AlignMap

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

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

Commentary

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

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

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

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

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

   ↩

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.

1. The presentation is available as slides with transcript or can be viewed in a  slides/video format↩
2. See CME Info↩

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:

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,

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 Alternative Interpretation

On tracking down the source of the chart from the legend on its lower left corner, I recognized the article, Barriers to Medication Adherence in Poorly Controlled Diabetes Mellitus,¹ as one I had previously read and, in fact, had referenced one conclusion, the link between difficulty reading the text of the prescription and poor control of diabetes as indicated by the A1c biological marker, in my own post, Check The Fine Print For Noncompliance – Part 1.

Excerpts from the study’s abstract follow:

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:

1. The patient population was selected in part because of their poor control of their diabetes, as signaled by A1c values of 9% and above
2. Data re adherence and the challenges to adherence were collected exclusively by self-report
3. 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 written:

More complete version:

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.


Footnotes

1. Peggy Soule Odegard and Shelly L. Gray, Barriers to Medication Adherence in Poorly Controlled Diabetes Mellitus, The Diabetes Educator, Vol. 34, No. 4, 692-697, 2008↩

This One Is About Adherence to COPD Treatment

Source
Patient Adherence In COPD
Bourbeau J, Bartlett SJ.,
Thorax. 2008 Sep;63(9):831-8

The Review

First, I must point out that Patient Adherence In COPD is a well-researched, well-written, accurate review of – well, patient adherence in COPD. It is, in fact, superior to most reviews, eschewing, for example, oversimplified, easy conclusions and recognizing the limitations of the research.

I chose this specific review, in fact, to serve as context for a discussion of the inherent problems with the current concept of patient compliance because it is competently done. I want to emphasize, as I suggested in Patient Compliance Research – Finding Precisely Accurate Answers To The Wrong Question?, that the issue isn’t the quality of the research or the thoroughness of the review; the issue is whether we’re asking the right questions.

The key  points of the article follows.

The Abstract

Section Headings

• Adherence: an overview (compliance, adherence and concordance)
• Medication and regimen factors
• Patient factors
• Healthcare provider and caregiver factors
• Patient adherence in the treatment of COPD: non-adherence to medication in COPD, suboptimal adherence to non-drug therapy in COPD, strategies to enhance adherence

Excerpt From Results

Excerpt From The Conclusion

It’s The Same Old Song

I’m the first to declaim that the standard patient compliance review is not a bad song; in fact, it’s a song I like at lot. I’ve participated in the occasional standing ovation. Heck, if I were on American Bandstand, I’d give it a 99. It’s just that we’ve heard it before – 50 or 60 or a few hundred times.

The fundamental sheet music template for a patient compliance review, which correlates highly with  Patient Adherence In COPD – and dozens of others reviews and reports – calls for  the opening bars to offer an Overview Of Compliance, typically comprising a history of organized medicine’s positions on compliance, a discussion of Adherence Vs Compliance Vs Concordance, selected statistics illustrating fiscal costs, morbidity and mortality, and prevalence. Standard elements of the midsection of the piece include the impact of the treatment and the disorder under discussion on compliance, the impact of the patient’s individual psychology, culture, family, and other background on adherence, and the vital role of the healthcare provider. Specific Results often follow, highlighted by the percentage of population of patients being studied who are noncompliant. Then comes the big finish, AKA The Conclusion – familiar lyrics that go a little something like this: patient compliance must be addressed, there are no evidence-proven compliance enhancement strategies, and – here comes the final refrain – further study is needed.

I think that just about covers it. A great performance won’t get the author on the cover of Rolling Stone, but they could well win a place in a few medical journals.

The question for compliance fans is how much value is left to be garnered by more performances of the same power ballad.

Who believes the problem is that the patient compliance reviews and research aren’t exacting enough, aren’t thorough enough, aren’t insightful enough, … ?  Show of hands.  OK, no one believes that. Who believes that the next review of adherence among tuberculosis patients will reveal a clinical truth of significant importance?  No one? OK, how about that same review written about asthma patients, adolescents with acne, lepers over 60 years old, bloggers following a physical therapy regimen after a hip pinning, … ?

Here’s my point:
Even if one loves Motown (and I do), eventually one learns (and I did) that listening to Leonard Cohen, Bruce Springsteen, or Death Cab For Cutie offers qualities that just aren’t available from The Supremes or Gladys Knight and The Pips. Listening exclusively to the same Top 40 on the same Golden Oldies station is unlikely to expand ones musical horizons.

Not These Rules

These Rules

Dr Rob at Musings of a Distractible Mind offers rules (recommendations, really) to improve the effectiveness of doctors and patients working together. I’ve excerpted one rule from each group to give a flavor of the others.

The only comment I’ll add is that I am more cynical than Dr Rob and have less faith in the power of logic and common sense to change ingrained behavior. Some patients, for example, I believe are psychologically unable to trust anyone, including their doctors. Regardless of the benefit they might derive from doing so, some folks are not able to follow the axioms to trust their doctors and be honest with them. And doctors are hardly immune from the same psychological forces. Nonetheless, I find Dr Rob’s Rules commendable in general and, if followed, capable of impressively reducing noncompliance.

Excerpt from Getting along: Part 1 – Doctor Rules

Rule 4. They [Patients] don’t want to look stupid. I remember when I broke my shoulder – a compression fracture of the neck of the humerus bone – and went to the orthopedist office. I always felt self-conscious about how much pain I was reporting. A colleague had fractured his humerus the year before and had reported he was back to doing surgery within a few weeks. Here I was, a few months out and couldn’t even lay down in bed. I felt like a wimp. Was this other guy just tougher than me? My orthopedist made me feel much better when he explained that my colleague had a mid-shaft fracture, while mine was right in the shoulder joint – a much slower place to heal. This event made me realize how many patients felt when they came into my office. People are often worried that they are over-reacting. They wonder what I must think for a person to come to the office with that symptom. This is especially true of parents bringing their children in. Nobody wants to be “that mother that over-reacts to everything.” In response to this, I try to specifically say, “I am glad you came to the office for this because…” or “Yeah, I can see how that worried you because it could be….”

Excerpt from Getting along: Part 2 – Patient Rules

Rule 2: Be Honest [With Your Doctor]. Nobody likes to look silly. I think the main reason most people are untruthful is that they are embarrassed about the truth. But sometimes symptoms are strange, like the man having a heart attack who described it as “a cold feeling when I take a deep breath.” Sometimes symptoms are embarrassing, like a testicular lump. Sometimes you just don’t want to feel like a wimp, so you downplay your pain. While I can sympathize with this feeling, I don’t see any good reason to be anything but truthful with your doctor. Yes, your symptom might sound strange. Yes, you may have flubbed up and not followed instructions properly. Yes, you may be afraid of what some of your symptoms may mean. But the goal is to fix (or prevent) problems, and trying to do that with bad information is an exercise in futility. We physicians hear it all. There are very few things a person can say to me in the exam room that will surprise me. My job is to help people, not judge them as “weird”, “crazy”, “wimpy”, or “panicky.” Don’t worry about making a good impression on your doctor. Just give the facts. That will give the best chance to get the desired outcome.

Source: One in 3 prescriptions are never redeemed: Primary nonadherence in an outpatient clinic, Andreas Storm, Stig Ejdrup Andersen, Eva Benfeldt, Jørgen Serup Journal of the American Academy of Dermatology. 59:1, 27-33

The Study

Using the Danish National Electronic Pharmacy Register, which contains all prescriptions issued within the past 2 years, Storm et al studied 322 people, who were prescribed a total of 390 medications.

At four weeks after the medications were prescribed, 30.7 percent of the subjects had not filled the prescriptions while most people who did obtain the medication did so within the first week after receiving the prescription.

Older patients and those who were treated by specialists were among those more likely to have filled their prescriptions while those with chronic disorders were less likely (when compared to patients treated for acute diseases).

Commentary

There are no surprises; these findings are in line with those of earlier, similar studies.

These confirmatory results do, however, have practical implications for treatment. For example, given how common it is for large numbers of patients to never begin a prescribed medication, clinicians must always give nonadherence a high priority on the differential diagnosis of any treatment failure.

That importance of that reactive step is clear. In addition, I would also suggest a less obvious, proactive step.

One of the few things worse than one-third of all patients not filling their prescriptions is the clinician not knowing that one-third of his or her patients did not get their prescriptions filled. I believe a solid case can be made for working with patients in such a way a to encourage them to disclose that, in this case, they did not obtain the medications prescribed rather than hide it from their healthcare professional. My take on this matter is part of the post in which I originally suggested this tactic:

How To (Correctly) Not Take Medications As Prescribed

Calvin: Let’s say that life is this square of the sidewalk. We are born at this crack and we die at that crack. Now we find ourselves somewhere inside the square and in the process of walking outside of it. Suddenly, we realize our time in here is fleeting. Is our quick experience here pointless? Does anything we say or do in here really matter? Have we done anything important? Have we been happy? Have we made the most of these precious few footsteps?

From Calvin To Compliance

Calvin’s use of the sidewalk as a metaphor to explore the meaning of life triggers Donald B Ardell, in Calvin, Deep Questions And Promoting Exercise, to apply the same questions to the value of health education:

Happily, there is some reason for cautious optimism. The post continues,

Commentary

I chose to post on this issue because (1) I’ve long been a big fan of Calvin & Hobbes so I jumped on the first semi-legit rationale to feature them on this blog, and (2) Donald Ardell makes an important point that isn’t often emphasized on this site.

Although I am a dedicated proponent of a tailored approach to improving compliance (i.e., selecting the most efficacious compliance-enhancing interventions for a given patient or patient group) and, indeed, promote that stance in a commercial venture,¹ there is substantial evidence, including the study Mr. Ardell references, that brief, non-specific counseling from a healthcare or wellness provider to exercise, to follow a healthy diet, to quit smoking, … can be effective for at least a portion of the population.² Given the small amount of time and the relative ease of offering such advice, there is little excuse not to do so and, as Calvin and Mr. Ardell would point out, profound gratification in providing this service to our clients.

For the record, Calvin and Hobbes do offer another approach to motivating others.

Footnotes

1. See EnrichMap and Emap Profile Now Online and the EnrichMap web site.↩
2. See, for example, How Physicians Can Help Their Patients Quit Smoking by Prochazka and Boyko, West J Med. 1988 August; 149(2): 188–194↩

Source: Effects of Depression and Selective Serotonin Reuptake Inhibitor use on Adherence to Highly Active Antiretroviral Therapy and on Clinical Outcomes in HIV-infected Patients Michael Alan Horberg, MD, MAS, FACP; Michael Jonah Silverberg, PhD, MPH; et al. J Acquir Immune Defic Syndr. 2008;47(3):384-390.

The Study

This large (3359 patients) retrospective cohort study was designed to “determine the impact of depression on highly active antiretroviral therapy (HAART) adherence and clinical measures and investigate if selective serotonin reuptake inhibitors (SSRIs) improve these measures.”

Design & Results: (Excerpted)

Commentary

Conclusions:
Depression significantly worsens HAART adherence and HIV viral control. Compliant SSRI use is associated with improved HIV adherence and laboratory parameters.

The conclusions¹ drawn by the authors are straightforward, immediately useful to clinicians, and heartening, an all too unusual set of qualities for a clinical study dealing with patient compliance.

Moreover, while the researchers are appropriately careful to limit these conclusions to those being treated for HIV, a disorder frequently accompanied by depression (a prevalence of greater than 30% in some studies in HIV-infected patients), it is certainly possible that depression and SSRI treatment have analogous effects on adherence to the treatments of other disorders. There is little evidence that depression associated with HIV is a different pathology than free-standing depression or depression associated with other diseases or that patterns of compliance and noncompliance with HAART are fundamentally different from adherence and nonadherence to other disorders.

Because adherence is a life or death matter for HIV patients and because the HAART regimen has been an especially rigorous and difficult protocol for patients to follow, clinicians and researchers working with this disorder have been long been concerned about compliance issues and their efforts have resulted in advances in clinical practice. My subjective impression is that the results of these labors have sometimes remained isolated to those working in this field. If so, perhaps it’s time for an organized effort to assure that patient compliance research is distributed across diagnostic and professional boundaries.

Footnotes

1. In more expanded form, the conclusions read … depression negatively affects adherence and clinical parameters among HIV-infected patients taking HAART, including the odds of achieving at least 90% adherence over 12 months and achieving an HIV RNA level <500 copies/mL by 12 months. We found that improved SSRI adherence is associated with improved HAART adherence, leading to improved HIV RNA levels and CD4 T-cell counts approaching or even exceeding results seen with nondepressed HIV-infected patients. SSRI use is likely beneficial in depressed HIV-infected patients if they can be compliant with their SSRI medication.↩

The Safety Issue and The Personal Medication Record

While my recent posts on the Personal Medication Record focused on its utility as a tool to decrease unintentional noncompliance,¹ the medication list also serves as an important safety function, as explained in What Medications Does Your Patient Take? Enhancing Medication Safety in the Outpatient Setting, an article published on the Institute for Healthcare Improvement web site.

I’ve included some excerpts to give a flavor of the essay:

Additional Sources

The Massachusetts Coalition has developed materials closely related to What Medications Does Your Patient Take? Enhancing Medication Safety in the Outpatient Setting. These include letters to patients, providers, and pharmacists to give patients and families useful tips for using medications wisely, and to inform providers and pharmacists about specific actions required to ensure patient health and medication safety:

Med List Letter to Patients
Med List Letter to Providers
Med List Letter to Pharmacists

Footnotes

1. The Alignmap posts dealing with Personal Medication Record include
   • Everyone Needs A Personal Medication Record
   • Choosing The Right Personal Medication Record
   • Compiling The Personal Medication Record
   • How To Create and Use A Personal Medication Record
   • Test-Driving The Personal Medication Record

   ↩

Primary Source: A Randomized Controlled Trial of the Impact of Targeted and Tailored Interventions on Colorectal Cancer Screening, Ronald E. Myers, Randa Sifri, et al, CANCER; Published Online: September 24, 2007; Print Issue Date: November 1, 2007.

Secondary Source & CME:
Targeted Interventions May Improve Rates of Colorectal Cancer Screening¹

The Study

Despite widespread recommendations from organizations such as the US Preventive Services Task Force (USPSTF) and the American Cancer Society, colorectal cancer screening remains underutilized. rates remain lower than desired. For example, the USPSTF recommends that persons aged 50 years or older have an annual screening stool blood test and/or other alternative CRC screening test every 5 years, a double-contrast barium enema every 5 years, or a colonoscopy every 10 years. However, data from the 2003 National Health Interview Survey showed that only 16% of Americans reported having a stool blood test within the past year, 36% underwent some type of endoscopic screening within the past 5 years, and 42% had either stool blood test screening within the past year or endoscopy screening within the past 5 years.

Dr. Myers, interviewed by Medscape, explained the barriers to higher compliance with screenings:
The reality is that most primary providers have essentially decided that there are 2 options. Colonoscopy is the preferred option followed by SBT [stool blood test]. One of these two screening options is commonly used. This needs to be addressed in the real world of patients and clinicians, who have made their choices. Another barrier to screening is that the procedures are fairly complex and require preparation. Although it has been simplified, the traditional guaiac smear test for fecal blood requires a special diet for 48 to 72 hours before the test, with the avoidance of certain foods. A colonoscopy is even more involved, requiring a person to take a day off from work and bowel preparation beginning several days ahead of the test. The process is becoming easier, but the lack of convenience and ease of screening is still an obstacle.

It is, however, the third reason, that primary care clinicians often do not promote CRC screening as a major issue in their practice and have not been as strident as they should be, that is the focus of this study.

This study looked at the impact on compliance with colorectal cancer screening of targeted interventions.

Methodology (excerpted from abstract):

Results(excerpted from abstract):
Screening rates in study groups were 33% in the control group, 46% in the SI group, 44% in the TI group, and 48% in the TIP

Commentary

The literature is replete with recommendations to tailor compliance enhancements. Rarely, however, does one see a study based, as this one is, on protocols that appear appropriate for day-to-day clinical use.

While it is disappointing that this study found that the compliance increased by the same statistical increment in all intervention groups rather than being improved the most by the customized interventions, that the issue is being studied at all is heartening.

My own, also unproven bias is that the interventions should be tailored not to the disorder or treatment but to the specific patient or, more practically, specific groups of patients.

Footnotes

1. News Author: Roxanne Nelson, CME Author: Désirée Lie, MD, MSEd, release Date: October 1, 2007; Valid for credit through October 1, 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; Nurses – 0.25 nursing contact hours -None of these credits is in the area of pharmacology↩

Large Study Reports On Multiple Variables Affecting Compliance

While I prefer and typically insist on reviewing the published article describing a clinical study before posting on it, this meeting report/press release from the American Heart Association regarding the presentation at that organization’s 61st Annual Fall Conference of the Council for High Blood Pressure Research of a large survey of patients being treated for hypertension contains enough information with potential impact on clinical practice that I have excerpted significant portions relevant to compliance for this post, appending only the caveat that, again, I have not seen the full writeup and cannot warrant the completeness or accuracy of this data beyond the referenced report.

The Study

To obtain a clearer picture of high blood pressure treatment in their state, David J. Reynen, M.P.P.A., M.P.H., lead author of the study, and his colleagues at the California Department of Public Health’s Heart Disease and Stroke Prevention Program in Sacramento proposed a series of questions to be included in the California Health Interview Survey, which is conducted by telephone every two years, and then analyzed the results.

Of 42,044 California adults, 11,467 said a doctor had told them they had high blood pressure. When adjusted for age, this yielded a prevalence rate of 24.5 percent.

Of those diagnosed with hypertension, 49.4 percent were not taking drugs to lower it.

People who had seen a physician during the prior year were more than five times more likely to be on medication than were those who had not. [My emphasis] “That was informative,” said David J. Reynen, M.P.P.A., M.P.H., lead author of the study. “It really underscores the importance of having routine care.” “Unfortunately, the data are collected in such a way that we don’t know to what degree the individual respondents have hypertension,” Reynen said. “One in four adults in California, including one in three African Americans, is hypertensive,” he said. “We talk about people needing to know their numbers. That means not just whether your blood pressure is high or low, but your actual numbers. This study reinforces that.”

Among those surveyed with high blood pressure, the analysis showed that the age-adjusted odds of a person taking drugs to lower blood pressure are:

• 5.23 times higher for people who saw a physician within the past year compared to those who did not;
• 2.47 times higher for those with diabetes than those without the disease;
• 2.05 times higher for those who had health insurance than those who did not;
• 1.71 times higher for African Americans than for whites (the racial/ethnic groups, respectively, with the highest and lowest high blood pressure rate);
• 1.46 times higher for people who described their health as poor or fair compared to those in good health;
• 1.40 times higher for patients diagnosed with heart disease than those without it;
• 1.38 times higher for smokers than nonsmokers;
• 1.27 times higher for U.S.-born individuals than foreign-born;
• 1.21 times higher for people with some form of formal education after graduating high school than those with less formal education.

The age-adjusted prevalence of high blood pressure and drug treatment sometimes varied considerably among the various groups surveyed:

• African Americans had the highest prevalence of high blood pressure (35 percent), followed by American Indians (29.8 percent), Pacific Islanders (27.2 percent), those of other race/ethnicity (25.9 percent), Latinos (25.0 percent), Asians (24.5 percent) and whites (23.1 percent).
• African Americans had the highest rate of drug use to control their high blood pressure (56.6 percent), followed by American Indians (53.1 percent), Asians (52.1 percent), Pacific Islanders (52 percent), whites (49 percent), Latinos (45.8 percent) and those of other race/ethnicity (44.4 percent).

Is Ethnicity An Independent Determinant Of Compliance?

Mechanisms for Racial and Ethnic Disparities in Glycemic Control in Middle-aged and Older Americans in the Health and Retirement Study
Michele Heisler, MD, MPA; Jessica D. Faul, MPH; Rodney A. Hayward, MD; Kenneth M. Langa, MD, PhD; Caroline Blaum, MD, MPH; David Weir, PhD. Arch Intern Med. 2007;167:1853-1860.

The Study

The researchers sent surveys to 1901 respondents 55 years or older with diabetes mellitus, 1233 of whom completed valid at-home hemoglobin A1c (HbA1c) kits. Multivariate regression models were used to examine racial/ethnic differences in HbA1c control and to explore the association of HbA1c level with sociodemographic and clinical factors, access to and quality of diabetes health care, and self-management behaviors and attitudes.

Results and Conclusions, excerpted from the abstract, follow:

Commentary

The pertinence of this study vis-a-vis patient compliance is its support for race as an independent determinant of adherence. Unfortunately, it is difficult and perhaps impossible to assess the significance of its conclusions because of the many other studies that show that race has no impact on compliance and the somewhat lesser number of other studies that indicate that race is a mild, moderate, or major influence on compliance.

And the complexity increases exponentially when race as an interactive factor is considered. For example, studies have looked at – and come to different conclusions regarding – the effect on compliance of racial differences or similarities of patient and doctor. The possibilities seem endless: it’s possible, for example, that variations exist between, say, Whites and Asians but not between Asians and Blacks; perhaps race is a more significant compliance factor in societies rife with racial conflict than in communities characterized by interracial harmony; race could be important in determining adherence for certain specific treatments or disorders but not others; … .

The improbability of controlling for so many confounding factors, alone or in combination, as well as the many conflicting studies about the importance of demographics like ethnicity should make one leery of basing clinical practices on this study’s finding that racial differences in compliance are significant. It is, in fact, difficult to imagine a practical, affordable scheme for investigating potential racial differences in compliance that would provide results that could be confidently used in clinical practice.