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Study Question: How many twins are born in human populations and how has this changed over recent decades?Summary Answer: Since the 1980s, the global twinning rate has increased by a third, from 9.1 to 12.0 twin deliveries per 1000 deliveries, to about 1.6 million twin pairs each year.What Is Known Already: It was already known that in the 1980s natural twinning rates were low in (East) Asia and South America, at an intermediate level in Europe and North America, and high in many African countries. It was also known that in recent decades, twinning rates have been increasing in the wealthier parts of our world as a result of the rise in medically assisted reproduction (MAR) and delayed childbearing.Study Design, Size, Duration: We have brought together all information on national twinning rates available from statistical offices, demographic research institutes, individual survey data and the medical literature for the 1980-1985 and the 2010-2015 periods.Participants/materials, Setting, Methods: For 165 countries, covering over 99% of the global population, we were able to collect or estimate twinning rates for the 2010-2015 period. For 112 countries, we were also able to obtain twinning rates for 1980-1985.Main Results and the Role Of Chance: Substantial increases in twinning rates were observed in many countries in Europe, North America and Asia. For 74 out of 112 countries the increase was more than 10%. Africa is still the continent with highest twinning rates, but Europe, North America and Oceania are catching up rapidly. Asia and Africa are currently home to 80% of all twin deliveries in the world.Limitations, Reasons For Caution: For some countries, data were derived from reports and papers based on hospital registrations which are less representative for the country as a whole than data based on public administrations and national surveys.Wider Implications Of the Findings: The absolute and relative number of twins for the world as a whole is peaking at an unprecedented level. An important reason for this is the tremendous increase in medically assisted reproduction in recent decades. This is highly relevant, as twin deliveries are associated with higher infant and child mortality rates and increased complications for mother and child during pregnancy and during and after delivery.Study Funding/competing Interest(s): The contribution of CM was partially supported by the European Research Council (ERC) under the European Union's Horizon 2020 Research and Innovation Programme (grant No 681546, FAMSIZEMATTERS), Nuffield College, and the Leverhulme Trust. The contribution of GP was partially supported by the French Agence Nationale de la Recherche (grant No ANR-18-CE36-0007-07). The authors declare no conflict of interest.Trial Registration Number: N/A. [ABSTRACT FROM AUTHOR]

Background: Accounting for patients' perspective has become increasingly important. Based on the Consumer Quality Index method (founded on Consumer Assessment of Healthcare Providers and Systems) a questionnaire was recently developed for Dutch cancer patients. As a next step, this study aimed to adapt and pilot this questionnaire for international comparison of cancer patients experience and satisfaction with care in six European countries.Method: The Consumer Quality Index was translated into the local language at the participating pilot sites using cross-translation. A minimum of 100 patients per site were surveyed through convenience sampling. Data from seven pilot sites in six countries was collected through an online and paper-based survey. Internal consistency was tested by calculating Cronbach's alpha and validity by means of cognitive interviews. Demographic factors were compared as possible influencing factors.Results: A total of 698 patients from six European countries filled the questionnaire. Cronbach's alpha was good or satisfactory in 8 out of 10 categories. Patient satisfaction significantly differed between the countries. We observed no difference in patient satisfaction for age, gender, education, and tumor type, but satisfaction was significantly higher in patients with a higher level of activation.Conclusion: This European Cancer Consumer Quality Index(ECCQI) showed promising scores on internal consistency (reliability) and a good internal validity. The ECCQI is to our knowledge the first to measure and compare experiences and satisfaction of cancer patients on an international level, it may enable healthcare providers to improve the quality of cancer care. [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]

Background: Health care organizations need to be responsive to the needs of increasingly diverse patient populations. We compared the contents of six publicly available approaches to organizational responsiveness to diversity. The central questions addressed in this paper are: what are the most consistently recommended issues for health care organizations to address in order to be responsive to the needs of diverse groups that differ from the majority population? How much consensus is there between various approaches?Methods: We purposively sampled six approaches from the US, Australia and Europe and used qualitative textual analysis to categorize the content of each approach into domains (conceptually distinct topic areas) and, within each domain, into dimensions (operationalizations). The resulting classification framework was used for comparative analysis of the content of the six approaches.Results: We identified seven domains that were represented in most or all approaches: organizational commitment, empirical evidence on inequalities and needs, a competent and diverse workforce, ensuring access for all users, ensuring responsiveness in care provision, fostering patient and community participation, and actively promoting responsiveness. Variations in the operationalization of these domains related to different scopes, contexts and types of diversity. For example, approaches that focus on ethnic diversity mostly provide recommendations to handle cultural and language differences; approaches that take an intersectional approach and broaden their target population to vulnerable groups in a more general sense also pay attention to factors such as socio-economic status and gender.Conclusions: Despite differences in labeling, there is a broad consensus about what health care organizations need to do in order to be responsive to patient diversity. This opens the way to full scale implementation of organizational responsiveness in healthcare and structured evaluation of its effectiveness in improving patient outcomes. [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]

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]

Background: People experiencing homelessness (PEH) are known to be at higher risk of adverse health outcomes and premature mortality when compared to the housed population and often face significant barriers when attempting to access health services. This study aimed to better understand the specific health care needs of PEH and the barriers and facilitators associated with their timely and equitable access to health services in the European context. Methods: We conducted an exploratory cross-national qualitative study involving people with lived experience of homelessness and health and social care professionals in Austria, Greece, Spain, and the UK. A total of 69 semi-structured interviews comprising 15 social care professionals, 19 health care professionals, and 35 PEH were completed, transcribed, and analysed thematically. Results: Findings were organised into three overarching themes relating to the research question: (a) Health care needs of PEH, (b) Barriers to health care access, and (c) Facilitators to health care access. Overall, the general health of PEH was depicted as extremely poor, and mainstream health services were portrayed as ill-equipped to respond to the needs of this population. Adopting tailored approaches to care, especially involving trusted professionals in the delivery of care, was identified as a key strategy for overcoming existing barriers. Conclusions: The results of this study indicate there to be a high degree of consistency in the health care needs of PEH and the barriers and facilitators associated with their access to health care across the various European settings. Homelessness in itself is recognized to represent an essential social determinant of health, with PEH at risk of unequal access to health services. Changes are thus required to facilitate PEH's access to mainstream primary care. This can also be further complemented by investment in 'in-reach' services and other tailored and person-centred forms of health care. Trial registration: This study was registered retrospectively on June 6, 2022, in the registry of ClinicalTrials.gov under the number NCT05406687. [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]

Background: Public health organizations have been alerted to the high levels of sedentary behaviour (SB) among adolescents as well as to the health and social consequences of excess sedentary time. However, SB changes of the European Union (EU) adolescents over time have not been reported yet. This study aimed to identify SB of the EU adolescents (15-17 years) in four-time points (2002, 2005, 2013 and 2017) and to analyse the prevalence of SB according to the sex.Methods: SB of 2542 adolescents (1335 boys and 1207 girls) as a whole sample and country-by-country was analysed in 2002, 2005, 2013, and 2017 using the Sport and Physical Activity EU Special Eurobarometers' data. SB was measured using the sitting time question from the short version of the International Physical Activity Questionnaire (IPAQ), such that 4h30min of daily sitting time was the delineating point to determine excess SB behaviour (≥4h30min of sitting time) or not (≤4h30min of sitting time). A χ2 test was used to compare the prevalence of SB between survey years. Furthermore, SB prevalence between sexes was analysed using a Z-Score test for two population proportions.Results: The prevalence of SB among EU adolescents across each of the four survey years ranged from 74.2 and 76.8%, rates that are considered high. High levels of SB were also displayed by both sexes (girls: 76.8 to 81.2%; boys: 71.7 to 76.7%). No significant differences in the prevalence of SB among years (p > 0.05) were found for the whole sample, and for either girls or boys. Also, no significant differences in the prevalence of SB between girls and boys were found.Conclusion: The SB prevalence in European adolescents is extremely high (76.8% in 2017) with no differences between girls and boys. No significant improvements have been seen between 2002 and 2017. Eurobarometer should increase the adolescents' sample to make possible benchmarking comparisons among the EU countries and extend the survey to the younger children population. [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]

Objective: The Animated Activity Questionnaire (AAQ) assesses activity limitations in patients with hip/knee osteoarthritis and consists of video animations; the patients choose the animation that best matches their own performance. The AAQ has shown good validity and reliability. This study aims to evaluate cross-cultural and construct validity of the AAQ.Methods: Cross-cultural validity was assessed using ordinal logistic regression analysis to evaluate differential item functioning (DIF) across 7 languages. Construct validity was assessed by testing correlations between the AAQ and a patient-reported outcome measure (PROM) and performance-based tests.Results: Data from 1,239 patients were available. Compared to the Dutch language (n = 279), none of the 17 items showed DIF in English (n = 202) or French (n = 193), 1 item showed uniform DIF in Spanish (n = 99) and Norwegian (n = 62), and 2 items showed uniform DIF in Danish (n = 201). In all these languages, the occurrence of DIF did not influence the total score, which remained comparable with the original Dutch version. For Italian (n = 203) versus Dutch, however, 6 items showed uniform DIF, and 1 item showed nonuniform DIF, indicating some problems with the cross-cultural validity between these countries. With regard to construct validity, the correlations with PROM (0.74) and performance-based tests (0.36-0.68) were partly as expected (>0.60).Conclusion: The AAQ, an innovative tool to measure activity limitations that can be placed on the continuum between PROMs and performance-based tests, showed a good overall cross-cultural validity, and seems to have great potential for international use in research and daily clinical practice in many European countries. [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: Effective, accessible, and affordable depression treatment is of high importance considering the large personal and economic burden of depression. Internet-based treatment is considered a promising clinical and cost-effective alternative to current routine depression treatment strategies such as face-to-face psychotherapy. However, it is not clear whether research findings translate to routine clinical practice such as primary or specialized mental health care. The E-COMPARED project aims to gain knowledge on the clinical and cost-effectiveness of blended depression treatment compared to treatment-as-usual in routine care.Methods/design: E-COMPARED will employ a pragmatic, multinational, randomized controlled, non-inferiority trial in eight European countries. Adults diagnosed with major depressive disorder (MDD) will be recruited in primary care (Germany, Poland, Spain, Sweden, and the United Kingdom) or specialized mental health care (France, The Netherlands, and Switzerland). Regular care for depression is compared to "blended" service delivery combining mobile and Internet technologies with face-to-face treatment in one treatment protocol. Participants will be followed up at 3, 6, and 12 months after baseline to determine clinical improvements in symptoms of depression (primary outcome: Patient Health Questionnaire-9), remission of depression, and cost-effectiveness. Main analyses will be conducted on the pooled data from the eight countries (n = 1200 in total, 150 participants in each country).Discussion: The E-COMPARED project will provide mental health care stakeholders with evidence-based information and recommendations on the clinical and cost-effectiveness of blended depression treatment.Trial Registration: France: ClinicalTrials.gov NCT02542891 . Registered on 4 September 2015; Germany: German Clinical Trials Register DRKS00006866 . Registered on 2 December 2014; The Netherlands: Netherlands Trials Register NTR4962 . Registered on 5 January 2015; Poland: ClinicalTrials.Gov NCT02389660 . Registered on 18 February 2015; Spain: ClinicalTrials.gov NCT02361684 . Registered on 8 January 2015; Sweden: ClinicalTrials.gov NCT02449447 . Registered on 30 March 2015; Switzerland: ClinicalTrials.gov NCT02410616 . Registered on 2 April 2015; United Kingdom: ISRCTN registry, ISRCTN12388725 . Registered on 20 March 2015. [ABSTRACT FROM AUTHOR]

Background: Health workforce (HWF) planning and monitoring processes face challenges regarding data and appropriate indicators. One such area fraught with difficulties is labour activity and, more specifically, defining headcount and full-time equivalent (FTE). This study aims to review national practices in FTE calculation formulas for selected EU Member States (MS).Methods: The research was conducted as a part of the Joint Action on European Health Workforce Planning and Forecasting. Definitions, categories and terms concerning the five sectoral professions were examined in 14 MS by conducting a survey. To gain a deeper understanding of the international data-reporting processes (Joint Questionnaire on Non-Monetary Health Care Statistics-JQ), six international expert interviews were conducted by using a semi-structured interview guide.Results: Of the 14 investigated countries, four MS indicated that they report FTE to the JQ and that they also calculate FTE data for national planning purposes. The other countries do not use FTE data for national purposes, but most of them do use special calculations and/or estimation methods for converting headcount to FTE. The findings revealed significant differences between national calculation methods when reporting FTE data to the JQ. This diversity in terms of calculations and estimations can lead to biases with respect to international comparisons. This finding was reinforced by the expert interviews, since the experts agreed that the activities of healthcare professionals are a fundamental factor in HWF monitoring and planning. Experts underscored that activity should also be measured by FTE, and not only by headcount.Conclusions: FTE and headcount are significant factors in HWF planning and monitoring; therefore, national data collections should place emphasis on collecting data and calculating the appropriate indicators. National FTE could serve as a call to action for HWF planners due to the lack of matching international FTE data. At the international level, it is beneficial to monitor the trends and numbers regarding human resources and working time. For the moment, the exchange of information and mutual assistance for developing the capacity to apply common methodology could be a first step towards the standardisation of data collections. [ABSTRACT FROM AUTHOR]

Background: The factors related to the treatment of nausea during pregnancy have not yet been investigated in several countries simultaneously. The present study aimed to describe differences in self-reported nausea during pregnancy and the patterns of use for both conventional and herbal medicines across countries. The factors related to nausea and its treatment and the relationships between different self-reported co-morbidities and nausea were also investigated.Methods: This cross-sectional study used data collected by a web-based questionnaire distributed between October 2011 and February 2012 in several countries within five regions: Western, Northern, and Eastern Europe, North America, and Australia. Women who were pregnant or had a child less than one year old were eligible to participate.Results: A total of 9113 women were included in the study, whereof 6701 (73.5%) had experienced nausea during pregnancy. Among respondents with nausea, conventional medicines were used by 1201 (17.9%) women and herbal medicines by 556 (8.3%) women. The extent of self-reported nausea and its treatment varied by country. Education, working status, and folic acid use were significantly associated with the use of conventional medicines against nausea. Respondents who had nausea also had a high burden of co-morbidity.Conclusion: The prevalence of nausea was high across all participating countries but its treatment varied, possibly due to cultural differences and differences in attitudes towards medicines. A high degree of co-morbidity was found among respondents with nausea. [ABSTRACT FROM AUTHOR]

Background: It is possible that some people who quit smoking experience improved mental health after cessation and therefore remain abstinent, whereas other people who quit may experience worse mental health after cessation and therefore be more likely to relapse to smoking. Thus, in this study we aimed to examine the association between an enduring change in mental health following the cessation period and future risk of relapse.Methods: A secondary analysis of prospective data pooled from five placebo-controlled randomised trials for smoking reduction conducted in Europe, USA and Australia. Change in mental health (SF-36, scored 0-100) was measured from baseline to four months for those who were biologically-validated as point-prevalence abstainers at four month follow-up. Thereafter we assessed whether relapse to smoking by 12 months was more likely in those whose mental health had worsened between baseline and four months compared with those who saw no change or an improvement.Results: After adjustment for baseline mental health and other major covariates, there was no greater tendency to relapse at 12 months for those whose mental health worsened after cessation compared with those who had no change or an improvement. The odds ratio and 95% confidence interval was 1.01 (0.97 to 1.05).Conclusions: People whose mental health worsens after smoking cessation are at no greater risk of subsequent relapse to smoking than those whose mental health stays the same or improves. [ABSTRACT FROM AUTHOR]

Accurate food and nutrient intake assessment is essential for investigating diet–disease relationships. In the present study, food and nutrient intake assessment among European adolescents using 24 h recalls (mean of two recalls) and a FFQ (separately and the combination of both) were evaluated using concentration biomarkers. Biomarkers included were vitamin C, β-carotene, DHA+EPA, vitamin B12 (cobalamin and holo-transcobalamin) and folate (erythrocyte folate and plasma folate). For the evaluation of the food intake assessment 390 adolescents were included, while 697 were included for the nutrient intake assessment evaluation. Spearman rank and Pearson correlations, and validity coefficients, which are correlations between intake estimated and habitual true intake, were calculated. Correlations were higher between frequency of food consumption (from the FFQ) and concentration biomarkers than between mean food intake (from the recalls) and concentration biomarkers, especially for DHA+EPA (r 0·35 v. r 0·27). Most correlations were higher among girls than boys. For boys, the highest validity coefficients were found for frequency of fruit consumption (0·88) and for DHA+EPA biomarker (0·71). In girls, the highest validity coefficients were found for fruit consumption frequency (0·76), vegetable consumption frequency (0·74), mean fruit intake (0·90) and DHA+EPA biomarker (0·69). After exclusion of underreporters, correlations slightly improved. Correlations between usual food intakes, adjusted for food consumption frequency, and concentration biomarkers were higher than correlations between mean food intakes and concentration biomarkers. In conclusion, two non-consecutive 24 h recalls in combination with a FFQ seem to be appropriate to rank subjects according to their usual food intake. [ABSTRACT FROM PUBLISHER]

Background: The project GULiVer explores how lay people in Belgium (Gent), the Netherlands (Utrecht), the UK (Liverpool) and Italy (Verona) evaluate physicians’ communicative skills. The aims are to present the study design and to assess the quality of collected data. Methods: In each centre one out of two sets of four videotaped consultations involving medical students with varying communication skills were shown to eight lay panels of six to nine participants each (n = 259). The selection of lay participants was stratified by gender and age in order to obtain a heterogeneous sample. Background characteristics included socio-demographics, participants’ general physical (COOP-WONCA) and mental health (GHQ), communication preferences (QUOTE-com) and trust in doctors (TMP). Participants were asked to give quantitative and qualitative evaluations of the student doctors’ performance in a mixed-methods design. Quality assessment of the collected data and protocol adherence of the four centres was carried out by Generalized Linear Model (GLM). Results: The overall sample comprised 259 participants. Participants were equally distributed among the centres and balanced in terms of age, gender and OSCE scenario, confirming the quality of collected data. Conclusion: The study design and the applied procedures will ensure a great richness of data allowing a wider European perspective on lay persons’ views, assessed both individually and through focus group discussion. [ABSTRACT FROM PUBLISHER]

Background: Endometriosis is prevalent and women need high-quality care, which should be patient-centered. This study aimed to develop a valid and reliable patient-centeredness questionnaire, based on a defined concept of patient-centered endometriosis care (PCEC).Methods: A literature review, focus groups (FGs) with patients and an expert panel defined PCEC with 10 dimensions. The ENDOCARE questionnaire (ECQ) was developed. FGs resulted in 43 specific statements covering the 10 dimensions of PCEC, for which the ECQ measured 'importance' and 'performance'. Medical and demographic questions and an open question were added. The Dutch ECQ questionnaire was piloted and reciprocally translated into English and Italian. Patients with endometriosis from Belgium, The Netherlands, Italy and the UK were invited to complete the ECQ online. Item analysis, inter-item analysis and confirmatory and exploratory factor analyses (EFA) and reliability analysis were performed. The theory-driven dimensions were adapted.Results: The ECQ was completed by 541 patients. Based on item analysis, five statements were deleted. Factor analysis was performed on 322 questionnaires (only from respondents with a partner). Insights from the data-driven EFA suggested adaptations of the theory-driven dimensions. The reliability statistics of 9/10 adapted theory-driven dimensions were satisfactory and the root mean square error of approximation was good.Conclusions: This study resulted in a valid and reliable instrument to measure PCEC. For data presentation, the adapted theory-driven dimensions of PCEC are preferred over the data-driven factors. The ECQ may serve to benchmark patient-centeredness, conduct cross-cultural European research and set targets for improvement. [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]

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]

Objective. To document family medicine research in the 25 EGPRN member countries in 2010. Design. Semi-structured survey with open-ended questions. Setting. Academic family medicine in 23 European countries, Israel, and Turkey. Subjects. 25 EGPRN national representatives. Main outcome measures. Demographics of the general population and family medicine. Assessments, opinions, and suggestions. Results. EGPRN has represented family medicine for almost half a billion people and > 300 000 general practitioners (GPs). Turkey had the largest number of family medicine departments and highest density of GPs, 2.1/1000 people, Belgium had 1.7, Austria 1.6, and France 1.5. Lowest GP density was reported from Israel 0.17, Greece 0.18, and Slovenia 0.4 GPs per 1000 people. Family medicine research networks were reported by 22 of 25 and undergraduate family medicine research education in 20 of the 25 member countries, and in 10 countries students were required to do research projects. Postgraduate family medicine research was reported by 18 of the member countries. Open-ended responses showed that EGPRN meetings promoted stimulating and interesting research questions such as comparative studies of chronic pain management, sleep disorders, elderly care, healthy lifestyle promotion, mental health, clinical competence, and appropriateness of specialist referrals. Many respondents reported a lack of interest in family medicine research related to poor incentives and low family medicine status in general and among medical students in particular. It was suggested that EGPRN exert political lobbying for family medicine research. Conclusion. Since 1974, EGPRN organizes biannual conferences that unite and promote primary care practice, clinical research and academic family medicine in 25 member countries. [ABSTRACT FROM AUTHOR]