Further Analysis of NINDS Study.

Following the initial publication of the National Institute of Neurological Disorders and Stroke (NINDS) tissue-plasminogen activator (t-PA) Stroke Trial results, the NINDS investigators published a series of additional data and analyses. These analyses were necessary because not all the relevant data could be included in the primary report, and to answer criticisms of the original article. Some of these analyses are summarized in other chapters, including Chapters 9 and 18. This chapter focuses on three important issues: cost effectiveness, subgroup selection, and long-term follow-up. The cost-effectiveness issue is critical because thrombolytic drugs are expensive. To show that the drug cost is worthwhile, the costs of stroke care absent treatment, including how costs might increase or decrease with successful treatment, were examined. Subgroup selection is addressed because some have advocated such analysis to help select patients at particular risk or susceptibility of benefit. Regression modeling was used to rigorously identify any subgroups that could be preferred for treatment. To ensure that the benefits of thrombolysis were sustained over the long term, the original cohort of patients up to 1 yr after stroke was followed. The essentials of these three follow-up analyses, cost effectiveness, subgroup selection, and longterm follow-up, have been published, so only brief descriptions of the methods are given here (1-3). The aim of this chapter is to put the results of these analyses into perspective for the practicing clinician. [ABSTRACT FROM AUTHOR]