Background: Trial recruitment of Black, indigenous, and people of color (BIPOC) is key for interventions that interact with socioeconomic factors and cultural norms, preferences, and values. We... Show moreBackground: Trial recruitment of Black, indigenous, and people of color (BIPOC) is key for interventions that interact with socioeconomic factors and cultural norms, preferences, and values. We report on our experience enrolling BIPOC participants into a multicenter trial of a shared decision-making intervention about anticoagulation to prevent strokes, in patients with atrial fibrillation (AF). Methods: We enrolled patients with AF and their clinicians in 5 healthcare systems (three academic medical centers, an urban/suburban community medical center, and a safety-net inner-city medical center) located in three states (Minnesota, Alabama, and Mississippi) in the United States. Clinical encounters were randomized to usual care with or without a shared decision-making tool about anticoagulation. Analysis: We analyzed BIPOC patient enrollment by site, categorized reasons for non-enrollment, and examined how enrollment of BIPOC patients was promoted across sites. Results: Of 2247 patients assessed, 922 were enrolled of which 147 (16%) were BIPOC patients. Eligible Black participants were significantly less likely (p < .001) to enroll (102, 11%) than trial-eligible White participants (185, 15%). The enrollment rate of BIPOC patients varied by site. The inclusion and prioritization of clinical practices that care for more BIPOC patients contributed to a higher enrollment rate into the trial. Specific efforts to reach BIPOC clinic attendees and prioritize their enrollment had lower yield. Conclusions: Best practices to optimize the enrollment of BIPOC participants into trials that examined complex and culturally sensitive interventions remain to be developed. This study suggests a high yield from enrolling BIPOC patients from practices that prioritize their care. Show less
Objectives: Purposeful SDM posits four modes of shared decision making (SDM). The use of each mode depends on the type of problem of care that is being addressed. We sought to identify how current... Show moreObjectives: Purposeful SDM posits four modes of shared decision making (SDM). The use of each mode depends on the type of problem of care that is being addressed. We sought to identify how current observer-based SDM measures apply to each mode of Purposeful SDM.Methods: Four coders, working independently, evaluated 192 items pertaining to 12 observer-based SDM process measures. They classified the items into 6 themes that vary across Purposeful SDM modes and then into one of the four modes (weighing, negotiating, problem-solving, developing insight). Disagreements were resolved by consensus.Results: The items were classified as pertaining to the following themes: problem (28), roles/participation (84), options (62), preferences (21), decision (15), and evaluation (6). They were then classified as pertaining particularly to the SDM modes of weighing (54), negotiating (5), problem-solving (0), and developing insight (0) modes, with 191 items applying broadly to all modes of Purposeful SDM.Conclusions: Observer-based SDM measures describe behaviors pertinent to all modes but lack items sensitive to behaviors particular to some modes of SDM. Practice Implications: New or revised observer-based measures of the SDM process could help estimate the extent to which the appropriate SDM mode is being used to address the patient's problem.(c) 2021 Elsevier B.V. All rights reserved. Show less
Noseworthy, P.A.; Branda, M.E.; Kunneman, M.; Hargraves, I.G.; Sivly, A.L.; Brito, J.P.; ... ; SDM4AFib Shared Decision-Making At 2022
BACKGROUND Guidelines promote shared decision-making (SDM) for anticoagulation in patients with atrial fibrillation. We recently showed that adding a within-encounter SDM tool to usual care (UC)... Show moreBACKGROUND Guidelines promote shared decision-making (SDM) for anticoagulation in patients with atrial fibrillation. We recently showed that adding a within-encounter SDM tool to usual care (UC) increases patient involvement in decision-making and clinician satisfaction, without affecting encounter length. We aimed to estimate the extent to which use of an SDM tool changed adherence to the decided care plan and clinical safety end points. METHODS AND RESULTS We conducted a multicenter, encounter-level, randomized trial assessing the efficacy of UC with versus without an SDM conversation tool for use during the clinical encounter (Anticoagulation Choice) in patients with nonvalvular atrial fibrillation considering starting or reviewing anticoagulation treatment. We conducted a chart and pharmacy review, blinded to randomization status, at 10 months after enrollment to assess primary adherence (proportion of patients who were prescribed an anticoagulant who filled their first prescription) and secondary adherence (estimated using the proportion of days for which treatment was supplied and filled for direct oral anticoagulant, and as time in therapeutic range for warfarin). We also noted any strokes, transient ischemic attacks, major bleeding, or deaths as safety end points. We enrolled 922 evaluable patient encounters (Anticoagulation Choice=463, and UC=459), of which 814 (88%) had pharmacy and clinical follow-up. We found no differences between arms in either primary adherence (78% of patients in the SDM arm filled their first prescription versus 81% in UC arm) or secondary adherence to anticoagulation (percentage days covered of the direct oral anticoagulant was 74.1% in SDM versus 71.6% in UC; time in therapeutic range for warfarin was 66.6% in SDM versus 64.4% in UC). Safety outcomes, mostly bleeds, occurred in 13% of participants in the SDM arm and 14% in the UC arm. CONCLUSIONS In this large, randomized trial comparing UC with a tool to promote SDM against UC alone, we found no significant differences between arms in primary or secondary adherence to anticoagulation or in clinical safety outcomes. Show less
Kamath, C.C.; Giblon, R.; Kunneman, M.; Lee, A.I.; Branda, M.E.; Hargraves, I.G.; ... ; Shared Decision Ma 2021
IMPORTANCE How patients with atrial fibrillation (AF) and their clinicians consider cost in forming care plans remains unknown.OBJECTIVE To identify factors that inform conversations regarding... Show moreIMPORTANCE How patients with atrial fibrillation (AF) and their clinicians consider cost in forming care plans remains unknown.OBJECTIVE To identify factors that inform conversations regarding costs of anticoagulants for treatment of AF between patients and clinicians and outcomes associated with these conversations.DESIGN, SETTING, AND PARTICIPANTS This cohort study of recorded encounters and participant surveys at 5 US medical centers (including academic, community, and safety-net centers) from the SDM4AFib randomized trial compared standard AF care with and without use of a shared decisionmaking (SDM) tool. Included patients were considering anticoagulation treatment and were recruited by their clinicians between January 30, 2017, and June 27, 2019. Data were analyzed between August and November 2019.MAIN OUTCOMES AND MEASURES The incidence of and factors associated with cost conversations, and the association of cost conversations with patients' consideration of treatment cost burden and their choice of anticoagulation. RESULTS A total of 830 encounters (out of 922 enrolled participants) were recorded. Patients' mean (SD) age was 71.0 (10.4) years; 511 patients (61.6%) were men, 704 (86.0%) were White, 303 (40.9%) earned between $40 000 and $99 999 in annual income, and 657 (79.2%) were receiving anticoagulants. Clinicians' mean (SD) agewas 44.8 (13.2) years; 75 clinicians (53.2%) were men, and 111 (76%) practiced as physicians, with approximately half (69 [48.9%]) specializing in either internal medicine or cardiology. Cost conversations occurred in 639 encounters (77.0%) andwere more likely in the SDM arm (378 [90%] vs 261 [64%]; OR, 9.69; 95% CI, 5.77-16.29). In multivariable analysis, cost conversations were more likely to occur with female clinicians (66 [47%]; OR, 2.85; 95% CI, 1.216.71); consultants vs in-training clinicians (113 [75%]; OR, 4.0; 95% CI, 1.4-11.1); clinicians practicing family medicine (24 [16%]; OR, 12.12; 95% CI, 2.75-53.38]), internal medicine (35 [23%]; OR, 3.82; 95% CI, 1.25-11.70), or other clinicians (21 [14%]; OR, 4.90; 95% CI, 1.32-18.16) when compared with cardiologists; and for patients with an annual household income between $ 40 000 and $99 999 (249 [82.2%]; OR, 1.86; 95% CI, 1.05-3.29) compared with income below $ 40 000 or above $99 999. More patients who had cost conversations reported cost as a factor in their decision (244 [89.1%] vs 327 [69.0%]; OR 3.66; 95% CI, 2.43-5.50), but cost conversations were not associated with the choice of anticoagulation agent.CONCLUSIONS AND RELEVANCE Cost conversations were common, particularly for middle-income patients and with female and consultant-level primary care clinicians, aswell as in encounters using an SDM tool; they were associated with patients' consideration of treatment cost burden but not final treatment choice. With increasing costs of care passed on to patients, these findings can inform efforts to promote cost conversations in practice. Show less
Kunneman, M.; Branda, M.E.; Hargraves, I.G.; Sivly, A.L.; Lee, A.T.; Gorr, H.; ... ; Shared Decision Making 2020
IMPORTANCE Shared decision-making (SDM) about anticoagulant treatment in patients with atrial fibrillation (AF) is widely recommended but its effectiveness is unclear.OBJECTIVE To assess the extent... Show moreIMPORTANCE Shared decision-making (SDM) about anticoagulant treatment in patients with atrial fibrillation (AF) is widely recommended but its effectiveness is unclear.OBJECTIVE To assess the extent to which the use of an SDM tool affects the quality of SDM and anticoagulant treatment decisions in at-risk patients with AF.DESIGN, SETTING, AND PARTICIPANTS This encounter-randomized trial recruited patients with nonvalvular AF who were considering starting or reviewing anticoagulant treatment and their clinicians at academic, community, and safety-net medical centers between January 30, 2017 and June 27, 2019. Encounters were randomized to either the standard care arm or care that included the use of an SDM tool (intervention arm). Data were analyzed from August 1 to November 30, 2019.INTERVENTIONS Standard care or care using the Anticoagulation Choice Shared Decision Making tool (which presents individualized risk estimates and compares anticoagulant treatment options across issues of importance to patients) during the clinical encounter.MAIN OUTCOMES AND MEASURES Quality of SDM (which included quality of communication, patient knowledge about AF and anticoagulant treatment, accuracy of patient estimates of their own stroke risk [within 30% of their estimate], decisional conflict, and satisfaction), decisions made during the encounter, duration of the encounter, and clinician involvement of patients in the SDM process.RESULTS The clinical trial enrolled 922 patients (559 men [60.6%]; mean [SD] age, 71 [11] years) and 244 clinicians. A total of 463 patients were randomized to the intervention arm and 459 patients to the standard care arm. Participants in both arms reported high communication quality, high knowledge, and low decisional conflict, demonstrated low accuracy in their risk perception, and would similarly recommend the approach used in their encounter. Clinicians were significantly more satisfied after intervention encounters (400 of 453 encounters [88.3%] vs 277 of 448 encounters [61.8%]; adjusted relative risk, 1.49; 95% CI, 1.42-1.53). A total of 747 of 873 patients (85.6%) chose to start or continue receiving an anticoagulant medication. Patient involvement in decision-making (as assessed through video recordings of the encounters using the Observing Patient Involvement in Decision Making 12-item scale) scores were significantly higher in the intervention arm (mean [SD] score, 33.0 [10.8] points vs 29.1 [13.1] points, respectively; adjusted mean difference, 4.2 points; 95% CI, 2.8-5.6 points). No significant between-arm difference was found in encounter duration (mean [SD] duration, 32 [16] minutes in the intervention arm vs 31 [17] minutes in the standard care arm; adjusted mean between-arm difference, 1.1; 95% CI, -0.3 to 2.5 minutes).CONCLUSION AND RELEVANCE The use of an SDM encounter tool improved several measures of SDM quality and clinician satisfaction, with no significant effect on treatment decisions or encounter duration. These results help to calibrate expectations about the value of implementing SDM tools in the care of patients with AF. Show less
Despite the evolving evidence in favor of shared decision making (SDM) and of decades-long calls for its adoption, SDM remains uncommon in routine care. Reflecting on this lack of progress, we... Show moreDespite the evolving evidence in favor of shared decision making (SDM) and of decades-long calls for its adoption, SDM remains uncommon in routine care. Reflecting on this lack of progress, we sought to reimagine the future of SDM and the path to take us there. In late 2017, a multidisciplinary and international group of six researchers were challenged by a senior SDM scholar to envision the future and, based on a provocatively critical view of the present, to write letters to themselves from the year 2028. Letters were exchanged and discussed electronically. The group then met in person to discuss the letters. Since the letters painted a dystopian picture, they triggered questions about the nature of SDM, who should benefit from SDM, how to measure its contribution to care, and what new ways can be invented to design and test interventions to implement SDM in routine care. Through contrasting the purposefully generated dystopias with an ideal future for SDM, we generated reflections on a research agenda for SDM. These reflections hinged on recognizing SDM's contributing to care, that is, as a way to advance the problematic human situation of patients. These focused on three distinct yet complimentary contributors to SDM: 1) the process of making decisions, 2) humanistic communication, and 3) fit-to-care of the resulting decision. The group then concluded that to move SDM from envisioned to routine practice, and to ensure it reaches all, particularly persons rendered vulnerable by current forms of health care, a substantial investment in implementation research is necessary. Perhaps the discussion of these reflections can contribute to a path forward that will improve the likelihood of the future we dream for SDM. Show less
Hargraves, I.G.; Montori, V.M.; Brito, J.P.; Kunneman, M.; Shaw, K.; LaVecchia, C.; ... ; Thorsteinsdottir, B. 2019
Objective: Patient involvement focused the growth of Shared Decision Making (SDM) in contemporary healthcare practice, research, and education. Whilst important, securing appropriate patient... Show moreObjective: Patient involvement focused the growth of Shared Decision Making (SDM) in contemporary healthcare practice, research, and education. Whilst important, securing appropriate patient involvement or equipping patients to choose is not necessarily the principal purpose of SDM. The purpose of SDM like all medical decision making is to act well in response to a patient's problem, broadly conceived. In which situations and how SDM addresses patient problems is unclear. We seek to develop a purposeful approach to SDM that is oriented to the kinds of problems that SDM might help resolve.Methods: Through vignettes of the experience of a patient, Rachel we demonstrate different kinds of situations in which Rachel, her family, and clinicians need to make decisions together.Results: Different methods of SDM are needed in situations of:Uncertain harms and benefits.Intra or interpersonal conflict.Intellectual, practical, and emotional incoherence.Existential transition.Conclusion: SDM may be understood as a range of methods that vary substantially with patients' situations and the purpose that they pursue.Practice Implications: Clinicians struggle to adopt SDM when they do not see it as relevant to clinical work. Orienting SDM to the problems that patients and clinicians routinely face may further SDM adoption, education, and research. (C) 2019 Elsevier B.V. All rights reserved. Show less
Bekkering, G.E.; Agoritsas, T.; Lytvyn, L.; Heen, A.F.; Feller, M.; Moutzouri, E.; ... ; Vermandere, M. 2019
Clinical question What are the benefits and harms of thyroid hormones for adults with subclinical hypothyroidism (SCH)? This guideline was triggered by a recent systematic review of randomised... Show moreClinical question What are the benefits and harms of thyroid hormones for adults with subclinical hypothyroidism (SCH)? This guideline was triggered by a recent systematic review of randomised controlled trials, which could alter practice. Current practice Current guidelines tend to recommend thyroid hormones for adults with thyroid stimulating hormone (TSH) levels >10 mIU/L and for people with lower TSH values who are young, symptomatic, or have specific indications for prescribing.Recommendation The guideline panel issues a strong recommendation against thyroid hormones in adults with SCH (elevated TSH levels and normal free T4 (thyroxine) levels). It does not apply to women who are trying to become pregnant or patients with TSH >20 mIU/L. It may not apply to patients with severe symptoms or young adults (such as those <= 30 years old).How this guideline was created A guideline panel including patients, clinicians, and methodologists produced this recommendation in adherence with standards for trustworthy guidelines using the GRADE approach.The evidence The systematic review included 21 trials with 2192 participants. For adults with SCH, thyroid hormones consistently demonstrate no clinically relevant benefits for quality of life or thyroid related symptoms, including depressive symptoms, fatigue, and body mass index (moderate to high quality evidence). Thyroid hormones may have little or no effect on cardiovascular events or mortality (low quality evidence), but harms were measured in only one trial with few events at two years' follow-up.Understanding the recommendation The panel concluded that almost all adults with SCH would not benefit from treatment with thyroid hormones. Other factors in the strong recommendation include the burden of lifelong management and uncertainty on potential harms. Instead, clinicians should monitor the progression or resolution of the thyroid dysfunction in these adults. Recommendations are made actionable for clinicians and their patients through visual overviews. These provide the relative and absolute benefits and harms of thyroid hormones in multilayered evidence summaries and decision aids available in MAGIC (https://app.magicapp.org/) to support shared decisions and adaptation of this guideline. Show less
