Topic
Mandatory Programs
About: Mandatory Programs is a research topic. Over the lifetime, 208 publications have been published within this topic receiving 3056 citations.
Papers published on a yearly basis
Papers
TL;DR: Examination of compliance with mandatory reporting of summary clinical trial results on ClinicalTrials.gov found most trials subject to mandatory reporting did not report results within a year of completion.
Abstract: Objective To examine compliance with mandatory reporting of summary clinical trial results (within one year of completion of trial) on ClinicalTrials.gov for studies that fall under the recent Food and Drug Administration Amendments Act (FDAAA) legislation.
Design Registry based study of clinical trial summaries.
Data sources ClinicalTrials.gov, searched on 19 January 2011, with cross referencing with Drugs@FDA to determine for which trials mandatory reporting was required within one year.
Selection criteria Studies registered on ClinicalTrials.gov with US sites which completed between 1 January and 31 December 2009.
Main outcome measure Proportion of trials for which results had been reported.
Results The ClinicalTrials.gov registry contained 83 579 entries for interventional trials, of which 5642 were completed within the timescale of interest. We identified trials as falling within the mandatory reporting rules if they were covered by the FDAAA (trials of a drug, device, or biological agent, which have at least one US site, and are of phase II or later) and if they investigated a drug that already had approval from the Food and Drug Administration. Of these, 163/738 (22%) had reported results within one year of completion of the trial compared with 76/727 (10%) trials that were not subject to mandatory reporting (95% confidence interval for the difference in proportions 7.8% to 15.5%; χ2 test, P=2.6×10−9). Later phase trials were more likely to report results (P=4.4×10−11), as were industry funded trials (P=2.2×10−16).
Conclusion Most trials subject to mandatory reporting did not report results within a year of completion.
295 citations
TL;DR: Serial cross-sectional data from nearly 7,000 German participants demonstrate that implementing a mandatory policy increased actual compliance despite moderate acceptance; mask wearing correlated positively with other protective behaviors.
Abstract: Mandatory and voluntary mask policies may have yet unknown social and behavioral consequences related to the effectiveness of the measure, stigmatization, and perceived fairness Serial cross-sectional data (April 14 to May 26, 2020) from nearly 7,000 German participants demonstrate that implementing a mandatory policy increased actual compliance despite moderate acceptance; mask wearing correlated positively with other protective behaviors A preregistered experiment (n = 925) further indicates that a voluntary policy would likely lead to insufficient compliance, would be perceived as less fair, and could intensify stigmatization A mandatory policy appears to be an effective, fair, and socially responsible solution to curb transmissions of airborne viruses
277 citations
TL;DR: In this article, the authors explore why educational development can be problematic for research supervisors and why they interpret such programs as further instances of the quality assurance agendas of governments and university administrators, and are justifiably suspicious of what some describe as the colonial underpinnings of educational development.
Abstract: Educational development for research supervisors is still a recent phenomenon. Early optional sessions on research supervision have now been replaced, particularly in the UK, continental Europe, and Australasia, by comprehensive and, in some cases, mandatory programs. Yet some of these programs focus solely on the administrative roles and responsibilities of supervisors, attempting to provide technical “fixes” that deny the genuine difficulties and complexities involved in supervision relationships. Some research supervisors resent the intrusion of educational developers into what many of them have regarded as a private pedagogical space. They interpret such programs as further instances of the quality assurance agendas of governments and university administrators, and are justifiably suspicious of what some describe as the colonial underpinnings of educational development. These reactions create tensions for educational developers. This article explores why educational development can be problematic for ...
193 citations
TL;DR: There is a moral imperative for HCWs to be immune and for healthcare institutions to ensure HCW vaccination, in particular for those working in settings with high-risk groups of patients, and if voluntary uptake of vaccination by HCWs is not optimal, patients’ welfare, public health and also the HCW’s own health interests should outweigh concerns about individual autonomy.
Abstract: Healthcare workers (HCWs) are at increased risk of contracting infections at work and further transmitting them to colleagues and patients. Immune HCWs would be protected themselves and act as a barrier against the spread of infections and maintain healthcare delivery during outbreaks, but vaccine uptake rates in HCWs have often been low. In order to achieve adequate immunisation rates in HCWs, mandatory vaccination policies are occasionally implemented by healthcare authorities, but such policies have raised considerable controversy. Here we review the background of this debate, analyse arguments for and against mandatory vaccination policies, and consider the principles and virtues of clinical, professional, institutional and public health ethics. We conclude that there is a moral imperative for HCWs to be immune and for healthcare institutions to ensure HCW vaccination, in particular for those working in settings with high-risk groups of patients. If voluntary uptake of vaccination by HCWs is not optimal, patients’ welfare, public health and also the HCW’s own health interests should outweigh concerns about individual autonomy: fair mandatory vaccination policies for HCWs might be acceptable. Differences in diseases, patient and HCW groups at risk and available vaccines should be taken into consideration when adopting the optimal policy.
135 citations
Related Topics (5)
Performance Metrics
| Year | Papers |
|---|---|
| 2021 | 12 |
| 2020 | 6 |
| 2019 | 4 |
| 2018 | 6 |
| 2017 | 7 |
| 2016 | 6 |