Hargraves, Ian

Abstract Objectives Diagnostic reconciliation is the collaborative process between patients and clinicians to create and reconcile evidence-based, feasible, and desirable care plans. However, the specific components of this process remain unclear. The objective of this study was to develop the first comprehensive framework to elucidate the diagnostic reconciliation process. Methods We followed a multi-step and iterative approach to develop the framework, including a focused systematic review of diagnostic conversations, quantitative evaluation of recordings of real-life clinical visits recordings, and stakeholder engagement (e.g., patients, clinicians, researchers). Results We identified 17 potential components to the process of diagnostic reconciliation through literature review and stakeholder engagement. After review of 56 clinical visits and further stakeholder engagement, we developed a final framework including four categories: 1) understanding the need for a test/referral, 2) logistics of test/referral scheduling, 3) test/referral information, and 4) test/referral results. Conclusions The proposed framework lays the foundation for evaluation and improvement of diagnostic conversations in practice. Clinicians can enhance patient-centered diagnosis by co-creating diagnostic plans of care in practice and using the components described in the novel diagnostic reconciliation framework.

Introduction: We validated the “Familial Hypercholesterolemia (FH) Decision Aid” to promote shared decision making (SDM) about lipid lowering therapy, based on patient-clinician encounters. Methods: Validation of the DA included an assessment of whether the content and design of the tool facilitated SDM and patient engagement and to determine how well the tool integrated with clinical workflow. Validation was conducted during patient-clinician encounters in the Mayo preventive cardiology clinic. As inclusion criteria we considered an upcoming appointment in the clinic, an LDL-C level ≥ ~160 mg/dL, and no prior diagnosis of FH. Prior to the encounters, each clinician viewed a demonstration of the online, interactive DA. During the encounters, the DA was shared with patients using the clinic room computer screen, either in-person or virtually. Patient-clinician encounters were video recorded for further analysis by two design researchers and experts in SDM. Results: Ten patients were enrolled in the study (7 male; average age 51 years). The average patient LDL-C level was 207 mg/dL, range 157 - 248 mg/dL. Review and qualitative analysis of the encounter recordings yielded 4 key findings: i) clinicians primarily used the cardiovascular risk estimate in the DA to guide conversation with patients; ii) highly trained specialists needed to change their usual approach to care and conversation to integrate the DA with their clinical workflows; iii) as clinicians became more familiar with the DA, they moved through the tool at a more efficient pace; and iv) each clinician developed his/her own style of navigating the DA, either moving through it one screen at a time or focusing on one specific section for the duration of the conversation. The DA effectively guided conversation and facilitated active patient engagement in 6 of 10 encounters. Social distancing and use of telemedicine encounters, due to the COVID-19 pandemic, limited patient engagement in 2 of 10 encounters. Overall, the DA promoted SDM regarding FH management in 9 of 10 encounters. Conclusion: Using patient-clinician encounters, we found the FH DA to facilitate SDM regarding lipid-lowering therapy. The tool has potential to improve care of FH patients and increase patient engagement and knowledge.

Introduction: Familial Hypercholesterolemia (FH) is a common inherited disorder of lipid metabolism. FH patients are at an increased risk of atherosclerotic cardiovascular disease (ASCVD) due to elevated low-density lipoprotein cholesterol (LDL-C) levels. Patients with FH may not reach target LDL-C levels despite maximally tolerated statin (±ezetimibe) therapy (MTT). The AHA scientific statement on FH highlighted the need for developing decision aids (DAs) to facilitate shared decision making (SDM) regarding additional therapy including PCSK9 inhibitors. Methods: A user-centered design process was initiated to understand FH treatment decisions and to develop prototype interventions. Patients with FH had their diagnosis confirmed by genetic testing. Encounters between FH patients and health care providers were video recorded and analyzed to assess how decisions are made regarding lipid lowering therapy. Nine encounters were recorded: 3 with a genetic counselor and 6 with an FH specialist. Informed by clinical encounters and literature review, we developed content for a DA related to available therapeutic options for FH patients on MTT. Results: A prototype online DA was created to support in-encounter discussion of a patient’s risk of adverse cardiovascular events and which therapies may be best suited to the patient (Figure). 5 and 10-year ASCVD risk is estimated using the SAFEHEART Risk Score (SRS). Risk is communicated in numbers using a 100-person icon array and the language “Out of 100 persons like you...”. Therapeutic options include watchful waiting, bile acid sequestrants, and PCSK9 inhibitors. For each option, the degree of risk reduction, costs, and side effects are presented. The tool is currently being refined by analyzing additional encounters with FH patients. Conclusion: We developed an interactive prototype DA to facilitate SDM for FH patients on MTT. After further iterative testing the tool will be deployed in the electronic health record.

Abstract Background: Venous thromboembolism (VTE) in pregnancy is a major cause of maternal morbidity and mortality, and the use of preventive low-molecular-weight heparin (LMWH) can be challenging. Clinical guidelines recommend eliciting pregnant individuals’ preferences towards the use of daily injections of LMWH and discussing the best option through a shared decision-making (SDM) approach. Our aim was to identify individuals’ preferences concerning each of the main clinical outcomes, and categorize attributes influencing the use of LMWH during pregnancy. Methods: Design: Convergent mixed-methods. Participants: Pregnant women or those planning a pregnancy with VTE recurrence risk. Intervention: A SDM intervention about thromboprophylaxis with LMWH in pregnancy. Analysis: Quantitatively, we report preference scores assigned to each of the health states. Qualitatively, we categorized preference attributes using Burke’s pentad of motives framework: scene, agent, agency, act, and purpose. We use mixed-method convergent analysis to report findings using side-by-side comparison of concordance/discordance. Results: The least valued health state was to experience a pulmonary embolism (PE), followed by major obstetrical bleeding (MOB), deep vein thrombosis (DVT), and using daily injections of LMWH (valued as closest to a ‘healthy pregnancy’). Women's previous experiences, access to care (scene) and shared decision-making (agent) affected preferences. LMWH's benefits were noted, but substantial drawbacks described (agency). The main goal was avoiding the risk of VTE (purpose). Side-by-side comparisons revealed concordance between motives and DVT and PE health states. Discordance appeared between using daily injections of LMWH and agent- and agency motives and between MOB and the agency motive. Conclusions: Mixed-methods provide a nuanced understanding of women's LMWH preferences, by quantifying health states preferences and exploring attributes qualitatively. Incorporating both methods may improve patient-centered care around preference-sensitive decisions in thromboprophylaxis during pregnancy.

Introduction Advancements in vascularized composite allotransplantation have made hand transplants possible for persons living with upper limb loss. Hand transplantation is not a life-saving procedure, but rather a quality-of-life enhancing procedure; hence the risk of morbidity and mortality must be weighed against improvements in function and appearance. This study explored the decision-making process of patients evaluated for hand transplantation. Methods/Approach A qualitative case series study using retrospective chart data of evaluations was conducted between January 1, 2011 and February 28, 2020. Notes were extracted and read by three reviewers. Each case was summarized noting similarities and differences. Findings Nine patients underwent evaluation. Eight were no longer under evaluation and did not receive transplant; one was still undergoing evaluation. Patient motivations for evaluation were dissatisfaction with prostheses or self-image, chronic pain, performing activities of daily living, occupation, burden placed on caregivers, and concerns about overuse of non-affected limbs. Patients chose not to pursue transplantation due to rehabilitation time, immunosuppression, alternative treatments, and social and financial challenges. The clinical team discontinued evaluations due to unmet evaluation requirements, medical contraindications, or treatment alternatives. Different modes of shared decision-making were present depending on the party most heavily featured in the charts as driving decisions. Discussion This was an examination of shared decision-making with hand transplant candidates who did not proceed to transplant. Reasons for choosing alternative strategies for management were multifactorial. Lessons learned regarding patient motivations and shared decision-making can inform future interventions to better support patients.

Introduction Decision aids (DAs) are helpful instruments used to support shared decision making (SDM). Patients with atrial fibrillation (AF) face complex decisions regarding stroke prevention strategies. While a few DAs have been made for AF stroke prevention, an encounter DA (EDA) and patient DA (PDA) have not been created to be used in conjunction with each other before. Design Using iterative user-centered design, we developed 2 DAs for anticoagulation choice and stroke prevention in AF. Prototypes were created, and we elicited feedback from patients and experts via observations of encounters, usability testing, and semistructured interviews. Results User testing was done with 33 experts (in AF and SDM) and 51 patients from 6 institutions. The EDA and PDA underwent 1 and 4 major iterations, respectively. Major differences between the DAs included AF pathophysiology and a preparation to meet with the clinician in the PDA as well as different language throughout. Content areas included personalized stroke risk, differences between anticoagulants, and risks of bleeding. Based on user feedback, developers 1) addressed feelings of isolation with AF, 2) improved navigation options, 3) modified content and flow for users new to AF and those experienced with AF, 4) updated stroke risk pictographs, and 5) added structure to the preparation for decision making in the PDA. Limitations These DAs focus only on anticoagulation for stroke prevention and are online, which may limit participation for those less comfortable with technology. Conclusions Designing complementary DAs for use in tandem or separately is a new method to support SDM between patients and clinicians. Extensive user testing is essential to creating high-quality tools that best meet the needs of those using them. Highlights First-time complementary encounter and patient decision aids have been designed to work together or separately. User feedback led to greater structure and different experiences for patients naïve or experienced with anticoagulants in patient decision aids. Online tools allow for easier dissemination, use in telehealth visits, and updating as new evidence comes out.

Introduction: Shared decision-making (SDM) about anticoagulant treatment in patients with atrial fibrillation (AF) is widely recommended but its effectiveness is unclear. We assessed the extent to which using an SDM tool promotes high-quality SDM. Hypothesis: SDM will improve communication quality, knowledge, and decisional conflict and will translate to improved medication adherence and outcomes. Methods: In this multicentre encounter-randomized trial, we included patients with nonvalvular AF considering starting/reviewing anticoagulation, and their clinicians. We compared usual care with or without ANTICOAGULATION CHOICE, an SDM conversation tool for use during the clinical encounter that presents individualized risk estimates and compares anticoagulation options across patient important issues. Results: We enrolled and video-recorded 922 patient-clinician encounters. So far, our data have shown that participants in both arms reported near-optimal communication quality, knowledge, and decisional conflict (JAMA IM-2020). Patients in intervention-arm estimated their stroke risks more accurately and were more involved in decision-making (JAMA IM-2020), clinicians were more satisfied (JAMA IM-2020), and cost conversation were more common (JAMA NO-2021). Use of the intervention had no effect on treatment decisions, encounter duration (JAMA IM-2020), treatment adherence, clinical outcomes (JAHA-epub) or patient-perceived sense of the care plan (PEC-epub). New analyses have shown that compared to eligible white participants, black participants more frequently did not enrol to the study. Enrolment of Black, indigenous, and people of colour benefited most form including and prioritizing practices most likely to care for them. We found no evidence of contamination (tool use, functional, or learned) between study arms. Conclusions: Use of an SDM tool improved some measures of SDM quality, without affecting treatment decisions and their sensibility, encounter duration, patient adherence, or clinical outcomes. Our results should calibrate expectations as to what could be accomplished by implementing SDM tools about anticoagulation in the care of patients with AF

Abstract Background/Aims In shared decision-making conversations, patients with or at risk of osteoporosis and their clinicians collaborate to decide which drug treatments fit best for each person. The Perceptions and Practicalities Approach (PAPA) specifies three core considerations of drug uptake and commitment: 1) patient’s perceived personal need for treatment (necessity beliefs). 2) patient concerns about the potential adverse consequences of drugs (e.g. side effects). 3) practical difficulties (e.g. limitations in capacity and resources). This study aims to explore how discussions about perceptions and practicalities of osteoporosis drug treatment arise and evolve in the context of clinical consultations about osteoporosis. Methods Secondary analysis of 38 video-recorded primary care consultations from a Mayo Clinic trial evaluating the Osteoporosis Choice Decision Aid. Video-recorded consultations included ‘usual care’ (n = 24) and decision aid (n = 14). Patient participants were aged 50 and over with osteopenia or osteoporosis not already receiving drug treatment. A quantitative coding scheme, informed by the PAPA, was developed to extract: i) how clinicians framed the ‘problem’ of osteoporosis, including: bone density results, fracture risk, physical impact, social impact, or psychological impact of fracture. ii) whether clinicians asked about the patients’ views of osteoporosis, patients own bone health, and the necessity, concerns, or practical issues associated with osteoporosis drugs. iii) whether clinicians personalised discussions about osteoporosis drugs to patients perceived: importance or need, side effects or harms, or practical issues. Two independent study team members dual extracted data, with a third member resolving discrepancies. Extracted data was summarised using descriptive statistics. Results Commonly, clinicians framed osteoporosis using the patient’s bone density results (n = 38,100%) and fracture risk (n = 30,79%). In contrast, few clinicians acknowledged the potential physical impacts of fracture (n = 5,13%), with no clinicians discussing the possible psychological or social impacts. Clinicians asked 24 questions to elicit patient views in 16 of the 38 encounters (42%, range 0-4 questions per consult). The 24 questions concerned patient views about osteoporosis (n = 1,4%), their bone health (n = 5,21%), or the necessity (n = 1,4%), concerns (n = 2,8%), or practical issues associated with osteoporosis drugs (n = 2,8%). Importantly, 14 consultations (37%) contained no questions to elicit patient views. Across the 38 consultations, clinicians personalised information about the patient’s need for osteoporosis drugs in 15 consultations (39%), with less personalisation about the side effects/harms (n = 10,26%), or practical issues (n = 6,16%) associated with osteoporosis drugs. Conclusion Clinical consultations rarely considered key personal determinants of osteoporosis drug uptake and commitment. Even when clinicians used an osteoporosis decision aid, few discussions specifically elicited or addressed patients’ personal treatment necessity beliefs, concerns and practical difficulties. Additionally, clinicians seldom acknowledged the potential physical and psychosocial impacts of osteoporosis. The findings demonstrate the need for multicomponent interventions, incorporating the PAPA-based approach, to facilitate shared decision-making that takes account of patient perceptions and practicalities. Disclosure A.W. Hawarden: Grants/research support; AH is funded by a Versus Arthritis Clinical Doctoral Fellowship (grant reference 227260). L. Bullock: None. M. León-García: Grants/research support; ML-G had financial support from the Spanish Health Institute Carlos III (ISCIII) co-funded by the European Regional Development Fund (Grant number: F18/00014).. S.A. Hartasanchez: None. I. Hargraves: None. R. Horne: None. A. Maraboto: None. M. Kunneman: Grants/research support; MK had financial support from the Dutch Research Council (NWO) and The Netherlands Organisation for Health Research and Development (ZonMw) (#016.196.138). C. Jinks: Grants/research support; CJ is part funded by NIHR Applied Research Collaboration (ARC) West Midlands. Z. Paskins: Grants/research support; ZP is funded by the National Institute for Health Research (NIHR) [Clinician Scientist Award (CS-2018-18-ST2-010)/NIHR Academy].