Shared decision making in adjuvant cancer treatment

Submitted by Marleen Kunneman

Involving patients in a shared decision making (SDM) process is increasingly the preferred approach to making healthcare decisions when more than one reasonable option is available, as is often the case in (neo-)adjuvant cancer treatment. In our recent studies, we aimed to gain insight in the extent to which the three key steps of SDM are followed during clinical encounters on (neo-)adjuvant cancer treatment. Our results showed that the steps of SDM are only followed to a limited extent. Below, we will describe our findings in more detail.

The first step in SDM is to create choice awareness, that is, to acknowledge that there is more than one sensible option available and that a decision needs to be made. We found that oncologists consistently omit the option of forgoing (neo-)adjuvant treatment during clinical encounters, and instead, focus on the one treatment strategy they recommend.1 In only 3 of the 100 encounters analysed, the oncologist indicated that a treatment decision still needed to be made. By that, oncologists miss a crucial opportunity to engage patients and facilitate SDM.

The second step in SDM is to discuss the possible treatment options in more detail. We showed that there is considerable variation between as well as within oncologists in information provision, both in the number and the type of benefits and harms that they addressed.2 The variation could not be explained by patient characteristics. This lack of clarity on which benefits and harms should be discussed during the clinical encounter hampers the process of SDM. For preoperative radiotherapy in rectal cancer, we were able to reach consensus among radiation oncologists and patients on a core list of topics that should always be addressed in the pre-treatment consultation.3 Of note, all items in this core list are long-term benefits and harms of treatment. We assessed congruence between the core list and routine clinical care, and found that patients receive information on fewer than half of the topics from the core list.3 In almost one in ten patients, none of the harms from the core list were addressed. This framing bias toward the beneficial effect of treatment was also found in another study on communication of probabilities.4 Oncologists virtually always mention probabilities of the beneficial effect of treatment, but probabilities of harms often go unmentioned. After the consultation, patients tended to overestimate the beneficial effect of treatment, and to underestimate the probability of harms. This suggests that many patients are overly optimistic and believe that there is no harm in undergoing (neo-)adjuvant treatment.

In the third step of SDM, the patient’s views and preferences should be discussed and considered. We found that less than half of the patients voice their values during the consultation, and only one in five patients voices a treatment preference.5 If patients’ values or treatment preferences had been addressed or if the oncologist had indicated that these were of importance when deciding about treatment, the patient felt that he or she was significantly more involved in the treatment decision-making process.

Our results show that in routine clinical care opportunities are missed to engage patients in a process of SDM. Small changes in doctor-patient communication during clinical encounters can facilitate patients’ involvement in deciding about treatment.

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Marleen Kunneman conducted her PhD research at the Leiden University Medical Center, under supervision of Prof. Anne Stiggelbout, Prof. Corrie Marijnen and Arwen Pieterse and is now a postdoctoral researcher at the Academic Medical Center, University of Amsterdam, the Netherlands. Her research is focused on doctor-patient communication during clinical encounters and shared decision making. Marleen has a Research Collaborator appointment at the Mayo Clinic, where she works with Prof. Victor Montori on assessing the impact of creating choice awareness as a prerequisite for more active patient involvement in clinical encounters.

References

  1. Kunneman M, Engelhardt EG, ten Hove FL, et al. Deciding about (neo-)adjuvant rectal and breast cancer treatment: Missed opportunities for shared decision making. Acta Oncol 2015;(epub ahead of print).
  2. Kunneman M, Marijnen CAM, Rozema T, et al. Decision consultations on preoperative radiotherapy for rectal cancer: Large variation in benefits and harms that are addressed. Br J Cancer. 2015;112:39-43.
  3. Kunneman M, Pieterse AH, Stiggelbout AM, Marijnen CAM. Which benefits and harms of preoperative radiotherapy should be addressed? A Delphi consensus study among rectal cancer patients and radiation oncologists. Radiother Oncol 2015;114:212-217.
  4. Kunneman M, Stiggelbout AM, Marijnen CAM, Pieterse AH. Probabilities of benefit and harms of preoperative radiotherapy for rectal cancer: What do radiation oncologists tell and what do patients understand? Patient Educ Couns. 2015;98:1092-1098.
  5. Kunneman M, Marijnen CA, Baas-Thijssen MC, et al. Considering patient values and treatment preferences enhances patient involvement in rectal cancer treatment decision making. Radiother Oncol 2015;(epub ahead of print).

Thinking Beyond the Clinical Encounter

Work in shared decision making tends to focus on the clinical encounter.  Some research has focused on how to prepare patients and clinicians for a decision making encounter.  Other work has focused on how to facilitate conversations during an encounter or measuring the extent of shared decision making that occurs between patient and provider.  This focus on the clinical encounter likely has multiple origins.  First, much of the research in shared decision making has focused on decisions that are relatively discrete and time-bound, such as surgeries or screening tests.  Second, the clinical encounter is easy to access and assess.  It occurs at a specific time and place.  It involves a set group of individuals.  It has a beginning and an end.

Particularly in the setting of chronic disease, a singular focus on the clinical encounter limits our understanding of decision-making processes.  In fact, in chronic conditions decision making is often thought of as being more of a process than an event.  However, little research has investigated the details of this process.  We sought to more fully explore this process through a longitudinal qualitative study of parents of children with chronic conditions.1

In this study we followed parents (n=29 from 21 families) for 6-10 weeks following an index clinical encounter at which they discussed a treatment change for their child’s chronic condition. Parents were interviewed multiple times and asked to describe their decision process, including aspects of the process that occurred before the index encounter.  For all participants, the decision evolved over time, neither starting nor ending at the clinical encounter, and involved conversations with family members and/or friends who had not been present at the clinical encounter. Some parents described a slow, steady progression towards a decision while others either felt the decision occurred in a step-wise process or that some event led to an abrupt decision.  Regardless of how the decision evolved, parents felt their role in the decision-making process did not change over time.  Furthermore, after the decision was officially made parents continued to think about it and consider whether they had made the right decision.

The concerns and expectations parents had about treatment changed over the course time.  Often after deciding to start a new treatment the expectations shifted from focusing on symptom improvement to focusing on side-effect avoidance.  Similarly, parents’ emotions often fluctuated between worry and hope.  Some experienced relief from worry when their child did well on the new treatment while others shifted from worrying about their child’s symptoms to worrying about potential side effects.

By prospectively following parents, we demonstrated that, indeed, decision making in chronic disease is a process not an event.  It is a process that follows distinct patterns of evolution, includes numerous people and involves shifting expectations and emotions.  How then do we best support and foster shared decision making in this environment?  We need tools that capitalize on the fact that decision-making occurs over time.  Tools that help patients and families converse with clinicians and then help those patients and families converse with other people in their life.  We need to acknowledge that what happens in the clinical encounter is likely only a small part of the decision-making process, an important part but not the only part.  Finally, in the setting of chronic conditions we need to develop programs, tools and interventions that capitalize on chronicity.  Few people impacted by chronic conditions will make only one treatment decision during the course of their illness; rather chronic conditions involve a series of decisions.  By taking advantage of this repetition we may be able to help families become more skilled, engaged decision makers through learning and practicing skills at each decision making opportunity.

Submitted by Ellen A. Lipstein MD, MPH

Ellen A. Lipstein, MD, MPH

Ellen A. Lipstein MD, MPH, is a general pediatrician and health services researcher at Cincinnati Children’s. Dr. Lipstein’s research is focused on family-centered medical decision making. She is particularly interested in understanding and improving the ways parents and patients with chronic conditions collaborate with healthcare providers to make treatment decisions. Her current program of funded research uses both qualitative and quantitative methods to explore decisions about high-risk treatments, in which both the potential benefits and risks are significant. Additionally, Dr. Lipstein is a collaborator on several studies which aim to develop diverse methods for engaging patients and parents in decision making.

 References

  1. Lipstein EA, Britto MT. Evolution of Pediatric Chronic Disease Treatment Decisions: A Qualitative, Longitudinal View of Parents’ Decision-Making Process. Med Decis Making. 2015.

Shared-decision making in cancer

By Khalid Benkhadra, M.D.

Recently, many studies have investigated the role patients want to play in the decision making process around how to manage their health.  This is of great importance, because while clinicians are experts in what works for a certain condition, patients are experts at what works for them. Shared decision making (SDM) is a mode of decision making where the expertise of both clinicians are respected and integrated into decision making through a process of collaborative deliberation..  Prior studies examining the role patients prefer when deciding on cancer treatment found that patients prefer to play a role in decisions, but that role varied from patient to patient1-3. To determine whether or not patient’s preference for SDM modified quality of care or physician communication Kehl et al4 conducted a survey. This survey was conducted among participants in the cancer care outcomes research and surveillance consortium (CanCORS).  Patients in this consortium were questioned about what their preferred role was when making cancer related treatment decisions and what actual role did they have in the decision making process around treatment for their cancer. They also reported on their perception of their overall quality of care.

Two thirds (67.8%) of patients reported that the overall quality of care they received was excellent and over half (55.8%) rated their physician’s communication highly. When they examined how these ratings correlated with the roles patients would prefer to play in the decision making process, they found that compared to patients who preferred share decisions patients who preferred that their physician control the decision making  were less likely to give top ratings to their physician. These patients also gave lower ratings of physician communication. The reasons behind these results are not clear and need further investigation.

Percentage of patients reporting excellent quality of care and high communication were both poorly calculated. For quality of care, results were reported by decisions; individual patient rating was not reported. For rating communication, analysis was restricted to patients who answered 3 out of 5 questions and answers were averaged.

In general, outcomes were very subjective and it was difficult to assess how strong the relationship between the patients answers and the actual encounter; there is a possibility a patient might rank an encounter low if he is not happy about a reason not related to the actual encounter. Besides, no information was reported about how educated tha patients were about SDM (and if yes, how much they were). Having a third party watching the encounter and assessing the communication would be a good addition as we can compare it with the patients response and see if both match (rather than taking only the patient’s response)

These findings in general suggest that providing information to patients with cancer and engaging them in decision making is valuable, even for patients who express a preference for a physician controlled decision making process.

References:

  1. Degner LF, Sloan JA. Decision making during serious illness: what role do patients really want to play? J Clin Epidemiol. Sep 1992;45(9):941-950.
  2. Keating NL, Guadagnoli E, Landrum MB, Borbas C, Weeks JC. Treatment decision making in early-stage breast cancer: should surgeons match patients’ desired level of involvement? J Clin Oncol. Mar 15 2002;20(6):1473-1479.
  3. Hawley ST, Lantz PM, Janz NK, et al. Factors associated with patient involvement in surgical treatment decision making for breast cancer. Patient Educ Couns. Mar 2007;65(3):387-395.
  4. Kehl KL, Landrum M, Arora NK, et al. Association of actual and preferred decision roles with patient-reported quality of care: Shared decision making in cancer care. JAMA Oncology. 2015;1(1):50-58.

For Empathic Decision Making


By Victor M Montori, Ian Hargraves, Annie LeBlanc

Policymakers fashionably prescribe shared decision making for patients who face fateful decisions. These patients have two or more medically reasonable courses of action that differ in important aspects. The extent to which these aspects differ in ways that matter to each individual patient justifies patient involvement in the decision-making process. Similarly, the extent to which clinicians can accurately predict the values and preferences of informed patients reduces the value of shared decision making. Only in circumstances where the distribution of patient preferences is very narrow can clinicians correctly deduct patient preferences (e.g., analgesics vs. no intervention for moderate to severe pain). This is often the case when the pros and cons of alternative courses of action are well known, their likelihood estimates are based on highly reliable research evidence, and difference between the benefits and the potential harms and inconveniences is large and clear. In such situations the distribution of patient preferences will be narrow enough that most clinicians can assume correctly what most patients will want. At the extreme, these decisions will seem purely technical, where the right course of action is apparent to those with a good understanding of the situation. This would include professionals with pertinent training. In situations that cannot be resolved by the application of technical knowledge, patients, when informed, will exhibit a range of preferences. It seems appropriate then that patients and clinicians partner to share information, deliberate, and arrive at a decision together. We call this process shared decision making.

Proponents of shared decision making assume that most clinicians and patients, when given the tools, time, and supportive setting necessary, will be able to implement shared decision making. Reality seems to behave differently: surveys suggest that patients are not universally inclined toward shared decision making, clinicians are often portrayed as barriers to this process, and environments have electronic medical records, phone calls, time pressures, competing demands, and noise that conspire to interfere with shared decision making. What’s going on if patients and clinicians aren’t adhering to the shared decision making prescribed on their behalf?

Our group, the KER UNIT, characterizes shared decision making as a conversation – an activity in which patients and clinicians turn with one another (the etymology of conversation—versare turn; con with). In conversation, the options with their attributes or issues are in dynamic interaction as the patient and clinician consider them and experimentally try them on. This highly interactive dynamic requires the active engagement and involvement of the patient and clinician. This turning-with of patients and clinician is the dance of shared decision making.

The clinician is used to contemplating the situations of patients and making tough decisions routinely; but for this patient, at this time, the task is anything but routine. Thus, it is natural to delegate to the more experienced and emotionally detached of the two the task of organizing the decision-making conversation. The clinician, leading the dance, will identify that a decision needs to be made, the relevant options and their relative desirable and undesirable features, and will invite the patient to consider these options and features. But, to what extent are patients willing and able to engage in deliberation?

We propose that the adequate way of answering this question is through empathy. In suggesting empathy we do not mean that clinicians should empathically divine the right decision for the patient; quite the opposite. We are suggesting that the co-creation of decision also involves the co-creation of the patient-clinician relationship and the conversational environment in which each decision is made. Empathy directs attention to the clinician’s active role in finding the right relationship and stance to join this patient at this time in decision making. Clinicians are trained and are expected to exhibit empathy when interviewing and examining patients, responding to patient concerns, and delivering bad news. The role of empathy in supporting decision making has not been fully discussed, to our knowledge. In this case, empathy requires attention to the situation of the patient and to the cues, verbal and nonverbal, the patient offers as the clinician invites the patient into the deliberative process. Some patients may be able to partner fully and co-create the decision; others may engage with the information, but delegate the rest of the tasks of deliberation and decision taking to the clinician. This is the expression of a preference that is being constructed on the spot (it follows that this preference cannot be adequately assessed with a survey tool, before the encounter and therefore out of context). The appropriate stance in the conversation is available to the clinician in subtle signs that the clinician can pick up through empathic attention to the patient. Focus on who the patient and clinician are, and can be, for each other in this conversation allows us to respect that the same patient may be willing to co-create one decision while preferring a lesser role for the next. The challenge for the clinician is to correctly respond, in real time, to these emerging preferences.

Shared decision-making tools produced for use during the clinical encounter need to account for this clinical task and be designed to support empathic decision making. When encounter tools offer too much information or script a step-by-step decision process, they may inadvertently limit the ability of the clinician to empathically guide the process. When tools are used in preparation for the visit, clinicians may assume that completion of the tool and associated worksheets signals that patients are fully engaged and ready to make decisions. That a tool should enable and support empathic decision making is not currently a requirement for their design of decision aids, or a metric for their impact.

In summary, shared decision making is one of an infinite set of ways in which patients and clinicians can engage in conversation about fateful decisions without a technically correct answer. To create the environment in which patients and clinicians co-create decisions, clinicians must actively invite and support patients in the process, empathically “reading” the patient to match their evolving preference for participation. Tools to support this process need to be designed to facilitate and not interfere with empathic decision making, and this may form the basis for new measures of decisional quality.

Thus, we are not just for shared decision making. We are for empathic decision making.

Increasing patient engagement with shared decision making

From Gaby Loria, medical market researcher for Software Advice

Physicians hoping to boost patient engagement in their practices can take heart in the findings of our recent survey report on shared decision making. In our report, 386 U.S. patients shared their thoughts on shared decision making (SDM), including how SDM can improve their experience at point of care and beyond.

Based on the survey, 68% of patient respondents reported that they wanted to make collaborative decisions with their healthcare providers. It is important to note not all medical decisions can or should be made jointly. However, in appropriate cases, SDM is emerging as an answer to patient demand for increased involvement in discussing treatment options.

As part of our survey, respondents watched a short video demonstration featuring Dr. Victor Montori of the Mayo Clinic’s KER Unit using his SDM decision aid cards with a patient. After viewing this video, 40% of the respondents said they have participated in a similar appointment with their provider, with 21% doing so in the past year. It’s encouraging to see such a significant percentage of patients experiencing SDM. However, these results also represent a call to action for advocates who would like to see the vast majority of practices implementing this collaborative patient-physician communication strategy.

Among respondents who had never participated in SDM with their provider, 47% said they would be “extremely” or “very likely” to switch to a provider who actively engages patients in decision making. These findings again reflect a substantial patient interest in the SDM treatment model. With the recent increase in healthcare legislation aimed at supporting and incentivizing value-based care measures like SDM, soon it may not be necessary for patients to leave their providers to get the care they want.

Since one of the primary objectives of SDM (and patient-centered care in general) is to help the patient feel more involved in treatment decisions, it makes sense that a combined 87% of the patients surveyed report that using an SDM model “significantly” or “somewhat” improves (or would improve) how involved they feel with their medical care.

When the patients were asked what—if anything—would discourage their participation in SDM appointments, 46% cited no concerns. This finding reflects a great deal of patient confidence in SDM. However, it is important to consider that 20% of respondents tell us they are concerned because they distrust their own decision making abilities. Dr. Montori points out that this lack of confidence is mostly due to patients having little or no involvement in past decision making sessions with healthcare providers. As more patients experience SDM, more should come to trust their own abilities to participate.

As SDM becomes more common in patient-physician interactions, priority should be placed not only on encouraging further adoption, but also on ensuring that physicians have the right tools for effective implementation. SDM decision aids, such as demonstration cards, are increasingly available for integration into digital patient charting systems like these, which help facilitate adoption of SDM into standard workflow processes. Taken as a whole, the report’s findings point to a bright future for shared decision-making, as this model continues to help improve the quality of treatment discussions and connections between patients and physicians.

Shared decision making and minimally disruptive medicine for COPD patients

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.

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


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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The New Statin Choice Decision Aid

By Victor M. Montori

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 not 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.

How patient-clinician communication can promote minimally disruptive medicine via shared decision-making

by Zackary Berger, MD, PhD

How can we get more clinicians to help the patient receive minimally disruptive medicine? The answer might lie in the improvement of patient-clinician communication. For many conditions, the doctor is encouraged to look into the book – or, more likely, UpToDate – and read out the recommendations of the latest guideline.

But there are two limitations to guidelines. The first, of course, is that all guidelines, whether from the United States Preventive Services Task Force or the International Association of Quackery, are only as good as the methodology and evidence that go into them. The second is that even the best guideline is not a magic recipe for appropriate care for the individual person in question.

If you are discussing screening for prostate cancer via the PSA test, whether you are a patient or provider, you will surely realize that the guidelines of the urologists and internists are now in rare agreement: universal screening is not recommended. What is now recommended is shared decision making, a series of tasks that patients and clinicians do together to communicate about the options and to deliberate to identify the one that fits best with the patient preference and context.

Whether it’s prostate cancer, diabetes, or depression, how can we bridge the gap from guidelines to individually sensitive care? I think there are two steps. The first, as I outline in my book, is to build a relationship between PCP and patient that can handle the intellectual and emotional stresses of decision making with unclear information. This requires mindfulness; emotional readiness; and specificity and clarity of options.

The second step is to contextualize clinical recommendations in a way that only good communication makes possible. Such contextualization is now being addressed by some fascinating new research. We have already known, through the work of communication researchers (chief among them Debra Roter), how to characterize a true dialogue between patient and clinician.

Unfortunately, the evidence is mixed as to the extent to which such dialogue leads to improved outcomes. In their recent work, Saul Weiner and colleagues at the University of Illinois at Chicago, and at Duke University, try to determine how often physicians take the next step after good communication: using an appreciation for the patient’s individual concerns and customizing their recommendation on that basis. It’s not enough to empathize, in other words, about someone’s job loss, poverty, broken family, or inability to navigate our health system: the doctor’s care must respond to those individualities. They find that physicians who manage that customization offer care which is more appropriate to an individual’s given situation (here is a video that demonstrates “red flags” about contextual issues designed to prompt clinician response, which rarely took place).

We know that maximally invasive care is often a shortcut taken by physicians (and patients) overwhelmed by the complexities of possible options, and daunted by the challenge of modifying medicine to a person’s unique needs. Contextualizing care through good communication can give us permission to be minimally invasive when appropriate, hopefully for the benefit of person and system alike.

Zackary Berger, MD, PhD, is an internist and researcher in doctor-patient communication at Johns Hopkins General Internal Medicine in Baltimore. He is particularly interested in the role of the primary care provider in cancer control. His book, Talking To Your Doctor, is out on July 16th, 2013.