Background: erenumab was safe and effective in clinical trials for the prevention of migraine. However, real-life data are still lacking. Here we report the clinical experience from an Italian real-world setting using erenumab in patients with chronic migraine experiencing previous unsuccessful preventive treatments. Methods: Seventy patients with chronic migraine and failure to ≥4 migraine preventive medication classes initially received monthly erenumab 70 mg s.c. Patients without a clinically meaningful improvement, considered as a > 30% reduction in headache days per month, after ≥3 months of therapy switched to monthly erenumab 140 mg. At the first administration and after 3 and 6 months, patients underwent extensive interviews to assess clinical parameters of disease severity and migraine-related disability and impact, and validated questionnaires to explore depression/ anxiety, sleep, and quality of life (QoL). Finally, the Pain Catastrophizing Scale, Allodynia Symptom Checklist-12 and MIGraine attacks-Subjective COGnitive impairments scale (MIG-SCOG) were administered. Results: 70% of patients were "responders" after the third administration of erenumab 70 mg, whereas 30% switched to erenumab 140 mg; 29% (6 pts) responded after the sixth administration. The headache-day frequency was reduced from 21.1 ± 0.7 to 11.4 ± 0.9 days after the third administration (p < 0.001) and to 8.9 ± 0.7 days after the sixth administration (p < 0.001). 53% and 70% of patients, respectively, showed a reduction of ≥50% of headache days/month after the third and the sixth administrations. Also improved were headache pain severity, migraine-related disability, and impact on daily living, QoL, pain catastrophizing and allodynia (all p < 0.001), quality of sleep, symptoms of depression or anxiety (p < 0.05) but not MIG-SCOG. There were no new adverse event signals.

Background Vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are used to reduce the risk of developing Coronavirus Disease 2019 (COVID-19). Despite the significant benefits in terms of reduced risk of hospitalization and death, different adverse events may present after vaccination: among them, headache is one of the most common, but nowadays there is no summary presentation of its incidence and no description of its main features. Methods We searched PubMed and EMBASE covering the period between January 1st 2020 and August 6th, 2021, looking for record in English and with an abstract and using three main search terms (with specific variations): COVID-19/SARS-CoV-2; Vaccination; headache/adverse events. We selected manuscript including information on subjects developing headache after injection, and such information had to be derived from a structured form (i.e. no free reporting). Pooled estimates and 95% confidence intervals were calculated. Analyses were carried out by vaccine vs. placebo, by first vs. second dose, and by mRNA-based vs. “traditional” vaccines; finally, we addressed the impact of age and gender on post-vaccine headache onset. Results Out of 9338 records, 84 papers were included in the review, accounting for 1.57 million participants, 94% of whom received BNT162b2 or ChAdOx1. Headache was generally the third most common AE: it was detected in 22% (95% CI 18–27%) of subjects after the first dose of vaccine and in 29% (95% CI 23–35%) after the second, with an extreme heterogeneity. Those receiving placebo reported headache in 10–12% of cases. No differences were detected across different vaccines or by mRNA-based vs. “traditional” ones. None of the studies reported information on headache features. A lower prevalence of headache after the first injection of BNT162b2 among older participants was shown. Conclusions Our results show that vaccines are associated to a two-fold risk of developing headache within 7 days from injection, and the lack of difference between vaccine types enable to hypothesize that headache is secondary to systemic immunological reaction than to a vaccine-type specific reaction. Some descriptions report onset within the first 24 h and that in around one-third of the cases, headache has migraine-like features with pulsating quality, phono and photophobia; in 40–60% of the cases aggravation with activity is observed. The majority of patients used some medication to treat headache, the one perceived as the most effective being acetylsalicylic acid.

The aim of this study is to implement the clinical use of the three-dimensional (3D) design and printing technology in pediatric pathologies requiring immobilization. We describe the manufacturing process of the 3D device in place of the plaster cast usually applied to a child 48/72 h after the access to the Trauma Center Traumatology Hub. This procedure had already been performed at Level II, Trauma Center, Campania Region, Orthopaedic Division of Santobono Children’s Hospital, Naples, Italy. The operative phase was performed by two 3D printers and a scanner in the bioengineering laboratory of the hospital’s outpatient area. The phase of software elaboration requires close cooperation among physicians and engineers. We decided to use a model with a double-shell design and holes varying in width to ensure complete ventilation and lightness of the device. We chose to treat nondisplaced metaphyseal distal fractures of the radius in 18 patients enrolled from January 2017 to November 2017. The flow chart includes clinical and radiological examinations of every enrolled child, collecting information required by the program and its elaboration by bioengineers, and then transfer of the results to 3D printers. The child, immobilized by a temporary splint, wore his 3D device after 12/24 h. Then, he underwent serial check-ups in which the effectiveness and appropriateness of the treatment were clinically monitored and evaluated using subjective scales: visual analogue scale and patient-rated wrist evaluation. All the fractures consolidated both radiologically and clinically after the treatment, with no complications reported. Only one partial breakage of the device happened because of an accidental fall. The statistical analysis of the visual analogue scale and patient-rated wrist evaluation data shows that children’s activities of everyday life improved during the immobilization thanks to this treatment. This first study shows that using a 3D device instead of a traditional plaster cast can be an effective alternative approach in the treatment of pediatric nondisplaced metaphyseal distal radius fractures, with high overall patient satisfaction. We believe that 3D technology could be extended to the treatment of more complex fractures; this will be the subject of our second study.

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Background and purpose Although the majority of migraine with aura (MwA) patients experience simple visual aura, a discrete percentage also report somatosensory, dysphasic or motor symptoms (the so‐called complex auras). The wide aura clinical spectrum led to an investigation of whether the heterogeneity of the aura phenomenon could be produced by different neural correlates, suggesting an increased visual cortical excitability in complex MwA. The aim was to explore whether complex MwA patients are characterized by more pronounced connectivity changes of the visual network and whether functional abnormalities may extend beyond the visual network encompassing also the sensorimotor network in complex MwA patients compared to simple visual MwA patients. Methods By using a resting‐state functional magnetic resonance imaging approach, the resting‐state functional connectivity (RS‐Fc) of both visual and sensorimotor networks in 20 complex MwA patients was compared with 20 simple visual MwA patients and 20 migraine without aura patients. Results Complex MwA patients showed a significantly higher RS‐Fc of the left lingual gyrus, within the visual network, and of the right anterior insula, within the sensorimotor network, compared to both simple visual MwA and migraine without aura patients (p < 0.001). The abnormal right anterior insula RS‐Fc was able to discriminate complex MwA patients from simple aura MwA patients as demonstrated by logistic regression analysis (area under the curve 0.83). Conclusion Our findings suggest that higher extrastriate RS‐Fc might promote cortical spreading depression onset representing the neural correlate of simple visual aura that can propagate to sensorimotor regions if an increased insula RS‐Fc coexists, leading to complex aura phenotypes.

Increasingly, medication is being administered at home by family and friends of the care-recipient. This study aims to identify and analyse risks associated with potential drug administration errors made by informal carers at home. We mapped medication administration at home with a multidisciplinary team that included carers, health care professionals and patients. Evidence-based risk-analysis methodologies were applied: Healthcare Failure Modes and Effect Analysis (HFMEA), Systematic Human Error Reduction and Prediction Analysis (SHERPA) and Systems-Theoretic Accident Model and Processes (STAMP). The process of administration comprises seven sub-processes. Thirty-four possible failure modes were identified and six of these were rated as high risk. These highlighted that medications may be given with a wrong dose, stored incorrectly, not discontinued as instructed, not recorded, or not ordered on time, and often caused by communication and support problems. Combined risk analyses contributed unique information helpful to better understand the medication administration risks and causes within homecare. Practitioner Summary: Increasingly, medication is being administered at home by family and friends of the care-recipient. This study identifies risks associated with potential drug administration errors made by informal carers at home through consensus-based quantitative techniques. The different analyses contribute unique information helpful to better understand the administration risks and causes.

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Objective Refractory migraine (Ref‐M) represents a conundrum that headache experts have to face with. We aim to investigate whether a peculiar profile may characterize patients with Ref‐M according to 2020 European Headache Federation criteria. Furthermore, to substantiate a dysfunctional dopaminergic pathway involvement in these patients, we explored the effectiveness of olanzapine. Materials & Methods Eighty‐four patients (fitting previous Ref‐M criteria of the 2014) were treated with erenumab for six months. Differences between clinical and demographic features of responder (Ref‐M according to 2014 criteria) and not‐responder (Ref‐M according to 2020 criteria) patients to CGRP‐mAbs were investigated and their predictive values assessed. In fifteen patients with Ref‐M not responders to CGRP‐mAbs, olanzapine was administered (5 mg/die) for 3 months and frequency and pain intensity of migraine attacks were estimated. Results Patients with Ref‐M not responsive to CGRP‐mAbs (29/84) when compared with Ref‐M responsive to CGRP‐mAbs showed higher baseline frequency of migraine attacks, medication overuse and pain catastrophizing scale (PCS) scores. Logistic regression analyses showed that frequency of attacks, medication overuse and PCS score represent independent negative predictors of CGRP‐mAbs response. A ≥50% reduction of headache days/month was observed after olanzapine treatment in 67% of patients with Ref‐M not responsive to CGRP‐mAbs. Conclusions We outline that higher frequency of migraine attacks, medication overuse and pain catastrophizing characterize patients with Ref‐M not responsive to CGRP‐mAbs. In this frame, olanzapine effectiveness on frequency and pain intensity of migraine attacks supports the hypothesis that migraine refractoriness may be subtended by a prominent involvement of the dopaminergic pathway.