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Interest in gamified physical activity has been driven by its potential to benefit student mental health. Integrating gamified practices for mental health improvement represents a significant innovation within multidisciplinary approaches to enhancing mental well-being. This review follows the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and was conducted using the Scopus and Web of Science (WOS) databases, primary sources for education-related studies. Thirteen papers were analyzed, yielding important insights into the relationship between gamified physical activity and mental health. The findings indicate that gamified physical activity positively influences adolescents' mental health and well-being. Additionally, there is a need for improved application and game design to enhance learning within school contexts. Tailoring exergames to fit specific disciplines and school-related characteristics can promote healthier mobile application usage and offer significant benefits for the mental health of young individuals. The difference between this study and previous ones is that it focuses on mobile applications for encouraging active living to improve quality of life and mental health. [ABSTRACT FROM AUTHOR]

Background: People with dementia are often marginalized and excluded from influence, also in relation to dementia research. There is, however, a growing requirement for inclusion through Patient and Public Involvement (PPI), but there is still limited knowledge on how researchers can fully benefit from the involvement of people with dementia in the development and testing of psychosocial interventions. This paper describes the results of a pan‐European consultation with people with dementia, synthesizing their views on outcomes of psychosocial interventions. Objective: To involve people with dementia in establishing what are meaningful outcomes when participating in psychosocial interventions. Setting and participants: Consultations took place at four divergent sites across Europe, involving twenty‐five people with dementia from nine European countries. Methods: The methods used for the consultation were developed through an iterative process involving people with dementia. Data from the consultation were analysed from a thematic analysis approach. Results: The results suggested that people with dementia wish to participate in interventions that enhance their well‐being, confidence, health, social participation and human rights. This highlights a need for improvements in psychosocial research to capture these outcomes. Discussion and conclusions: Involving people with dementia in discussions of psychosocial interventions has enhanced our understanding about meaningful outcome measures in research and methods of data collection. This study suggests that new outcome measures in psychosocial research are needed where concepts of positive psychology and social health can guide innovation and outcome measurement. [ABSTRACT FROM AUTHOR]

Objective: The main aims of this paper are to analyse the monetary value of informal care time using different techniques and to identify significant variables associated with the number of caregiving hours. Data and methods: A multicentre study in two Spanish regions in adult caregivers was conducted. A total sample of 604 people was available. A multivariate analysis was performed to identify the variables associated with the number of hours of caregiving time. In the monetary valuation of informal care provided, three approaches were used: replacement cost method, opportunity cost and contingent valuation (willingness to pay and willingness to accept). Results: The main determinants of the amount of time of informal care provided were age, gender, the level of care receiver´s dependence and the professional care services received (at home and out of home). The value estimated for informal care time ranges from EUROS 80,247 (replacement cost method) to EUROS 14,325 (willingness to pay), with intermediate values of EUROS 27,140 and EUROS 29,343 (opportunity cost and willingness to accept, respectively). Several sensitivity analyses were performed over the base cases, confirming the previous results. Conclusions: Time of informal care represents a great social value, regardless of the applied technique. However, the results can differ strongly depending on the technique chosen. Therefore, the choice of technique of valuation is not neutral. Among the determinants of informal care time, the professional care received at home has a complementary character to informal care, while the formal care outside the home has a substitute character. [ABSTRACT FROM AUTHOR]

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Background: The European Organisation for Research and Treatment of Cancer (EORTC) Group has developed a new multidimensional instrument measuring cancer-related fatigue to be used in conjunction with the quality of life core questionnaire (EORTC QLQ-C30). The module EORTC QLQ-FA13 assesses physical, cognitive, and emotional aspects of cancer-related fatigue.Methods: The methodology follows the EORTC guidelines for phase IV validation of modules. This paper focuses on the results of the psychometric validation of the factorial structure of the module. For validation and cross-validation confirmatory factor analysis (maximum likelihood estimation), intraclass correlation and Cronbach alpha for internal consistency were employed. The study involved an international multicenter collaboration of 11 European and non-European countries.Results: A total of 946 patients with various tumor diagnoses were enrolled. Based on the confirmatory factor analysis, we could approve the three-dimensional structure of the module. Removing one item and reassigning the factorial mapping of another item resulted in the EORTC QLQ-FA12. For the revised scale, we found evidence supporting good local (indicator reliability ≥ 0.60, factor reliability ≥ 0.82) and global model fit (GFI t1|t2 = 0.965/0.957, CFI t1|t2 = 0.976/0.972, RMSEA t1|t2 = 0.060/0.069) for both measurement points. For each scale, test-retest reliability proved to be very good (intraclass correlation: R t1-t2 = 0.905-0.921) and internal consistency proved to be good to high (Cronbach alpha = .79-.90).Conclusion: Based on the former phase III module, the multidimensional structure was revised as a phase IV module (EORTC FA12) with an improved scale structure. For a comprehensive validation of the EORTC FA12, further aspects of convergent and divergent validity as well as sensitivity to change should be determined. [ABSTRACT FROM AUTHOR]

The Wound‐QoL assesses the impact of chronic wounds on patients' health‐related quality of life (HRQoL). A 17‐item and a shortened 14‐item version are available. The Wound‐QoL‐17 has been validated for multiple languages. For the Wound‐QoL‐14, psychometric properties beyond internal consistency were lacking. We aimed to validate both Wound‐QoL versions for international samples representing a broad range of European countries, including countries for which validation data had yet been pending. Patients with chronic wounds of any aetiology or location were recruited in Austria, Lithuania, the Netherlands, Poland, Slovakia, Spain, Switzerland and Ukraine. Psychometric properties were determined for both Wound‐QoL versions for the overall sample and, if feasible, country‐wise. We included 305 patients (age 68.5 years; 52.8% males). Internal consistency was high in both Wound‐QoL‐17 (Cronbach's α: 0.820–0.933) and Wound‐QoL‐14 (0.779–0.925). Test–retest reliability was moderate to good (intraclass correlation coefficient: 0.618–0.808). For Wound‐QoL‐17 and Wound‐QoL‐14, convergent validity analyses showed highest correlations with global HRQoL rating (r = 0.765; r = 0.751) and DLQI total score (r = 0.684; r = 0.681). Regarding clinical data, correlations were largest with odour (r = −0.371; r = −0.388) and wound size (r = 0.381; r = 0.383). Country‐wise results were similar. Both Wound‐QoL versions are valid to assess HRQoL of patients with chronic wounds. Due to its psychometric properties and brevity, the Wound‐QoL‐14 might be preferrable in clinical practice where time is rare. The availability of various language versions allows for the use of this questionnaire in international studies and in clinical practice when foreign language patients are being treated. [ABSTRACT FROM AUTHOR]

A child's disability, long-term illness, or mental ill-health is known to affect siblings' health, social life, school engagement, and quality of life. This article addresses a research gap by its focus on young sibling carers and the impact of providing care to a sibling. A cross-national survey study was conducted in 2018–2019 (Italy, the Netherlands, Slovenia, Sweden, Switzerland, the UK) to examine the incidence of adolescent sibling carers, the extent of care they provide, and their self-reported health, well-being, and school situation. The survey was completed by 7146 adolescents, aged 15–17, and 1444 of them provided care to family members with health-related conditions. Out of these, 286 were identified as Sibling Carers and 668 as Parent Carers, while 181 had both sibling(s) and parent(s) with health-related conditions, and thus were identified as Sibling–Parent Carers. Sibling Carers and Sibling–Parent Carers carried out higher levels of caring activities compared to Parent Carers. They reported both positive aspects of caring, such as increased maturity, and negative aspects, such as mental ill-health, impact on schooling and a lack of support. To reduce the negative aspects of a sibling carer role, it is important to recognise them and to implement early preventive measures and formal support. [ABSTRACT FROM AUTHOR]

The progressive population ageing observed in Western countries determines a growing need for long-term care for older people. At the same time, migrants and refugees often have integration difficulties in regards to the hosting country society and labour market, with one reason being the lack of EU recognition of the educational degrees obtained in their native country. Creating educational opportunities in elderly care for migrants may facilitate their social inclusion, increase their employability, and constitute a response to the growing labor demand. The HERO project moved in this direction by planning, designing, and carrying out an original training curriculum targeted to migrants and refugees from African and Middle Eastern countries, piloted in four Mediterranean countries (Cyprus, Greece, Italy, and Portugal). The impact of the training on migrants and refugees' quality of life was assessed through the WHOQOL-BREF questionnaire, while social inclusion was assessed through semistructured interviews and participant observation carried out during the internship in elderly care facilities. Eighty-two migrants (70.7 percent women) were involved in the study. The results showed that despite the fact that the training did not have an impact on the trainees' quality of life, it was associated with social inclusion. Four ideal types of migrant learners were drawn: "ex-professional trainees," "fall-back trainees," "care-oriented trainees," and "nonprofessional care workers," based on which as many possible educational pathways were drawn to optimise the trainees' learning process. The study results shaped the formulation of suggestions on migrants' education in elderly care. [ABSTRACT FROM AUTHOR]

Health-related quality of life (HRQOL) assessment in children and adolescents with chronic health conditions is increasingly considered as a relevant topic. The aim of the EU-funded DISABKIDS project is to develop, test, and implement European instruments for the assessment of HRQOL of children and adolescents with disabilities and their families. The current paper describes the development and pilot testing of a chronic generic HRQOL measure. Using literature searches, expert consulting and focus groups with children/adolescents and their families, items of the instruments were developed and translated into the respective languages. A pilot test with 360 children and adolescents was conducted. Children and adolescents (8-12, 13-16 years) with different chronic health conditions (asthma, epilepsy, diabetes, arthritis, atopic dermatitis, cerebral palsy, and cystic fibrosis) as well as their families were included. Data were analysed according to predefined psychometric and content criteria. Psychometric analyses resulted in a 56-item chronic generic HRQOL questionnaire with six domains ('Medication', 'Physical', 'Emotion', 'Independence', 'Social Inclusion', 'Social Exclusion') with acceptable internal consistency. [ABSTRACT FROM AUTHOR]

Background: Migraine is a highly prevalent primary headache disorder and a leading cause of disability. Difficulties in access to care during diagnostic and therapeutic journey contribute to the disease burden. Several target-specific drugs have reached the market in the past four years and have modified the treatment paradigm in migraine. The aim of this study is to provide an updated snapshot of the pathways and hurdles to care for migraine in different European countries by directly asking patients. Methods: In 2021 the European Migraine and Headache Alliance proposed a 39-item questionnaire that was administered online to an adult migraine population in European countries. Questions were focused on socio-demographic and migraine data, access to diagnosis and treatment, disease-related burden and the main channel for disease information. Results: A total of 3169 questionnaires were returned from 10 European countries. Responders were predominantly females, age range 25–59 years, with a migraine history longer than 10 years in 82% of cases, and with at least 8 headache days per month in 57% of cases. Respondents reported limitations in social, working and personal life during both the ictal and interictal phase. The activities mostly impaired during the attacks were driving (55%), cooking or eating (42%), taking care of family/childcare (40%) and getting medicines at the pharmacy (40%). The most frequently reported unmet need was the long delay between the first visit and migraine diagnosis: 34% of respondents had to see ≥ 4 specialists before being correctly diagnosed, and between the diagnosis and treatment prescription: > 5 years in 40% of cases. The most relevant needs in terms of quality of life were the desire for a lower migraine frequency, an effective treatment and a greater involvement in society. Conclusions: Data from the present survey point to the existence and persistence of multiple hurdles that result in significant limitations to access to care and to the patients' social life. A close cooperation between decision makers, healthcare workers and patients is needed to overcome these barriers. [ABSTRACT FROM AUTHOR]

Background and purpose -- Routine outcome measurement has been shown to improve performance in several fields of healthcare. National spine surgery registries have been initiated in 5 Nordic countries. However, there is no agreement on which outcomes are essential to measure for adolescent and young adult patients with a spinal deformity. The aim of this study was to develop a core outcome set (COS) that will facilitate benchmarking within and between the 5 countries of the Nordic Spinal Deformity Society (NSDS) and other registries worldwide. Material and methods -- From August 2015 to September 2016, 7 representatives (panelists) of the national spinal surgery registries from each of the NSDS countries participated in a modified Delphi study. With a systematic literature review as a basis and the International Classification of Functioning, Disability and Health framework as guidance, 4 consensus rounds were held. Consensus was defined as agreement between at least 5 of the 7 representatives. Data were analyzed qualitatively and quantitatively. Results -- Consensus was reached on the inclusion of 13 core outcome domains: "satisfaction with overall outcome of surgery", "satisfaction with cosmetic result of surgery", "pain interference", physical functioning", "health-related quality of life", "recreation and leisure", "pulmonary fatigue", "change in deformity", "selfimage", "pain intensity", "physical function", "complications", and "re-operation". Panelists agreed that the SRS-22r, EQ-5D, and a pulmonary fatigue questionnaire (yet to be developed) are the most appropriate set of patient-reported measurement instruments that cover these outcome domains. Interpretation -- We have identified a COS for a large subgroup of spinal deformity patients for implementation and validation in the NSDS countries. This is the first study to further develop a COS in a global perspective. [ABSTRACT FROM AUTHOR]

To explore the value of antiandrogen therapy for advanced prostate cancer, two clinical trials of similar design were recently conducted in six countries throughout Europe. A total of 550 patients with previously untreated metastatic prostate cancer were randomized either to treatment with an antiandrogen or castration. While time to treatment failure, objective tumour response and survival were expected to be similar between study treatments, their effects on health-related quality of life (HRQOL) were expected to differ and were therefore a focus of concern in this trial. To assess these effects, we developed a brief self-administered patient questionnaire covering 10 domains of HRQOL (general health perceptions, pain, emotional well-being, vitality, social functioning, physical capacity, sexual interest, sexual functioning, activity limitation and bed disability), which we translated from English into several other languages. In this paper, we describe the development, content and translation of this survey instrument and report on its reliability and validity in six countries based on data collected for the first 487 patients to complete questionnaires at study entry. [ABSTRACT FROM AUTHOR]

This study aimed to investigate associations between individual-level (personality traits, quality of life) and country-level (gross domestic product per capita, number of policies and action plans for physical activity) factors with self-reported and accelerometer-based physical activity and cross-level interactions among European countries. Based on the Survey of Health, Ageing and Retirement in Europe (SHARE) from 2019–2020, self-reported physical activity (N = 46,617 from 27 countries) and accelerometer-based average acceleration and intensity gradient (N = 855 from 10 countries) were analyzed. Mixed-model regressions with two levels (individuals nested within countries) were used for analyses. Between countries differences accounted for relatively small portions of the variability in self-reported physical activity (intraclass correlation, ICC = 7.5%), average acceleration (ICC = 3.5%), and intensity gradient (ICC = 1.9%). There were more associations between individual- and country-level factors and self-reported physical activity than with accelerometer-based physical activity. The association between individual-level variables and accelerometer-based physical activity did not differ between countries. Cross-level interactions suggested that associations between some personality traits and self-reported physical activity were stronger in countries with lower GDP. Both individual- and country-level factors are related to participation in more intensive physical activities. Adults with less resilient personality traits living in countries with lower resources are at the highest risk for physical inactivity. [ABSTRACT FROM AUTHOR]

Background: The proportion of elderly is on the rise both in Europe and in Hungary. The challenge is to increase the number of years spent in good health as well as to improve quality of life of those 60 years and above. This study focuses on the impact of physical activity on this age group.Methods: A nationally representative sample of 2000 respondents were surveyed in an age range of 15-74. Our data concerns those being 60-74 years of age. The focus of our investigation was level and impact of physical activity in the group above. First, we used Chi-squared tests and correspondence analysis to identify the deviation in the answers of different groups in our sample. After we built a hierarchical linear regression model to get a deeper understanding of the impact of physical activity for elderly.Results: Those reporting no physical/sports activity at all have to do with the negative culture of exercising. Only 9.3% reported being engaged with any sports; 72% reported no regular exercising throughout their lives. The relationship between sport activity and self-reported health was significant (p = 0.009, Cramer's V = 0.2). Elderly were characterized by walking, hiking and less intense sports.Conclusions: Those who actively exercised in this research reported better health outcomes than those who stopped or had never been engaged in any sports. We conclude that of all variables tested, physical activity was most effective to improve personal health of the elderly in this sample. Compared to European data on physical activity of elderly populations, Hungary seems to fall behind and needs to consider concentrated efforts to improve the future health of its senior populace. [ABSTRACT FROM AUTHOR]

Patient satisfaction with the general practitioner (GP) is lower in older persons with a higher level of complexity of health problems. This study investigates whether, in these older persons, changes in satisfaction with their GP, on receiving improved integrated care, is related to their perceived health state.Using the Integrated Systematic Care for Older People (ISCOPE) trial (aimed at improving person- centered integrated care) this study compared changes in satisfaction with the GP in older persons (aged ≥75 years) with a high level of complex health problems on receiving integrated care, stratified for perceived health state at baseline. Satisfaction with the GP was registered on a 5-point Likert scale. Perceived health state was estimated with the Older Persons and Informal Caregivers Survey-Composite End Point (TOPICS-CEP) at baseline, stratified into 33% percentiles. Differences in satisfaction change between the intervention and usual care/control groups (overall and stratified for perceived health state) are presented by percentages of ‘very satisfied’ participants and improving or deteriorating 1 or more points on the Likert scale. At baseline, the intervention (n = 151) and control group (n = 603) were mainly female (75%) and living alone (62%); mean age was 83 years. Medical status, perceived health state and characteristics of participants were similar. Overall, at baseline 44.4% of respondents in the intervention group were ‘very satisfied’ compared with 37.1% at follow-up, (difference -7.3%). In the control group, ‘very satisfied’ at baseline was 32% and at follow up 29.2% (difference -2.8%). The p-value for this difference in change is 0.56. After stratification for TOPICS-CEP the results were the same. In older persons with a high level of complexity of health problems, implementation of person- centered integrated healthcare did not influence their satisfaction with the GP, also not among those with the highest or lowest perceived health state. [ABSTRACT FROM AUTHOR]

Purpose: 1) To systematically review the available scientific literature regarding specific instruments developed and/or tested in a Spanish population, to assess these PROMs in hip arthroplasty; 2) to carry out a standardized assessment of their measurement properties; and 3) to identify the best tools for use in Spain in an arthroplasty registry context. Methods: A systematic review of PubMed/MEDLINE and EMBASE and CINHAL was done. Furthermore, a standardized assessment of the questionnaires identified using the Evaluating the Measurement of Patient-Reported Outcomes (EMPRO) tool was performed. All developments, validation and studies aiming to assess the measurement properties of PROMs in hip arthroplasty in the Spanish population were included. Data from the questionnaires on metric properties was taken into account to identify the best candidates for inclusion in a register. Results: A total of 853 documents were found. After screening title and abstract, 13 full text documents were reviewed and 8 questionnaires adapted and validated to assess some of the aspects of hip arthroplasty in the Spanish population were identified. After the EMPRO assessment, 4 questionnaires showed suitable properties (WOMAC, OAKHQOL, mini-OAKHQOL and PFH). Conclusions: In Spain, there are a few suitable hip-specific questionnaires currently available to assess PROMs in hip arthroplasty surgery. Some of the more widely used questionnaires, like the OHS and HOOS, have not been validated in the Spanish population until now. Identified tools are suitable for use in a clinical context, however their use in an arthroplasty register is more questionable due to the lack of validation studies of the widely used tools in other registers. [ABSTRACT FROM AUTHOR]

Background: Traumatic injury is the fourth leading cause of death globally. Half of all trauma deaths are due to bleeding and most of these will occur within 6 h of injury. Haemorrhagic shock following injury has been shown to induce a clotting dysfunction within minutes, and this early trauma-induced coagulopathy (TIC) may exacerbate bleeding and is associated with higher mortality and morbidity. In spite of improved resuscitation strategies over the last decade, current transfusion therapy still fails to correct TIC during ongoing haemorrhage and evidence for the optimal management of bleeding trauma patients is lacking. Recent publications describe increasing the use of Viscoelastic Haemostatic Assays (VHAs) in trauma haemorrhage; however, there is insufficient evidence to support their superiority to conventional coagulation tests (CCTs).Methods/design: This multicentre, randomised controlled study will compare the haemostatic effect of an evidence-based VHA-guided versus an optimised CCT-guided transfusion algorithm in haemorrhaging trauma patients. A total of 392 adult trauma patients will be enrolled at major trauma centres. Participants will be eligible if they present with clinical signs of haemorrhagic shock, activate the local massive haemorrhage protocol and initiate first blood transfusion. Enrolled patients will be block randomised per centre to either VHA-guided or CCT-guided transfusion therapy in addition to that therapy delivered as part of standard care, until haemostasis is achieved. Patients will be followed until discharge or 28 days. The primary endpoint is the proportion of subjects alive and free of massive transfusion (less than 10 units of red blood cells) at 24 h. Secondary outcomes include the effect of CCT- versus VHA-guided therapy on organ failure, total hospital and intensive care lengths of stay, health care resources needed and mortality. Surviving patients will be asked to complete a quality of life questionnaire (EuroQol EQ-5DTM) at day 90.Discussion: CCTs have traditionally been used to detect TIC and monitor response to treatment in traumatic major haemorrhage. The use of VHAs is increasing, but limited evidence exists to support the superiority of these technologies (or comparatively) for patient-centred outcomes. This knowledge gap will be addressed by this trial.Trial Registration: ClinicalTrials.gov, ID: NCT02593877 . Registered on 15 October 2015. Trial sponsor Queen Mary University of London The contact person of the above sponsor organisation is: Dr. Sally Burtles, Director of Research Services and Business Development, Joint Research Management Office, QM Innovation Building, 5 Walden Street, London E1 2EF; phone: 020 7882 7260; Email: sponsorsrep@bartshealth.nhs.uk Trial sites Academic Medical Centre, Amsterdam, The Netherlands Kliniken der Stadt Köln gGmbH, Cologne, Germany Rigshospitalet (Copenhagen University Hospital), Copenhagen, Denmark John Radcliff Hospital, Oxford, United Kingdom Oslo University Hospital, Oslo, Norway The Royal London Hospital, London, United Kingdom Centre for Trauma Sciences, Blizard Institute, Queen Mary University of London, London, United Kingdom Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom Sites that are planning to start recruitment in mid/late 2017 Nottingham University Hospitals, Queen's Medical Centre, Nottingham, United Kingdom University of Kansas Hospital (UKH), Kansas City, MO, USA Protocol version: 3.0/14.03.2017 (Additional file 1). [ABSTRACT FROM AUTHOR]

Background: It is important to know whether the relationships between experienced and evaluative well-being and health are consistent across countries with different income levels. This would allow to confirm whether the evidence found in high income countries is the same as in low- and middle-income countries and to suggest policy recommendations that are generalisable across countries. We assessed the association of well-being with health status; analysed the differential relationship that positive affect, negative affect, and evaluative well-being have with health status; and examined whether these relationships are similar across countries.Methods: In this cross-sectional study, interviews were conducted amongst 53,269 adults from nine countries in Africa, Asia, Europe, and Latin America. Evaluative well-being was measured with a short version of the World Health Organization (WHO) Quality of Life instrument, and experienced well-being was measured with the Day Reconstruction Method. Decrements in health were assessed with the 12-item version of WHO Disability Assessment Schedule 2.0. Block-wise linear regression and structural equation models were employed.Results: Considering the overall sample, evaluative well-being was more strongly associated with health (β = -0.35) than experienced well-being (β = -0.14), and negative affect was more strongly associated with health (β = 0.10) than positive affect (β = -0.02). The relationship between health and well-being was similar across countries. Lower scores in evaluative well-being and a higher age were the factors more strongly related with a worse health.Conclusions: The different patterns observed across countries may be related to differences in the countries' gross domestic product, social protection system, economic situation, health care provision, lifestyle behaviours, or living conditions. The fact that evaluative well-being is more predictive of health than experienced well-being suggests that our level of satisfaction with our lives might be more important for our health than the actual emotions than we experience in our day-to-day lives and points out the need of interventions that improve the way people evaluate their lives. [ABSTRACT FROM AUTHOR]

Background: Severe haemophilia is associated with major psychological and economic burden for patients, caregivers, and the wider health care system. This burden has been quantified and documented for a number of European countries in recent years. However, few studies have taken a standardised methodology across multiple countries simultaneously, and sought to amalgamate all three levels of burden for severe disease. The overall aim of the 'Cost of Haemophilia in Europe: a Socioeconomic Survey' (CHESS) study was to capture the annualised economic and psychosocial burden of severe haemophilia in five European countries. A cross-section of haemophilia specialists (surveyed between January and April 2015) provided demographic and clinical information and 12-month ambulatory and secondary care activity for patients via an online survey. In turn, patients provided corresponding direct and indirect non-medical cost information, including work loss and out-of-pocket expenses, as well as information on quality of life and adherence. The direct and indirect costs for the patient sample were calculated and extrapolated to population level.Results: Clinical reports for a total of 1,285 patients were received. Five hundred and fifty-two patients (43% of the sample) provided information on indirect costs and health-related quality of life via the PSC. The total annual cost of severe haemophilia across the five countries for 2014 was estimated at EUR 1.4 billion, or just under EUR 200,000 per patient. The highest per-patient costs were in Germany (mean EUR 319,024) and the lowest were in the United Kingdom (mean EUR 129,365), with a study average of EUR 199,541. As expected, consumption of clotting factor replacement therapy represented the vast majority of costs (up to 99%). Indirect costs are driven by patient and caregiver work loss.Conclusions: The results of the CHESS study reflect previous research findings suggesting that costs of factor replacement therapy account for the vast majority of the cost burden in severe haemophilia. However, the importance of the indirect impact of haemophilia on the patient and family should not be overlooked. The CHESS study highlights the benefits of observational study methodologies in capturing a 'snapshot' of information for patients with rare diseases. [ABSTRACT FROM AUTHOR]

Background: Understanding of the physical, functional and psychosocial health problems and needs of cancer survivors requires cross-national and cross-cultural standardization of health-related quality of life (HRQoL) questionnaires that capture the full range of issues relevant to cancer survivors. To our knowledge, only one study has investigated in a comprehensive way whether a questionnaire used to evaluate HRQoL in cancer patients under active treatment is also reliable and valid when used among (long-term) cancer survivors. In this study we evaluated, in an international context, the psychometrics of HRQoL questionnaires for use among long-term, disease-free, survivors of testicular and prostate cancer.Methods: In this cross-sectional study, we recruited long-term survivors of testicular and prostate cancer from Northern and Southern Europe and from the United Kingdom who had participated in two phase III EORTC clinical trials. Participants completed the SF-36 Health Survey, the EORTC QLQ-C30 questionnaire, the QLQ-PR25 (for prostate cancer) or the QLQ-TC26 (for testicular cancer) questionnaires, and the Impact of Cancer questionnaire. Testicular cancer survivors also completed subscales from the Nordic Questionnaire for Monitoring the Age Diverse Workforce.Results: Two hundred forty-two men (66% response rate) were recruited into the study. The average time since treatment was more than 10 years. Overall, there were few missing questionnaire data, although scales related to sexuality, satisfaction with care and relationship concerns of men without partners were missing in more than 10% of cases. Debriefing showed that in general the questionnaires were accepted well. Many of the survivors scored at the upper extremes of the questionnaires, resulting in floor and ceiling effects in 64% of the scales. All of the questionnaires investigated met the threshold of 0.70 for group level reliability, with the exception of the QLQ-TC26 (mean reliability .64) and the QLQ-PR25 (mean reliability .69). The questionnaires were able to discriminate clearly between patients with and without comorbid conditions.Conclusions: The currently available HRQoL questionnaires exhibit acceptable psychometric properties and were well received by patients, but additional efforts are needed to ensure that the full range of survivor-specific issues is assessed. [ABSTRACT FROM AUTHOR]

Objectives. The aim was to evaluate the cross-cultural validity of the Lupus Impact Tracker (LIT) in five European countries and to assess its acceptability and feasibility from the patient and physician perspectives. Methods. A prospective, observational, cross-sectional and multicentre validation study was conducted in clinical settings. Before the visit, patients completed LIT, Short Form 36 (SF-36) and care satisfaction questionnaires. During the visit, physicians assessed disease activity [Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI], organ damage [SLICC/ACR damage index (SDI)] and flare occurrence. Cross-cultural validity was assessed using the Differential Item Functioning method. Results. Five hundred and sixty-nine SLE patients were included by 25 specialists; 91.7% were outpatients and 89.9% female, with mean age 43.5(13.0) years. Disease profile was as follows: 18.3% experienced flares; mean SELENA-SLEDAI score 3.4 (4.5); mean SDI score 0.8 (1.4); and SF-36 mean physical and mental component summary scores: physical component summary 42.8(10.8) and mental component summary 43.0(12.3). Mean LIT score was 34.2(22.3) (median: 32.5), indicating that lupus moderately impacted patients' daily life. A cultural Differential Item Functioning of negligible magnitude was detected across countries (pseudo-R2 difference of 0.01-0.04). Differences were observed between LIT scores and Physician Global Assessment, SELENA-SLEDAI, SDI scores = 0 (P < 0.035) and absence of flares (P = 0.004). The LIT showed a strong association with SF-36 physical and social role functioning, vitality, bodily pain and mental health (P < 0.001). The LIT was well accepted by patients and physicians. It was reliable, with Cronbach a coefficients ranging from 0.89 to 0.92 among countries. Conclusion. The LIT is validated in the five participating European countries. The results show its reliability and cultural invariability across countries. They suggest that LIT can be used in routine clinical practice to evaluate and follow patient-reported outcomes in order to improve patient-physician interaction. [ABSTRACT FROM AUTHOR]

Background: The strict and demanding dietary treatment and mild cognitive abnormalities seen in PKU treated from a young age can be expected to affect the health-related quality of life (HRQoL) of patients and their families. Our aim was to describe the HRQoL of patients with PKU from a large international study, using generic HRQoL measures and an innovative PKU-specific HRQoL questionnaire (PKU-QOL). Analyses were exploratory, performed post-hoc on data collected primarily to validate the PKU-QOL. Methods: A multicentre, prospective, non-interventional, observational study conducted in France, Germany, Italy, The Netherlands, Spain, Turkey and the UK. Patients diagnosed with PKU aged =9 years old and treated with a Phe-restricted diet and/or Phe-free amino acid protein supplements and/or pharmacological therapy were included in the study; parents of at least one patient with PKU aged <18 years were also included. HRQoL was assessed by generic measures (Pediatric Quality-of-Life Inventory; Medical Outcome Survey 36 item Short Form; Child Health Questionnaire 28 item Parent Form) and the newly developed PKU-QOL. Mean generic domain scores were interpreted using published reference values from the general population. PKU-QOL domain scores were described overall and in different subgroups of patients defined according to severity of PKU, overall assessment of patient's health status by the investigator and treatment with tetrahydrobiopterin (BH4). Results: Data from 559 subjects were analysed: 306 patients (92 children, 110 adolescents, 104 adults) and 253 parents. Mean domain scores of generic measures in the study were comparable to the general population. The highest PKU-QOL impact scores (indicating greater impact) were for emotional impact of PKU, anxiety about blood Phe levels, guilt regarding poor adherence to dietary restrictions or Phe-free amino acid supplement intake and anxiety regarding blood Phe levels during pregnancy. Patients with mild/moderate PKU and those receiving BH4 reported lower practical and emotional impacts of the diet and Phe-free amino acid supplement intake. Conclusion: Patients with PKU showed good HRQoL in the study, both with the generic and PKU-specific measures. Negative impacts of PKU on a patient's life, including the emotional impact of PKU and its management, was delineated by the PKU-QOLs across all age groups. [ABSTRACT FROM AUTHOR]

This study employs the concept of structured ambivalence to analyse the effect of grandchild care on quality of life (QoL) in different cultural contexts. We define structured ambivalence as the contradiction between behaviour and cultural norms. The analysis is based on the Survey of Health, Ageing and Retirement in Europe with 14 countries in the sample. We focus on grandparents aged 50 and over with at least one grandchild 12 years old or younger ( n = 12,740). In countries with high grandparent obligations, grandparents who did not look after their grandchildren reported a lower quality of life. Compliance with such grandparental obligations (e.g. providing grandchild care in a country with high grandparent obligations) was found to increase the QoL of grandparents. Family policy should consider family practices that better match the realities of current grandparents' lives in order to reduce structured ambivalence and increase the QoL of grandparents. [ABSTRACT FROM AUTHOR]

Background: Whether socioeconomic inequalities in health and well-being persist into old age and are narrower in more generous welfare states is debated. We investigated the magnitude of socioeconomic inequality in the quality of life of Europeans in early old age and the influence of the welfare regime type on these relationships. Methods: Data from individuals aged 50–75 years (n = 16 074) residing in 13 European countries were derived from Waves 2 and 3 of the Survey of Health, Ageing and Retirement in Europe. Slope indices of inequality (SIIs) were calculated for the association between socioeconomic position and CASP-12, a measure of positive quality of life. Multilevel linear regression was used to assess the overall relationship between socioeconomic position and quality of life, using interaction terms to investigate the influence of the type of welfare regime (Southern, Scandinavian, Post-communist or Bismarckian). Results: Socioeconomic inequalities in quality of life were narrowest in the Scandinavian and Bismarckian regimes, and were largest by measures of current wealth. Compared with the Scandinavian welfare regime, where narrow inequalities in quality of life by education level were found in both men (SII = 0.02, 95% CI: −1.09 to 1.13) and women (SII = 1.11, 95% CI: 0.05–2.17), the difference in quality of life between the least and most educated was particularly wide in Southern and Post-communist regimes. Conclusion: Individuals in more generous welfare regimes experienced higher levels of quality of life, as well as narrower socioeconomic inequalities in quality of life. [ABSTRACT FROM AUTHOR]

Background Recurrent vulvovaginal candidosis (RVVC) is a chronic condition causing discomfort and pain. Health status and health-related quality of life (HRQoL) in RVVC were never previously described using validated questionnaires. The objective of this study is to describe subjective health status and HRQoL and estimate health state utilities among women with RVVC. Methods A cross-sectional online survey was conducted among women who reported having suffered four or more yeast infections over the past 12 months, in five European countries (France, Germany, Italy, Spain and the UK) and the USA. Index scores were derived from the EQ-5D, a questionnaire providing a single index value for health status. The SF-36 questionnaire was used for HRQoL assessment. Information on disease severity, treatment patterns and productivity was also collected. Results 12,834 members of online research panels were contacted. Among them, 620 women with RVVC (5%) were selected to complete the full questionnaire. The mean EQ-5D index score was 0.70 (95% confidence interval: [0.67, 0.72]) and the difference between women with a yeast infection at the time of questionnaire completion and other respondents was 0.05 (p = 0.47). The EQ-5D index score increased significantly with the time since last infection (p < 0.001). 68% of women reported depression/anxiety problems during acute episode, and 54% outside episodes, compared to less than 20% in general population (p < 0.001). All SF-36 domain scores were significantly below general population norms. Mental health domains were the most affected. The impact on productivity was estimated at 33 lost work hours per year on average, corresponding to estimated costs between €266/year and €1.130/year depending on the country. Conclusions Subjective health status and HRQoL during and in between acute inflammatory episodes in women with RVVC are significantly worse than in the general population, despite the use of antifungal therapy. The average index score in women with RVVC is comparable to other diseases such as asthma or COPD and worse than diseases such as headache/migraine according to US and UK catalogs of index scores. The survey also revealed a significant loss of productivity associated with RVVC. [ABSTRACT FROM AUTHOR]

Background: Little is known about factors that determine health status decline in clinical trials of COPD.Objectives: To examine health status changes over 3 years in the TORCH study of salmeterol+fluticasone propionate (SFC) vs. salmeterol alone, fluticasone propionate alone or placebo.Methods: St George's Respiratory Questionnaire (SGRQ) was administered at baseline then every 6 months.Measurements and Main Results: Data from 4951 patients in 28 countries were available. SFC produced significant improvements over placebo in all three SGRQ domains during the study: (Symptoms -3.6 [95% CI -4.8, -2.4], Activity -2.8 [95% CI -3.9, -1.6], Impacts -3.2 [95% CI -4.3, -2.1]) but the pattern of change over time differed between domains. SGRQ deteriorated faster in patients with Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages III & IV relative to GOLD stage II (p < 0.001). There was no difference in the relationship between deterioration in SGRQ Total score and forced expiratory volume in one second (FEV1) decline (as % predicted) in men and women. Significantly faster deterioration in Total score relative to FEV1 % predicted was seen in older patients (≥ 65 years) and there was an age-related change in Total score that was independent of change in FEV1. The relationship between deterioration in FEV1 and SGRQ did not differ in different world regions, but patients in Asia-Pacific showed a large improvement in score that was unrelated to FEV1 change.Conclusions: In addition to treatment effects, health status changes in clinical trials may be influenced by demographic and disease-related factors. Deterioration in health status appears to be fastest in older persons and those with severe airflow limitation.Trial Registration: ClinicalTrials.gov: NCT00268216. [ABSTRACT FROM AUTHOR]

Background: The long-term efficacy and safety of aclidinium bromide, a novel, long-acting muscarinic antagonist, were investigated in patients with moderate to severe chronic obstructive pulmonary disease (COPD).Methods: In two double-blind, 52-week studies, ACCLAIM/COPD I (n=843) and II (n=804), patients were randomised to inhaled aclidinium 200 μg or placebo once-daily. Patients were required to have a post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity ratio of ≤70% and FEV1<80% of the predicted value. The primary endpoint was trough FEV1 at 12 and 28 weeks. Secondary endpoints were health status measured by St George's Respiratory Questionnaire (SGRQ) and time to first moderate or severe COPD exacerbation.Results: At 12 and 28 weeks, aclidinium improved trough FEV1 versus placebo in ACCLAIM/COPD I (by 61 and 67 mL; both p<0.001) and ACCLAIM/COPD II (by 63 and 59 mL; both p<0.001). More patients had a SGRQ improvement≥4 units at 52 weeks with aclidinium versus placebo in ACCLAIM/COPD I (48.1% versus 39.5%; p=0.025) and ACCLAIM/COPD II (39.0% versus 32.8%; p=0.074). The time to first exacerbation was significantly delayed by aclidinium in ACCLAIM/COPD II (hazard ratio [HR] 0.7; 95% confidence interval [CI] 0.55 to 0.92; p=0.01), but not ACCLAIM/COPD I (HR 1.0; 95% CI 0.72 to 1.33; p=0.9). Adverse events were minor in both studies.Conclusion: Aclidinium is effective and well tolerated in patients with moderate to severe COPD.Trial Registration: ClinicalTrials.gov: NCT00363896 (ACCLAIM/COPD I) and NCT00358436 (ACCLAIM/COPD II). [ABSTRACT FROM AUTHOR]

Study design: Longitudinal, multiple wave panel design. Objectives: To investigate the degree to which current thinking in terms of early appraisals and coping predicts adjustment and quality of life outcomes after spinal cord injury, and to what degree social and demographic variables are involved. Setting: Data were analysed from 266 patients recruited as part of an ongoing study from specialist units in selected British, Swiss, German and Irish spinal centres. Method:Questionnaire booklets were administered as soon as possible after injury onset and after 12 weeks to patients with newly acquired spinal cord injuries. Individuals included had sustained their injury between the ages of 16 and 83. Results: Significant improvements in outcome measures were found across the data set within the first 12 weeks after spinal cord injury and changes observed in the appraisals and coping strategies employed. Significant differences were found between participating centres on both outcome measures and in the coping and appraisal processes used. Coping and appraisal processes at 6 weeks after injury were found to contribute significantly to the variation in psychological well-being at 12 weeks after injury. Conclusion: This study shows the process of adjustment to spinal cord injury to begin in the early stages of rehabilitation, and initial appraisals are important to how an individual will cope with their injury and to their psychological well-being. Support is also given to the importance of psychological factors to functional outcomes. [ABSTRACT FROM AUTHOR]

Using the first two waves from the Survey of Health, Ageing and Retirement in Europe (SHARE) we explore dynamics of participation in two different types of productive activities (voluntary work and care for a person) and test their association with changes in well-being across 11 European countries ( N = 10,309) among people aged 50 and older. In order to measure changes in well-being, we use a standardized instrument of quality of life in early old age (CASP-12) and assess relevant decreases and increases between both waves, applying the Edwards–Nunnally method. Main findings demonstrate that older people who maintain or start their productive activity in terms of volunteering between both waves have a lower probability of experiencing a relevant decrease in well-being, while no association with a relevant increase in well-being is observed. In case of caring for a person changes in participation remain unrelated to changes in well-being. These results are maintained after adjusting for important confounders, such as functional limitation, socioeconomic position and living with a partner. These latter conditions were also strongly related to changes in well-being. Our results support a core assumption of the activity theory of ageing claiming that the initiation and maintenance of a productive activity is beneficial for older people’s well-being. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study is to assess the structural and cross-cultural validity of the KIDSCREEN-27 questionnaire.Methods: The 27-item version of the KIDSCREEN instrument was derived from a longer 52-item version and was administered to young people aged 8-18 years in 13 European countries in a cross-sectional survey. Structural and cross-cultural validity were tested using multitrait multi-item analysis, exploratory and confirmatory factor analysis, and Rasch analyses. Zumbo's logistic regression method was applied to assess differential item functioning (DIF) across countries. Reliability was assessed using Cronbach's alpha.Results: Responses were obtained from n = 22,827 respondents (response rate 68.9%). For the combined sample from all countries, exploratory factor analysis with procrustean rotations revealed a five-factor structure which explained 56.9% of the variance. Confirmatory factor analysis indicated an acceptable model fit (RMSEA = 0.068, CFI = 0.960). The unidimensionality of all dimensions was confirmed (INFIT: 0.81-1.15). Differential item functioning (DIF) results across the 13 countries showed that 5 items presented uniform DIF whereas 10 displayed non-uniform DIF. Reliability was acceptable (Cronbach's alpha = 0.78-0.84 for individual dimensions).Conclusions: There was substantial evidence for the cross-cultural equivalence of the KIDSCREEN-27 across the countries studied and the factor structure was highly replicable in individual countries. Further research is needed to correct scores based on DIF results. The KIDSCREEN-27 is a new short and promising tool for use in clinical and epidemiological studies. [ABSTRACT FROM AUTHOR]

Objective: To assess the construct and criterion validity of the KIDSCREEN-27 health-related quality of life (HRQoL) questionnaire, a shorter version of the KIDSCREEN-52.Methods: The five-dimensional KIDSCREEN-27 was tested in a sample of 22,827. For criterion validity the correlation with and the percentage explained variance of the scores of the KIDSCREEN-52 instrument were examined. Construct validity was assessed by testing a priori expected associations with other generic HRQoL measures (YQOL-S, PedsQL, CHIP), indicators of physical and mental health, and socioeconomic status. Age and gender differences were investigated.Results: Correlation with corresponding scales of the KIDSCREEN-52 ranged from r = 0.63 to r = 0.96, and r2 ranged from 0.39 to 0.92. Correlations between other HRQoL questionnaires and KIDSCREEN-27 dimensions were moderate to high for those assessing similar constructs (r = 0.36 to 0.63). Statistically significant and sizeable differences between physically and mentally healthy and ill children were found in all KIDSCREEN-27 dimensions together with strong associations with psychosomatic complaints (r = -0.52). Most of the KIDSCREEN-27 dimensions showed a gradient according to socio-economic status, age and gender.Conclusions: The KIDSCREEN-27 seems to be a valid measure of HRQoL in children and adolescents. Further research is needed to assess longitudinal validity and sensitivity to change. [ABSTRACT FROM AUTHOR]

Objective: Self-report questionnaires are widely used to measure health-related quality of life (HRQOL). Ideally, such questionnaires should be adapted to the individual patient and at the same time scores should be directly comparable across patients. This may be achieved using computerized adaptive testing (CAT). Usually, CAT is carried out for a single domain at a time. However, many HRQOL domains are highly correlated. Multidimensional CAT may utilize these correlations to improve measurement efficiency. We investigated the possible advantages and difficulties of multidimensional CAT.Study Design and Setting: We evaluated multidimensional CAT of three scales from the EORTC QLQ-C30: the physical functioning, emotional functioning, and fatigue scales. Analyses utilised a database with 2958 European cancer patients.Results: It was possible to obtain scores for the three domains with five to seven items administered using multidimensional CAT that were very close to the scores obtained using all 12 items and with no or little loss of measurement precision.Conclusion: The findings suggest that multidimensional CAT may significantly improve measurement precision and efficiency and encourage further research into multidimensional CAT. Particularly, the estimation of the model underlying the multidimensional CAT and the conceptual aspects need further investigations. [ABSTRACT FROM AUTHOR]

Background: Migraine is a distinct neurological disease that imposes a significant burden on patients, society, and the healthcare system. This study aimed to characterize the incremental burden of migraine in individuals who suffer from ≥4 monthly headache days (MHDs) by examining health-related quality of life (HRQoL), impairments to work productivity and daily activities, and healthcare resource utilization (HRU) in the EU5 (France, Germany, Italy, Spain, United Kingdom).Methods: This retrospective cross-sectional study used data from the 2016 National Health and Wellness Survey (NHWS; N = 80,600). Short-Form 36-Item Health Survey, version 2 (SF-36v2) physical and mental component summary scores (PCS and MCS), Short-form-6D (SF-6D), and EuroQoL (EQ-5D), impairments to work productivity and daily activities (Work Productivity and Activity Impairment Questionnaire (WPAI), and HRU were compared between migraine respondents suffering from ≥4 MHDs (n = 218) and non-migraine controls (n = 218) by propensity score matching using sociodemographic characteristics. Chi-square, T-tests, and Mann-Whitney tests were performed to determine significant differences between the groups after propensity score matching.Results: HRQoL was lower in migraine individuals suffering from ≥4 MHDs compared with non-migraine controls, with reduced SF-36v2 PCS (46.00 vs 50.51) and MCS (37.69 vs 44.82), SF-6D health state utility score (0.62 vs 0.71), and EQ-5D score (0.68 vs 0.81) (for all, p < 0.001). Respondents with migraine suffering from ≥4 MHDs also reported higher levels of absenteeism from work (14.43% vs 9.46%; p = 0.001), presenteeism (35.52% vs 20.97%), overall work impairment (38.70% vs 23.27%), and activity impairment (44.17% vs 27.75%) than non-migraine controls (for all, p < 0.001). Additionally, HRU was significantly higher for individuals with ≥4 MHDs compared to their matched controls. Consistently, migraine subgroups (4-7 MHDs, 8-14 MHDs and CM) had lower HRQoL, greater overall work and activity impairment, and higher HRU compared to non-migraine controls.Conclusions: Migraine of ≥4 MHDs was associated with poorer HRQoL, greater work productivity loss, and higher HRU compared with non-migraine controls. The findings of the study suggest that an unmet need exists among individuals suffering from ≥4 MHDs in the EU5 suggesting the need for effective prophylactic treatments to lessen the humanistic and economic burden of migraine. [ABSTRACT FROM AUTHOR]

Background: Around 20% of venous thromboembolism (VTE) cases occur in patients with cancer. Current guidelines recommend low molecular weight heparin (LMWH) as the preferred anticoagulant for VTE treatment. However, some guidelines state that vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs) are acceptable alternatives for long-term therapy in some patients if LMWHs are not available. LMWHs and VKAs have a number of drawbacks that can increase the burden on patients. DOACs, such as rivaroxaban, can ameliorate some burdens and may offer an opportunity to increase patient satisfaction and health-related quality of life (HRQoL). The Cancer-associated thrOmboSIs – patient-reported outcoMes with rivarOxaban (COSIMO) study is designed to provide real-world information on treatment satisfaction in patients with active cancer who switch from LMWH or VKA to rivaroxaban for the treatment of acute VTE or to prevent recurrent VTE. Methods: COSIMO is a prospective, non-interventional, single-arm cohort study that aims to recruit 500 patients in Europe, Canada and Australia. Adults with active cancer who are switching to rivaroxaban having received LMWH/VKA for the treatment and secondary prevention of recurrent VTE for at least the previous 4 weeks are eligible. Patients will be followed for 6 months. The primary outcome is treatment satisfaction assessed as change in the Anti-Clot Treatment Scale (ACTS) Burdens score at week 4 after enrolment compared with baseline. Secondary outcomes include treatment preferences, measured using a discrete choice experiment, change in ACTS Burdens score at months 3 and 6, and change in HRQoL (assessed using the Functional Assessment of Chronic Illness Therapy – Fatigue questionnaire). COSIMO will collect data on patients’ medical history, patterns of anticoagulant use and incidence of bleeding and thromboembolic events. Study recruitment started in autumn 2016. Conclusions: COSIMO will provide information on outcomes associated with switching from LMWH or VKA therapy to rivaroxaban for the treatment or secondary prevention of cancer-associated thrombosis in a real-life setting. The key goal is to assess whether there is a change in patient-reported treatment satisfaction. In addition, COSIMO will facilitate the evaluation of the safety and effectiveness of rivaroxaban in preventing recurrent VTE in this patient population. Trial registration: NCT02742623. Registered 19 April 2016. [ABSTRACT FROM AUTHOR]