BACKGROUND: Care within a stroke unit reduces death or dependency after stroke. However, studies have found significant variations in clinical practice, access to stroke unit care, organisation of patient care, and clinical outcome. Stroke care pathways have been introduced as a method to promote organised and efficient patient care that is based on best evidence and guidelines. OBJECTIVES: We aimed to assess the effects of care pathways, as compared to standard medical care, among patients with acute stroke who had been admitted to hospital. SEARCH STRATEGY: We searched the Cochrane Stroke Group Specialised Trials Register (last searched in May 2001), the Cochrane Controlled Trials Register (Issue 4, 2000), MEDLINE (1975-2000), EMBASE (1980-2000), CINAHL (1982-2000), the Index to Scientific and Technical Proceedings (ISTP, May 2001), and HealthSTAR (May 2001). We also handsearched the Journal of Managed Care (1997 to 1998), which was later renamed the Journal of Integrated Care (1998 to 2001). Reference lists of articles were searched. SELECTION CRITERIA: We considered randomised controlled trials and non-randomised studies (quasi-randomised trials, comparative studies, controlled and uncontrolled before and after studies, and interrupted time series) that compared care pathway care with standard medical care. DATA COLLECTION AND ANALYSIS: One reviewer selected studies for inclusion and the other independently checked the decisions. Two reviewers independently assessed the methodological quality of the studies. One reviewer extracted the data and the other checked the extracted data. Data from randomised and non-randomised studies were analysed separately. We found significant statistical heterogeneity in the analysis of two outcomes (computed tomography brain scanning and duration of stay). MAIN RESULTS: There were three randomised controlled trials (total of 340 patients) and seven non-randomised studies (total of 1673 patients) that compared care pathway care with standard medical care. We found no difference between care pathway and control groups in terms of death, dependency, or discharge destination. Evidence from mainly non-randomised studies suggests that patients managed using a care pathway may be: a) less likely to suffer a urinary tract infection (OR 0.38, CI 0.18 to 0.79), b) less likely to be readmitted (OR 0.11, CI 0.03 to 0.39), and c) more likely to have a computed tomography brain scan (OR 3.66, CI 1.45 to 9.27) or carotid duplex study (OR 2.45, CI 1.3 to 4.61). Evidence from randomised trials suggests that patient satisfaction and quality of life may be significantly lower in the care pathway group (P=0.02 and P<0.005 respectively). REVIEWER'S CONCLUSIONS: The use of care pathways to manage stroke patients in hospital may be associated with both positive and negative effects on the process of care and clinical outcomes. Since most of the results have been derived from non-randomised studies, they are likely to be influenced by potential biases and confounding factors. There is currently insufficient supporting evidence to justify routine implementation of care pathways for acute stroke management or stroke rehabilitation.