AlignMap

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.”↩

Impact of Theology on Adherence To Treatment

Source:
Bashir Qureshi, FRCGP, Diabetes in Ramadan J R Soc Med. 2002 October; 95(10): 489–490.

Managing Diabetic Patients Practicing Devotional Fasting and Other Religious Behaviors

This article centers on pragmatic clinical tips on the medical management of diabetic Muslims celebrating Ramadan.

A brief summary of the relevant customs of Ramadan is followed by “Ten Points Towards Improving Diabetes Care In Muslim Patients.”¹ These examples from that list are representative:

Other recommendations are less specific to diabetes or Ramadan; Point #8, for example, advises that:

Commentary

While this article focuses on a relatively narrow audience, clinicians with limited knowledge of Muslim practices who are providing care for diabetics who are followers of that religion, its readily apparent implications regarding compliance extend far beyond the treatment of a given disease or methods for dealing with those who conform to a single set of theological doctrines. The message to healthcare professionals is clear:

1. Only nine points are listed under the heading, “Ten Points Towards Improving Diabetes Care In Muslim Patients.”↩

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~

Improving Patient Adherence To Cancer Treatment Ell, Kathleen R. Cancer Control Research; National Cancer Institute

Improving Adherence To Cancer Treatment

Excerpt From Abstract of Proposal:

Commentary

While this research is, as far as I can determine, ongoing and no preliminary report has been issued,² the paucity of clinical investigations of culturally tailored interventions to enhance compliance – and, more pertinently, tailored compliance enhancement methods of any sort – prompts me to note this project’s existence and express hopes that results will soon be available.

Update: Information about the status of this project obtained via personal communication with the project’s Director is available at Status Of Improving Patient Adherence To Cancer Treatment Project

Footnotes

1. Although it is not specified in the abstract, I assume IMPAACT refers to Improving Patient Access and Adherence to Cancer Treatment, the National Cancer Institute-funded clinical trial of a system of structured interventions based on the case management model applied to 500 women with breast or gynecological cancer with the goal of improving compliance to cancer treatment.↩
2. I did find (1) a reference to a presentation, “IMPAACT: Improving Patient Access and Adherence to Cancer Treatment. Barriers to Treatment Adherence in Minorities and Persons Living in Poverty” at the National Institutes of Health Conference, Bethesda, Maryland, February, 2006, but was unable to locate any publication of this material and (2) a summary of a presentation, Reducing Disparity in Recruitment of Ethnic Minority Patients in Cancer Clinical Trials: A Priority in Enhancing Culturally Competent Practice made 13 January 2007 at the Society for Social Work and Research meeting, Bridging Disciplinary Boundaries. That paper, however, addressed “socio-culturally grounded strategies to enhance the recruitment of low-income, predominantly Latina women with cancer that have resulted in relatively high rates of participation in two NIH funded clinical trials of social work interventions.”↩

Literature Source For Failed Transplant Cost Calculation

In summarizing the article by Willoughby, et al, Health insurance considerations for adolescent transplant recipients as they transition to adulthood,¹ the 14 March 2007 AlignMap blog post, Out Of Pocket Costs and Transplant Failures Rise In Concert, included the statement that “… the healthcare costs of failed [kidney] transplants are 10 times higher than functioning transplants.”

While the cost calculation was noted in the Willoughby article, its original source is

This citation has also been added to the original post.

Footnotes

1. Full citation: Lisa M. Willoughby, Sumina Fukami, Suphamai Bunnapradist, Jeffrey A. Gavard, Krista L. Lentine, Karen L. Hardinger, Thomas E. Burroughs, Steven K. Takemoto, Mark A. Schnitzler (2007) Health insurance considerations for adolescent transplant recipients as they transition to adulthood Pediatric Transplantation 11 (2), 127–131.↩

[Note: This graphic is not illustrative of the actual device discussed below.¹]

Automating Motivation With Medication Dispensing

The following are excerpts from the patent application for Patient compliance system and method to promote patient compliance:²

Description

Incentives

Commentary

A significant number of devices that automatically dispense medication at the appropriate time and alert the patient or care provider and documents that the medication was “administered” (in this context, “administered” almost always means the medication was removed from the container, “whether or not the pharmaceutical was successfully ingested, inhaled, etc. by the patient”) are on the market. In some cases, the failure to remove a dose from the machine within a given time causes a notification to be sent to a caregiver (e.g., a concerned family member), prescribing physician, pharmacists, or another healthcare professional or organization.

In most cases, no specific incentive for compliance is given. If these devices provide motivation for compliance, it is typically a negative reinforcement (e.g., the implied threat that a family member or a clinician will be notified of noncompliance or the persistence of a noxious reminder, such as a recurrent auditory signal, until the medication is administered³ ). The device described in this patent application does directly address incentives, which have been shown in other situations to be effective compliance enhancements.⁴

I harbor doubts about the practicality and effectiveness of the specific incentive scheme suggested. Deferred rewards (e.g., coupons or codes to be redeemed at a later date) are less effective, especially for children, than immediately available reinforcements. And, one wonders who will purchase the “toys, games, clothes (hats, scarves, t-shirts, etc.), jewelry (e.g., pins, ear rings, pendants, necklaces, bracelets, rings, etc.), candy, books” used as incentives. Further, it is a behavioral modification 101 principle that reinforcements must be selected for their appeal to a given subject and must be varied over time to sustain that appeal.

Consequently, I laud the notion of automating incentives but suspect the reward program in the application, based on a oversimplified concept of behavioral modification, would be far more effective if a more sophisticated, research-based reinforcement system were used.

The Slot Machine Illustration
I happened onto the slot machine graphic while searching for an illustration for this post (I don’t have access to the drawings in the patent application). I decided to use it even though it wasn’t the kind of graphic I had in mind because, it occurred to me, a reward scheme that emulated a slot machine would ameliorate although not completely resolve some of the problems I describe with this device.

• “Buying a chance to win” with compliance would appeal to some, albeit not all, individuals
• Intermittent reinforcement is more effective than continuous reinforcement
• Rewarding incentives only on “winning” doses rather than every dose reduces the number of incentives needed and lessens the frequency with which they must be changed

Just a thought.

1. For an explanation of the use of the slot machine graphic in this post, see section labeled, "Commentary"↩
2. Patent Application #20070039624↩
3. For an outstanding example of this latter strategy and the marketing utility of compliance definitions, see 98.6% Medication Compliance↩
4. I have not made a thorough survey of all such devices, and it is possible and even likely that devices providing positive enforcement for compliance exist. This is the first that has come to my notice↩

Leonard Cohen and Depression

Leonard Cohen’s music¹ has long been associated with depression, as noted in this introductory paragraph from an article in The Observer:

His depression,² in fact, seems to have been a significant factor in his life until it lifted in the 1990s. While Cohen has taken antidepressants, they were not the key to the dissipation of his despondency.

In this interview,³ he discusses, with his characteristic candor and dark humor, his course of treatment and his decision to unilaterally discontinue these medications:

Commentary

Other than being the most recent addition to the AlignMap blog’s celebrity series,⁴ the story in this case is all too typical: Doctor prescribes antidepressants, Patient takes antidepressants, Antidepressants don’t help and also cause side-effects, Patient, without consulting doctor, stops taking antidepressants.

Footnotes

1. Leonard Cohen is one of my favorite artists and I write about him quite often in my personal blog, Heck Of A Guy. For my non-medical Leonard Cohen posts, see The Leonard Cohen Posts at Heck Of A Guy↩
2. Cohen’s commentary on depression in general follows: “The term clinical depression finds its way into too many conversations these days. One has a sense that a catastrophe has occurred in the psychic landscape.”↩
3. Mireille Silcott, A Happy Man, Saturday Night, Canada September 15, 2001, found at http://www.webheights.net/10newsongs/press/satnite.htm↩
4. See also:
   ~Paris Hilton & Patient Noncompliance~
   ~Letterman, Pills, & Compliance Enhancement~↩

Lisa M. Willoughby, Sumina Fukami, Suphamai Bunnapradist, Jeffrey A. Gavard, Krista L. Lentine, Karen L. Hardinger, Thomas E. Burroughs, Steven K. Takemoto, Mark A. Schnitzler (2007) Health insurance considerations for adolescent transplant recipients as they transition to adulthood Pediatric Transplantation 11 (2), 127–131.

What Happens When The Money Runs Out?

Advances in medical and surgical techniques often prolong life and decrease mortality but also create new problems.

In this case, improved immunosuppression and allograft outcomes have resulted in more than 90 percent of pediatric and adolescent patients not only surviving but doing well one year post-operation. That means there is also a growing number of patients taking expensive immunosuppressive medications for the rest of their lives.

While the costs of most transplantation procedures in the USA currently are covered by Medicare, these benefits end 36–44 months after transplantation or when the patient reaches adulthood. Immunosuppressive drugs can cost in excess of $13,000 a year, representing a significant financial burden for even those families with private health insurance because of co-payments . The patients themselves, especially young adults, can rarely afford to pay for these drugs, especially since only about 30 percent of young adults have health insurance.

The consequence of this economic predicament is that preventable rejections of many transplanted organs take place and patients’ lives are shortened. In one reviewed study, the rate of graft loss doubled with the termination of Medicare coverage. And, once the transplanted kidney no longer works, the risk of death increases by a factor of 9. Further, the healthcare costs of failed transplants are 10 times higher than functioning transplants.¹

Commentary

The message is simple and stark: Chronic diseases require chronic care and entail chronic costs.

Individuals, families, and society must make difficult decisions about the long-term consequences of interventions such as transplantation – specifically, how costs and compliance can be managed.

1. G. Machnicki, L. Seriai, M. Schnitzler, Economics of transplantation: a review of the literature. Transplantation Reviews, April 2006. Volume 20, Issue 2, Pages 61-75↩

Increasing Compliance By Coaching Patients To Participate In Their Healthcare

A review in the latest issue of The Cochrane Library indicates that coaching can increase the participation of some older patients’ (+65 years) in their healthcare.

The review found only three studies, involving a total of 433 patients, focused on assisting older patients to increase the effectiveness of doctor visits (many more such studies are available for younger patients). Further, two of those studies had too few patients for the reviewers to feel confident recommending the interventions used. The three studies dealt primarily with two kinds of pre-visit interventions:
1. Person-to-person coaching
2. Written materials

According to one study, 54 percent of patients had not identified specific issues to discuss before their visit to the doctor, and 80 percent did not bring a list of questions, problems or medications to the visit and asked no questions about their illness or tests or procedures. More than three-quarters of these patients did nothing whatsoever to prepare for their visits.

In another study, 45 patients were divided between an intervention group and a control group. Before seeing the doctor, those in the intervention group met with a medical student who questioned them and helped identify questions they had about their treatment. Fourteen of those 22 patients asked at least one question during their session with the doctor, compared with eight of 23 patients in the control group.

Coaching and other methods, however, were insufficient, according to one of the studies reviewed, to prompt the majority of older patients to become adequately involved in their doctor visits.

According to The Cochrane Review, it would be impractical to provide coaching for the entire population, but supplying coaching to hose specific groups of patients who could benefit most could result in a positive benefit to cost issue.

A key principle of the studies, according to lead author Raymond Wetzels, a general practitioner at the Radboud University Nijmegen Medical Center in the Netherlands, is that “more-involved patients tend to adhere to advice better.”

Commentary

As usual, The Cochrane Review is careful not to make pronouncements without sufficient evidence from studies. While the secondary pieces about the Cochrane article seem to emphasize the positive, i.e., that coaching and written materials may increase patient involvement in treatment, the evidence is that even the immediate beneficial effect, which might decay over time, is demonstrated in only a minority of patients.

Further, while there is evidence that patients who are more involved in treatment tend to exhibit higher rates of adherence, much less is known about the impact on compliance when patients, especially older patients, are mentored to become more involved in treatment.

Primary Source
Wetzels R et al. Interventions for improving older patients’ involvement in primary care episodes. Cochrane Database of Systematic Reviews 2007, Issue 1. Art. No.: CD004273. DOI: 10.1002/14651858.CD004273.pub2.

Secondary Source
Coaching Can Help Older Adults Speak Up at Medical Visits
Joan Hennessy, Health Behavior News Service February 15, 2007