Search

A significant barrier to understanding the psychosocial antecedents of doping use among adolescent athletes is the lack of valid measures. In order to address this issue, the first aim of this paper was to develop and validate the Adolescent Sport Drug Inventory (ASDI) among adolescent athletes from Asia, Europe, North America, and Oceania. The second aim was to assess the construct validity of the ASDI. As such, this paper is divided into two parts. Part 1 relates to the development of the ASDI and contains two studies: item development (Study 1) and factorial validity (Study 2). Part 2 contains information on how the psychosocial variables measured in the ASDI are associated with situational temptation, and honesty (Study 3), maturation (Study 4), stress and coping (Study 5), and coaching (Study 6). In devising the ASDI, 19 different models were examined, which culminated in a 9-factor, 43-item ASDI. Coping, mastery-approach goals, and cognitive-social maturity were associated with doping attitudes. Caring motivational climates, strong coach-athlete relationships, and positive coach behaviors were associated with athletes being less susceptible toward doping, which provides construct validity for the ASDI. The ASDI is a valid tool to assess the psychosocial factors associated with doping among adolescent athletes. This questionnaire can be used to identify athletes who are the most at risk of doping, assess how the psychosocial factors associated with doping change over time, and to monitor the impact of antidoping interventions for adolescent athletes. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Objectives: Non-randomised clinical trial designs involving comparisons against external controls or specific standards can be used to support regulatory submissions for indications in diseases that are rare, with high unmet need, without approved therapies and/or where placebo is considered unethical. The objective of this review was to summarise the characteristics of non-randomised trials submitted to the European Medicines Agency (EMA) or Food and Drug Administration (FDA) for indications in haematological cancers, haematological non-malignant conditions, stem cell transplants or rare metabolic diseases., Methods: We conducted systematic searches of EMA databases of conditional approvals, exceptional circumstances, or orphan drug designations and FDA inventories of orphan drug designations, accelerated approvals, breakthrough therapy, fast-track and priority approvals. Products were included if reviewed by at least one agency between 2005 and 2017, the primary evidence base was non-randomised trial(s) and the indication was for haematological cancers, stem cell transplantation, haematological conditions or rare metabolic conditions., Results: We identified 43 eligible indication-specific products using non-randomised study designs involving comparisons with external controls, submitted to the EMA (n=34) and/or FDA (n=41). Of the 43 indication-specific products, 4 involved matching external controls to the population of a non-randomised interventional study using individual patient-level data (IPD), 12 referred to external controls without IPD and 27 did not explicitly reference external controls. The FDA approved 98% of submissions, with 56% accelerated approvals; most required postapproval confirmatory randomised controlled trials (RCT). The EMA approved 79% of submissions, with a quarter of approvals conditional on completion of a postapproval RCT or additional non-randomised trials., Conclusions: There has been a large increase in submissions to the EMA and FDA using non-randomised study designs involving comparisons with external controls in recent years. This study demonstrated that regulators may be willing to approve such submissions, although approvals are often conditional on further confirmatory evidence from postapproval studies., Competing Interests: Competing interests: AT is an employee of Takeda. EEK, TJJL and KM are employees of ICON, a CRO that was paid by Takeda to perform this study and to draft this manuscript. SG was an employee and is a consultant for ICON. ARL is a consultant for ICON. NF has received funding for research, travel or consultation from Sanofi Aventis, Takeda, Allegan, Biopharma, Ipsen, Servier, Pfizer and Novo Nordisk., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To describe patterns of healthcare resource utilisation and associated costs for patients with advanced melanoma in the United Kingdom (UK), Italy, and France., Methods: For patients receiving systemic treatment, or supportive care, data describing hospitalisations, hospice care, and outpatient visits were retrieved retrospectively from advanced disease diagnosis as part of a multicountry observational study. Costs were estimated by multiplying utilisation level by unit cost. In an exploratory analysis, costs were compared between individuals who died within one year of initiating first-line treatment (short-term survivors) and those with ≥ 1 year follow-up (long-term survivors)., Results: Hospitalisation costs were highest in France (€6262 per-person compared with €3225 in the UK and €2486 in Italy), reflecting higher rates of hospitalisation. In contrast, outpatient costs were highest in the UK (€782 per-person, compared with €115 in France and €72 in Italy), reflecting the highest rate and frequency of outpatient visits and the highest cost per visit. Hospitalisation rates were consistently higher during supportive care compared with systemic therapy. Roughly one-third of patients entered clinical trials and were not included in the analysis. In exploratory analysis, total costs were generally higher for long-term survivors, but monthly per-patient costs were generally lower for long-term survivors, consistent with a hypothesis that resource utilisation and costs do not necessarily increase proportionally with extended survival., Conclusion: Total costs associated with resource utilisation for advanced melanoma patients varied across countries. Overall cost differences were due to differences in frequency and intensity of utilisation patterns and variation in unit costs of health resources., (Copyright © 2012. Published by Elsevier Ltd.)

Unlabelled: A comprehensive review of literature was conducted to investigate variation in hip fracture incident rates around the world. The original crude incidence rates were standardized for age and sex for comparability. After standardization, the highest rates of hip fracture were found in Scandinavia and the lowest rates in Africa., Introduction: This study was conducted to investigate the geographic trends of the incidence of osteoporotic hip fractures through a comprehensive review of literature., Methods: Studies were identified for inclusion in the review by searching the MEDLINE database via PubMed and applying strict inclusion and exclusion criteria. Age-specific incidence rates were extracted from the articles, and in order to provide a common platform for analysis, we used directly age-standardized and age-sex-standardized rates (using the 2005 United Nations estimates of the world population as standard) to complete the analysis., Results: Forty-six full text articles spanning 33 countries/regions were included in the review. For ease of comparison, the results were analyzed by geographic regions: North America, Latin America, Scandinavia, Europe (excluding Scandinavia), Africa, Asia, and Australia. The highest hip fracture rates were found in Scandinavia and the lowest in Africa. We found comparable rates from countries in North America, Australia, and Europe outside of Scandinavia. The diverse makeup of the Asian continent also resulted in quite variable hip fracture rates: ranging from relatively high rates in Iran to low rates, comparable to those from Africa, in mainland China., Conclusions: Given the aging of populations globally, and in the industrialized countries specifically, hip fractures will become a progressively larger public health burden. The geographic trends observed in hip fracture incidence rates can provide important clues to etiology and prevention.