R.J. de Haan

Prediction of poor outcome within the first 3 days of postanoxic coma

Objective: To determine the optimal timing of somatosensory evoked potential (SSEP) recordings and the additional value of clinical and biochemical variables for the prediction of poor outcome in patients who remain comatose after cardiopulmonary resuscitation (CPR). Methods: A prospective cohort study was conducted in 32 intensive care units including adult patients still unconscious 24 hours after CPR. Clinical, neurophysiologic, and biochemical variables were recorded 24, 48, and 72 hours after CPR and related to death or persisting unconsciousness after 1 month. Results: Of 407 included patients, 356 (87%) had a poor outcome. In 301 of 305 patients unconscious at 72 hours, at least one SSEP was recorded, and in 136 (45%), at least one recording showed bilateral absence of N20. All these patients had a poor outcome (95% CI of false positive rate 0 to 3%), irrespective of the timing of SSEP. In the same 305 patients, neuron-specific enolase (NSE) was determined at least once in 231, and all 138 (60%) with a value >33 μg/L at any time had a poor outcome (95% CI of false positive rate 0 to 3%). The test results of SSEP and NSE overlapped only partially. The performance of all clinical tests was inferior to SSEP and NSE testing, with lower prevalences of abnormal test results and wider 95% CI of false positive rates. Conclusion: Poor outcome in postanoxic coma can be reliably predicted with somatosensory evoked potentials and neuron-specific enolase as early as 24 hours after cardiopulmonary resuscitation in a substantial number of patients.

The Frenchay Activities Index. Assessment of functional status in stroke patients.

Background and Purpose Assessment of functional status in stroke patients is of major importance in both clinical practice and outcome studies. The Frenchay Activities Index has been developed specifically for measuring disability and handicap in stroke patients. The purpose of the study was to evaluate the metric properties of this instrument and to obtain normal values in a group of unselected elderly subjects. Methods The Frenchay Activities Index was tested in a group of stroke patients and a group of unselected subjects aged 65 or older. The functional status of the stroke patients was measured 26 weeks after stroke. Their prestroke status was registered retrospectively. Reliability and validity of the instrument were assessed. Results The mean scores in the prestroke, poststroke, and control group demonstrated differences in functional status. The reliability of unweighted scores (range of Cronbachs α coefficients, 0.78 to 0.87) was sufficient. The construct validity was supported by meaningful correlations between the Frenchay Activities Index and scores on the Barthel Index and Sickness Impact Profile. Principal-components analysis indicated that the Frenchay Activities Index showed two traits: instrumental disability and some aspects of handicap. The reliability of the instrument could be improved by deleting two items and by creating two subscale scores: domestic and outdoors activities. Conclusions The Frenchay Activities Index is a useful stroke-specific instrument to assess functional status. Completion of the questionnaire is easy and takes only a few minutes. Currently, the instrument is suitable for use in patient care and cross-sectional, descriptive studies.

Clinical features and prognostic factors of cerebral venous sinus thrombosis in a prospective series of 59 patients

The prognosis of cerebral venous sinus thrombosis (CVST) is variable, and outcome may range from complete recovery to death. Prognostic factors to predict outcome in the acute phase of CVST have not been analysed in a prospective study. Prognostic factors in patients enrolled in a clinical treatment trial were prospectively investigated. Poor outcome after 12 weeks, defined as death or dependency (Oxford handicap score⩾3), was used as the principle outcome measure. Univariate relations between possible prognostic factors and outcome at 12 weeks were analyzed with χ2 tests. Treatment and all factors associated with prognosis (p⩽ 0.25) were forced into a logistic regression model with a forward selection procedure. Fifty nine patients (50 women, nine men) were studied, with a mean age of 37 years (range 18 to 80 years). After 12 weeks 10 patients (17%) had a poor outcome. The univariate identified factors related to poor outcome were papilloedema, altered consciousness, coma, age older than 33 years, diagnostic delay⩽10 days, intracerebral haemorrhage, and involvement of the straight sinus. Isolated intracranial hypertension and a delta sign on CT were associated with good outcome. In the multivariate analysis coma and cerebral haemorrhage were significantly associated with a poor outcome, with odds ratios of 8.2 (95% confidence interval (95% CI) 1.3–50.1) and 20.7 (95% CI 1.6–264.3) respectively. Involvement of the straight sinus was also weakly, but not significantly, associated with poor outcome. In conclusion, coma and intracerebral haemorrhage are independent predictors for poor outcome of CVST.

Unilateral pallidotomy versus bilateral subthalamic nucleus stimulation in PD A randomized trial

Objective: To compare the efficacy of unilateral pallidotomy and bilateral subthalamic nucleus (STN) stimulation in patients with advanced Parkinson disease (PD) in a randomized, observer-blind, multicenter trial. Methods: Thirty-four patients with advanced PD were randomly assigned to have unilateral pallidotomy or bilateral STN stimulation. The primary outcome was the change from baseline to 6 months in the motor part of the Unified PD Rating Scale (motor UPDRS) in the off phase. Secondary outcomes were parkinsonian symptoms in the on phase (motor UPDRS), dyskinesias (Clinical Dyskinesia Rating Scale and dyskinesias UPDRS), functional status (activities of daily living UPDRS and Schwab and England scale), PD Quality of Life questionnaire, changes in drug treatment, and adverse effects. Results: The off phase motor UPDRS score improved from 46.5 to 37 points in the group of pallidotomy patients and from 51.5 to 26.5 in the STN stimulation patients (p = 0.002). Of the secondary outcome measures, on phase motor UPDRS and dyskinesias UPDRS improved significantly in favor of the STN stimulation patients. Reduction of antiparkinsonian drugs was greater after STN stimulation than after pallidotomy. One patient in each group had a major adverse effect. Conclusions: Bilateral STN stimulation is more effective than unilateral pallidotomy in reducing parkinsonian symptoms in patients with advanced PD.

Determinants of disability and quality of life in mild to moderate Parkinson disease

Objective: To identify factors that independently contribute to disability and quality of life (QoL) in patients with mild to moderate Parkinson disease (PD). Methods: A group of 190 patients with PD recruited from outpatient clinics and the Dutch Parkinson’s Disease Association participated in this cross-sectional study. Data on demographic and clinical factors, motor symptoms, cognitive functions, affective symptoms, comorbidity, and social support were collected during neurologic and neuropsychological examinations. Disability was rated using the Schwab and England Activities of Daily Living Scale (SE-ADL), the AMC Linear Disability Score (ALDS), and the Functional Independence Measure (FIM). QoL was assessed with the Parkinson’s Disease Quality of Life questionnaire (PDQL) and the Medical Outcome Study Short Form (SF-36). Multiple linear regression analyses were conducted to identify determinants of disability and poor QoL. Results: Axial impairment (postural instability and gait difficulty) explained the largest proportion of variance in disability. Bradykinesia and comorbidity contributed to disability, but to a lesser extent. Self-reported mood symptoms and axial impairment were the two factors most closely associated with poorer QoL, but comorbidity and bradykinesia additionally contributed to the explanatory power. Semantic fluency and psychomotor skills were the only cognitive variables related to some aspects of functional outcome. Conclusion: Axial impairment is strongly associated with disability in patients with mild to moderate Parkinson disease (PD). Self-report indices of mood status and axial impairment are identified as the main determinants of poor quality of life (QoL). The results of this study may help to identify patients with PD at risk for functional dependence and reduced QoL.

Complications and outcome in patients with aneurysmal subarachnoid haemorrhage: a prospective hospital based cohort study in the Netherlands

OBJECTIVE The aim of this study was to investigate prospectively in an unselected series of patients with an aneurysmal subarachnoid haemorrhage what at present the complications are, what the outcome is, how many of these patients have “modern treatment”—that is, early obliteration of the aneurysm and treatment with calcium antagonists—what factors cause a delay in surgical or endovascular treatment, and what the estimated effect on outcome will be of improved treatment. METHODS A prospective, observational cohort study of all patients with aneurysmal subarachnoid haemorrhage in the hospitals of a specified region in The Netherlands. The condition on admission, diagnostic procedures, and treatments were recorded. If a patient had a clinical deterioration, the change in Glasgow coma score (GCS), the presence of focal neurological signs, the results of additional investigations, and the final diagnosed cause of the deterioration were recorded. Clinical outcome was assessed with the Glasgow outcome scale (GOS) at 3 month follow up. In patients with poor outcome at follow up, the cause was diagnosed. RESULTS Of the 110 patients, 47 (43%) had a poor outcome. Cerebral ischaemia, 31 patients (28%), was the most often occurring complication. Major causes of poor outcome were the effects of the initial haemorrhage and rebleeding in 34% and 30% of the patients with poor outcome respectively. Of all patients 102 (93%) were treated with calcium antagonists and 45 (41%) patients had early treatment to obliterate the aneurysm. The major causes of delay of treatment were a poor condition on admission or deterioration shortly after admission, in 31% and 23% respectively. CONCLUSIONS In two thirds of the patients with poor outcome the causes of poor outcome are the effects of the initial bleeding and rebleeding. Improved treatment of delayed or postoperative ischaemia will have only minor effects on the outcome of patients with subarachnoid haemorrhage.

Risk Factors for Falls of Hospitalized Stroke Patients

BACKGROUND AND PURPOSE Patients with stroke are at a high risk for falling. We assessed the fall incidence and risk factors for patients hospitalized as the result of an acute stroke. METHODS We studied a cohort of 720 stroke patients from 23 hospitals in The Netherlands. The data were abstracted from the medical and nursing records. RESULTS We studied 346 women and 374 men with a median age of 75 years; 77% of the patients had had a cerebral infarct, 17% had had a hemorrhage, and 6% had had an undefined stroke. We recorded 104 patients (14%) who fell at least once; there were a total of 173 falls. The incidence of falls was 8.9/1000 patients per day. The daily incidence was 6.2/1000 patients for first falls and 17.9/1000 patients for second falls. Heart disease (relative risk [RR], 1.6; 95% confidence interval [CI], 1.0 to 2.4), mental decline (RR, 1.6; 95% CI, 1.0 to 2.4), and urinary incontinence (RR, 2.3; 95% CI, 1.3 to 4.1) were incremental risk factors for first falls, whereas the use of major psychotropic drugs lowered the fall risk (RR, 0.5; 95% CI, 0.3 to 0.8). The fall RR for patients with one previous fall was 2.2 (95% CI, 1.5 to 3.2), adjusted for the other risk factors. Most falls occurred during the day. Approximately 25% of the falls caused slight-to-severe injury, whereas three falls (2%) led to hip fractures. CONCLUSIONS Stroke patients have at risk of falling. The identification of patients at risk may be a first step toward the implementation of fall-prevention measures for these patients.

Very Early Nimodipine Use in Stroke (VENUS): a randomized, double-blind, placebo-controlled trial.

Backgound and Purpose — The Very Early Nimodipine Use in Stroke (VENUS) trial was designed to test the hypothesis that early treatment with nimodipine has a positive effect on survival and functional outcome after stroke. This was suggested in a previous meta-analysis on the use of nimodipine in stroke. However, in a recent Cochrane review we were unable to reproduce these positive results. This led to the early termination of VENUS after an interim analysis. Methods — In this randomized, double-blind, placebo-controlled trial, treatment was started by general practitioners or neurologists within 6 hours after stroke onset (oral nimodipine 30 mg QID or identical placebo, for 10 days). Main analyses included comparisons of the primary end point (poor outcome, defined as death or dependency after 3 months) and secondary end points (neurological status and blood pressure 24 hours after inclusion, mortality after 10 days, and adverse events) between treatment groups. Subgroup analyses (on final diagnosis and based on the per-protocol data set) were performed. Results — At trial termination, after inclusion of 454 patients (225 nimodipine, 229 placebo), no effect of nimodipine was found. After 3 months of follow-up, 32% (n=71) of patients in the nimodipine group had a poor outcome compared with 27% (n=62) in the placebo group (relative risk, 1.2; 95% CI, 0.9 to 1.6). A treatment effect was not found for secondary outcomes and in the subgroup analyses. Conclusions — The results of VENUS do not support the hypothesis of a beneficial effect of early nimodipine in stroke patients.

A Stroke-Adapted 30-Item Version of the Sickness Impact Profile to Assess Quality of Life (SA-SIP30)

BACKGROUND AND PURPOSE In view of the growing therapeutic options in stroke, measurement of quality of life has become increasingly relevant as an outcome parameters. The Sickness Impact Profile (SIP) is one of the most widely used measures to assess quality of life. To overcome the major disadvantage of the SIP, its length, we constructed a short stroke adapted 30-item SIP version (SA-SIP30). METHODS Data on the original SIP version were collected for 319 communicative patients at 6 months after stroke. The 12 subscales and the 136 items of the original SIP were reduced to 8 subscales with 30 items in a three step procedure, on the basis of relevancy and homogeneity. Reliability of the SA-SIP30 was evaluated by means of an analysis of homogeneity (Cronbachs alpha coefficient). Different types of validity were assessed: construct, clinical, and external validities. RESULTS Homogeneity of the SA-SIP30 was demonstrated by a high Cronbachs alpha (0.85). Principal component analyses revealed the same two dimensions as in the original SIP (a physical and a psychosocial dimension). The SA-SIP30 could explain 91% of the variation in scores of the original SIP in the same cohort of patients, and 89% in a different cohort. Furthermore, the SA-SIP30 was related to other functional health measures similar to how the original SIP was. We could demonstrate that the SA-SIP30 was able to distinguish patients with lacunar infarctions from patients with cortical or subcortical lesions. CONCLUSIONS We conclude that the SA-SIP30 is a feasible and clinimetrically sound measure to assess quality of life after stroke.

Treatment of chronic tension‐type headache with botulinum toxin: a double‐blind, placebo‐controlled clinical trial

Botulinum toxin is increasingly advocated as effective treatment in chronic tension-type headache. We conducted a randomized, placebo-controlled clinical trial to prove efficacy of botulinum toxin in chronic tension-type headache. Patients were randomly assigned to receive botulinum toxin (maximum 100 units) or placebo (saline) in muscles with increased tenderness. After 12 weeks there was no significant difference between the two treatment groups in decrease of headache intensity on VAS (-3.5 mm, 95% confidence interval (CI) -20 to +13), mean number of headache days (-7%; 95% CI -20 to +4), headache hours per day (-1.4%; 95% CI -3.9 to +1.1), days on which symptomatic treatment was taken (-1.9%; 95% CI -11 to +7) and number of analgesics taken per day (-0.01; 95% CI -0.25-0.22). There was no significant difference in patients assessment of improvement after week 4, 8 and 12. Botulinum toxin was not proven effective in treatment of chronic tension-type headache. Increased muscle tenderness might not be as important in pathophysiology of chronic tension-type headache as hitherto believed.