Swiss QUality of life and healthcare impact Assessment in a Real-world Erenumab treated migraine population (SQUARE study): interim results.

BACKGROUND: The fully human monoclonal antibody erenumab, which targets the calcitonin gene-related peptide (CGRP) receptor, was licensed in Switzerland in July 2018 for the prophylactic treatment of migraine. To complement findings from the pivotal program, this observational study was designed to collect and evaluate clinical data on the impact of erenumab on several endpoints, such as quality of life, migraine-related impairment and treatment satisfaction in a real-world setting. METHODS: An interim analysis was conducted after all patients completed 6 months of erenumab treatment. Patients kept a headache diary and completed questionnaires at follow up visits. The overall study duration comprises 24 months. RESULTS: In total, 172 adults with chronic or episodic migraine from 19 different sites across Switzerland were enrolled to receive erenumab every 4 weeks. At baseline, patients had 16.6 ± 7.2 monthly migraine days (MMD) and 11.6 ± 7.0 acute migraine-specific medication days per month. After 6 months, erenumab treatment reduced Headache Impact Test (HIT-6™) scores by 7.7 ± 8.4 (p < 0.001), the modified Migraine Disability Assessment (mMIDAS) by 14.1 ± 17.8 (p < 0.001), MMD by 7.6 ± 7.0 (p < 0.001) and acute migraine-specific medication days per month by 6.6 ± 5.4 (p < 0.001). Erenumab also reduced the impact of migraine on social and family life, as evidenced by a reduction of Impact of Migraine on Partners and Adolescent Children (IMPAC) scores by 6.1 ± 6.7 (p < 0.001). Patients reported a mean effectiveness of 67.1, convenience of 82.4 and global satisfaction of 72.4 in the Treatment Satisfaction Questionnaire for Medication (TSQM-9). In total, 99 adverse events (AE) and 12 serious adverse events (SAE) were observed in 62 and 11 patients, respectively. All SAE were regarded as not related to the study medication. CONCLUSIONS: Overall quality of life improved and treatment satisfaction was rated high with erenumab treatment in real-world clinical practice. In addition, the reported impact of migraine on spouses and children of patients was reduced. TRIAL REGISTRATION: BASEC ID 2018-02,375 in the Register of All Projects in Switzerland (RAPS).

Delayed headache after COVID-19 vaccination: a red flag for vaccine induced cerebral venous thrombosis.

BACKGROUND: Headache is a frequent symptom following COVID-19 immunization with a typical onset within days post-vaccination. Cases of cerebral venous thrombosis (CVT) have been reported in adenovirus vector-based COVID-19 vaccine recipients. FINDINGS: We reviewed all vaccine related CVT published cases by April 30, 2021. We assessed demographic, clinical variables and the interval between the vaccination and onset of headache. We assessed whether the presence of headache was associated with higher probability of death or intracranial hemorrhage. We identified 77 cases of CVT after COVID-19 vaccination. Patients' age was below 60 years in 74/77 (95.8%) cases and 61/68 (89.7%) were women. Headache was described in 38/77 (49.4%) cases, and in 35/38 (92.1%) was associated with other symptoms. Multiple organ thrombosis was reported in 19/77 (24.7%) cases, intracranial hemorrhage in 33/77 (42.9%) cases and 19/77 (24.7%) patients died. The median time between vaccination and CVT-related headache onset was 8 (interquartile range 7.0-9.7) days. The presence of headache was associated with a higher odd of intracranial hemorrhage (OR 7.4; 95% CI: 2.7-20.8, p < 0.001), but not with death (OR: 0.51, 95% CI: 0.18-1.47, p = 0.213). CONCLUSION: Delayed onset of headache following an adenovirus vector-based COVID-19 vaccine is associated with development of CVT. Patients with new-onset headache, 1 week after vaccination with an adenovirus vector-based vaccine, should receive a thorough clinical evaluation and CVT must be ruled out.

[COVID-19 and Headaches]. / COVID-19 und Kopfschmerzen.

COVID-19 and Headaches Abstract. Headaches are a common symptom of COVID-19 infections. Patients generally describe them as bilateral, predominantly frontal, squeezing and of moderate or severe intensity. Searching for "Red Flags" often allows distinction from primary headaches - usually fever, cough, and elevated inflammatory markers accompany COVID-19-associated headaches. Prospective studies did not confirm caveats against the use of ibuprofen as symptomatic treatment. While carrying facial masks often caused headaches, probably by compressing sensory nerves, many patients' migraine frequencies dropped during lockdown. Treatment of patients with primary headaches was complicated by quarantine and many centres offered online consultations.

Triaging advanced GI endoscopy procedures during the COVID-19 Pandemic: consensus recommendations using the Delphi method

Background and Aims There remains a lack of consensus on which gastrointestinal endoscopic procedures should be performed during the COVID-19 pandemic, and which procedures could be safely deferred without significantly impacting outcomes. Methods We selected a panel of 14 expert endoscopists. We identified 41 common indications for advanced endoscopic procedures from the ASGE Appropriate Use of GI Endoscopy guidelines. Using a modified Delphi method, we first achieved consensus on patient-important outcome for each procedural indication. Panelists prioritized consensus patient-important outcome when categorizing each indication into one of the following 3 procedural time periods: (1) time-sensitive emergent (schedule within 1 week), (2) time-sensitive urgent (schedule within 1 to 8 weeks), and (3) non-time sensitive (defer for >8 weeks and then reassess the timing). Three anonymous rounds of voting were allowed before attempts at consensus were abandoned. Results All 14 invited experts agreed to participate in the study. The prespecified consensus threshold of 51% was achieved for assigning patient-important outcome/s to each advanced endoscopy indication. The prespecified consensus threshold of 66.7% was achieved for 40 out of 41 advanced endoscopy indications in stratifying them into 1 of 3 procedural time periods. For 12 out of 41 indications 100% consensus, and for 20 out of 41 indications 75% to 99% consensus was achieved. Conclusions By using a Modified Delphi method that prioritized patient-important outcomes, we developed consensus recommendations on procedural timing for common indications for advanced endoscopy. These recommendations and the structured decision framework provided by our study can inform decision-making as endoscopy services are reopened.

ESGE and ESGENA Position Statement on gastrointestinal endoscopy and the COVID-19 pandemic.

We are currently living in the throes of the COVID-19 pandemic that imposes a significant stress on health care providers and facilities. Europe is severely affected with an exponential increase in incident infections and deaths. The clinical manifestations of COVID-19 can be subtle, encompassing a broad spectrum from asymptomatic mild disease to severe respiratory illness. Health care professionals in endoscopy units are at increased risk of infection from COVID-19. Infection prevention and control has been shown to be dramatically effective in assuring the safety of both health care professionals and patients. The European Society of Gastrointestinal Endoscopy (www.esge.com) and the European Society of Gastroenterology and Endoscopy Nurses and Associates (www.esgena.org) are joining forces to provide guidance during this pandemic to help assure the highest level of endoscopy care and protection against COVID-19 for both patients and endoscopy unit personnel. This guidance is based upon the best available evidence regarding assessment of risk during the current status of the pandemic and a consensus on which procedures to perform and the priorities on resumption. We appreciate the gaps in knowledge and evidence, especially on the proper strategy(ies) for the resumption of normal endoscopy practice during the upcoming phases and end of the pandemic and therefore a list of potential research questions is presented. New evidence may result in an updated statement.