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Martin McKee a London School of
Hygiene and Tropical Medicine, London WC1E 7HT, b University of Queensland Medical School, Brisbane 4006, Australia
Correspondence to: Martin
McKeem.mckee@lshtm.ac.uk
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Evaluations of healthcare interventions can either randomise subjects to comparison groups, or not. In both designs there are potential threats to validity, which can be external (the extent to which they are generalisable to all potential recipients) or internal (whether differences in observed effects can be attributed to differences in the intervention). Randomisation should ensure that comparison groups of sufficient size differ only in their exposure to the intervention concerned. However, some investigators have argued that randomised controlled trials (RCTs) tend to exclude, consciously or otherwise, some types of patient to whom results will subsequently be applied. Furthermore, in unblinded trials the outcome of treatment may be influenced by practitioners' and patients' preferences for one or other intervention. Though non-randomised studies are less selective in terms of recruitment, they are subject to selection bias in allocation if treatment is related to initial prognosis.
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These issues have led to extensive debate,
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