Entries Tagged as 'Transforming Compliance'
April 20th, 2010 · Comments Off
As promised in A Review Of Treatment Adherence – 2010, Part 2 of the summary review of patient noncompliance is now live on pharmaphorum at Rethinking patient noncompliance (Part 2).
As before, I am posting only the major headings from the piece here.
Patient noncompliance: Misunderstood concept – ineffective solutions
Development of an effective methodology for managing patient noncompliance remains unlikely as long as the strategies being investigated are limited to those already shown to be ineffective.
Key Point: Noncompliance is not exclusively a medical issue but a personality trait that manifests in many areas of life. Treating patient compliance as though it’s a straightforward, sui generis phenomenon independent of other human behavior all but eliminates the potential for significant advances in the field.
Employing a Copernican perspective to find compliance solutions that work
- Do away with the restrictions implicit in the contention that healthcare compliance is unique.
- Change the compliance game from clinician vs. patient to clinician & patient vs. problem being treated
Readers interested in the complete paper can find it at Rethinking patient noncompliance (Part 2).
Tags: Transforming Compliance
April 14th, 2010 · Comments Off
Rethinking Patient Noncompliance – Again
Once more unto the breach, dear friends, once more
Paul Tunnah, founder of pharmaphorum, an online pharma discussion and networking site, invited me to submit an overview of patient noncompliance. The first portion of that paper was published today at Rethinking patient noncompliance (Part 1).
While those who have followed my efforts on AlignMap will find little that is surprising, the article does, I think, offer a coherent, condensed summary of the current, problematic status of treatment adherence. The main points, sans discussion, follow:
The Dysfunctional Concept Of Patient Compliance
1. Patient compliance, as described by its standard definition, is a useful statistical measure but an inadequate and often counterproductive explanatory concept.
Key Point: The term patient noncompliance, by definition, is no more than a descriptive label given to a phenomenon and indicates nothing about the cause of that phenomenon.
2. Noncompliance leads to inadequate implementation of treatment recommendations, which itself leads to devastating economic and personal consequences.
Key Point: Characterizing the financial, physiological, and social costs of patient noncompliance as catastrophic is neither hyperbole nor hysteria, just fact.
3. Patient noncompliance is, by any measure and from any perspective, pervasive and difficult to detect.
Key Point: While patient compliance varies, a reasonable expectation, absent evidence to the contrary, is an average compliance rate of 50%.
4. No practical methodology has been shown to significantly, reliably, and enduringly enhances compliance for a diverse patient population.
Key Point: Many methodologies designed to enhance compliance are effective – for some patients some of the time; none of these methodologies are effective for most patients most of the time. Further, no methodologies have been demonstrated to predict which patients will and will not follow treatment recommendations or which patients will respond to which compliance enhancement techniques.
Solutions, AKA Coming Attractions
A new perspective on treatment adherence that offers potential solutions is the focus of Part 2 of Rethinking Patient Noncompliance, which will be published at pharmaphorum next week.
Part 1 of this piece is available now, in its entirety, at Rethinking patient noncompliance (Part 1).
Tags: Transforming Compliance
October 20th, 2009 · Comments Off
AdherenceLand - Where Compliance is FUN
Adherence Enhancement – Fun vs Futility
Yesterday, Jonathan Richman at Dose Of Digital, published The Only Way Pharma Can Improve Compliance: Fun, a post with three commendable aspects:
- The perspicacious identification of AlignMap as the “ultimate in compliance resources”
- The equally perspicacious and arguably more significant observation that “… the reason we haven’t made an impact is because we test and use one intervention at a time. … What we need to offer is a wide choice of different compliance programs with each individual enrolled in the programs that are going to impact them.”
- The proposition that fun might well be a motivator for adherence behaviors
Why Fun Is Important In Transforming Compliance
The argument made for fun is convincing and – well, fun.
It’s also important.
It’s important because the Adherence Can Be Fun hypothesis looks like it might work. Rather than repeat the argument Jonathon Richmond makes, I suggest you read his post and see for yourself. I think you’ll be impressed.
It’s important because, as I have pointed out on occasion, repeating the same processes tends to produce the same results. In the case of patient compliance, that means trying the same adherence enhancement that didn’t work the first 821 times probably won’t work the 822nd time. Trying something new (not just another version of the same tired idea), is essential; trying something new, such as fun, which has proven successful in changing behaviors in other fields is astutely logical.
Finally, it’s important because we need to be looking for methodologies that enhance compliance by enhancing the alliance of the patient with those involved in his or her healthcare, including clinicians, Pharma, third party payers, and other stakeholders. Fun would be a potent force to effect that alignment.
Now, hit that link and read Jonathan Richman’s piece – heck, have fun with it: The Only Way Pharma Can Improve Compliance: Fun
Tags: Transforming Compliance
October 1st, 2009 · Comments Off
The How To Fix Patient Compliance Now Series
This is the third in a series of posts offering steps to improve the study of and communication about patient compliance. These recommendations are simple and inexpensive; their implementation, in fact, is solely a function of motivation on the part of those working in the field. Finally, the benefits of these recommendations are magnificently self-apparent.
Previous Steps follow:
- Always provide context-pertinent definitions of Patient Compliance terminology
- Differentiate between unintentional and intentional noncompliance
Step #3. Support compliance claims
AKA Back it up or shut it up
AKA Don’t claim it if you can’t name it
Claims that, for example, medication compliance will be or has been improved by a new drug or the use of an automated reminder service has achieved X% adherence rate for participation in a disease screening program exam, must be accompanied by evidence.
Not doing so could mislead a naive audience; even worse, claims made without evidence to a more knowledgeable (or more cynical) audience may well play a role in making the entire field dealing with treatment adherence suspect. After all, if retailers of compliance enhancements, developers of a specific compliance model, and adherence promotions run by third party payers, pharmaceutical manufacturers, and independent firms boast of compliance rates so high they would mark a major breakthrough in the field but provide no support or only allude to vaguely defined “studies” that, if existent, can’t be found, readers and viewers will (and should) be suspicious of compliance claims in general.
An Example From Real Life
When a medication adherence program administered under the imprimatur of a major health insurer claims a 95% compliance rate for treatments that typically carry a significantly lower rate of adherence, their press releases, especially those directed to clinicians, are, I contend, obligated to show the evidence. Was there a blind study with a control group? How was the rate calculated? If there was a study, was it run by an independent party or was it done internally? Without that basic information, the claim of a 95% compliance rate is little more than puffery.
That my repeated emails to the program director asking for this information receive no response is, unfortunately, all too typical and tends to abet my suspicions that something is being hidden.
Proprietary Is Not A Magic Word
I’ve been involved in enough business matters to understand the value of trade secrets and necessity of not revealing proprietary information.
On the other hand, I also know the difference between abracadabra and proprietary. And, I know there is something fundamentally wrong about declaring that the substance of a proprietary study must be kept secret while simultaneously claiming the alleged findings from that same study as evidence that a given compliance intervention or program is successful.
Tags: Transforming Compliance
September 28th, 2009 · Comments Off
The How To Fix Patient Compliance Now Series
This is the second in a series of posts offering steps to improve the study of and communication about patient compliance.
These recommendations are simple and inexpensive; their implementation, in fact, is solely a function of motivation on the part of those working in the field.
Finally, the benefits of these recommendations are magnificently self-apparent.
These traits are demonstrated by the first step, which was discussed in the previous post, How To Fix Patient Compliance Now – Practical Steps To Rehabilitate The Concept Of Adherence:
1. Always provide context-pertinent definitions of Patient Compliance terminology
Step #1 is, again, simple, inexpensive, and obviously beneficial. After all, since there are no standard, universally applicable definitions of the most basic terms, including “compliance” and “adherence,” it seems clear that using those words in professional literature or commercial promotions obligates the author to provide definitions.
Step #2. Differentiate between unintentional and intentional noncompliance
One can slice and dice noncompliance in a myriad of ways (e.g., according to the type of treatment with which a patient is noncompliant, whether the patient is completely or partially noncompliant, the cause of the noncompliance, etc.). Depending on the situation, certain classifications will be useful or even vital.
In any clinical discussion of noncompliance, however, it is always essential to identify whether noncompliance is intentional or unintentional. (The exceptions are cases in which noncompliance is discussed exclusively as a global concept rather than a clinical event)
If both intentional and unintentional noncompliance are present, those groups must be broken out and described separately.
It’s essential to differentiate between unintentional and intentional noncompliance because intentional and unintentional compliance are fundamentally different events – much as, say, a death due to murder committed for hire by a mob hit man is different from a death caused by pancreatic cancer.
Drawing conclusions, comparing results, or developing patient care methodologies is a hopeless task if unintentional and intentional noncompliance cannot be specifically identified.
Of course, there may be instances in which information distinguishing between intentional and unintentional noncompliance is not available (e.g., reporting on a study that didn’t include that parameter). Happily, there is an simple solution. Studies in which unintentional and intentional noncompliance cannot be differentiated are simply eliminated from consideration.
Tags: Transforming Compliance
September 22nd, 2009 · Comments Off
Revolutionary Overthrow Of Compliance Concept Delayed
Bringing down the current concept of patient compliance and replacing it with a functional set of principles is taking for-freaking-ever.
The current hangup is the manifesto. Any revolution worth its salt has to have a manifesto. Since it’s not the sort of thing one can knock off on a Saturday afternoon while watching college football on TV, it’s hardly a surprise that composing a manifesto requires time and effort.
But, it turns out that just designing and printing a manifesto in a format that bespeaks authority yet is simultaneously cool in that ironically subversive way, the stylistic goal to which the really hip manifestos aspire, is no small task. The bids for engraving the final product on stone tablets came back way over budget so I have to rework the publication process, substituting simulated calligraphy on recycled parchment for chiseled granite. That should reduce costs considerably, but it all takes time.
While awaiting the completion of the manifesto and the beginning of the revolution, however, much can be done to (partially) rehabilitate patient compliance into a concept that is, if not an efficacious construct, at least one that is more useful, less likely to result in mistakes and misunderstandings, and – well, less embarrassing.
Things To Do Until The Manifesto Is Finished
Starting with this entry and continuing for the next several posts, I will introduce, one at a time, principles which are simple and inexpensive to implement in any context yet can massively improve the field of treatment adherence.
Moreover, these axioms are so self-apparent – and should, in fact, have been in use for years – that the failure to implement them should be a res ipsa loquitur case of fundamental miscommunication, whether intentional or unintentional, and/or profoundly flawed scientific method.
Step #1: Always provide context-pertinent definitions of Patient Compliance terminology
The choice of Patient Compliance terminology (e.g, “compliance,” “adherence,” “concordance,” etc.) is a matter of taste. Provision of context-pertinent definitions of those terms in every case in which they are published is invariably an obligation.
This is, as advertised, a simple proposition: because there are no standard definitions of “compliance,” “adherence,” “concordance,” etc., that apply universally, using one or more of these terms (or their negatives) in any formal or informal publication (including but not limited to articles, press releases, abstracts, advertisements, white papers, editorials, dissertations, studies, feature stories in the lay press, and poster sessions), obligates the author to define those words pertinent to their context.
A key feature of this step is the bypassing of the inevitably interminable debates over the “correct” definitions and the inevitably unsuccessful efforts to coerce everyone in the field to follow the mandated official Glossary Of Patient Compliance Terminology. Authors, researchers, marketers, clinicians, professors, and anyone else dealing with the field can use terms to mean whatever they prefer – as long as those meanings are clearly explained.
“Context-pertinent” means the definition must be sufficient to allow a reader to understand precisely what behavior qualifies as “adherence” or “non-adherence” in the circumstances described by the article or advertisement.
A press release, for example, claiming a medication program results in “95% Adherence” would necessarily include an explanation of “adherence” as used in the copy (e.g, “For the purposes of this report, adherence is the percentage of patients who reported taking at least 80% of their medications every week over a period of 6 months”).
This is fundamental and essential information, yet by my casual count, it is absent from more than 75% of the press releases and promotional pieces that include claims of high or improved compliance. And, that fundamental and essential information is absent in a discouragingly large fraction of the scientific literature I peruse.
One of the advantages of always providing definitions of adherence terminology is that nonspecific (or vague or nebulous or vacuous) applications of these words are acceptable as long as it’s made clear that the usage is nonspecific (or vague or nebulous or vacuous). Those four-color brochures about the 6th format of a medication can still boast that “Medication X is now available in once a day dose for better compliance,” simply by adding, “‘Better compliance’ in this case means we think, based on some studies, none of which involved Medication X, patients will, one way or another, be more likely to take the right dose at the right time with the once a day dose as compared to patients taking the same medication two or more times a day.”
The definitions can be within the text, in a footnote, part of a glossary on a sidebar, … as long as they are obvious and, most importantly, available in every publication format. The abstracts of scientific papers, for example, must include the definitions since they may be published independently of the paper itself. And no fair writing that “definitions are available on request.”
Advantages Of Implementing Step #1 – Inclusion Of Definitions
Being certain about what a study or a press release means by the words “improved adherence” seems, from my perspective, itself sufficient justification for implementing this step. Studies can be compared, anomalies understood, and the significance of findings determined. (I would also have fewer emails to write, asking for missing data.)
But there are other potential gains.
With luck, for example, the automatic inclusion of definitions might detoxify some of the terminology and might even decrease the noise level of the arguments about which synonym of adherence is most coercive and condescending.
Perhaps best of all, the altogether reasonable expectation that publications about compliance include definitions of the pertinent terminology would go far toward eliminating much of the confusion and conflicting claims that plague the clinical, research, and commercial aspects of the treatment adherence concept and preclude most unintentional miscommunication about compliance and at least render the creation of intentionally misleading claims more difficult.
Tags: Transforming Compliance
August 10th, 2009 · Comments Off
My most recent post, dealing with profiling (segmentation) as it is used in the credit card industry and its potential applications to treatment implementation, can be found on the eyeforpharma.com site at The Potential Power Of Patient Profiling
Tags: Transforming Compliance
August 4th, 2009 · Comments Off
Epiphany Du Jour – Training To Be An Effective Patient That Begins Post-Diagnosis Begins Too Late
Question #1: What is the likelihood that an individual reaching adulthood in the US will eventually find himself or herself in the role of a patient?
Answer #1: Almost certain, according to my calculations.
Question #2: When and how does one typically learn to how to operate effectively in the patient role?
Answer #2: While learning to operate in the patient role theoretically takes place whenever one visits a clinician for any reason, that process, which could charitably be called “learning by doing,” is a hit or miss affair that routinely receives little attention until one is concerned about the possibility of or diagnosed with an anxiety-provoking disorder.
Question #3: What is the worst possible way and the worst possible time to learn to operate effectively in the patient role?
Answer #3: See Answer #2.
A Illustrative Scenario
Consider this example: An asymptomatic, intelligent 34 year old woman with only minor interactions previously with organized medicine is diagnosed with breast cancer during a routine exam. Her doctor informs her (accurately) that any delay in treatment increases her risk. She is immediately faced with the decision of whether or not to follow the primary recommendation for surgical intervention and, if she agrees, which of the 2-4 possible procedures she wishes. If she declines the surgical procedures, she must decide which, if any, of the alternative treatments she will undergo. She also has to deal with the impact the diagnosis and treatment will have on her spouse, her children, her job, her friends, and her extended family.
This is, I submit, a suboptimal situation for learning to be an effective patient, the intensity of ones motivation notwithstanding.
The Solution – Teaching How To Be An Effective Patient In The K-12 Curriculum
An explicit goal of elementary, middle, and high schools is preparing children to undertake adult tasks. Thus, in addition to learning basic math, writing methodology, and reading comprehension, students also take courses in sex education, nutrition, consumer skills, and managing relationships.
Learning the skills necessary to be an effective patient, such as what to expect from, how to communicate with, and when to seek help from healthcare professionals, how to understand medical reports, pharmaceutical ads, and other pertinent printed and online literature, … , is at least as important as learning about the risks of unprotected sex or the need to save a portion of ones paycheck against future needs.
Making “How To Be An Effective Patient” part of the K-12 school Health curriculum is no panacea, but it seems a rational and promising alternative that is likely to substantially improve the current “just too late” methodology.
Credit Due Department: The photo portrait atop this post was taken by Bhernandez. The schoolroom photo was taken by Rob Shenk
Tags: Patient Education · Patient's Role · Transforming Compliance
July 23rd, 2009 · Comments Off
How We Got Here: The Failure Of Patient Compliance
The currently used Patient Compliance paradigm, as I’ve subtly suggested in previous posts, has not yielded a positive return on the time, money, and effort spent in its pursuit.
The consensus of experience and research in and experience with these efforts to improve adherence to treatment can be succinctly and accurately characterized by these three points:
- Many of the currently used individual compliance-enhancement interventions benefit some of the patients under some conditions some of the time.
- None of the currently used individual compliance-enhancement interventions benefit most patients in most conditions.
- Reliably predicting if a specific compliance-enhancement intervention will benefit a specific patient in a specific situation is an unachieved goal.
From these principles, one can infer that offering several different interventions at once might well be beneficial. And, in fact, there is evidence that a package of several, multi-layered compliance-enhancement interventions can be effective across the patient population. As one would suspect, however, such shotgun approaches are neither efficient or economic. This extract from a Cochrane Review of medication compliance enhancements elegantly summarizes the current state of affairs:
Several complex strategies, including combinations of more thorough patient instructions and counseling, reminders, close follow-up, supervised self-monitoring, and rewards for success can improve adherence and treatment outcomes. However, these complex strategies for improving adherence with long-term medication prescriptions are not very effective despite the amount of effort and resources they consume.
My conviction is that the failure to develop pragmatic solutions for noncompliance is due to the concept of medical noncompliance itself, manifested in a widespread misunderstanding of that concept, a denial of its complexity, and an obsessive drive to find a panacea for a problem that is more ideological than pathological.
Medical Noncompliance has ultimately become no more than a label we’ve assigned to an extraordinarily wide and varied category of non-optimal behaviors patients exhibit in response to their clinicians’ treatment recommendations. Instances of noncompliance, as already noted, can appear in an infinite variety of forms and be caused by an infinite number of causes. And to flip the late Justice Potter Stewart’s famous statement about pornography,
We can define medical noncompliance
but we often don’t know it when we see it
Why Now: Money – And Saving A Life Or Two
Remarkably, there has been so much emphasis placed on the potential cost-saving to be wrung from increased treatment adherence rates that it seems incumbent to note that the primary goal in improving the effectiveness of medical treatments is to maintain and improve the health of individuals, thus reducing suffering and the loss of life.
That improving the effectiveness of medical treatment by increasing treatment adherence rates will decrease primary healthcare expenses and secondary costs due (e.g., losses due to absenteeism from work) is a pleasant bonus (OK, make that an incredibly wonderful bonus).
That point duly documented, the economic cataclysm created by spiraling healthcare costs during a period of general economic chaos is the tipping point precipitating long overdue changes in how healthcare is managed, politically, professionally, and administratively. Healthcare expenses in some industries are the most expensive budget category other than salaries. A 2004 McKinsey Quarterly presciently opened an article on controlling healthcare benefits with the observation that “In a few years, the average Fortune 500 company may be spending as much on health benefits as it earns in profits.” Further, responsibility for healthcare costs have arguably become the primary conflict between management and labor. In these circumstances, the inability to efficiently improve medical compliance rates, the most significant cause of unnecessasry healthcare costs has escalated from painful and frustrating to catastrophic.
The healthcare community has a responsibility to find a solution. We should start by looking for that solution in the most likely places.
A passerby walking home late at night sees a drunk on his knees under a streetlight, searching for something. The passerby asks the drunk, “What are you doing?” “Looking for my apartment key,” says the drunk. The passerby, trying to be helpful, walks to the area near the drunk and begins looking for the key. After 15 minutes, it becomes clear that the key is not in the vicinity. The newcomer asks, “Are you sure you lost your key here?” “No, actually I first noticed it was missing when I was walking over there,” the drunk says, pointing to an area a half block away. The passerby, a bit perplexed, asks, “Then, why are you looking here if you lost your key over there?” Responds the drunk, “Because the light is better here, under the streetlight.”
I’ve used that joke before, but it fits too well here to pass it up. The point, of course, is that we can’t afford to keep looking for solutions in areas that have repeatedly been shown to be bereft of answers even if those areas are more familiar.
What Has To Change: New Solutions To Noncompliance
One might hypothesize that the current system has been perpetuated simply because no alternatives have been found.
In this instance, one would, however, be wrong.
Heck, not only are there promising alternatives but those alternatives are well known and in place – in other fields
Compliance and noncompliance are issues in many areas of human endeavor other than healthcare. The legal system is, in fact, built around the notion of citizens complying with laws. Politicians work to bring us into compliance with their ideas. Adherence is an essential element in educational institutions, military units, and professional communities. And, of course, marketing is all about getting potential buyers to comply with recommendations to buy a particular product or set of goods.
Here’s the key:
Noncompliance is not exclusively a medical issue.
It’s a personality trait that manifests in many areas of life.
Consequently, a reasonable source of potential tactics for managing noncompliance is that set of strategies that have been successful in these other fields.
For today, I’ll ask the reader to be content with one example with the promise (i.e., threat) of several other possibilities to follow in the future.
What Next: Population Segmentation – One Promising Option To Improve Treatment Effectiveness
In keeping with the principles of full disclosure, I want to alert readers to the fact that I am involved with EnrichMap, which offers a system of interventions based on population segmentation (also called patient profiling).
Marketing research uses population segmentation to identify the likely users of a product or service and the specific appeals to which those users are most likely to respond. Within that definition, however, are several varieties of segmentation. Large groups may be broken down into subgroups based on age, ethnic background, economic status, cultural mores, psychological traits, … .
Ironically, Big Pharma is one of many industry sectors that use population segmentation extensively. Most commonly, however, pharmaceutical manufacturers use patient segmentation only for determining the characteristics of the patient group whose needs best match a given product.
Today, sophisticated statistical techniques are used to divide the pharmaceutical marketplace into distinct segments of patients, based on their clinical profiles and the type of medical care they receive. When done well, patient segmentation reveals the size of the market, which segments hold the most value for a brand, and which product attributes will appeal to each patient sector.
And, population segmentation is used extensively in health care planning, i.e., anticipating future needs, allotting resources, and constructing delivery systems.
To create a valid, reliable, and useful segmentation is not a trivial task; the specific methodology required is, thankfully, beyond the scope of this post. On the other hand, the potential utility of such groupings is intuitively apparent.
If, for example, market segmentation shows that 85-90% of your product, a digital caliper with built-in GPS, is purchased by 45-55 year old Asian women with postgraduate engineering degrees, you can probably turn down that commercial time on SpongeBob SquarePants the ad company is pushing you to buy, regardless of how low the ad rates or how huge the show’s audience (unless there is convincing evidence that the program’s viewership skews to 45-55 year old Asian women with postgraduate engineering degrees).
Similarly, if population segmentation shows that 94% of a working mothers of school-age children strongly believe keeping their kids’ immunizations up to date is essential but find it difficult to keep track of current recommendations, document which immunizations their children have already had, and arrange the logistics of getting their offspring immunized, public health officials might consider (1) decreasing the monies spent on educating mothers about the importance of immunizations (2) developing an automated means of alerting parents to changes in immunization recommendations, and (3) constructing a system, perhaps in cooperation with the schools or other community institutions, to conveniently provide and document the immunizations.
And, on a doctor-patient level, if a physician knows that a patient is part of a population segment that typically becomes ill at ease, uncertain, and confused when dealing with healthcare decisions or treatment instructions, the doctor might decide to institute special measures for that patient that might not be used for others with the same diagnosis. After the explanation of a treatment plan, for example, the patient might be asked to describe the recommendations in his own words or to complete a simple test about the treatment to check his understanding of the plan. The clinician might also provide that patient with auxiliary calendars indicating dosing times and dates, arrange for the patient to enroll in a system of automated reminders or, if the risk from the disorder is high, use an automated medication dispenser that alerts care-givers and the clinical staff if the medication is not dispensed, schedule more frequent follow-up appointments, and request that staff call the patient the next day to assure that the treatment is being correctly implemented.
How Segmentation Differentiates Compliance Interventions
Patient Segmentation matches the specific patient with the interventions most likely to succeed in improving treatment implementation rather than searching for one panacea for all noncompliance. While one might argue that all the measures listed in the case described in the preceding paragraph could be beneficial to every patient, patient segmentation shows that a significant percentage of patients will implement treatment correctly without these aids, another significant percentage of patients will be unlikely to correctly follow any treatment whether or not they are provided these aids, and still another significant percentage of patients will demonstrate a meager improvement with the described assistance but will show a more robust response to other interventions.
Further, segmentation techniques can identify patients that are comparatively more responsive to incentives, personal interventions by the physician, comprehensive explanations, peer support groups, and a myriad of other interventions now applied to a population on an all or nothing basis.
Patient Segmentation focuses on the realistic goal of managing noncompliance rather than the incredibly difficult if possible at all goal of curing noncompliance.
And, given that (1) improving communications between physician and patient can improve patient behaviors (including implementation of prescribed treatment) and (2) communications with patients can be managed more efficaciously than attempting to directly manage behaviors of patients, reaching the ultimate goal – improved treatment effectiveness – is more likely to be accomplished by shifting from the current efforts to coerce higher compliance rates to using Patient Segmentation to enhance the doctor-patient communication systems.
What’s The Catch?
Patient Segmentation sounds pretty good, doesn’t it?
So, why isn’t this kind of tool in use everywhere now?
The reflexive response is that there is no definitive proof that interventions based on segmentation effectively improves the successful implementation of treatment – which only transforms the question to why a patient segmentation approach to treatment adherence isn’t being vigorously explored.
Why are clinical organizations, academics, the government, pharmaceutical companies, and other healthcare stakeholders far more willing to fund studies of traditional compliance tactics which have been repeatedly shown to be unsuccessful than segmentation strategies, which have been demonstrated effective in other fields?
It’s a puzzlement.
Future posts will address other alternatives (i.e., in addition to population segmentation) to the conventional patient compliance model.
Tags: Transforming Compliance
June 29th, 2009 · Comments Off
My post, It’s Time To Stop The Damage Caused By Today’s Patient Compliance Paradigm, went online at the eyeforpharma.com site today.
While fundamentally a summary of the preceding posts on this blog, It’s Time To Stop The Damage Caused By Today’s Patient Compliance Paradigm can claim an original introduction, which, I think, is worth sharing here:
Imagine that, say, a well known Fortune 500 manufacturer of state of the art medical devices and the Feds co-funded a $14.2 million multi–center study at four prestigious universities to determine the effectiveness of a newly designed stereotactic laser bloodletting* machine (with optional Facebook connection) in treating diabetes.
Doesn’t it seem likely that a whistle-blower – or, failing that, a Senator coming up for re-election, an investigative reporter desperate for a story, a publicity-seeking Attorney General of one state or another, a gadfly shareholder, a do-gooder looking for a cause, or a Ralph Nader wannabe – would be loudly decrying the use of public and shareholder monies on a clinical trial of a treatment never shown to be of benefit to patients with this disease despite many, many years of use? One would, in fact, think that congressional committees would be convened, newspaper stories written, blog posts posted, accusations leveled and denied, indictments brought, damage control instituted, scapegoats designated, and heads rolled.
At the least, the medical device company, the Federal agency that handed over the bucks, and the academic institutions involved would be called upon to justify their choice of investments, i.e., explain why the limited amount of money and skilled researchers were designated to be expended on this project instead of a potentially effective therapy – or at least one that has not already proven useless.
I contend that the now dominant paradigm of adherence to treatment, has, like bloodletting, been so unsuccessful for so long (see previous posts: The Tragedy Of Patient Compliance and Patient Compliance – So Wrong For So Long) that continuing to explore the same familiar primrose paths of the patient compliance model entails an intellectual responsibility to provide an explicit rationale for taking this tack.
Next: Alternatives To the Current Patient Compliance Model
The posts in this sequence have thus far focused on the why the treatment adherence paradigm is ineffective and the danger of its continued use.
As noted already, the next entries will begin a discussion of possible alternatives to the current model.
Tags: Transforming Compliance
This is the second post in this series on the inadequacy of the current treatment adherence paradigm. The link to the first post in this series follows: Why Today’s Treatment Adherence Paradigm Must Be Destroyed – Part 1.
The photo atop this post, “Instant Of Impact,” was taken by Jeff Lowe
Patient Compliance – The Concept That Wouldn’t Die
The status of Patient Compliance (AKA Treatment Adherence, AKA Concordance, … ) as an organized field of study is baffling.
On one hand,I find no convincing arguments refuting, entirely, in part, or in degree, the assessment of the effectiveness of patient compliance I published over three years ago:
After almost 2500 years of pondering, healthcare’s consensus is that compliance problems are complex, and the most promising solutions are also complex, as well as impractical and diverse, with no sure means of determining which interventions are most likely to work for a specific patient. And, few reviewers confidently endorse any specific tactic without extensive hedging.
Heck, the only reason I haven’t submitted Patient Compliance to one of those web sites that collect urban legends, online hoaxes, and the like is my inability to find folks who believe that the efforts expended in the name of treatment adherence have contributed much in the way of useful information or tactics. It’s not a legend, urban or otherwise, if no one believes in it.
On the other hand, I notice that Pfizer Canada, AstraZeneca, and Merck Frosst Canada have each kicked in $400,000 and the Canadian provincial government has contributed $500,000 to fund a new Research Chair in Patient Adherence to Drug Therapy at the University of Saskatchewan, leading one to assume somebody in those companies and in the Canadian government either has faith in the concept or too much money left in the budget at the end of the fiscal year.
This morning, I was excited to find, in a recently published (23 June 2009) article, Group kicks off effort to improve medication compliance, the information that
… a new initiative by the New England Healthcare Institute hopes to determine which strategies are most likely to control this problem. The Institute is forming work groups composed of key healthcare stakeholders, including payers, patients, providers, caregivers, health IT execs and employers, to examine strategies for combatting non-compliance with med regiments [sic].
The next paragraph, however, transformed my excitement into discouragement:
Strategies under consideration include patient education, dosing schedules, packaging and financial incentives to comply with physicians’ recommendations.
The piece I originally found turned out to be a rewrite of another article, Initiative aiming for better medication adherence, which is no more forthcoming on this point:
The institute will establish work groups out of its participating stakeholders to identify strategies to combat nonadherence, including patient education, dose schedules, packaging and financial incentives.
After the most promising strategies are selected,
… the institute will create demonstration projects to test those strategies.
Let’s recapitulate: The New England Healthcare Institute, an organization considered well grounded and admirably innovated by some folks, is working with “key healthcare stakeholders, including payers, patients, providers, caregivers, health IT execs and employers,” many or most of whom are, one assumes, knowledgeable about patient compliance, to select strategies from candidates such as “patient education, dosing schedules, packaging and financial incentives” to for demonstration projects to “improve patients’ adherence to their medication.”
My question is:
What is the rationale for pursuing compliance enhancement within the framework of a system that has yet to show substantial results after decades of attempts, especially given that all of the strategies named have been subjected to a significant number of clinical trials already?
As follow-up, I also have the following rhetorical questions which are, of course, no more than thinly disguised elements of my ongoing rant:
- Do they think they will generate different results from implementing the same methodologies?
- Do they think the problem is that the research groups who performed the previous studies didn’t do a good job?
- Are they going to implement these previously tested strategies in a unique way, and, if so, what do they have in mind?
- Are they going to consider only previously tested, mainstream approaches?
- How does one get in on a gig like this? Do they need a consultant with a moderately varying point of view?
Patient Compliance Accomplishments
Another dichotomy contributes to the befuddlement: my jeremiads on the the near absence of effective compliance enhancements contrast with my astonishment over the amount of material produced under the aegis of treatment adherence.
Workers in the field have, for example, generated all manner of books, graduate theses, articles in the medical and sociological literature, newspapers, and periodicals from Parade to Tallahassee Magazine, government grants, marketing projects by pharmaceutical firms, books, medication reminder appliances that range from novelty items to sophisticated, state of the art electronics, salaried positions, workshops, panels, international conferences, and other boondoggles.
The presumption of improved adherence is also, of course, the rationale that launched a thousand new drug applications.
How many industries or scientific fields remain viable after spending 30-40 years producing libraries of research papers, handbooks, and published articles, battalions of machines and devices, and a plethora of PowerPoint presentations with only a handful of achievements that actually produce the desired effect?
I Believe For Every Drop Of Rain That Falls, …
Notwithstanding the massive investments of money, time, and effort, when it comes to empirical results, the relative impotency of patient compliance enhancements ranks among the worst kept secrets in healthcare.
Oh, we try to be polite about it. For example, David E. Williams, in his recent post, The last lever for big pharma, noted
Meanwhile there is one other major lever: medication adherence. If big pharma can find a way to encourage existing patients to sustain their therapy, there is also a significant growth opportunity. That’s easier said than done, however, and pharma companies are still struggling to find cost effective approaches to this challenge. [emphasis mine]
I don’t know Mr. Williams, but I’ll bet he’s a nice guy – because instead of writing “… pharma companies are still struggling to find cost effective approaches to this challenge,” he could have, with equal accuracy, written “… pharma companies have repeatedly failed to find cost effective, comprehensive approaches to this catastrophic problem.”
Moreover, he could have, again with equal accuracy (and more thoroughness), written, “… pharma companies, academic researchers, healthcare organizations, clinicians, health insurers, governmental agencies, and other third party payors have repeatedly failed to find cost effective, comprehensive approaches to this catastrophic problem.”
The smart money, in fact, is on Diogenes finally stumbling across that honest man before a stakeholder in treatment adherence (who isn’t hawking the latest and greatest compliance enhancement product) championing the historical accomplishments of and future prospects for the field turns up.
Exceptions and Outliers
To save folks the trouble of emailing protestations that their program, gizmo, or incantation does so improve patient compliance and, in fact, returns $22,655 in health savings for every $1 investment in said program/gizmo/incantation, I am willing to stipulate that islands of success may indeed exist somewhere in the vast, uncharted seas of patient compliance enhancement failure.
The supposed examples of success I’ve examined thus far, however, have turned out to involve complex, labor-intensive sets of multiple interventions, special circumstances (e.g., self-selected populations of clients likely to be compliant with or without enhancements), inaccessible, unvalidated evidence (e.g., favorable results from proprietary studies, the data of which are kept secret), or other magical assumptions (e.g., defining the removal of a medication from a dispenser as equivalent to appropriate ingestion of that medication). This is a bit like a government agency charged with improving mine safety claiming success based on a single, unpublished study, the data for which was gathered from the miners’ recall of accidents over the past year, showing a “low rate of significant preventable injuries directly attributable to mine engineering” in a single model mine in Idaho. I can’t determine what the so-called evidence means – other than I won’t be strolling through that mine.
So, If Patient Compliance Is Useless, Why Do We Keep Using It
Well, it sounds a bit like a shared delusion, but a delusion is an unshakable belief in something untrue. That “unshakable belief” criterion pretty much rules out this diagnosis since there exist few hard-core supporters of the concept of patient compliance. Perhaps that makes it the first case of pseudo-folie à plusieurs (”false madness of many”).
Or maybe it’s a discipline-wide repetition compulsion.
Or, maybe there isn’t a name for the problem but I do know a joke that covers it:
A passerby walking home late at night sees a drunk on his knees under a streetlight, searching for something. The passerby asks the drunk, “What are you doing?” “Looking for my apartment key,” says the drunk. The passerby, trying to be helpful, walks to the area near the drunk and begins looking for the key. After 15 minutes, it becomes clear that the key is not in the vicinity. The newcomer asks, “Are You sure you lost your key here?” “No, actually I first noticed it was missing when I was walking over there,” the drunk says, pointing to an area a half block away. The passerby, a bit perplexed, asks, “Then, why are you looking here if you lost your key over there?” Responds the drunk, “Because the light is better here, under the streetlight.”
It’s time to do the merciful thing and pull the plug on this flat-lined concept.
Next Post: Alternatives To The Patient Compliance Paradigm
Tags: Transforming Compliance
Because The Survival Of The Current Patient Compliance Concept Endangers Patients
But more about that later.
Understanding both the catastrophic risk and the seemingly inexplicable persistence of the patient compliance model is facilitated by first considering a parallel case of another incorrect medical hypothesis.
There Will Be Blood: Bloodletting As A Model For Adherence
While mistaken beliefs in many fields of knowledge can impair or imperil individuals, the calculus of the danger represented by erroneous medical concepts can be especially evident. Prescribing an ineffective treatment, for example, can be a death sentence to a patient with a serious disorder. Some treatments that were once widely accepted, in fact, are now known to be toxic even to otherwise healthy individuals.
Nonetheless, detecting and rooting out such errors has frequently proved to be an extraordinarily arduous and prolonged task.
Medical theories and practices that now appear blatantly fallacious and even ludicrous were often founded on logical premises, were seemingly congruent with the available evidence, and were supported and used by competent, careful, and conscientious practitioners. Many treatments that we now know were disastrous wrong were not the work of quacks, greedy producers and sellers of worthless or poisonous potions, charismatic charlatans, sociopaths, or religious fanatics. In fact, the most widespread and enduring – and therefore the most dangerous – mistaken medical methodologies were those formed and held by clinicians acting thoughtfully and in good faith.
Consider bloodletting, as described in Wikipedia:
Bloodletting (or blood-letting) is the withdrawal of often considerable quantities of blood from a patient in the belief that this would cure or prevent a great many illnesses and diseases. It was a tremendously popular medical practice from antiquity up to the late 19th century, a time span of almost 2,000 years. The practice has been abandoned for all except a few very specific conditions. It is conceivable that historically, in the absence of other treatments for hypertension, bloodletting could sometimes have had a beneficial effect in temporarily reducing blood pressure by a reduction in blood volume. However, since hypertension is very often asymptomatic and thus undiagnosable without modern methods, this effect was unintentional. In the overwhelming majority of cases, the historical use of bloodletting was harmful to patients.
Bloodletting was founded on a logical, albeit inaccurate, notion:
“Bleeding” a patient to health was modeled on the process of menstruation. Hippocrates believed that menstruation functioned to “purge women of bad humors”. Galen of Rome, a student of Hippocrates, began physician-initiated bloodletting.
And, scientific discoveries supported it.
The popularity of bloodletting in Greece was reinforced by the ideas of Galen, after he discovered that veins and arteries were filled with blood, not air as was commonly believed at the time.
Bloodletting was not cavalierly formulated. Rather the associated theoretical explanations became increasingly sophisticated.
Galen created a complex system of how much blood should be removed based on the patient’s age, constitution, the season, the weather and the place. Symptoms of plethora were believed to include fever, apoplexy, and headache. The blood to be let was of a specific nature determined by the disease: either arterial or venous, and distant or close to the area of the body affected. He linked different blood vessels with different organs, according to their supposed drainage. For example, the vein in the right hand would be let for liver problems and the vein in the left hand for problems with the spleen. The more severe the disease, the more blood would be let. Fevers required copious amounts of bloodletting.
Bloodletting was widespread, and became one of of those principles so obviously true that it was integrated into common sense.
The Talmud recommended a specific day of the week and days of the month for bloodletting, and similar rules, though less codified, can be found among Christian writings advising which saints’ days were favourable for bloodletting. Islamic medical authors too advised bloodletting, particularly for fevers. The practice was probably passed to them by the Greeks; when Islamic theories became known in the Latin-speaking countries of Europe, bloodletting became more widespread. Together with cautery, it was central to Arabic surgery; the key texts Kitab al-Qanun and especially Al-Tasrif li-man ‘ajaza ‘an al-ta’lif both recommended it. It was also known in Ayurvedic medicine, described in the Susruta Samhita.
Bloodletting Machine Mechanism
Not everyone, however, bought into the idea. Some, in fact, began demonstrating that, at least in some classes of cases, bloodletting was valueless.
William Harvey disproved the basis of the practice in 1628, and the introduction of scientific medicine, la méthode numérique, allowed Pierre Charles Alexandre Louis to demonstrate that phlebotomy was entirely ineffective in the treatment of pneumonia and various fevers in the 1830s.
By the mid-1800s, there was substantial empirical evidence this method didn’t work in a number of specific cases. These findings not only failed to stop the practice but likewise failed to slow its growth. Indeed, bloodletting enjoyed a surge of popularity during this period with it being touted as a potential treatment for almost every imaginable ailment.
… in 1840, a lecturer at the Royal College of Physicians would still state that “blood-letting is a remedy which, when judiciously employed, it is hardly possible to estimate too highly”, and Louis was dogged by the sanguinary Broussais, who could recommend leeches fifty at a time.
Bloodletting was used to treat almost every disease. One British medical text recommended bloodletting for acne, asthma, cancer, cholera, coma, convulsions, diabetes, epilepsy, gangrene, gout, herpes, indigestion, insanity, jaundice, leprosy, ophthalmia, plague, pneumonia, scurvy, smallpox, stroke, tetanus, tuberculosis, and for some one hundred other diseases. Bloodletting was even used to treat most forms of hemorrhaging such as nosebleed, excessive menstruation, or hemorrhoidal bleeding. Before surgery or at the onset of childbirth, blood was removed to prevent inflammation. Before amputation, it was customary to remove a quantity of blood equal to the amount believed to circulate in the limb that was to be removed.
Leeches became especially popular in the early nineteenth century. In the 1830s, the French imported about forty million leeches a year for medical purposes, and in the next decade, England imported six million leeches a year from France alone. Through the early decades of the century, hundreds of millions of leeches were used by physicians throughout Europe.
Bloodletting persisted into the 20th century and was even recommended by Sir William Osler in the 1923 edition of his textbook The Principles and Practice of Medicine
The question becomes, why did bloodletting persist for 2,000 years even though for all but a handful of cases it provided no physiological advantage in the fight against disease? As it turns out, one need not invoke conspiracy theories about nefarious plots carried out by the Leech-sellers Guild and the physicians to fool the public to explain the longevity of bloodletting.
One reason for the continued popularity of bloodletting (and purging) was that, while anatomical knowledge, surgical and diagnostic skills increased tremendously in Europe from the 17th century, the key to curing disease remained elusive, and the underlying belief was that it was better to give any treatment than nothing at all. The psychological benefit of bloodletting to the patient (a placebo effect) may sometimes have outweighed the physiological problems it caused. Bloodletting slowly lost favour during the 19th century, but a number of other ineffective or harmful treatments were available as placebos—mesmerism, various processes involving the new technology of electricity, many potions, tonics, and elixirs. [Emphasis mine]
And, there are a limited number of cases in which bloodletting is helpful:
In the absence of other treatments, bloodletting actually is beneficial in some circumstances, including the fluid overload of heart failure, and possibly simply to reduce blood pressure. In other cases, such as those involving agitation, the reduction in blood pressure might appear beneficial due to the sedative effect.
Summary: Comparing Bloodletting And Patient Compliance
Bloodletting is a practice dating back to Hippocrates which was, until 200 years ago when it began to fall out of favor, the standard of care for a wide scope of disorders throughout the civilized world. A multitude of explanatory theories and methodologies of implementation were devised. Skilled physicians, surgeons, and barbers, aided by cleverly designed mechanical devices and leeches (biological machines), became ever more efficient in performing the procedure. That the process could not be shown to result in positive outcomes in the overwhelming majority of cases was explained away or ignored, as was the scientific evidence that the process was therapeutically ineffective in given disorders, perhaps in the belief that it was better to give any treatment than nothing at all.
Treatment adherence is a model dating back to Hippocrates which continues to be the standard of care throughout the civilized world. A multitude of explanatory theories and methodologies of implementation have been devised. Skilled physicians, other clinicians, and researchers, aided by cleverly designed mechanical devices, have become ever more efficient in performing a set of compliance enhancement procedures (such as reminding the patient to take a pill, educating the patient, packaging all of a patient’s medication in dose packs, etc.). That the process has not been shown to result in significant improvements in the overwhelming majority of cases has been explained away or ignored, as has the scientific evidence that certain specific procedures are ineffective, perhaps in the belief that it is better to try to improve compliance by any means available than do nothing at all.
On the other hand, I can find no evidence that anyone has suggested that patient compliance can be enhanced by the use of leeches.
The Potential Risk Of Bloodletting And Patient Compliance
The danger of bloodletting was not, except in a small number of cases, death by exsanguination. Instead, the harm done to centuries of patients was in the form of what economists call opportunity cost. If, for example, one purchases a car for $30,000, the opportunity to invest that $30,000 in ones next best choice, say starting ones own business, is lost.
During the time that bloodletting was in favor, it was the dominant investment target for available intellectual, financial, and medical professional capital. Consequently, the opportunity to use those resources to develop and implement other, perhaps more effective, therapies was lost. Every day that the practice of bloodletting slowed the development of more effective therapies was a day treatment outcomes were worse than they could have been – that means some patients died, suffered incapacities, recovered more slowly, and, at best, endured the pain and cost of treatment needlessly.
Similarly, as long as intellectual, financial, and medical professional capital are devoted to the current patient compliance paradigm, developing and implementing other, perhaps more effective, alternatives is unlikely. And, every day that the current patient compliance paradigm slows the development of more effective enhancement of treatment implementation is a day treatment outcomes are worse than they could have been – that means some patients die, suffer incapacities, recover more slowly, and, at best, endure the discomfort, inconvenience, and cost of treatment needlessly.
Incorrect, ineffective patient compliance theory is not trivial – it is literally a matter of life and death.
And that is why I resort to posts like this with accurate but admittedly sensationalist titles like “Why Today’s Treatment Adherence Paradigm Must Be Destroyed.”
Coming In Part 2
- A brief exposition on my contention that the patient compliance paradigm is ineffective and wastes resources yet doesn’t have the good grace to die on its own.
- The lack of enthusiasm for the contemporary concept of patient compliance paradoxically coupled with continuing use of that system as a basis for research and interventions.
- The Showdown: My dismissal of treatment adherence compliance as a system capable of generating effective compliance enhancements could be wrong, but I’ve found almost no support for the opposing view. I maintain that, at this point, those continuing to pursue research, offer programs, invest in a Chair in Patient Adherence to Drug Therapy, … have the intellectual responsibility to present their arguments for staying the course or indicate the changes they intend to institute.
- Possible alternatives to patient compliance.
Credit Due Department:
The photo atop this post, ”4 Seasons Hotel Implosion,” was taken by Mozambique – Moments.
Tags: Transforming Compliance