promoting Bang & Olufsen Medicom, perhaps my expectations were unreasonable. Nonetheless, it is disappointing to find Bang & Olufsen, a company with extensive resources and a reputation for design and quality, focused primarily on updated, electronic versions of older methodologies, especially reminders and patient education. While contemporary technology does offer added value, such as providing feedback to prescribing clinicians, the underlying processes have not historically resulted in notable improvements in adherence. One fears that this may be a case of developing a new, more attractive version, with extra bells and whistles, of minimally useful tools.

Depressive Symptoms and Adherence to Asthma Therapy After Hospital Discharge
Amena Smith, Jerry A. Krishnan, Andrew Bilderback, Kristin A. Riekert, Cynthia S. Rand, and Susan J. Bartlett. Chest 130: 1034-1038

Depressed Asthmatics Often Stop Treatment
Megan Rauscher Reuters. Scientific American October 20, 2006

[Note: This post is an addendum to and expansion of an earlier blog entry, Depression & Decreased Adherence To Asthma Therapy. Information about CME associated with this study is available in that earlier post.]


This study is a straightforward, valuable assessment of “the effect of depressive symptoms on adherence to therapy after discharge in patients hospitalized for asthma exacerbations.

Study Parameters

A prospective cohort of 59 adult patients hospitalized for an exacerbation of asthma were assessed for depression with the Center for Epidemiological Studies-Depression scale and then electronically monitored for adherence to their prescribed regimens of inhaled corticosteroid and oral corticosteroid for 2 weeks following discharge.

Results

Adherence was lower in the 41% of patients who met criteria for depression even after adjustments for potential confounders (age, gender, and education).

Commentary

Dr. Barlett’s comment, as quoted in Scientific American captures the implications of the study:

The study’s authors were careful to note that it is unproven whether or not treating the depression in such patients would improve medication adherence, but confirming the long held clinical suspicion that affective symptoms, an especially common comorbidity with asthma, has a negative impact on compliance is a significant step forward.