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April 2nd, 2015

Shared decision making and minimally disruptive medicine for COPD patients

By Victor M. Montori manosin

COPD is the third most common cause of death in the USA (1). Fifteen million Americans report that they have been diagnosed with COPD (2), but the actual number is likely to be higher, as more than 50% of adults with low pulmonary function are not aware that they have COPD (3).The national medical costs for COPD were $32.1 billion dollars annually in 2010, and are expected to rise to $49 billion dollars annually by 2020 (4).

But there is not only the impact of COPD on health care services and medical cost; there is a significant burden associated with COPD and COPD treatment that patients have to bear. When COPD patients were asked in a study to define their condition in their own words, 29% percent defined their condition with the sensations of burden, limitation, or disability (5).

Consider the case Mrs. S. who is a 70-year-old cachectic woman who has had 3 hospital admissions for acute exacerbations of COPD in the past year and a total of 12 hospital admissions in the last 5 years. Her COPD is severe based on lung function testing with an FEV1 of 25% predicted and she has chronic severe hypoxaemia with a Pa02< 55 mmHg (<7.3kPa). She gets breathless when she walks more than 30 meters (98 feet). She has been a smoker for 45 years and, unfortunately, she continues to smoke, despite successfully giving up smoking for 6 months- supported by nicotine replacement therapy- a couple of years ago. Her medical specialists and her primary care doctor keep nagging her about her smoking. She is on home oxygen therapy (prescribed to her at the time when she stopped smoking), and recently experienced an anxiety attack when her oxygen concentrator would not work during a power outage. She has a history of congestive cardiac failure, arterial hypertension, rheumatoid arthritis, chronic back pain caused by several vertebral fractures of the thoracic and lumbar spine secondary to long term systemic corticosteroid therapy, hypothyroidism, anxiety and depression.

In the past, she has often not shown up for her specialist appointments because she does not have anybody to drive her to the appointments; she is too unwell to come by public transport; and she cannot afford a taxi. Her pulmonary specialist had referred her to the outpatient pulmonary rehabilitation program at the hospital, but she dropped out after the first session because of transportation problems.  She is not taking the tablets she has been prescribed other than pain medication and thyroxin tablets, because she does not feel that they do a lot for her. She finds it difficult to handle the metered dose inhalers with her arthritic fingers and thus often skips the inhalation treatment. She lives on her own; her two daughters live a few hours’ drive away, and she only sees them a few times every year. She does not have any close friends. She feels that most people around her are blaming her for her COPD because she smokes.

It is easy to see that COPD reduces Mrs. S. quality of life significantly, and it apparent that she is overwhelmed by managing the treatment of her disease. What could shared decision making (SDM) and minimally disruptive medicine (MDM) offer to somebody like Mrs. S.? The following scenario could unfold when SDM and MDM are integrated in Mrs. S.’ clinical care:

During the next clinical encounter her pulmonologist uses a decision aid that has been designed to facilitate collaborative deliberation of treatment options in COPD (6). Mrs. S. is invited to choose which outcome goal she would like to discuss first given a choice of ‘improving symptoms of COPD (shortness of breath, cough)’, ‘reducing flare-ups of COPD’, ‘increasing life expectancy’, ‘improving function in everyday life’. She chooses ‘improving function in everyday life’ and learns how important pulmonary rehabilitation is to maintain and improve her function in everyday life. Her pulmonologist shows her a graphic display of the functional improvement that can be achieved with pulmonary rehabilitation in comparison with other measures, such as inhalation therapy. Mrs. S. is surprised to see that pulmonary rehabilitation can do more for her functioning in everyday life than inhalers, and she now wants to give this another try. Because problems with transportation to the clinic have been the major barrier to attending the pulmonary rehabilitation program at the clinic before, the pulmonologist helps her to find a pulmonary rehabilitation program closer to her home that also provides complimentary bus pick up (facilitating social interactions with other COPD patients on the bus- an additional benefit!).

The decision aid further points out that anxiety and depression negatively impact on function in everyday life. Together with her pulmonologist, Mrs. S. decides that she wants to address her anxiety and depression; they agree that he should be treated with an antidepressant. As smoking cessation has also been listed as important for functional improvement, the pulmonologist and patient decide that they will discuss smoking cessation aids during the next consultation.

To address the fact that Mrs. S. feels overwhelmed with all her medications for different diseases, her primary-care doctor and her pulmonologist use an electronic decision support tool that addresses multimorbidity in elderly patients integrating principles of MDM. This decision support tool takes into account Mrs. S.’ individual patient profile and tailors treatment recommendations to her circumstances and preferences. The electronic decision support tool provides information about the types of outcomes achieved with different treatments (e.g. ‘improving quality of life’, ‘increasing life expectancy’) and the impact in reduction of risk across specific scenarios. The tool assist the clinician and Mrs. S. in ranking these treatments based on benefit, harms, and, importantly, burden. After she and her primary-care doctor have discussed the information from the electronic decision tool, they can now understand why some medications are more important for her than others. Perhaps as importantly, they both gain understanding as to the reasons the patient has to value certain aspects of her care.

The electronic decision support tool suggests antidepressant therapy with mirtazapine for her because this medication has also been shown to stimulate appetite and promote weight gain, which would be a desired effect for her.

Regarding inhaler therapy, she decides that she does not want to use inhaled corticosteroids because of the increased risk of pneumonia and her history of previous COPD flare-ups triggered by pneumonia, but she is now motivated to use a combination inhaler with a long-acting bronchodilator and a long-acting muscarinic antagonist because the potential improvement in dyspnoea she can achieve with this treatment. She determines with her pulmonologist that she will stop the inhaler treatment if she does not notice any improvement with her breathing within 3 months. They work with a pharmacist to identify the type of inhaler device needed to account for her problem with handling devices due to arthritis.

Because transport to the clinic poses a significant barrier to attending specialist appointments, her pulmonologist offers her to do a teleconsultation next time.

This futuristic tale has illustrated some of the potential benefits of SDM and MDM in COPD patients. I am particularly focused on helping realize this vision of integrating MDM and SDM into the routine care of patients with COPD.

Dobler

Submitted by Claudia Dobler, M.D.
South Western Sydney Clinical School, University of New South Wales, Australia

 References

  1. Centers for Disease Control and Prevention. National Center for Health Statistics. National Vital Statistics Report. Deaths: Final Data for 2010. May 2013; 61(04).
  2. Centers for Disease Control and Prevention. Chronic obstructive pulmonary disease among adults—United States, 2011. MMWR. 2012;61(46):938-943.
  3. Mannino DM, Gagnon RC, Petty TL, Lydick E. Obstructive lung disease and low lung function in adults in the United States: data from the National Health and Nutrition Examination Survey, 1988-1994. Archives of internal medicine 2000; 160: 1683-1689.
  4. Ford ES, Murphy LB, Khavjou O, Giles WH, Holt JB, Croft JB. Total and State-Specific Medical and Absenteeism Costs of COPD Among Adults Aged >/= 18 Years in the United States for 2010 and Projections Through 2020. Chest 2015; 147: 31-45.
  5. Partridge MR, Dal Negro RW, Olivieri D. Understanding patients with asthma and COPD: insights from a European study. Primary care respiratory journal : journal of the General Practice Airways Group 2011; 20: 315-323, 317 p following 323.
  6. Agoritsas T, Heen AF, Brandt L, Alonso-Coello P, Kristiansen A, Akl EA, Neumann I, Tikkinen KA, Weijden T, Elwyn G, Montori VM, Guyatt GH, Vandvik PO. Decision aids that really promote shared decision making: the pace quickens. BMJ (Clinical research ed) 2015: 350: g7624.

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Tags: COPD, MDM, minima, sdm, Shared Decision Making


March 19th, 2015

MAGIC: Time to create guidelines and decision aids we can trust, use, and share

By Victor M. Montori manosin

By Per Olav Vandvik, Anja Fog Heen, Thomas Agoritsas

Some problems with current guidelines

To succeed in evidence-based diagnosis and treatment at the point of care, health care personnel need access to the best current research evidence, for example through trustworthy clinical practice guidelines. Most guidelines suffer from methodological weaknesses (e.g., identification and assessment of research evidence, development of recommendations), suboptimal presentation formats and infrequent updating of content. New standards for trustworthy guidelines  and advanced systems for evidence assessment and creating recommendations  provide better opportunities to succeed in development of guidelines but also illuminate the demand for methodological competence, clinical expertise and time. Equally important as providing trustworthy content in guidelines is to achieve effective dissemination at the point of care, to allow shared decision-making with patients and to perform timely updates of content.

 

Solutions through MAGIC

Our insights on current limitations with guidelines has resulted in an urge to provide solutions to current problems with creating, disseminating and updating guidelines. We have operationalized the solutions through what we call the MAking GRADE the Irresistible Choice (MAGIC) research and innovation program and non-profit initiative (1). A key innovation in the MAGIC program is a web-based authoring- and publication-platform (MAGICapp) that allows parallel development and publication of guidelines on the web, in tablets and smartphones, as well as integration of guidelines into electronic health records.

 

The guideline content is presented to end-users in what we call “top layer formats” that defines the minimum amount of information clinicians need to apply recommendations in practice. This multilayered presentation format has been developed through extensive research in the MAGIC and the DECIDE project (2).

 

Importantly, the MAGICapp includes structured content of all guideline content in a database based on the PICO questions that underlie all recommendations. Structured guideline content facilitates not only the development and publication of the guidelines but also facilitates dynamic updates of the guidelines on a recommendation per recommendation basis once new evidence emerges.

Decision aids that really promote shared decision-making

Most recommendations in trustworthy guidelines are weak. Weak recommendations reflect a fine balance between benefits and harms of treatment alternatives and implies that clinicians should apply the recommendations in a balanced manner in encounters with individual patients. In such situations shared decision-making - through use of decision aids available through the MAGICapp - may come into play (3). The clinician and patient can together deliberate on treatment options  through the use of a decision aid on a tablet computer, designed to create conversations. The decision aid visualizes anticipated benefits, harms and practical issues of the possible treatment alternatives. Our decision aids are based on pioneering work by - and fruitful collaboration with - Dr. Victor Montori and colleagues the Mayo clinic.

 

What next for MAGIC?

The MAGICapp is available for use for organizations charged with development of guidelines. We are now expanding our scope to include the development of multilayered evidence summaries and decision aids also in the context of trustworthy systematic reviews. We welcome you to test MAGICapp and provide feedback to further improve functionality of the authoring process and publication outputs, to the benefit of clinicians and patients at the point of care.

References:

  1. Vandvik PO, Alonso-Coello P, Treweek S, Akl EA, Kristiansen A, Heen AF, Agoritsas T, Montori VM, Guyatt GH. Creating clinical practice guidelines we can trust, use and share: A new era is imminent. Chest. 2013;144:381-9.
  2. Kristiansen A, Brandt L, Agoritsas T, Akl EA, Granan LP, Guyatt G, Vandvik PO. Applying new strategies for the national adaptation, updating and dissemination of trustworthy guidelines: Results from the Norwegian adaptation of the American College of Chest Physicians Evidence-based Guidelines on Antithrombotic Therapy and the Prevention of Thrombosis, 9th Edition. CHEST, 2014. doi:10.1378/chest.13-299
  3. Agoritsas T, Heen AF, Brandt L, Alonso-Coello P, Kristiansen A, Akl E, Neumann I, Tikkinen K, van der Weijden T, Elwyn G, Montori VM, Guyatt G, Vandvik PO. Decision aids that really promote shared decision making:the pace quickens. BMJ 2015 350:g7624 doi

 

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Tags: evidence based medicine, MAGIC, sdm, Shared Decision Making


March 4th, 2015

REPOST: Stop blaming “demanding patients” for driving up health care costs (2/24/2015)

By Victor M. Montori manosin

Posts like this, make http://www.healthnewsreview.org/blog/ our go-to blog for news reviews from an evidence-based patient-centered perspective.  You must bookmark it, follow it on Facebook and twitter and do what you do to keep connected to its content. Thank you, Gary Schwitzer (@garyschwitzer) and your team for keeping this going on and strong!

 

 

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Tags: evidence based medicine, Shared Decision Making


February 17th, 2015

Was a decision made? An assessment of patient-clinician discordance in medical oncology encounters.

By Victor M. Montori manosin

Oncology encounters are highly complex. Communication is suboptimal and there is evidence that patients and clinicians often fail to "get on the same page." Shared decision making is being promoted as a means of facilitating effective and patient-centered communication in oncology. Here, Dr. Aaron Leppin and colleagues survey patients and clinicians immediately after an oncology encounter to determine the extent to which they agree on whether a cancer care decision was made during that encounter. The extent of agreement is impressively low. These findings have implications for the way we think about shared decision making and the validity of its measurement in oncology. (click here for  abstract)

by Aaron Leppin

 

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December 12th, 2014

New Shared Decision Making iPad® Supplement for Circulation: Cardiovascular Quality and Outcomes

By Victor M. Montori manosin

Circulation: Cardiovascular Quality and Outcomes has released a free iPad® Supplement devoted to the topic of Shared Decision Making (SDM). The topics included in the supplement are intended to provide a comprehensive overview of the state of the art in SDM within cardiovascular diseases.

Featured articles include:

1.    Shared Decision Making: Science and Action
Henry H. Ting, Juan Pablo Brito, and Victor M. Montori

2.    Shared Decision Making: State of the Science
Grace A. Lin and Angela Fagerlin

3.    Design and Testing of Tools for Shared Decision Making
Daniel D. Matlock and Erica S. Spatz

4.    Measuring Shared Decision Making: A Review of Constructs, Measures, and Opportunities for Cardiovascular Care
Karen R. Sepucha and Isabelle Scholl

5.    Implementation of Shared Decision Making in Cardiovascular Care: Past, Present, and Future
Erik P. Hess, Megan Coylewright, Dominick L. Frosch, and Nilay D. Shah

6.    Higher Integrity Health Care: Evidence-Based Shared Decision Making
Glyn Elwyn and Elliott Fisher

To access the free supplement, visit the App Store℠ and download Circulation: Cardiovascular Quality and Outcomes for the iPad® for free. Both the app and the supplement are available free of charge.

 

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November 19th, 2014

The New Statin Choice Decision Aid

By Victor M. Montori manosin

With a new interface that includes versions in English, Spanish, and Chinese, the Statin Choice decision aid (http://statindecisionaid.mayoclinic.org) is out. With over 70,000 uses worldwide year-to-date and new policy endorsements for its use (JAMA Article), the Statin Choice decision aid is helping patients and their clinicians have meaningful conversations about whether to use statins to reduce cardiovascular risk. It helps them adhere to the new guidelines, in a patient-centered manner. And with new work to integrate the tool into all major EHR providers, it may be the best demonstration of meaningful use.

Enhancements from the first version also include two options for printing in the office: color and black-and-white, in addition to the existing option to emailing the tool after its use to the patient, a family member, or another clinician. In terms of new content, the biggest difference is the exclusion of the aspirin component (see below).  We have also beefed up the Documentation tab, an copy-and-paste interim solution before full integration into EHR to enable documentation of shared decision making, a key step toward advancing these conversations as a measure of quality of care.

This version is the result of hundreds of notes suggesting changes and enhancements that result form the experience of using it in practice. We hope to have responded properly. And thank you.

Why was aspirin removed from the latest version of the Statin Choice decision aid?

In response to the new AHA/ACC guidelines for cardiovascular prevention, there has been renewed interest in using the Statin Choice decision aid to translate the recommendations in a patient-centered way.  With this attention, there has been interest from preventive cardiologists in using this tool. They brought to our attention that indeed the evidence about efficacy of aspirin for the primary prevention of cardiovascular disease is inconsistent: clearer effect in men in relation to heart attacks but not stroke, in women about preventing strokes but no so much heart attacks and a series of negative trials in patients with diabetes and peripheral vascular disease have made it difficult to provide a simple message to all at-risk patients: a baby aspirin can reduce your risk of cardiovascular events. Also, emerging evidence suggests that the risk of bleeding with aspirin goes up as the risk of cardiovascular events, such that those who may benefit the most are also most likely to be harmed (although most aspirin bleeds are relatively inconsequential compared to a heart attack or a stroke).

This inconsistency is reflected, for example, in the US Preventive Services Task Force guidelines: http://www.ahrq.gov/professionals/clinicians-providers/resources/aspprovider.html.

Concerns are best reflected in this FDA advisory against primary prevention with aspirin from May 2014: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm390574.htm

It is telling when experts are talking more about using aspirin to prevent colon cancer than to prevent cardiovascular events (to our knowledge no one is yet recommending it for this purpose).

We will continue to monitor this evidence as we, the producers of Statin Choice, thought the evidence was good enough to add to and keep in the tool, and we will have a low threshold to put it back in as new evidence emerges, both of its efficacy and harm.

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Tags: AHA/ACC guidelines, Shared Decision Making, statin choice


October 31st, 2014

Making a case for patient-centered care

By Victor M. Montori manosin

During the period 2013-2014, authors in the KER UNIT have published JAMA viewpoints that have expressed our philosophy of clinical care and research.

In June 2013, Hassan Murad and I wrote a viewpoint paper called Synthesizing Evidence: shifting the focus from individual studies to the body of evidence. In this article, we pointed out five reasons why it was important to focus on the body of evidence rather than on individual studies. Among these, was the importance of avoiding misleading evidence that results from design features focused on enhancing the stand-alone value of the single paper. Our bottom line was to rescue the importance of generosity in the construction of systematic reviews and meta-analysis that offer evidence that can support people at the frontline trying to practice evidence-based care.

In December 2013, again with that Hassan Murad and Juan Pablo Brito, we published the viewpoint entitled The Optimal Practice of Evidence-based Medicine: incorporating patient preferences in practice guidelines. In this article, which was focused on the challenges of incorporating preferences guidelines, we pointed out the importance of taking into account patient view in the consideration of the full range of outcomes that patient experience and consider critical, and in deciding the relative importance of these outcomes. We also made the case that guideline panels should not make strong recommendations when the best course of action heavily depends in patients’ context, values, and preferences. This opened the door to connecting guidelines with decision aids that could support the construction of informed preferences in patients who face clinical dilemmas with their clinicians. Of interest we also pointed out that the clinicians should remember that taking care of patients is supposed to be difficult and that guidelines while simplifying this task cannot really do so when patient preferences and context matter and in that case they cannot replace “clinicians’ compassionate and mindful engagement of the patient in making decisions together”. We pointed out that this, patient-centered care, is indeed the optimal practice of evidence-based medicine.

A couple of months later, again with Dr. Brito and Dr. Ting, we published a viewpoint applying these principles to the new cholesterol guidelines. In this instance, we were able to offer a video of the process of using the Statin Choice decision aid in patients that the guideline considered for the use of statins. We point out in this paper that the principal value of the new cholesterol guidelines was their ability to realize the opportunity to advance patient centered care and shared decision-making, enabling new conversations between clinicians and patients. We also invited policymakers to consider that the new performance measure target should be the proportion of eligible patients who were able to take part in shared decision-making.

Finally in October 2014, in collaboration with my colleagues Tammy Hoffman and Chris del Mar, we published a viewpoint making the connection between evidence-based medicine and shared decision-making, presenting shared decision-making as a manifestation of evidence-based medicine that uses patient centered communication to engage patients (figure). Perhaps the most important message of this paper was a statement that medicine cannot and should not be practice without up-to-date evidence and without knowing and respecting the informed preferences of patients. It called for clinicians, researchers, teachers, and patients to be aware of and actively facilitate the interdependent relationship of these approaches. The piece concluded with the notion that evidence-based medicine needs shared decision-making and that shared decision-making needs evidence based medicine. It finished by stating that patients need both. The two indeed will come together to some extent at the International Society for Evidence-based Healthcare meeting in Taipei and more fully in the joint meeting of this society and the International Shared Decision Making conference in July in Sydney.

This has been a wonderful year for a journey in which we have been able to make statements connecting the tools of evidence-based medicine (guidelines) with tools for shared decision making (decision aids) with our principles of patient centered care, integrity, and generosity that underpin the work of the KER UNIT.

 Victor Montori

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Tags: Chris del Mar, decision aids, evidence based medicine, Hassan Murad, Henry Ting, Jaun Pablo Brito, KER Unit, Minimally Disruptive Medicine, Montori, patient-centered care, Shared Decision Making, Tamy Hoffman, viewpoint


April 2nd, 2013

Share decisions because it is the right thing to do

By Kasey Boehmer kaseyboehmer

Written by Victor M. Montori, MD and Jon C. Tilburt, MD

Lee and Emanuel raise the profile of the shared decision making (SDM) provisions in the Patient Protection and Affordable Care Act. We concur that those provisions should spur research and development in SDM. However, their claims, that we already know how to implement SDM and that it is time for pay-for-performance for use of certified decision aids, are both premature and misguided.

Studies of decision aids implemented outside clinical visits show improvements in patient knowledge about the available options and about their risks and benefits, but not in actual sharing of decision making. Decision aids for use by patients and clinicians during the visit may work better. Video data from hundreds of recorded visits show a stark difference: patients in decision aid visits are better informed and participate more in making decisions. Patients and clinicians end up more comfortable with decisions they made together. In-visit decision aids galvanize patients and clinicians around a shared a purpose – to make the best possible evidence-based decision given the patient's values, preferences, goals, and context. Yet, getting this degree of patient engagement does not happen with the flip of a switch and routine implementation remains untested.

Lee and Emanuel rightly point out the potential utilitarian benefits of SDM, particularly about surgical decisions. However, in so doing they jeopardize the patient-centered vision at the core of SDM. Moreover, their economic claim of cost-savings overreaches the current state of the evidence, making their SDM-linked pay for performance proposal premature. Research on SDM implementation is green, clinicians and patients are not ready, training and tools are just evolving. Thus, we support the law's push for research and development. Their proposal is also dangerous. A focus on cost containment and pay for performance can corrupt the journey toward implementing SDM for all: we fear that the next time a clinician pulls out a decision aid, the clinician will be thinking about reimbursement while the patient wonders whether the clinician has her back.

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February 19th, 2013

National Cancer Institute Launches SDM Measures Repository

By Kasey Boehmer kaseyboehmer

From the NCI Website:

In the last twenty years, numerous studies have empirically examined decision making processes and outcomes in clinical settings. One of challenges that the shared decision making (SDM) research community faces is a paucity of standardized measures of the SDM antecedents, process, quality, and outcomes.

The GEM-Shared Decision Making Workspace (GEM-SDM), a project initiated by the National Cancer Institute's Process of Care Research and Science of Research and Technology Branches, is intended to facilitate discussion in the research community about priority SDM antecedent, process and outcome measures. Specifically, this project aims to identify measures related to shared decisions taking place in a clinical setting, involving patients and health care providers, and is limited to acute (one-time or very infrequent) decisions, as opposed to frequent or often recurring decisions.

GEM-SDM allows the research community to contribute their own SDM measures in the workspace and to provide feedback on the suggested measures. Measures added to the GEM-SDM workspace may include observational or self-reported measures examining the antecedents, process, quality, and outcomes of interactions between patient and medical providers (example: decision quality, prevalence of SDM in various clinical settings.)

The goal of this project is to build consensus around SDM measures for use in future studies, increase standardization of measurement, and promote data harmoniza...tion across studies. Increased use of standardized SDM measures will enable comparability across future studies and help the research community articulate research agendas in SDM.

Visit the website here

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November 16th, 2012

Diabetes Decision Aids in the Media

By

Dr. Montori was recently featured on Mayo Clinic Medical Edge Radio, which produces a daily 60-second health segment. His discussion about the diabetes decision aids and shared decision making can be heard here.

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