4 found
  1.  16
    Strengthening the Ethical Assessment of Placebo-Controlled Surgical Trials: Three Proposals.Wendy Rogers, Katrina Hutchison, Zoë C. Skea & Marion K. Campbell - 2014 - BMC Medical Ethics 15 (1):78.
    Placebo-controlled surgical trials can provide important information about the efficacy of surgical interventions. However, they are ethically contentious as placebo surgery entails the risk of harms to recipients, such as pain, scarring or anaesthetic misadventure. This has led to claims that placebo-controlled surgical trials are inherently unethical. On the other hand, without placebo-controlled surgical trials, it may be impossible to know whether an apparent benefit from surgery is due to the intervention itself or to the placebo effect.
    Direct download (3 more)  
    Export citation  
    Bookmark   2 citations  
  2.  35
    Stakeholder Views Regarding Ethical Issues in the Design and Conduct of Pragmatic Trials: Study Protocol.Stuart G. Nicholls, Kelly Carroll, Jamie Brehaut, Charles Weijer, Spencer Phillips Hey, Cory E. Goldstein, Merrick Zwarenstein, Ian D. Graham, Joanne E. McKenzie, Lauralyn McIntyre, Vipul Jairath, Marion K. Campbell, Jeremy M. Grimshaw, Dean A. Fergusson & Monica Taljaard - 2018 - BMC Medical Ethics 19 (1):90.
    Randomized controlled trial trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions, whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. Interest in, and the number of, pragmatic trials has grown substantially (...)
    Direct download (4 more)  
    Export citation  
  3.  15
    A Recruitment Strategy for Cluster Randomized Trials in Secondary Care Settings.Anne E. Walker, Marion K. Campbell, Jeremy M. Grimshaw & the Tempest Group - 2000 - Journal of Evaluation in Clinical Practice 6 (2):185-192.
  4.  3
    Protocol for the Development of a CONSORT Extension for RCTs Using Cohorts and Routinely Collected Health Data.Brett D. Thombs, David Torgerson, Maureen Sauvé, David Erlinge, Eric I. Benchimol, Helena M. Verkooijen, Rudolf Uher, Lehana Thabane, Tjeerd P. van Staa, Kimberly A. Mc Cord, Marion K. Campbell, Philippe Ravaud, Isabelle Boutron, David Moher, Sinéad M. Langan, Merrick Zwarenstein, Chris Gale, Clare Relton, Ole Fröbert, Margaret Sampson, Lars G. Hemkens, Edmund Juszczak & Linda Kwakkenbos - 2018 - Research Integrity and Peer Review 3 (1).
    BackgroundRandomized controlled trials are often complex and expensive to perform. Less than one third achieve planned recruitment targets, follow-up can be labor-intensive, and many have limited real-world generalizability. Designs for RCTs conducted using cohorts and routinely collected health data, including registries, electronic health records, and administrative databases, have been proposed to address these challenges and are being rapidly adopted. These designs, however, are relatively recent innovations, and published RCT reports often do not describe important aspects of their methodology in a (...)
    No categories
    Direct download  
    Export citation