We assessed the validity and reliability of simple questions to assess outcome after stroke in a group of 60 patients. 100 consecutive patients admitted to hospital with acute stroke were prospectively studied, and survivors were randomised to follow-up either by postal questionnaire or telephone interview. The responses to the postal or telephone assessment from the 60 patients who could participate in the study were compared to the Barthel Index (BI) and Oxford Handicap Scale (OHS) obtained from a face-to-face interview by a trained nurse (who was ''blind'' to the postal or telephone responses). The response to the postal questionnaire or telephone interview item: ''In the last 2 weeks, did you require help from another person for everyday activities?'', had an accuracy of 75% in identifying patients with bad outcome (defined by a BI <20/20) and an accuracy of 83% when bad outcome was defined by an OHS category of 3,4 or 5. The answer to the item ''Do you feel that you have made a complete recovery from your stroke?'' had an accuracy of 90% when compared with an OHS category of 0 obtained at the nurse interview. The responses to the simple ''dependency'' and ''recovery'' questions obtained by postal questionnaire and telephone interview agreed well with the responses to the same questions administered by the nurse ĸ= 0.62 and 0.73, respectively). There was no difference between outcome assessed by postal or telephone methods, and no clinically important difference between self- or carer-completed questionnaires. These results suggest that very simple measures of outcome after stroke can be developed. The two simple questions were practical, valid, reliable and could be administered effectively by post or telephone, without the need for a face-to-face interview; this method would therefore be suitable for all types of very large-scale studies of outcome after stroke (e.g. randomised trials, observational studies and multicentre audits of stroke care).
BACKGROUND AND PURPOSE: To test the design and feasibility of a very large randomised controlled trial assessing the efficacy and safety of antithrombotic therapy started within 48 hours of symptom onset in patients with suspected acute ischaemic stroke. DESIGN: Randomised controlled multicentre open study, with a 3 x 2 factorial design, allocating patients to: medium dose subcutaneous heparin (12,500 units twice per day), versus low dose subcutaneous heparin (5000 units twice per day) versus no heparin; and aspirin (300 mg daily) versus no aspirin. Treatment was given for two weeks or until discharge from hospital if sooner. RESULTS: 984 patients were randomised. CT was performed in 924 (94%) (before randomisation in 622/984 (63%). Within 14 days: 97 patients had died (10%), 30 (3.0%) had a fatal or non-fatal recurrent ischaemic stroke, nine (0.9%) had fatal or non-fatal recurrent stroke due to intracranial haemorrhage, and eight (0.8%) had a fatal or non-fatal pulmonary embolus. At six months, vital status was known for 975 patients (99%), of whom 210 (22%) were dead, 373 (38%) were alive but dependent, and 225 (23%) were independent but not fully recovered. CONCLUSIONS: The trial procedures proved practicable and a wide variety of patients were recruited. Sample size calculation based on the event rates confirmed that reliable evidence on the balance of risk and benefit of early antithrombotic therapy might require a study with more than 20,000 patients. Recruitment rates in the pilot study indicated that if about 200 hospitals participated, recruitment could be completed by 1997.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.