BackgroundPhysicians often do not initiate or intensify treatments when clearly warranted, a phenomenon known as therapeutic inertia (TI). Limited information is available on educational interventions to ameliorate knowledge-to-action gaps in TI.ObjectivesTo evaluate the feasibility and efficacy of an educational intervention compared to usual care among practicing neurologists caring for patients with multiple sclerosis (MS).MethodsWe conducted a pilot double-blind, parallel-group, randomized clinical trial. Inclusion criteria included neurologists who are actively involved in managing MS patients. Participants were exposed to 20 simulated case-scenarios (10 cases at baseline, and 10 cases post-randomization to usual care vs. educational intervention) of relapsing–remitting MS with moderate or high risk of disease progression. The educational intervention employed a traffic light system (TLS) to facilitate decisions, allowing participants to easily recognize high-risk scenarios requiring treatment escalation. We also measured differences between blocks to invoke decision fatigue. The control group responded as they would do in their usual clinical practice not exposed to the educational intervention. The primary feasibility outcome was the proportion of participants who completed the study and the proportion of participants who correctly identified a high-risk case-scenario with the “red traffic light.” Secondary outcomes included decision fatigue (defined as an increment of TI in the second block of case-scenarios compared to the first block) and the efficacy of the educational intervention measured as a reduction in TI for MS treatment.ResultsOf 30 neurologists invited to be part of the study, the participation rate was 83.3% (n = 25). Of the 25 participants, 14 were randomly assigned to the control group and 11 to the intervention group. TI was present in 72.0% of participants in at least one case scenario. For the primary feasibility outcome, the completion rate of the study was 100% (25/25 participants). Overall, 77.4% of participants correctly identified the “red traffic light” for clinical-scenarios with high risk of disease progression. Similarly, 86.4% of participants correctly identified the “yellow traffic light” for cases that would require a reassessment within 6–12 months. For the secondary fatigue outcome, within-group analysis showed a significant increased prevalence of TI in the second block of case-scenarios (decision fatigue) among participants randomized to the control group (TI pre-intervention 57.1% vs. TI post-intervention 71.4%; p = 0.015), but not in the active group (TI pre-intervention 54.6% vs. TI post-intervention 63.6%; p = 0.14). For the efficacy outcome, we found a non-significant reduction in TI for the targeted intervention compared to controls (22.6 vs. 33.9% post-intervention; OR 0.57; 95% CI 0.26–1.22).ConclusionAn educational intervention applying the TLS is feasible and shows some promising results in the identification of high-risk scenarios to reduce decision fatigue and...
Background: Therapeutic inertia (TI) is a common phenomenon among physicians who care for patients with chronic conditions. We evaluated the efficacy of the traffic light system (TLS) educational intervention to reduce TI among neurologists with MS expertise. Methods: In this randomised, controlled trial, 90 neurologists who provide care to MS patients were randomly assigned to the TLS intervention ( n = 45) or to the control group ( n = 45). The educational intervention employed the TLS, a behavioral strategy that facilitates therapeutic choices by facilitating reflective decisions. The TLS consisted in a short, structured, single session intervention of 5-7 min duration. Participants made therapeutic choices of 10 simulated case-scenarios. The primary outcome was a reduction in TI based on a published TI score (case-scenarios in which a participant showed TI divided by the total number of scenarios where TI was possible ranging from 0 to 8). Results: All participants completed the study and were included in the primary analysis. TI was lower in the TLS group (1.47, 95% CI 1.32-1.61) compared to controls (1.93; 95% CI 1.79-2.08). The TLS group had a lower prevalence of TI compared to controls (0.67, 95% CI 0.62-0.71 vs. 0.82, 95% CI 0.78-0.86; p = 0.001). The multivariate analysis, adjusted for age, specialty, years of practice, and risk preference showed a 70% reduction in TI for the TLS intervention compared to controls (OR 0.30; 95% CI 0.10-0.89). Conclusions: In this randomized trial, the TLS strategy decreases the incidence of TI in MS care irrespective of age, expertise, years for training, and risk preference of participants, which would lead to better patient outcomes.
Background: Decisions based on erroneous assessments may result in unrealistic patient and family expectations, suboptimal advice, incorrect treatment, or costly medical errors. Regret is a common emotion in daily life that involves counterfactual thinking when considering alternative choices. Limited information is available on care-related regret affecting healthcare professionals managing patients with multiple sclerosis (MS).Methods: We reviewed identified gaps in the literature by searching for the combination of the following keywords in Pubmed: “regret and decision,” “regret and physicians,” and “regret and nurses.” An expert panel of neurologists, a nurse, a psychiatrist, a pharmacist, and a psychometrics specialist participated in the study design. Care-related regret will be assessed by a behavioral battery including the standardized questionnaire Regret Intensity Scale (RIS-10) and 15 new specific items. Six items will evaluate regret in the most common social domains affecting individuals (financial, driving, sports—recreation, work, own health, and confidence in people). Another nine items will explore past and recent regret experiences in common situations experienced by healthcare professionals caring for patients with MS. We will also assess concomitant behavioral characteristics of healthcare professionals that could be associated with regret: coping strategies, life satisfaction, mood, positive social behaviors, occupational burnout, and tolerance to uncertainty.Planned Outcomes: This is the first comprehensive and standardized protocol to assess care-related regret and associated behavioral factors among healthcare professionals managing MS. These results will allow to understand and ameliorate regret in healthcare professionals.Spanish National Register (SL42129-20/598-E).
IMPORTANCE There is growing interest in understanding and addressing factors that govern the decision-making process in multiple sclerosis (MS) care. Therapeutic inertia (TI) is the failure to escalate therapy when goals are unmet. Limited data are available on the prevalence of TI and factors affecting therapeutic decisions in the management of patients with MS worldwide. OBJECTIVES To compare TI across 4 countries (Canada, Argentina, Chile, and Spain) and to identify factors contributing to TI.
Introduction: According to previous studies, therapeutic inertia (TI) may affect 7 out of 10 physicians who care for MS patients, particularly in countries where clinical guidelines are not widely used. Limited information is available on the prevalence of TI and its associated factors across Canada.Objectives: (i) To evaluate factors associated with TI amongst neurologists caring for MS patients across Canada; (ii) to compare the prevalence of TI observed in Canadian neurologists to the prevalence of TI observed in Argentinean, Chilean, and Spanish neurologists (historical controls from prior studies).Design: One hundred and eight neurologists with expertise in MS were invited to participate in an online study in Canada. Participants answered questions regarding their clinical practice, risk preferences, management of 10 simulated case-scenarios. The design of that study was similar to that of the prior studies completed in Argentina and Chile (n = 115). TI was defined as lack of treatment initiation or escalation when there was clear evidence of clinical and radiological disease activity (8 case-scenarios, 440 individual responses). A TI score was created & defined as the number of case-scenarios that fit the TI criteria over the total number of presented cases (score range from 0 to 8), with a higher score corresponding to a higher TI. TI scores observed in the Canadian study were compared with those observed in Argentina and Chile, as both studies followed the same design, case-scenarios and methodologies. Predictors of TI included demographic data, MS specialist vs. general neurologist, practice setting, years of practice, volume of MS patients and risk preferences.Results: Fifty-five Canadian neurologists completed the study (completion rate: 50.9%). The mean age (±SD) was 38.3 (±15) years; 47.3% of the participants were female and 56.4% self-identified as MS specialists. Overall, 54 of 440 (12.3%) individual responses were classified as TI. 60% of participants displayed TI in at least one case-scenario. The mean TI score across Canada [0.98 (SD = 1.15)] was significantly lower than the TI score observed in the Argentinean-Chilean [1.82 (SD = 1.47); p < 0.001] study. The multivariable analysis revealed that older age (p = 0.018), years of experience (p = 0.04) and willingness to risk further disease progression by avoiding treatment initiation or treatment change (p = 0.043) were independent predictors of TI.Conclusions: TI in Canada was observed in 6 out of 10 neurologists, affecting on average 1 in 8 therapeutic decisions in MS care. TI in Canada is significantly lower than in the other studied countries. Factors associated with TI include older age, lower years of experience, and willingness to risk disease progression by avoiding treatment initiation or treatment change. Differences in clinical practice patterns and adherence/access to accepted MS guidelines may explain how TI in Canada differs significantly from TI in Argentina-Chile.
IMPORTANCETherapeutic inertia (TI) is the failure to escalate therapy when treatment goals are unmet and is associated with low tolerance to uncertainty and aversion to ambiguity in physician decision-making. Limited information is available on how physicians handle therapeutic decisionmaking in the context of uncertainty. OBJECTIVE To evaluate whether an educational intervention decreases TI by reducing autonomic arousal response (pupil dilation), a proxy measure of how physicians respond to uncertainty during treatment decisions. DESIGN, SETTING, AND PARTICIPANTS In this randomized clinical trial, 34 neurologists with expertise in multiple sclerosis (MS) practicing at 15 outpatient MS clinics in academic and community institutions from across Canada were enrolled. Participants were randomly assigned to receive an educational intervention that facilitates treatment decisions (active group) or to receive no exposure to the intervention (usual care [control group]) from December 2017 to March 2018. Participants listened to 20 audio-recorded simulated case scenarios as pupil responses were assessed by eye trackers. Autonomic arousal was assessed as pupil dilation in periods in which critical information was provided (first period [T1]: clinical data, second period [T2]: neurologic status, and third period [T3]: magnetic resonance imaging data). Data were analyzed from September 2018 to March 2020. INTERVENTIONS The traffic light system (TLS)-based educational intervention vs usual care (unexposed). The TLS (use of established associations between traffic light colors and actions to stop or proceed) assists participants in identifying factors associated with worse prognosis in MS care, thereby facilitating the treatment decision-making process by use of established associations between red, green, and yellow colors and risk levels, and actions (treatment decisions). MAIN OUTCOMES AND MEASURESPupil assessment was the primary autonomic outcome. To test the treatment effect of the educational intervention (TLS), difference-in-differences models (also called untreated control group design with pretest and posttest) were used. RESULTSOf 38 eligible participants, 34 (89.4%) neurologists completed the study. The mean (SD) age was 44.6 (11.6) years; 38.3% were female and 20 (58.8%) were MS specialists. Therapeutic inertia was present in 50.0% (17 of 34) of all participants and was associated with greater pupil dilation. For every additional SD of pupil dilation, the odds of TI increased by 51% for T1 (odds ratio, 1.51; 95% CI, 1.12-2.03), by 31% for T2 (odds ratio, 1.31; 95% CI, 1.08-1.59), and by 49% for T3 (odds ratio, 1.49; 95% CI, 1.13-1.97). The intervention significantly reduced TI (risk reduction, 31.5%; 95% CI, (continued) Key Points Question How do physicians handle uncertainty when making live therapeutic decisions? Findings In this randomized clinical trial of 34 neurologists from Canada, an educational intervention showed a significant 31% reduction in therapeutic inertia compared with the control group. Pupil d...
Crucial elements for achieving optimal longterm outcomes in multiple sclerosis (MS) are patient confidence and effective physician-patient communication. Patient-reported instruments may provide the means to fill the gap in currently available clinician-rated measures. The SymptoMScreen (SMSS) is a brief selfassessment tool for measuring symptom severity in 12 neurologic domains commonly affected by MS. We conducted a non-interventional study to assess the dimensional structure and item characteristics of the SMSS. A total of 218 patients with relapsing-remitting MS and mild disability (median Expanded Disability Status Scale score 2.0) were studied. Symptom severity was low (SMSS score 13.5, interquartile range 4.2-27), fatigue being the domain with the highest impact. A non-parametric item response theory, i.e., Mokken analysis, found that the SMSS is a robust one-dimensional scale (overall scalability index H 0.60) with high reliability (Cronbach's alpha 0.94). The confirmatory factor analysis model confirmed the unidimensional structure (comparative fit index 1.0, rootmean-square error of approximation 0.001). Samejima's model fitted well an unconstrained model with different item difficulties. The SMSS shows appropriate psychometric characteristics and may constitute a valuable and easy-to-Gustavo Saposnik and Javier Ballesteros have contributed equally to this work.
Importance: The prescription of generic (non-proprietary) compared to brand-name drugs is increasing worldwide. In many developing and emerging countries, generics companies market products at similar costs as brand-name competitors benefiting from more flexible compliance rules and regulations for marketing their products in the health system. Together, this phenomenon may influence prescriber's behavior (e.g., maintaining the same treatment despite guideline's recommendations or despite evidence of disease progression).Objectives: To compare the prevalence of therapeutic inertia (TI) between primary prescription of brand-name vs. generic drugs in the management of MS in Argentina.Design: We conducted a population-based online study comprising 117 neurologists with expertise in MS. Participants answered questions regarding their clinical practice, most commonly prescribed disease modifying agents, and therapeutic choices of 10 simulated case-scenarios that assessed TI. Inertia was defined as the lack of treatment initiation or escalation despite evidence of clinical and radiological activity (8 case-scenarios, 720 individual responses). We created the generic-brand name score (GBS) according to the 5 most frequently prescribed generic (n = 16) vs. brand-name (n = 9) drugs for MS, where scores higher than 1 indicated higher prescription of generic drugs and scores lower than 1 indicated higher prescription of brand-name agents. Candidate predictors of prescribing generic drugs included demographic data, MS specialist vs. general neurologist, practice setting, years of practice, volume of MS patients, risk preferences, costs of annual treatment.Participants and setting: population-based prospective study using including neurologists who care for patients with multiple sclerosis across Argentina.Exposure: prescription of generic vs. brand-name MS drugsMain outcome of interest: Therapeutic inertia (TI), defined as lack of treatment escalation when goals are unmet. Secondary outcomes included factors associated with generic drug prescription and costs of MS treatment.Results: Ninety participants completed the study (completion rate 76.9%). TI was observed in 153 (21.3%) of participants' responses. The evaluation of aggregate responses revealed a mean GBS score (SD) of 3.44 (2.1), with 46 (51.1%) participants having a GBS equal to or higher than 1. Older age (OR 1.19; 95% CI 1.00–1.42), being a general neurologist (OR 3.91; 95% CI 1.19–12.8), and being more willing to take risks in multiple domains (SOEP score OR 1.06, 95% CI 1.01–1.12) were associated with higher prescription of generic drugs in MS care. Costs of treatment were not associated with prescribing generic drugs. There was no difference in the annual costs of MS treatment for primary prescribers of brand-name vs. generic drugs (67,500 US$ vs. 67,496 US$; p = 0.99).The evaluation of individual responses revealed that participants with higher prescription of generics—reflected by a higher GBS—had higher incident risk of TI (mean GBS 3.61 for TI vs. 2.96 for n...
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