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Abstract: Background Clearly structured and comprehensive protocols are an essential component to ensure safety of participants, data validity, successful conduct, and credibility of results of randomized clinical trials (RCTs). Funding agencies, research ethics committees (RECs), regulatory agencies, medical journals, systematic reviewers, and other stakeholders rely on protocols to appraise the conduct and reporting of RCTs. In response to evidence of poor protocol quality, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guideline was published in 2013 to improve the accuracy and completeness of clinical trial protocols. The impact of these recommendations o...
Abstract: Background Little is known about publication agreements between industry and academic investigators in trial protocols and the consistency of these agreements with corresponding statements in publications. We aimed to investigate (i) the existence and types of publication agreements in trial protocols, (ii) the completeness and consistency of the reporting of these agreements in subsequent publications, and (iii) the frequency of co-authorship by industry employees. Methods and Findings We used a retrospective cohort of randomized clinical trials (RCTs) based on archived protocols approved by six research ethics committees between 13 January 2000 and 25 November 2003. Only RCTs wit...
Abstract: Background: Categorizing an inherently continuous predictor in prognostic analyses raises several critical methodological issues: dependence of the statistical significance on the number and position of the chosen cut-point(s), loss of statistical power, and faulty interpretation of the results if a non-linear association is incorrectly assumed to be linear. This also applies to a therapeutic context where investigators of randomized clinical trials (RCTs) are interested in interactions between treatment assignment and one or more continuous predictors. Methods/Design: Our goal is to apply the multivariable fractional polynomial interaction (MFPI) approach to investigate interactio...
Abstract: Background Home-dwelling frail older adults are often faced with multimorbidity and complex care needs, requiring health and social care systems that support frail older adults to age in place. The objective of this paper was to investigate the types of formal health and social care as well as informal care and social support used by home-dwelling frail older adults; whether they perceive their support as sufficient; and their experience with and preferences for care and support. Methods Using an explanatory sequential mixed methods design, we first conducted a secondary analysis of a subset of cross-sectional data from the ImplemeNtation of a community-baSed care Program for home ...
Abstract: In health research, statistical methods are frequently used to address a wide variety of research questions. For almost every analytical challenge, different methods are available. But how do we choose between different methods and how do we judge whether the chosen method is appropriate for our specific study? Like in any science, in statistics, experiments can be run to find out which methods should be used under which circumstances. The main objective of this paper is to demonstrate that simulation studies, that is, experiments investigating synthetic data with known properties, are an invaluable tool for addressing these questions. We aim to provide a first introduction to simu...
When should you engage with difficult arguments against your cherished controversial beliefs? The primary conclusion of this book is that your obligations to engage with counterarguments are more limited than is often thought. In some standard situations, you shouldn't engage with difficult counterarguments and, if you do, you shouldn't engage with them open-mindedly. This conclusion runs counter to aspects of the Millian political tradition and political liberalism, as well as what people working in informal logic tend to say about argumentation. Not all misleading arguments wear their flaws on their sleeve. Each step of a misleading argument might seem compelling and you might not be able ...
In this first-ever history of contemporary liberal theory, Forrester shows how liberal egalitarianism--a set of ideas about justice, equality, obligation, and the state--became dominant, and traces its emergence from the political and ideological context of the postwar United States and Britain.d Britain.
The revised edition of the Handbook offers the only guide on how to conduct, report and maintain a Cochrane Review The second edition of The Cochrane Handbook for Systematic Reviews of Interventions contains essential guidance for preparing and maintaining Cochrane Reviews of the effects of health interventions. Designed to be an accessible resource, the Handbook will also be of interest to anyone undertaking systematic reviews of interventions outside Cochrane, and many of the principles and methods presented are appropriate for systematic reviews addressing research questions other than effects of interventions. This fully updated edition contains extensive new material on systematic revie...
Renowned in the disciplines of political theory and philosophy, Hannah Arendt’s searing critiques of modernity continue to resonate in other fields of thought decades after she wrote them. In Communication Ethics in Dark Times: Hannah Arendt’s Rhetoric of Warning and Hope, author Ronald C. Arnett offers a groundbreaking examination of fifteen of Arendt’s major scholarly works, considering the German writer’s contributions to the areas of rhetoric and communication ethics for the first time. Arnett focuses on Arendt’s use of the phrase “dark times” to describe the mistakes of modernity, defined by Arendt as the post-Enlightenment social conditions, discourses, and processes rule...