The tragedy of patient compliance

This post begins an examination of the flawed concept of Patient Compliance, its implications, and possible remedies.

By Allan Showalter on May 18, 2009

This post begins an examination of the flawed concept of Patient Compliance, its implications, and possible remedies.

By way of introduction, Im a psychiatrist who became interested in patient compliance during medical school in the 1970s. I began reading everything I could find about the topic and thinking about how instances of compliance and noncompliance played out in my private practice and in the hospital and outpatient environments I oversaw administratively. For the past three years, I've been blogging about the subject at my own, non-commercial site, AlignMap. Finally, because readers should be alerted to an author's possible biases and because it has given me insights into practical applications of ideas for improving adherence I would have otherwise lacked, I will mention that I am involved in a business with a product that falls in the category of compliance enhancement; anyone who is curious (or suspicious) can find information about that venture at EnrichMap.

As a result of these years of observing, reading about, and pondering on patient compliance, I've reached certain conclusions about the state of the art.

And, I am not the sort of fellow to keep such information to himself.

So, buckle up. It could be a bumpy ride.

For today, let's start with a principle that goes a little something like this ...

Compliance Is A Useful Statistic, Not A Platform For Improving Treatment Effectiveness
Quite often it is helpful to know a patient's statistical compliance rate (e.g., 98% - or 58% or 8% - of the patient's medication doses were taken as prescribed).

Rarely, however, does it prove helpful to use the concept of compliance (e.g., the degree to which a patient's pill-taking behavior conforms to the clinician's recommendations) as the platform for improving treatment outcome.

It's a bit like confusing a baseball player's batting average with his batting technique.

What Hath Compliance Wrought?
While there are many problematic issues with patient compliance, some of which will be examined in later posts, today, let's cut to the chase and apply the ultimate pragmatic criterion: Has the current concept of patient compliance contributed to improved treatment outcomes?

After all, the contemporary concept of compliance has been around in documented form at least since the 1970s, when Sackett and Haynes published their seminal work, and arguably as long as a couple of millennia, going back to when Hippocrates, (460 to 377 BC) issued what has since become the obligatory quote for papers on compliance, Keep watch also on the faults of the patients which often make them lie about the taking of things prescribed, and the Old Testament story of Naaman took place (probably 852-841 BC, according to Bromiley, The International Standard Bible Encyclopedia, p 465).

That means patient compliance has had between 30 and almost 3000 years to do its stuff.

So, what have we got to show in the way of pragmatic gains in return for all the research, campaigns to increase disease screenings, adherence enhancement programs administered by clinicians, nonprofits, health insurers, and drug companies, pill dispensing devices, self-initiated activities by conscientious individual clinicians, medication regimen manipulations, pharmaceutical development projects, patient empowerment efforts, doctor-patient relationship training, and other measures undertaken in the name of compliance improvement, not to mention the time and money expended in these pursuits?

Bupkis - that's what we've got.

Oh, we've figured out a few specifics. Incentives, for example, seem to promote compliance. Except when, for inexplicable reasons, a study shows they don't. And there is that matter of folks who think it's unethical and others who object to using funds they've paid via insurance fees or taxes to finance compliance enhancement incentives. Now, it does look as though the fewer doses of medication prescribed per day, the more likely patients are able to comply with the regimen - probably. Well, there are those studies that indicate otherwise. Naw, fewer doses - better adherence, that's pretty solid. Maybe. Regardless, the potential benefit of this strategy would be more dramatic if doctors weren't trained trained to routinely prescribe, all things being equal, as few daily doses of every medication as possible.

Just think, if the principle of extrapolation holds, we should be able to double this list in another 30 years.

Instead of citing such dismal statistics, let's go with a generously skewed-to-the-positive interpretation of the consensus of experience with and research on efforts to improve treatment adherence:

  1. Some, and perhaps most, of the currently used compliance-enhancement interventions benefit some of the patients under some conditions some of the time.
  2. None of the currently used compliance-enhancement interventions benefit most patients in most conditions.
  3. Reliably predicting when a specific compliance-enhancement intervention will benefit a specific patient in a specific situation is an unachieved goal.

The most damning evidence of the practical ineffectiveness of contemporary compliance enhancement percepts and programs is the absence of their influence on routine, day to day clinical practice.

My experience and that of my colleagues over many years of medical practice in various settings, locations, and specialties is that patient compliance is only rarely a discrete topic in clinical discussions or an issue that comes quickly to the minds of most clinicians - even in situations, such as treatment failure, in which noncompliance is a likely, and perhaps, the likely cause. Even fewer clinicians (other than those treating a few special populations, such as HIV infected patients and organ transplant candidates, for whom adherence is always a life or death issue) implement specific interventions with the goal of managing noncompliance.

Still, it is undeniably tricky to prove the absence of an effect on a system as ambiguous, variegated, and unwieldy as American healthcare.

A reasonable proxy, however, is available; the following passages are drawn from medical literature dealing with compliance and not only summarize the findings of the article from which they were excerpted but are also representative of the overwhelming majority of scholarly and clinical reviews on the topic:

  • Most methods of improving adherence have involved combinations of behavioral interventions and reinforcements in addition to increasing the convenience of care, providing educational information about the patients condition and the treatment, and other forms of supervision or attention. Successful methods are complex and labor intensive, and innovative strategies will need to be developed that are practical for routine clinical use. (Osterberg L, Blaschke, T. Adherence to Medication. N Engl J Med 2005;353:487-97)
  • Several complex strategies, including combinations of more thorough patient instructions and counselling, 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. (Haynes RB, McDonald H, Garg AX, Montague P. Interventions for helping patients to follow prescriptions for medications. (Reprint of a Cochrane review 2003, Issue 4) Update Software Ltd, Summertown Pavilion, Middle Way, Oxford OX2 7LG, UK. 9)
  • The conundrum of compliance is extremely complex, and as yet whilst there are possible indicators as to some possible understandings and explanations, amongst some patients, in some contexts, with some areas of treatment/advice, these are still rather theoretical. Despite the wealth of research into determinants and management of compliance, few simple conclusions can be drawn. (Playle J. Concepts of compliance: Understandings and approaches, Br J Fam Plann 2000: 26(4): 213-219)
  • It is unlikely that there will ever be a cure for noncompliance. No single, specific strategy that will enhance compliance in all patientsor even in the majority of patientshas been found. Compliance researchers agree that a range of strategies must be used, targeted to the underlying cause or causes of noncompliance and tailored to the needs and circumstances of each individual patient. (American Pharmacists Association and Pfizer U.S. Pharmaceuticals, Medication Compliance-Adherence-Persistence (CAP) Digest. 2003. pp 7-8)
  • No single approach to improving adherence can be recommended on the basis of the evidence reviewed. Complex interventions may improve adherence and control in difficult patients. Worksite, nurse-led, protocol-guided care may have some advantages over usual care in younger men. Unfortunately, the wide variation in the types of intervention used and the outcomes measured make statistical meta-analysis methods inappropriate. (Ebrahim, S. Detection, adherence and control of hypertension for the prevention of stroke: a systematic review. Health Technol Assess 1998; Vol. 2: No. 11 p 25)

So there it is. After hundreds of years of dealing with noncompliance, healthcares 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.

What Have We Learned Today?
As we've seen, the results of interventions based on patient compliance have been uniformly disappointing, a finding which will surprise few who are familiar with the field.

Considering that finding in the light of the observation (attributed to at least three different people) that "Every system is perfectly designed to get the results it gets" transforms it into the insight that the problem lies not in the development and execution of the specific interventions but in the underlying system itself, which brings us back to Compliance Is A Useful Statistic, Not A Platform For Improving Treatment Effectiveness

Coming Attractions: The next posts will focus on these questions:

  • What is the concept of patient compliance?
  • Why doesn't patient compliance work?
  • If all this patient compliance activity isn't generating results, what is it producing?
  • Has anyone else noticed that decades of research and centuries of clinical practice haven't significantly improved compliance?
  • Isn't ongoing work in the field likely to avoid or correct previous mistakes that have stymied progress?
  • If so, why haven't we tried something else?

Once that groundwork is laid, we'll get to the fun stuff: How To Make Compliance A Useful Concept - Things To Do Until The Manifesto Is Finished

Sources: Some of the material in this post was originally published at AlignMap - The Verdict On Compliance