The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: a study protocol for three multicentre randomised controlled trials.

BACKGROUND: Several small trials have suggested that fluoxetine improves neurological recovery from stroke. FOCUS, AFFINITY and EFFECTS are a family of investigator-led, multicentre, parallel group, randomised, placebo-controlled trials that aim to determine whether routine administration of fluoxetine (20 mg daily) for 6 months after acute stroke improves patients' functional outcome. METHODS/DESIGN: The three trial investigator teams have collaboratively developed a core protocol. Minor variations have been tailored to the national setting in the UK (FOCUS), Australia and New Zealand (AFFINITY) and Sweden (EFFECTS). Each trial is run and funded independently and will report its own results. A prospectively planned individual patient data meta-analysis of all three trials will subsequently provide the most precise estimate of the overall effect of fluoxetine after stroke and establish whether any effects differ between trials and subgroups of patients. The trials include patients ≥18 years old with a clinical diagnosis of stroke, persisting focal neurological deficits at randomisation between 2 and 15 days after stroke onset. Patients are randomised centrally via web-based randomisation systems using a common minimisation algorithm. Patients are allocated fluoxetine 20 mg once daily or matching placebo capsules for 6 months. Our primary outcome measure is the modified Rankin scale (mRS) at 6 months. Secondary outcomes include the Stroke Impact Scale, EuroQol (EQ5D-5 L), the vitality subscale of the Short-Form 36, diagnosis of depression, adherence to medication, adverse events and resource use. Outcomes are collected at 6 and 12 months. The methods of collecting these data are tailored to the national setting. If FOCUS, AFFINITY and EFFECTS combined enrol 6000 participants as planned, they would have 90 % power (alpha 5 %) to detect a common odds ratio of 1.16, equivalent to a 3.7 % absolute difference in percentage with mRS 0-2 (44.0 % to 47.7 %). This is based on an ordinal analysis of mRS adjusted for baseline variables included in the minimisation algorithm. DISCUSSION: If fluoxetine is safe and effective in promoting functional recovery, it could be rapidly, widely and affordably implemented in routine clinical practice and reduce the burden of disability due to stroke. FOCUS: ISRCTN83290762 (23/05/2012), AFFINITY: ACTRN12611000774921 (22/07/2011). EFFECTS: ISRCTN13020412 (19/12/2014).

Protocol for the perfusion and angiography imaging sub-study of the Third International Stroke Trial (IST-3) of alteplase treatment within six-hours of acute ischemic stroke.

RATIONALE: Intravenous thrombolysis with recombinant tissue Plasminogen Activator improves outcomes in patients treated early after stroke but at the risk of causing intracranial hemorrhage. Restricting recombinant tissue Plasminogen Activator use to patients with evidence of still salvageable tissue, or with definite arterial occlusion, might help reduce risk, increase benefit and identify patients for treatment at late time windows. AIMS: To determine if perfusion or angiographic imaging with computed tomography or magnetic resonance help identify patients who are more likely to benefit from recombinant tissue Plasminogen Activator in the context of a large multicenter randomized trial of recombinant tissue Plasminogen Activator given within six-hours of onset of acute ischemic stroke, the Third International Stroke Trial. DESIGN: Third International Stroke Trial is a prospective multicenter randomized controlled trial testing recombinant tissue Plasminogen Activator (0·9 mg/kg, maximum dose 90 mg) started up to six-hours after onset of acute ischemic stroke, in patients with no clear indication for or contraindication to recombinant tissue Plasminogen Activator. Brain imaging (computed tomography or magnetic resonance) was mandatory pre-randomization to exclude hemorrhage. Scans were read centrally, blinded to treatment and clinical information. In centers where perfusion and/or angiography imaging were used routinely in stroke, these images were also collected centrally, processed and assessed using validated visual scores and computational measures. STUDY OUTCOMES: The primary outcome in Third International Stroke Trial is alive and independent (Oxford Handicap Score 0-2) at 6 months; secondary outcomes are symptomatic and fatal intracranial hemorrhage, early and late death. The perfusion and angiography study additionally will examine interactions between recombinant tissue Plasminogen Activator and clinical outcomes, infarct growth and recanalization in the presence or absence of perfusion lesions and/or arterial occlusion at presentation. The study is registered ISRCTN25765518.

Thrombolysis for acute ischaemic stroke.

BACKGROUND: Most strokes are due to blockage of an artery in the brain by a blood clot. Prompt treatment with thrombolytic drugs can restore blood flow before major brain damage has occurred and improve recovery after stroke in some people. Thrombolytic drugs, however, can also cause serious bleeding in the brain, which can be fatal. One drug, recombinant tissue plasminogen activator (rt-PA), is licensed for use in selected patients within 4.5 hours of stroke in Europe and within three hours in the USA. There is an upper age limit of 80 years in some countries, and a limitation to mainly non-severe stroke in others. Forty per cent more data are available since this review was last updated in 2009. OBJECTIVES: To determine whether, and in what circumstances, thrombolytic therapy might be an effective and safe treatment for acute ischaemic stroke. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register (last searched November 2013), MEDLINE (1966 to November 2013) and EMBASE (1980 to November 2013). We also handsearched conference proceedings and journals, searched reference lists and contacted pharmaceutical companies and trialists. SELECTION CRITERIA: Randomised trials of any thrombolytic agent compared with control in people with definite ischaemic stroke. DATA COLLECTION AND ANALYSIS: Two review authors applied the inclusion criteria, extracted data and assessed trial quality. We verified the extracted data with investigators of all major trials, obtaining additional unpublished data if available. MAIN RESULTS: We included 27 trials, involving 10,187 participants, testing urokinase, streptokinase, rt-PA, recombinant pro-urokinase or desmoteplase. Four trials used intra-arterial administration, while the rest used the intravenous route. Most data come from trials that started treatment up to six hours after stroke. About 44% of the trials (about 70% of the participants) were testing intravenous rt-PA. In earlier studies very few of the participants (0.5%) were aged over 80 years; in this update, 16% of participants are over 80 years of age due to the inclusion of IST-3 (53% of participants in this trial were aged over 80 years). Trials published more recently utilised computerised randomisation, so there are less likely to be baseline imbalances than in previous versions of the review. More than 50% of trials fulfilled criteria for high-grade concealment; there were few losses to follow-up for the main outcomes.Thrombolytic therapy, mostly administered up to six hours after ischaemic stroke, significantly reduced the proportion of participants who were dead or dependent (modified Rankin 3 to 6) at three to six months after stroke (odds ratio (OR) 0.85, 95% confidence interval (CI) 0.78 to 0.93). Thrombolytic therapy increased the risk of symptomatic intracranial haemorrhage (OR 3.75, 95% CI 3.11 to 4.51), early death (OR 1.69, 95% CI 1.44 to 1.98; 13 trials, 7458 participants) and death by three to six months after stroke (OR 1.18, 95% CI 1.06 to 1.30). Early death after thrombolysis was mostly attributable to intracranial haemorrhage. Treatment within three hours of stroke was more effective in reducing death or dependency (OR 0.66, 95% CI 0.56 to 0.79) without any increase in death (OR 0.99, 95% CI 0.82 to 1.21; 11 trials, 2187 participants). There was heterogeneity between the trials. Contemporaneous antithrombotic drugs increased the risk of death. Trials testing rt-PA showed a significant reduction in death or dependency with treatment up to six hours (OR 0.84, 95% CI 0.77 to 0.93, P = 0.0006; 8 trials, 6729 participants) with significant heterogeneity; treatment within three hours was more beneficial (OR 0.65, 95% CI 0.54 to 0.80, P < 0.0001; 6 trials, 1779 participants) without heterogeneity. Participants aged over 80 years benefited equally to those aged under 80 years, particularly if treated within three hours of stroke. AUTHORS' CONCLUSIONS: Thrombolytic therapy given up to six hours after stroke reduces the proportion of dead or dependent people. Those treated within the first three hours derive substantially more benefit than with later treatment. This overall benefit was apparent despite an increase in symptomatic intracranial haemorrhage, deaths at seven to 10 days, and deaths at final follow-up (except for trials testing rt-PA, which had no effect on death at final follow-up). Further trials are needed to identify the latest time window, whether people with mild stroke benefit from thrombolysis, to find ways of reducing symptomatic intracranial haemorrhage and deaths, and to identify the environment in which thrombolysis may best be given in routine practice.

Recombinant tissue plasminogen activator for acute ischaemic stroke: an updated systematic review and meta-analysis.

BACKGROUND: Recombinant tissue plasminogen activator (rt-PA, alteplase) improved functional outcome in patients treated soon after acute ischaemic stroke in randomised trials, but licensing is restrictive and use varies widely. The IST-3 trial adds substantial new data. We therefore assessed all the evidence from randomised trials for rt-PA in acute ischaemic stroke in an updated systematic review and meta-analysis. METHODS: We searched for randomised trials of intravenous rt-PA versus control given within 6 h of onset of acute ischaemic stroke up to March 30, 2012. We estimated summary odds ratios (ORs) and 95% CI in the primary analysis for prespecified outcomes within 7 days and at the final follow-up of all patients treated up to 6 h after stroke. FINDINGS: In up to 12 trials (7012 patients), rt-PA given within 6 h of stroke significantly increased the odds of being alive and independent (modified Rankin Scale, mRS 0-2) at final follow-up (1611/3483 [46·3%] vs 1434/3404 [42·1%], OR 1·17, 95% CI 1·06-1·29; p=0·001), absolute increase of 42 (19-66) per 1000 people treated, and favourable outcome (mRS 0-1) absolute increase of 55 (95% CI 33-77) per 1000. The benefit of rt-PA was greatest in patients treated within 3 h (mRS 0-2, 365/896 [40·7%] vs 280/883 [31·7%], 1·53, 1·26-1·86, p<0·0001), absolute benefit of 90 (46-135) per 1000 people treated, and mRS 0-1 (283/896 [31·6%] vs 202/883 [22·9%], 1·61, 1·30-1·90; p<0·0001), absolute benefit 87 (46-128) per 1000 treated. Numbers of deaths within 7 days were increased (250/2807 [8·9%] vs 174/2728 [6·4%], 1·44, 1·18-1·76; p=0·0003), but by final follow-up the excess was no longer significant (679/3548 [19·1%] vs 640/3464 [18·5%], 1·06, 0·94-1·20; p=0·33). Symptomatic intracranial haemorrhage (272/3548 [7·7%] vs 63/3463 [1·8%], 3·72, 2·98-4·64; p<0·0001) accounted for most of the early excess deaths. Patients older than 80 years achieved similar benefit to those aged 80 years or younger, particularly when treated early. INTERPRETATION: The evidence indicates that intravenous rt-PA increased the proportion of patients who were alive with favourable outcome and alive and independent at final follow-up. The data strengthen previous evidence to treat patients as early as possible after acute ischaemic stroke, although some patients might benefit up to 6 h after stroke. FUNDING: UK Medical Research Council, Stroke Association, University of Edinburgh, National Health Service Health Technology Assessment Programme, Swedish Heart-Lung Fund, AFA Insurances Stockholm (Arbetsmarknadens Partners Forsakringsbolag), Karolinska Institute, Marianne and Marcus Wallenberg Foundation, Research Council of Norway, Oslo University Hospital.

The benefits and harms of intravenous thrombolysis with recombinant tissue plasminogen activator within 6 h of acute ischaemic stroke (the third international stroke trial [IST-3]): a randomised controlled trial.

BACKGROUND: Thrombolysis is of net benefit in patients with acute ischaemic stroke, who are younger than 80 years of age and are treated within 4·5 h of onset. The third International Stroke Trial (IST-3) sought to determine whether a wider range of patients might benefit up to 6 h from stroke onset. METHODS: In this international, multicentre, randomised, open-treatment trial, patients were allocated to 0·9 mg/kg intravenous recombinant tissue plasminogen activator (rt-PA) or to control. The primary analysis was of the proportion of patients alive and independent, as defined by an Oxford Handicap Score (OHS) of 0-2 at 6 months. The study is registered, ISRCTN25765518. FINDINGS: 3035 patients were enrolled by 156 hospitals in 12 countries. All of these patients were included in the analyses (1515 in the rt-PA group vs 1520 in the control group), of whom 1617 (53%) were older than 80 years of age. At 6 months, 554 (37%) patients in the rt-PA group versus 534 (35%) in the control group were alive and independent (OHS 0-2; adjusted odds ratio [OR] 1·13, 95% CI 0·95-1·35, p=0·181; a non-significant absolute increase of 14/1000, 95% CI -20 to 48). An ordinal analysis showed a significant shift in OHS scores; common OR 1·27 (95% CI 1·10-1·47, p=0·001). Fatal or non-fatal symptomatic intracranial haemorrhage within 7 days occurred in 104 (7%) patients in the rt-PA group versus 16 (1%) in the control group (adjusted OR 6·94, 95% CI 4·07-11·8; absolute excess 58/1000, 95% CI 44-72). More deaths occurred within 7 days in the rt-PA group (163 [11%]) than in the control group (107 [7%], adjusted OR 1·60, 95% CI 1·22-2·08, p=0·001; absolute increase 37/1000, 95% CI 17-57), but between 7 days and 6 months there were fewer deaths in the rt-PA group than in the control group, so that by 6 months, similar numbers, in total, had died (408 [27%] in the rt-PA group vs 407 [27%] in the control group). INTERPRETATION: For the types of patient recruited in IST-3, despite the early hazards, thrombolysis within 6 h improved functional outcome. Benefit did not seem to be diminished in elderly patients. FUNDING: UK Medical Research Council, Health Foundation UK, Stroke Association UK, Research Council of Norway, Arbetsmarknadens Partners Forsakringsbolag (AFA) Insurances Sweden, Swedish Heart Lung Fund, The Foundation of Marianne and Marcus Wallenberg, Polish Ministry of Science and Education, the Australian Heart Foundation, Australian National Health and Medical Research Council (NHMRC), Swiss National Research Foundation, Swiss Heart Foundation, Assessorato alla Sanita, Regione dell'Umbria, Italy, and Danube University.

Update on the third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke and baseline features of the 3035 patients recruited.

BACKGROUND: Intravenous recombinant tissue plasminogen activator (rtPA) is approved in Europe for use in patients with acute ischaemic stroke who meet strictly defined criteria. IST-3 sought to improve the external validity and precision of the estimates of the overall treatment effects (efficacy and safety) of rtPA in acute ischaemic stroke, and to determine whether a wider range of patients might benefit. DESIGN: International, multi-centre, prospective, randomized, open, blinded endpoint (PROBE) trial of intravenous rtPA in acute ischaemic stroke. Suitable patients had to be assessed and able to start treatment within 6 hours of developing symptoms, and brain imaging must have excluded intracranial haemorrhage and stroke mimics. RESULTS: The initial pilot phase was double blind and then, on 01/08/2003, changed to an open design. Recruitment began on 05/05/2000 and closed on 31/07/2011, by which time 3035 patients had been included, only 61 (2%) of whom met the criteria for the 2003 European approval for thrombolysis. 1617 patients were aged over 80 years at trial entry. The analysis plan will be finalised, without reference to the unblinded data, and published before the trial data are unblinded in early 2012. The main trial results will be presented at the European Stroke Conference in Lisbon in May 2012 with the aim to publish simultaneously in a peer-reviewed journal. The trial result will be presented in the context of an updated Cochrane systematic review. We also intend to include the trial data in an individual patient data meta-analysis of all the relevant randomised trials. CONCLUSION: The data from the trial will: improve the external validity and precision of the estimates of the overall treatment effects (efficacy and safety) of iv rtPA in acute ischaemic stroke; provide: new evidence on the balance of risk and benefit of intravenous rtPA among types of patients who do not clearly meet the terms of the current EU approval; and, provide the first large-scale randomised evidence on effects in patients over 80, an age group which had largely been excluded from previous acute stroke trials. TRIAL REGISTRATION: ISRCTN25765518.

Rivermead mobility index can be used to predict length of stay for elderly persons, 5 days after stroke onset.

BACKGROUND: Recovery after acute stroke is expected to continue for a long time but is most rapid during the first few days after onset. Because the cost of hospital care is rising constantly, there is increasing pressure from various administrative bodies to reduce the duration of hospital stay. To select the optimal level of care for elderly patients with stroke-related disability, it is important to be aware of adequate discharge destinations and to have reliable predictors for the length of institutional stay (LOS) (ie in hospital or nursing home). PURPOSE: The purpose of the study was to find feasible prognostic indicators for the LOS, to be used 5 days after acute stroke, in persons 65 years and older. METHODS: One hundred fifteen consecutive persons, 65 years and older, were assessed 5 days poststroke for the following: consciousness (Glasgow Coma Scale), language (aphasia/no aphasia), perceptual (Cancellation Tasks and Block Test), emotional (lability/no lability), energy and drive (Montgomery-Åsberg Depression Scale), mental (Mini-Mental State Examination), somatosensory (normal/impaired), and urinary (continent/incontinent) functions; mobility (Rivermead mobility index [RMI]); activities of daily living (Barthel Index); and side of hemiplegia or hemiparesis. In addition, previous living arrangements (alone vs with another person), stroke characteristics, and demographic information were documented. Length of institutional stay was recorded 5 days to 3 months poststroke onset. RESULTS: Multiple regression survival analyses showed that the factors with the greatest positive impact on short LOS, 5 days poststroke, were the following: no previous stroke; Glasgow Coma Scale ≥ 13 (mild brain injury); and RMI ≥ 4 points, corresponding to the ability to rise from a chair in less than 15 seconds and stand there for 15 seconds with or without an aid. CONCLUSIONS: In addition to medical appraisal, the RMI ≥ 4 points, a quickly performed test, can be used to predict short LOS for persons with stroke as early as 5 days after stroke onset.

Thrombolysis for acute ischaemic stroke.

BACKGROUND: The majority of strokes are due to blockage of an artery in the brain by a blood clot. Prompt treatment with thrombolytic drugs can restore blood flow before major brain damage has occurred and could improve recovery after stroke. Thrombolytic drugs, however, can also cause serious bleeding in the brain, which can be fatal. One drug, recombinant tissue plasminogen activator (rt-PA), is licensed for use in highly selected patients within three hours of stroke. OBJECTIVES: To assess the safety and efficacy of thrombolytic agents in patients with acute ischaemic stroke. SEARCH STRATEGY: We searched the Cochrane Stroke Group Trials Register (last searched October 2008), MEDLINE (1966 to October 2008) and EMBASE (1980 to October 2008). We contacted researchers and pharmaceutical companies, attended relevant conferences and handsearched pertinent journals. SELECTION CRITERIA: Randomised trials of any thrombolytic agent compared with control in patients with definite ischaemic stroke. DATA COLLECTION AND ANALYSIS: Two review authors applied the inclusion criteria and extracted data. We assessed trial quality. We verified the extracted data with the principal investigators of all major trials. We obtained both published and unpublished data if available. MAIN RESULTS: We included 26 trials involving 7152 patients. Not all trials contributed data to each outcome. The trials tested urokinase, streptokinase, recombinant tissue plasminogen activator, recombinant pro-urokinase or desmoteplase. Four trials used intra-arterial administration, the rest used the intravenous route. Most data come from trials that started treatment up to six hours after stroke; three trials started treatment up to nine hours and one small trial up to 24 hours after stroke. About 55% of the data (patients and trials) come from trials testing intravenous tissue plasminogen activator. Very few of the patients (0.5%) were aged over 80 years. Many trials had some imbalances in key prognostic variables. Several trials did not have complete blinding of outcome assessment. Thrombolytic therapy, mostly administered up to six hours after ischaemic stroke, significantly reduced the proportion of patients who were dead or dependent (modified Rankin 3 to 6) at three to six months after stroke (odds ratio (OR) 0.81, 95% confidence interval (CI) 0.73 to 0.90). Thrombolytic therapy increased the risk of symptomatic intracranial haemorrhage (OR 3.49, 95% CI 2.81 to 4.33) and death by three to six months after stroke (OR 1.31, 95% CI 1.14 to 1.50). Treatment within three hours of stroke appeared more effective in reducing death or dependency (OR 0.71, 95% CI 0.52 to 0.96) with no statistically significant adverse effect on death (OR 1.13, 95% CI 0.86 to 1.48). There was heterogeneity between the trials in part attributable to concomitant antithrombotic drug use (P = 0.02), stroke severity and time to treatment. Antithrombotic drugs given soon after thrombolysis may increase the risk of death. AUTHORS' CONCLUSIONS: Overall, thrombolytic therapy appears to result in a significant net reduction in the proportion of patients dead or dependent in activities of daily living. This overall benefit was apparent despite an increase both in deaths (evident at seven to 10 days and at final follow up) and in symptomatic intracranial haemorrhages. Further trials are needed to identify which patients are most likely to benefit from treatment and the environment in which thrombolysis may best be given in routine practice.

Third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke.

BACKGROUND: Intravenous recombinant tissue plasminogen activator (rt-PA) is approved for use in selected patients with ischaemic stroke within 3 hours of symptom onset. IST-3 seeks to determine whether a wider range of patients may benefit. DESIGN: International, multi-centre, prospective, randomized, open, blinded endpoint (PROBE) trial of intravenous rt-PA in acute ischaemic stroke. Suitable patients must be assessed and able to start treatment within 6 hours of developing symptoms, and brain imaging must have excluded intracerebral haemorrhage. With 1000 patients, the trial can detect a 7% absolute difference in the primary outcome. With 3500 patients, it can detect a 4.0% absolute benefit & with 6000, (mostly treated between 3 & 6 hours), it can detect a 3% benefit. TRIAL PROCEDURES: Patients are entered into the trial by telephoning a fast, secure computerised central randomisation system or via a secure web interface. Repeat brain imaging must be performed at 24-48 hours. The scans are reviewed 'blind' by expert readers. The primary measure of outcome is the proportion of patients alive and independent (Modified Rankin 0-2) at six months (assessed via a postal questionnaire mailed directly to the patient). Secondary outcomes include: events within 7 days (death, recurrent stroke, symptomatic intracranial haemorrhage), outcome at six months (death, functional status, EuroQol). TRIAL REGISTRATION: ISRCTN25765518.

Predictors of life situation among significant others of depressed or aphasic stroke patients.

AIM: The aim of this study was to examine predictors of the life situation of the significant other of depressed or aphasic stroke patients. BACKGROUND: Depression and aphasia are common consequences of stroke, and both may put pressure on the significant other who have to deal not only with a possible physical handicap but also with communication and/or serious psychiatric difficulties. DESIGN: Descriptive, cross-sectional study. METHODS: The participants were significant others of 71 depressed and 77 aphasic stroke patients. Depression was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorder, and degree of aphasia was diagnosed with the Amsterdam Nijmegen Everyday Language Test. Assessments of the life situation, state of depression and aggression, personality change and need of assistance were made through questionnaires issued to the significant others. RESULTS: Perceived need of assistance was the only common predictor of life situation of the significant other in both groups (p < 0.001). With respect to the aphasic patients, perceived personality change (p < 0.001) and living with the patient (p = 0.004) were factors that had a negative effect on the life situation of the significant other. CONCLUSIONS: This study highlights that the perception of the patient's need of assistance is an important factor in predicting the life situation among spouses of depressed as well as aphasic stroke patients. A comparison of the two groups to explain the life situation of the significant others revealed greater explanatory power for the aphasic group. RELEVANCE TO CLINICAL PRACTICE: Assessments of the spouses' perception as well as of the patients' factual situation may identify those significant others at risk. With this new approach, necessary steps may be taken to alleviate pressure on the significant other.

The impact of gender regarding psychological well-being and general life situation among spouses of stroke patients during the first year after the patients' stroke event: a longitudinal study.

BACKGROUND: The informal caregivers perceive lack of choice to take on the role of caregiving, receiving little or no preparation for the caregiving role at home. The typical informal caregiver is female, either a spouse or adult child of the care recipient, and seldom shares the responsibilities of caregiving with other family members. The spouses worry about the ill relative, but also about what consequences the disease might have for their own life. The worries seem to vary with gender and disease. There are, to our knowledge, few previous longitudinal studies that have focused on gender differences among spouses of stroke patients. OBJECTIVES: To explore gender differences among spouses in perceived psychological well-being and general life situation, during the first year after the patients' stroke event. DESIGN: Longitudinal study with three assessments regarding psychological well-being and general life situation during 1 year. SETTINGS: The study took place at a stroke ward, Stockholm, Sweden. PARTICIPANTS: Consecutively 80 female and 20 male spouses of stroke patients admitted to a stroke unit participated. METHODS: Data were analysed using analyses of variance. RESULTS: Female spouses have a negative impact on psychological well-being, while male spouses have a lower occurrence of emotional contacts in their social network. Consistently, the female spouses reported lower quality of life and well-being than the male spouses. CONCLUSIONS: This study generates the hypotheses that there are gender differences among spousal caregivers of stroke patients; female spouses are more negatively affected in their life situation due to the patients' stroke event than the male spouses. It is important to take the individual differences under consideration when designing a nursing intervention, to meet the different needs and demands of male and female caregivers. The interventions should focus on individual support, so that the caregivers can adapt to their new role and be comfortable and effective as informal caregivers.

Determinants of mobility and self-care in older people with stroke: importance of somatosensory and perceptual functions.

BACKGROUND AND PURPOSE: Somatosensory as well as mental impairments are easily overlooked after acute stroke. Furthermore, their associations with activity limitations are not fully understood. The purpose of this study was to examine this association and whether the assessment of somatosensory functions will provide information on perceptual functions after acute stroke. SUBJECTS AND METHODS: In 115 subjects who were > or =65 years of age, the following parameters were assessed 5 days after stroke: somatosensory (touch and proprioceptive), perceptual, and cognitive functions; depressive symptoms; mobility; and self-care. RESULTS: Multivariate analyses showed that normal proprioceptive function was significantly associated with better mobility. Normal perceptual and touch functions were significantly associated with better self-care. Subjects with normal proprioceptive function were 8.6 times as likely to have normal perceptual function as subjects with proprioceptive impairment. DISCUSSION AND CONCLUSION: Somatosensory and perceptual functions were significantly associated with subjects' activity levels. Normal proprioceptive function also might indicate normal perceptual function.

Clinical and prognostic properties of standardized and functional aphasia assessments.

OBJECTIVE: To compare standardized and functional aphasia tests in patients after acute stroke. DESIGN: Data were collected at baseline and at 6 months in 2 prospective single-centre studies: one observational study (study I, n=119) and one randomized trial of moclobemide vs placebo (study II, n=89). SUBJECTS: Patients with aphasia after acute stroke. METHODS: Degree of aphasia was examined using the Coefficient (Coeff) in Norsk Grunntest for Afasi (standardized) and the Amsterdam-Nijmegen Everyday Language Test (ANELT) (functional). Statistical comparisons were made using one-way analysis of variance and multivariate regression analyses. RESULTS: The degree of aphasia measured with Coeff and ANELT correlated closely throughout the study (r2=0.71-0.87, p<0.0001). In study I, 24 patients recovered completely within 6 months. A Coeff >or= 49 and ANELT >or= 3.5 predicted complete recovery equally well. Coeff was sensitive to differentiate between patients with low values on ANELT, whereas ANELT was sensitive to differentiate between patients with high Coeff values. CONCLUSION: The 2 tests show a close and consistent correlation over time and are equally sensitive to improvement. They have a similar capacity to predict complete recovery. A standardized test appears to be more suitable for patients with aphasia in the acute stage, while a functional test is more suitable in the subacute/chronic stage.

Predictors of psychological health in spouses of persons affected by stroke.

AIM: To identify predictors of psychological health and examine if these predictors change over time in spouses of stroke patients during the first year after stroke. A second aim was to identify gender differences in psychological health among the spouses. BACKGROUND: The impact of burden in long-term caregivers may result in psychological consequences for the spouse. The rehabilitation process for the patient can be negatively affected by a stressed caregiver and result in long-term hospitalization. To identify spouses at risk for physical and psychological distress is, therefore, essential to support those in need. DESIGN: Longitudinal, comparative study. METHODS: One hundred spouses of stroke patients were assessed at baseline, as well as after six and 12 months, regarding psychological health, well-being, own illness, need of assistance from general practitioner and/or district nurse, social network and knowledge about stroke. Stepwise multiple regression analyses were conducted for baseline, six- and 12-month assessments, respectively, with psychological health as the dependent variable. RESULTS: General well-being and presence of illness in spouse were the most prominent predictors of psychological health, throughout the first year. CONCLUSIONS: Enhancing psychological health and preventing medical problems in the caregiver are essential considerations to enable patients with stroke-related disabilities to continue to live at home. RELEVANCE TO CLINICAL PRACTICE: Evaluating the situation for spouses of stroke patients is an important component when planning for the future care of the patient.

Post-stroke depression - effect on the life situation of the significant other.

The aim of this study was to describe the life situation among 'significant others' to patients with post-stroke depression, and to identify associations between the life situation of the significant others and patient characteristics. Seventy-one dyads consisting of patients with a diagnosed post-stroke depression and their significant others were included. The patients were assessed for depression with the Montgomery-Asberg Depression Rating Scale and diagnosed according to the DSM-IV. The assessments of significant others included their own life situation and proxy assessments of the patients' state of depression, anger, change of personality, and need of assistance. Significant others of male stroke patients reported a more negative impact on their life situation, than did significant others of female stroke patients (p = 0.04). There was a significant association between the patient's level of depression and physical function [activities of daily living (ADL)], with those with less impaired ADL having more major depression than those with more impaired ADL (p = 0.007). This study indicates that major post-stroke depression is more common among patients with limited functional deficits. This highlights the importance of assessment for depression also among seemingly recovered stroke patients in order to treat and support those in need. This study also stresses the importance of identifying different needs of the significant others in order to provide appropriate support in their caregiving role.