Epiphany Du Jour – Training To Be An Effective Patient That Begins Post-Diagnosis Begins Too Late1
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.2
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.3
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.4
Credit Due Department: The photo portrait atop this post was taken by Bhernandez. The schoolroom photo was taken by Rob Shenk
Author’s Note: Patient Effectiveness Training is part and parcel of the system I (ambiguously) envision as a replacement for the current, non-functioning patient compliance model. The focus of this piece, that such training should take be part of the public education curriculum, is, admittedly, a tangent, and I am willing to stipulate that I am devoting a post to the notion less because of its impact on treatment adherence rates (although that impact could be significant) than because I think it’s a clever, useful idea. … and, it’s my blog.↩
Almost all of us who make it to adulthood in the US (or Canada or Britain or Germany or Scandinavia, …) will sooner or later be a patient. The exceptions are at most a tiny fraction of the population: those who consciously and conscientiously avoid doctors because of reasoned principles, irrational fears, religious beliefs, cultural mores, or psychological disorders and also manage to avoid membership in organizations such as the armed forces that insist on involvement by clinicians and remain healthy enough that they are not forced into healthcare (e.g., taken in an unconscious state secondary to a cardiovascular accident into an emergency department) until they die.↩
In addition, there are educational processes that are even more sporadic and variable in quality: individuals may, for example, read articles about “how to be a good patient,” attend a workshop at the local hospital about “how to communicate with your doctor,” or receive information through various ad campaigns recommending that viewers ask their doctor about using one or another medication.↩
This is one of those ideas that seems so obvious that one assumes it is being done already. And maybe it is, but I can’t find any discussion of it.↩
Nocebo-Effect Noncompliance: When Telling The Patient Enough May Be Too Much
Power of Suggestion: When Drug Labels Make You Sick1 is an article on placebo and nocebo effects,2 the sort of piece that appears regularly in the popular press,with little to surprise anyone familiar with clinical practice. It is, however, a useful stepping-off point for a consideration of the impact a clinician’s manner of imparting information about treatment to a patient has on that patient’s response to the treatment and, inevitably, that patient’s adherence to the prescribed treatment regimen.
The following excerpts contain the core issues:
Research has shown that expecting to feel ill can bring illness on in some instances, particularly when stress is involved. The technical term is the “nocebo effect,” and it’s placebo’s evil twin. “It’s not a psychiatric disorder — it’s the way the mind works,” says Arthur Barsky, director of Psychiatric Research at Brigham and Women’s Hospital in Boston.
… in one 1960s test, when hospital patients were given sugar water and told it would make them vomit, 80% of them did. Studies have also shown that patients forewarned about possible side effects are more likely to encounter them. In a study last year at the University of Turin, Italy, men taking finesteride for enlarged prostates who were informed that it could cause erectile dysfunction and decreased libido were three times as likely to experience such side effects as men who weren’t told.
… Doctors may unwittingly foster placebo or nocebo effects by how enthusiastically or warily they discuss medication. “Physician communication with patients is the closest thing to magic. It gets communicated in incredibly subtle ways—a flash in the eye, a smile, a spring in the step,” says Daniel Moerman, an emeritus professor of anthropology at the University of Michigan-Dearborn. Doctors may also subconsciously transmit an expectation of pain. In a double-blind study of 60 patients who had wisdom teeth extracted, when clinicians thought they might be administering a medication that could heighten the pain instead of lessen it, the patients reported much more pain—even though they were really receiving placebos.
Should doctors discuss all those risks with patients, or can they be a self-fulfilling prophecy? It depends on the patient and the drug. “Patients should be made aware of anything that could be dangerous, so they don’t keel over on the street,” says Flavia Golden, an internist in New York City. “But if it’s minor like a headache, I don’t mention it. It’s better to keep the channels of communication open and say, ‘Call me if you have any problems.’ “
Patient-Clinician Interaction, Treatment Recommendations, Nocebo Effect, and Adherence
For the purposes of this exercise, I ask readers to stipulate that (1) the placebo and nocebo effects operate as described in the excerpts and can cause some patients to suffer significantly negative symptoms and (2) a significant number of patients will not follow a recommended treatment regimen if they suffer those significantly negative symptoms.
Now, you’re the physician recommending medication XYZ to your patient (as long as we’re stipulating, let’s also stipulate that this is the optimal medication for this patient, who will be 5 times more likely to recover from the affliction being treated than would be the case if a placebo were taken). Like most medications, there is a reasonable chance XYZ will cause some minor side-effects in a large fraction of patients and a relatively small chance it will cause a severe side-effects in a few patients.
The question is what you tell the patient and how you tell the patient about about (1) the likelihood of a favorable outcome and (2) the side-effects, including which side-effects (all, none, some) and the likelihood of those side-effects.
Keep in mind that, because of the placebo and nocebo effects, an optimistic appraisal of the outcome delivered enthusiastically is likely to cause some patients to achieve that outcome and encourage the patient to pursue the recommended treatment. Similarly, every side-effect you list for some patients will increase the likelihood they will suffer that side-effect and, as a result, increase the risk they will terminate the treatment. Of course, you can modulate that effect by how you describe the chances the side-effect will occur or how severe it may be.
It’s important to understand that the information you offer is not benign. The choice you make to tell your 100 patients taking drug XYZ that it can cause debilitating fatigue means, taking the nocebo effect into account, that some of those patients who would not have suffered debilitating fatigue will do so only because you chose to tell them about this potential side-effect. Further, some of those affected by this side-effect may well refuse to continue drug XYZ because they may think debilitating fatigue is worse than their original ailment, i.e. some patients will drop out of their optimal treatment plan only because you chose to tell them about this potential side-effect.
Are you proud of yourself?
Of course, you could decide not to tell any of them about the risk of debilitating fatigue. That’s fine – if you don’t mind hiding potentially important information from your patients and, in the process, perhaps violating ethical canons. Heck, if there is a hot shot plaintiff’s lawyer involved, you may find a jury of 12 of your peers have decided you’ve committed malpractice by not providing informed consent.
Naturally, you believe the patient must always be a partner on the clinical team so you can’t revert to the paternalistic Dr. Welby methodology of telling each patient only what you think that particular patient needs to know. And, to be fair, even if you were into retro-medical practice, unless you’re a TV doctor with good scriptwriters you won’t have more than a hunch which patients you should tell what.
Incidentally, that bit in the excerpt, “But if it’s minor like a headache, I don’t mention it. It’s better to keep the channels of communication open and say, ‘Call me if you have any problems,’ ” works better as a sound bite than as a general practice. It turns out that lots of patients are seriously miffed when they discover from the doctor taking call for you over the weekend that the headache that kept them from going to Thanksgiving dinner was a side-effect you knew could happen but chose not to tell them.3
Notice that the decision about how to inform a patient about the side-effects of a prescribed medication resolves rather straightforwardly into a forced choice about how you will manipulate the patient. Because of the placebo-nocebo effects, the reaction of some patients (and, no, you can’t tell which ones) to data, even when its transmission is seemingly neutral, is dramatically distorted. Consequently, what the clinician chooses to tell – or chooses not to tell – a patient about the side-effects of a single medication has a necessarily exaggerated impact (at least for a large number of patients), making that task, that may take place a dozen times in a morning clinic, incredibly challenging. Discussing a complex, comprehensive treatment plan for a disorder like diabetes is exponentially more difficult.
Hey, don’t look at me – I’ve been trying to figure this out for 25 years.
The only answer I’ve come up with so far is the same declaration that opens this post:
Clinicians can choose how, not if,
they influence patient compliance
Power of Suggestion: When Drug Labels Make You Sick by Melinda Beck. WSJ November 18, 2008.↩
A convincing argument can be made that the terms, “placebo effect” and “nocebo effect,” as they are used in the referenced article and in this post are ambiguous and counterproductive, but this is beyond the scope of today’s effort. See Stewart-Williams, S. & Podd, J., “The Placebo Effect: Dissolving the Expectancy Versus Conditioning Debate”, Psychological Bulletin, Vol.130, No.2, (March 2004), pp.324-340.↩
I suspect the doctor quoted would agree that this is not a one size fits all sort of tactic. Quotes for articles in the lay press are seldom complete and typically are lifted out of context.↩
Adherence: The Silent CV Risk Factor,1 presented by Dr. Keith C. Ferdinand, Dr. Lars G. Osterberg, and Dr. Roger S. Blumenthal, is a solid review of the basics of adherence (although special attention is directed, as the title indicates, to cardiovascular disease, almost all of the principles are transparently applicable to compliance in general) but also offers insights in areas not typically covered by analogous reviews.
Rather than attempt to characterize these usually neglected points that are discussed in this piece, I will provide a few examples.
For instance, while the presenters trot out the familiar stats to indicate the extent of the problem,
… greater than $100 billion are wasted annually due to nonadherence; 125,000 unnecessary deaths are due to nonadherence; and of all medication related hospital admissions, 33% to 69% are due to poor medication adherence.
… they also include the much less commonly addressed point that practitioners rarely have an organized approach to compliance:
We did a pre-survey and results demonstrated that nurse practitioners and physicians’ assistants are more likely than physicians to change treatment strategies to improve adherence. However, 74% of health care providers do not have an active adherence program.
Similarly, they do a nice job explalining the adherence versus compliance issue, defining concordance, and distringuishing betweeen adherence, compliance, and pesistence.
… researchers have recently defined adherence and compliance a bit differently, compliance meaning the day-to-day way patients take their medications from drug prescription as prescribed by the physician; persistence meaning the time they are on their medications, and it actually may discontinue before the actual prescription is ended. Adherence has been used to include the overarching term of compliance and persistence in medication-taking behavior. The British terminology actually uses a term called concordance, which implies more of a patient-centered approach in that the prescription is really a contract between the patient and the physician and that both are really responsible for the medication-taking. The National Council on Patient Information and Education has really now adopted the term adherence as the proper term because it really implies a more patient-centered approach.
They also make a interesting point about the specialist (cardiology is discussed but many other specialists would face the same conundrum) who has to be concerned about compliance in a patient who might only be seen by that practitioner once each year.
One of the challenges that we have in cardiology is that in the past, we used to be able to see certain patients more frequently, but now, almost always, Keith, patients need to get referrals from their primary care provider to see us. It is harder as a cardiologist to provide some of that reinforcement that I think the patient needs. And with the proliferation of managed care and everybody trying to cut costs, we have a struggle of trying to make sure we have gotten all the information we can from the visit to the referring physician and the patient. It is a lot harder for chronic diseases for the primary care physician to pay as much attention sometimes about lipid lowering medicine, blood pressure lowering medicine when the patient has come in for acute issue.
That is interesting: preauthorization may help keep costs down but it may actually lead to greater nonadherence.
I have always felt that when we see a specialist, it is always helpful to have some goals set not just from the medication point of view in terms of what the blood pressure and lipids would be, but also what they are doing from a lifestyle point of view. With the system we have now with the preauthorization, it is often a lot harder for us to see a nonacute patient back within a period of a few months. Many times, the best we can do is maybe see him back in a year.
And consider this economic insight:
One of the biggest issues that we are all struggling with and now, of course, we are dealing with the bailout of financial firms here, is the issue of money. Many of the medications that we prescribe to patients that are still on patent may be $2.00 or $3.00 a day, so the issue of needing to save money, and many times, physicians do not think of perhaps a less potent generic alternative. It would be nice to have a 50% LDL reduction in everybody, but if we can give a generic statin that may give us a 35% or 40% reduction and have people work on their lifestyle habits, that may work out just as well if they take the medicine and may work out better.
Over-reliance On Patient Education
The presentation does fall short in a few areas. The discussion of a chart showing “Reasons For Not Taking Medication,” for example, should have included mention of how this data was collected (patient self-report I surmise) and, if it was by self-report, the possibility that the patient might not have provided accurate information.
My major concern, however, is the overwhelming faith demonstrated in patient education as a compliance enhancer.
… one of the things that I guess we are all trying to do is figure out ways for people to better understand why certain medications are prescribed and try to make these clinical trials that are the basis for the guidelines be more understandable. I have often thought that it would be helpful if the patient got a copy of the notes that we send to the referring physicians, but many times, that is not as easy for our office staff to do. But I think it just points to the fact that to improve adherence and compliance, we need to do a better job of making sure the patient understands why the medicine is prescribed and can relate to the clinical trial data, if there is any, related to blood pressure or cholesterol about why this is important.
While this may be a matter of emphasis, I believe that a teaching presentation such as this should acknowledge that some patients who fully understand the illness, the treatment, and the implications of compliance to their cases will nonetheless fail to adhere to the prescribed regimen unless other steps are taken.
Summary: Worthwhile Review Of Basics Plus Bonuses
That said, I return to my contention that this review is head and shoulders above the usual run of competent offerings and well worth reading, if only for the succinct, helpful summary of the Federal Study of Adherence to Medication in the Elderly (FAME).
In addition, one can earn CME credits2 for completing Adherence: The Silent CV Risk Factor.
A plethora of compliance-pertinent videos are now available online. I’ve begun posting some of these flicks on this blog’s tumblelog counterpart, AlignMap In Cites.
Videos selected for the AlignMap In Cites Patient Compliance Theater meet one or more of the following inclusion criteria:
Presentations of patient compliance research that briefly and clearly present highlights of findings
Tips targeted to patients or clinicians that may improve adherence
Demonstrations of and infomercials about devices that ostensibly enhance adherence – or at least amuse me.
Testimonials from patients and pontifications from clinicians that provide useful information, reveal pertinent attitudes that could have a positive or negative impact on patient compliance, or surpass a difficult to articulate but easy to recognize threshold of – oh, let’s call it eccentricity.
Anything else that strikes my fancy.
The following videos in the list that follows have been posted to AlignMap In Cites in the past 24 hours. The links below go directly and only to the post indicated. These posts can also be accessed en masse by going to the AlignMap In Cites home page and scrolling back through the chronologically listed posts.
The AlignMap In Cites Patient Compliance Theater
Importance of Patient Compliance in Healing: Presented by a clinician and targeted to patients. Excerpt: So, do what the doctor tells you. Try to be compliant. Try to get better. And if you need our help, we’re Baker Chiropractic. We put patients first.
One of my patient compliance alerts this morning linked to Drug Compliance: Barriers to Care at Endo Blog where I found the attractive chart atop this post along with a discussion of the data it displays. Those findings are summarized in this excerpt:
As expected, according to patients cost is the main driver of non-compliance but nearly equally important is failure to remember to take medication. Difficulty in reading prescription bottle labels and inability to obtain refills are about equally important.
From my reading of the post, it appears that the focus is on extracting from the chart (and the article whence the chart originated) practical recommendations for diabetic patients to enhance their ability to follow their treatment regimens. And from that perspective, the post is on target. The author advises, for example,
Do not request refills when you are out of medication. That’s too late. You will invariably have a gap of 2-3 days before you prescription can be called in. Plan ahead, and call for a refill when you have about a week’s worth of medication.
I’ve issued similar suggestions to my own patients, after learning (the hard way, of course) not to assume that patients were not born with the knowledge that orders for prescription refills could not always be issued immediately nor could the pharmacy always immediately produce a bottle of pills.
So far, so good. But I do want to use this post as an example of the risks of summarizing a study’s findings too concisely or, as I suspect is the case here, to present that summary in a public forum with only one segment of the potential audience in mind.
The purpose of this study is to characterize the adherence and medication management barriers for adults with poorly controlled type 2 diabetes mellitus (DM) (those with A1c 9% or above) and to identify specific adherence characteristics associated with poor diabetes control.
Evaluation measures for medication adherence included self-reported adherence and medication management challenges using the Morisky question format and difficulty with taking medications for each diabetes medication based on the Brief Medication Questionnaire. Specific adherence characteristics associated with poor diabetes control (A1c >9%) were identified using multivariate regression analysis.
Seventy-seven subjects (mean A1c, 10.4%; mean duration of DM, 7 years) were studied. The most common adherence challenges included paying for medications (34%), remembering doses (31%), reading prescription labels (21%), and obtaining refills (21%). Taking more than 2 doses of DM medication daily (β = .78, SE = 0.32, P = .02) and difficulty reading the DM medication prescription label (β = .76, SE = 0.37, P = .04) were significantly associated with higher hemoglobin A1c. Self-reported adherence was not related to A1c control. [emphasis mine]
The problem lies not in what was written about the study but in what was not written.
Specifically, the following information wasn’t available to those who read only the post about the study:
The patient population was selected in part because of their poor control of their diabetes, as signaled by A1c values of 9% and above
Data re adherence and the challenges to adherence were collected exclusively by self-report
As noted in the abstract, “Self-reported adherence was not related to A1c control,” but “Taking more than 2 doses of DM medication daily and difficulty reading the DM medication prescription label were significantly associated with higher hemoglobin A1c.”
Now, the absence of that information has little or no impact on the advice offered to patients in the post. And the phrase, “according to patients, … ,” does indicate the source of the information.
Nonetheless, that declaration of results, while hardly egregious, is problematic, as can be seen by comparing the statement as written to a more complete version of the information.
As expected, according to patients cost is the main driver of non-compliance but nearly equally important is failure to remember to take medication. Difficulty in reading prescription bottle labels and inability to obtain refills are about equally important.
More complete version:
According to information gained by interviews with 77 patients, all recruited for the study because of their inadequate A!c control, cost is the main driver of their self-reported non-compliance (listed by about 26 patients) but nearly equally important is failure to remember to take medication (listed by about 24 patients). While less often reported by patients as a challenge to adherence, difficulty in reading prescription bottle labels (listed by about 16 patients) is notable for being significantly associated, along with taking more than 2 doses of DM medication daily, with higher hemoglobin A1c while the level of medication adherence professed by the patients is not related to A1c control.
My contention is that those two versions may have significantly different impacts, at least on certain readers.
And that is the point: public blogs are – well, public. Posts can be read by, among others, patients, clinicians, reporters, elected officials hoping to find justification for public policy changes, students writing doctoral papers, nurses from Africa caring for HIV patients who deny they are infected, lawyers working the compliance angles on behalf of their clients, colleagues with points of view congruent with the content, colleges with opposing points of view, marketing folks from pharmaceutical companies, and other bloggers.
That is only a partial list of those who have contacted me after reading something at AlignMap.com; that list is also the reason I write – and urge other bloggers to write – with the assumption that their readers will come to their posts with an extraordinarily wide variety of experience with and knowledge of the topic and with an even wider range of motivations.
We conducted structured interviews of 140 adult English-speaking patients or their primary caregivers after ED discharge in 2 health systems. Participants rated their subjective understanding of 4 domains: (1) diagnosis and cause; (2) ED care; (3) post-ED care, and (4) return instructions. We assessed patient comprehension as the degree of agreement (concordance) between patients’ recall of each of these domains and information obtained from chart review. Two authors scored each case independently and discussed discrepancies before providing a final concordance rating (no concordance, minimal concordance, partial concordance, near concordance, complete concordance).
Seventy-eight percent of patients demonstrated deficient comprehension (less than complete concordance) in at least 1 domain; 51% of patients, in 2 or more domains. Greater than a third of these deficiencies (34%) involved patients’ understanding of post-ED care, whereas only 15% were for diagnosis and cause. The majority of patients with comprehension deficits failed to perceive them. Patients perceived difficulty with comprehension only 20% of the time when they demonstrated deficient comprehension.
Many patients do not understand their ED care or their discharge instructions. Moreover, most patients appear to be unaware of their lack of understanding and report inappropriate confidence in their comprehension and recall.
The Times article elaborates:
Dr. Paul M. Schyve, senior vice president of the Joint Commission, the main organization that accredits hospitals, said: “This study showed that this is much more common than you think. It’s not the rare patient.”
Similar results have been found for patients leaving hospitals, not just emergency rooms. And experts say they help explain why about 18 percent of Medicare patients discharged from a hospital are readmitted within 30 days.
The problem is particularly acute when it comes to drugs. A patient-education program used in 130 health delivery systems across the country found that about 40 percent of patients 65 or older have a medication error after they leave the hospital. A 2006 report by the Institute of Medicine found that doctors and nurses were contributing to these errors by not providing information in an effective way.
78% Of ER Patients Misunderstand Or Lack Discharge Instructions
Based purely on subjective recall of my own limited experience working in Emergency Departments and my treatment of patients who had been referred by Emergency Rooms, I would have guessed at least 60-70% of these clients would demonstrate serious misunderstandings of their discharge instructions. I suspect other clinicians would report similar speculations with some variance based on the presence or absence of a patient population whose native language is different than that used by local clinicians.
Consequently, the finding that 78% of patients in the study left the ER with at least one significant misunderstanding re their discharge instructions falls into that category, familiar to ongoing readers of these posts, of Old News, relegating the chief value of the study to confirmation rather than revelation, the enthusiasm of the New York Times notwithstanding.
On the other hand, this article does raise an important question pertinent to patient compliance:
Is The Problem Noncompliance Or Health Illiteracy Or Both?
And Why Should Anyone Care?
Dr. Eric Coleman, Director of the Care Transitions Program at the University of Colorado (not involved in the study), contributes this observation to the Times article:
In the past, patients who did not follow discharge instructions were often labeled noncompliant. “Now, it’s being called health illiteracy,”1
In fact, the classic definition of medication noncompliance by Sackett and Haynes is “failure or refusal to comply with treatment recommendations.”2 Extrapolating from medication noncompliance to patient noncompliance in general, it would seem that failure to follow ER discharge instructions, whatever the reason, qualifies as noncompliance.
And that is exactly the problem
with the concept of patient noncompliance.
The following may well be a recycled rant for return readers – steel yourselves.
The concept of patient compliance, as used today is not clinically relevant as a management tool because the multitude of factors that have an impact on adherence transcends complexity, commingling disparate categories, primary causes and collateral effects, and generally making a hash of it.
At best, noncompliance is a statistical phenomenon, a nonspecific symptom. If a patient’s body temperature exceeds a given point, that patient has a fever. If another patient demonstrates less behavioral inhibition than a certain percentile of the population, that patient is clinically impulsive. A patient does not take a specified amount (often a seemingly arbitrary percentage) of the total medications prescribed; that patient is noncompliant. Now, symptoms are obviously useful in some ways. They may warn the physician, for example, of an impending catastrophe. Patients spiking a fever of 108, patients so impulsive that they attack bystanders for trivial slights, and patients who take far too many or far too few pills are potential disasters. Bu the fundamental benefit of symptoms is their role in the service of diagnosis and determining etiology of health problems. In this aspect, noncompliance is a no-show. The difference between fever and impulsiveness on one hand and noncompliance on the other as symptoms is that few clinicians would be content to end a workup of a patient once “fever” or “impulsiveness” are identified.
At worst, noncompliance is a truism: patients are noncompliant because they don’t adhere to treatment recommendations; those patients don’t adhere to treatment recommendations because they are noncompliant.
The real clinker, of course, is that exploring a clinically irrelevant concept by pursuing ever more well-designed, ever larger studies and expending more intellectual effort developing models of that concept’s operations will result – if all goes well – in more elaborate and precise explanations that are also clinically irrelevant.
Who knows? Maybe that is part of the reason there have been no significant strides forward in the field of compliance in the past 100 years despite the thousands of articles, books, and reports dedicated to the theme.
Oversimplification in the service of stukffing material into the column inches allotted it has resulted, I believe, in a false dichotomy, i.e., that patients suffer from either noncompliance or health illiteracy. Aside from health illiteracy being commonly considered a cause of noncompliance, I would wager that even if all of these patients had been educated to the point of expertise, a large percentage would nonetheless succumb to one or another of the other 42,823 varieties of noncompliance.↩
Haynes RB, Taylor DW, Sackett DL: Compliance in health care. Baltimore: Johns Hopkins University Press; 1979↩
I’ve included some excerpts to give a flavor of the essay:
… we recognized that the need for accurate information about a patient’s medication spans the continuum and shouldn’t be limited to the inpatient setting.
Indeed, inpatient and outpatient health care professionals rely on each other’s records as patients cross back and forth between care settings. It’s important, for example, for emergency department (ED) staff to know what medications a patient has been taking when he or she arrives for emergency care. And depending on the circumstances, patients arriving at the ED aren’t necessarily the best source. They may not be in a condition to communicate or remember accurately, and patients who do carry their medication lists with them may not have a list that is up to date.
Patients may assume all providers have access to the same information, regardless of the setting, and are often surprised to learn that this goal has yet to be realized. Records aren’t always immediately accessible, and clinicians who see a lot of patients may not have systems in place to quickly update and transmit large amounts of data.
While medication errors in the outpatient setting are harder to measure, in its 2006 report, Preventing Medication Errors, the IOM estimates that about 530,000 medication-related injuries occur annually just among Medicare recipients at outpatient clinics.
Launched in October 2006 after a pilot phase, the project seeks to improve communication about medications between patients and providers, and also among providers, through the use of a paper medication list (called the Med List) that patients maintain and regularly review with their providers.
Effie Brickman, Director of the Ambulatory Medication Safety Project at the Massachusetts Coalition for the Prevention of Medical Errors, says that the Med List helps improve medication safety in three ways.
First, the Med List gives patients a single place to write down all their medications, regardless of how many pharmacies they use. Space is provided to list both prescribed and over-the-counter medications, any herbal, vitamin or dietary supplements they are taking, along with start and stop dates, the purpose of each medication, possible danger signs, and if monitoring is required.
Second, because patients are encouraged to bring the list to each medical appointment, there’s a built in prompt and reference for discussing everything on it, including medications a patient used to take. And third, the Med List enables providers to reconcile the patient’s list with the information in the medical record, looking for omissions, duplications, and potentially problematic interactions.
Putting the patient in charge of creating and maintaining an accurate medication list reflects two things, one a problem, the other an opportunity: the difficulty that physicians’ offices have coordinating information in a fragmented system where electronic record-keeping and reliable communication is still not the norm, and the impact of the movement toward more patient-centered care that seeks to give patients more access to information and involvement in decision making.
Brickman says the practices that tested and helped refine the Med List during the pilot phase often revealed important information. “The biggest surprise for most doctors was how many patients thought the physician already knew all the medications the patient was taking, even those prescribed by other physicians. Physicians also learned how patients were thinking about and using their medications,” says Brickman. “One doctor learned that some patients didn’t consider birth control pills to be medication, for example. And other patients didn’t think it was important to report use of herbal and over-the-counter medications. Doctors do want to know this information because herbals and over-the-counter drugs sometimes negatively interact with prescription medications.”
Patients Unable to Provide Names of Their Medications
This post started out as another of those How About That? items.
This news release version of a study to be published in the November issue of the Journal of General Internal Medicine resolves to a single punchline,
Almost 40% of 119 patients taking blood pressure medication
in three clinics could not accurately recall the drugs they were taking.
Those familiar with AlignMap posts on health literacy1 will not find that result (nor the additional fact that the “number jumped to 60 percent for those with low health literacy”) surprising.
This is a specific area within patient compliance – noncompliance by error – that, it would seem, could be directly addressed by treatment plan presentation protocols, technology, and didactic efforts. And, in fact, I have come across some promising ideas lately.
Consequently, the next AlignMap posts will deal with pragmatic tips for decreasing medication noncompliance by error with methods now available.
The study looked prospectively at 3260 Medicare managed-care enrollees in 4 US metropolitan areas who were interviewed in 1997 to determine their demographic characteristics, chronic conditions, self-reported physical and mental health, and health behaviors. Participants also completed the shortened version of the Test of Functional Health Literacy in Adults. Main outcome measures included all-cause and cause-specific (cardiovascular, cancer, and other) mortality using data from the National Death Index through 2003.
The crude mortality rates for participants with adequate (n = 2094), marginal (n = 366), and inadequate (n = 800) health literacy were 18.9%, 28.7%, and 39.4%, respectively (P less than .001). After adjusting for demographics, socioeconomic status, and baseline health, the hazard ratios for all-cause mortality were 1.52 (95% confidence interval, 1.26-1.83) and 1.13 (95% confidence interval, 0.90-1.41) for participants with inadequate and marginal health literacy, respectively, compared with participants with adequate health literacy. In contrast, years of school completed was only weakly associated with mortality in bivariate analyses and was not significant in multivariate models. Participants with inadequate health literacy had higher risk-adjusted rates of cardiovascular death but not of death due to cancer.
Adherence to treatment for chronic illnesses such as asthma, diabetes and heart disease can be difficult in the best of circumstances. For those with literacy problems, following a treatment plan that goes beyond “take the blue pill twice a day” may prove impossible without extensive and expensive assistance. And, as this study indicates, the inability to follow treatment instructions is deadly.
While campaigns to end illiteracy may be a long term solution, the immediate problem of millions of individuals who today cannot comprehend written medical information should prompt further work in alternative means of communicating this information.
The survey presented scenarios regarding a hypothetical drug therapy to reduce the risk for heart attacks (1754 respondents) or hip fractures (1000 respondents). The data sources for both scenarios were clinical trials. Respondents were randomly assigned to a scenario with 1 of 3 outcomes after 5 years of treatment. For the drug to prevent heart attacks, the outcomes were postponement by 2 months for all patients, postponement by 8 months for 1 of 4 patients, or an NNT of 13 patients to prevent 1 heart attack. For the drug to prevent hip fractures, the outcomes were postponement by 16 days for all patients, postponement by 16 months for 3 of 100 patients, or an NNT of 57 patients to prevent 1 fracture. … The overall rate of response to the survey was 81%. In the heart attack scenarios, 93% of respondents who were presented with the NNT outcome consented to drug therapy, 82% who were presented with the outcome of large postponement for some patients consented to therapy, and 69% who were presented with the outcome of short postponement for all patients consented to therapy (chi-square, 89.6; P less than 0.001). Corresponding consent rates for the hip fracture scenarios were 74%, 56%, and 34%, respectively (chi-square, 91.5, P less than 0.001). Respondents who said that they understood the treatment effect were more likely to consent to therapy.
Summarizing their results, the study’s authors write
Treatment effects expressed in terms of NNT yielded higher consent rates than did those expressed as equivalent postponements. This result suggests that the description of the anticipated outcome may influence the patient’s willingness to accept a recommended intervention.
While the difficulty of communicating statistically valid information about possible outcomes to medical professionals as well as patients has long been recognized, this study is valuable for its emphasis on the impact this process has on treatment decisions made by the patient.
On the other hand, I am not convinced that the specific results (e.g., that using the number needed to treat results in higher consent rates than postponement of events) has been proven by this study’s use of hypothetical scenarios rather than actual clinical situations, especially when the patients’ understanding of the scenarios is unclear.
I do agree with the editorial by Harold C. Sox, MD, in the same issue of Annals of Internal Medicine,
Halvorsen and colleagues’ findings are welcome because they remind us about framing effects and show how they could affect decisions about preventative interventions. They show that it is hard to communicate the risk for events realistically and without biasing our patients. Hopefully, this reminder will stimulate researchers, medical students, and practicing physicians.
Because it is beyond the legitimate scope of the article, an important issue on which this editorial statement touches but does not elaborate is the ethics of framing information. It is by no means certain, for example, that increasing the proportion of patients agreeing to treatment is necessarily the “good outcome.”
CME Valid for credit through June 20, 2008. Credits Available: Physicians – maximum of 0.25 AMA PRA Category 1 Credit(s) for physicians; Family Physicians – up to 0.25 AAFP Prescribed credit(s) for physicians. See CME Information↩
HIV InSite, developed by the Center for HIV Information at the University of California San Francisco, aspires to provide free, anonymous access to “comprehensive, in-depth HIV/AIDS information and knowledge,” including an extensive Knowledge Base and other on-site materials as well as thousands of links to to other web sites.
The resources listed are extensive and many are immediately recognizable as frequently cited and highly regarded references.
That said, some improvements could increase the value of this index.
Updating The Listing: This morning, the Resources web page carries the legend, “Content reviewed July 2005,” although many of the articles were published in 2006. That apparent discrepancy should be clarified. More significantly, an accurate “Last revised” date should be listed for the benefit of those using this index. If no articles published in the past year are listed, one shouldn’t have to guess whether that is the consequence of a judgment that older references serve the reader’s purpose better than more recent publications or the result of the list lying dormant for that time. Also, some links are broken (e.g., Adherence to Potent Antiretroviral Therapy, in: Guidelines for the Use of Antiretroviral Agents Among HIV-Infected Adults and Adolescents)
More useful annotations: Currently, many annotations are no more than citations. The reader should have at least enough information to know why a given article or reference is listed. For example, the first item is Antiretroviral Drug Profiles, a heading which leaves the information’s pertinence to adherence a matter of speculation. Do those profiles contain compliance rates? Are they provided to inform one of factors that might affect adherence, such as side-effects or dosing schedules?
Provision of criteria for selection: The range of material listed is so varied that the qualification standards are not apparent. Even if these were chosen based on a group’s personal preferences, that should be known to the reader.
Differentiation of commercial vs academic sites: Some of the links are connected to for-profit web sites (e.g., The annotation of the link to e-pill.com is limited to “Offers a range of interesting medication adherence/compliance tools for patients”). Again, this is acceptable, but it would be helpful if that were indicated in the annotations.