Paul Dorman

Is the EuroQol a Valid Measure of Health-Related Quality of Life After Stroke?

BACKGROUND AND PURPOSE The EuroQol measures aspects of quality of life that are highly relevant to stroke patients. It is short and simple and many stroke patients can complete the form without help. However, its validity has not been adequately assessed after stroke. We therefore assessed its concurrent and discriminant validity in a group of prospectively studied stroke survivors. METHODS We assessed the validity of the EuroQol in a series of 152 patients with stroke who were all visited by a study nurse. The nurse gave the patients the EuroQol, the Frenchay Activities Index, a visual analogue pain scale, and the Hospital Anxiety and Depression Scale in the form of questionnaires to be self-completed where possible. The nurse interviewed the patient directly to assess disability using the Office of Population Censuses and Surveys Disability scale and Barthel Index. RESULTS The nurse assessed 152 patients; of these 92 were able to complete the EuroQol without help, the remaining 60 could only be assessed by interview. The EuroQol had reasonable concurrent validity; median scores on the relevant standard instruments varied significantly (and in the appropriate direction) for groups defined by their response to the relevant EuroQol domain. The EuroQol had reasonable discriminant validity since the responses enabled separation between patients with differing stroke syndromes and stroke severities. Accuracy for predicting outcome after stroke was good for both self-completed and interview-completed questionnaires. CONCLUSIONS The EuroQol appears to have acceptable concurrent and discriminant validity for the measurement of health-related quality of life after stroke. It may be administered by either a questionnaire for self-completion in patients with mild to moderate stroke or by interview in patients with significant motor deficits.

Qualitative Comparison of the Reliability of Health Status Assessments With the EuroQol and SF-36 Questionnaires After Stroke

BACKGROUND AND PURPOSE The reliability of the EuroQol and SF-36 questionnaires after stroke is not known. We therefore aimed to assess and compare the test-retest reliability of both instruments in a group of stroke patients. METHODS A total of 2253 patients with stroke entered by United Kingdom hospitals in the International Stroke Trial were randomized to follow up with either the EuroQol or the SF-36 instruments. For both instruments, we randomly selected one third of respondents and asked them to complete another, identical questionnaire. We assessed test-retest reliability using agreement statistics: unweighted kappa statistics for the categorical domains of the EuroQol and intraclass correlation coefficients for the EuroQol visual analog scale, utility scores, and SF-36. RESULTS For the five categorical domains of the EuroQol, reproducibility was generally good (kappa ranged from 0.63 to 0.80). The reproducibility of the domains of the SF-36 was qualitatively similar for all the domains except mental health (intraclass correlation coefficient=.28). However, the 95% confidence intervals for the difference in scores between test and retest were substantial. For both instruments, reproducibility was better when the patient completed the questionnaires than when a proxy did. CONCLUSIONS Both the EuroQol and SF-36 have acceptable and qualitatively similar test-retest reliability. Therefore, either instrument might function effectively as a discriminatory measure for assessing health-related quality-of-life outcomes in groups of patients after stroke. However, our data do not support the use of either instrument for serial assessments in individual patients unless very large differences over time are expected.

Impact of functional status at six months on long term survival in patients with ischaemic stroke : prospective cohort studies

Objective To estimate the impact on long term survival of functional status at six months after ischaemic stroke. Design Prospective cohort study. Settings Three cohorts: Oxfordshire community stroke project, Lothian stroke register, and the first international stroke trial (in the United Kingdom). Participants 7710 patients with ischaemic stroke registered between 1981 and 2000 and followed up for a maximum of 19 years. Main outcome measures Functional status at six months after stroke assessed with modified Rankin scale or “two simple questions.” Mortality during follow-up. Survival analysis with Kaplan-Meier curves, log rank test, and Cox’s regression model. Results In a combined analysis of all three cohorts, among patients who survived to assessment six months after the index stroke, the subsequent median length of survival among those independent in daily living and those dependent was 9.7 years (95% confidence interval 8.9 to 10.6) and 6.0 years (5.7 to 6.4), respectively. In a combined analysis of the Oxfordshire and Lothian cohorts, subsequent median survival fell progressively from 12.9 years (10.0 to 15.9) for patients with a Rankin score of 0-1 at six months after the stroke to 2.5 years (1.4 to 3.5) for patients with a Rankin score of 5. All previously stated differences in median survival were significant (log rank test P<0.001). The influence of functional outcome on survival remained significant (P<0.05) in each cohort after adjustment for relevant covariates (such as age, presence of atrial fibrillation, visible infarct on computed tomography, subtype of stroke) in a Cox’s regression model. Conclusion Functional status six months after an ischaemic stroke is associated with long term survival. Early interventions that reduce dependency at six months might have positive effects on long term survival.

Can stroke physicians and neuroradiologists identify signs of early cerebral infarction on CT

Doctors managing acute stroke are expected to recognise signs of early infarction on CT before choosing thrombolytic treatment, according to recent trials and guidelines. The ability of 13 physicians and two neuroradiologists to recognise early infarct signs and decide whether patients should be randomised in a hypothetical stroke treatment trial was tested. Only 65% of the CT scans from 14 stroke patients were correctly identified as normal or abnormal (95% CI 60–69%). Neither observer experience nor knowledge of symptoms significantly improved recognition of abnormality, although experience did significantly improve the observers’ ability to reproduce their results. Parenchymal hypodensity was the least well recognised sign. Only 45% (95% CI 40%–50%) of patients were identified correctly for the hypothetical acute stroke treatment trial. Early infarction on CT is not well recognised even by experienced doctors. Part of the problem may be in understanding the definitions of the extent of infarction. These difficulties should be considered in the design of acute stroke treatment trials and in the introduction of any new acute stroke treatments.

Fatigue after stroke: baseline predictors and influence on survival. Analysis of data from UK patients recruited in the International Stroke Trial.

Background and Purpose Little is known about the associations of post-stroke fatigue or its influence on survival. The vitality component of the Short Form 36 (SF-36) is a valid and reliable measure of post-stroke fatigue. We sought to identify associates of post-stroke fatigue and determine whether fatigue predicted survival. Methods We used SF-36 vitality scores obtained by postal questionnaires from 1080 UK patients randomised in the International Stroke Trial, at a mean of 64 weeks after stroke onset. We used logistic regression to explore factors at randomisation which predicted SF-36 vitality at follow-up, and the relationship between SF-36 vitality and both SF-36 mental health and SF-36 emotional role function at follow-up. We used Cox proportional hazards to explore the influence of SF-36 vitality at follow-up on subsequent survival, using four different statistical models for handling missing data. Results Female sex, increasing age, lower mental health and lower emotional role function scores were associated with greater degrees of fatigue after stroke (i.e. lower vitality scores) but these factors explained <30% of the variance (R2) in fatigue. In two models, fatigue at follow-up was associated with shorter subsequent survival. Conclusion Increasing age, female sex, emotional role function and mental health were associated with increased fatigue at a mean of 64 weeks after stroke onset, but explained less than 30% of the variance. Fatigue was associated with reduced subsequent long-term survival in 2/4 models. Further work is needed to identify the biological substrate of fatigue and to clarify its influence on survival.

Considerations in the Design of Clinical Trials of Neuroprotective Therapy in Acute Stroke

Any therapeutic trial of a new treatment for stroke must provide sufficient reliable evidence to convince clinicians and healthcare purchasers of its merits. Clinicians are most likely to be convinced by large independent studies that provide clear evidence of benefit. If the trial is really to alter healthcare delivery, it should also confirm that the treatment is cost-effective enough to satisfy the increasingly critical demands of the healthcare purchasers. Although some of the current trials will be able to detect large benefits, reliable detection of the moderate benefits that seem more plausible with neuroprotection will need to wait until completion of trials that are perhaps an order of magnitude larger. If tens of thousands of patients are to be recruited into trials of neuroprotective therapy, it is essential that the trials have simple practicable designs that allow participation not only by interested university hospitals but also busy general hospitals with few research resources.

Reports of Randomized Trials in Acute Stroke, 1955 to 1995 What Proportions Were Commercially Sponsored?

BACKGROUND AND PURPOSE Research in acute stroke has expanded rapidly. Many potentially important interventions lack commercial potential (eg, admission to a stroke unit). We therefore wished to examine the frequency of reports of randomized trials of interventions for acute stroke over the past 40 years, the source of support for such trials, the reporting of the commercial involvement, and whether the proportion of commercially supported trials had changed. METHODS Eligible trials were identified from the Cochrane Stroke Groups specialized register of controlled clinical trials. We included all randomized trials in patients with acute stroke which published a full text report, in English, between 1955 and 1995. Two reviewers independently extracted data on the involvement of the pharmaceutical industry in all eligible trials. RESULTS There was a substantial increase in the number of acute stroke trials published per year between 1955 and 1995. The description of pharmaceutical industry involvement in each trial report was poor. Only a minority of supported trials made explicit statements about the role of the sponsoring company. The proportion of trials apparently supported by the pharmaceutical industry has increased substantially. CONCLUSIONS The increasingly important role of the pharmaceutical industry in evaluating new treatments gives substantial scope for bias and may not be in the interests of public health. Poor reporting of the sponsors involvement suggests that modifications to the guidelines for the reporting of randomized controlled trials to include more details of the sponsors involvement in the design, conduct, management, analysis, and reporting of the trial are justified.

Recently Developed Neuroprotective Therapies for Acute Stroke

SummaryAn increased understanding of the pathophysiological consequences of stroke and, in particular, the notion of an ischaemic penumbra in acute cerebral infarction has led to the development of novel neuroprotective treatments. These act at different stages of the pathophysiological cascade that leads to ischaemic neuronal damage.A bewildering number of potentially neuroprotective treatments are currently in preclinical and clinical development. This article systematically reviews all the completed and ongoing randomised controlled trials evaluating the effect of the more recently developed neuroprotective agents on clinical outcomes in patients with acute stroke. These agents are focused on because more detailed quantitative meta-analyses are available for many of the earlier neuroprotective agents.A simple classification of all the current neuroprotective agents on the basis of common potential mechanisms of action is presented. The agents are classified into 8 major groups: modulators of excitatory amino acids, modulators of calcium influx, metabolic activators, antioedema agents, inhibitors of leucocyte adhesion, free radical scavengers, promoters of membrane repair and those with an unknown mechanism of action.The data emerging from clinical trials of currently available neuroprotective therapies have not provided clear evidence of the benefit of this type of treatment. Further large randomised trials involving patients with both ischaemic and haemorrhagic stroke are required before the routine use of neuroprotective therapy in clinical practice can be recommended.

Access to computed tomography in British accident and emergency departments.

Editor–Julien Bogousslavsky highlights the need for further trials of thrombolysis in patients presenting soon after the onset of acute ischaemic stroke.1 However, before randomisation the patient must have computed tomography to exclude intracranial haemorrhage as the cause of the stroke. Computed tomography has not been widely available in the United Kingdom.2 Accident and emergency departments are well placed to perform the initial triage and assessment of patients presenting with acute stroke, but a selective audit suggested that access to computed tomography in these departments was patchy.3 We …