Arthur F Fonville1, Neshika Samarasekera, Aidan Hutchison, David Perry, Yvo B Roos, Rustam Al-Shahi Salman. 1. From the Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands (A.F.F., Y.B.R.); and Division of Clinical Neurosciences, Center for Clinical Brain Sciences, University of Edinburgh, Western General Hospital, Edinburgh, United Kingdom (N.S., A.H., D.P., R.A.-S.S.).
Abstract
BACKGROUND AND PURPOSE: Acute treatments specifically for intracerebral hemorrhage (ICH) are being sought in randomized controlled trials. The treatment effect sizes in ongoing and future trials are likely to be small, necessitating large sample sizes. METHODS: We searched online trial registries for randomized controlled trials investigating an acute treatment for ICH. For the trials whose eligibility criteria could be assessed in a prospective, community-based ICH cohort study (2010-2011), we quantified the proportions of patients who were eligible and investigated influences on these proportions. RESULTS: We applied the eligibility criteria of 17 trials to 166 adults with ICH, of whom between 0.6% (95% confidence interval, 0.1-3.3) to 40% (95% confidence interval, 33-48) were eligible for each trial. Fewer patients were eligible for trials restricted to patients randomized within 12 hours of ICH onset (versus trials with a longer time window; P=0.03) and trials restricting eligibility according to premorbid disability (versus trials without this restriction; P=0.046). Each additional eligibility criterion reduced the portion of eligible patients by 1.3% (95% confidence interval, 0.4-2.2; adjusted R(2)=0.47; P=0.004). CONCLUSIONS: Less than half of patients with ICH were eligible for current randomized controlled trials. Future trials could maximize enrollment by minimizing the number of eligibility criteria, maximizing the time window for recruiting patients after ICH onset, permitting premorbid disability, and using a simulator to assess the impact of other eligibility critiera (www.dcn.ed.ac.uk/ICHsimulator/).
BACKGROUND AND PURPOSE: Acute treatments specifically for intracerebral hemorrhage (ICH) are being sought in randomized controlled trials. The treatment effect sizes in ongoing and future trials are likely to be small, necessitating large sample sizes. METHODS: We searched online trial registries for randomized controlled trials investigating an acute treatment for ICH. For the trials whose eligibility criteria could be assessed in a prospective, community-based ICH cohort study (2010-2011), we quantified the proportions of patients who were eligible and investigated influences on these proportions. RESULTS: We applied the eligibility criteria of 17 trials to 166 adults with ICH, of whom between 0.6% (95% confidence interval, 0.1-3.3) to 40% (95% confidence interval, 33-48) were eligible for each trial. Fewer patients were eligible for trials restricted to patients randomized within 12 hours of ICH onset (versus trials with a longer time window; P=0.03) and trials restricting eligibility according to premorbid disability (versus trials without this restriction; P=0.046). Each additional eligibility criterion reduced the portion of eligible patients by 1.3% (95% confidence interval, 0.4-2.2; adjusted R(2)=0.47; P=0.004). CONCLUSIONS: Less than half of patients with ICH were eligible for current randomized controlled trials. Future trials could maximize enrollment by minimizing the number of eligibility criteria, maximizing the time window for recruiting patients after ICH onset, permitting premorbid disability, and using a simulator to assess the impact of other eligibility critiera (www.dcn.ed.ac.uk/ICHsimulator/).
Authors: Kimberly L Feng; Cheryl Person; Jacqueline Phillips-Sabol; Bethany Williams; Chunyan Cai; Amber N Jacobs; Hari Indupuru; Linda Aramburo-Maldonado; Loren Shen; James C Grotta; Andrew D Barreto Journal: Stroke Date: 2014-09-30 Impact factor: 7.914
Authors: Amy E Maxwell; Richard A Parker; Jonathan Drever; Anthony Rudd; Martin S Dennis; Christopher J Weir; Rustam Al-Shahi Salman Journal: Trials Date: 2017-12-28 Impact factor: 2.279
Authors: Amy E Maxwell; Mary Joan MacLeod; Anu Joyson; Sharon Johnson; Hawraman Ramadan; Ruth Bellfield; Anthony Byrne; Caroline McGhee; Anthony Rudd; Fiona Price; Evangelos Vasileiadis; Melinda Holden; Jonathan Hewitt; Michael Carpenter; Ann Needle; Stacey Valentine; Farzana Patel; Frances Harrington; Paul Mudd; Hedley Emsley; Bindu Gregary; Ingrid Kane; Keith Muir; Divya Tiwari; Peter Owusu-Agyei; Natalie Temple; Lakshmanan Sekaran; Suzanne Ragab; Timothy England; Amanda Hedstrom; Phil Jones; Sarah Jones; Mandy Doherty; Mark O McCarron; David L Cohen; Sharon Tysoe; Rustam Al-Shahi Salman Journal: Trials Date: 2017-04-05 Impact factor: 2.279
Authors: Amy E Maxwell; Martin Dennis; Anthony Rudd; Christopher J Weir; Richard A Parker; Rustam Al-Shahi Salman Journal: Trials Date: 2017-03-01 Impact factor: 2.279
Authors: Andrea Morotti; Gregoire Boulouis; Andreas Charidimou; Qi Li; Loris Poli; Paolo Costa; Valeria De Giuli; Eleonora Leuci; Federico Mazzacane; Giorgio Busto; Francesco Arba; Laura Brancaleoni; Sebastiano Giacomozzi; Luigi Simonetti; Michele Laudisi; Giuseppe Micieli; Anna Cavallini; Elisa Candeloro; Massimo Gamba; Mauro Magoni; Andrew D Warren; Christopher D Anderson; M Edip Gurol; Alessandro Biffi; Anand Viswanathan; Ilaria Casetta; Enrico Fainardi; Andrea Zini; Alessandro Pezzini; Alessandro Padovani; Steven M Greenberg; Jonathan Rosand; Joshua N Goldstein Journal: Neurology Date: 2021-04-01 Impact factor: 9.910