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Introduction: Since the beginning of the Covid-19 epidemic produced by SARS2-Cov virus, olfactory alterations have been observed at a greater frequency than in other coronavirus epidemics. While olfactory alterations may be observed in patients with rhinovirus, influenza virus, or parainfluenza virus infection, they are typically explained by nasal obstruction with mucus or direct epithelial damage; in the case of SARS-CoV-2, olfactory alterations may present without nasal congestion with mucus. We performed a study of patients presenting olfactory/gustatory alterations in the context of SARS-CoV-2 infection in order to contribute to the understanding of this phenomenon. Material and Methods: We performed a descriptive, cross-sectional, observational study of the clinical characteristics of olfactory/gustatory alterations using a self-administered, anonymous online questionnaire. Results: A total of 909 patients with SARS-CoV-2 infection and olfactory/gustatory alterations responded to the questionnaire in the 4-day data collection period; 824 cases (90.65%) reported simultaneous olfactory and gustatory involvement. Patients' responses to the questionnaire revealed ageusia (581, 64.1% of respondents), hypogeusia (256, 28.2%), dysgeusia (22, 2.4%), anosmia (752 82.8%), hyposmia (142, 15.6%), and dysosmia (8, 0.9%). Fifty-four percent (489) did not report concomitant nasal congestion or mucus. Conclusion: Olfactory alterations are frequent in patients with SARS-CoV-2 infection and is only associated with nasal congestion in half of the cases.

BACKGROUND Patients are key stakeholders in medical decision-making, and there is a growing emphasis on patient empowerment. The website midolordecabeza.org promotes the participation of patients with migraine with the aim of organizing the information on headache, including the latest research, making it accessible and useful for all stakeholders. Digital tools in chronic disorders help to empower patients and foster patient-centered outcomes research. OBJECTIVE To validate the social impact of midolordecabeza.org, by analyzing the activity on the web and analyzing users’ needs through open surveys. METHODS We analyzed using Google Analytics the web activity, geographical distribution of access, social behavior, electronic devices performance and temporary references with greater web activity. We also conducted open surveys focused on: (1) the impact of migraine, (2) the strategies they use to cope, (3) the answers they are looking for (4) and the solutions that they find. RESULTS From January 2015 until December 2019, the website registered 1,091,043 users; 1,728,118 visits and 3,715,416 page views with an average time per session for nearly two minutes. This implies an average annual increase of 10.8% of users, 13.4% of visits and 8.0% of views. Higher data traffic has been registered in Spanish-speaking regions such as Spain (29.7%), Mexico (16.0%) and Argentina (14.5%). In regards to social behavior, 75.8% of accesses were performed via mobile phone. Statistically significantly usage is registered during the spring and in the evening (8-11 pm). Users are 76.1% women, between 25 and 54 years old (71.0%); 71.5% describe their migraine as a disabling disease with the presence of anxiety and depression. 59.4% ignore their type of headache and 51.8% do not have any medical follow-up. 66.7% do not know how to anticipate to their migraine attacks and 61.5% feel stigmatized. 73.8% of patients feel dissatisfied with current therapeutic methods. CONCLUSIONS Migraine promotes an excellent research environment for the development of digital platforms due to its high prevalence, high socioeconomic impact, concerns about current treatment and easy access to the Internet. Patient-centered outcomes research platforms improve communication among medical communities and drive patient empowerment.

En este trabajo estudiamos la gestión participativa y sus diferentes herramientas de aplicación desde un punto de vista tanto teórico como aplicado. En la primera parte se presenta un estudio teórico acerca del concepto de gestión participativa, definición, características, tipos de programas y efectos. En la segunda parte real izamos un trabajo de campo mediante una encuesta que se ha puesto a disposición de las organizaciones de la red de economía solidaria REAS. La encuesta permite valorar la situación actual y muestra el interés de las organizaciones por implementar este tipo de programas de participación en la gestión. También se evidencian limitaciones como el desconocimiento de algunas herramientas o la necesidad de formación y acompañamiento en su implementación. Por último, presentamos una propuesta de preguntas relaciona das con la gestión participativa para integrar en la Auditoria Social que realizan las organizaciones de REAS. In this project we study participatory management and its different application tools from a theoretical and applied point of view. In the first part, a theoretical study is presented about the concept of participative management, definition, characteristics, types of programs and effects. In the second part, we carried out a fieldwork through a survey that has been made available to the organizations of the REAS solidarity economy network. The survey allows to evaluate the actual situation and shows the interest of the organizations to implement this type of participation programs in the management. There are also limitations such as the lack of knowledge of some tools or the need for training and accompaniment in their implementation. Finally, we present a proposal of questions related to participative management to integrate in the Social Audit carried out by REAS organizations. Graduado o Graduada en Relaciones Laborales y Recursos Humanos por la Universidad Pública de Navarra Lan Harremanetan eta Giza Baliabideetan Graduatua Nafarroako Unibertsitate Publikoan

For chemical manufacturing processes, the chemical kinetics literature contains virtually no mention of quantitative models that involve batch-to-batch variation. Models for chemical process manufacturing quality improvement are being more carefully considered, particularly by the pharmaceutical industry and its regulators. This is evidenced in part by the recent ICH Q11 regulatory guidance on drug substance manufacture and quality. Quality improvement has been defined as a reduction in variation about a target. Hence the modeling of process variation plays an important role in quantifying quality improvement. Given that batch-to-batch variation is often a dominant source of process variation (usually exceeding measurement error variation), it is important for process models to incorporate such variance components. In this paper, we show how chemical kinetic models can incorporate batch-to-batch variation as well as measurement error. In addition, we show that these models can be used to quantify the reli...

Background Medication-overuse headache (MOH) is a chronic disabling condition associated with a high rate of relapse. Methods We evaluated whether the adoption of electronic-assisted monitoring, advice and communication would improve the outcome over a follow-up of 6 months in a controlled, multicentre, multinational study conducted in six headache centres located in Europe and Latin America. A total of 663 MOH subjects were enrolled and divided into two groups: the Comoestas group was monitored with an electronic diary associated with an alert system and a facilitated communication option, and the Classic group with a paper headache diary. Results We observed a significantly higher percentage of overuse-free subjects in the Comoestas group compared with the Classic group: 73.1 vs 64.1% (odds ratio 1.45, 95% confidence interval 1.07–2.09, p = 0.046). The Comoestas group performed better also regarding the number of days/month with intake of acute drugs and the level of disability [Migraine Disability Assessment Score: Comoestas group – 42.5 ± 53.6 (35.5–49.3) and Classic group – 27.5 ± 56.1 (20.6–34.3) ( p Conclusion The adoption of the electronic tool improved the outcome of patients suffering from MOH after withdrawal from overused drugs. Information and communication technology represents a valid aid for optimizing the management of chronic conditions at risk of worsening or of relapsing. Trial registration The trial was registered at ClinicalTrials.gov (no. NCT02435056).

Background: Headache disorders and psychiatric disorders are both common, while evidence, mostly pertaining to migraine, suggests they are comorbid more often than might be expected by chance. There are good reasons for establishing whether they are: symptoms of comorbid illnesses may summate synergistically; comorbidities hinder management, negatively influencing outcomes; high-level comorbidity indicates that, where one disease occurs, the other should be looked for. The Eurolight project gathered population-based data on these disorders from 6624 participants. Methods: Eurolight was a cross-sectional survey sampling from the adult populations (18–65 years) of 10 EU countries. We used data from six. The questionnaire included headache-diagnostic questions based on ICHD-II, the Headache-Attributed Lost Time (HALT) questionnaire, and HADS for depression and anxiety. We estimated odds ratios (ORs) to show associations between migraine, tension-type headache (TTH) or probable medication-overuse headache (pMOH) and depression or anxiety. Results: pMOH was most strongly associated with both psychiatric disorders: for depression, ORs (vs no headache) were 5.5 [2.2–13.5] (p

Background Most primary headaches are episodic, and most estimates of the heavy disability burden attributed to headache derive from epidemiological data focused on the episodic subtypes of migraine and tension-type headache (TTH). These disorders give rise directly but intermittently to symptom burden. Nevertheless, people with these disorders may not be symptom-free between attacks. We analysed the Eurolight dataset for interictal burden. Methods Eurolight was a cross-sectional survey using modified cluster sampling from the adult population (18–65 years) in 10 countries of the European Union. We used data from nine. The questionnaire included headache-diagnostic questions based on ICHD-II and several question sets addressing impact, including interictal and cumulative burdens. Results There were 6455 participants with headache (male 2444 [37.9 %]). Interictal symptoms were reported by 26.0 % of those with migraine and 18.9 % with TTH: interictal anxiety by 10.6 % with migraine and avoidance (lifestyle compromise) by 14.8 %, both much more common than in TTH (3.1 % [OR 3.8] and 4.7 % [OR 3.5] respectively). Mean time spent in the interictal state was 317 days/year for migraine, 331 days/year for TTH. Those who were “rarely” or “never” in control of their headaches (migraine 15.2 %, TTH 9.6 %) had significantly raised odds of interictal anxiety, avoidance and other interictal symptoms. Among those with migraine, interictal anxiety increased markedly with headache intensity and frequency, avoidance less so but still significantly. Lost productive time was associated with high ORs (up to 5.3) of anxiety and avoidance. A third (32.9 %) with migraine and a quarter (26.7 %) with TTH (difference: p

Supplemental material, Supplementary material Consensus protocol for The added value of an electronic monitoring and alerting system in the management of medication-overuse headache: A controlled multicentre study by Cristina Tassorelli, Rigmor Jensen, Marta Allena, Roberto De Icco, Zaza Katsarava, J Miguel Lainez, Jorge A Leston, Ricardo Fadic, Santiago Spadafora, Marco Pagani and Giuseppe Nappi; the COMOESTAS Consortium in Cephalalgia

Supplemental material, Supplementary material Summary for The added value of an electronic monitoring and alerting system in the management of medication-overuse headache: A controlled multicentre study by Cristina Tassorelli, Rigmor Jensen, Marta Allena, Roberto De Icco, Zaza Katsarava, J Miguel Lainez, Jorge A Leston, Ricardo Fadic, Santiago Spadafora, Marco Pagani and Giuseppe Nappi; the COMOESTAS Consortium in Cephalalgia

Background and purpose: Headache disorders are very common, but their monetary costs in Europe are unknown. We performed the first comprehensive estimation of how economic resources are lost to headache in Europe. Methods: From November 2008 to August 2009, a cross-sectional survey was conducted in eight countries representing 55% of the adult EU population. Participation rates varied between 11% and 59%. In total, 8412 questionnaires contributed to this analysis. Using bottom-up methodology, we estimated direct (medications, outpatient health care, hospitalization and investigations) and indirect (work absenteeism and reduced productivity at work) annual per-person costs. Prevalence data, simultaneously collected and, for migraine, also derived from a systematic review, were used to impute national costs. Results: Mean per-person annual costs were €1222 for migraine (95% CI 1055–1389; indirect costs 93%), €303 for tension-type headache (TTH, 95% CI 230–376; indirect costs 92%), €3561 for medication-overuse headache (MOH, 95% CI 2487–4635; indirect costs 92%), and €253 for other headaches (95% CI 99–407; indirect costs 82%). In the EU, the total annual cost of headache amongst adults aged 18–65 years was calculated, according to our prevalence estimates, at €173 billion, apportioned to migraine (€111 billion; 64%), TTH (€21 billion; 12%), MOH (€37 billion; 21%) and other headaches (€3 billion; 2%). Using the 15% systematic review prevalence of migraine, calculated costs were somewhat lower (migraine €50 billion, all headache €112 billion annually). Conclusions: Headache disorders are prominent health-related drivers of immense economic losses for the EU. This has immediate implications for healthcare policy. Health care for headache can be both improved and cost saving.

We developed a 103-item self-reporting questionnaire to assess the burden of primary headache disorders on those affected by them, including headache characteristics, associated disability, co-morbidities, disease-management and quality of life. We validated the questionnaire in five languages with 426 participants (131 in UK, 60 in Italy, 107 in Spain, 83 in Germany/Austria, and 45 in France). After a linguistic and a face-content validation, we tested the questionnaire for comprehensibility, internal consistency and test–retest reliability at an interval of one month. In the different countries, response rates were between 73% and 100%. Test–retest reliability varied between –0.27 to 1.0 depending of the nature of the expected agreement. The internal consistency was between 0.69 and 0.91. The EUROLIGHT questionnaire is suitable for evaluating the burden of primary headache disorders, and can be used in English, German, French, Italian and Spanish.

The mission of the European Headache Federation (EHF) is to improve life for those affected by headache disorders in Europe. Progress depends upon improving access to good headache-related health care for people affected by these disorders. Education about headache-its nature, causes, consequences and management-is a key activity of EHF that supports this aim. It is also important to achieve an organisation of headache-related services within the health systems of Europe in order that they can best deliver care in response to what are very high levels of need. This publication assesses this need, and sets out proposals for service organisation, on three levels, to meet the resultant demand.

Background Surveys enquiring about burden of headache over a prior period of time (eg, 3 months) are subject to recall bias. To eliminate this as far as possible, we focused on presence and impact of headache on the preceding day (“headache yesterday”). Methods Adults (18-65 years) were surveyed from the general populations of Germany, Italy, Lithuania, Luxembourg and the Netherlands, from a work-force population in Spain and from mostly non-headache patient populations of Austria, France and UK. A study of non-responders in some countries allowed detection of potential participation bias where initial participation rates were low. Results Participation rates varied between 11% and 59% (mean 27%). Non-responder studies suggested that, because of participation bias, headache prevalence might be overestimated in initial responders by up to 2% (absolute). Across all countries, 1,422 of 8,271 participants (15-17%, depending on correction for participation bias) had headache yesterday lasting on average for 6 hours. It was bad or very bad in 56% of cases and caused absence from work or school in 6%. Among those who worked despite headache, 20% reported productivity reduced by >50%. Social activities were lost by 24%. Women (21%) were more likely than men (12%) to have headache yesterday, but impact was similar in the two genders. Conclusions With recall biases avoided, our findings indicate that headache costs at least 0.7% of working capacity in Europe. This calculation takes into account that most of those who missed work could make up for this later, which, however, means that leisure and social activities are even more influenced by headache.

Background European data, at least from Western Europe, are relatively good on migraine prevalence but less sound for tension-type headache (TTH) and medication-overuse headache (MOH). Evidence on impact of headache disorders is very limited. Eurolight was a data-gathering exercise primarily to inform health policy in the European Union (EU). This manuscript reports personal impact. Methods The study was cross-sectional with modified cluster sampling. Surveys were conducted by structured questionnaire, including diagnostic questions based on ICHD-II and various measures of impact, and are reported from Austria, France, Germany, Italy, Lithuania, Luxembourg, Netherlands, Spain and United Kingdom. Different methods of sampling were used in each. The full methodology is described elsewhere. Results Questionnaires were analysed from 8,271 participants (58% female, mean age 43.4 y). Participation-rates, where calculable, varied from 10.6% to 58.8%. Moderate interest-bias was detected. Unadjusted lifetime prevalence of any headache was 91.3%. Gender-adjusted 1-year prevalences were: any headache 78.6%; migraine 35.3%; TTH 38.2%, headache on ≥15 d/mo 7.2%; probable MOH 3.1%. Personal impact was high, and included ictal symptom burden, interictal burden, cumulative burden and impact on others (partners and children). There was a general gradient of probable MOH > migraine > TTH, and most measures indicated higher impact among females. Lost useful time was substantial: 17.7% of males and 28.0% of females with migraine lost >10% of days; 44.7% of males and 53.7% of females with probable MOH lost >20%. Conclusions The common headache disorders have very high personal impact in the EU, with important implications for health policy. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0), which permits use, duplication, adaptation, distribution, and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

The Clomethiazole Acute Stroke Study (CLASS) showed no difference in outcome between patients treated with clomethiazole or placebo for all patients treated, but a beneficial effect in patients classified as a total anterior circulation syndrome (TACS). These are patients with clinical symptoms of a large stroke. Safety and tolerability data are reported here with emphasis on the safety of treating stroke patients with a sedative drug. In total, 1,356 patients were eligible for safety analysis. Mortality at 90 days was equal between the treatment groups (clomethiazole, 19.5%; placebo, 19.7%). Clomethiazole was generally well-tolerated. The most common adverse event was sedation (clomethiazole, 53%; placebo, 10%). Clomethiazole also produced some respiratory adverse events (e.g., rhinitis and increased sputum). Serious adverse events associated with sedation were more commonly reported in the clomethiazole group during treatment. However, the incidence was low. There was no difference in the incidence of serious adverse events between the treatment groups for pulmonary conditions, cardiovascular conditions, or other conditions. Clomethiazole produced a small decrease in blood pressure, but this was not associated with a worse outcome. Safety and tolerability in TACS patients was similar to that for all patients treated with the exception that these patients were more sensitive to the sedative effects of the drug. Despite this, mortality was slightly lower, and functional outcome was better in clomethiazole-treated TACS patients compared with placebo. In conclusion, clomethiazole was generally well-tolerated. The sedation observed did not increase the risk for complications, such as pulmonary serious adverse events or affect the outcome in a negative way. Clomethiazole appeared to be safe to use in stroke patients in general and in patients with a large stroke. The efficacy and safety in large strokes will be studied further in a new study, which is ongoing.

Background The management of medication overuse headache (MOH) is rewarding but also challenging because effective treatment is frequently followed by relapses. Information and Communication Technology has recently been proposed as a valid aid to improve healthcare quality in chronic conditions. In this frame, we developed a headache diary associated with an alert/alarm logic for the interactive monitoring and the professional support of MOH patients after detoxification.

Background Medication overuse headache (MOH) is a very disabling and costly disorder due to indirect costs, medication and healthcare utilization. The aim of the study was to describe general demographic and clinical characteristics of MOH, along with the national referral pathways and national painkillers distribution in several European and Latin American (LA) Countries. Methods This descriptive cross-sectional observational study included 669 patients with MOH referred to headache-centers in Europe and LA as a part of the COMOESTAS project. Information about acute medication and healthcare utilization were collected by extensive questionnaires, supplemented with structured patient interviews. Results Triptans were overused by 31 % European patients and by 6 % in LA (p