Fully Randomized Controlled Experiment

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A Fully Randomized Controlled Experiment is a randomized controlled experiment that is a subject-level assignment experiment.



References

2013

  1. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG (2010). "CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials". Br Med J 340: c869. doi:10.1136/bmj.c869. PMC 2844943. PMID 20332511. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=2844943. 
  2. Ranjith G (2005). "Interferon-α-induced depression: when a randomized trial is not a randomized controlled trial". Psychother Psychosom 74 (6): 387. doi:10.1159/000087787. PMID 16244516. 
  3. Chalmers TC, Smith H Jr, Blackburn B, Silverman B, Schroeder B, Reitman D, Ambroz A (1981). "A method for assessing the quality of a randomized control trial". Control Clin Trials 2 (1): 31–49. doi:10.1016/0197-2456(81)90056-8. PMID 7261638. 
  4. Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG (1976). "Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design". Br J Cancer 34 (6): 585–612. doi:10.1038/bjc.1976.220. PMC 2025229. PMID 795448. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=2025229. 
  5. Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG (1977). "Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examples". Br J Cancer 35 (1): 1–39. doi:10.1038/bjc.1977.1. PMC 2025310. PMID 831755. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pmcentrez&artid=2025310. 
  6. Wollert KC, Meyer GP, Lotz J, Ringes-Lichtenberg S, Lippolt P, Breidenbach C, Fichtner S, Korte T, Hornig B, Messinger D, Arseniev L, Hertenstein B, Ganser A, Drexler H (2004). "Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial". Lancet 364 (9429): 141–8. doi:10.1016/S0140-6736(04)16626-9. PMID 15246726. 


2010

  • (AMTA, 2010) ⇒ American Massage Theory Association. (2010). “Glossary of Research Terminology."
    • QUOTE: Randomized Controlled Trial (or True Experimental) Research Method: One of four research methods included under the difference-oriented research strategy. It is operationally defined as a research method necessitating two major research procedures/features]]: (a) the random assignment of participants to the two or more comparison groups (i.e., the levels of the independent variable) and (b) the use of a manipulated independent variable as the study’s treatment or intervention. (Please note that the term controlled in the expression randomized controlled trial designates that the group being compared to the experimental group is a no treatment or “do nothing” control group or, possibly, a waiting-list control group. As suggested by Hagino (2003), the expression randomized clinical trial is preferred when the comparison to the experimental group involves a comparison treatment control group as is the case with a standard treatment control group, placebo-attention control group, or placebo-sham treatment control group.)

2008

  • http://www.drcath.net/toolkit/intervention.html
    • The randomised controlled trial is considered to be the gold standard of clinical research because it is the only known way to avoid selection and confounding biases. It approximates the controlled experiment of basic science. The aim of a trial is to apply the conclusions of the experiment to people in the general population.

      An important feature of Randomised Controlled Trials is randomisation. Here, participants (volunteers) are assigned to exposures purely by the play of chance. This reduces the likelihood of bias in the determination of outcomes and precludes selction bias and confounding bias. If participants and researchers are blinded as to the exposure the participant is receiving (called 'double-blinding'), information bias is also reduced. Allocation of people to treatment and control groups can be done by simple randomisation, randomsiation in blocks, randomisation by strata or minimisation. Minimisation is an acceptable non-random method of group allocation in trials. It considers people who are already allocated and allocates the next patient in such a way as to keep the composition of the two groups as similar as possible with respect to certain specified factors.

2007

2000