Endgames Statistical Question

Bias in clinical trials

BMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d4176 (Published 06 July 2011) Cite this as: BMJ 2011;343:d4176
  1. Philip Sedgwick, senior lecturer in medical statistics
  1. 1Section of Medical and Healthcare Education, St George’s, University of London, Tooting, London, UK
  1. p.sedgwick{at}sgul.ac.uk

Researchers assessed the effects of full length 5 degree lateral wedge insoles on improving symptoms and slowing structural disease progression in medial knee osteoarthritis. A randomised double blind, controlled trial was performed. The control treatment was flat insoles. Both types of insole were worn inside the shoes daily for 12 months.1

Participants were recruited from the community if they were aged 50 years or over and had a clinical and radiographic diagnosis of mild to moderately severe medial knee osteoarthritis. In total, 103 individuals were randomised to lateral wedge insoles and 97 to flat insoles. The primary symptomatic outcome was self rated overall knee pain in the past week. The primary structural outcome …

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