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Title: Does asymmetry in patient recruitment in large critical care trials follow the Pareto principle?
Austin Authors: Ramanan, Mahesh;Billot, Laurent;Rajbhandari, Dorrilyn;Myburgh, John;Finfer, Simon;Bellomo, Rinaldo ;Venkatesh, Balasubramanian
Affiliation: Intensive Care Unit, Princess Alexandra Hospital, Brisbane, Australia
University of Queensland, Brisbane, Australia
Intensive Care Unit, Wesley Hospital, Brisbane, Australia
Intensive Care
University of Melbourne, Melbourne, Australia
Australia New Zealand Intensive Care Research Centre, Melbourne, Australia
University of Sydney, Sydney, Australia
Intensive Care Unit, Sydney Adventist Hospital, Sydney, Australia
Critical Care Division, The George Institute for Global Health, Sydney, Australia
University of New South Wales, Sydney, Australia
Statistics Division, The George Institute for Global Health, Sydney, Australia
Intensive Care Unit, Caboolture and The Prince Charles Hospitals, Brisbane, Australia
Issue Date: 5-May-2020
Date: 2020-05-05
Publication information: Trials 2020; 21(1): 378
Abstract: Randomised controlled trials (RCT) may be hindered by slow recruitment rates, particularly in critically ill patients. While statistical models to predict recruitment rates have been described, no systematic assessment has been conducted of the distribution of recruitment across sites, temporal trends in site participation and impact of competing trials on patient recruitment. We used recruitment and screening logs from the SAFE, NICE-SUGAR, RENAL, CHEST and ADRENAL trials, five of the largest critical care RCTs. We quantified the extent of recruitment asymmetry between sites using Lorenz curves and Gini coefficients and assessed whether the recruitment distribution across sites follow the Pareto principle, which states that 80% of effects come from 20% of causes. Peak recruitment rates and growth in participating sites were calculated. In total, 25,412 patients were randomised in 99 intensive care units (ICUs) for the five trials. Distribution of recruitment was asymmetric, with a small number of ICUs recruiting a large proportion of the patients. The Gini coefficients ranged from 0.14 to 0.52. The time to peak recruitment rate ranged from 7 to 41 months and was variable (7, 31, 41, 10 and 40 months). Over time, the proportion of recruitment at non-tertiary ICUs increased from 15% to 34%. There is asymmetry of recruitment with a small proportion of ICUs recruiting a large proportion of patients. The distributions of recruitment were not consistent with the Pareto principle. There has been increasing participation of non-tertiary ICUs in clinical trials.
DOI: 10.1186/s13063-020-04279-1
ORCID: 0000-0002-1650-8939
Journal: Trials
PubMed URL: 32370789
Type: Journal Article
Subjects: Critical illness, Clinical trials, Intensive care unit, Pareto, Trial recruitment
Appears in Collections:Journal articles

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