The safety and efficacy of the tetanus vaccine intramuscularly versus subcutaneously in anticoagulated patients: a randomized clinical trial

BACKGROUND: In patients treated with oral anticoagulants, subcutaneous injections of anti-tetanus vaccine are usually recommended to reduce the risk of bleeding, although the effectiveness of the vaccine has only been proven for intramuscular injection. The objective of this study was to compare the safety and efficacy of intramuscular and subcutaneous injections of tetanus-diphtheria vaccine in patients treated with oral anticoagulants. METHODS/DESIGN: We present a prospective, double blinded, clinical trial comparing two groups of patients with oral anticoagulants: one group was administered tetanus-diphtheria vaccine by intramuscular injection, while the other was administered the same vaccine by subcutaneous injection. Allocation to each group was randomized and the duration of the study was six years. STUDY POPULATION: all patients treated with oral anticoagulants, who had been administered with at least one dose of vaccine, at 15 Health Centres in Vigo (Spain), and who agreed to participate in the study. The sample size was 115 patients in each group. The main variables for the safety analysis were the measurement of the brachial diameter, the appearance of basic injuries at the vaccine administration site, the appearance of pain and systemic reactions. The variable used for the efficacy analysis was a significant increase in the titres of anti-tetanus toxoid antibodies.An Intention-to-treat analysis will be performed. Details will be classified according to the administration route, while within each group a 3-tiered stratification will be defined by the administered number of doses. As a measure of association, relative risk will be estimated; the reduction of relative risk will also measured. For safety and to control the confounder effect, a logistic regression analysis will be carried out. As a measure of impact the reduction of absolute risk in relation to the total number of patients to be treated and the Number Needed to Treat will be estimated.CONSORT 2010 guidelines were applied for reporting parallel group randomised trials. DISCUSSION: The most significant difficulties on the project are related to the large number of participating centres, required to obtain a viable study population sample size, and the coordination given the scattering of the centres and researchers. TRIAL REGISTRATION: ISRCTN69942081

Tax Return as a Political Statement

The accuracy of a tax return is usually interpreted as an outcome of the tax evasion decision by an individual. However, in non-democratic regimes with predatory blackmail tax systems it is possible that large sums voluntarily reported by influential politicians or businessmen may be used as political statements. By openly acknowledging one's personal income an individual can signal the strength of one's position, or, on the contrary, the submissiveness to the political leadership. In this paper we explore the idea of the tax return as a political statement and test it using a unique dataset of the tax returns filed by the Russian regional governors and the members of their families for the year 2009. Our results conjecture that Russian governors may deliberately file their tax return as a political statement to signal their strength vis-à-vis the central government

Acute and residual soccer match-related fatigue: A systematic review and Meta-analysis

BACKGROUND: Understanding soccer players' match-related fatigue and recovery profiles likely helps with developing conditioning programs that increase team performance and reduce injuries and illnesses. In order to improve match recovery (the return-to-play process and ergogenic interventions) it is also pivotal to determine if match simulation protocols and actual match-play lead to similar responses. OBJECTIVES: To thoroughly describe the development of fatigue during actual soccer match play and its recovery time course in terms of physiological, neuromuscular, technical, biochemical and perceptual responses, and (2) to determine similarities of recovery responses between actual competition (11 vs. 11) and match simulations. METHODS: A first screening phase consisted of a systematic search on PubMed (MEDLINE) and SportDiscus databases until March 2016. Inclusion criteria were: longitudinal study with soccer players; match or validated protocol; duration > 45 min; and published in English. RESULTS: A total of 77 eligible studies (n = 1105) were used to compute 1196 effect sizes (ES). Half-time assessments revealed small to large alterations in immunological parameters (e.g. leukocytes, ES = 1.9), a moderate decrement in insulin concentration (ES = - 0.9) and a small to moderate impairment in lower-limb muscle function (ES = - 0.5 to - 0.7) and physical performance measures (e.g. linear sprint, ES = - 0.3 to - 1.0). All the systematically analyzed fatigue-related markers were substantially altered at post-match. Hamstrings force production capacity (ES = - 0.7), physical performance (2-4%, ES = 0.3-0.5), creatine kinase (CK, ES = 0.4), well-being (ES = 0.2-0.4) and delayed onset muscle soreness (DOMS, ES = 0.6-1.3) remained substantially impaired at G + 72 h. Compared to simulation protocols, 11 vs. 11 match format (CK, ES = 1.8) induced a greater magnitude of change in muscle damage (i.e. CK, ES = 1.8 vs. 0.7), inflammatory (IL-6, ES = 2.6 vs. 1.1) and immunological markers and DOMS (ES = 1.5 vs. 0.7) than simulation protocols at post-assessments. Neuromuscular performances at post-match did not differ between protocols. CONCLUSION: While some parameters are fully recovered (e.g. hormonal and technical), our systematic review shows that a period of 72 h post-match play is not long enough to completely restore homeostatic balance (e.g. muscle damage, physical and well-being status). The extent of the recovery period post-soccer game cannot consist of a 'one size fits all approach'. Additionally, the 'real match' (11 vs. 11 format) likely induces greater magnitudes of perceptual (DOMS) and biochemical alterations (e.g. muscle damage), while neuromuscular alterations were essentially similar. Overall, coaches must adjust the structure and content of the training sessions during the 72-h post-match intervention to effectively manage the training load within this time-frame