ArticleEuropean stroke journal2018
Professional guideline versus product label selection for treatment with IV thrombolysis: An analysis from SITS registry.
Article in European stroke journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Alteplase for Acute Ischemic Stroke in Patients Aged >80 Years: Pooled Analyses of Individual Patient Data.Stroke · 2020Pooled it
- Combining Machine Learning With Real-World Data to Identify Gaps in Clinical Practice Guidelines: Feasibility Study Using the Prospective German Stroke Registry and the National Acute Ischemic Stroke Guidelines.JMIR medical informatics · 2025Observational
- Does the Addition of Non-Approved Inclusion and Exclusion Criteria for rtPA Impact Treatment Rates? Findings in Australia, the UK, and the USA.Interventional neurology · 2020Article
- Article
Corrections and comments
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Authors and funding
9 authors.
Funding
Abstract
introductionThrombolysis usage in ischaemic stroke varies across sites. Divergent advice from professional guidelines and product labels may contribute. PATIENTS AND
methodsWe analysed SITS-International registry patients enrolled January 2010 through June 2016. We grouped sites into organisational tertiles by number of patients arriving ≤2.5 h and treated ≤3 h, percentage arriving ≤2.5 h and treated ≤3 h, and numbers treated ≤3 h. We assigned scores of 1-3 (lower/middle/upper) per variable and 2 for onsite thrombectomy. We classified sites as lower efficiency (summed scores 3-5), medium efficiency (6-8) or higher efficiency (9-11). Sites were also grouped by adherence with European product label and ESO guideline: 'label adherent' (>95% on-label), 'guideline adherent' (≥5% off-label, ≥95% on-guideline) or 'guideline non-adherent' (>5% off-guideline). We cross-tabulated site-efficiency and adherence. We estimated the potential benefit of universally selecting by ESO guidance, using onset-to-treatment time-specific numbers needed to treat for day 90 mRS 0-1.
resultsA total of 56,689 patients at 597 sites were included: 163 sites were higher efficiency, 204 medium efficiency and 230 lower efficiency. Fifty-six sites were 'label adherent', 204 'guideline adherent' and 337 'guideline non-adherent'. There were strong associations between site-efficiency and adherence (P < 0.001). Almost all 'label adherent' sites (55, 98%) were lower efficiency. If all patients were treated by ESO guidelines, an additional 17,031 would receive alteplase, which translates into 1922 more patients with favourable three-month outcomes. DISCUSSION: Adherence with product labels is highest in lower efficiency sites. Closer alignment with professional guidelines would increase patients treated and favourable outcomes.
conclusionProduct labels should be revised to allow treatment of patients ≤4.5 h from onset and aged ≥80 years.
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