Protocol violations in community-based rTPA stroke treatment are associated with symptomatic intracerebral hemorrhage.

BACKGROUND: Recombinant tissue plasminogen activator (rTPA) is an established treatment for acute ischemic stroke. The rate and type of protocol violations in rTPA use and their effect on patient outcomes in this setting are not well understood. OBJECTIVE: The objective of this study was to examine associations between protocol violations and outcomes in community-based rTPA use. METHODS: We reviewed medical records of stroke patients treated with rTPA in 10 acute-care hospitals in Indianapolis from July 1996 to February 1998 and assessed complications and outcome. Retrospective National Institute of Health Stroke Scale (on admission and discharge), Canadian Neurological Scale, and length of hospital stay were calculated. Appropriate use of rTPA was determined by the National Institute of Neurological Disorders and Stroke (NINDS) protocol. RESULTS: Fifty patients (mean age, 66 years; 76% white; 56% men) were treated by general neurologists (70%), stroke neurologists (24%), or emergency physicians (6%). Mean times to hospital arrival, brain CT, and start of rTPA infusion were 44, 86, and 141 minutes, respectively. In-hospital mortality rate was 10% (4 intracerebral hemorrhage [ICH], 1 cardiogenic shock). Complications were more frequent among patients with protocol violations (n=8) compared with those without all hemorrhages (75% versus 10%, P:<0.001), symptomatic ICH (38% versus 5%, P:<0.02), and ICH attributable to rTPA, occurring within 36 hours (38% versus 2.4%, P:<0.01), respectively. CONCLUSIONS: NINDS protocol violations are relatively common and are associated with symptomatic cerebral and systemic hemorrhages. When the NINDS protocol is strictly followed, hemorrhage rates in community-based rTPA use are similar to those in the NINDS trial.

Retrospective assessment of initial stroke severity with the NIH Stroke Scale.

BACKGROUND AND PURPOSE: It is important to adjust stroke outcomes for differences in initial stroke severity. The NIH Stroke Scale (NIHSS) is a commonly used stroke severity measure but has been validated for retrospective scoring only in a subset of stroke clinical trial participants. The purpose of this research was to assess the validity and reliability of an algorithm for retrospective NIHSS scoring in a setting with usual chart documentation. METHODS: An algorithm for retrospective NIHSS scoring was developed with written history and physical admission notes. Missing physical examination data were scored as normal. One investigator prospectively scored the admission NIHSS in 32 consecutive stroke patients. Two raters retrospectively scored the NIHSS by applying the algorithm to photocopied admission notes. Linear regression was used to assess interrater reliability and agreement between prospective and retrospective NIHSS scores. The Wilcoxon signed rank test was used to assess systematic scoring bias. Weighted kappa statistics were calculated to assess the level of agreement of individual NIHSS items. RESULTS: Only 1 admission note was complete for all NIHSS elements. Interrater reliability was near perfect (r(2)=0.98, P<0. 001). Agreement between prospective and retrospective NIHSS score was also excellent (r(2)=0.94, P<0.001) and there was no systematic bias in retrospective scores. Agreement for individual items was moderate to high for all items except level of consciousness. CONCLUSIONS: Retrospective NIHSS scoring with the algorithm is reliable and unbiased even when physical examination elements are missing from the written record. Stroke research using retrospective review of charts or of administrative databases should adjust for differences in stroke severity using such an algorithm.