Clinician use of the Statin Choice Shared Decision-making Encounter Tool in a Major Health System.

BACKGROUND: Effective shared decision-making (SDM) tools for use during clinical encounters are available, but, outside of study settings, little is known about clinician use of these tools in practice. OBJECTIVE: To describe real-world use of an SDM encounter tool for statin prescribing, Statin Choice, embedded into the workflow of an electronic health record. DESIGN: Cross-sectional study. PARTICIPANTS: Clinicians and their statin-eligible patients who had outpatient encounters between January 2020 and June 2021 in Cleveland Clinic Health System. MAIN MEASURES: Clinician use of Statin Choice was recorded within the Epic record system. We categorized each patient's 10-year atherosclerotic cardiovascular disease risk into low (< 5%), borderline (5-7.5%), intermediate (7.5-20%), and high (≥ 20%). Other patient factors included age, sex, insurance, and race. We used mixed effects logistic regression to assess the odds of using Statin Choice for statin-eligible patients, accounting for clustering by clinician and site. We generated a residual intraclass correlation coefficient (ICC) to characterize the impact of the clinician on Statin Choice use. KEY RESULTS: Statin Choice was used in 7% of 68,505 eligible patients. Of 1047 clinicians, 48% used Statin Choice with ≥ 1 patient, and these clinicians used it with a median 9% of their patients (interquartile range: 3-22%). In the mixed effects logistic regression model, patient age (adjusted OR per year: 1.04; 95%CI 1.03-1.04) and 10-year ASVCD risk (aOR for 5-7.5% versus < 5% risk: 1.28; 95%CI: 1.14-1.44) were associated with use of Statin Choice. Black versus White race was associated with a lower odds of Statin Choice use (aOR: 0.83; 95%CI: 0.73-0.95), as was female versus male sex (aOR: 0.83; 95%CI: 0.76-0.90). The model ICC demonstrated that 53% of the variation in use of Statin Choice was clinician-driven. CONCLUSIONS: Patient factors, including race and sex, were associated with clinician use of Statin Choice; half the variation in use was attributable to individual clinicians.

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.Annals "Online First" article.

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.

Assessing collaborative efforts of making care fit for each patient: A systematic review.

INTRODUCTION: For too many people, their care plans are designed without fully accounting for who they are, the lives they live, what matters to them or what they aspire to achieve. We aimed to summarize instruments capable of measuring dimensions of patient-clinician collaboration to make care fit. METHODS: We systematically searched several databases (Medline, Embase, Cochrane, Scopus and Web of Science) from inception to September 2021 for studies using quantitative measures to assess, evaluate or rate the work of making care fit by any participant in real-life clinical encounters. Eligibility was assessed in duplicate. After extracting all items from relevant instruments, we coded them deductively on dimensions relevant to making care fit (as presented in a recent Making Care Fit Manifesto), and inductively on the main action described. RESULTS: We included 189 papers, mostly from North America (N = 83, 44%) and in the context of primary care (N = 54, 29%). Half of the papers (N = 88, 47%) were published in the last 5 years. We found 1243 relevant items to assess efforts of making care fit, included within 151 instruments. Most items related to the dimensions 'Patient-clinician collaboration: content' (N = 396, 32%) and 'Patient-clinician collaboration: manner' (N = 382, 31%) and the least related to 'Ongoing and iterative process' (N = 22, 2%) and in 'Minimally disruptive of patient lives' (N = 29, 2%). The items referred to 27 specific actions. Most items referred to 'Informing' (N = 308, 25%) and 'Exploring' (N = 93, 8%), the fewest items referred to 'Following up', 'Comforting' and 'Praising' (each N = 3, 0.2%). DISCUSSION: Measures of the work that patients and clinicians do together to make care fit focus heavily on the content of their collaborations, particularly on exchanging information. Other dimensions and actions previously identified as crucial to making care fit are assessed infrequently or not at all. The breadth of extant measures of making care fit and the lack of appropriate measures of this key construct limit both the assessment and the successful implementation of efforts to improve patient care. PATIENT CONTRIBUTION: Patients and caregivers from the 'Making care fit Collaborative' were involved in drafting the dimensions relevant to patient-clinician collaboration.

Telemedicine and the assessment of clinician time: a scoping review.

OBJECTIVES: Telemedicine may improve healthcare access and efficiency if it demands less clinician time than usual care. We sought to describe the degree to which telemedicine trials assess the effect of telemedicine on clinicians' time and to discuss how including the time needed to treat (TNT) in health technology assessment (HTA) could affect the design of telemedicine services and studies. METHODS: We conducted a scoping review by searching clinicaltrials.gov using the search term "telemedicine" and limiting results to randomized trials or observational studies registered between January 2012 and October 2023. We then reviewed trial registration data to determine if any of the outcomes assessed in the trials measured effect on clinicians' time. RESULTS: We found 113 studies and of these 78 studies of telemedicine met the inclusion criteria and were included. Nine (12 percent) of the 78 studies had some measure of clinician time as a primary outcome, and 11 (14 percent) as a secondary outcome. Four studies compared direct measures of TNT with telemedicine versus usual care, but no statistically significant difference was found. Of the sixteen studies including indirect measures of clinician time, thirteen found no significant effects, two found a statistically significant reduction, and one found a statistically significant increase. CONCLUSIONS: This scoping review found that clinician time is not commonly measured in studies of telemedicine interventions. Attention to telemedicine's TNT in clinical studies and HTAs of telemedicine in practice may bring attention to the organization of clinical workflows and increase the value of telemedicine.

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.

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.

Decision aids for localized prostate cancer in diverse minority men: Primary outcome results from a multicenter cancer care delivery trial (Alliance A191402CD).

BACKGROUND: Decision aids (DAs) can improve knowledge for prostate cancer treatment. However, the relative effects of DAs delivered within the clinical encounter and in more diverse patient populations are unknown. A multicenter cluster randomized controlled trial with a 2×2 factorial design was performed to test the effectiveness of within-visit and previsit DAs for localized prostate cancer, and minority men were oversampled. METHODS: The interventions were delivered in urology practices affiliated with the NCI Community Oncology Research Program Alliance Research Base. The primary outcome was prostate cancer knowledge (percent correct on a 12-item measure) assessed immediately after a urology consultation. RESULTS: Four sites administered the previsit DA (39 patients), 4 sites administered the within-visit DA (44 patients), 3 sites administered both previsit and within-visit DAs (25 patients), and 4 sites provided usual care (50 patients). The median percent correct in prostate cancer knowledge, based on the postvisit knowledge assessment after the intervention delivery, was as follows: 75% for the pre+within-visit DA study arm, 67% for the previsit DA only arm, 58% for the within-visit DA only arm, and 58% for the usual-care arm. Neither the previsit DA nor the within-visit DA had a significant impact on patient knowledge of prostate cancer treatments at the prespecified 2.5% significance level (P = .132 and P = .977, respectively). CONCLUSIONS: DAs for localized prostate cancer treatment provided at 2 different points in the care continuum in a trial that oversampled minority men did not confer measurable gains in prostate cancer knowledge.

Randomized evaluation of decision support interventions for atrial fibrillation: Rationale and design of the RED-AF study.

BACKGROUND: Shared decision making (SDM) improves the likelihood that patients will receive care in a manner consistent with their priorities. To facilitate SDM, decision aids (DA) are commonly used, both to prepare a patient before their clinician visit, as well as to facilitate discussion during the visit. However, the relative efficacy of patient-focused or encounter-based DAs on SDM and patient outcomes remains largely unknown. We aim to directly estimate the comparative effectiveness of two DA's on SDM observed in encounters to discuss stroke prevention strategies in patients with atrial fibrillation (AF). METHODS: The study aims to recruit 1200 adult patients with non-valvular AF who qualify for anticoagulation therapy, and their clinicians who manage stroke prevention strategies, in a 2x2 cluster randomized multi-center trial at six sites. Two DA's were developed as interactive, online, non-linear tools: a patient decision aid (PDA) to be used by patients before the encounter, and an encounter decision aid (EDA) to be used by clinicians with their patients during the encounter. Patients will be randomized to PDA or usual care; clinicians will be randomized to EDA or usual care. RESULTS: Primary outcomes are quality of SDM, patient decision making, and patient knowledge. Secondary outcomes include anticoagulation choice, adherence, and clinical events. CONCLUSION: This trial is the first randomized, head-to-head comparison of the effects of an EDA versus a PDA on SDM. Our results will help to inform future SDM interventions to improve patients' AF outcomes and experiences with stroke prevention strategies.

Development and pilot testing of a conversation aid to support the evaluation of patients with thyroid nodules.

OBJECTIVE: To support patient-centred care and the collaboration of patients and clinicians, we developed and pilot tested a conversation aid for patients with thyroid nodules. DESIGN, PATIENT AND MEASUREMENTS: We developed a web-based Thyroid NOdule Conversation aid (TNOC) following a human-centred design. A proof of concept observational pre-post study was conducted (TNOC vs. usual care [UC]) to assess the impact of TNOC on the quality of conversations. Data sources included recordings of clinical visits, post-encounter surveys and review of electronic health records. Summary statistics and group comparisons are reported. RESULTS: Sixty-five patients were analysed (32 in the UC and 33 in the TNOC cohort). Most patients were women (89%) with a median age of 57 years and were incidentally found to have a thyroid nodule (62%). Most thyroid nodules were at low risk for thyroid cancer (71%) and the median size was 1.4 cm. At baseline, the groups were similar except for higher numeracy in the TNOC cohort. The use of TNOC was associated with increased involvement of patients in the decision-making process, clinician satisfaction and discussion of relevant topics for decision making. In addition, decreased decisional conflict and fewer thyroid biopsies as the next management step were noted in the TNOC cohort. No differences in terms of knowledge transfer, length of consultation, thyroid cancer risk perception or concern for thyroid cancer diagnosis were found. CONCLUSION: In this pilot observational study, using TNOC in clinical practice was feasible and seemed to help the collaboration of patients and clinicians.

Decision aids for localized prostate cancer treatment choice: Systematic review and meta-analysis.

Patients who are diagnosed with localized prostate cancer need to make critical treatment decisions that are sensitive to their values and preferences. The role of decision aids in facilitating these decisions is unknown. The authors conducted a systematic review of randomized trials of decision aids for localized prostate cancer. Teams of 2 reviewers independently identified, selected, and abstracted data from 14 eligible trials (n = 3377 men), of which 10 were conducted in North America. Of these, 11 trials compared decision aids with usual care, and 3 trials compared decision aids with other decision aids. Two trials suggested a modest positive impact on decisional regret. Results across studies varied widely for decisional conflict (4 studies), satisfaction with decision (2 studies), and knowledge (2 studies). No impact on treatment choices was observed (6 studies). In conclusion, scant evidence at high risk of bias suggests the variable impact of existing decision aids on a limited set of decisional processes and outcomes. Because current decision aids provide information but do not directly facilitate shared decision making, subsequent efforts would benefit from user-centered design of decision aids that promote shared decision making.

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).

Minimally disruptive medicine (MDM) in clinical practice: a qualitative case study of the human immunodeficiency virus (HIV) clinic care model.

BACKGROUND: Recent evidence suggests the need to reframe healthcare delivery for patients with chronic conditions, with emphasis on minimizing healthcare footprint/workload on patients, caregivers, clinicians and health systems through the proposed Minimally Disruptive Medicine (MDM) care model named. HIV care models have evolved to further focus on understanding barriers and facilitators to care delivery while improving patient-centered outcomes (e.g., disease progression, adherence, access, quality of life). It is hypothesized that these models may provide an example of MDM care model in clinic practice. Therefore, this study aimed to observe and ascertain MDM-concordant and discordant elements that may exist within a tertiary-setting HIV clinic care model for patients living with HIV or AIDS (PLWHA). We also aimed to identify lessons learned from this setting to inform improving the feasibility and usefulness of MDM care model. METHODS: This qualitative case study occurred in multidisciplinary HIV comprehensive-care clinic within an urban tertiary-medical center. Participants included Adult PLWHA and informal caregivers (e.g. family/friends) attending the clinic for regular appointments were recruited. All clinic staff were eligible for recruitment. Measurements included; semi-guided interviews with patients, caregivers, or both; semi-guided interviews with varied clinicians (individually); and direct observations of clinical encounters (patient-clinicians), as well as staff daily operations in 2015-2017. The qualitative-data synthesis used iterative, mainly inductive thematic coding. RESULTS: Researcher interviews and observations data included 28 patients, 5 caregivers, and 14 care-team members. With few exceptions, the clinic care model elements aligned closely to the MDM model of care through supporting patient capacity/abilities (with some patients receiving minimal social support and limited assistance with reframing their biography) and minimizing workload/demands (with some patients challenged by the clinic hours of operation). CONCLUSIONS: The studied HIV clinic incorporated many of the MDM tenants, contributing to its validation, and informing gaps in knowledge. While these findings may support the design and implementation of care that is both minimally disruptive and maximally supportive, the impact of MDM on patient-important outcomes and different care settings require further studying.

In patients with ASCVD and elevated LDL-C with maximal statin therapy, inclisiran reduced LDL-C levels at 18 months.

SOURCE CITATION: Ray KK, Wright RS, Kallend D, et al. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol. N Engl J Med. 2020;382:1507-19. 32187462.

What is the effect of a decision aid in potentially vulnerable parents? Insights from the head CT choice randomized trial.

OBJECTIVE: To test the hypotheses that use of the Head CT Choice decision aid would be similarly effective in all parent/patient dyads but parents with high (vs low) numeracy experience a greater increase in knowledge while those with low (vs high) health literacy experience a greater increase in trust. METHODS: This was a secondary analysis of a cluster randomized trial conducted at seven sites. One hundred seventy-two clinicians caring for 971 children at intermediate risk for clinically important traumatic brain injuries were randomized to shared decision making facilitated by the DA (n = 493) or to usual care (n = 478). We assessed for subgroup effects based on patient and parent characteristics, including socioeconomic status (health literacy, numeracy and income). We tested for interactions using regression models with indicators for arm assignment and study site. RESULTS: The decision aid did not increase knowledge more in parents with high numeracy (P for interaction [Pint ] = 0.14) or physician trust more in parents with low health literacy (Pint  = 0.34). The decision aid decreased decisional conflict more in non-white parents (decisional conflict scale, -8.14, 95% CI: -12.33 to -3.95; Pint  = 0.05) and increased physician trust more in socioeconomically disadvantaged parents (trust in physician scale, OR: 8.59, 95% CI: 2.35-14.83; Pint  = 0.04). CONCLUSIONS: Use of the Head CT Choice decision aid resulted in less decisional conflict in non-white parents and greater physician trust in socioeconomically disadvantaged parents. Decision aids may be particularly effective in potentially vulnerable parents.

Curare Aude-Caring for Patients, with Them.

We reflect on Dr. Iserson's article in this journal, in which he suggests that clinicians must "shove" patients towards appropriate care. While recognizing that overt clinical guidance is part of care, we suggest that its use should be tempered by the guidance's responsiveness to the human and emotional experience of each patient.

A Multicenter Comparison of Complementary and Alternative Medicine (CAM) Discussions in Oncology Care: The Role of Time, Patient-Centeredness, and Practice Context.

BACKGROUND: Little is known about how complementary and alternative medicine (CAM) is discussed in cancer care across varied settings in the U.S. METHODS: In two practices affiliated with one academic medical center in southern California (SoCal), and one in the upper Midwest (UM), we audio-recorded patient-clinician interactions in medical oncology outpatient practices. We counted the frequency and duration of CAM-related conversations. We coded recordings using the Roter Interaction Analysis System. We used chi-square tests for bivariate analysis of categorical variables and generalized linear models for continuous variables to examine associations between dialogue characteristics, practice setting, and population characteristics with the occurrence of CAM discussion in each setting followed by multivariate models adjusting for clinician clustering. RESULTS: Sixty-one clinicians and 529 patients participated. Sixty-two of 529 (12%) interactions included CAM discussions, with significantly more observed in the SoCal university practice than in the other settings. Visits that included CAM were on average 6 minutes longer, with CAM content lasting an average of 78 seconds. In bivariate tests of association, conversations containing CAM included more psychosocial statements from both clinicians and patients, higher patient-centeredness, more positive patient and clinician affect, and greater patient engagement. In a multivariable model including significant bivariate terms, conversations containing CAM were independently associated with higher patient-centeredness, slightly longer visits, and being at the SoCal university site. CONCLUSION: The frequency of CAM-related discussion in oncology varied substantially across sites. Visits that included CAM discussion were longer and more patient centered. IMPLICATIONS FOR PRACTICE: The Institute of Medicine and the American Society of Clinical Oncology have called for more open discussions of complementary and alternative medicine (CAM). But little is known about the role population characteristics and care contexts may play in the frequency and nature of those discussions. The present data characterizing actual conversations in practice complements a much larger literature based on patient and clinician self-report about CAM disclosure and use. It was found that CAM discussions in academic oncology visits varied significantly by practice context, that the majority were initiated by the patient, and that they may occur more when visit time exists for lifestyle, self-care, and psychosocial concerns.

Eliciting the Patient's Agenda- Secondary Analysis of Recorded Clinical Encounters.

BACKGROUND: Eliciting patient concerns and listening carefully to them contributes to patient-centered care. Yet, clinicians often fail to elicit the patient's agenda and, when they do, they interrupt the patient's discourse. OBJECTIVE: We aimed to describe the extent to which patients' concerns are elicited across different clinical settings and how shared decision-making tools impact agenda elicitation. DESIGN AND PARTICIPANTS: We performed a secondary analysis of a random sample of 112 clinical encounters recorded during trials testing the efficacy of shared decision-making tools. MAIN MEASURES: Two reviewers, working independently, characterized the elicitation of the patient agenda and the time to interruption or to complete statement; we analyzed the distribution of agenda elicitation according to setting and use of shared decision-making tools. KEY RESULTS: Clinicians elicited the patient's agenda in 40 of 112 (36%) encounters. Agendas were elicited more often in primary care (30/61 encounters, 49%) than in specialty care (10/51 encounters, 20%); p = .058. Shared decision-making tools did not affect the likelihood of eliciting the patient's agenda (34 vs. 37% in encounters with and without these tools; p = .09). In 27 of the 40 (67%) encounters in which clinicians elicited patient concerns, the clinician interrupted the patient after a median of 11 seconds (interquartile range 7-22; range 3 to 234 s). Uninterrupted patients took a median of 6 s (interquartile range 3-19; range 2 to 108 s) to state their concern. CONCLUSIONS: Clinicians seldom elicit the patient's agenda; when they do, they interrupt patients sooner than previously reported. Physicians in specialty care elicited the patient's agenda less often compared to physicians in primary care. Failure to elicit the patient's agenda reduces the chance that clinicians will orient the priorities of a clinical encounter toward specific aspects that matter to each patient.

The Care and Learn Model: a Practice and Research Model for Improving Healthcare Quality and Outcomes.

The Agency for Healthcare Research and Quality conducted internal work to formulate a model that could be used to analyze the Agency's research portfolio, identify gaps, develop and prioritize its research agenda, and evaluate its performance. Existing models described the structure and components of the healthcare system. Instead, we produced a model of two functions: caring and learning. Central to this model is the commitment to and participation of people-patients, communities, and health professionals-and the organization of systems to respond to people's problems using evidence. As a product of caring, the system produces evidence that is then used to adapt and continuously improve this response, closely integrating caring and learning. The Agency and the health services research and improvement communities can use this Care and Learn Model to frame an evidence-based understanding of vexing clinical, healthcare delivery, and population health problems and to identify targets for investment, innovation, and investigation.

Adaptation and validation of a Spanish version of the treatment burden questionnaire in patients with multiple sclerosis.

BACKGROUND: The Treatment Burden Questionnaire (TBQ) is a self-reported measure of the effect of treatment workload on patient wellbeing. We sought to validate the TBQ in Spanish and use it to estimate the burden of treatment in Argentinian patients with multiple sclerosis (MS). METHODS: The TBQ was forward-backward translated into Spanish. Two focus groups and 25 semi-structured interviews focused on wording and possible item exclusion. Validation was performed in 2 steps. First, 162 patients across a range of MS severity completed the questionnaire. Confirmatory factor analysis assessed the dimensional structure of the TBQ. Construct validity was assessed by studying correlations with fatigue and quality of life (QoL). Then, in a second cohort of 171 patients, we evaluated the association between TBQ scores and patients' sex, age, education level, employment status, type of MS, disease duration, comorbidities, EDSS, pharmacological treatment and medication adherence. RESULTS: The questionnaire presented a 3-factor structure in which burden was related to pharmacological treatment; comprehensive health assistance; and psycho-social-economic context. Composite reliability was > 0.8 for all factors. TBQ showed positive correlation with fatigue (rs = 0.467, p = 0.006), negative correlation with QoL (rs - 0.446, p = 0.009). For the second cohort, total TBQ score was 43 (SD 29). Lowest scores were observed on self-monitoring (0.53, SD 1.3) and highest for administrative load (4.2, SD 3.4). Inverse association was found between the TBQ score and medication adherence (r 0.243 p = 0.001). TBQ scores also correlated with daily patient pill/injection requirements (r 0.175 p = 0.020). Individuals receiving injectable treatment scored higher than patients on oral drugs (total TBQ 51 (SD 32) vs 39 (SD 27) p = 0.002). CONCLUSIONS: The TBQ in Spanish is a reliable instrument and showed adequate correlation with QoL and adherence scales in MS patients. TBQ may benefit health resources allocation and provide tailor therapeutic interventions to construct a minimally disruptive care.