AlignMap

A Patient Compliance And Literacy Problem
Or A Failure In The Healthcare System?

Introduction

Despite federal mandates to translate prescriptions,¹ the technical capacity to do so, and the rather obvious clinical need for prescription information in the language of non-English speaking patients , many pharmacies in New York City do not provide translated labels,according to an April 27, 2007 presentation by Linda Weiss, PhD, at the annual meeting of the Society for General Internal Medicine held in Toronto, Ontario, Canada.

As Dr. Weiss notes:

Study Parameters and Results

Of the 2186 New York City pharmacies licensed in 2006, 200 pharmacies were surveyed.

“Health literacy is the strongest predictor of a person’s health status,” Ann Zweber, RPh, director of assessment and senior instructor of pharmacy practice at Oregon State University in Corvallis, told Medscape in response to a request for independent commentary. She was not involved with this study.

“If patients do not understand their medical condition and how to manage it, including how to use their medications, they are more likely to suffer from poor health outcomes,” Dr. Zweber said.

Translation Capacities

Even those pharmacists who provided translated printed information did so only when they happened to notice a patient having difficulty with English (54%) or if specifically asked (33%). Less than 20% of the pharmacies surveyed had protocols to systematically identify patients who need might need translated labels; less than 10% had signs indicating that translated materials were available.

Commentary

First, I recommend reading the article, which also includes speculation about the reasons pharmacies appear less likely than other healthcare providers to offer translated information, thoughts about informal strategies by some pharmacies to provide patients information in their own language, and services being developed to provide more sophisticated and specialized translation services.

Although, as the authors note, the research has limitations,² its revelation that a large proportion of a randomly selected sampling of pharmacies lacked a systematic means of providing clinical information to a patient in his or her own language is astounding. My contention, in fact, is that this problem transcends issues of patient compliance and patient literacy.

Conceptualizing a patient as noncompliant because of a failure to following instructions provided in a language that patient doesn’t comprehend may meet some technical definition of compliance but certainly has little in common, for example, with a patient who unilaterally changes a medication dose because of side-effects or another who never has a prescription filled because of distrust of doctors.

Similarly, a recent immigrant who speaks only Spanish may somehow be described as functionally illiterate in an environment dominated by users of the English language, but describing the problem in terms of “health illiteracy” risks misrepresenting the problem as a deficit on the part of the patient when, given the rather easy availability of translation software, the primary responsibility rests upon the pharmacies.

As one of those doctors who are reflexively resistant to government “interference,” I have fastidiously looked to – well, to anyone else but government solve problems in the healthcare system. In this case, however, I am foursquare in favor of an approach that first addresses enforcement of the altogether reasonable regulations that all healthcare providers, including pharmacies, provide materials translated into an language understood by the patients served.³

Source: Pharmacies May Not Always Translate Prescription Labels for Non-English Speaking Patients Laurie Barclay, MD Medscape Medical News 2007.


Footnotes

1. All healthcare providers receiving federal funds are, by legislation, required to offer language services to limited English proficient patients↩
2. E.g., the data were collected “through a relatively brief telephone survey (shorter than 5 minutes), preventing probing any item in detail; and reliance on self-report, which most likely biases the findings toward overestimation of pharmacy translation practices.”↩
3. Yes, the regulations must be practical. Not every pharmacy in southwest Missouri can provide labels written in an obscure dialect spoken only by the last 83 members of an isolated tribe living on a tributary of the Amazon. That kind of exception, however, should not be confused with a New York pharmacy not offering prescription levels in Spanish.↩

The Value of Brief Physician Interventions

Source: Kaner EFS, et al. Effectiveness of brief alcohol interventions in primary care populations (Review). The Cochrane Database of Systematic Reviews 2007, Issue 2.

As is often the case, this chief virtue of this Cochrane Review is its authoritative confirmation of a concept already verified by several studies.

After reviewing 21 randomized controlled trials with 7,286 participants, Eileen Kaner, the lead author, summarized the findings thusly:

More specifically, the results indicated that a single, brief intervention, typically as short as five minutes, decreased alcohol intake by an average of four drinks per week.

The target group consisted of patients who were heavy drinkers but not alcoholics.

Commentary

While the Cochrane Review dealt with alcohol use, parallel studies (although not a Cochrane Review) have demonstrated that brief interventions can have positive effects on smoking.

My clinical stance, equally influenced by cynicism and pragmatism, has been that, given the catastrophic risks of smoking and excessive drinking and the brief amount of time required for such an intervention, even a success rate as small as, say, 5% justified, if not mandated, that these issues be addressed in the office. This Cochrane Review reaffirms that notion.

One result of patient compliance is rendering treatment outcome somewhat of a numbers game. Just as more sales calls result in more sales and more at-bats result in more base hits (assuming the participants are competent), the more patients to whom a clinician recommends a decrease in drinking or a cessation of tobacco use, the more successful clinical outcomes.

And, we now know that those recommendations can be made efficiently without sacrificing effectiveness.

Primary Source: Family history of diabetes, awareness of risk factors, and health behaviors among African Americans. Baptiste-Roberts et al. Am J Public Health. 2007 Mar 29

Secondary Source: Better Diabetes Awareness Doesn’t Equal Better Habits for Some Blacks
Glenda Fauntleroy Health Behavior News Service

The Study

The study population consisted of 1,122 African-American adults, none of who was diagnosed with diabetes but 36 percent of whom reported that an immediate family member had type 2 diabetes.

Among that subgroup with a family history of diabetes, “nearly 60 percent had a better-than-average awareness of the diabetes risk factors” compared to 47 percent of the the control group (no family history of diabetes) who history demonstrated that level of awareness.”¹

This larger proportion of individuals with family histories positive for diabetes, aware of the risk factors was not reflected in positive health behaviors. For example,

Possible reasons proffered for this discrepancy and corrective actions recommended included:

On the other hand, those subjects with diabetic family members were more likely to consume 5 or more servings of fruits and vegetables per day and to have been screened for diabetes.

Commentary

This article is one more indication that informing a patient about his or her disorder and its treatment is insufficient to assure adherence to treatment.

It is notable that the conclusion of the primary article itself is African Americans with a family history of diabetes were more aware of diabetes risk factors and more likely to engage in certain health behaviors than were African Americans without a family history of the disease while the review of that article, using the same data, observed that a patient’s greater awareness didn’t necessarily translate into healthy behavior.

Perhaps the most useful take-home message is the observation of Kate Lorig, R.N., a professor at Stanford University’s Patient Education Research Center,

Footnotes

1. The awareness scored was based on participants being shown “a seven-item list and asked whether any of the factors increase a person’s risk of developing diabetes. All seven items on the list are risk factors for diabetes — minority race or ethnicity, overweight, family history of diabetes, sedentary lifestyle, older age, high-calorie diet and diabetes during pregnancy.”↩

A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines¹

DK Raynor, A Blenkinsopp, P Knapp, J Grime, DJ Nicolson, K Pollock, G Dorer, S Gilbody, D Dickinson, AJ Maule and P Spoor. Health Technology Assessment 2007; Vol 11:number 5

Medication Information Leaflets Fail To Meet Patient Needs

This monograph is the culmination of a review of 70 studies² concerning patient medication information published in the United Kingdom, Europe, Australia and the United States, two patient workshops convened specifically for this report, and a survey of the expert literature on information design.

Because the heterogeneity of the studies precluded data pooling and synthesis, the monograph elaborates on the primary source information for nearly 200 pages, but the findings can be summarized in a few lines:

• Patients consistently report that leaflets provided with prescription medications do not meet their needs
• The leaflets do not improve patient understanding of their medications
• Patients express the desire for information that better helps them evaluate pros and cons of a specific medication
• Patients value the idea of information that is tailored, set in the context of the particular illness of the individual patient
• Patients want written information in addition to — not instead of — spoken instructions from their health care professionals
• No evidence was found that the information affected patient satisfaction or affected compliance
• Patients do not see improving compliance as a function of the leaflets (an informed decision not to take a medicine is an acceptable outcome); many healthcare professionals, in contrast, view increasing compliance as a primary goal of the leaflets

Further, according to the Partnership for Clear Health Communication, nearly half of all American adults have difficulty understanding and using health information. In fact, the organization says, literacy skills are a stronger predictor of an individual’s health status than age, income, employment status, education level or racial/ethnic group.

An unanswered question is the means by which to convey the likelihood of benefits and adverse drug effects. Colloquial descriptors such as “rare” or “common” are viewed as too vague to be useful, but terminology more typical of the professional literature such as percentages or “numbers needed to treat” often proves confusing to patients.

Not only is the text faulty but, according to the studies, the design and layout make navigation problematic, especially in the United States.

Recommendations, primarily culled from information design textbooks, include

• Use short, familiar words and short sentences
• Use short headings that stand out
• Use the largest possible type size
• Leave plenty of white space
• Use bullet points to organize lists

Commentary

I suspect that few individuals who have tried to read the information provided with medications will find any surprises in the conclusions of this review.

The only addition I suggest (and it may have been covered in some of those 200 pages that I haven’t read) is that the print on the leaflets should be large enough and contrast enough with the background for the typical over-50 individual  adult with just a tad of presbyopia to read without the necessity of finding his reading glasses.

It is a superfluous but irresistible observation that the recommendations are little different than my 9th grade English teacher’s instructions on writing essays and need to be applied in many other areas as well as drug leaflets (software Help dialogs, toy assembly directions, and blogging guidelines come to mind).

Implications For Patient Compliance

Finally, I am especially taken with this finding,

I would maintain that this dichotomy of views speaks to the meaning of patient compliance as well as (or perhaps rather than) the purpose of medication leaflets.

This disparity resonates with what I’ve written before (for example, in How To (Correctly) Not Take Medications As Prescribed) about the problem of directly or indirectly coercing even “empowered patients” to follow instructions and the need to extend patient compliance to include the patient communicating to the clinician the decision not to take a prescribed medication.

Clarifying the purpose of medication leaflets as information for decision-making by the patient rather than propaganda to persuade the patient to follow orders seems an ideal step in redefining patient compliance into a clinically useful concept.

Just a thought.

Footnotes

1. This is the link to the Executive Summary of this monograph. The PDF of the full monograph as well as the PDF of the Executive Summary can be viewed or downloaded from this site.↩
2. From over 50,000 citations, 413 were considered. Of these, 64 papers reporting 70 studies were included↩

Examination of mediating variables in a partner assistance intervention designed to increase performance of skin self-examination

Robinson JK, Turrisi R, Stapleton J, Journal of the American Academy of Dermatology- 2007 03 (Vol. 56, Issue 3) Published online 12 December 2006.






Robinson and colleagues, who had previously demonstrated that patients at risk for melanomas who were trained together with their significant others to perform a skin self-examination (SSE) were more likely to perform the exams as scheduled than those who were trained alone, undertook this study to discover the reasons for that differentiation.

130 participants drawn from a melanoma hospital registry were randomly assigned to a solo-learning control group (n = 65) or a partner-learning group (n = 65). The intervention was a 10-minute educational presentation and skills training session based on the ABCDE rule of early melanoma detection. The main outcome measure was SSE performance as measured by use of a body map.

The mediators measured included

• Attitudes toward SSE
• Self-efficacy/confidence in the ability to effectively perform SSE
• Comfort with having a partner help with SSE
• Perceived melanoma/skin cancer risk
• Concern about developing skin cancer/skin damage
• Melanoma/skin cancer knowledge

Of these, the most significant mediators were found to be

• Attitudes toward SSE
• Self-efficacy
• Comfort with having a partner help with SSE
• Concern about developing sun-damaged skin

The conclusions, as excerpted from the abstract, follow:

Commentary

That training in medical self-examination is enhanced by partner-oriented rather than solo instruction is intuitively appealing and has far-reaching implications.

Nonetheless, a more rigorous evaluation of the consequences of this improvement would seem to be in order; i.e., do these patients who are trained as couples actually find a higher percentage of potential lesions over time than those trained individually? The clinical trials thus far appear to be a good start, not a finished product.

The PicturRx Prescription Picture Cards

Improving Patient Comprehension Of Medication Instructions

PictureRx¹ has a simple solution to one possible cause of medication noncompliance: the inability of some patients to understand instructions about taking their prescribed drugs.

PictureRx produces graphical cards, such as the one pictured above, for each patient with a photo of each medication taken by that patient, instructions on the medication schedule and dosage, and an explanation of the purpose of that medication. While prose is included, the emphasis appears to be on conveying as much information as possible by the use of graphical elements.

This excerpt from the PictureRx web site identifies the rationale for this methodology.

This abstract elaborates the same concept:

Katz, Marra G.; Kripalani, Sunil; Weiss, Barry D. Use of pictorial aids in medication instructions: A review of the literature. American Journal of Health-System Pharmacy. 63(23):2391-2397, December 1, 2006.

[Note: At least one of the authors "serves as a consultant to and holds equity in PictureRx, LLC"]

Commentary

As previously noted in this blog (see Health Literacy: A Clear Problem Without A Clear Solution), health illiteracy is widespread and a significant contributor to noncompliance. The use of graphically enhanced instructions is an appealing response to the problem.

Questions do, however, arise. It is unclear, for example, who will be responsible for the additional cost of the picture card (e.g., the patient, the third party payer, the pharmaceutical industry). How will the logistics be managed (e.g., Will new cards be issued with every medication change? What if the patient becomes confused about which picture card is the currently valid one?) If, as the abstract states, there is research “suggesting that patients be trained to use pictorial medication information before they are expected to use icons as an aid for medication administration,” who will provide and pay for that training? And the notion that individuals must be trained to use a simpler protocol is itself somewhat disconcerting. None of these potential problems appear irresolvable, but the solutions implemented could be key to this product’s clinical usefulness and commercial success.

At the risk of nitpicking, I also suggest the company’s promotion should clearly point out that health literacy deficits may be a significant cause of noncompliance but is hardly the only cause. Consider these two sentences placed adjacent to each other on the web site, implying a cause-effect relationship:

If this were a test asking how these two statements are related, the correct answer would be “True, True, and Unrelated.” I.e., both statements are accurate but “limited literacy skills” are not the sole cause of “only 50% of patients tak(ing) medication as directed.”

Nonetheless, if a system for efficient management of the economics and logistics of the picture cards have been or can be developed, they could well prove one step toward improved adherence to medication regimens.

Footnotes

1. According to the LinkIn Profile of Arun Moran, the company’s Director, PictureRx is a privately held startup company “focused on improving medication compliance by simplifying prescription information.”↩

Last week, I serendipitously discovered within hours of one another, Jerome Groopman’s How Doctors Think,¹ which focuses on the reasons doctors misdiagnose a significant number of their patients and, because of a comment she made to a post on this blog,² the story of Trisha Torrey, who was the victim of a misdiagnosis of potentially catastrophic proportions.³

Trisha Torrey’s medical misadventure is fascinating – as well as scary – reading that complements Groopman’s book. That narrative can be found at
~Who is Trisha?~

Ms. Torrey’s misdiagnosis and her subsequent course led to her current career as a patient advocate and the creation of her advocacy web sites at ~EPA Websites~ and her blog at ~Every Patient’s Advocate~

While Ms. Torrey’s inclusion here is primarily the result of the fit between her medical history and Groopman’s book, I also believe that patient advocates could play an important role in improving adherence by helping, as Groopman suggests, patients understand how their doctors operate.


Footnotes

1. See Helping Patients Help Their Doctors↩
2. The comment referred to my March 12, 2007 post, Coaching Patient Compliance↩
3. Her comment had no direct connection to her history of being misdiagnosed↩

How Doctors Think by Jerome Groopman

While my comments on this book were entered on my personal blog, the author’s premise has significant implications for the patient-clinician relationship and for compliance and is thus relevant for the professional healthcare audience as well.

My observations can be found at ~The Good News Is That 80% Of The Time The Doctor Is Right~

Solving the Diet Dilemma for Children Written for the American Association of Kidney Patients web site by Donna L. Morton de Souza, MPH, RD

This page at the American Association of Kidney Patients web site suggests methods by which parents of children on dialysis can encourage adherence to the dietary restrictions necessitated by that treatment.

Most of the advice is standard, as evidenced by the main headings:

• Reason With Your Child
• Offer Rewards for Positive Efforts
• Provide an Appropriate Environment to Promote Success
• Elicit the Support of Others
• Encourage Independence
• Encourage Daily Exercise as Approved by the Physician
• Educational Games and Activities

One section, however, seems counterintuitive although it is a relatively common strategy in the management of diets for weight loss, diabetes, dialysis, and other health problems: Allow For “Cheat Treats”
[Excerpt from article follows:]

Commentary

This parental advisory is well written and could be helpful because it collects in one document the most significant topics dealing with dietary compliance for children in dialysis.

The notion of promoting limited episodes of noncompliant compliant behavior in the service of long term adherence is intriguing.

Allowing patients on dietary restrictions controlled, planned “cheats,” the oxymoronic phrasing notwithstanding, appeals to common sense and is advocated by many professionals. In my quick and dirty searches this morning, however, I am experiencing difficulty finding well contracted studies that support this notion.¹ I plan to pursue followup on the research and publish a post re the impact that “permission to cheat” may have on dietary compliance.

Of course, cheating, sanctioned or not, takes place in treatment adherence situations other than diet. I suspect, however, that therapist-approved cheating on diets is the most common form, and the abundance of cases as well as its relatively stigma-free status may make it easiest to examine, and principles thus derived for dieting may have implications in other fields as well.

Footnotes

1. The difficulty may have more to do with finding the correct combination of search terms for this somewhat ambiguous topic than the lack of studies.↩

Prime time to learn By Susan Brink, Los Angeles Times November 13, 2006

This especially interesting article convincingly presents an intriguing premise outlined in its first paragraph:

Screenwriters are far more capable than healthcare professionals to gain and retain the viewer’s attention, to educate, and to inspire without sacrificing accuracy.

Examples of the power of television programming to move the audience include an increase in contraceptive sales of 23% the first year a Mexican telenovela, “Acompañame,” dealing with an impoverished woman’s efforts to prevent having more children, aired (compared with an increase of 7% the previous year) and an increase in the reported condom use during the last sexual encounter from 34% among South Africans who did not tune into a soap opera called “Tsha Tsha” to 60% among those who watched 10 or more of the programs.

According to the article,

Further, a popular TV program accesses an audience much larger than any group of physicians can hope to reach.

Commentary

My only caveat is that this well-researched article is dedicated to the thesis that TV programming is a positive force for healthcare. Little attention is given to the potential problems such programming could cause. An example that comes quickly to mind is the creation of unrealistic expectations by the physicians portrayed by expert actors abetted by a script that describes miraculous cures, astounding diagnoses, and cases wrapped up in 60 minutes compared to real-life clinicians who are harried and haven’t the advantage of a convenient script to fall back on.

Nonetheless, this is a valuable idea and one that seems potentially useful conveying a concept as complex as adherence to treatment.

Saving the World, One Video Game at a Time
by Clive Thompson

Peacemaker

In the video game, Peacemaker, participants take the roles of either the Israeli prime minister or the Palestinian president, develop and execute a strategy to deal with the conflict, and play to completion.

While Peacemaker has no direct link to medicine, it has at least two elements with potential healthcare applications.

1. Peacemaker reflects real life. For example, tactics that benefit Israel typically anger Palestine, causing reactions that are harmful to Israel, who can, in turn, retaliate. The game can be repeated, allowing players to audition different tactics and experience the varying outcomes, ranging from peaceful resolution to catastrophic violence.
2. Peacemaker is designed to change beliefs and behavior. Entertainment and competition are, in this case, means to an end. The ultimate goals are understanding and adaptability.

Asi Burak, who helped develop the game, notes

Healthcare Applications

Video game concepts have, of course, been used to promote healthcare in numerous ways, including, for example, promoting sociopolitical policies, distracting those suffering from chronic pain, teaching rudiments of a treatment regimen, and enhancing neuromuscular development. As far as I can determine, however, adherence to treatment has not been a target although the potential benefit seems obvious.

A long lamented problem with an impact on treatment compliance has been the difficulty in effectively educating patients. A process such as video games that engages players and allows them to safely experience in an hour the likely outcome of following, not following, or partially following a treatment plan for a given disorder would seem to hold significant promise for at least some proportion of adults as well as adolescents and children who may be less responsive to traditional didactic methods.

A Randomized Controlled Trial Testing an HIV Prevention Intervention for Latino Youth Antonia M. Villarruel, PhD, RN; John B. Jemmott III, PhD; Loretta S. Jemmott, PhD, RN. Arch Pediatr Adolesc Med. 2006;160:772-777.

Successful Anti-HIV Program Targets Hispanic Teens Yahool News Tue Aug 8, 11:47 PM ET
________________________________

550 Latinos aged 13 through 18 years were enrolled in the study. Control interventions consisted of six 50-minute modules delivered by adult facilitators to small, mixed-gender groups in English or Spanish while the HIV intervention focused solely on HIV prevention. The HIV prevention program also incorporated issues thought to be especially significant in the Hispanic culture, such as the importance of family.

Those in the HIV intervention were, according to the abstract, “less likely to report sexual intercourse (odds ratio, 0.66; 95% confidence interval [CI], 0.46-0.96), multiple partners (odds ratio, 0.53; 95% CI, 0.31-0.90), and days of unprotected intercourse (relative risk, 0.47; 95% CI, 0.26-0.84) and more likely to report using condoms consistently (odds ratio, 1.91; 95% CI, 1.24-2.93).”

Commentary

While encouraging, it must be noted that this study, as is true with many others, depends entirely on self-report from the adolescents studied.