Mirroring everyday clinical practice in clinical trial design: a new concept to improve the external validity of randomized double-blind placebo-controlled trials in the pharmacological treatment of major depression

When we manage our patients both they and we would like to know that the interventions we prescribe have been tested and shown to be safe and effective for the uses to which they are put. The most powerful tool to determine the utility of specific interventions in the discipline of medicine is the double-blind placebo-controlled randomized clinical trial (RCT). Some of the complex problems encountered in psychogeriatrics do not lend themselves to straightforward yes or no outcomes, and some of the multifaceted interventions developed for the management of common psychogeriatric syndromes are difficult to test using standard RCT design, especially with regard to effective blinding and appropriate control conditions (Llewellyn-Jones et al. 1999; Haynes, 1999; Ames, 1999). Nevertheless, there are specific interventions for which RCT data have been very useful in refining treatment guidelines and advice (e.g. Doody et al., 2001) and, where this is the appropriate trial design, RCTs comprise the “gold standard” by which to assess the efficacy of a treatment or “management package”.

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Prognostic implications of imaging in atrophic macular degeneration and its use in clinical practice and clinical trial design

Clinical and Experimental Ophthalmology ◽

10.1111/ceo.12671 ◽

2016 ◽

Vol 44 (5) ◽

pp. 410-421 ◽

Cited By ~ 2

Author(s):

Paul CC Lim ◽

Christopher J Layton

Keyword(s):

Clinical Trial ◽

Clinical Practice ◽

Macular Degeneration ◽

Trial Design ◽

Clinical Trial Design ◽

Prognostic Implications

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M1319 Do IBS Patients Understand the Difference Between Abdominal Pain vs. Discomfort? Implications for Clinical Practice and Clinical Trial Design

Gastroenterology ◽

10.1016/s0016-5085(10)61743-x ◽

2010 ◽

Vol 138 (5) ◽

pp. S-379

Author(s):

Brennan M. Spiegel ◽

Roger E. Bolus ◽

Lucinda A. Harris ◽

Susan L. Lucak ◽

Eric Esrailian ◽

...

Keyword(s):

Clinical Trial ◽

Abdominal Pain ◽

Clinical Practice ◽

Trial Design ◽

Clinical Trial Design ◽

The Difference

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An experimental double-blind clinical trial method in homoeopathy

British Homeopathic Journal ◽

10.1016/s0007-0785(86)80009-6 ◽

1986 ◽

Vol 75 (03) ◽

pp. 142-147 ◽

Cited By ~ 22

Author(s):

Peter Fisher

Keyword(s):

Clinical Trial ◽

Statistical Methods ◽

Controlled Trials ◽

Double Blind ◽

Double Blind Placebo ◽

Novel Approach ◽

Double Blind Clinical Trial ◽

Non Parametric

AbstractA small number of double-blind, placebo-controlled trials of homœopathic treatment in rheumatological conditions have been carried out. These have used differing methodologies, leading to varying results. This paper describes a novel approach in the treatment of fibrositis, a syndrome which lacks a pathological definition, but is defined solely in terms of its symptomatology.24 patients were prescribed for 3 months, according to indication, one of three homœopathic remedies (Arnica, Bryonia, Rhus tox.), each patient remaining on the same remedy throughout. They were followed monthly on the following parameters: pain, number of tender spots and sleep. An ‘indication score’ was allotted to each prescription. The results were analyzed by non-parametric statistical methods, showing that homœopathy produced a statistically significant improvement, but only when the prescribed remedy was well indicated.

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