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1.
J Interprof Care ; : 1-11, 2024 Jul 09.
Article in English | MEDLINE | ID: mdl-38978481

ABSTRACT

Interprofessional collaboration (IPC) in stroke care is accepted as best practice and necessary given the multi-system challenges and array of professionals involved. Our two-part stroke team simulations offer an intentional interprofessional educational experience (IPE) embedded in pre-licensure occupational therapy, physical therapy, pharmacy, medicine, nursing and speech-language pathology curricula. This six-year mixed method program evaluation aimed to determine if simulation delivery differences necessitated by COVID-19 impacted students' IPC perception, ratings, and reported learning. Following both simulations, the Interprofessional Collaborative Competency Assessment Scale (ICCAS) and free-text self-reported learning was voluntarily and anonymously collected. A factorial ANOVA using the ICCAS interprofessional competency factors compared scores across delivery methods. Content and category analysis was done for free-text responses. Overall, delivery formats did not affect positive changes in pre-post ICCAS scores. However, pre and post ICCAS scores were significantly different for interprofessional competencies of roles/responsibilities and collaborative patient/family centered approach. Analysis of over 10,000 written response to four open-ended questions revealed the simulation designs evoked better understanding of others' and own scope of practice, how roles and shared leadership change based on context and client need, and the value of each team member's expertise. Virtual-experience-only students noted preference for an in-person stroke clinic simulation opportunity.

2.
Stroke ; 55(3): 524-531, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38275116

ABSTRACT

BACKGROUND: Recent evidence from thrombolysis trials indicates the noninferiority of intravenous tenecteplase to intravenous alteplase with respect to good functional outcomes in patients with acute stroke. We examined whether the health-related quality of life (HRQOL) of patients with acute stroke differs by the type of thrombolysis treatment received. In addition, we examined the association between the modified Rankin Scale score 0 to 1 and HRQOL and patient-reported return to prebaseline stroke functioning at 90 days. METHODS: Data were from all patients included in the AcT trial (Alteplase Compared to Tenecteplase), a pragmatic, registry-linked randomized trial comparing tenecteplase with alteplase. HRQOL at 90-day post-randomization was assessed using the 5-item EuroQOL questionnaire (EQ5D), which consists of 5 items and a visual analog scale (VAS). EQ5D index values were estimated from the EQ5D items using the time tradeoff approach based on Canadian norms. Tobit regression and quantile regression models were used to evaluate the adjusted effect of tenecteplase versus alteplase treatment on the EQ5D index values and VAS score, respectively. The association between return to prebaseline stroke functioning and the modified Rankin Scale score 0 to 1 and HRQOL was quantified using correlation coefficient (r) with 95% CI. RESULTS: Of 1577 included in the intention-to-treat analysis patients, 1503 (95.3%) had complete data on the EQ5D. Of this, 769 (51.2%) were administered tenecteplase and 717 (47.7%) were female. The mean EQ5D VAS score and EQ5D index values were not significantly higher for those who received intravenous tenecteplase compared with those who received intravenous alteplase (P=0.10). Older age (P<0.01), more severe stroke assessed using the National Institutes of Health Stroke Scale (P<0.01), and longer stroke onset-to-needle time (P=0.004) were associated with lower EQ5D index and VAS scores. There was a strong association (r, 0.85 [95% CI, 0.81-0.89]) between patient-reported return to prebaseline functioning and modified Rankin Scale score 0 to 1 Similarly, there was a moderate association between return to prebaseline functioning and EQ5D index (r, 0.45 [95% CI, 0.40-0.49]) and EQ5D VAS scores (r, 0.42 [95% CI, 0.37-0.46]). CONCLUSIONS: Although there is no differential effect of thrombolysis type on patient-reported global HRQOL and EQ 5D-5L index values in patients with acute stroke, sex- and age-related differences in HRQOL were noted in this study. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03889249.


Subject(s)
Brain Ischemia , Ischemic Stroke , Stroke , Humans , Female , Male , Tissue Plasminogen Activator , Tenecteplase/adverse effects , Fibrinolytic Agents , Ischemic Stroke/drug therapy , Quality of Life , Brain Ischemia/drug therapy , Brain Ischemia/chemically induced , Canada , Stroke/drug therapy , Stroke/chemically induced , Thrombolytic Therapy , Treatment Outcome
3.
J Palliat Med ; 25(2): 243-249, 2022 02.
Article in English | MEDLINE | ID: mdl-34546096

ABSTRACT

Background: Medical assistance in dying (MAiD) was legalized in Canada on June 17, 2016, yet many who request MAiD do not complete the assessment process and instead experience a natural death. This analysis of patients who made a formal request for MAiD aims to clarify timelines and factors associated with completion of the MAiD assessment process, and factors associated with completion or noncompletion of MAiD once eligible. Materials and Methods: This retrospective cohort study included all patients in Nova Scotia who requested MAiD between January 1, 2018 and December 31, 2018, were deceased at the time of analysis, did not withdraw their request, and were not formally deemed ineligible for the procedure (n = 218). Descriptive statistics, Kaplan-Meier curves, and logistic regression were used in data analysis. Results: Of 218 patients, 48 did not complete the MAiD assessment process. Of the 170 patients who completed the assessment process and were deemed eligible for MAiD, 79.4% (n = 135) completed the procedure. Those with an incomplete assessment had a median survival from request to death of 8.0 days (interquartile range [IQR] = 11.5), whereas for those deemed eligible, median survival from request to determination of MAiD eligibility was also 8.0 days (IQR = 16.0). Interpretation: Proximity to natural death and poor performance status at the time of MAiD request may drive incomplete MAiD assessments. The majority of patients deemed eligible for MAiD complete the procedure, and as such, patients who did not complete the MAiD assessment process may not have experienced their preferred mode of death.


Subject(s)
Suicide, Assisted , Canada , Humans , Logistic Models , Medical Assistance , Nova Scotia , Retrospective Studies
4.
Neurorehabil Neural Repair ; 36(2): 119-130, 2022 02.
Article in English | MEDLINE | ID: mdl-34788569

ABSTRACT

BACKGROUND: Non-disabling stroke (NDS) and transient ischemic attack (TIA) herald the possibility of future, more debilitating vascular events. Evidence is conflicting about potency of exercise and education in reducing risk factors for second stroke. METHODS: Three-site, single-blinded, randomized controlled trial with 184 participants <3 months of NDS or TIA (mean age, 65 years; 66% male) randomized to usual care (UC) or UC + 12-week program of exercise and education (PREVENT). Primary (resting systolic blood pressure) and secondary outcomes (diastolic blood pressure [DBPrest], high-density lipoprotein cholesterol [HDL-C], low-density lipoprotein cholesterol [LDL-C], total cholesterol [TC], TC/HDL, triglycerides, fasting glucose, and body mass index) were assessed at baseline, post-intervention, and 6- and 12-month follow-up. Peak oxygen consumption (VO2peak) was measured at baseline, post-intervention, 12-month assessments. RESULTS: Significant between-group differences at post-intervention favored PREVENT group over UC: DBPrest (mean difference [MD]: -3.2 mmHg, 95% confidence interval [CI]: -6.3, -.2, P = .04) and LDL-C (MD: -.31 mmol/L, 95% CI: -.42, -.20, P = .02). Trends of improvement in PREVENT group were noted in several variables between baseline and 6-month follow-up but not sustained at 12-month follow-up. Of note, VO2 peak did not change over time in either group. CONCLUSION: Impact of PREVENT on vascular risk factor reduction was more modest than anticipated, possibly because several outcome variables approximated normative values at baseline and training intensity may have been sub-optimal. Further investigation is warranted to determine when exercise and education programs are viable adjuncts to pharmaceutical management for reduction of risk factors for second stroke.Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: #NCT00885456.


Subject(s)
Exercise Therapy , Heart Disease Risk Factors , Ischemic Attack, Transient/rehabilitation , Patient Education as Topic , Stroke Rehabilitation , Stroke/therapy , Aged , Exercise Therapy/methods , Female , Follow-Up Studies , Humans , Ischemic Attack, Transient/blood , Male , Middle Aged , Outcome Assessment, Health Care , Patient Acuity , Patient Education as Topic/methods , Single-Blind Method , Stroke/blood , Stroke Rehabilitation/methods
5.
BMJ Open ; 11(7): e048698, 2021 07 26.
Article in English | MEDLINE | ID: mdl-34312206

ABSTRACT

OBJECTIVES: The aims of this study are: (1) to create a flowchart process model of how medical assistance in dying (MAID) occurs in Nova Scotia (NS), Canada and (2) to detail how NS healthcare professionals are involved in each stage of MAID. The research questions are: how is the MAID process carried out and which professionals are involved at which points? and which roles and activities do professionals carry out during MAID? DESIGN: Qualitative process model flowchart study with semistructured interviews. SETTING: Primary and secondary care in NS, Canada. PARTICIPANTS: Thirty-two interviewees self-selected to participate (12 physicians, 3 nurse practitioners (NP), 6 nurses, 6 pharmacists and 5 healthcare administrators and advocates). Participants were included if they conduct assessments, provide MAID, fill prescriptions, insert the intravenous lines, organise care and so on. RESULTS: The flowchart process model details five stages of how MAID occurs in NS: (1) starting the MAID process, (2) MAID assessments, (3) MAID preparation (hospital in-patient, hospital outpatient, non-hospital), (4) day of MAID and (5) post-MAID (hospital in-patient and outpatient, non-hospital, after leaving setting). Nineteen points where the process could stop or be delayed were identified. MAID differs slightly by location and multiple professionals from different organisations are involved at different points. Some physicians and NP provide MAID for free as they cannot be reimbursed or find it too difficult to be reimbursed. CONCLUSIONS: Our study adds knowledge about the MAID activities and roles of NS professionals, which are not documented in the international literature. Clinicians and pharmacists spend significant additional time to participate, raising questions about MAID's sustainability and uncompensated costs. The process model flowchart identifies where MAID can stop or be delayed, signalling where resources, training and relationship-building may need to occur. Knowing where potential delays can occur can help clinicians, administrators and policymakers in other jurisdictions improve MAID.


Subject(s)
Physicians , Suicide, Assisted , Canada , Humans , Medical Assistance , Nova Scotia , Software Design
6.
J Palliat Med ; 24(7): 1011-1016, 2021 07.
Article in English | MEDLINE | ID: mdl-33216683

ABSTRACT

Background: Since legalization of medical assistance in dying (MAiD) in Canada on June 17, 2016, there has been limited information regarding how outcomes of those requesting MAiD relates to comorbidity, social circumstances, geographic location, and access to care. This study aims to identify characteristics associated with the completion of MAiD, once requested, with specialist palliative care (SPC) as the primary exposure of interest. Methods: This retrospective cohort study consists of all patients in Nova Scotia who requested MAiD between June 17, 2016 and December 31, 2018 and were deceased at the time of analysis (n = 383). Descriptive statistics and logistic regression were performed. Results: A smaller proportion of patients who completed MAiD were seen in consultation by SPC (69.4% vs. 81.1%, p = 0.01). SPC was associated with decreased odds of completing MAiD (odds ratio [OR] 0.59, 95% confidence interval [CI] 0.36-0.96, p = 0.04), as was cohabitation (OR 0.64, 95% CI 0.41-0.99, p = 0.05) and Charlson comorbidity index >6 (OR 0.64, 95% CI 0.41-0.99, p = 0.05). Interpretation: SPC consultation was associated with significantly reduced likelihood of MAiD completion. Contributing factors may include differences in access to SPC services, those completing MAiD being more likely to decline a consultation with SPC, or the impact of SPC upon patient preferences and access to MAiD. While the interface between SPC and MAiD is in its early stages, our findings are supportive of a more integrated approach to coordination of SPC and MAiD services.


Subject(s)
Suicide, Assisted , Canada , Humans , Logistic Models , Nova Scotia , Patient Preference , Retrospective Studies
7.
Stroke ; 51(4): 1107-1110, 2020 04.
Article in English | MEDLINE | ID: mdl-32151235

ABSTRACT

Background and Purpose- Patients with intracerebral hemorrhage (ICH) are often subject to rapid deterioration due to hematoma expansion. Current prognostic scores are largely based on the assessment of baseline radiographic characteristics and do not account for subsequent changes. We propose that calculation of prognostic scores using delayed imaging will have better predictive values for long-term mortality compared with baseline assessments. Methods- We analyzed prospectively collected data from the multicenter PREDICT study (Prediction of Hematoma Growth and Outcome in Patients With Intracerebral Hemorrhage Using the CT-Angiography Spot Sign). We calculated the ICH Score, Functional Outcome in Patients With Primary Intracerebral Hemorrhage (FUNC) Score, and modified ICH Score using imaging data at initial presentation and at 24 hours. The primary outcome was mortality at 90 days. We generated receiver operating characteristic curves for all 3 scores, both at baseline and at 24 hours, and assessed predictive accuracy for 90-day mortality with their respective area under the curve. Competing curves were assessed with nonparametric methods. Results- The analysis included 280 patients, with a 90-day mortality rate of 25.4%. All 3 prognostic scores calculated using 24-hour imaging were more predictive of mortality as compared with baseline: the area under the curve was 0.82 at 24 hours (95% CI, 0.76-0.87) compared with 0.78 at baseline (95% CI, 0.72-0.84) for ICH Score, 0.84 at 24 hours (95% CI, 0.79-0.89) compared with 0.76 at baseline (95% CI, 0.70-0.83) for FUNC, and 0.82 at 24 hours (95% CI, 0.76-0.88) compared with 0.74 at baseline (95% CI, 0.67-0.81) for modified ICH Score. Conclusions- Calculation of the ICH Score, FUNC Score, and modified ICH Score using 24-hour imaging demonstrated better prognostic value in predicting 90-day mortality compared with those calculated at presentation.


Subject(s)
Cerebral Angiography/standards , Cerebral Hemorrhage/diagnostic imaging , Computed Tomography Angiography/standards , Hematoma/diagnostic imaging , Aged , Aged, 80 and over , Cerebral Angiography/trends , Cerebral Hemorrhage/mortality , Cohort Studies , Computed Tomography Angiography/trends , Female , Hematoma/mortality , Humans , Male , Middle Aged , Predictive Value of Tests , Prognosis , Prospective Studies , Treatment Outcome
8.
J Patient Exp ; 7(6): 951-956, 2020 Dec.
Article in English | MEDLINE | ID: mdl-33457527

ABSTRACT

Actively engaging people with lived experience (PWLE) in stroke-related clinical practice guideline development has not been effectively implemented. This pilot project evaluated the feasibility, perceived value, and effectiveness of the Community Consultation and Review Panel (CCRP), a new model to engage PWLE in the writing and review of Canadian Stroke Best Practice Recommendations. Responses to a standardized evaluation tool indicated that participants perceived the CCRP as valued, impactful, effective, and beneficial to stroke care. This project successfully demonstrated that values, experiences, and recommendations of PWLE can be effectively incorporated into guideline content and is applicable to all guideline development processes.

9.
Stroke ; 49(1): 201-203, 2018 01.
Article in English | MEDLINE | ID: mdl-29167385

ABSTRACT

BACKGROUND AND PURPOSE: The computed tomographic angiography spot sign as a predictor of hematoma expansion is limited by its modest sensitivity and positive predictive value. It is possible that hematoma expansion in spot-positive patients is missed because of decompression of intracerebral hemorrhage (ICH) into the ventricular space. We hypothesized that revising hematoma expansion definitions to include intraventricular hemorrhage (IVH) expansion will improve the predictive performance of the spot sign. Our objectives were to determine the proportion of ICH nonexpanders who actually have IVH expansion, determine the proportion of false-positive spot signs that have IVH expansion, and compare the known predictive performance of the spot sign to a revised definition incorporating IVH expansion. METHODS: We analyzed patients from the multicenter PREDICT ICH spot sign study. We defined hematoma expansion as ≥6 mL or ≥33% ICH expansion or >2 mL IVH expansion and compared spot sign performance using this revised definition with the conventional 6 mL/33% definition using receiver operating curve analysis. RESULTS: Of 311 patients, 213 did not meet the 6-mL/33% expansion definition (nonexpanders). Only 13 of 213 (6.1%) nonexpanders had ≥2 mL IVH expansion. Of the false-positive spot signs, 4 of 40 (10%) had >2 mL ventricular expansion. The area under the curve for spot sign to predict significant ICH expansion was 0.65 (95% confidence interval, 0.58-0.72), which was no different than when IVH expansion was added to the definition (area under the curve, 0.66; 95% confidence interval, 0.58-0.71). CONCLUSIONS: Although IVH expansion does indeed occur in a minority of ICH nonexpanders, its inclusion into a revised hematoma expansion definition does not alter the predictive performance of the spot sign.


Subject(s)
Cerebral Intraventricular Hemorrhage/diagnostic imaging , Computed Tomography Angiography , Hematoma, Subdural, Intracranial/diagnostic imaging , Aged , Aged, 80 and over , Cerebral Intraventricular Hemorrhage/physiopathology , Cerebral Intraventricular Hemorrhage/surgery , False Positive Reactions , Female , Hematoma, Subdural, Intracranial/physiopathology , Hematoma, Subdural, Intracranial/surgery , Humans , Male , Middle Aged
11.
J Interprof Care ; 31(6): 793-796, 2017 Nov.
Article in English | MEDLINE | ID: mdl-28862889

ABSTRACT

Interprofessional practice (IPP) is the accepted standard of care for clients following a stroke. A brief, embedded and evidence-based IPP team simulation was designed to address stroke care knowledge and IPP competencies for students within limited curriculum space. Each team was required to construct a collaborative care plan for their patient during the simulation and submit the care plan for evaluation of best practice stroke care knowledge and implementation with evidence of interprofessional collaboration (IPC). A total of 302 students (274 on-site, 28 by distance technology) representing four professions comprised of 55 teams took part in this experience. Post-simulation, voluntary and anonymous programme evaluations were completed using the standardised interprofessional collaborative competency assessment scale (ICCAS) and open-ended free-text responses to five questions. There was a significant improvement for all pre-post ratings on the ICCAS regardless of profession or previous interprofessional experience. Additionally, the open-ended responses indicated perceived changes to role clarification, communication, and teamwork. The combined interpretation of the programme evaluation results supports interprofessional team simulation as an effective and efficient learning experience for students regardless of previous interprofessional experience, and demonstrated positive changes in stroke best-practice knowledge and IPC competencies.


Subject(s)
Cooperative Behavior , Health Knowledge, Attitudes, Practice , Interprofessional Relations , Patient Care Team/organization & administration , Stroke/therapy , Communication , Humans , Professional Competence , Simulation Training
13.
CJEM ; 18(5): 331-9, 2016 Sep.
Article in English | MEDLINE | ID: mdl-26879765

ABSTRACT

OBJECTIVES: 1) To evaluate whether transient ischemic attack (TIA) management in emergency departments (EDs) of the Nova Scotia Capital District Health Authority followed Canadian Best Practice Recommendations, and 2) to assess the impact of being followed up in a dedicated outpatient neurovascular clinic. METHODS: Retrospective chart review of all patients discharged from EDs in our district from January 1, 2011 to December 31, 2012 with a diagnosis of TIA. Cox proportional hazards models, Kaplan-Meier survival curve, and propensity matched analyses were used to evaluate 90-day mortality and readmission. RESULTS: Of the 686 patients seen in the ED for TIA, 88.3% received computed tomography (CT) scanning, 86.3% received an electrocardiogram (ECG), 35% received vascular imaging within 24 hours of triage, 36% were seen in a neurovascular clinic, and 4.2% experienced stroke, myocardial infarction, or vascular death within 90 days. Rates of antithrombotic use were increased in patients seen in a neurovascular clinic compared to those who were not (94% v. 86.3%, p<0.0001). After adjustment for age, sex, vascular disease risk factors, and stroke symptoms, the risk of readmission for stroke, myocardial infarction, or vascular death was lower for those seen in a neurovascular clinic compared to those who were not (adjusted hazard ratio 0.28; 95% confidence interval 0.08-0.99, p=0.048). CONCLUSION: The majority of patients in our study were treated with antithrombotic agents in the ED and investigated with CT and ECG within 24 hours; however, vascular imaging and neurovascular clinic follow-up were underutilized. For those with neurovascular clinic follow-up, there was an association with reduced risk of subsequent stroke, myocardial infarction, or vascular death.


Subject(s)
Ambulatory Care Facilities , Emergency Service, Hospital , Ischemic Attack, Transient/mortality , Ischemic Attack, Transient/therapy , Aged , Aged, 80 and over , Ambulatory Care/methods , Anticoagulants/therapeutic use , Cerebrovascular Disorders/diagnosis , Cerebrovascular Disorders/mortality , Cerebrovascular Disorders/therapy , Cohort Studies , Disease Progression , Endarterectomy, Carotid/methods , Female , Follow-Up Studies , Humans , Ischemic Attack, Transient/diagnosis , Kaplan-Meier Estimate , Male , Middle Aged , Nova Scotia , Propensity Score , Proportional Hazards Models , Retrospective Studies , Risk Assessment , Survival Rate , Time Factors , Treatment Outcome
16.
Cephalalgia ; 34(9): 717-720, 2014 Aug.
Article in English | MEDLINE | ID: mdl-24646835

ABSTRACT

INTRODUCTION: Migrainous infarction accounts for 12.8% of ischemic strokes of unusual etiology. CASE REPORT: A 59-year-old woman with longstanding migraine with aura experienced what appeared to be migrainous infarction characterized by dysmetropsia and transient Cotard's syndrome. Imaging demonstrated right temporal-parietal-occipital changes with apparent cortical laminar necrosis. CONCLUSION: The spectrum of the pathophysiology of migrainous infarction has not been established; however, cortical spreading depression may explain the appearance of imaging findings that do not obey a vascular territory.

17.
18.
Can J Neurol Sci ; 39(5): 619-25, 2012 Sep.
Article in English | MEDLINE | ID: mdl-22931703

ABSTRACT

BACKGROUND: Fatigue affects 33-77% of stroke survivors. There is no consensus concerning risk factors for fatigue post-stroke, perhaps reflecting the multifaceted nature of fatigue. We characterized post-stroke fatigue using the Fatigue Impact Scale (FIS), a validated questionnaire capturing physical, cognitive, and psychosocial aspects of fatigue. METHODS: The Stroke Outcomes Study (SOS) prospectively enrolled ischemic stroke patients from 2001-2002. Measures collected included basic demographics, pre-morbid function (Oxford Handicap Scale, OHS), stroke severity (Stroke Severity Scale, SSS), stroke subtype (Oxfordshire Community Stroke Project Classification, OCSP), and discharge function (OHS; Barthel Index, BI). An interview was performed at 12 months evaluating function (BI; Modified Rankin Score, mRS), quality of life (Reintegration into Normal living Scale, RNL), depression (Geriatric Depression Scale, GDS), and fatigue (FIS). RESULTS: We enrolled 522 ischemic stroke patients and 228 (57.6%) survivors completed one-year follow-up. In total, 36.8% endorsed fatigue (59.5% rated one of worst post-stroke symptoms). Linear regression demonstrated younger age was associated with increased fatigue frequency (ß=-0.20;p=0.01), duration (ß=-0.22;p<0.01), and disability (ß=-0.24;p<0.01). Younger patients were more likely to describe fatigue as one of the worst symptoms post-stroke (ß=-0.24;p=0.001). Younger patients experienced greater impact on cognitive (ß=-0.27;p<0.05) and psychosocial (ß=-0.27;p<0.05) function due to fatigue. Fatigue was correlated with depressive symptoms and diminished quality of life. Fatigue occurred without depression as 49.0% of respondents with fatigue as one of their worst symptoms did not have an elevated GDS. CONCLUSIONS: Age was the only consistent predictor of fatigue severity at one year. Younger participants experienced increased cognitive and psychosocial fatigue.


Subject(s)
Fatigue/diagnosis , Fatigue/etiology , Stroke/complications , Survivors/psychology , Age Factors , Aged , Aged, 80 and over , Disability Evaluation , Female , Follow-Up Studies , Humans , Linear Models , Male , Middle Aged , Predictive Value of Tests , Quality of Life , Severity of Illness Index
19.
Trials ; 12: 252, 2011 Nov 30.
Article in English | MEDLINE | ID: mdl-22129158

ABSTRACT

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.


Subject(s)
Brain Ischemia/drug therapy , Fibrinolytic Agents/therapeutic use , Stroke/drug therapy , Thrombolytic Therapy , Tissue Plasminogen Activator/therapeutic use , Acute Disease , Double-Blind Method , Humans , Prospective Studies , Sample Size
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