AlignMap

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.

Patient-specific Qualitative Data Made Understandable

Sample Patient Decision Aid For Low-risk Patient (click to enlarge)

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

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 Mayo Research↩

Online CME

The Impact of Adherence and Persistence in the Pharmacological Management of Osteoporosis is the summary of a Roche sponsored Roundtable on compliance with a osteoporosis medication regimen held in October 1006 that featured Drs Stuart L. Silverman, Paul Miller, Steven T. Harris, and Jeffrey P. Levine, all of whom have special expertise in the area of osteoporosis, and Joyce Cramer, BA, who is known for her research in patient compliance.

The skew toward osteoporosis-specific experts in the faculty notwithstanding, the presentation and CME goals and testing are targeted on compliance and persistence. In fact, except for questions dealing with specific studies, one could safely respond to the test queries based on general compliance principles and trends. This is hardy a criticism. General principles should apply in most cases.

Open communication between clinician and patient is much lauded as is the use of monthly rather than weekly medication intervals.¹

The presentation does cover studies showing the link between noncompliance with treatment and increased risk of osteoporosis, a consideration of possible causes of nonadherence, some practical suggestions for scripting a discussion of compliance with patients, and an especially insightful discussion of the methodology of compliance and persistence studies.

CME Information

The Postgraduate Institute for Medicine designates this educational activity for a maximum of 1.75 AMA PRA Category 1 Credits™. Obtaining credits requires registration (no cost) and online completion of the usual pre-test, post-test, and course evaluation. The presentation offers data in these formats:

• 90-Minute Roundtable Discussion From October 9, 2006 (Flash Presentation)
• 60-Minute Archived Webinar With Q&A From October 19, 2006 (Flash Presentation)
• 60-Minute Archived Webinar With Q&A from October 25, 2006 (Flash Presentation)
• Roundtable Slide Deck (PDF Format)
• Roundtable Discussion Summary (PDF Format)

1. It should be noted that the Roundtable sponsor, Roche, produces oral Boniva (ibandronate sodium), a once-a-month medicine for the treatment of postmenopausal osteoporosis. That does not, of course, negate the efficaciousness of a medication administered once-monthly instead of once weekly, but those who read these materials should be aware of the potential tie-in.↩

Source: Nivedita Bhatta Dhar, J. Stephen Jones, Amit Bhatt, Denize Babineau (2007) A prospective evaluation of the impact of scheduled follow-up appointments with compliance rates after vasectomy BJU International 99 (5), 1094–1097. doi:10.1111/j.1464-410X.2006.06725.x

Study Parameters

To prospectively determine the impact of scheduled follow-up appointments with compliance rates after vasectomy, 228 consecutive who men had a vasectomy were studied. Of those, 114 were instructed to bring a semen sample to the office and 114 were given a follow-up appointment to submit samples. All men were instructed to submit specimens at 2 months after vasectomy and at 1-month intervals until two consecutive samples were azoospermic. Over the 18 month study, the mean (range) follow-up was 16 (6–24) months.

Results

Commentary

That many men post-vasectomy don’t follow-up with a semen sample to assure that the procedure was successful is not surprising, given that significant rates of noncompliance are common for most healthcare processes.

I am, however, surprised to find that simply scheduling a formal appointment results in a significant improvement in compliance, at least with one sample,

On the other hand, the majority of men in both groups failed to have a second confirmatory test, which intuitively seems most likely the result of “the hassle factor.”

The take-home message from this study, in fact, may well be that reducing obstacles to compliance is always a good strategy.

Empathic Young Doctor Empowers Patient

Elliot, although less skilled clinically than Dr. Cox, has insight into the patient that he lacks because of her own experiences.

Because of Elliot’s empathy (key point: teenaged girls have no control over their own lives), the patient reveals she is “so tired of people telling [her] what to do, when to be home, what to wear, when to take [her] medicine, …” and declares she can handle her own treatment.

Elliot builds rapport [note her forward leaning to signify interest in the patient] and then empowers patient by putting control of her medication in her hands. (Prescription will go to patient instead of parents; she will be in charge of getting and taking her Dilantin.)

Patient says “Thank you” to Elliot [and, one suspects, becomes 100% compliant and lives happily ever after]. Dr. Cox learns a valuable lesson from Elliot.

Upcoming: Commentary On The Scrubs Patient Compliance Subplot

Taking The Right Pills At The Right Time

In yesterday’s Wall Street Journal Health Journal column, Take Your Medicine: Strategies for Sticking to a Drug Regimen, Tara Parker-Pope takes on the practical problems of medication compliance, focusing on pill organizers, reminders, and a few of the strategies previously discussed in this blog: Picture-cards, Alerting Devices, The Asheville Pharmacist-driven Project, and Pharma-sponsored Compliance Programs.

Commentary

My criticism of this article is – well, that it’s not the article I would have written.¹ The time and space restrictions on a columnist are not issues I face posting here. If I skip a day, someone might complain, but I won’t be fired. And, if I am rant-oriented, I can write as many pages if I wish. Ms Parker-Pope does not enjoy such luxuries.

That said, I still believe the columnist’s criteria for usefulness when it comes to compliance methodologies is a tad lax. As the Dodo declares after a race in Alice’s Adventures in Wonderland, “Everybody has won, and all must have prizes.” While one may be able to find instances in which each of the techniques listed made a difference for a given individual or group of individuals, but convincing evidence of overall efficacy is lacking for most.

Interventions to Enhance Medication Adherence in Chronic Medical Conditions: A Systematic Review by Kripalani and colleagues,² an article referenced in the column, concludes its abstract with a sobering line, “Several types of interventions are effective in improving medication adherence in chronic medical conditions, but few significantly affected clinical outcomes.” I would contend that the column should have emphasized both clauses of that statement rather than focus exclusively on the first.

Footnotes

1. If I were to write a single piece for a periodical like the WSJ, I would want to delve into the research, the conceptual basis of compliance, the political and economic implications, … , creating a tome which would displace all other news, columns, and features for weeks. Consequently, the risk to readers is, I suspect, slight.↩
2. Sunil Kripalani, MD, MSc; Xiaomei Yao, MD; R. Brian Haynes, MD, PhD. Interventions to Enhance Medication Adherence in Chronic Medical Conditions: A Systematic Review. Arch Intern Med. 2007;167:540-549↩

Pompous Doctor Unable to Deal With Noncompliance

Source: Scrubs: My Big Move. Episode 90, Season 4, First Aired: April 12, 2005

The Story

Dr. Cox confronts his 16 year old patient, with whom he mistakenly feels he has good rapport, on her nonadherence to her anti-epileptic medication regimen, informing her that she will die if she doesn’t take the medication appropriately. Elliot [AKA "Blond Haired Doctor"], is appalled.

The patient meekly agrees to take her medication, but [gasp] doesn’t do so.

Guilty to discover that shouting at his patient caused her to cry, Dr. Cox awkwardly tries to establish communication with his patient by talking about issues he, again mistakenly, thinks teenaged girls would find interesting.

Dr. Cox, despite hours of effort, fails to forge a working relationship with his patient.

Updated: The Scrubs Patient Compliance Subplot – Part II

Impact Of Asthma Screenings Blocked by Nonadherence

An American Thoracic Society workshop reports that while population screenings make sense in theory, the benefits are unproven for children with asthma.






According to Lynn Gerald, Ph.D., M.S.P.H., workshop co-chair,

Commentary

I’ve focused on this concern that noncompliance blocks implementation of clinical action when screenings detect possible pathology because it spotlights a hidden cost of nonadherence.

It is an often overlooked albeit obvious fact that the time, human resources, and money expended to discover a case of untreated asthma – or any other disease – are lost unless the that patient pursues clinical confirmation of the disorder and any necessary treatment.

The reality of noncompliance is crystallized in Dr. Gerald’s recommendation that the limited resources of public health should be used for children with active symptomatology rather than screenings.

Source:News-Medical.Net

Complementary Or Alternative Medicine?

Complementary and alternative medicine use decreases adherence to HAART in HIV-positive women. Owen-Smith A, Diclemente R, Wingood G. AIDS Care. 2007 May;19(5):589-93.

The Study

366 HIV-positive, mostly African-American women, aged 18-50 years in Alabama and Georgia who were enrolled in an intervention to reduce high-risk sexual behavior. Data collection at time of enrollment was used to identify participants as complementary and alternative medicine (CAM) users if they reported taking herbal or natural immunity boosters (Chinese herbs, mushrooms, garlic, ginseng or algae) or multivitamins, or if they reported using religious or psychic health or bodywork to treat HIV. Women were classified as non-adherent if they reported missing any doses of their HAART medication in the 30 days preceding baseline assessment. Logistic regressions models, adjusted for potential confounders, were used to investigate the relationship between CAM use and HAART adherence.

Results

From the abstract:

Commentary

The potential implications of these findings are, of course, profound and extensive. And, while one study with numerous obvious methodological limitations cannot support widespread changes in dealing with CAM, it should alert clinicians to exercise renewed vigilance regarding compliance in those cases in which patients use herbal, religious, or other alternatives to conventional evidence-based healthcare.

It should also serve as reminder that maintaining an open mind toward imaginable benefits of CAM does not preclude the possibility that such use of CAM may have deleterious effects. If nothing else, this study belies the casual, wishful “what could it hurt?” response I’ve occasionally heard from patients and other clinicians in regard to CAM.

Finally, as has been the case in many analogous situations, I hold the author’s recommendation that “health care providers and patients should have explicit dialogues about how to effectively integrate CAM practices into traditional treatment regimens” to be a necessary but not sufficient element in managing adherence to prescribed treatment.

The Annual Report on Suicide Prevention

Source: National Suicide Prevention Strategy For England – 2006 Report

In a generally optimistic report by the National Institute for Mental Health in England on the effort to reduce suicide in that nation by 20 per cent by 2010, there is a somber note about the role of noncompliance in suicide:


The Avoidable deaths report published last year estimated that 56 mental health patients discharged from hospital die every year following non-compliance with medication or loss of contact with services. Supervised Community Treatment, a measure to improve clinical risk management that the Government is introducing in its Mental Health Bill, has the potential to help prevent those deaths. Having a severe mental illness is a known risk factor of suicide and a significant number of suicides occur during in-patient care or shortly after discharge. Avoidable deaths showed around 200 suicides a year – or 14 per cent of all suicides – follow non-compliance with treatment. Better compliance with treatment and closer supervision were highlighted by clinicians as the main ways of reducing suicide risk.

Commentary

I’ve selected this as the focus of today’s post to serve as a dramatic reminder of the importance of compliance enhancement efforts.

Political Agenda As Treatment Plan

According to a 9 May 2007 news release, Zero Tolerance to Asthma Attacks – Make Asthma a Political and Medical Priority, a “group of medical experts and patient representatives today called on politicians, clinicians, regulators and colleagues to take immediate action and work together to ease the plight of the 32 million people in Europe with asthma, and free up more than eight million hospital days each year. The statement is part of the Brussels Declaration, a ten point action plan to challenge the current status quo and make asthma a political and medical priority.”

These excerpts characterize the Declaration:

The ten points identified for action are summarized as follows:

1. All stakeholders must recognize asthma as a serious public health issue and consequently make asthma care a political priority.

2. Policy makers and Professional Bodies, including European Patients’ Associations must respond now to the developing understanding of asthma including recognition as a respiratory manifestation of systemic inflammatory processes.

3. The medical community, guided by its Professional Bodies, must ensure that it rapidly responds to the latest scientific understanding of asthma, recognising that asthma presents differently for adults, children and infants and different ethnic groups and management cannot necessarily be extrapolated from one group to the other. Studies and recommendations must recognise this.

4. There should be an immediate update of the European Medicines Agency (EMEA) Regulatory Guidance Note on asthma which is essential to ensure that asthma treatment and diagnosis responds to the latest scientific knowledge, clinical and real world experience, and that relevant national organisations, including patient groups and organisations, should be involved in a process for an ongoing and timely update of asthma management guidelines for both adults and children, backed by support for clinicians and patient organisations to help them integrate these guidelines into practice.

5. Guidelines should continue to use the results of traditional randomised clinical trials where these add to our understanding; however, in addition, they should seek evidence from other studies such as health economic and health outcomes studies that focus on a broader range of end points and patients that reflect ‘real-world’ patient care and family life including studies that particularly address the child/infant.

6. Funders at national and EU level must consider funding new studies that help to answer questions about the impact of co-morbidities on asthma, how to promote adherence to optimal treatment by both professionals and patients and advance patient-centred care, effective prevention strategies and prevalence studies.

7. Policy makers, politicians, clinicians and third parties (including those representing patients’ perspectives and opinions) must explore variation in asthma care across Europe and distinguish between normal variation due to differences in healthcare systems and cultures, and variation that can be reduced through policies that improve organization of care and clinical practice and create a more informed and engaged public who are aware of the needs of patients with asthma and allergies.

8. National policies should incentivize the organization of care so that people with asthma can actively participate in and make choices about their care. The EU and national agencies must improve their ongoing pharmacovigilance processes and medical utilisations in asthma to ensure that medications are used appropriately and that potential safety issues in terms of medicines and their usage are quickly and clearly identified, communicated and monitored.

9. The EU and national governments must liaise with other agencies to understand and reduce the impact of environmental factors on asthma such as smoking, air pollution, hazards in schools, day care, the work place and home, as well as other environmental triggers.

10. National policies should set targets for healthcare providers to keep registries, reduce hospitalisations, emergency healthcare use, days off work and days off school experienced by people with asthma and encourage use of tools/instruments to assess asthma control and reasons for poor control where it exists in the individual.

Commentary

The importance of treating asthma optimally is unquestioned.

And, the importance of treating major depression optimally is unquestioned.

And, the importance of treating cardiac disease, AIDS, tuberculosis, traumatic head injury syndromes, schizophrenia, … optimally is unquestioned.

Can they all have priority?

Is competitive lobbying the best use of the talents and time of medical experts?

Is a disease by disease approach to compliance, as exemplified in such clauses as “National policies should incentivize the organization of care so that people with asthma can actively participate in and make choices about their care” and “Funders at national and EU level must consider funding new studies that help to answer questions about the impact of co-morbidities on asthma, how to promote adherence to optimal treatment by both professionals and patients and advance patient-centred care, effective prevention strategies and prevalence studies.” viable?

Patient Compliance and Furious Seasons

Philip Dawdy has been blogging at Furious Seasons¹ since September 2005 from this perspective:

He is also an award winning professional journalist who has reported for years on mental health issues and who has interviewed doctors, researchers, and hundreds of individuals with psychiatric diagnoses, which he points out

While today’s title is lifted from The Norm, Hope And Statistics, Dawdy’s 26 April 2006 post, references to his high rate of adherence to his medication regimen are prominent and frequent throughout his posts. These posts, for example, directly address compliance:

• And Now for Something Different
• Just How Bipolar Is America, And Treatment Notes
• Pete Earley Now Has A Problem

Commentary

The author’s disclaimers notwithstanding, Furious Seasons perhaps comes closer than any other blog to integrating the writer’s experiences as a patient and his point of view as a reporter in equal proportions. While posts can be strident,² there is much to admire in his thoughtful, clearly written prose. As an example, I suggest a careful reading of the post discussing his notions on recovery: Slouching Toward Recovery. While I do not endorse all its ideas and recommendations, this post is a brave and honest distillation of years of experience that has been successful in managing major, potentially disabling symptomatology.

I am, naturally enough, especially interested in how patient compliance is treated by bloggers and can find no better way to conclude this post than with an excerpt indicative of Mr. Dawdy’s no-nonsense approach:

Footnotes

1. Although I found no confirmation at Mr. Dawdy’s blog, my working assumption is that “Furious Seasons” references the title of Raymond Carver’s first published short story, which I once read as an assignment. I recall that it was Faulknerian by design and therefore dark and convoluted with a stream of consciousness style that constantly reshuffled chronology. Heavy handed psychosexual symbolism studded a melodramatic plot that featured incest and murder. OK, it wasn’t my favorite Raymond Chandler story. Independent of the story itself, the title effectively invokes the experience of bipolar disorder episodes.↩
2. Other bloggers are “strident” or even “vehement;” I, on the other hand, veer toward “deeply principled.”↩