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Applicability of Clinical Trials in an Unselected Cohort of Patients With Intracerebral Hemorrhage

Hansen, Björn M. LU ; Ullman, Natalie; Norrving, Bo LU ; Hanley, Daniel F. and Lindgren, Arne LU (2016) In Stroke: a journal of cerebral circulation
Abstract

BACKGROUND AND PURPOSE—: Patient selection in clinical trials on intracerebral hemorrhage (ICH) affects overall applicability of results. We estimated eligibility for completed, ongoing, and planned clinical trials in an unselected cohort of patients with ICH. METHODS—: Large clinical ICH trials were identified using trial registration databases. Each trial’s inclusion criteria were applied to a consecutive group of patients with ICH from the prospective hospital-based Lund Stroke Register. Survival status was obtained from the National Census Office and 90-day poor functional outcome (modified Rankin Scale ≥4) from the Swedish Stroke Register or medical files. RESULTS—: Among 253 patients with ICH, estimated eligibility proportions... (More)

BACKGROUND AND PURPOSE—: Patient selection in clinical trials on intracerebral hemorrhage (ICH) affects overall applicability of results. We estimated eligibility for completed, ongoing, and planned clinical trials in an unselected cohort of patients with ICH. METHODS—: Large clinical ICH trials were identified using trial registration databases. Each trial’s inclusion criteria were applied to a consecutive group of patients with ICH from the prospective hospital-based Lund Stroke Register. Survival status was obtained from the National Census Office and 90-day poor functional outcome (modified Rankin Scale ≥4) from the Swedish Stroke Register or medical files. RESULTS—: Among 253 patients with ICH, estimated eligibility proportions ranged between 2% and 36% for the 11 identified clinical trials. Patients not eligible for any trial (n=96) had more intraventricular hemorrhage, lower baseline level of consciousness, higher rates of cerebellar ICH, and lower rates of lobar ICH (P≤0.001). Thirty-day case fatality for noneligible patients was 54% versus 18% among patients eligible in ≥1 trial (95% confidence interval, 44%–64% versus 13%–25%; P<0.001). Noneligible ICH patients more frequently had poor functional outcome (75% versus 48%; 95% confidence interval, 65%–83% versus 40%–56%; P<0.001). CONCLUSIONS—: There is large variation in proportions of patients with ICH eligible for inclusion in clinical trials and over a third of patients with ICH are not eligible for any trial.

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author
organization
publishing date
type
Contribution to journal
publication status
epub
subject
in
Stroke: a journal of cerebral circulation
publisher
American Heart Association
external identifiers
  • Scopus:84987652837
ISSN
0039-2499
DOI
10.1161/STROKEAHA.116.014203
language
English
LU publication?
yes
id
52ee8c97-003d-4d13-89fb-9247521721d2
date added to LUP
2016-10-03 15:30:05
date last changed
2016-10-04 03:00:03
@misc{52ee8c97-003d-4d13-89fb-9247521721d2,
  abstract     = {<p>BACKGROUND AND PURPOSE—: Patient selection in clinical trials on intracerebral hemorrhage (ICH) affects overall applicability of results. We estimated eligibility for completed, ongoing, and planned clinical trials in an unselected cohort of patients with ICH. METHODS—: Large clinical ICH trials were identified using trial registration databases. Each trial’s inclusion criteria were applied to a consecutive group of patients with ICH from the prospective hospital-based Lund Stroke Register. Survival status was obtained from the National Census Office and 90-day poor functional outcome (modified Rankin Scale ≥4) from the Swedish Stroke Register or medical files. RESULTS—: Among 253 patients with ICH, estimated eligibility proportions ranged between 2% and 36% for the 11 identified clinical trials. Patients not eligible for any trial (n=96) had more intraventricular hemorrhage, lower baseline level of consciousness, higher rates of cerebellar ICH, and lower rates of lobar ICH (P≤0.001). Thirty-day case fatality for noneligible patients was 54% versus 18% among patients eligible in ≥1 trial (95% confidence interval, 44%–64% versus 13%–25%; P&lt;0.001). Noneligible ICH patients more frequently had poor functional outcome (75% versus 48%; 95% confidence interval, 65%–83% versus 40%–56%; P&lt;0.001). CONCLUSIONS—: There is large variation in proportions of patients with ICH eligible for inclusion in clinical trials and over a third of patients with ICH are not eligible for any trial.</p>},
  author       = {Hansen, Björn M. and Ullman, Natalie and Norrving, Bo and Hanley, Daniel F. and Lindgren, Arne},
  issn         = {0039-2499},
  language     = {eng},
  month        = {09},
  publisher    = {ARRAY(0xd4c4698)},
  series       = { Stroke: a journal of cerebral circulation},
  title        = {Applicability of Clinical Trials in an Unselected Cohort of Patients With Intracerebral Hemorrhage},
  url          = {http://dx.doi.org/10.1161/STROKEAHA.116.014203},
  year         = {2016},
}