Patient choice promotes adherence in preventive treatment for latent tuberculosis
T. W. Rennie, G. H. Bothamley, D. Engova, and I. P. Bates. Eur Respir J 2007; 30:728-735

The Study

This study’s abstract follows:

Commentary

Offering patients treatment choices may indeed promote adherence, but I’m not convinced the results of this study are evidence of this hypothesis.

First, the study is complex. The population included patients treated by one of two methods, 3 months of rifampicin and isoniazid or 6 months of isoniazid, over a six year period. During the first two years, the treatment for a given patient was chosen by the doctor (the reasons one method or the other was chosen were not provided) while the patients were offered their choice of treatments over the last four years of the study.

That the majority of patients (78%) chose the shorter treatment is hardly surprising. (Nor is it surprising that more patients completed a three month course of treatment than a six month course of treatment.) Since the split between 3 month treatments and 6 month treatments among all patients was almost equal (3 month treatment: 53% of patients; 6 month treatment: 47% if all patients) the majority of the physician-assigned patients must have received the longer treatment.

I suggest that conclusions based on comparisons between these inherently dissimilar groups are, at best, tenuous.

Further, as is often the case in compliance studies, the definitions of successful completion, potentially successful completion, and failure to complete are rational but somewhat arbitrary:

And, for the purposes of this study’s statistics,

While these decisions can be justified and, indeed, may be necessary, it is unlikely that the definitions of adherence and nonadherence used in this research are a perfect match for the notions of adherence and nonadherence used in everyday clinical practice.

There are other, less overt, problems with this study enroute to the conclusion that patient choice enhances compliance but these should be sufficient to cast doubt on the unequivocal declaration of the title. A shame, that.

• Tuberculosis Adherence Self-Study Module
• Celebrating Compliance
• Fixed-Dose Combinations Improve Medication Compliance: A Meta-Analysis
• Coerced Treatment Of Tuberculosis & HIV
• Adherence To Tuberculosis In Botswana

Helping Patients With Type 2 Diabetes Mellitus Make Treatment Decisions Audrey J. Weymiller, CNP; Victor M. Montori, MD, MSc; Lesley A. Jones; Amiram Gafni, PhD; Gordon H. Guyatt, MD, MSc; Sandra C. Bryant, MS; Teresa J. H. Christianson, BS; Rebecca J. Mullan, MS; Steven A. Smith, MD Arch Intern Med. 2007;167:1076-1082.

The Clinical Trial

Today’s entry is a follow-up to Patients’ Tool Improves Treatment Decisions, Adherence, covering a recently publish study of the effectiveness of the Statin Choice Tool discussed in that post.

Abstract

Additional Study Information
Patients were given a self-administered written questionnaire immediately that included 7-point scales to explore patient perceptions of the amount, clarity, and helpfulness of the information, willingness to recommend the way statins were discussed with others, and desirability of using the process of sharing information in future decisions. The questionnaire also included 14 knowledge questions to assess patient understanding of the relative merits of using or not using statins. Nine of these questions were addressed in the decision aid; 5 were not. At 3 months, surveys were mailed to patients to determine whether they were taking statins and, using a single-question,9 whether they had missed any doses in the last week. Nonrespondents were telephoned.

Patient Education and Decision-making Results

• Participants receiving either the decision aid or the control pamphlet scored similarly on questions irrelevant to the statin choice.
• Patients allocated to receive the interventions from their clinicians during the visit achieved better knowledge scores when using the decision aid than when using the control pamphlet.
• Patients allocated to receive the interventions from the clinicians during the visit were most accurate when reporting the relevant cardiovascular risk without statins when using the decision aid than when using the control pamphlet.
• Participants receiving the decision aid were more likely to accurately estimate the potential absolute risk reduction afforded by statin use than participants receiving the control pamphlet.
• Compared with the control group, the decision aid group had significantly less postvisit decisional conflict.
• Participants using the decision aid thought they were better informed about the options than did participants using the control pamphlet.

Statin Therapy Starts

• Among participants not receiving statin therapy at baseline, 7 (30%) of 23 in the decision aid group (6 of whom received the decision aid from their clinician during the visit) and 4 (21%) of 19 in the control group decided to start statin therapy immediately after the visit.
• Eight of these starts occurred among participants with 10-year cardiovascular risk greater than 15%.
• Of the 3 starts in the group with cardiovascular risk less than 15%, 2 occurred in the control group.
• At 3 months, 9 (39%) of 23 participants in the intervention group and 6 (32%) of 19 participants in the control group had started statin therapy (OR, 1.5; 95% CI, 0.3-6.8).
• Two of 4 patients with interim starts received Statin Choice from the clinician during the visit.

Adherence At 3 Months
At 3 months, 33 (63%) of the 52 participants in the decision aid treatment arm and 29 (63%) of the 46 participants in the control treatment arm reported taking statins (OR, 1.4; 95% CI, 0.8-2.4). Overall, there was no difference in adherence to patient choice at 3 months (analysis adjusted by sex, cardiovascular risk, and number of medications; OR, 1.9; 95% CI, 0.4-9.8). Of those patients taking statins at 3 months, 2 of 33 participants in the decision aid group reported missing 1 dose or more in the last week compared with 6 of 29 participants in the control group (OR for adherence, 3.4; 95% CI, 1.5-7.5).

Unanswered Questions And Future Research
Elements in the agenda for future research include evaluation of the role of decision aids in chronic conditions requiring decision revisions over time, testing Statin Choice in primary care and with less educated patients, use of multiple measures of adherence to medication regimen, estimation of the costs and burdens (eg, time) of implementing decision aids in practice, use of decision aids as tools to educate physicians-in-training to better enhance patient-clinician communication and decision making, and development of decisional quality as an outcome of clinical trials and as a measure for quality of care.

Commentary

It is significant - and the authors are careful to point out - that this clinical trial was undertaken by the same folks that developed the Statin Choice Tool being evaluated.

Further, it is also significant that the compliance rates were calculated from the patient’s self-report, a notoriously unreliable data source. Again, the authors point this out, specifically suggesting that future studies look at the “use of multiple measures of adherence to medication regimen.”

Otherwise, the study indicates that the statin choice tool is promising as a decision-making aid but far from proven. Perhaps I’ve grown cynical about compliance research, but I find, because self-report was the only data source, little compelling evidence of improved adherence although there is reason for cautious optimism.

I will be interested in the results of future trials, especially if they more rigorously assess the tool’s effect on patient compliance.

• Patients’ Tool Improves Treatment Decisions, Adherence
• Decision-Making Processes Of Prostate Cancer Patients
• Statin Compliance
• From The Patient’s Point Of View
• Lipitor Would Rather Fight Than (Have Patients) Switch

Patient-specific Qualitative Data Made Understandable

[Click on graphic to view larger image]

The Statin Choice Tool

The Statin Choice Tool was developed as part of the The Wiser Choices Program,¹ which was itself created at the Montori Lab of the Mayo Clinic.

The Wiser Choices Program is described in this excerpt from the Mayo web site:

These decision aids present evidence-based estimates, specific to a given patient, of the potential benefits and disadvantages of the available treatment options in straightforward language augmented with graphical representation of statistical findings (see image atop this post). The interlinked goals are to involve the patient in the decision-making process in a meaningful way, improve the acceptability of the treatment decision to the patient, enhance adherence, and improve the clinical outcome.

Commentary

Making decisions about treatment is a difficult process, even if one buys into the premise that such decisions should be based on research-based evidence.

Healthcare professionals themselves often misinterpret statistical findings; a patient who lacks training in statistics, research, and the pathology and treatment of his or her disorder can hardly be expected to be immediately capable of making a choice in his or her own best interest. Educating such a patient can be an arduous, time-consuming task for the patient and clinician, especially since the effort must be accomplished when the patient is under stress.

Complicating the situation is the concern that the clinician will exert undue influence on the patient, rendering the patient’s role in that decision a sham. Some bioethicists would hold that a physician should lay out the patient’s treatment options with each choice’s risks and benefits, carefully abstaining from any indication of a preference for one or another, even if the patient requests that information. Others contend that such a mechanical process belies the human relationship between patient and clinician and robs the patient of the professional’s expertise.

The Wiser Choice Program and its Statin Choice Tool are attempts to efficaciously convey essential information about treatment to the patient in such a way that the patient’s role in determining treatment is legitimate and meaningful.

Tomorrow’s post will focus on a recently published study designed to determine if the Statin Choice Tool accomplishes that goal.

Update: Statin Choice Tool Clinical Trial

Footnotes

1. Further information about the Wiser Choices Program, including this documentation:
   * Statin Choice Instruction Manual for Providers
   * Statin Choice Decision Aid Informational Booklet for Patients
   * Case 1 – High-Risk
   * Case 2 – Mid-Risk
   * Case 3 – Low-Risk
   * Pen-and-paper coronary risk estimator based on the UKPDS

   can be found at mayoresearch.mayo.edu/…/decision-aids.cfm [back]

• Statin Choice Tool Clinical Trial
• Decision-Making Processes Of Prostate Cancer Patients
• Statin Compliance
• From The Patient’s Point Of View
• Lipitor Would Rather Fight Than (Have Patients) Switch

Many of the ‘ADD generation’ say no to meds; Newly minted grown-ups are carrying out a massive natural experiment by choosing to do without the drugs that profoundly affected their experience of childhood. By Melissa Healy, Las Angeles Times December 18, 2006¹

This article focuses primarily on a number of young adults who, diagnosed with and treated with medication for Attention Deficit Disorder in childhood, have chosen to discontinue those stimulants.

Commentary

This article exemplifies one of the most problematic aspects of the lay press reporting on healthcare issues by promoting a point of view that could influence readers.

There is no indication that any aspect of the story is inaccurate or intentionally misleading. On the other hand, each of the individuals who decided to stop taking their ADD medications is reported to have done well. Further, support for the discontinuation of medication is presented uncritically while doubt is cast upon theories and studies favoring the ongoing use of these medications.

And, consider the tone of these excerpts:

The penultimate portion of the article is devoted to Dr. Lawrence Diller, the author of “The Last Normal Child,” in which he “raises concerns about the effect on society and children when parents, schools and the medical establishment reach too easily for such medication [for ADD].”

The issues raised, whether ADHD medications should be taken indefinitely and, if not, how the decision to continue or discontinue the medication is determined, is both legitimate and important. A reporter’s responsibilities in presenting the story are less clear. In this case, a newspaper story that features reports of interesting individuals who seem to have made the right decision going off a medication, breezy summaries of research and ideas about the disease, and a clear air of approbation for independence-minded young adults who defy their parents and doctors by discontinuing their medications is, it would seem, more likely to influence those facing this decision than pages of grey print reporting findings of scientific studies.


Footnotes

1. Also see Related Stories “in their own words” [back]

• Interview-based Patient Adherence Observations
• Medication Adherence Is Half The Battle
• I Am Non-Compliant And It Sucks
• How To Create and Use A Personal Medication Record
• Managing Noncompliant Patients

I Want It Now! The curious economics of temptation By Tim Harford Slate.com Nov. 25, 2006

While this brief article at Slate.com, an entry in that online publication’s “Undercover Economist” column, does not mention healthcare or compliance, the applicability of its message to those areas is apparent. That message is set forth in these two excerpts:

The author goes on to point out the utility of this insight, describing, as an example, a plan called:

Commentary

Every clinician has dealt with the patient who will follow his blood sugars assiduously, take her pills precisely as prescribed, or adhere to his diet – tomorrow. The idea raised in this article should, at least, remind physicians that it’s likely that the patient’s explanations are manifestations of the value he or she places on immediacy rather than a failure of will power or an excuse offered in hopes of avoiding compliance.

And, perhaps lifestyle shifts (e.g., terminating smoking) are more likely to be effected if the clinician recommending the change suggests that the commitment to change be made now with the actual behavioral alteration taking place in the future.

• Yep, The AlignMap In The Slate Article Is This AlignMap
• How The Economics Of US Health Insurance Work Against Compliance With Preventive Care
• Neuroeconomics, The Rational Man, & Noncompliance
• About AlignMap
• Adherence Improvement Battle Fought On Many Fronts

Mind Games John Cassidy New Yorker 2006-09-18
What neuroeconomics tells us about money and the brain

This essay from The New Yorker does not directly address patient compliance or adherence, yet it does offer valuable insight in the process of decision-making, including healthcare decision-making.

For some time, I’ve railed against the Rational Man fallacy,¹ especially as it applies to theories of patient compliance. (See, for example, Patient Behavior, Current Models, and Decision-Making Processes Of Prostate Cancer Patients )

The same mental and psychological processes involved when individuals make investment decisions, the focus of this article, are, I would hold, similar if not identical to those involved in making healthcare decisions and in determining compliance.

The author’s point of view is neatly summarized in his statement,

Happily for him and us, the writer became involved in neuroeconomics research being carried out at New York University’s Center for Brain Imaging, using imaging technology to examine the neurology of decision-making as it pertains to economics.

The article describes the imaging research, explains how its findings correlate with observations about irrational decision-making derived primarily from studies by economists and psychologists, and examines the implications for investment behaviors.

The article is interesting and rewarding so providing a comprehensive review is less efficacious than simply recommending that it be read from the perspective of its possible applicability to healthcare decision-making as well as economics.

Toward that end, it is worth noting that, until the 1970s, academic economists and psychologists had little to do with one another, at least not since the 1800’s, when they were both considered “moral sciences.” Psychology then became progressively more empirical, based on quantifiable observations of human behavior. Simultaneously, economics became, in many ways, a theoretical science focused on mathematical models and predictive equations. This attempt to reduce economic behavior to mathematics led theoreticians to create Homo economicus, an individual whose psychological state was invariable and whose decisions were always rational. To be fair, economists have routinely acknowledged the hypothetical and arbitrary nature of this version of Rational Man, but this concept, a legitimate tool for exploring ideas when carefully used, has seduced many economists, politicians, and other professionals into ill conceived actions based on the assumption that the human beings actually involved in whatever schemes being concocted would behave as rationally as the hypothetical Economic Man. Eventually, stock market and housing bubbles, retail shopping frenzies, and similar “irrational” phenomena coerced the admission of the limitations of the Rational Man assumptions. In the last 25 years, more and more economists have used ideas and insights from psychological studies to study investment behavior.

I would hold that healthcare academics and clinicians have fallen into the same trap as the economists, albeit with less apparent reasons and having made less apparent progress toward rectifying this fundamental error.

The concluding sentences are also worth quoting:

Substitute “Compliance Theory” for “economics,” and it rings true to my ears.


Footnotes

1. Rational Man and Economic Man are terms used in economics, law, and other settings to stipulate a hypothetical individual that uniformly and inevitably acts logically to achieve the highest possible well-being for himself using whatever pertinent information is available. More formally, The Washington University Economic Geography Glossary defines Economic Man as the “Highly abstract model of human economic behavior based on simplifying but extreme assumptions of perfect information and perfect ability to use such information in a rational way (i.e. to achieve optimal ends)” [back]

• Healthcare-Enhancing Video Games
• Changing Behavior With Video Games
• The Top Ten Patient Compliance Points: #2
• Healthcare Payment Cap Proves Disincentive To Compliance
• Automated Incentives For Medication Adherence

Prostate Cancer Decisions Often Based on Fallacies
By Nicholas Bakalar
New York Times July 4, 2006
__________________________________

This article describes a study¹ of the processes by which 20 prostate cancer patients chose their course of treatment. Prostate cancer, because of the variety of treatments available and the lack of hard data conclusively indicating which of these treatments is superior, offers an opportune field for this kind of study.

After a urologist made the diagnosis and discussed options with the patients, each was interviewed for 60-90 minutes about their decision-making processes.

Especially striking among the findings were the following:

• Nineteen of the 20 patients were influenced in their choice of treatment by experiences of a friend or relative with the disease.
• Despite the understanding that prostate cancer was slow-growing and, in some cases, that the cancers were of low histological grade and that the bone and CT scans were negative, 12 of the 20 wanted treatment as soon as possible, and 8 of those were convinced that surgery was the best option.
• Those who desired surgery felt that decision was common sense and mistakenly believed that if the tumor was confined to the prostate, the surgery would cure the illness.
• Those who chose surgery were confident about this decision and were resistant to consider other options; those who rejected surgery were more willing to consider a variety of treatments.

Commentary

This is further evidence of the fallacy of the “rational man” on which most conceptualizations of patient compliance rely. (See Patient Behavior)

Footnotes

1. The referenced study appears in the Aug. 1 issue of Cancer [back]

• NY Times Coverage Of Patient Compliance
• Neuroeconomics, The Rational Man, & Noncompliance
• Noncompliance With Cancer Therapy Rising As Number Of Elderly Patients Increases
• Healthcare-Enhancing Video Games
• Judging Competency To Comply With Or Refuse Treatment