Maaike Dirks

Hospital rates of thrombolysis for acute ischemic stroke: The influence of organizational culture

Background and Purpose— The purpose of this study was to determine if organizational culture explains differences in rates of intravenous thrombolysis for acute ischemic stroke between different hospitals. Methods— A cohort study was done in 12 centers admitting 5515 consecutive patients with acute stroke in The Netherlands. A multilevel logistic regression model was used to relate the likelihood of treatment with thrombolysis to characteristics of the organizational culture of the centers. Organizational culture was defined by 10 characteristics and scored by a panel. A sum score was created by adding all scores and dividing by 10. Results— Thrombolysis rates varied from 5.7% to 21.7%. We observed an association between thrombolysis and the availability of informal and formal feedback (OR, 1.18; 95% CI, 1.09 to 1.28); a learning culture (OR, 1.12; 95% CI, 1.02 to 1.23); uncompromising, individual clinical leadership (OR, 1.12; 95% CI, 1.03 to 1.23); explicit goals (OR, 1.08; 95% CI, 1.01 to 1.17); and with the sum score (OR, 1.12; 95% CI, 1.02 to 1.23). Conclusions— Several cultural characteristics of the hospital organization are related to thrombolysis rate. Organizational culture may be an important target for interventions aimed at increasing rates of thrombolysis for acute ischemic stroke in hospitals.

Intravenous thrombolysis in acute ischaemic stroke: from trial exclusion criteria to clinical contraindications. An international Delphi study

Objective: Several studies indicate that only a small proportion of patients with acute ischaemic stroke are treated with intravenous thrombolysis. Indications and contraindications for this treatment are usually based on the inclusion and exclusion criteria of randomised clinical trials. The trial context of these criteria hampers implementation in real life settings. We therefore aimed to obtain specialist opinion in a Delphi consensus on these contraindications. Methods: We used the Delphi approach on an international group of specialists in the field of thrombolysis. Inclusion and exclusion criteria were reworded into 18 quantitatively phrased propositions. Feedback consisted of the median score, interquartile range and the panellist’s own score in the previous round. For each item, we defined consensus as the achievement of an interdecile range within two prespecified clinically relevant units. Results: Thirty-one specialists participated in the first round and 30 completed all three rounds. Consensus was reached on 12 of the 18 propositions: previous ischaemic stroke, head trauma and gastrointestinal tract bleeding should not have taken place earlier than 1.5 months, 2 months and 14 days, respectively; the severity of the neurological deficit is defined as a National Institutes of Health Stroke Scale (NIHSS) score of 2–3 or more, and blood pressure level should not be >185/110 mmHg; platelet count should be >90×1012/l, glucose levels 2.7–22 mmol/l, international normalised ratio <1.5 and activated partial thromboplastin time <50 s. No consensus was reached on propositions concerning the stroke onset to treatment time, patient’s age, recent medical procedures, spontaneous improvement rate and blood pressure treatment. Conclusions: We present specialists’ opinion on contraindications for intravenous thrombolysis in ischaemic stroke. The results of this study may be relevant for routine clinical practice as they may help to increase the number of treated patients.

Lifetime health effects and medical costs of integrated stroke services - a non-randomized controlled cluster-trial based life table approach

BackgroundEconomic evaluation of stroke services indicates that such services may lead to improved quality of life at affordable cost. The present study assesses lifetime health impact and cost consequences of stroke in an integrated service setting.MethodsThe EDISSE study is a prospective non-randomized controlled cluster trial that compared stroke services (n = 151 patients) to usual care (n = 187 patients). Health status and cost trial-data were entered in multi-dimensional stroke life-tables. The tables distinguish four levels of disability which are defined by the modified Rankin scale. Quality-of-life scores (EuroQoL-5D), transition and survival probabilities are based on concurrent Dutch follow-up studies. Outcomes are quality-adjusted life years lived and lifetime medical cost by disability category. An economic analysis compares outcomes from a successful stroke service to usual care, by bootstrapping individual costs and effects data from patients in each arm.ResultsLifetime costs and QALYs after stroke depend on age-of-onset of first-ever stroke. Lifetime QALYs after stroke are 2.42 (90% CI - 0.49 - 2.75) for male patients in usual care and 2.75 (-0.61; 6.26) for females. Lifetime costs for men in the usual care setting are €39,335 (15,951; 79,837) and €42,944 (14,081; 95,944) for women. A comparison with the stroke service results in an ICER of €11,685 saved per QALY gained (€14,211 and €7,745 for men and women respectively). This stroke service is with 90% certainty cost-effective.ConclusionsOur analysis shows the potential of large health benefits and cost savings of stroke services, taking a lifetime perspective, also in other European settings.

Unequal Access to Treatment With Intravenous Alteplase for Women With Acute Ischemic Stroke

Background and Purpose— A recent meta-analysis showed that women with acute ischemic stroke are less likely to receive treatment with intravenous alteplase than men. The aim of this study was to assess sex differences in treatment with intravenous alteplase and to explore the reasons for these differences. Methods— We analyzed data from the Promoting Acute Thrombolysis for Ischaemic Stroke (PRACTISE) study. We applied a multiple logistic regression model and expressed the association between sex and treatment with an age-adjusted odds ratio with 95% confidence interval. Results— In total, 5515 patients were included in PRACTISE. Women were an average of 4 years older than men. The median National Institutes of Health Stroke Scale score was 6 in women and 5 in men. Fewer women were treated with intravenous alteplase (11% versus 14%; adjusted odds ratio, 0.8; 95% confidence interval, 0.7–1.0). However, fewer women arrived within 4 hours after onset (27% versus 33%; adjusted odds ratio, 0.8; 95% confidence interval, 0.7–0.9). Conclusions— Fewer women present themselves within 4 hours from stroke onset than men and consequently less often receive thrombolytic treatment. This difference may be caused by the older age of women on average and consequently women more often living alone. Clinical Trial Registration— URL: http://www.controlled-trials.com. Unique identifier: ISRCTN20405426.

Promoting acute thrombolysis for ischaemic stroke (PRACTISE)

Rationale Thrombolysis with intravenous rtPA is an effective treatment for patients with ischaemic stroke if given within 3 h from onset. Generally, more than 20% of stroke patients arrive in time to be treated with thrombolysis. Nevertheless, in most hospitals, only 1–8% of all stroke patients are actually treated. Interorganisational, intraorganisational, medical and psychological barriers are hampering broad implementation of thrombolysis for acute ischaemic stroke. Aims To evaluate the effect of a high-intensity implementation strategy for intravenous thrombolysis in acute ischaemic stroke, compared with regular implementation; to identify success factors and obstacles for implementation and to assess its cost-effectiveness, taking into account the costs of implementation. Design The PRACTISE study is a national cluster-randomised-controlled trial. Twelve hospitals have been assigned to the regular or high-intensity intervention by random allocation after pair-wise matching. The high-intensity implementation consists of training sessions in conformity with the Breakthrough model, and a tool kit. All patients who are admitted with acute stroke and onset of symptoms not longer than 24 h are registered. Study outcomes The primary outcome measure is treatment with thrombolysis. Secondary outcomes are admission within 4 h after onset of symptoms, death or disability at 3 months, the rate of haemorrhagic complications in patients treated with thrombolysis, and costs of implementation and stroke care in the acute setting. Tertiary outcomes are derived from detailed criteria for the organisational characteristics, such as door-to-needle time and protocol violations. These can be used to monitor the implementation process and study the effectiveness of specific interventions. Discussion This study will provide important information on the effectiveness and cost-effectiveness of actively implementing an established treatment for acute ischaemic stroke. The multifaceted aspect of the intervention will make it difficult to attribute a difference in the primary outcome measure to a specific aspect of the intervention. However, careful monitoring of intermediate parameters as well as monitoring of accomplished SMART tasks can be expected to provide useful insights into the nature and role of factors associated with implementation of thrombolysis for acute ischaemic stroke, and of effective acute interventions in general.

Real-life costs and effects of an implementation program to increase thrombolysis in stroke

Objectives: We have shown that a Breakthrough Series–based implementation program increases the number of patients with acute ischemic stroke treated with alteplase 4.5% in real-life settings. It is unclear whether such an implementation program is cost-effective. Methods: The practice study includes 12 randomized hospitals and 5,515 patients. Its present cost-effectiveness analysis involves 1,657 patients with ischemic stroke admitted within 4 hours from onset. Defined primary outcomes are thrombolysis rate and actual health care costs up to 3 months, including additional implementation efforts. Secondary outcomes are lifetime quality-adjusted years (QALYs) and lifetime costs of individual trial patients, using a validated probabilistic, disability-stratified stroke life table. Differences in outcome include 95% confidence intervals (CI), adjusted for intracluster correlation. Results: The thrombolysis rate in the intervention group was 44.3% vs 39.8% in the control group (difference 4.5%; 95% CI 3.1% to 5.9%. Mean costs per patient at 3 months (euros were converted to 2010 USD) were

Elevated pretreatment blood pressure and IV thrombolysis in stroke

9,192 USD in the intervention group and

Implementation of thrombolysis for ischaemic stroke

9,647 USD in the control group (difference −

Effectiveness of thrombolysis with intravenous alteplase for acute ischemic stroke in older adults

455 USD; 95% CI −

The effectiveness of thrombolysis with intravenous alteplase for acute ischemic stroke in daily practice

232 to −