Headache Education Adaptation During the COVID-19 Pandemic: Impact on Undergraduate and Graduate Medical Education.

PURPOSE OF REVIEW: Our goal was to describe the changes to headache and neurological education that occurred as a result of the COVID-19 pandemic, and the impact this had on medical learners. We also discuss subsequent implications for the future of education in the field of headache medicine. RECENT FINDINGS: Both educators and learners faced many challenges during the pandemic. These include the following: cancellation of in-person educational meetings, limited in-person networking and wellness events, disengagement from virtual didactic curricula, limitations in procedure-based learning, redeployment to inpatient settings with a decrease in outpatient exposures, and blurred boundaries between home and work life due to more virtual collaboration and home computer use. The development of telehealth programs and trainee wellness initiatives, improved collaboration opportunities among geographically distant institutions, and greater access to conferences for learners are among the many improvements forged by these challenging times in medical education. Given the high prevalence of headache disorders and the paucity of headache specialists, training new clinicians with competency in headache medicine is essential. There were many educational challenges and opportunities identified in the literature that resulted from the pressures of the pandemic. Educators need to develop assessments that capture any gaps in learning that may have occurred during this tumultuous time and be vigilant of remediation needs in our learners over the coming years. It is imperative to intentionally design curricula for the future by harnessing new pedagogical tools, innovations, and perspectives gleaned from our experience with the COVID-19 pandemic.

Safety and Tolerability of 3 CGRP Monoclonal Antibodies in Practice: A Retrospective Cohort Study.

OBJECTIVE: We sought to assess the safety and tolerability of 3 calcitonin gene-related peptide (CGRP) monoclonal antibodies in patients with chronic migraine who have failed multiple classes of migraine preventive therapies. BACKGROUND: CGRP is an important neuromodulator implicated in the pathogenesis of migraine. They are approved for the treatment of episodic and chronic migraine. In current clinical practice, CGRP monoclonal antibodies are used in patients who have failed multiple preventive agents, but safety, tolerability, and efficacy have not been well described in real-world populations outside of clinical trials. METHODS: This was a single-center, observational, retrospective study in adults with chronic migraine treated with a CGRP monoclonal antibody between May 1, 2018 and September 30, 2019. Charts were reviewed at 0, 3, and 6 months after treatment. RESULTS: From May 1, 2018 to September 30, 2019, 77 patients with chronic migraine were prescribed 90 treatment trials of a CGRP monoclonal antibody. Patients reported adverse outcomes in 2/5 (40.0%) with erenumab 70 mg, 32/46 (69.6%) with erenumab 140 mg, 8/16 (50.0%) with fremanezumab, and 15/23 (65.2%) with galcanezumab. The most frequent adverse effects were constipation and injection site reactions. Adverse effects leading to discontinuation were reported as follows: erenumab 70 mg 1/5 (20.0%), erenumab 140 mg 10/46 (22.7%), fremanezumab 1/16 (6.3%), and galcanezumab 1/23 (4.3%), with 13/90 (14.4%) discontinuation rate overall. The most frequent reasons for discontinuation were lack of improvement in 17/90 (18.9%) and constipation in 4/90 (4.4%). A 50% or greater reduction in the number of severe headache days per month was achieved for 32/66 (48.5%) at 3 months and 17/48 (35.4%) at 6 months. CONCLUSIONS: In patients with chronic migraine, the 3 CGRP monoclonal antibodies were well tolerated, and reduced the number of severe headache days.

Ten Eleven Things Not to Say to Healthcare Professionals During the Coronavirus Disease 2019 Pandemic.

On March 11, 2020, the infection caused by the coronavirus disease 2019 (COVID-19) virus was declared a pandemic. Throughout this pandemic, healthcare professionals (HCPs) have experienced difficulties stemming from poor communications, resource scarcity, lack of transparency, disbelief, and threats to the safety of their loved ones, their patients, and themselves. As part of these hardships, negative statements have been heard repeatedly. This paper describes 11 scenarios of unhelpful and dysfunctional messages heard by the authors and their colleagues during the COVID-19 pandemic, reported to us by a combination of peers, administrative leadership, and the public. We explain why not to use such messaging, and we suggest more helpful and compassionate expressions based upon recommendations published by scientific organizations and well-established psychological principles. The first 10 scenarios discussed include (1) lack of understanding regarding the extent of the pandemic; (2) shaming over not seeing patients in person; (3) lack of clear and consistent communication from leadership on pandemic-related practice changes; (4) opinions that personal protective equipment (PPE) use by HCPs causes fear or is unnecessary; (5) forcing in-person care without appropriate PPE; (6) the risk of exposure to asymptomatic individuals as it relates to opening clinics; (7) media gag orders; (8) pay and benefit reductions; (9) spreading of misinformation about the COVID-19 pandemic; and (10) workload expectations. The 11th scenario addresses HCPs' psychological and physical reactions to this challenging and prolonged stressful situation. We close by discussing the need for support and compassion at this difficult and unpredictable time and by offering suggestions to foster resilience and feelings of self-efficacy among HCPs.

Cerebrospinal Fluid Removal for Idiopathic Intracranial Hypertension: Less Cerebrospinal Fluid Is Best.

BACKGROUND: Although lumbar punctures (LPs) are used for diagnostic evaluation in idiopathic intracranial hypertension (IIH), they can also provide relief from IIH-associated headache. Conversely, low-pressure headache secondary to LP can be debilitating. Low-volume cerebrospinal fluid (CSF) removal to a "high-normal" closing pressure (CP), approximately 18-20 cm H2O, may result in relief of IIH-associated headache with a lowered frequency of post-LP headache. METHODS: We conducted a single-center retrospective analysis from 2011 to 2016 of patients who underwent fluoroscopic LPs aiming for high-normal CPs. Inclusion criteria were as follows: 1) pre-existing diagnosis of IIH, or opening pressure (OP) and clinical findings diagnostic for IIH; 2) height and weight recorded within 1 year; 3) documented LP data parameters; and 4) one week post-LP follow-up documenting whether headache was worse, unchanged, or better. RESULTS: One hundred forty-six patients met the inclusion criteria. Mean age was 34.9 years ± 11.0, and mean body mass index was 39.2 kg/m ± 10.5. Mean volume removed was 9.7 mL ± 4.6. The mean CP was 17.9 cm H2O ±2.7. The mean pressure change (OP-CP) per volume removed was 1.50 cm H2O/mL ±0.6. Headache symptoms at follow-up were improved in 64% (80/125) of patients, worse in 26% (33/125), and unchanged in 10% (12/125). Eleven patients were headache-free, and 11 patients required hospital care for post-LP headache. CONCLUSIONS: Low-volume CSF removal to approximately 18 cm H2O resulted in relief of IIH-associated headache in most patients and a low incidence of post-LP headache. Although clinically variable, these data suggest that for every 1 mL of CSF removed, the CP decreases approximately 1.5 cm H2O.

Headache in Pregnancy, the Puerperium, and menopause.

Headache is a neurologic disorder that displays gender dichotomy. It is well established that there is a strong link between migraine headache and sex hormones, specifically estrogen, which influences the severity of migraines during the menstrual cycle, pregnancy, and menopause. Furthermore, the epidemiology of headaches during pregnancy and the postpartum period is very distinct from that in males or nonpregnant females, in part due to the hemodynamic and hematologic changes that occur during pregnancy. These changes put women at higher risk for cerebral venous thrombosis, hemorrhagic stroke, and hypertensive disorders of pregnancy like preeclampsia, eclampsia, posterior reversible encephalopathy syndrome, and reversible cerebral vasoconstriction syndrome. Headache in pregnancy and the puerperium can be a cause of heightened anxiety in most women, who are concerned not only about the effect of the headache itself on the pregnancy but also about the effect of the treatment options on the pregnancy and the fetus. In this review, we discuss the latest literature on type and distribution of headaches during pregnancy and the postpartum period, and provide a digestible overview of the safety profile of commonly used abortive and prophylactic medications. We also discuss important considerations when treating migraine during menopause.

Safety Problems With a Transdermal Patch for Migraine: Lessons From the Development, Approval, and Marketing Process.

OBJECTIVE: We sought to analyze publicly available information about patient harm associated with an iontophoretic sumatriptan patch, to identify what went wrong and to suggest ways in which similar problems might be prevented in the future. BACKGROUND: The Zecuity® sumatriptan iontophoretic transdermal system was marketed for acute treatment of migraine. The patch was withdrawn less than 10 months after its introduction because of multiple reports of scarring and burning. As of 2018, the FDA Adverse Event Reporting System public dashboard lists a total of 2889 reports of safety problems with the patch, 904 of which were classified as serious. METHODS: For this narrative review, we examined US Food and Drug Administration documents related to the new drug application for this product and its approval. We searched Clinicaltrials.gov, PubMed, Google, Facebook, Twitter, and Instagram public posts for relevant information relating to the patch, its approval, marketing, and complications. RESULTS: The FDA knew about problems with burns and scarring prior to approval of the product, and turned down the initial new drug application for this reason and because of other quality problems with the patch. The reapplication was approved despite continued concerns of several FDA reviewers about safety. The approval required the manufacturer to comply with enhanced postmarketing safety reporting. However, product information and labeling did not mention the possibility of burns or scarring. Approval was based on 1 clinical trial and 2 open label studies in which reporting of adverse events was suboptimal. The clinical trials had been prospectively registered but outcomes had been changed around the time the trial concluded. Aggressive marketing efforts and social media activity may have contributed to inaccurate perceptions of safety and efficacy, but social media also provided a written and photographic record of burns and other harm suffered by patients who used the patch. CONCLUSIONS: Our review identified several problems with the development, testing, approval, and marketing of the Zecuity patch. To improve the process of developing headache treatments, it is important to consider the lessons that can be drawn from an examination of this high-profile failure of the drug development and regulatory system.

PFO and Migraine: Is There a Role for Closure?

Observational studies suggest that closure of a patent foramen ovale for other indications may reduce or even eliminate migraine attacks, particularly migraine with aura. The first randomized clinical trial of patent foramen ovale (PFO) closure for prevention of migraine, the MIST trial, showed negative results. The results of the other two completed studies in this area have recently been published in the last year. PRIMA and PREMIUM were also both negative for their primary endpoints. The PREMIUM trial did show a reduction in headache days in the migraine with aura subgroup but the final results of this subset analysis have not been published. There may be an as yet undetermined subgroup of patients with migraine who would benefit from closure, but slow recruitment has been a barrier to further study. Several potentially life-threatening procedure-related adverse events occurred in the clinical trials. At this time, we recommend against offering PFO closure as a preventive treatment for migraine. Based on available observational data, patients for whom PFO closure is indicated for other reasons may see some improvement in their migraines.

An Analysis of UCNS Certified Headache Center Patient Intake Forms.

OBJECTIVE: Compare the similarities and differences among headache intake forms from headache centers with United Council of Neurologic Subspecialties (UCNS) accredited headache medicine fellowships in the United States. Patient intake forms establish a first communication with patients. There have been no studies evaluating them at headache centers. Analysis of these forms can provide insight into their content and potential for improvement. METHODS: This observational study involved collection and analysis of intake forms from 25 UCNS fellowship accredited headache centers from July 2014 to October 2014. Forms were compared and contrasted in terms of data fields included, response format, and use of validated assessment tools. RESULTS: Forms shared many common elements, yet were highly variable in content, style, scales, and methods of analysis. Twenty percent (5/20) of centers did not have a formal intake form. Forms ranged from 1 to 28 pages. Seventy percent (12/17) utilized a check box format, 23% (4/17) utilized an open ended/fill in the blank format, and 6% (1/17) utilized a circle the response(s) format. Family history was inquired about in 82% (14/17) of forms and past medical history (PMH) in 58% (10/17) of forms. Gender questions were asked 82% (14/17) of the time for women, 29% (5/17) for men. Eighty-eight percent (15/17) of forms had questions concerning any type of previous medication tried. DISCUSSION: Patient intake forms are useful for clinical purposes, but vary markedly between UCNS headache centers. Ultimately, a universal intake form could be generated, providing a research-based alternative to the form currently used at each center. Use of a standardized intake form by UCNS centers would streamline data collection, a good first step in the eventual generation of a headache registry.

Headache Rounds: Sudden, Transient Neurologic Symptoms in a Woman With Migraine.

The following article is a Graham Headache Center headache rounds presentation at the Brigham and Women's Faulkner Hospital by fellows Roni Sharon and Melissa Rayhill with special guest Tobias Kurth. It summarizes the case of a 36-year-old female with no history of migraine in the past, presenting with several transient neurological episodes associated with headache. Her history, symptoms, imaging workup is reviewed. Following the case is a discussion of the differential diagnosis for the patient's symptoms along with a review of the association of migraine with and without aura with vascular neurological insult such as stroke. The article also discusses the clinical implications of migraine as a risk factor for stroke along with possible treatment recommendations.

Headache in Pregnancy and Lactation.

PURPOSE OF REVIEW: This article discusses the many tools available for the treatment of pregnant and postpartum patients with headache. Adequate treatment of headache is an essential part of good prenatal and postnatal care. RECENT FINDINGS: New therapies such as the calcitonin gene-related peptide monoclonal antibodies, lasmiditan, direct calcitonin gene-related peptide antagonists, and neuromodulation devices are available for the treatment of headache. This article contextualizes these new therapies in practice as they relate to the treatment of migraine in pregnancy and lactation. SUMMARY: Headache is common in pregnancy, and neurologists should be prepared to care for pregnant patients with headache. Preconception counseling is an important part of providing safe care to patients of childbearing potential with headache. Identifying potentially dangerous secondary headache syndromes during pregnancy and the puerperium is also essential. The repertoire of available acute and preventive headache treatments is expanding. It is important to discuss the effectiveness and safety of these therapies in the context of individual patient circumstances during pregnancy and lactation in coordination with the patient's obstetric team.

Registration status and outcome reporting of trials published in core headache medicine journals.

OBJECTIVES: To evaluate randomized controlled trial (RCT) registration and outcome reporting compliance in core headache medicine journals. METHODS: We identified RCTs published in core journals (Headache, Cephalalgia, and the Journal of Headache and Pain) from 2005 through 2014. We searched articles for trial registration numbers, which were verified in the corresponding trial registry. We categorized trial funding sources as industry, academic, government, or mixed. We contacted corresponding authors to assess reasons for nonregistration. We evaluated whether primary outcomes in trial registries matched those in corresponding publications. RESULTS: The journals published 225 RCTs over the study period. Fifty-eight of 225 (26%) reported a trial registration number in the article that could be linked to a corresponding registry entry. Trial registration rates increased over the 9 years of the study. Forty-six of 118 (39%) of industry-funded studies were registered compared with 27% of academic and 0% of government-funded studies. Only 5% of RCTs were prospectively registered, reported primary outcomes identical to those in the trial registry, and did not report unacknowledged post hoc outcomes. The most common reason for nonregistration was lack of awareness. CONCLUSIONS: Only about a quarter of the articles published in the core headache medicine journals are compliant with trial registration, but compliance has increased over time. Selective reporting of outcomes remains a problem, and very few trials met all 3 reporting standards assessed in this study. Efforts to improve the quality of trial reporting in the headache literature should continue.