Search

Objective: To study the effect of natural menopause on multiple sclerosis clinical course., Methods: This was an observational, retrospective, multicentre, cohort study. Menopause onset was defined by the final menstrual period (FMP) beyond which no menses occurred for 12 months. We included multiple sclerosis (MS) patients with FMP occurred after 2005 and a recorded follow-up of at least 2 years pre-FMP and post-FMP. We excluded patients with primary progressive course, iatrogenic menopause and with other confounders that could mask menopause onset. We compared relapse-rate and expanded disability status scale (EDSS) scores pre-FMP and post-FMP, searching for possible interactions with age, disease duration, cigarette smoking and nulliparity status., Results: 148 patients were included (mean observation: 3.5 years pre-FMP and post-FMP). Most patients (92%) received disease-modifying therapies, mainly first-lines. After menopause the annualised relapse rate (ARR) significantly decreased (from 0.21±0.31 to 0.13± 0.24; p=0.005), while disability worsened (increase of mean 0.4 vs 0.2 points after menopause; p<0.001). Older age and long-lasting disease were associated with ARR reduction (p=0.013), but not with disability worsening. Cigarette smokers showed a trend to a higher disability accumulation after menopause (p=0.059)., Conclusion: Natural menopause seems to be a turning point to a more progressive phase of MS. Relapse rate is also reduced after menopause, but this effect could be driven most by ageing and shifting to progressive phase in patients with long-lasting disease. Cigarette smoking could speed up disability progression after menopause., Competing Interests: Competing interests: DB received travel grants from Genzyme, Merck and Biogen for participation at national and international congresses; he received speaking honoraria from Sanofi and Novartis, and personal compensation from Almirall for scientific publication. POA received honoraria for lecturing and participation in advisory boards, and/or travel expenses for attending congresses and meetings from Merck, Biogen, Teva, Sanofi- Genzyme, Mylan, Almirall, Roche and Novartis. NDR received speaker honoraria from Biogen Idec, Genzyme, Novartis, Sanofi-Aventis; received funding for participation in advisory board to Novartis and Genzyme-Sanofi and for traveling to scientific meetings from Biogen Idec, teva, Sanofi-Genzyme, Roche, Almirall and NovartisGiulia Mallucci received support to travel to scientific meetings from Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Roche, Sanofi-Aventis, Teva; received speaker honoraria from Biogen Idec and served on the scientific advisory board for Biogen, Genzyme and Merck SeronoValentina Torri Clerici acted as an Advisory Board member of Novartis and Merck-Serono, received funding for travelling and honoraria for speaking or writing from Teva, Biogen, Genzyme, Merk-Serono and Almirall. She received support for research project by Almirall. Simone Tonietti received honoraria for lecturing from Teva and Sanofi-Genzime, for writing from Teva, for participation in advisory boards from Merck and Biogen and for travel expenses for attending congresses and meetings from Merck, Biogen, Teva, Sanofi-Genzyme and Novartis. MJM received funding for travelling and honoraria for speaking or writing from Genzyme. MR received travel grants for congresses participation from Biogen, Genzyme, Novartis e Merck. He received honoraria for conferences organisation from Biogen. He received honoraria from Merck, Novartis, Biogen for advisory boards participation. VB received speaking honoraria and/or consultant fees from Biogen Idec, Merck Serono, Bayer, Sanofi-Genzyme, Novartis. Vittorio Mantero received honoraria for participation to advisory boards and/or travel expenses for attending congresses and meetings from Merck, Biogen, Teva, Sanofi-Genzyme, Roche and Novartis. PC was a board member of Biogen Idec, received travel grants from Sanofi, Biogen and Merck Serono. RC was consulting fees from Biogen, Teva, Genzyme, Merck Serono, and Novartis. Mauro Zaffaroni received honoraria for lecturing or participation in advisory boards, and financial support for attending congresses from Almirall, Biogen Idec, Genzyme, Merck Serono, Novartis, and Teva. Emanuela Susani, Maria Letizia Fusco, Caterina Barrilà, Luca Chiveri, Loredana La Mantia, Maria Teresa Ferrò, Raffaella Clerici, Ottavia Ferraro, Elena Colombo and Lucia Abate have nothing to disclose., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: This study aimed to assess the physical, psychological, and economic burden shouldered by severely injured two-wheel users in three European countries as well as the cost resulting from their hospitalization., Methods: A total of seven public hospitals were involved in three countries: Greece, Italy, and Germany. Participants enrolled during a 12-month period starting in April 2013. Eligibility criteria included an injury sustained at Road Traffic Crashes (RTC) irrespective of the type of vehicle, hospitalization 1 day in the Intensive Care Unit (ICU) or sub-ICU, and age 18 years or over. Patients were interviewed at 1, 6, and 12 months upon admission. The study used widely recommended classifications for injury severity (Abbreviated Injury Severity [AIS]; Maximum Abbreviated Injury Severity [MAIS]) and standardized measures such as the Disability Assessment Schedule II (WHODAS 2.0), "Impact of Event Scale" (IES-R), Center for Epidemiological Studies Depression Scale (CES-D Scale). Health Care Expenditure was assessed through the Monash University Accident Research Centre (MUARC's) framework, which included measures of 'Direct' and 'Indirect' costs. Diagnosis-related groups (DRGs) were used to estimate hospitalization costs., Results: A total of 54 two-wheel users enrolled in the study in all the countries and 32 completed all follow-up questionnaires. Physical disability increased over 12 months following the injury. Post Traumatic Stress Disorder (PTSD) symptoms of avoidance remained at high levels over the study period. PTSD symptoms of intrusion improved significantly during the second half of the year under investigation. The total annual cost of injury for the two-wheel users who were hospitalized in the selected ICU of all the partner countries for severe injury in 2013/2014, was estimated at €714,491 made up of €123,457 direct and €591,034 indirect costs. Men, aged 50-64 years and those who sustained slight injuries primarily at the lower extremities presented higher indirect costs per person. A total of €1032.092 was spent on hospitalization payments. Women, aged 65+ and those who sustained severe injuries at the central body region presented higher direct costs per person. Women, aged 50-64 years, those with severe injuries and a major injury at the central body and the upper body region presented the highest hospitalization costs per person., Conclusions: There is a need for effective strategies to early detect and treat groups at risk of being confronted with prolonged psychosocial and economic consequences., Practical Implications: A holistic understanding of the impact of injury on individuals is important in order to achieve effective treatment of psychological co-morbidities in a timely manner., (Copyright © 2018 Elsevier Ltd and National Safety Council. All rights reserved.)