Possible research strategies for evaluating CAM interventions

Thomas, Kate; Fitter, Mike

doi:10.1016/b978-0-443-06367-1.50008-9

Cited by 13 publications

(18 citation statements)

References 14 publications

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“…Furthermore, randomisation may also disrespect the patient's right to choice of treatment (Knipschild 1993;Reitemeier 2002). To overcome these latter concerns, the use of partially randomised or patient preference trials have been suggested (Thomas & Fitter 2002), with claims that randomised trials do not differ from welldesigned observational studies (Lewith et al 2002). Nonetheless, whilst randomisation may neglect an individual's right to choice of treatment, the absence of randomisation may cast doubt over the validity of findings, and in turn, delay the release of potential benefits to the community.…”

Section: Randomisationmentioning

confidence: 99%

Barriers to conducting randomised controlled trials: Lessons learnt from the Horsechestnut & Venous Leg Ulcer Trial (HAVLUT)

Leach

2003

Contemporary Nurse

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The RCT is considered the gold standard for testing a therapeutic intervention.However, the conduct of an RCT is not without numerous obstacles. As illustrated through the recent Horsechestnut and Venous Leg Ulcer Trial (HAVLUT), these barriers can be attributed to randomisation, recruitment, retention, blinding and sampling procedures, and to gate keeping. These obstacles, together with strategies to prevent and overcome them, are detailed throughout this article, and are aimed at ameliorating the future design and conduct of RCTs.

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Section: Randomisationmentioning

confidence: 99%

Barriers to conducting randomised controlled trials: Lessons learnt from the Horsechestnut & Venous Leg Ulcer Trial (HAVLUT)

Leach

2003

Contemporary Nurse

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“…Why are randomized placebo-controlled clinical trials, or "efficacy" 32,33 trials conducted? The simplest answer is that " .…”

Section: Why the Placebo Control?mentioning

confidence: 99%

“…32 Because a therapy has specific effects (mechanisms or active ingredients) associated with it and a variety of other effects not specific to that therapy, then placebo-controlled studies are conducted to examine the size of the specific effects by controlling for (subtracting) the nonspecific effects. 13,[33][34][35] These nonspecific effects include effects caused by placebo responses, and effects such as regression to the mean, natural course of the disease. 29,30 Randomization is thought to distribute the latter effects equally between treatment groups.…”

Section: Why the Placebo Control?mentioning

confidence: 99%

A Review and Analysis of Placebo Treatments, Placebo Effects, and Placebo Controls in Trials of Medical Procedures When Sham Is Not Inert

Birch¹

2006

The Journal of Alternative and Complementary Medicine

137

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Researchers examining the efficacy of medical procedures make assumptions about the nature of placebo. From these assumptions they select the sham interventions to be used in their trials. However, placebo is not well defined. A number of definitions are contradictory and sometimes misleading. This leads to problems in sham-controlled studies of medical procedures and difficulties interpreting their results. The author explores some of the contradictory definitions of placebo and assumptions and consequences of these. Principal among these is the assumption that the placebo is inert when it is not, which introduces bias against the tested medical procedures and devices. To illustrate the problem, the author examines the use of sham procedures in clinical trials of the medical procedures surgery and acupuncture in which the sham was assumed to be inert but was not. Trials of surgery and acupuncture should be re-examined in light of this.

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“…Furthermore, by its very nature of being individualized and patient centered, cancer care cannot be standardized and administered as an intervention that is independent of a person's life. It has been proposed that variations on the RCT, such as preference or pragmatic trials (IOM), may be more appropriate for whole systems of treatment or care [6,7,15].…”

Section: Evaluating Cancer Carementioning

confidence: 99%