Inappropriateness of randomised trials for complex phenomena: Single trial is never enough evidence to base decisions on

doi:10.1136/bmj.330.7482.94-a

BMJ 2005;330:94 (8 January), doi:10.1136/bmj.330.7482.94-a

Letter

Inappropriateness of randomised trials for complex phenomena

Single trial is never enough evidence to base decisions on

The first 150 words of the full text of this article appear below.

EDITOR—Kotaska outlines the importance of care providers'skill and the experience of a unit when assessing non-pharmacologicaltreatments such as vaginal breech delivery in randomised trials.¹We agree that evaluation of non-pharmacological treatment raisesspecific methodological issues, including the skill of careproviders.²

Care providers are part of the intervention to be tested, andhaving highly skilled or experienced care providers in one armand low skilled or less experienced care providers in the othercould lead to bias. Equally, bias can occur when care providershave more experience in performing one of the interventionstested than the other. However, appropriate methodological planningof randomised trials could circumvent this bias. To allow thesurgical procedure to be assessed in the context of the skillsrequired to achieve it, care providers participating in a surgerytrial could be trained and selected only if they achieve setstandards,³ selected according . . . [Full text of this article]

Isabelle Boutron, research fellow

Isabelle.boultron@bch.ap-hop-paris.fr, Département d'Epidémiologie, Biostatistique et Recherche Clinique, INSERM EMI 0357, Groupe Hospitalier Bichat-Claude Bernard (AP-HP), Faculté de Médecine Xavier Bichat, Université Paris VII, 46 rue Henri Huchard, 75877 Paris, France

Philippe Ravaud, head

Département d'Epidémiologie, Biostatistique et Recherche Clinique, INSERM EMI 0357, Groupe Hospitalier Bichat-Claude Bernard (AP-HP), Faculté de Médecine Xavier Bichat, Université Paris VII, 46 rue Henri Huchard, 75877 Paris, France

Bruno Giraudeau, assistant professor

INSERM CIC 202, Tours, France

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