Does the Addition of Non-Approved Inclusion and Exclusion Criteria for rtPA Impact Treatment Rates? Findings in Australia, the UK, and the USA

Louise E. Craig, Sandy Middleton, Helen Hamilton, Fern Cudlip, Victoria Swatzell, Andrei V. Alexandrov, Elizabeth Lightbody, Dame Caroline Watkins, Sheeba Philip, Dominique A. Cadilhac, Elizabeth McInnes, Simeon Dale, Anne W. Alexandrov

Research output: Contribution to journalArticle

Abstract

Background: Strict criteria for recombinant tissue plasminogen activator (rtPA) eligibility are stipulated on licences for use in ischaemic stroke; however, practitioners may also add non-standard rtPA criteria. We examined eligibility criteria variation in 3 English-speaking countries including use of non-standard criteria, in relation to rtPA treatment rates. Methods: Surveys were mailed to 566 eligible hospitals in Australia (AUS), the UK, and the USA. Criteria were pre-classified as standard (approved indication and contraindications) or non-standard (approved warning or researcher "decoy"). Percentage for criterion selection was calculated/compared; linear regression was used to assess the association between use of non-standard criteria and rtPA treatment rates, and to identify factors associated with addition of non-standard criteria. Results: Response rates were 74% AUS, 65% UK, and 68% USA; mean rtPA treatment rates were 8.7% AUS, 12.7% UK, and 8.7% USA. Median percentage of non-standard inclusions was 33% (all 3 countries) and included National Institutes of Health Stroke Scale (NIHSS) scores > 4, computed tomography (CT) angiography documented occlusion, and favourable CT perfusion. Median percentage of non-standard exclusions was 25% AUS, 28% UK, and 60% USA, and included depressed consciousness, NIHSS > 25, and use of antihypertensive infusions. No AUS or UK sites selected 100% of standard exclusions. Conclusions: Non-standard criteria for rtPA eligibility were evident in all three countries and could, in part, explain comparably low use of rtPA. Differences in the use of standard criteria may signify practitioner intolerance for those derived from original efficacy studies that are no longer relevant.

LanguageEnglish
Pages1-12
Number of pages12
JournalInterventional Neurology
Volume8
Issue number1
DOIs
Publication statusPublished - 2019

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Tissue Plasminogen Activator
Stroke
National Institutes of Health (U.S.)
Therapeutics
Licensure
Consciousness
Patient Selection
Antihypertensive Agents
Linear Models
Perfusion
Tomography
Research Personnel

Cite this

Craig, Louise E. ; Middleton, Sandy ; Hamilton, Helen ; Cudlip, Fern ; Swatzell, Victoria ; Alexandrov, Andrei V. ; Lightbody, Elizabeth ; Watkins, Dame Caroline ; Philip, Sheeba ; Cadilhac, Dominique A. ; McInnes, Elizabeth ; Dale, Simeon ; Alexandrov, Anne W. / Does the Addition of Non-Approved Inclusion and Exclusion Criteria for rtPA Impact Treatment Rates? Findings in Australia, the UK, and the USA. In: Interventional Neurology. 2019 ; Vol. 8, No. 1. pp. 1-12.
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abstract = "Background: Strict criteria for recombinant tissue plasminogen activator (rtPA) eligibility are stipulated on licences for use in ischaemic stroke; however, practitioners may also add non-standard rtPA criteria. We examined eligibility criteria variation in 3 English-speaking countries including use of non-standard criteria, in relation to rtPA treatment rates. Methods: Surveys were mailed to 566 eligible hospitals in Australia (AUS), the UK, and the USA. Criteria were pre-classified as standard (approved indication and contraindications) or non-standard (approved warning or researcher {"}decoy{"}). Percentage for criterion selection was calculated/compared; linear regression was used to assess the association between use of non-standard criteria and rtPA treatment rates, and to identify factors associated with addition of non-standard criteria. Results: Response rates were 74{\%} AUS, 65{\%} UK, and 68{\%} USA; mean rtPA treatment rates were 8.7{\%} AUS, 12.7{\%} UK, and 8.7{\%} USA. Median percentage of non-standard inclusions was 33{\%} (all 3 countries) and included National Institutes of Health Stroke Scale (NIHSS) scores > 4, computed tomography (CT) angiography documented occlusion, and favourable CT perfusion. Median percentage of non-standard exclusions was 25{\%} AUS, 28{\%} UK, and 60{\%} USA, and included depressed consciousness, NIHSS > 25, and use of antihypertensive infusions. No AUS or UK sites selected 100{\%} of standard exclusions. Conclusions: Non-standard criteria for rtPA eligibility were evident in all three countries and could, in part, explain comparably low use of rtPA. Differences in the use of standard criteria may signify practitioner intolerance for those derived from original efficacy studies that are no longer relevant.",
author = "Craig, {Louise E.} and Sandy Middleton and Helen Hamilton and Fern Cudlip and Victoria Swatzell and Alexandrov, {Andrei V.} and Elizabeth Lightbody and Watkins, {Dame Caroline} and Sheeba Philip and Cadilhac, {Dominique A.} and Elizabeth McInnes and Simeon Dale and Alexandrov, {Anne W.}",
year = "2019",
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Craig, LE, Middleton, S, Hamilton, H, Cudlip, F, Swatzell, V, Alexandrov, AV, Lightbody, E, Watkins, DC, Philip, S, Cadilhac, DA, McInnes, E, Dale, S & Alexandrov, AW 2019, '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, vol. 8, no. 1, pp. 1-12. https://doi.org/10.1159/000493020

Does the Addition of Non-Approved Inclusion and Exclusion Criteria for rtPA Impact Treatment Rates? Findings in Australia, the UK, and the USA. / Craig, Louise E.; Middleton, Sandy; Hamilton, Helen; Cudlip, Fern; Swatzell, Victoria; Alexandrov, Andrei V.; Lightbody, Elizabeth; Watkins, Dame Caroline; Philip, Sheeba; Cadilhac, Dominique A.; McInnes, Elizabeth; Dale, Simeon; Alexandrov, Anne W.

In: Interventional Neurology, Vol. 8, No. 1, 2019, p. 1-12.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Does the Addition of Non-Approved Inclusion and Exclusion Criteria for rtPA Impact Treatment Rates? Findings in Australia, the UK, and the USA

AU - Craig, Louise E.

AU - Middleton, Sandy

AU - Hamilton, Helen

AU - Cudlip, Fern

AU - Swatzell, Victoria

AU - Alexandrov, Andrei V.

AU - Lightbody, Elizabeth

AU - Watkins, Dame Caroline

AU - Philip, Sheeba

AU - Cadilhac, Dominique A.

AU - McInnes, Elizabeth

AU - Dale, Simeon

AU - Alexandrov, Anne W.

PY - 2019

Y1 - 2019

N2 - Background: Strict criteria for recombinant tissue plasminogen activator (rtPA) eligibility are stipulated on licences for use in ischaemic stroke; however, practitioners may also add non-standard rtPA criteria. We examined eligibility criteria variation in 3 English-speaking countries including use of non-standard criteria, in relation to rtPA treatment rates. Methods: Surveys were mailed to 566 eligible hospitals in Australia (AUS), the UK, and the USA. Criteria were pre-classified as standard (approved indication and contraindications) or non-standard (approved warning or researcher "decoy"). Percentage for criterion selection was calculated/compared; linear regression was used to assess the association between use of non-standard criteria and rtPA treatment rates, and to identify factors associated with addition of non-standard criteria. Results: Response rates were 74% AUS, 65% UK, and 68% USA; mean rtPA treatment rates were 8.7% AUS, 12.7% UK, and 8.7% USA. Median percentage of non-standard inclusions was 33% (all 3 countries) and included National Institutes of Health Stroke Scale (NIHSS) scores > 4, computed tomography (CT) angiography documented occlusion, and favourable CT perfusion. Median percentage of non-standard exclusions was 25% AUS, 28% UK, and 60% USA, and included depressed consciousness, NIHSS > 25, and use of antihypertensive infusions. No AUS or UK sites selected 100% of standard exclusions. Conclusions: Non-standard criteria for rtPA eligibility were evident in all three countries and could, in part, explain comparably low use of rtPA. Differences in the use of standard criteria may signify practitioner intolerance for those derived from original efficacy studies that are no longer relevant.

AB - Background: Strict criteria for recombinant tissue plasminogen activator (rtPA) eligibility are stipulated on licences for use in ischaemic stroke; however, practitioners may also add non-standard rtPA criteria. We examined eligibility criteria variation in 3 English-speaking countries including use of non-standard criteria, in relation to rtPA treatment rates. Methods: Surveys were mailed to 566 eligible hospitals in Australia (AUS), the UK, and the USA. Criteria were pre-classified as standard (approved indication and contraindications) or non-standard (approved warning or researcher "decoy"). Percentage for criterion selection was calculated/compared; linear regression was used to assess the association between use of non-standard criteria and rtPA treatment rates, and to identify factors associated with addition of non-standard criteria. Results: Response rates were 74% AUS, 65% UK, and 68% USA; mean rtPA treatment rates were 8.7% AUS, 12.7% UK, and 8.7% USA. Median percentage of non-standard inclusions was 33% (all 3 countries) and included National Institutes of Health Stroke Scale (NIHSS) scores > 4, computed tomography (CT) angiography documented occlusion, and favourable CT perfusion. Median percentage of non-standard exclusions was 25% AUS, 28% UK, and 60% USA, and included depressed consciousness, NIHSS > 25, and use of antihypertensive infusions. No AUS or UK sites selected 100% of standard exclusions. Conclusions: Non-standard criteria for rtPA eligibility were evident in all three countries and could, in part, explain comparably low use of rtPA. Differences in the use of standard criteria may signify practitioner intolerance for those derived from original efficacy studies that are no longer relevant.

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DO - 10.1159/000493020

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T2 - Interventional Neurology

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SN - 1664-9737

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