Access to unpublished protocols and statistical analysis plans of randomised trials

Background: Access to protocols and statistical analysis plans (SAPs) increases the transparency of randomised trial by allowing readers to identify and interpret unplanned changes to study methods, however they are often not made publicly available. We sought to determine how often study investigators would share unavailable documents upon request. Methods: We used trials from two previously identified cohorts (cohort 1: 101 trials published in high impact factor journals between January and April of 2018; cohort 2: 100 trials published in June 2018 in journals indexed in PubMed) to determine whether study investigators would share unavailable protocols/SAPs upon request. We emailed corresponding authors of trials with no publicly available protocol or SAP up to four times. Results: Overall, 96 of 201 trials (48%) across the two cohorts had no publicly available protocol or SAP (11/101 high-impact cohort, 85/100 PubMed cohort). In total, 8/96 authors (8%) shared some trial documentation (protocol only [n = 5]; protocol and SAP [n = 1]; excerpt from protocol [n = 1]; research ethics application form [n = 1]). We received protocols for 6/96 trials (6%), and a SAP for 1/96 trial (1%). Seventy-three authors (76%) did not respond, 7 authors responded (7%) but declined to share a protocol or SAP, and eight email addresses were invalid (8%). A total of 329 emails were sent (an average of 41 emails for every trial which sent documentation). After emailing authors, the total number of trials with an available protocol increased by only 3%, from 52% in to 55%. Conclusions: Most study investigators did not share their unpublished protocols or SAPs upon direct request. Alternative strategies are needed to increase transparency of randomised trials and ensure access to protocols and SAPs

Allograft and Xenograft Acceptance under FK‐506 and Other Immunosuppressant Treatment

We will focus on two issues, both involving, but not confined to FK-506: first, the meaning of the graft acceptance, which is, after all, the objective of immunosuppression for the transplant surgeon; and second, how to take the next great step of xenotransplantation

Core pinning by intragranular nanoprecipitates in polycrystalline MgCNi_3

The nanostructure and magnetic properties of polycrystalline MgCNi_3 were studied by x-ray diffraction, electron microscopy, and vibrating sample magnetometry. While the bulk flux-pinning force curve F_p(H) indicates the expected grain-boundary pinning mechanism just below T_c = 7.2 K, a systematic change to pinning by a nanometer-scale distribution of core pinning sites is indicated by a shift of F_p(H) with decreasing temperature. The lack of scaling of F_p(H) suggests the presence of 10 to 20% of nonsuperconducting regions inside the grains, which are smaller than the diameter of fluxon cores 2xi at high temperature and become effective with decreasing temperature when xi(T) approaches the nanostructural scale. Transmission electron microscopy revealed cubic and graphite nanoprecipitates with 2 to 5 nm size, consistent with the above hypothesis since xi(0) = 6 nm. High critical current densities, more than 10^6 A/cm^2 at 1 T and 4.2 K, were obtained for grain colonies separated by carbon. Dirty-limit behavior seen in previous studies may be tied to electron scattering by the precipitates, indicating the possibility that strong core pinning might be combined with a technologically useful upper critical field if versions of MgCNi_3 with higher T_c can be found.Comment: 5 pages, 6 figures, submitted to PR

Brief of Corporate Law Professors as Amici Curie in Support of Respondents

The Supreme Court has looked to the rights of corporate shareholders in determining the rights of union members and non-members to control political spending, and vice versa. The Court sometimes assumes that if shareholders disapprove of corporate political expression, they can easily sell their shares or exercise control over corporate spending. This assumption is mistaken. Because of how capital is saved and invested, most individual shareholders cannot obtain full information about corporate political activities, even after the fact, nor can they prevent their savings from being used to speak in ways with which they disagree. Individual shareholders have no “opt out” rights or practical ability to avoid subsidizing corporate political expression with which they disagree. Nor do individuals have the practical option to refrain from putting their savings into equity investments, as doing so would impose damaging economic penalties and ignore conventional financial guidance for individual investors

Screening for data clustering in multicenter studies: the residual intraclass correlation

status: publishe

Randomised trial of indwelling pleural catheters for refractory transudative pleural effusions

Objective: Refractory symptomatic transudative pleural effusions are an indication for pleural drainage. There has been supportive observational evidence for the use of indwelling pleural catheters (IPCs) for transudative effusions, but no randomised trials. We aimed to investigate the effect of IPCs on breathlessness in patients with transudative pleural effusions when compared with standard care. / Methods: A multicentre randomised controlled trial, in which patients with transudative pleural effusions were randomly assigned to either an IPC (intervention) or therapeutic thoracentesis (TT; standard care). The primary outcome was mean daily breathlessness score over 12 weeks from randomisation. / Results: 220 patients were screened from April 2015 to August 2019 across 13 centres, with 33 randomised to intervention (IPC) and 35 to standard care (TT). Underlying aetiology was heart failure in 46 patients, liver failure in 16 and renal failure in six. In primary outcome analysis, the mean±sd breathlessness score over the 12-week study period was 39.7±29.4 mm in the IPC group and 45.0±26.1 mm in the TT group (p=0.67). Secondary outcomes analysis demonstrated that mean±sd drainage was 17 412±17 936 mL and 2901±2416 mL in the IPC and TT groups, respectively. A greater proportion of patients had at least one adverse event in the IPC group (p=0.04). / Conclusion: We found no significant difference in breathlessness over 12 weeks between IPCs or TT. TT is associated with fewer complications and IPCs reduced the number of invasive pleural procedures required. Patient preference and circumstances should be considered in selecting the intervention in this cohort

What lies beneath: exploring links between asylum policy and hate crime in the UK

This paper explores the link between increasing incidents of hate crime and the asylum policy of successive British governments with its central emphasis on deterrence. The constant problematisation of asylum seekers in the media and political discourse ensures that 'anti-immigrant' prejudice becomes mainstr earned as a common-sense response. The victims are not only the asylum seekers hoping for a better life but democratic society itself with its inherent values of pluralism and tolerance debased and destabilised

Trust in Nanotechnology? On Trust as Analytical Tool in Social Research on Emerging Technologies

Trust has become an important aspect of evaluating the relationship between lay public and technology implementation. Experiences have shown that a focus on trust provides a richer understanding of reasons for backlashes of technology in society than a mere focus of public understanding of risks and science communication. Therefore, trust is also widely used as a key concept for understanding and predicting trust or distrust in emerging technologies. But whereas trust broadens the scope for understanding established technologies with well-defined questions and controversies, it easily fails to do so with emerging technologies, where there are no shared questions, a lack of public familiarity with the technology in question, and a restricted understanding amongst social researchers as to where distrust is likely to arise and how and under which form the technology will actually be implemented. Rather contrary, ‘trust’ might sometimes even direct social research into fixed structures that makes it even more difficult for social research to provide socially robust knowledge. This article therefore suggests that if trust is to maintain its important role in evaluating emerging technologies, the approach has to be widened and initially focus not on people’s motivations for trust, but rather the object of trust it self, as to predicting how and where distrust might appear, how the object is established as an object of trust, and how it is established in relation with the public

The microstructure of coaching practice:Behaviours and activities of an elite rugby union head coach during preparation and competition

The activities and behaviours of a female head coach of a national rugby union team were recorded in both training and competition, across a whole rugby season, using the newly developed Rugby Coach Activities and Behaviours Instrument (RCABI). The instrument incorporates 24 categories of behaviour, embedded within three forms of activity (training form, playing form and competitive match) and seven sub-activity types. In contrast to traditional drill-based coaching, 58.5% of training time was found to have been spent in playing form activities. Moreover, the proportion of playing form activities increased to a peak average of 83.8% in proximity to the team’s annual international championship. Uniquely, one of the coach’s most prolific behaviours was conferring with associates (23.3%), highlighting the importance of interactions with assistant coaches, medical staff and others in shaping the coaching process. Additionally, the frequencies of key behaviours such as questioning and praise were found to vary between the different activity forms and types, raising questions about previous conceptions of effective coaching practice. The findings are discussed in the light of the Game Sense philosophy and the role of the head coach