Who Is Most Burdened in Health Care? An Analysis of Responses to the ICAN Discussion Aid.

OBJECTIVE: To create a model based on patients' characteristics that can predict the number of burdens reported using the ICAN Discussion Aid, to target use of this tool to patients likeliest to benefit. PATIENTS AND METHODS: Six hundred thirty-five patients (aged ≥18 years) completed the ICAN Discussion Aid at a Scottsdale, Arizona, family medicine clinic. Patient characteristics were gathered from their health records. Regression trees with Poisson splitting criteria were used to model the data. RESULTS: Our model suggests the patients with the most burdens had major depressive disorder, with twice as many overall burdens (personal plus health care burdens) than patients without depression. Patients with depression who were younger than 38 years had the highest number of personal burdens. A body mass index (BMI) of 26 or greater was associated with increased health care burden versus a BMI below 26. CONCLUSION: The number of burdens a patient will report on the ICAN Discussion Aid can be approximated based on certain patient characteristics. Adults with major depression, a BMI of 26 or greater, and younger age may have greater reported burdens on ICAN, but this finding needs to be validated in independent samples.

Problem-based shared decision-making in diabetes care: a secondary analysis of video-recorded encounters.

OBJECTIVES: To describe the range of collaborative approaches to shared decision-making (SDM) observed in clinical encounters of patients with diabetes and their clinicians. DESIGN: A secondary analysis of videorecordings obtained in a randomised trial comparing usual diabetes primary care with or without using a within-encounter conversation SDM tool. SETTING: Using the purposeful SDM framework, we classified the forms of SDM observed in a random sample of 100 video-recorded clinical encounters of patients with type 2 diabetes in primary care. MAIN OUTCOME MEASURES: We assessed the correlation between the extent to which each form of SDM was used and patient involvement (OPTION12-scale). RESULTS: We observed at least one instance of SDM in 86 of 100 encounters. In 31 (36%) of these 86 encounters, we found only one form of SDM, in 25 (29%) two forms, and in 30 (35%), we found ≥3 forms of SDM. In these encounters, 196 instances of SDM were identified, with weighing alternatives (n=64 of 196, 33%), negotiating conflicting desires (n=59, 30%) and problemsolving (n=70, 36%) being similarly prevalent and developing existential insight accounting for only 1% (n=3) of instances. Only the form of SDM focused on weighing alternatives was correlated with a higher OPTION12-score. More forms of SDM were used when medications were changed (2.4 SDM forms (SD 1.48) vs 1.8 (SD 1.46); p=0.050). CONCLUSIONS: After considering forms of SDM beyond weighing alternatives, SDM was present in most encounters. Clinicians and patients often used different forms of SDM within the same encounter. Recognising a range of SDM forms that clinicians and patients use to respond to problematic situations, as demonstrated in this study, opens new lines of research, education and practice that may advance patient-centred, evidence-based care.

The Impact of Within-Consultation and Pre-Consultation Decision Aids for Localized Prostate Cancer on Patient Knowledge: Results of a Patient-Level Randomized Trial.

OBJECTIVE: To evaluate the role of timing (either before or during initial consultation) on the effectiveness of DAs to support shared decision making (SDM) in a minority-enriched sample of patients with localized prostate cancer using a patient-level randomized controlled trial design. METHODS: We conducted a 3-arm, patient-level-randomized trial in urology and radiation oncology practices in Ohio, South Dakota, and Alaska, testing the effect of pre-consultation and within-consultation DAs on patient knowledge elements deemed essential to make treatment decisions about localized prostate cancer, all measured immediately following the initial urology consultation using a 12-item Prostate Cancer Treatment Questionnaire (score range 0 [no questions correct] to 1 [all questions correct]), compared to usual care (no DAs). RESULTS: Between 2017 and 2018, 103 patients - including 16 Black/African American and 17 American Indian or Alaska Native men - were enrolled and randomly assigned to receive usual care (n=33) or usual care and a DA before (n=37) or during (n=33) the consultation. After adjusting for baseline characteristics, there were no statistically significant proportional score differences in patient knowledge between the pre-consultation DA arm (0.06 knowledge change, 95% CI -0.02-0.12, p=0.1) or the within-consultation DA arm (0.04 knowledge change, 95% CI -0.03-0.11, p=0.3) and usual care. CONCLUSION: In this trial oversampling minority men with localized prostate cancer, DAs presented at different times relative to the specialist consultation showed no improvement in patient knowledge above usual care.

Disparities in Shared Decision-Making Research and Practice: The Case for Black American Patients.

OBJECTIVE: The extent of shared decision making (SDM) use in the care of Black patients is limited. We explored preferences, needs, and challenges of Black patients to enhance SDM offerings. METHODS: We performed interviews with 32 Black patients receiving type 2 diabetes care in safety-net primary care practices caring predominantly for Black people. RESULTS: The following 4 themes emerged: preference for humanistic communication, need to account for the role of family in decision making, need for medical information sharing, and mistrust of clinicians. CONCLUSION: Given the dearth of research on SDM among ethnic and racial minorities, this study offers patient-perspective recommendations to improve SDM offerings for Black patients in primary care settings. To enhance SDM with Black patients, acknowledgment of the importance of storytelling as a strategy, to place medical information in a context that makes it meaningful and memorable, is recommended. Triadic SDM, in which family members are centrally involved in decision making, is preferred over classical dyadic SDM. There is a need to reconsider the universalism assumption underlying contemporary SDM models and the relevancy of current SDM practices that were developed mostly without the feedback of participants of ethnic, racial, and cultural minorities.

Video-based observation research: A systematic review of studies in outpatient health care settings.

OBJECTIVE: To examine the use of video-based observation research in outpatient health care encounter research. METHODS: We conducted a systematic search of MEDLINE, Scopus, Cochrane and other databases from database inception to October 2020 for reports of studies that used video recording to investigate ambulatory patient-clinician interactions. Two authors independently reviewed all studies for eligibility and extracted information related to study setting and purpose, participant recruitment and consent processes, data collection procedures, method of analysis, and participant sample characteristics. RESULTS: 175 articles were included. Most studies (65%) took place in a primary care or family practice setting. Study objectives were overwhelmingly focused on patient-clinician communication (81%). Reporting of key study elements was inconsistent across included studies. CONCLUSION: Video recording has been used as a research method in outpatient health care in a limited number and scope of clinical contexts and research domains. In addition, reporting of study design, methodological characteristics, and ethical considerations needs improvement. PRACTICE IMPLICATIONS: Video recording as a method has been relatively underutilized within many clinical and research contexts. This review will serve as a practical resource for health care researchers as they plan and execute future video-based studies.

Statin intolerance management: a systematic review.

BACKGROUND: Statin intolerance is a key barrier to the effective prevention of atherosclerotic cardiovascular disease (ASCVD). Experts do not agree on what it is and how to respond to this problem clinically. OBJECTIVE: To characterize the range of expert recommendations about the care of patients with statin intolerance. METHODS: Systematic review registered in PROSPERO that searched on April 1 2022 in PubMed, EMBASE, Scopus, Cochrane, online textbooks, and specialty textbooks for expert reviews (e.g., review articles and book chapters), systematic reviews, or clinical practice guidelines published in the past 5 years without language restriction. Authors working in duplicate extracted definitions, management recommendations, and supportive evidence cited. RESULTS: We identified 26 eligible articles, none of which described a systematic method to summarize the evidence or to develop and grade recommendations. Of these, 14 (54%) offered a definition of statin intolerance. A sequenced approach to management of statin intolerance was suggested in 24 (92%) articles describing 12 different approaches without supporting evidence of efficacy. Investigating for other causes was the most common first step. All authors suggested rechallenging after a washout period with either the same or other statin. Few considered nonlipid approaches to reducing ASCVD risk and none recommended involving patients in shared decision making. CONCLUSION: We found substantial variability in the definition and management of statin intolerance among experts. Few focused on ASCVD risk reduction and none promoted the participation of patients in shared decision making about how to address the threat of ASCVD with or without statins.

Problem-based shared decision making: The role of canonical SDM steps.

OBJECTIVE: To evaluate the extent to which the canonical steps of shared decision making (SDM) take place in clinical encounters in practice and across SDM forms. METHODS: We assessed 100 randomly selected video-recorded primary care encounters, obtained as part of a randomized trial of an SDM intervention in patients with type 2 diabetes. Two coders, working independently, noted each instance of SDM, classified it as one of four problem-based forms to SDM (weighing alternatives, negotiating conflicting issues, solving problems, or developing existential insight), and noted the occurrence and timing of each of the four canonical SDM steps: fostering choice awareness, providing information, stating preferences, and deciding. Descriptive analyses sought to determine the relative frequency of these steps across each of the four SDM forms within each encounter. RESULTS: There were 485 SDM steps noted (mean 4.85 steps per encounter), of which providing information and stating preferences were the most common. There were 2.7 (38 steps in 14 encounters) steps per encounter observed in encounters with no discernible SDM form, 3.4 (105 steps in 31 encounters) with one SDM form, 5.2 (129 steps in 25 encounters) with two SDM forms, and 7.1 (213 steps in 30 encounters) when ≥3 SDM forms were observed within the encounter. The prescribed order of the four SDM steps was observed in, at best, 16 of the 100 encounters. Stating preferences was a common step when weighing alternatives (38%) or negotiating conflicts (59.3%) but less common when solving problems (29.2%). The distribution of SDM steps was similar to usual care with or without the SDM intervention. CONCLUSION: The normative steps of SDM are infrequently observed in their prescribed order regardless of whether an SDM intervention was used. Some steps are more likely in some SDM forms but no pattern of steps appears to distinguish among SDM forms. CLINICAL TRIAL REGISTRATION: ClinicalTrial.gov: NCT01293578.

The design and development of an encounter tool to support shared decision making about preventing cardiovascular events.

Patients at high risk for cardiovascular disease (CVD) tend to receive less intensive preventive care. Clinical practice guidelines recommend shared decision making (SDM) to improve the quality of primary CVD prevention. There are tools for use during the clinical encounter that promote SDM, but, to our knowledge, there are no SDM encounter tools that support conversations about available lifestyle and pharmacological options that can lead to preventive care that is congruent with patient goals and CVD risk. Using the best available evidence and human-centered design (iterative design in the context of ultimate use with users), our team developed a SDM encounter tool, CV Prevention Choice. Each subsequent version during the iterative development process was evaluated in terms of content, usefulness, and usability by testing it in real preventive encounters. The final version of the tool includes a calculator that estimates the patient's risk of a major atherosclerotic CVD event in the next 10 years. Lifestyle and medication options are presented, alongside their pros, cons, costs, and other burdens. The risk reduction achieved by the selected prevention program is then displayed to support collaborative deliberation and decision making. A U.S. multicenter trial is estimating the effectiveness of CV Prevention Choice in achieving risk-concordant CV prevention while identifying the best strategies for increasing the adoption of the SDM encounter tool and its routine use in practice.

Encounter-based randomization did not result in contamination in a shared decision-making trial: a secondary analysis.

OBJECTIVES: To estimate the level of contamination in an encounter-randomized trial evaluating a shared decision-making (SDM) tool. STUDY DESIGN AND SETTING: We assessed contamination at three levels: (1) tool contamination (whether the tool was physically present in the usual care encounter), (2) functional contamination (whether components of the SDM tool were recreated in the usual care encounters without directly accessing the tool), and (3) learned contamination (whether clinicians "got better at SDM" in the usual care encounters as assessed by the OPTION-12 score). For functional and learned contamination, the interaction with the number of exposures to the tool was assessed. RESULTS: We recorded and analyzed 830 of 922 randomized encounters. Of the 411 recorded encounters randomized to usual care, the SDM tool was used in nine (2.2%) encounters. Clinicians discussed at least one patient-important issue in 377 usual care encounters (92%) and the risk of stroke in 214 encounters (52%). We found no significant interaction between number of times the SDM tool was used and subsequent functional or learned contamination. CONCLUSION: Despite randomly assigning clinicians to use an SDM tool in some and not other encounters, we found no evidence of contamination in usual care encounters.

In type 2 diabetes, SGLT2 inhibitors reduced risk for serious hyperkalemia without increasing hypokalemia.

SOURCE CITATION: Neuen BL, Oshima M, Agarwal R, et al. Sodium-glucose cotransporter 2 inhibitors and risk of hyperkalemia in people with type 2 diabetes: a meta-analysis of individual participant data from randomized, controlled trials. Circulation. 2022;145:1460-70. 35394821.

Enrolling people of color to evaluate a practice intervention: lessons from the shared decision-making for atrial fibrillation (SDM4AFib) trial.

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 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. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02905032).

Patients surviving COVID-19 had increased risk for incident diabetes vs. persons without COVID-19.

SOURCE CITATION: Xie Y, Al-Aly Z. Risks and burdens of incident diabetes in long COVID: a cohort study. Lancet Diabetes Endocrinol. 2022;10:311-21. 35325624.

A scoping review of medical practice variation research within the informatics literature.

RATIONALE: We performed a scoping review of informatics core literature about medical practice variation (MPV) as an agile summary of the subject in our field. MATERIALS AND METHODS: The Ovid integrated database was searched between 1946 and 2022 to identify MPV studies published in major informatics journals and conference proceedings. Two reviewers performed relevance screening, with assistance from another independent reviewer for adjudication. The included articles were then thematically analyzed and summarized through discussion among all three reviewers. RESULTS: A total of 43 articles were included and went through the thematic analysis. About half (n = 21) of the included articles were published in conference proceedings. Five articles reported the effect of MPV on patient outcomes. The variation of interest was most frequently in treatment decisions. In terms of the role informatics played (multiple roles allowed), 39 (90.7%) articles pertained to detection of MPV, 5 were about prevention of MPV and 4 about learning from MPV. DISCUSSION: MPV remains a critical issue in health care, yet most informatics research has been focused on simple tasks such as automating the detection of MPV and assessing compliance to decision-support systems, and less focused on addressing the causes of variation or supporting learning from variation. CONCLUSION: Our scoping review found that informatics studies have focused on detecting of MPV, especially variability in treatments and deviation from practice guidelines. Technological advances should promote more informatics research focused on explaining and learning from MPV.

Shared Decision-Making for Patients Hospitalized with Acute Myocardial Infarction: A Randomized Trial.

Objective: Adherence to guideline-recommended medications after acute myocardial infarction (AMI) is suboptimal. Patient fidelity to treatment regimens may be related to their knowledge of the risk of death following AMI, the pros and cons of medications, and to their involvement in treatment decisions. Shared decision-making may improve both patients' knowledge and involvement in treatment decisions. Methods: In a pilot trial, patients hospitalized with AMI were randomized to the use of the AMI Choice conversation tool or to usual care. AMI Choice includes a pictogram of the patient's estimated risk of mortality at 6 months with and without guideline-recommended medications, ie, aspirin, statins, beta-blockers, and angiotensin-converting enzyme inhibitors. Primary outcomes were patient knowledge and conflict with the decision made assessed via post-encounter surveys. Secondary outcomes were patient involvement in the decision-making process (observer-based OPTION12 scale) and 6-month medication adherence. Results: Patient knowledge of the expected survival benefit from taking medications was significantly higher (62% vs 16%, p<0.0001) in the AMI Choice group (n = 53) compared to the usual care group (n = 53). Both groups reported similarly low levels of conflict with the decision to start the medications (13 (SD 24.2) vs 16 (SD 22) out of 100; p=0.16). The extent to which clinicians in the AMI Choice group involved their patients in the decision-making process was high (OPTION12 score 53 out of 100, SD 12). Medication adherence at 6-months was relatively high in both groups and not different between groups. Conclusion: The AMI Choice conversation tool improved patients' knowledge of their estimated risk of short-term mortality after an AMI and the pros and cons of treatments to reduce this risk. The effect on patient fidelity to recommended medications of using this SDM tool and of SDM in general should be tested in larger trials enrolling patients at high risk for nonadherence. Trial Registration Number: NCT00888537.

Documentation of Psychosocial Distress and Its Antecedents in Children with Rare or Life-Limiting Chronic Conditions.

Children with rare or life-limiting chronic conditions and their families are at high risk of psychosocial distress. However, despite its impact on patient and family health and functioning, psychosocial distress and its antecedents may not routinely be captured in medical records. The purpose of this study was to characterize current medical record documentation practices around psychosocial distress among children with rare or life-limiting chronic conditions and their families. Medical records for patients with rare or life-limiting chronic conditions (n = 60) followed by a pediatric complex care program were reviewed. Study team members extracted both structured data elements (e.g., diagnoses, demographic information) and note narratives from the most recent visit with a clinician in the program. Psychosocial topics were analyzed using a mixed quantitative (i.e., frequency counts of topics) and qualitative approach. Topics related to psychosocial distress that were documented in notes included child and parent emotional problems, parent social support, sibling emotional or physical problems, family structure (e.g., whether parents were together), and financial concerns. However, 35% of notes lacked any mention of psychosocial concerns. Although examples of psychosocial concerns were included in some notes, none were present in over one-third of this sample. For both patients with rare or life-limiting chronic conditions and their caregivers, more active elicitation and standard documentation of psychosocial concerns may improve the ability of healthcare providers to identify and intervene on psychosocial concerns and their risk factors.