Methods and processes for the reanalysis of the NINDS tissue plasminogen activator for acute ischemic stroke treatment trial.

Background: Treatment group imbalances in baseline stroke severity in the NINDS intravenous t-PA for acute stroke treatment trial led to controversy regarding the efficacy of tissue plasminogen activator (t-PA) in the treatment of acute ischemic stroke.

Purpose: Describe the steps used to independently re-evaluate this trial.

Methods: NIH appointed an independent multidisciplinary committee that gained access to the original data.

Findings from the reanalysis of the NINDS tissue plasminogen activator for acute ischemic stroke treatment trial.

Background And Purpose: Following publication of concerns about the results of the National Institute of Neurological Disorders and Stroke (NINDS) intravenous tissue plasminogen activator (t-PA) in acute stroke treatment trial, NINDS commissioned an independent committee "to address whether there is concern that eligible stroke patients may not benefit from t-PA given according to the protocol used in the trials and, whether the subgroup imbalance (in baseline stroke severity) invalidates the entire trial."

Methods: The original NINDS trial data were reanalyzed to assess the t-PA treatment effect, the effect of the baseline imbalance in stroke severity between the treatment groups on the t-PA treatment effect, and whether subgroups of patients did not benefit from receiving t-PA.

Results: A clinically important and statistically significant benefit of t-PA therapy was identified despite subgroup imbalances in baseline stroke severity and an increased incidence of symptomatic intracerebral hemorrhage in t-PA treated patients.

Frequency of abnormal hand and wrist radiographs at time of diagnosis of polyarticular juvenile rheumatoid arthritis.

Objective: To determine the frequency of radiographic abnormalities in hand/wrist radiographs of children with newly diagnosed polyarticular juvenile rheumatoid arthritis (polyJRA) because radiographs of small joints are an important tool in assessing outcomes in RA and there are clinical similarities between RA and polyJRA.

Methods: A medical record review was performed to identify cases of polyJRA seen at Mayo Clinic from January 1, 1994, to December 31, 2001. Hand/wrist radiographs, obtained at the time of diagnosis, were reviewed by 3 radiologists with attention to periarticular osteopenia, joint space narrowing (JSN), or erosion.

Long-term fracture risk in patients with Crohn's disease: a population-based study in Olmsted County, Minnesota.

Background & Aims: Osteoporosis is common in patients with Crohn's disease, but less is known about their risk of actual fractures.

Methods: The medical records of all 238 Olmsted County, Minnesota, residents diagnosed with Crohn's disease between 1940 and 1993 were reviewed for evidence of subsequent fractures compared with a control group of county residents matched by age and sex. The risk ratio of fracture in patients relative to controls was estimated using the Cox proportional hazards regression model.

Formation of the killer Ig-like receptor repertoire on CD4+CD28null T cells.

Killer Ig-like receptors (KIRs) are expressed on CD4(+)CD28(null) T cells, a highly oligoclonal subset of T cells that is expanded in patients with rheumatoid arthritis. It is unclear at what stage of development these T cells acquire KIR expression. To determine whether KIR expression is a consequence of clonal expansion and replicative senescence, multiple CD4(+)CD28(null) T cell clones expressing the in vivo dominant TCR beta-chain sequences were identified in three patients and analyzed for their KIR gene expression pattern.