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Sexual harassment is a particularly pernicious form of harassment that can result in long-lasting psychological damage to victims. In health care, it has deleterious effects on teamwork and communication and may affect patient care. Although concerns regarding sexual harassment in the workplace, including within health care, are not new, increased attention has been focused on this topic since late 2017 as a result of the #MeToo movement. As in other sectors, health care centers have experienced instances of sexual harassment. Evidence indicates that harassment in health care centers is not uncommon and has not decreased with time. Beyond reporting and addressing, health care institutions must establish policies that clearly outline the unacceptability of harassing behaviors. Moreover, institutions must have a systematic method to thoroughly investigate allegations of sexual harassment and to impose fair and consistent corrective actions when allegations are substantiated. This article describes Mayo Clinic's approach to this complex problem, including targeted efforts toward developing a culture intolerant of sexually harassing behavior., (Copyright © 2020. Published by Elsevier Inc.)

Objective: To assess adherence to and individual or systematic deviations from predicted physician compensation by gender or race/ethnicity at a large academic medical center that uses a salary-only structured compensation model incorporating national benchmarks and clear standardized pay steps and increments., Participants and Methods: All permanent staff physicians employed at Mayo Clinic medical practices in Minnesota, Arizona, and Florida who served in clinical roles as of January 2017. Each physician's pay, demographics, specialty, full-time equivalent status, benchmark pay for the specialty, leadership role(s), and other factors that may influence compensation within the plan were collected and analyzed. For each individual, the natural log of pay was used to determine predicted pay and 95% CI based on the structured compensation plan, compared with their actual salary., Results: Among 2845 physicians (861 women, 722 nonwhites), pay equity was affirmed in 96% (n=2730). Of the 80 physicians (2.8%) with higher and 35 (1.2%) with lower than predicted pay, there was no interaction with gender or race/ethnicity. More men (31.4%; 623 of 1984) than women (15.9%; 137 of 861) held or had held a compensable leadership position. More men (34.7%; 688 of 1984) than women (20.5%; 177 of 861) were represented in the most highly compensated specialties., Conclusion: A structured compensation model was successfully applied to all physicians at a multisite large academic medical system and resulted in pay equity. However, achieving overall gender pay equality will only be fully realized when women achieve parity in the ranks of the most highly compensated specialties and in leadership roles., (Copyright © 2019. Published by Elsevier Inc.)

Introduction: The pace of medical discovery is accelerating to the point where caregivers can no longer keep up with the latest diagnosis or treatment recommendations. At the same time, sophisticated and complex electronic medical records and clinical systems are generating increasing volumes of patient data, making it difficult to find the important information required for patient care. To address these challenges, Mayo Clinic established a knowledge management program to curate, store, and disseminate clinical knowledge., Methods: The authors describe AskMayoExpert, a point-of-care knowledge delivery system, and discuss the process by which the clinical knowledge is captured, vetted by clinicians, annotated, and stored in a knowledge content management system. The content generated for AskMayoExpert is considered to be core clinical content and serves as the basis for knowledge diffusion to clinicians through order sets and clinical decision support rules, as well as to patients and consumers through patient education materials and internet content. The authors evaluate alternative approaches for better integration of knowledge into the clinical workflow through development of computer-interpretable care process models., Results: Each of the modeling approaches evaluated has shown promise. However, because each of them addresses the problem from a different perspective, there have been challenges in coming to a common model. Given the current state of guideline modeling and the need for a near-term solution, Mayo Clinic will likely focus on breaking down care process models into components and on standardization of those components, deferring, for now, the orchestration., Conclusion: A point-of-care knowledge resource developed to support an individualized approach to patient care has grown into a formal knowledge management program. Translation of the textual knowledge into machine executable knowledge will allow integration of the knowledge with specific patient data and truly serve as a colleague and mentor for the physicians taking care of the patient.

These are challenging times for health care executives. The health care field is experiencing unprecedented changes that threaten the survival of many health care organizations. To successfully navigate these challenges, health care executives need committed and productive physicians working in collaboration with organization leaders. Unfortunately, national studies suggest that at least 50% of US physicians are experiencing professional burnout, indicating that most executives face this challenge with a disillusioned physician workforce. Burnout is a syndrome characterized by exhaustion, cynicism, and reduced effectiveness. Physician burnout has been shown to influence quality of care, patient safety, physician turnover, and patient satisfaction. Although burnout is a system issue, most institutions operate under the erroneous framework that burnout and professional satisfaction are solely the responsibility of the individual physician. Engagement is the positive antithesis of burnout and is characterized by vigor, dedication, and absorption in work. There is a strong business case for organizations to invest in efforts to reduce physician burnout and promote engagement. Herein, we summarize 9 organizational strategies to promote physician engagement and describe how we have operationalized some of these approaches at Mayo Clinic. Our experience demonstrates that deliberate, sustained, and comprehensive efforts by the organization to reduce burnout and promote engagement can make a difference. Many effective interventions are relatively inexpensive, and small investments can have a large impact. Leadership and sustained attention from the highest level of the organization are the keys to making progress., (Copyright © 2016 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.)

Objective: To evaluate the relationship between early relapse recovery and onset of progressive multiple sclerosis (MS)., Methods: We studied a population-based cohort (105 patients with relapsing-remitting MS, 86 with bout-onset progressive MS) and a clinic-based cohort (415 patients with bout-onset progressive MS), excluding patients with primary progressive MS. Bout-onset progressive MS includes patients with single-attack progressive and secondary progressive MS. "Good recovery" (as opposed to "poor recovery") was assigned if the peak deficit of the relapse improved completely or almost completely (patient-reported and examination-confirmed outcome measured ≥6 months post relapse). Impact of initial relapse recovery and first 5-year average relapse recovery on cumulative incidence of progressive MS was studied accounting for patients yet to develop progressive MS in the population-based cohort (Kaplan-Meier analyses). Impact of initial relapse recovery on time to progressive MS onset was also studied in the clinic-based cohort with already-established progressive MS (t test)., Results: In the population-based cohort, 153 patients (80.1%) had on average good recovery from first 5-year relapses, whereas 30 patients (15.7%) had on average poor recovery. Half of the good recoverers developed progressive MS by 30.2 years after MS onset, whereas half of the poor recoverers developed progressive MS by 8.3 years after MS onset (p = 0.001). In the clinic-based cohort, good recovery from the first relapse alone was also associated with a delay in progressive disease onset (p < 0.001). A brainstem, cerebellar, or spinal cord syndrome (p = 0.001) or a fulminant relapse (p < 0.0001) was associated with a poor recovery from the initial relapse., Conclusions: Patients with MS with poor recovery from early relapses will develop progressive disease course earlier than those with good recovery., (© 2015 American Academy of Neurology.)

Background: It is unclear if all patients with relapsing-remitting multiple sclerosis (RRMS) ultimately develop progressive MS. Onset of progressive disease course seems to be age- rather than disease duration-dependent. Some forms of progressive MS (e.g. primary progressive MS (PPMS)) are uncommon in population-based studies. Ascertainment of patients with PPMS from clinic-based populations can facilitate a powerful comparison of age at progression onset between secondary progressive MS (SPMS) and PPMS but may introduce unclear biases., Objective: Our aim is to confirm that onset of progressive disease course is more relevant to the patient's age than the presence or duration of a pre-progression relapsing disease course in MS., Methods: We studied a population-based MS cohort (n=210, RRMS n=109, progressive MS n=101) and a clinic-based progressive MS cohort (n=754). Progressive course was classified as primary (PPMS; n=322), single attack (SAPMS; n=112) and secondary progressive (SPMS; n=421). We studied demographics (chi(2) or t-test), age-of-progression-onset (t-test) and time to Expanded Disability Status Scale of 6 (EDSS6) (Kaplan-Meier analyses)., Results: Sex ratio (p=0.58), age at progression onset (p=0.37) and time to EDSS6 (p=0.16) did not differ between the cohorts. Progression had developed before age 75 in 99% of patients with known progressive disease course; 38% with RRMS did not develop progression by age 75. Age at progression onset did not differ between SPMS (44.9±9.6), SAPMS (45.5±9.6) and PPMS (45.7±10.8). In either cohort, only 2% of patients had reached EDSS6 before onset of progression., Conclusions: Patients with RRMS do not inevitably develop a progressive disease course. Onset of progression is more dependent on age than the presence or duration of a pre-progression symptomatic disease course. Moderate disability is sustained predominantly after the onset of a progressive disease course in MS.

The authors present Mayo Clinic's Value Creation System, a coherent systems engineering approach to delivering a single high-value practice. There are 4 tightly linked, interdependent phases of the system: alignment, discovery, managed diffusion, and measurement. The methodology is described and examples of the results to date are presented. The Value Creation System has been demonstrated to improve the quality of patient care while reducing costs and increasing productivity.

Background: Inferences about long-term effects of therapies in multiple sclerosis (MS) have been based on surrogate markers studied in short-term trials. Preventing progressive disability is the key therapeutic goal but there remains no validated definition for its measurement in a trial context. Meanwhile, MS trials continue to shorten and to depend on unvalidated surrogates. Since there have been no treatment claims for improving unremitting disability, worsening of disability in the placebo/control arm must occur for effectiveness on this outcome to be shown., Methods: We examined widely-used clinical surrogates of long-term disability progression in individual patients with MS within a unique database from the placebo arms of 31 randomized clinical trials., Results: Detection of treatment effects in secondary progressive MS trials is undermined by noise in disability measurement. Whereas existing measures can be partially validated in secondary progressive MS, this is not the case in relapsing-remitting MS. Here, examination of widely used definitions of treatment failure demonstrated that disability progression was no more likely than similarly defined improvement. Existing definitions of disease progression in short-term intervention trials in relapsing-remitting patients reflect random variation, measurement error, and remitting relapses., Conclusion: Clinical surrogates of unremitting disability used in trials of relapsing-remitting multiple sclerosis cannot be validated. Trials have been too short or degrees of disability change too small to measure the key outcomes. These analyses highlight the difficulty in determining effectiveness of therapy in chronic diseases.

Background: Quality of life (QOL) is becoming an increasingly important factor in measurement of disease impact as well as an outcome measure in clinical trials., Objectives: To study the QOL of patients with multiple sclerosis (MS) in a population-based prevalence cohort and compare it with the general US population., Design: Population-based prevalence cohort., Setting: Olmsted County, Minn, population., Participants: All patients with definite MS (N = 201) alive and residing in Olmsted County on December 1, 2000., Intervention: None., Main Outcome Measures: The expanded disability status scale (EDSS) and the Multiple Sclerosis Quality of Life Health Survey (MSQOL-54), which consisted of Short Form 36 (SF-36) with an additional 18 items pertinent to MS., Results: The MSQOL-54 form was completed by 185 patients. Patients with MS had worse scores than the general US population with respect to physical functioning, vitality, and general health dimensions of the SF-36 QOL measure. Many QOL domains (pain, role emotional, mental health, and social functioning) were, however, similar for the 2000 MS cohort compared with the general US population. Duration of MS and EDSS score correlated significantly with physical functioning (P<.001). The QOL correlation with EDSS score was less than expected. No significant difference in the scores for the 8 QOL dimensions were found for patients with quick vs slow progression (quick progression defined as <5 years from onset to EDSS score of 3). The majority of patients with MS (77%) were mostly satisfied or delighted with their QOL., Conclusion: Though MS can cause significant disability, most patients with MS in the Olmsted County prevalence cohort continue to report a good QOL.

Purpose of the Review: The present review of multiple sclerosis (MS) therapeutic trials published in 2002 is intended to assist the reader in understanding the most current advances in the care of their patients., Recent Findings: A substantial number of pivotal and preliminary reports continue to demonstrate encouraging new evidence that advances are being made in the care of patients with MS. Several short-term studies in relapsing/remitting MS have demonstrated that it is possible to complete head-to-head comparison trials of active agents in MS (e.g. without a placebo control group). The findings of these trials remain open to interpretation and have generated considerable controversy, as expected. A phase 3 trial [the International MS Secondary Progressive Avonex Controlled Trial (IMPACT)] became the fourth study of the beta interferons (interferon-beta-1a, in this case) to demonstrate a partial effect on disease activity in secondary progressive MS. Two trials demonstrated apparent partial efficacy for the anthrecenedione mitoxantrone in active and progressive MS. Disappointing results were announced for a number of large pivotal trials, although those results have not yet been published (e.g. oral glatiramer acetate in relapsing/remitting MS, glatiramer acetate in primary progressive MS, and intravenous immunoglobulin in secondary progressive MS)., Summary: The MS research community needs to determine how best to address two key unanswered questions. Is late clinical deterioration often or invariably tied to the initial inflammatory/demyelinating phase of the disease? What is the optimal research design to address whether current and future experimental strategies affect the later phases of MS (e.g. does early treatment delay or prevent clinical disability)?

MS poses formidable challenges to clinical investigators. Obstacles to the study of MS therapies include disease chronicity, an unpredictable clinical course, radiologic and pathologic heterogeneity, and limited understanding of the underlying pathophysiology. Randomized controlled trials (RCTs) provide a means to assess therapeutic efficacy while reducing the risks of study bias and confounding factors that influence interpretation of results. RCTs have demonstrated that type 1 interferons and glatiramer acetate alter the short-term natural history of MS and have served as the basis of approval for the marketing of these treatments. Improvements and optimization of trial methodology may hasten the discovery of effective therapies and facilitate better comparisons of the results of individual drug trials. The most urgent need is for improved surrogate end points for clinical outcome with predictive validity for long-term disability. Even if RCT methodology is optimal, however, several limitations inherent to MS trials threaten to impede further progress, including obstacles to long-term studies (e.g., costs), patient withdrawal, and escalating sample size requirements to detect partial therapeutic benefit. There is a crucial need to develop alternative investigative methods, possibly through enhanced collaboration across centers and with industry, and by exploring innovative techniques to use existing RCT and natural history databases to greater advantage.

Objective: To provide recommendations on the use of disease-modifying agents in the management of multiple sclerosis (MS) and to ensure that treatment will be available to those patients who may benefit., Methods: An initial draft of the consensus statement was prepared by the Steering Committee and amended in the light of written comments from a group of MS specialists. At a subsequent workshop, the wording of the consensus statement was discussed, modified if necessary, and the participants indicated their level of support using an electronic voting system. A new draft of the statement was then sent to a much larger group of international opinion leaders in MS for further comment., Results: A number of statements were agreed, which outline the criteria for consideration of disease-modifying therapy for MS and recommendations for treatment. Each statement was accepted completely, or with only minor reservations by 95% or more of those present at the workshop., Conclusions: Periodic reviews and modifications to the statement will be required, as new approaches to the treatment of MS and other therapeutic agents become available.

Multiple sclerosis (MS) is a common inflammatory disease of the central nervous system (CNS). Diagnosis rests upon identifying typical clinical symptoms and interpreting supportive laboratory and radiological investigations. The etiology is unknown; however, strong evidence suggests that MS is an autoimmune disease directed against CNS myelin or oligodendrocytes. Genetic factors are important in the development of MS. Contributing environmental determinants (possibly including infectious agents) appear important but remain unidentified. Both cell-mediated and humorally mediated immune mechanisms contribute to pathological injury. Axonal damage occurs in addition to demyelination and may be the cause of later permanent disability. Distinct pathological subtypes may differentiate among patients with MS. Treatment is directed at acute attacks (with corticosteroids) and reduction of attack frequency (primarily with type-1 beta interferons and glatiramer acetate). Research into the causes and treatments of MS has expanded our knowledge of this disease and promises improved care for MS patients in the future.

Objective: To determine whether IV immunoglobulin (IVIg) reverses chronic visual impairment in MS patients with optic neuritis (ON)., Methods: In this double-blind, placebo-controlled Phase II trial, 55 patients with persistent acuity loss after ON were randomized to receive either IVIg 0.4 g/kg daily for 5 days followed by three single infusions monthly for 3 months, or placebo., Results: The trial was terminated by the National Eye Institute because of negative results when 55 of the planned 60 patients had been enrolled. Fifty-two patients completed the scheduled infusions, and 53 patients completed 12 months of follow-up. Analysis of this data indicated that a difference between treatment groups was not observed for the primary outcome measure, improvement in logMAR visual scores at 6 months (p = 0.766). Exploratory secondary analyses suggested that IVIg treatment was associated with improvement in visual function (including logMAR visual scores at 6 months and visual fields at 6 and 12 months) in patients with clinically stable MS during the trial., Conclusions: IVIg administration does not reverse persistent visual loss from ON to a degree that merits general use.

Multiple sclerosis (MS) is an often disabling disease primarily affecting young adults that exhibits extraordinary clinical, radiological, and pathological heterogeneity. We review the following: (a) known environmental and genetic factors that contribute to MS susceptibility; (b) current knowledge regarding fundamental pathophysiological processes in MS, including immune cell recruitment and entry into the central nervous system (CNS), formation of the plaque, and orchestration of the immune response; (c) descriptive and qualitative distinct pathological patterns in MS and their implications; (d) the evidence supporting the causative role of direct toxins, cell-mediated and humorally mediated immune mechanisms, and the concept of a "primary oligodendrogliopathy" in demyelination and axonal injury; (e) the potential benefits of inflammation; (f) the prospects for remyelination; and (g) therapeutic implications and approaches suggested by putative pathophysiological mechanisms.

Background: A significant correlation exists between disability and the volume of black holes (BHL VOL), defined as hypointense lesions on T1-weighted cranial magnetic resonance imaging. A consistent correlation has also been reported between urinary myelin basic protein-like material (MBPLM) and the transition toward secondary progression (SP) from relapsing-remitting (RR) multiple sclerosis (MS)., Objective: To improve the management of MS through a noninvasive and cost-effective test for monitoring disease activity or disease status., Design and Methods: From 662 patients with MS (86 with RR MS, 259 with SP MS without continued attacks, and 317 with SP MS with continued attacks), 24-hour urine samples were obtained at enrollment in the phase 3 Linomide (roquinimex) drug study. The urine specimens were analyzed for MBPLM and correlated with clinical features and findings on cranial magnetic resonance imaging., Results: Significant but weak correlations existed between urinary MBPLM and BHL VOL in all patients with MS (r = 0.114, P =.003; n = 662), patients with SP MS without attacks (r = 0.185, P =.003; n = 259), and all patients with SP MS (r = 0.122, P =.003; n = 576). No significant correlations were detected in the RR MS group or any of the disease groups or subgroups whose Expanded Disability Status Scale score was 5.0 or lower. In subgroup analysis, the most significant correlation was detected between urinary MBPLM after adjustment for creatinine and BHL VOL in patients with SP MS with an Expanded Disability Status Scale score of 5.5 or higher but without continued relapses (r = 0.417, P<.001; n = 138)., Conclusions: In patients with advanced SP MS, urinary MBPLM may possibly serve as an indicator of failed remission and axonal damage. Urinary MBPLM correlates with disease status in MS, especially the transition of RR MS to SP MS with advancing disability.

Background: Immunoglobulin (Ig) administration induces remyelination in the Theiler's virus model of MS., Methods: A randomized, double-blinded, placebo-controlled trial of IV immunoglobulin (IVIg) was performed in patients with MS who had persistent muscle weakness that had been stable for between 4 and 18 months to determine whether this would improve muscle strength (primary outcome: isometric muscle strength). Patients received either IVIg (0.4 g/kg) or placebo daily for 5 days, then single infusions every 2 weeks for 3 months (total, 11 infusions). Muscle groups identified by clinical measures to have unchanging significant weakness were the major targets for therapeutic response (targeted neurologic deficit [TND])., Results: IVIg was well tolerated. An interim analysis after 67 patients were enrolled indicated no difference in the degree of change in strength between treatment groups in either the TND or non-TND muscle groups at 6 months, and the trial was terminated. There was no apparent benefit in relapse behavior or impairment measures during the 6-month observation period. Nor was there apparent benefit in either patients who remained clinically stable or in those with evidence of disease activity. Patients with active MS during the trial worsened in both TND and non-TND muscle groups. This worsening was seen regardless of whether the clinical manifestations of disease activity involved the TND muscle groups., Conclusions: IVIg does not reverse established weakness in MS. Measurements of isometric muscle strength were reliable (reproducible) indices of strength and may be sensitive, objective methods to document functional changes in impairment in future MS trials.

Objective: To determine whether linomide (roquinimex) is better than placebo in slowing the time to confirmed clinical worsening in patients with relapsing-remitting (RR) and secondary progressive (SP) MS., Methods: In this 27-center, randomized, double-blind, placebo-controlled, multiple-dose, phase III trial, 715 patients with active RRMS (n = 90) or SPMS (n = 625) were randomized to receive either linomide (1.0, 2.5, or 7.5 mg orally daily) or placebo. Patients were evaluated at 3-month intervals clinically and with MRI. The planned primary outcome was the time to the development of "confirmed" clinical worsening (increase of >/= 1.0 Expanded Disability Status Scale [EDSS] score for an enrollment EDSS score /= 0.5 point for an enrollment EDSS score of >/= 5.5) not associated with an acute relapse., Results: The trial was terminated 1 month after it became fully enrolled due to unanticipated serious cardiopulmonary toxicities (pericarditis, pleural effusion, myocardial infarction, and possible pulmonary embolism), pancreatitis, and death. Notable arthralgia, myalgia, bursitis, and facial and peripheral edema were common adverse events. The high dose of linomide (7.5 mg) was not well tolerated. The trial was too brief to determine unequivocal clinical benefits. Trends suggested an unconfirmed early effect on change in EDSS score at 6 months for the medium dose (2.5 mg daily)., Conclusion: MS patients may be more prone to develop important linomide treatment-related adverse events than other previously studied patients. However, linomide may be a potentially more toxic drug than was suspected from observations made in smaller studies for other indications. Phase III trials may identify infrequent and important toxicities that may not be anticipated by phase I and II trials.

Objective: To determine the safety and efficacy of roquinimex (linomide) in the management of relapsing-remitting and secondary progressive MS as monitored by MRI., Background: Preclinical studies and several short term randomized trials of linomide suggested clinical and MRI-measured benefits with acceptable risk for closely followed MS patients., Methods: The North American Linomide Trial formally screened 853 individuals for relapsing or secondary progressive, clinically definite MS; recent disease activity or progression; and an Expanded Disability Status Scale score at entry of 3.0 to 6.5 inclusive. MRI was obtained on 811 subjects at pre-enrollment, 718 cases at enrollment, and then at three monthly intervals until the trial was prematurely terminated for unacceptable toxicity., Results: Enhancement was found on 40.2% of 718 entry scans. Statistically robust correlations were found between clinical demographic data and several entry MRI measures including CSF volume, a reflection of brain atrophy. Assessment of the effect of treatment on MRI-measured disease was limited by early trial termination. However, active treatment for 3 months reduced the proportion of patients with one or more enhancements. An exploratory analysis suggested that 2.5 mg was the most active of three doses tested in limiting the total volume of enhanced tissue, the proportion of MRI-defined lesions designated as "black holes," and by a novel MRI composite disease measure., Conclusions: The short term signature of the effect of linomide on MRI-measured aspects of the disease suggests that safer drugs of this class might be useful in the management of MS. The use of a composite index of the heterogeneous nature of the pathology of MS as captured by MRI may have merit as an outcome measure in clinical trials.