International Patient Decision Aid Standards Research Articles

Consult decision aid to translate systematic review evidence to facilitate shared decision making

Background: Patient decision aids are effective knowledge translation tools mostly used to prepare patients for decision making. Over 115 trials of patient decision aids show improved decision quality and patient participation in decision making. Many clinical practice guidelines recommend shared decision making. However, successful interventions for facilitating shared decision making during the consultation need to target the patient and healthcare professional. Objective: The objective is to develop a consult decision aid in order to facilitate shared decision making during the consultation. Methods: Building upon over 20 years of developing and evaluating patient decision aids, a template for a consult decision aid was designed for use within consultations. The template is informed by evidence from systematic reviews and meets the International Patient Decision Aid Standards (IPDAS) criteria proposed for certification. Usability feedback was collected from a patient and experts in knowledge translation, systematic reviews, practitioners, computer science, and communications. Results: The consult decision aid title is the targeted decision. Five sections include: a) condition; b) options being considered; c) benefits and risks of each option using probabilities and explicit values clarification exercise; d) question about preferred option; and e) SURE Test (copyright) to screen for decision making needs. It was designed to be 1-page long with hyperlinked additional information including definitions, graphical representation of probabilities, interpretation of the SURE Test (copyright), developers, and references. An online training program is available free-of-charge for developing a consult decision aid. Discussion: The consult decision aid is a briefer format, bridging international decision aid standards and guidance from clinical practice guidelines, and has the potential to enhance shared decision making during the consultation. Further research is underway. Conclusion: Interventions and tools are required to stimulate shared decision making. The consult decision aid can be populated with evidence from systematic reviews and be used within clinical consultations to discuss evidence on options and patients preferences.

Design and Testing of Tools for Shared Decision Making

Shared decision making (SDM) is grounded in a compelling theoretical framework that ideally helps patients make decisions that are informed and concordant with their goals and values.1,2 Yet operationalizing SDM within routine clinical care remains an important challenge. Several approaches have been studied to improve SDM; such strategies include educating clinicians on communication techniques, using a multidisciplinary medical team, incorporating trained decision coaches, and using tools to support patients in their decision making. These tools, commonly referred to as patient decision aids (PtDAs), have garnered the most interest in operationalizing SDM.3 Accordingly, this article will focus specifically on the development and testing of PtDAs highlighting some important key points (see Box). ### Key Points of the Article on Decision Tool Development 1. PtDAs should be used in conjunction with a conversation with a clinician. 2. Helping patients consider and clarify their values around a decision is what makes a PtDA different from an information pamphlet. 3. Development is iterative, and the key tasks are to make sure the information is understandable, accurate, and unbiased and that the tool fits the needs and workflow of the end-users. 4. Trials designed to test the effectiveness of a decision aid need to consider both the patient’s and the clinician’s experience with the tool. 5. Decision aids should be living documents that will require updating when new information arises. Extensive work has been undertaken by the International Patient Decision Aid Standards (IPDAS) collaboration to provide guidance in this arena. Founded in 2003, IPDAS aims to “enhance the quality and effectiveness of PtDAs by establishing an evidence-informed framework for improving their content, development, implementation, and evaluation.”4,5 This article will draw on the extensive work of the IPDAS collaboration to describe a 4-step development process for those interested in developing PtDAs, which includes, step 1: understanding the decision; step 2: drafting the first …

Refining a brief decision aid in stable CAD: cognitive interviews

BackgroundWe describe the results of cognitive interviews to refine the “Making Choices©” Decision Aid (DA) for shared decision-making (SDM) about stress testing in patients with stable coronary artery disease (CAD).MethodsWe conducted a systematic development process to design a DA consistent with International Patient Decision Aid Standards (IPDAS) focused on Alpha testing criteria. Cognitive interviews were conducted with ten stable CAD patients using the “think aloud” interview technique to assess the clarity, usefulness, and design of each page of the DA.ResultsParticipants identified three main messages: 1) patients have multiple options based on stress tests and they should be discussed with a physician, 2) take care of yourself, 3) the stress test is the gold standard for determining the severity of your heart disease. Revisions corrected the inaccurate assumption of item number three.ConclusionsCognitive interviews proved critical for engaging patients in the development process and highlighted the necessity of clear message development and use of design principles that make decision materials easy to read and easy to use. Cognitive interviews appear to contribute critical information from the patient perspective to the overall systematic development process for designing decision aids.

Información escrita a pacientes: de papeles a documentos

IntroductionThere is a high variability in the level of information intended for patients, with different content, format and presentation. ObjectiveTo determine the perceived safety of the patients treated at the Country Hospital of Melilla (HCML) and to assess the quality of the documents using criteria adapted to the «International Patient Decision Aid Standards» (IPDAS). MethodDescriptive study of the documents given to patients by the HCML. They included questionnaires on perceived safety, classification of the documents, and the level of adherence to the IPDAS criteria. ResultsThe Information given to patients during their stay in the HCML, their participation in decision-making, and the information about medication, did not exceed the average on the acceptance scale. Only 40 documents were studied (of the 131 collected), on being published in-house, and were classified, following the definitions of the RAE, into instructions (20), recommendations (14) and guidelines (6). Of these, only the 27.5% showed hospital logo.In the content analysis according to the IPDAS criteria, there was an overall adherence rate of 24.1% in instructions, 24.8% in recommendations, and 61.5% in guidelines. ConclusionsThe perception of patient safety expressed in the questionnaire, and its assessment according IPDAS criteria, shows there may be a significant improvement within the organization. Furthermore, the quality of patient documentation provided can help decision making.

Development of a Decision Aid about fertility preservation for women with breast cancer in the Netherlands

Objectives: To improve information provision about fertility preservation for breast cancer patients in the Netherlands, a web-based Decision Aid (DA) with additional values clarification exercise was developed according to the International Patient Decision Aid Standards criteria. This study reports on development of the DA.Methods: Development consisted of four stages: (I) development of a draft DA, (II) acceptability of the draft DA to patients, (III) understanding (knowledge) in healthy populations, (IV) acceptability of the revised DA among patients and physicians. The study population consisted of 185 participants: 20 patients, 17 physicians and 148 healthy volunteers.Results: The draft DA was considered to be relevant and understandable by patients, physicians and healthy volunteers. The values clarification exercise needed adaptation in explanation and navigation, which was done after stage II. Knowledge scores improved by 18% for lower educated women (from 4.1 (41%) to 5.9 (59%) correct answers), and by 34% for higher educated women after viewing the website (from 3.9 (39%) to 7.3 (73%) correct answers). Design of the DA was evaluated to be clear, but not always very appealing.Conclusions: The DA was regarded as a relevant source of information that seemed coherent and understandable.

Ten years of the International Patient Decision Aid Standards Collaboration: evolution of the core dimensions for assessing the quality of patient decision aids

In 2003, the International Patient Decision Aid Standards (IPDAS) Collaboration was established to enhance the quality and effectiveness of patient decision aids by establishing an evidence-informed framework for improving their content, development, implementation, and evaluation. Over this 10 year period, the Collaboration has established: a) the background document on 12 core dimensions to inform the original modified Delphi process to establish the IPDAS checklist (74 items); b) the valid and reliable IPDAS instrument (47 items); and c) the IPDAS qualifying (6 items), certifying (6 items + 4 items for screening), and quality criteria (28 items). The objective of this paper is to describe the evolution of the IPDAS Collaboration and discuss the standardized process used to update the background documents on the theoretical rationales, evidence and emerging issues underlying the 12 core dimensions for assessing the quality of patient decision aids.

Clarifying values: an updated review

BackgroundConsensus guidelines have recommended that decision aids include a process for helping patients clarify their values. We sought to examine the theoretical and empirical evidence related to the use of values clarification methods in patient decision aids.MethodsBuilding on the International Patient Decision Aid Standards (IPDAS) Collaboration’s 2005 review of values clarification methods in decision aids, we convened a multi-disciplinary expert group to examine key definitions, decision-making process theories, and empirical evidence about the effects of values clarification methods in decision aids. To summarize the current state of theory and evidence about the role of values clarification methods in decision aids, we undertook a process of evidence review and summary.ResultsValues clarification methods (VCMs) are best defined as methods to help patients think about the desirability of options or attributes of options within a specific decision context, in order to identify which option he/she prefers. Several decision making process theories were identified that can inform the design of values clarification methods, but no single “best” practice for how such methods should be constructed was determined. Our evidence review found that existing VCMs were used for a variety of different decisions, rarely referenced underlying theory for their design, but generally were well described in regard to their development process. Listing the pros and cons of a decision was the most common method used. The 13 trials that compared decision support with or without VCMs reached mixed results: some found that VCMs improved some decision-making processes, while others found no effect.ConclusionsValues clarification methods may improve decision-making processes and potentially more distal outcomes. However, the small number of evaluations of VCMs and, where evaluations exist, the heterogeneity in outcome measures makes it difficult to determine their overall effectiveness or the specific characteristics that increase effectiveness.

A systematic development process for patient decision aids

BackgroundThe original version of the International Patient Decision Aid Standards (IPDAS) recommended that patient decision aids (PtDAs) should be carefully developed, user-tested and open to scrutiny, with a well-documented and systematically applied development process. We carried out a review to check the relevance and scope of this quality dimension and, if necessary, to update it.MethodsOur review drew on three sources: a) published papers describing PtDAs evaluated in randomised controlled trials and included in the most recent Cochrane Collaboration review; b) linked papers cited in the trial reports that described how the PtDAs had been developed; and c) papers and web reports outlining the development process used by organisations experienced in developing multiple PtDAs. We then developed an extended model of the development process indicating the various steps on which documentation is required, as well as a checklist to assess the frequency with which each of the elements was publicly reported.ResultsKey features common to all patient decision aid (PtDA) development processes include: scoping and design; development of a prototype; ‘alpha’ testing with patients and clinicians in an iterative process; ‘beta’ testing in ‘real life’ conditions (field tests); and production of a final version for use and/or further evaluation. Only about half of the published reports on the development of PtDAs that we reviewed appear to have been field tested with patients, and even fewer had been reviewed or tested by clinicians not involved in the development process. Very few described a distribution strategy, and surprisingly few (17%) described a method for reviewing and synthesizing the clinical evidence. We describe a model development process that includes all the original elements of the original IPDAS criterion, expanded to include consideration of format and distribution plans as well as prototype development.ConclusionsThe case for including each of the elements outlined in our model development process is pragmatic rather than evidence-based. Optimal methods for ensuring that each stage of the process is carried out effectively require further development and testing.

Delivering patient decision aids on the Internet: definitions, theories, current evidence, and emerging research areas

BackgroundIn 2005, the International Patient Decision Aids Standards Collaboration identified twelve quality dimensions to guide assessment of patient decision aids. One dimension—the delivery of patient decision aids on the Internet—is relevant when the Internet is used to provide some or all components of a patient decision aid. Building on the original background chapter, this paper provides an updated definition for this dimension, outlines a theoretical rationale, describes current evidence, and discusses emerging research areas.MethodsAn international, multidisciplinary panel of authors examined the relevant theoretical literature and empirical evidence through 2012.ResultsThe updated definition distinguishes Internet-delivery of patient decision aids from online health information and clinical practice guidelines. Theories in cognitive psychology, decision psychology, communication, and education support the value of Internet features for providing interactive information and deliberative support. Dissemination and implementation theories support Internet-delivery for providing the right information (rapidly updated), to the right person (tailored), at the right time (the appropriate point in the decision making process). Additional efforts are needed to integrate the theoretical rationale and empirical evidence from health technology perspectives, such as consumer health informatics, user experience design, and human-computer interaction.Despite Internet usage ranging from 74% to 85% in developed countries and 80% of users searching for health information, it is unknown how many individuals specifically seek patient decision aids on the Internet. Among the 86 randomized controlled trials in the 2011 Cochrane Collaboration’s review of patient decision aids, only four studies focused on Internet-delivery. Given the limited number of published studies, this paper particularly focused on identifying gaps in the empirical evidence base and identifying emerging areas of research.ConclusionsAs of 2012, the updated theoretical rationale and emerging evidence suggest potential benefits to delivering patient decision aids on the Internet. However, additional research is needed to identify best practices and quality metrics for Internet-based development, evaluation, and dissemination, particularly in the areas of interactivity, multimedia components, socially-generated information, and implementation strategies.

Basing information on comprehensive, critically appraised, and up-to-date syntheses of the scientific evidence: a quality dimension of the International Patient Decision Aid Standards

BackgroundPatients and clinicians expect patient decision aids to be based on the best available research evidence. Since 2005, this expectation has translated into a quality dimension of the International Patient Decision Aid Standards.MethodsWe reviewed the 2005 standards and the available literature on the evidence base of decision aids as well as searched for parallel activities in which evidence is brought to bear to inform clinical decisions. In conducting this work, we noted emerging and research issues that require attention and may inform this quality dimension in the future.ResultsThis dimension requires patient decision aids to be based on research evidence about the relevant options and the nature and likelihood of their effect on outcomes that matter to patients. The synthesis of evidence should be comprehensive and up-to-date, and the evidence itself subject to critical appraisal. Ethical (informed patient choice), quality-of-care (patient-centered care), and scientific (evidence-based medicine) arguments justify this requirement. Empirical evidence suggests that over two thirds of available decision aids are based on high-quality evidence syntheses. Emerging issues identified include the duties of developers regarding the conduct of systematic reviews, the impact of comparative effectiveness research, their link with guidelines based on the same evidence, and how to present the developers’ confidence in the estimates to the end-users. Systematic application of the GRADE system, common in contemporary practice guideline development, could enhance satisfaction of this dimension.ConclusionsWhile theoretical and practical issues remained to be addressed, high-quality patient decision aids should adhere to this dimension requiring they be based on comprehensive and up-to-date summaries of critically appraised evidence.

Factors explaining the heterogeneity of effects of patient decision aids on knowledge of outcome probabilities: a systematic review sub-analysis

BackgroundThere is considerable unexplained heterogeneity in previous meta-analyses of randomized controlled trials (RCTs) evaluating the effects of patient decision aids on the accuracy of knowledge of outcome probabilities. The purpose of this review was to explore possible effect modification by three covariates: the type of control intervention, decision aid quality and patients' baseline knowledge of probabilities.MethodsA sub-analysis of studies previously identified in the 2011 Cochrane review on decision aids for people facing treatment and screening decisions was conducted. Additional unpublished data were requested from relevant study authors to maximize the number of eligible studies. RCTs (to 2009) comparing decision aids with standardized probability information to control interventions (lacking such information) and assessing the accuracy of patient knowledge of outcome probabilities were included. The proportions of patients with accurate knowledge of outcome probabilities in each group were converted into relative effect measures. Intervention quality was assessed using the International Patient Decision Aid Standards instrument (IPDASi) probabilities domain.ResultsA main effects analysis of 17 eligible studies confirmed that decision aids significantly improve the accuracy of patient knowledge of outcome probabilities (relative risk = 1.80 [1.51, 2.16]), with considerable heterogeneity (87%). The type of control did not modify effects. Meta-regression suggested that the IPDASi probabilities domain score (reflecting decision aid quality) is a potential effect modifier (P = 0.037), accounting for a quarter of the variability (R2 = 0.28). Meta-regression indicated the control event rate (reflecting baseline knowledge) is a significant effect modifier (P = 0.001), with over half the variability in ln(OR) explained by the linear relationship with log-odds for the control group (R2 = 0.52); this relationship was slightly strengthened after correcting for the statistical dependence of the effect measure on the control event rate.ConclusionsPatients’ baseline level of knowledge of outcome probabilities is an important variable that explains the heterogeneity of effects of decision aids on improving accuracy of this knowledge. Greater relative effects are observed when the baseline proportion of patients with accurate knowledge is lower. This may indicate that decision aids are more effective in populations with lower knowledge.

051 Can We Automatically Produce Generic Decision Aids for the Clinical Encounter Directly from GRADE Guideline Recommendations? Experience from the Share-It Project

BackgroundAlthough decision aids (DA) can help to communicate evidence to patients, their production is time consuming, often not based on the best available evidence or rapidly outdated. Linking trustworthy guidelines...

Orthopaedic Healthcare Worldwide: Shared Medical Decision Making in Orthopaedics

Orthopaedic Healthcare Worldwide: Shared Medical Decision Making in Orthopaedics

Finding Information by Quality Providers Is an Issue

The International Patient Decision Aid Standards Collaboration (IPDAS) and other networks have shown how to respond to the dearth of good-quality information for patients: by cooperation and qualification. In this spirit, the Gute Praxis Gesundheitsinformation (good practice health information) initiative was founded in Germany (1): under the umbrella of the German Network for Evidence Based Medicine (2), information providers have formulated requirements that health information should meet and have committed to implementing and further developing these. If we want to improve the information landscape, we will have to establish evidence based practice on the one hand and simultaneously create a network of providers that have signed up to implementing this criterion. An important task for this network will be to offer further support to those who are seriously on their way to evidence based activities. At the same time we should ensure that patients can actually find the information provided by quality providers. We can only counteract the enormous amount of information biased by financial or intellectual interests if we stand united. It would be inadvisable to leave information seekers alone until an “optimum” has been reached. We think the better alternative is for the “quality” providers (good, not optimum) need to cooperate and jointly seek further qualification. Doctors are important partners in disseminating quality information as they have direct contact with patients. And the need for evidence based information among doctors is great. The opportunity to familiarize doctors with “good practice” should not be missed by Deutsches Arzteblatt.

Engaging Patients in Health Care Decisions in the Emergency Department Through Shared Decision‐making: A Systematic Review

Many decisions in the emergency department (ED) may benefit from patient involvement, even though this setting has been considered least conducive to shared decision-making (SDM). The objective was to conduct a systematic review to evaluate the approaches, methods, and tools used to engage patients or their surrogates in SDM in the ED. Five electronic databases were searched in conjunction with contacting content experts, reviewing selected bibliographies, and conducting citation searches using the Web of Knowledge database. Two reviewers independently selected eligible studies that addressed patient involvement and engagement in decision-making in the ED setting via the use of decision support interventions (DSIs), defined as decision aids or decision support designed to communicate probabilistic information on the risks and benefits of treatment options to patients as part of an SDM process. Eligible studies described and assessed at least one of the following outcomes: patient knowledge, experiences and perspectives on participating in treatment or management decisions, clinician or patient satisfaction, preference for involvement and/or degree of engagement in decision-making and treatment preferences, and clinical outcomes (e.g., rates of hospital admission/readmission, rates of medical or surgical interventions). Two reviewers extracted data on study characteristics, methodologic quality, and outcomes. The authors also assessed the extent to which SDM interventions adhered to good practice for the presentation of information on outcome probabilities (eight probability items from the International Patient Decision Aid Standards Instrument [IPDASi]) and had comprehensive development processes. Five studies met inclusion criteria and were synthesized using a narrative approach. Each study was of satisfactory methodologic quality and used a DSI to engage patients or their surrogates in decision-making in the ED across four domains: 1) management options for children with small lacerations; 2) options for rehydrating children presenting with vomiting or diarrhea or both; 3) risk of bacteremia (and associated complications), tests, and treatment options for febrile children; and 4) short-term risk of acute coronary syndrome (ACS) in adults with low-risk nontraumatic chest pain. Three studies had poor IPDASi probabilities and development process scores and lacked development informed by theory or involvement of clinicians and patients in development and usability testing. Overall, DSIs were associated with improvements in patients' knowledge and satisfaction with the explanation of their care, preferences for involvement, and engagement in decision-making and demonstrated utility for eliciting patients' preferences and values about management and treatment options. Two computerized DSIs (designed to predict risk of ACS in adults presenting to the ED with chest pain) were shown to reduce health care use without evidence of harm. None of the studies reported lack of feasibility of SDM in the ED. Early investigation of SDM in the ED suggests that patients may benefit from involvement in decision-making and offers no empirical evidence to suggest that SDM is not feasible. Future work is needed to develop and test additional SDM interventions in the ED and to identify contextual barriers and facilitators to implementation in practice.

Patient decision aids for cancer treatment

Although patient decision aids (pDAs) are effective, widespread use of pDAs for cancer treatment has not been achieved. The objectives of this study were to perform a systematic review to identify alternate types of decision support interventions (DSIs) for cancer treatment and a meta-analysis to compare the effectiveness of these DSIs to pDAs. The inclusion criteria for the study were: 1) all published studies using a randomized, controlled trial design, and 2) DSIs involving treatment decision-making for breast, prostate, colorectal, and/or lung cancer. For this analysis, DSIs were classified as pDAs if: 1) one reported outcome measure mapped onto the International Patient Decision Aids Standards Collaboration effectiveness criterion, and 2) the DSI was evaluated relative to standard consultation. Random effects models were used to compare the effectiveness of pDAs relative to other identified DSIs for reported outcomes. A total of 71 studies were reviewed, and 24 met the inclusion criteria. Overall, there were no significant differences in knowledge, satisfaction, anxiety, or decisional conflict scores between pDAs and other DSIs. This study showed that the effectiveness of other DSIs, including question prompt lists and audiorecording of the consultation, is similar to pDAs. This is important because it may be that these less complex DSIs may be all that is necessary to achieve similar outcomes as pDAs for cancer treatment.

A Patient Decision Aid for Psoriasis Based on Current Clinical Practice Guidelines

To develop a patient decision aid (PDA) for psoriasis with content derived from current clinical practice guidelines. This PDA was developed in accordance with international patient decision aid standards. Primary sources of treatment outcome information were English-language, evidence-based clinical practice guidelines for plaque psoriasis published between January 1, 2006, and December 31, 2010. Patients with psoriasis from a private practice in Windsor, Ontario, Canada, and a focus group of dermatologists across Canada. Focus groups of dermatologists (n=5) and patients with psoriasis (n=7) were convened to provide feedback on balance, clarity, practicality, and items for inclusion and exclusion. Physician's global assessment, overall lesional assessment, and 75% reduction in Psoriasis Area and Severity Index. Efficacy measures selected to reflect good control in the PDA were physician's global assessment (clear or almost clear) or overall lesional assessment (none or very mild) for topical agents and 75% reduction in Psoriasis Area and Severity Index for phototherapy and systemic agents. Where available, outcomes for serious adverse effects were displayed figuratively with efficacy measures. Deliberative questions for self-completion and a values clarification exercise were also incorporated. This psoriasis PDA was developed according to international standards based on content derived from current clinical practice guidelines.

Informed consent documents do not encourage good-quality decision making

ObjectiveInformed consent for research has emphasized information provision over support to people making a difficult decision. We assessed the extent to which existing informed consent documents (ICDs) conform to the International Patient Decision Aid Standards for supporting decision making. Study Design and SettingOne hundred thirty-nine ICDs for trials registered with ClinicalTrials.gov were obtained from study investigators. Using a four-point scale, two raters assessed each ICD on 32 items. ResultsOverall agreement between raters was 95.1% (linear weighted kappa—0.745). For 12 items focused on providing enough information, conformity was above 50% for three, and 0% for another four. For all eight items focused on how to present outcome probabilities, conformity was below 20%. For two items focused on clarifying and expressing values, conformity was below 10%. For two items focused on improving structured guidance, conformity was below 5%. For four items focused on using evidence, one item showed conformity of 74%; all others showed conformity below 5%. For four items focused on transparency, conformity was high (above 60% for two, above 80% for the others). ConclusionsExisting ICDs do not meet most validated standards for encouraging good decision making. These standards make clear predictions about how one might improve ICDs ensure that research participants are fully informed.

Assessing the conceptual clarity and evidence base of quality criteria/standards developed for evaluating decision aids

Promoting patient participation in treatment decision making is of increasing interest to researchers, clinicians and policy makers. Decision aids (DAs) are advocated as one way to help achieve this goal. Despite their proliferation, there has been little agreement on criteria or standards for evaluating these tools. To fill this gap, an international collaboration of researchers and others interested in the development, content and quality of DAs have worked over the past several years to develop a checklist and, based on this checklist, an instrument for determining whether any given DA meets a defined set of quality criteria. In this paper, we offer a framework for assessing the conceptual clarity and evidence base used to support the development of quality criteria/standards for evaluating DAs. We then apply this framework to assess the conceptual clarity and evidence base underlying the International Patient Decision Aids Standards (IPDAS) checklist criteria for one of the checklist domains: how best to present in DAs probability information to patients on treatment benefits and risks. We found that some of the central concepts underlying the presenting probabilities domain were not defined. We also found gaps in the empirical evidence and theoretical support for this domain and criteria within this domain. Finally, we offer suggestions for steps that should be undertaken for further development and refinement of quality standards for DAs in the future.

Development of a tool to improve the quality of decision making in atrial fibrillation

BackgroundDecision-making about appropriate therapy to reduce the stroke risk associated with non-valvular atrial fibrillation (NVAF) involves the consideration of trade-offs among the benefits, risks, and inconveniences of different treatment options. The objective of this paper is to describe the development of a decision support tool for NVAF based on the provision of individualized risk estimates for stroke and bleeding and on preparing patients to communicate with their physicians about their values and potential treatment options.MethodsWe developed a tool based on the principles of the International Patient Decision Aids Standards. The tool focuses on the patient-physician dyad as the decision-making unit and emphasizes improving the interaction between the two. It is built on the recognition that the application of patient values to a specific treatment decision is complex and that the final treatment choice is best made through a process of patient-clinician communication.ResultsThe tool provides education incorporating patients ' illness perceptions to explain the relationship between NVAF and stroke, and then presents individualized risk estimates, derived using separate risk calculators for stroke and bleeding over a clinically meaningful time period (5 years) associated with no treatment, aspirin, and warfarin. Sequelae of both stroke and bleeding outcomes are also described. Patients are encouraged to verbalize how they value the incremental risks and benefits associated with each option and write down specific concerns to address with their physician. A physician prompt to encourage patients to discuss their opinions is included as part of the decision support tool. In pilot testing with 11 participants (mean age 78 ± 9 years, 64% with ≤ high-school education), 8 (72%) rated ease of completion as "very easy," and 9 (81%) rated amount of information as "just right."ConclusionsThe risks and benefits of different treatment options for reduction of stroke in NVAF vary widely according to patients' comorbidities. This tool facilitates the provision of individualized outcome data and encourages patients to communicate with their physicians about these risks and benefits. Future studies will examine whether use of the tool is associated with improved quality of decision making.