Care That Fits Blog

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.

Where art thou o shared decision making?

By Heidi McLeod

Recent policy legislation is replete with references to shared decision making (SDM) as a way of improving the quality of care in clinical encounters (PPACA 2010). Even though these are unfunded policy exhortations, researchers are encouraged to pursue shared decision making, a process where clinicians share evidence based options with patients while respecting their needs and preferences, as an ethically viable form of healthcare delivery (Elwyn et al. 2012). In discussing how shared decision making can contribute to reducing the costs of healthcare, there has been a call to focus on patient preferences (Mulley, Trimble and Elwyn 2012). To date however, the research around shared decision making has focused more on risk communication and the process of information sharing than on the more holistic aspects of shared decision making; notably, the concept of respect.

Respect is defined as “recognition of the unconditional value of patients as persons” (Beach et al. 2007) and is as important to patients as information sharing and being involved in decision making. Indeed, both being treated with respect and decision making has independent associations with adherence, satisfaction and preventive care (Beach et al. 2005). Clinicians who are perceived as respectful to patients are shown to provide more information and express more positive affect in these visits (Beach et al. 2006). Therefore, one could postulate that without having a foundation of respect, a concept that is central to shared decision making, the rest of the process may falter. This may explain that despite decades of research, hundreds of trials, thousands of papers and policy initiatives, shared decision making has failed to take root and be implemented in everyday practice. By continuing to ignore the concept of respect in shared decision making, we are disrespecting respect.

The disrespect for respect is further evident in how we measure shared decision making. The gold standard for measuring whether shared decision making has actually occurred within an encounter is the OPTION scale (Elwyn et al. 2003). The OPTION scale assesses to what extent the clinician has engaged in shared decision making with patients and is based on a 12-point scale which determines the efficacy of the decision-making process. OPTION as well as other scales to measure shared decision making (e.g. DEEP-SDM) are not designed to measure respect (although some items may reflect respectful practices), thus it is clear that respect is not recognized as a fundamental or at least measurable construct of shared decision making.  As such, we lack the necessary tools to answer important theoretical and practical questions on the importance of respect in the shared decision making process. Developing a measure of respect could further our understanding of shared decision making as a theoretical construct. This will have practical consequences as a better understanding of respect may help researchers develop interventions to promote and clinicians to practice respect with their patients.

Developing a measure of respect has its own challenges, especially as the concept has not been clearly described by patients and clinicians. Most studies that look at respect use single item survey questions that assume the definition of respect is sufficiently intuitive to respondents. How respect is operationalized as a measure may also be problematic. While we are grappling with these issues in developing a measure of respect, we can look towards research in the healthcare communication literature as a guide on how respect may impact outcomes. Patient-centered communication can influence how satisfied patients are with their clinicians and the encounter itself and can affect adherence (Finset 2014). More psychosocial (non-biomedical) language is also associated with higher patient satisfaction (Roter et al. 1997). This is an area which can potentially help us to understand the effectiveness of SDM, particularly if we can develop a measure of respect based on verbal and non-verbal cues in the encounter. If we think about measuring the complexity of SDM in a broader framework, degrees of shared decision making bounded by respectful communication may become evident. As recently described, measures might not tell us only about the performance of a process, they might actually “drive the performance” and as such, “the right measure can be transformative” (Collins 2014).

We have been discussing shared decision making at a research and policy level for a long time. Yet there has been a disconnect between research and practice. By being able to measure respect for patients and their needs and preferences, the emergent conversation around treatment options might be far more shared than the present focus on risk communication suggests. If we begin to pay more attention to other aspects of shared decision making, and consider ways of measuring such concepts as respect, we may facilitate shared decision making’s translation into practice and improve the quality of the clinical encounter for patients and clinicians alike.

Acknowledgements:

Michael Gionfriddo, Pharm.D and PhD candidate in the KER Unit at Mayo Clinic, contributed to this blog by editing various drafts.

References:

Elwyn, G., Frosch, D., Thomson, R., Joseph-Williams, N., Lloyd, A., Kinnersley, P., Cording, E., Tomson, D., Dodd, C., Rollnick, S., Edwards, A. and Barry, A. (2012) “Shared Decision Making: A Model for Clinical Practice”, Journal of General Internal Medicine 27(10):1361-1367

Mulley, A.G., Trimble, C. and Elwyn, G. (2012) “Stop the silent misdiagnosis: patients’ preferences matter” BMJ 2012:345

Beach, M.C., Duggan, P.S., Cassel, C.K., and Geller, G.  (2007) “What Does ‘Respect’ Mean? Exploring the Moral Pbligation of Health Professionals to Respect Patients”, Journal of General Internal Medicine 22 (2007):692-695

Beach, M.C., Sugarman, J., Johnson, R.L, Arbelaez, J.J., Duggan, P.S. and Cooper, L.A. (2005) “Do Patients Treated With Dignity Report Higher Satisfaction, Adherence and Receipt of Preventive Care?”, Annals of Family Medicine 3(4): 331-338

Beach, M.C., Roter, D.L., Wang, N-Y., Duggan, P.S. and Cooper, L.S. (2006) “Are Physicians’ Attitudes of Respect Accurately Perceived by Patients and Associated with more Positive Communication Behaviors?” Patient Education and Counseling 62 (2006): 347-354

Elwyn, G., Edwards, A., Wensing, M., Hood, K., Atwell, C. and Grol, R. (2003) “Shared Decision Making: developing the OPTION scale for measuring patient involvement” Quality Safety Health Care 12 (2003): 93-99

Clayman, M.L., Makhoul, G. Harper M.M., Koby, D.G., and Williams, A.R. (2012) “Development of a shared decision making coding system for analysis of patient-healthcare provider encounters”, Patient Education and Counseling 88 (2012): 367-372

Finset, A. (2014) “50 Years of Research on the Effect of Physician Communication Behavior on Health Outcomes”, Patient Education and Counseling 96 (2014) 1-2.

Roter, D.L, Stewart, M. Putnam, S.M., Lipkin, M., Stiles, W. and Inui, T.S. (1997) “Communication Patterns of Primary Care Physicians”, JAMA 277 (1997): 350-356

Collins, A. (2014) “Measuring What Really Matters. Towards a coherent measurement system to support person-centered care” Thought Paper. The Health Foundation.

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.

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

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

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 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.