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Lack
of concealment of allocation can increase the effect size observed in randomised
controlled trials. (Schulz 1995) The most
secure randomisation method requires the clinician to contact an external randomisation
service after obtaining informed consent.However,complexities in the randomisation process
may deter general practitioners from recruiting patients. Assessing eligibility,
explaining trial, addressing patients' questions and obtaining consent, randomising, and
collecting baseline data are time consuming for participating practitioners.(Wilson
1999).The additional workload may lead to some practices suspending recruitment at busy
times ( e.g. Monday mornings,holidays, flu season, etc). |