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Published in: BMC Medical Informatics and Decision Making 1/2015

Open Access 01-12-2015 | Research article

Development of a computerised decision aid for thrombolysis in acute stroke care

Authors: Darren Flynn, Daniel J Nesbitt, Gary A Ford, Peter McMeekin, Helen Rodgers, Christopher Price, Christian Kray, Richard G Thomson

Published in: BMC Medical Informatics and Decision Making | Issue 1/2015

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Abstract

Background

Thrombolytic treatment for acute ischaemic stroke improves prognosis, although there is a risk of bleeding complications leading to early death/severe disability. Benefit from thrombolysis is time dependent and treatment must be administered within 4.5 hours from onset of symptoms, which presents unique challenges for development of tools to support decision making and patient understanding about treatment. Our aim was to develop a decision aid to support patient-specific clinical decision-making about thrombolysis for acute ischaemic stroke, and clinical communication of personalised information on benefits/risks of thrombolysis by clinicians to patients/relatives.

Methods

Using mixed methods we developed a COMPuterised decision Aid for Stroke thrombolysiS (COMPASS) in an iterative staged process (review of available tools; a decision analytic model; interactive group workshops with clinicians and patients/relatives; and prototype usability testing). We then tested the tool in simulated situations with final testing in real life stroke thrombolysis decisions in hospitals. Clinicians used COMPASS pragmatically in managing acute stroke patients potentially eligible for thrombolysis; their experience was assessed using self-completion forms and interviews. Computer logged data assessed time in use, and utilisation of graphical risk presentations and additional features. Patients’/relatives’ experiences of discussions supported by COMPASS were explored using interviews.

Results

COMPASS expresses predicted outcomes (bleeding complications, death, and extent of disability) with and without thrombolysis, presented numerically (percentages and natural frequencies) and graphically (pictographs, bar graphs and flowcharts). COMPASS was used for 25 patients and no adverse effects of use were reported. Median time in use was 2.8 minutes. Graphical risk presentations were shared with 14 patients/relatives. Clinicians (n = 10) valued the patient-specific predictions of benefit from thrombolysis, and the support of better risk communication with patients/relatives. Patients (n = 2) and relatives (n = 6) reported that graphical risk presentations facilitated understanding of benefits/risks of thrombolysis. Additional features (e.g. dosage calculator) were suggested and subsequently embedded within COMPASS to enhance usability.

Conclusions

Our structured development process led to the development of a gamma prototype computerised decision aid. Initial evaluation has demonstrated reasonable acceptability of COMPASS amongst patients, relatives and clinicians. The impact of COMPASS on clinical outcomes requires wider prospective evaluation in clinical settings.
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Literature
1.
go back to reference Wardlaw JM, Murray V, Berge E, del Zoppo G, Sandercock P, Lindley RL, et al. Recombinant tissue plasminogen activator for acute ischaemic stroke: an updated systematic review and meta-analysis. Lancet. 2012;379:2364–72.CrossRefPubMedPubMedCentral Wardlaw JM, Murray V, Berge E, del Zoppo G, Sandercock P, Lindley RL, et al. Recombinant tissue plasminogen activator for acute ischaemic stroke: an updated systematic review and meta-analysis. Lancet. 2012;379:2364–72.CrossRefPubMedPubMedCentral
2.
go back to reference Lansberg MG, Albers GW, Wijman CA. Symptomatic intracerebral hemorrhage following thrombolytic therapy for acute ischemic stroke: a review of the risk factors. Cerebrovasc Dis. 2007;24:1–10.CrossRefPubMed Lansberg MG, Albers GW, Wijman CA. Symptomatic intracerebral hemorrhage following thrombolytic therapy for acute ischemic stroke: a review of the risk factors. Cerebrovasc Dis. 2007;24:1–10.CrossRefPubMed
3.
go back to reference Murtagh MJ, Burges Watson DL, Jenkings KN, Lie ML, Mackintosh JE, Ford GA, et al. Situationally-sensitive knowledge translation and relational decision making in hyperacute stroke: a qualitative study. PLoS One. 2012;7(6):e37066. doi: 10.1371/journal.pone.0037066.CrossRefPubMedPubMedCentral Murtagh MJ, Burges Watson DL, Jenkings KN, Lie ML, Mackintosh JE, Ford GA, et al. Situationally-sensitive knowledge translation and relational decision making in hyperacute stroke: a qualitative study. PLoS One. 2012;7(6):e37066. doi: 10.1371/journal.pone.0037066.CrossRefPubMedPubMedCentral
4.
go back to reference Hacke W, Kaste M, Bluhmki E, Brozman M, Dávalos A, Guidetti D, et al. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. New Engl J of Med. 2008;359:1317–29.CrossRef Hacke W, Kaste M, Bluhmki E, Brozman M, Dávalos A, Guidetti D, et al. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. New Engl J of Med. 2008;359:1317–29.CrossRef
5.
go back to reference Lees KR, Bluhmki E, Kummer R, Brott TG, Toni D, Grotta JC, et al. Time to treatment with intravenous alteplase and outcome in stroke: an updated pooled analysis of ECASS, ATLANTIS, NINDS and EPITHET trials. Lancet. 2010;375:1695–703.CrossRefPubMed Lees KR, Bluhmki E, Kummer R, Brott TG, Toni D, Grotta JC, et al. Time to treatment with intravenous alteplase and outcome in stroke: an updated pooled analysis of ECASS, ATLANTIS, NINDS and EPITHET trials. Lancet. 2010;375:1695–703.CrossRefPubMed
6.
go back to reference Flynn D, Ford GA, Stobbart L, Rodgers H, Murtagh MJ, Thomson RG. A review of decision support, risk communication and patient information tools for thrombolytic treatment in acute stroke: lessons for tool developers. BMC Health Serv Res. 2013;13(1):225. doi: 10.1186/1472-6963-13-225.CrossRefPubMedPubMedCentral Flynn D, Ford GA, Stobbart L, Rodgers H, Murtagh MJ, Thomson RG. A review of decision support, risk communication and patient information tools for thrombolytic treatment in acute stroke: lessons for tool developers. BMC Health Serv Res. 2013;13(1):225. doi: 10.1186/1472-6963-13-225.CrossRefPubMedPubMedCentral
8.
go back to reference Wahlgren N, Ahmed N, Dávalos A, Ford GA, Grond M, Hacke W, et al. Thrombolysis with alteplase for acute ischaemic stroke in the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST): an observational study. Lancet. 2007;369:275–82.CrossRefPubMed Wahlgren N, Ahmed N, Dávalos A, Ford GA, Grond M, Hacke W, et al. Thrombolysis with alteplase for acute ischaemic stroke in the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST): an observational study. Lancet. 2007;369:275–82.CrossRefPubMed
9.
go back to reference Lecouturier J, Murtagh MJ, Thomson RG, Ford GA, White M, Eccles M, et al. Response to symptoms of stroke in the UK: a systematic review. BMC Health Serv Res. 2010;10:157. doi: 10.1186/1472-6963-10-157.CrossRefPubMedPubMedCentral Lecouturier J, Murtagh MJ, Thomson RG, Ford GA, White M, Eccles M, et al. Response to symptoms of stroke in the UK: a systematic review. BMC Health Serv Res. 2010;10:157. doi: 10.1186/1472-6963-10-157.CrossRefPubMedPubMedCentral
10.
go back to reference National Audit Office. Progress in improving stroke care: a good practice guide. London: National Audit Office; 2010. National Audit Office. Progress in improving stroke care: a good practice guide. London: National Audit Office; 2010.
11.
13.
go back to reference Kwan J, Hand P, Sandercock P. A systematic review of barriers to delivery of thrombolysis for acute stroke. Age Ageing. 2004;33:116–21.CrossRefPubMed Kwan J, Hand P, Sandercock P. A systematic review of barriers to delivery of thrombolysis for acute stroke. Age Ageing. 2004;33:116–21.CrossRefPubMed
14.
go back to reference Brown DL, Barsan WG, Lisabeth LD, Gallery ME, Morgenstern LB. Survey of emergency physicians about recombinant tissue plasminogen activator for acute ischemic stroke. Ann Emerg Med. 2005;46:56–60.CrossRefPubMed Brown DL, Barsan WG, Lisabeth LD, Gallery ME, Morgenstern LB. Survey of emergency physicians about recombinant tissue plasminogen activator for acute ischemic stroke. Ann Emerg Med. 2005;46:56–60.CrossRefPubMed
15.
go back to reference Dirks M, Niessen LW, Koudstaal PJ, Franke CL, van Oostenbrugge RJ, Dippel DW. Intravenous thrombolysis in acute ischaemic stroke: from trial exclusion criteria to clinical contraindications. An international Delphi study. J Neurol Neurosurg Psychiatry. 2007;78:685–9.CrossRefPubMedPubMedCentral Dirks M, Niessen LW, Koudstaal PJ, Franke CL, van Oostenbrugge RJ, Dippel DW. Intravenous thrombolysis in acute ischaemic stroke: from trial exclusion criteria to clinical contraindications. An international Delphi study. J Neurol Neurosurg Psychiatry. 2007;78:685–9.CrossRefPubMedPubMedCentral
16.
go back to reference Wardlaw JM, Murray V, Berge E, del Zoppo GJ. Thrombolysis for acute ischaemic stroke. Cochrane Database Syst Rev. 2009;4:CD000213. Wardlaw JM, Murray V, Berge E, del Zoppo GJ. Thrombolysis for acute ischaemic stroke. Cochrane Database Syst Rev. 2009;4:CD000213.
17.
go back to reference Stacey D, Bennett CL, Barry MJ, Col NF, Eden KB, Holmes-Rovner M, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2011;10:CD001431. doi: 10.1002/14651858.CD001431.pub3. Stacey D, Bennett CL, Barry MJ, Col NF, Eden KB, Holmes-Rovner M, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2011;10:CD001431. doi: 10.1002/14651858.CD001431.pub3.
18.
go back to reference Eissa A, Krass I, Bajorek BV. Barriers to the utilization of thrombolysis for acute ischaemic stroke. J Clin Pharm Ther. 2012;37:399–409.CrossRefPubMed Eissa A, Krass I, Bajorek BV. Barriers to the utilization of thrombolysis for acute ischaemic stroke. J Clin Pharm Ther. 2012;37:399–409.CrossRefPubMed
19.
go back to reference Flynn D, Pierce M, Hess E, Murad MH, Erwin PJ, Montori VM, et al. Engaging patients in healthcare decisions in the emergency department through shared decision making: a systematic review. Acad Emerg Med. 2012;19:959–67.CrossRefPubMed Flynn D, Pierce M, Hess E, Murad MH, Erwin PJ, Montori VM, et al. Engaging patients in healthcare decisions in the emergency department through shared decision making: a systematic review. Acad Emerg Med. 2012;19:959–67.CrossRefPubMed
20.
go back to reference Mangset M, Berge E, Førde R, Nessa J, Wyller TB. “Two per cent isn’t a lot, but when it comes to death it seems quite a lot anyway”: patients’ perception of risk and willingness to accept risks associated with thrombolytic drug treatment for acute stroke. J Med Ethics. 2009;35:42–6.CrossRefPubMed Mangset M, Berge E, Førde R, Nessa J, Wyller TB. “Two per cent isn’t a lot, but when it comes to death it seems quite a lot anyway”: patients’ perception of risk and willingness to accept risks associated with thrombolytic drug treatment for acute stroke. J Med Ethics. 2009;35:42–6.CrossRefPubMed
21.
go back to reference Bruins Slot K, Berge E. Thrombolytic treatment for stroke: patient preferences for treatment, information and involvement. J Stroke Cerebrovasc Dis. 2009;18:17–22.CrossRef Bruins Slot K, Berge E. Thrombolytic treatment for stroke: patient preferences for treatment, information and involvement. J Stroke Cerebrovasc Dis. 2009;18:17–22.CrossRef
22.
go back to reference Solomon NA, Glick HA, Russo CJ, Lee J, Schulman KA. Patient preferences for stroke outcomes. Stroke. 1994;25:1721–5.CrossRefPubMed Solomon NA, Glick HA, Russo CJ, Lee J, Schulman KA. Patient preferences for stroke outcomes. Stroke. 1994;25:1721–5.CrossRefPubMed
23.
go back to reference Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, et al. Framework for design and evaluation of complex interventions to improve health. Brit Med J. 2000;321:694–6.CrossRefPubMedPubMedCentral Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, et al. Framework for design and evaluation of complex interventions to improve health. Brit Med J. 2000;321:694–6.CrossRefPubMedPubMedCentral
24.
go back to reference Elwyn G, Kreuwel I, Durand MA, Sivell S, Joseph-Williams N, Evans R, et al. How to develop web-based decision support interventions for patients: a process map. Patient Educ Couns. 2011;82:260–5.CrossRefPubMed Elwyn G, Kreuwel I, Durand MA, Sivell S, Joseph-Williams N, Evans R, et al. How to develop web-based decision support interventions for patients: a process map. Patient Educ Couns. 2011;82:260–5.CrossRefPubMed
25.
go back to reference McMeekin P, Flynn D, Ford GA, Rodgers H, Gray J, Thomson RG: Development of a decision analytic model to support decision-making and risk communication about thrombolytic treatment. BMC Med Inform Decis Mak 2014 (under review). McMeekin P, Flynn D, Ford GA, Rodgers H, Gray J, Thomson RG: Development of a decision analytic model to support decision-making and risk communication about thrombolytic treatment. BMC Med Inform Decis Mak 2014 (under review).
26.
go back to reference Kent D, Selker HP, Ruthazer R, Bluhmki E, Hacke W. The Stroke–Thrombolytic Predictive Instrument: a predictive instrument for intravenous thrombolysis in acute ischemic stroke. Stroke. 2006;37:2957–62.CrossRefPubMed Kent D, Selker HP, Ruthazer R, Bluhmki E, Hacke W. The Stroke–Thrombolytic Predictive Instrument: a predictive instrument for intravenous thrombolysis in acute ischemic stroke. Stroke. 2006;37:2957–62.CrossRefPubMed
27.
go back to reference Uyttenboogaart M, Stewart RE, Vroomen PC, Luijckx GJ, De Keyser J. Utility of the stroke-thrombolytic predictive instrument. J Neurol Neurosurg Psychiatry. 2008;79:1079–81.CrossRefPubMed Uyttenboogaart M, Stewart RE, Vroomen PC, Luijckx GJ, De Keyser J. Utility of the stroke-thrombolytic predictive instrument. J Neurol Neurosurg Psychiatry. 2008;79:1079–81.CrossRefPubMed
28.
go back to reference McMeekin P, Flynn D, Ford GA, Rodgers H, Thomson RG. Validating the Stroke-Thrombolytic Predictive Instrument in a Population in the United Kingdom. Stroke. 2012;43:3378–81.CrossRefPubMed McMeekin P, Flynn D, Ford GA, Rodgers H, Thomson RG. Validating the Stroke-Thrombolytic Predictive Instrument in a Population in the United Kingdom. Stroke. 2012;43:3378–81.CrossRefPubMed
29.
go back to reference Wahlgren N, Ahmed N, Eriksson N, Aichner F, Bluhmki E, Dávalos A, et al. Multivariable analysis of outcome predictors and adjustment of main outcome results to baseline data profile in randomized controlled trials safe implementation of thrombolysis in stroke-monitoring study (SITS-MOST). Stroke. 2008;39:3316–22.CrossRefPubMed Wahlgren N, Ahmed N, Eriksson N, Aichner F, Bluhmki E, Dávalos A, et al. Multivariable analysis of outcome predictors and adjustment of main outcome results to baseline data profile in randomized controlled trials safe implementation of thrombolysis in stroke-monitoring study (SITS-MOST). Stroke. 2008;39:3316–22.CrossRefPubMed
30.
go back to reference Ali M, Bath P, Brady M, Davis S, Diener HC, Donnan G, et al. Development, expansion and use of a stroke clinical trials resource for novel exploratory analyses. Int J Stroke. 2012;7:133–8.CrossRefPubMed Ali M, Bath P, Brady M, Davis S, Diener HC, Donnan G, et al. Development, expansion and use of a stroke clinical trials resource for novel exploratory analyses. Int J Stroke. 2012;7:133–8.CrossRefPubMed
31.
go back to reference Mazya M, Egido JA, Ford GA, Lees KR, Mikulik R, Toni D, et al. Predicting the risk of symptomatic intracerebral hemorrhage in ischemic stroke treated with intravenous alteplase: safe implementation of treatments in stroke (SITS) symptomatic intracerebral hemorrhage risk score. Stroke. 2012;43:1524–31.CrossRefPubMed Mazya M, Egido JA, Ford GA, Lees KR, Mikulik R, Toni D, et al. Predicting the risk of symptomatic intracerebral hemorrhage in ischemic stroke treated with intravenous alteplase: safe implementation of treatments in stroke (SITS) symptomatic intracerebral hemorrhage risk score. Stroke. 2012;43:1524–31.CrossRefPubMed
32.
go back to reference Cucchiara B, Kasner SE, Tanne D. Factors associated with intracerebral hemorrhage after thrombolytic therapy for ischemic stroke: pooled analysis of placebo data from the Stroke-Acute Ischemic NXY Treatment (SAINT) 1 and SAINT II trials. Stroke. 2009;40:3067–72.CrossRefPubMed Cucchiara B, Kasner SE, Tanne D. Factors associated with intracerebral hemorrhage after thrombolytic therapy for ischemic stroke: pooled analysis of placebo data from the Stroke-Acute Ischemic NXY Treatment (SAINT) 1 and SAINT II trials. Stroke. 2009;40:3067–72.CrossRefPubMed
34.
go back to reference Galitz WO. The essential guide to user interface design: an introduction to GUI design principles and techniques. 3rd ed. Indianapolis, IN: Wiley Publishing Inc; 2007. Galitz WO. The essential guide to user interface design: an introduction to GUI design principles and techniques. 3rd ed. Indianapolis, IN: Wiley Publishing Inc; 2007.
35.
go back to reference Snyder C. Paper prototyping: The fast and easy way to design and refine user interfaces. San Francisco, CA: Morgan Kaufman Publishers; 2003. Snyder C. Paper prototyping: The fast and easy way to design and refine user interfaces. San Francisco, CA: Morgan Kaufman Publishers; 2003.
36.
go back to reference Krippendorff K. Content analysis: an introduction to its methodology. 2nd ed. Thousand Oaks, CA: Sage; 2004. Krippendorff K. Content analysis: an introduction to its methodology. 2nd ed. Thousand Oaks, CA: Sage; 2004.
38.
go back to reference Hawley ST, Zikmund-Fisher BJ, Ubel PA, Jancovic A, Lucas T, Fagerlin A. The impact of the format of graphical presentation on health-related knowledge and treatment choices. Patient Educ Couns. 2008;73:448–55.CrossRefPubMed Hawley ST, Zikmund-Fisher BJ, Ubel PA, Jancovic A, Lucas T, Fagerlin A. The impact of the format of graphical presentation on health-related knowledge and treatment choices. Patient Educ Couns. 2008;73:448–55.CrossRefPubMed
39.
go back to reference Elwyn G, Laitner S, Coulter A, Walker E, Watson P, Thomson R. Implementing shared decision making in the NHS. Brit Med J. 2010;341:971–3.CrossRef Elwyn G, Laitner S, Coulter A, Walker E, Watson P, Thomson R. Implementing shared decision making in the NHS. Brit Med J. 2010;341:971–3.CrossRef
Metadata
Title
Development of a computerised decision aid for thrombolysis in acute stroke care
Authors
Darren Flynn
Daniel J Nesbitt
Gary A Ford
Peter McMeekin
Helen Rodgers
Christopher Price
Christian Kray
Richard G Thomson
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Medical Informatics and Decision Making / Issue 1/2015
Electronic ISSN: 1472-6947
DOI
https://doi.org/10.1186/s12911-014-0127-1

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