S. P. Balasubramanian

A letter in the August edition of the British Journal of Surgery 2003 from Balasubramanain critisises this paper on the basis that it does not conform to the CONSORT guidelines for randomised clinical trials [1]. Specific critisisms are that;

• Qualitative data analysed by ANOVA
• No explanatory flow diagram
• Lack of clear randomization methodology
• Lack of details of exclusions
• Lack of allocation concealment and assessor blinding
• Inclusion of multiple episodes in a single patient as independent observations in a controlled trial