PPT Slide
History of the cluster RCT
1935 - RA Fisher publishes his seminal work on the importance of randomization in “The Design of Experiments”.
1940 - text for educational researchers, based on Fishers work, describes cRCTs.
1946 - British Medical Council publishes first RCT (streptomycin for the tx of TB).
1963 - Ferebee et al publish a 433 cluster (28,000 patient) RCT. (isoniazid for the tx of TB).
1991 - approximately 50% of RCTs published in the medical literature are found to be statistically flawed.
Late 1990’s - 25% of cluster RCTs perform appropriate sample size calculations and only 50% conducted appropriate analysis.
1996 - CONSORT statement published to improve the conduct and reporting of RCTs.
2001 - proposal to extend CONSORT statement to improve the conduct and reporting of cRCTs.