2. Computerised Decision aid for Stroke Thrombolysis - User Guide2
Contents
3 COMPASS Background
4 Summary of data sources /
predictive equations
5 COMPASS User Guide
5 Introduction
6 Overview of Key Functions
7 Additional Features and Tools
8 NIHSS Calculator
8 Timeline Graph
9 Save functionality
10 Print functionality
11 Using COMPASS as a clinical
training aid
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Thrombolysis is a critically important
treatment for acute ischaemic
(blocked artery) strokes that needs to
be administered as soon as possible
and within 4.5 hours following stroke
onset.
The importance of early treatment is encapsulated
in the ‘Time is Brain’ aphorism that stroke teams
work to, with stroke teams aiming to assess, obtain a
brain CT scan and administer thrombolysis within
30 minutes of arrival at hospital. Thrombolysis
reduces the likelihood that patients will be left
with long-term disability (on average 14 out of 100
patients treated are functionally independent who
would otherwise have been left disabled) but it is
associated with a risk of symptomatic intracranial
haemorrhage (brain bleeding that usually leads to
clinical deterioration or death) in about 3 in every
100 patients treated. However, these are average
figures and the balance of risks and benefits varies
considerably between individual patients and this
is dependent on complex computation of multiple
variables to support a rapid decision on what to
recommend to patients/family.
Following a systematic development process that
involved stroke clinicians, stroke patients and their
relatives in an iterative design process, the research
team designed a COMPuterised decision Aid for
Stroke thrombolySis (COMPASS).
COMPASS allows stroke clinicians to input the
details of an individual stroke patient into a tablet
device and formulate numerical (percentages
and natural frequencies - out of 100 patients) and
graphical risk presentations (coloured pictographs,
bar charts or flow diagrams alongside stacked
bar charts) showing the predicted likelihood of
functional independence [complete recovery
or minor disability], dependence [moderate to
severe disability] and death at three months,
with and without thrombolysis, including risk of
symptomatic intracranial haemorrhage (SICH) and
the impact of any SICH.
COMPASS includes the capability to save and
print out copies of patient-specific predictions,
which can be shared with the patient and/or family
either on screen or on paper to support consent
and effectively engage patients/family in decisions
on whether to accept or decline thrombolysis
based on evidence-based and personalised data. In
addition, it includes a National Institute of Health
Stroke Scale (NIHSS - used by stroke physicians to
assess the severity and extent of impairments due
to stroke) calculator, an onset time to treatment
and thrombolysis dosage calculator, and weight
(stones/lbs to Kg) and glucose conversion (mg/
dl to mmol/L) tools. In current practice these are
largely undertaken using paper-based materials.
COMPASS also includes a timeline graph showing
the decrease in predicted net benefit from
thrombolytic treatment as a function of increasing
stroke onset time to treatment, which further
emphasises the aphorism - time is brain!
The decision aid can be used by any stroke
physician, neurologist or emergency medicine
specialist who is offering thrombolysis to stroke
patients. The numerical/graphical presentations
that are generated by COMPASS can be used by the
treating stroke clinician to weigh-up patient-specific
risks and benefits of treating an individual acute
ischaemic stroke patient, and can also be shown to
the patient or family member to support informed
consent and shared decision making. COMPASS
can also be used as a clinical training aid and as an
adjunct to the telemedicine model of acute stroke
care.
COMPASS can help to optimise thrombolysis
COMPASS
Background
4. Computerised Decision aid for Stroke Thrombolysis - User Guide4
treatment and support high quality informed
consent with patients/relatives by aiding
the treating clinician in communicating the
‘personalised’ benefits and risks in an easily
understandable way, thus enabling patients/
relatives to be more involved in the decision
making discussion with clinicians.
COMPASS presents independent research
commissioned by the National Institute for Health
Research (NIHR) under its Programme Grants
for Applied Research scheme (RP-PG-0606-1241).
The views expressed here are those of the author(s)
and not necessarily those of the NHS, the NIHR or
the Department of Health. The NIHR had no role
in the design or development of COMPASS. The
pharmaceutical company (Boehringer Ingelheim) is
the manufacturer of thrombolysis (Alteplase), but
they have had no involvement in the development
of COMPASS.
COMPASS expresses predictions for acute stroke
outcomes (functional independence [mRS 0 to
2], dependence [mRS 3 to 5] and death at three
months), with and without thrombolysis, including
risk of symptomatic intracranial haemorrhage1
,
as a function of individual patient characteristics
derived from an embedded decision analytic model
(see figure).
1
Symptomatic intracerebral haemorrhage (SICH - bleeding in
the brain) is defined in accordance with SITS-MOST:
• local or remote parenchymal haemorrhage type 2 on the
imaging scan at 22-36 h after treatment, combined with a
neurological deterioration of 4 or more points on the NIHSS
from baseline, or from the lowest NIHSS score between
baseline and 24 h, or leading to death
Summary of data sources / predictive equations
Probability of Dependance (mRS 3 to 5) = 1 (pDeath + pIndependence)
STPI = StrokeThrombolytic Predictive Instrument
Probability of Independance (mRS 0 to 2)
1. Onset time to treatment
2. Systolic blood pressure
3. Diabetes
4. Stroke severity (NIHSS score)
5. Age
6. Gender
7. Previous stroke
8. Signs of current infraction on pre-treatment scan
Probability of SICH
1. Onset time to treatment
2. Systolic blood pressure
3. Stroke severity (NIHSS score)
4. Age
5. Blood glucose
6. Asprin and Clopidogrel
7. Asprin monotherapy
8. Weight (kg)
9. History of hypertension
Probability of Death (mRS 6)
1. Age
2. Blood glucose
3. Stroke severity (NIHSS score)
S-TPI model‘good outcome’(mRS 0 to
1)
Kent et al. 2006 Stroke;37:2957-62
Calibrated using SITS-UK dataset (N = 1,996
patients with mRS 0 - 5 at 3 months), and a
predictor of mRS 0 to 2 reported byWahlgreen et
al. Stroke 2008; 39:3316-22
Validation of S-TPI model for a
catastropic outcome (mRS 5 to 6)
SITS-UK dataset (N = 2,401)
Scoring Model for SICH
Mazya et al. Stroke 2012;43:1524-1531
Outcomes post-haemorrhage
9%, 33% & 58% mRS 0 to 2; 3 to 5; and 6
repectively
6. Computerised Decision aid for Stroke Thrombolysis - User Guide6
1) The screenshot below shows the ‘Patient Details’
that need to be entered by the treating clinician for an
individual patient.
2) After entering the patient’s details, the treating
clinician then selects ‘Calculate outcomes’.
3) COMPASS then generates numerical (percentages
and natural frequencies - out of 100 patients) and
graphical risk presentations for the following outcomes
at 3 months with and without thrombolysis:
• independence [complete recovery or minor disability,
mRS 0 to 2] - green
• dependence [moderate to severe disability, mRS 3 to
5] - amber
• death - black
• risk of symptomatic intracranial haemorrhage (SICH)
and impact of any
The default graphical risk presentation is coloured
pictographs (shown here). By selecting the tabs at
the top of the output screen, the same information is
displayed in the form of bar charts or flow diagrams
alongside stacked bar graphs.
4) This box shows the overall likely net benefit (or harm)
from treatment with thrombolysis.
The information in the output screen can be used by
clinicians as a guide to decide whether or not offer
thrombolysis to stroke patients, and they can show the
information on benefits/risks of thrombolysis (via the
screen or on paper) to patients/relatives to support high-
quality consent and shared decision making.
Overview of Key Functions
Toenhancepatientsafetyandsecuritywithdatavalidation,COMPASS
supports‘instantvalidation’. Warningmessagesaredisplayedafter
selectingcalculateoutcomeswhenenteredvaluesareinvalidoroutside
thelicensingcriteriaforthrombolysis.
Greenticks(shownhere)totherightoftextboxes(e.g.,age)indicate
thatenteredvaluesarewithinthelicensingcriteriaforthrombolysis.
NB:outcomesapplytopatientswithpre-strokemRS0to2.Outcome
probabilitiesshownareforillustrativepurposesonlyandmaynot
reflectthoseinthefinalversionofCOMPASS.Pleasenotethatthelistof
patientdetailsisnotachecklistforcontraindicationsforIVrt-PA.
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Calculator icons to the right of several text boxes can
be used to access additional features, which in current
practice are largely undertaken using paper-based
materials.
Timeline graph – selecting this tab shows
the decrease in predicted net benefit from
thrombolytic treatment as a function of increasing
stroke onset time to treatment (see next page)
Glucose convertor (mg/dl to mmol/L)
National Institute of Health Stroke Scale
(NIHSS) – see next page
Weight conversion (stones/lbs to Kg)
Calculated onset time to treatment in
minutes (derived from patient values entered for
onset tome and estimated time likely to treat)
Thrombolysis (rt-PA) dosage calculator
(derived from value entered for a patient’s
weight).
Selecting the shows figures for:
• Total rt-PA dose (mg)
• 10% bolus (ml)
• 90% IV infusion (ml/hr)
• No of 50mg rt-~PA vials needed
Additional Features and Tools
8. Computerised Decision aid for Stroke Thrombolysis - User Guide8
NumericalValue TimelineTabTextual Description
NIHSS Calculator Timeline Graph
An electronic version of the NIHSS (used by trained qualified stroke physicians
to assess the severity and extent of impairments due to stroke) is embedded in
COMPASS.
By selecting the numerical value for the corresponding category in the NIHSS a textual
description for the value selected is displayed to the right of the screen
After patient details have been populated and the treating clinician has selected
‘calculate outcomes, by selecting the timeline tab the following information is
displayed:
• Numerical values (out of 100 patients) for predicted net benefit (mRS 0 to 2) from
thrombolytic treatment as a function of increasing stroke onset time to treatment in
15 minutes intervals
• The same information is shown in the line graph (green line)
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Save functionality
Tap here to save entered patient
details and predicted clinical outcomes
Tap here to open and view saved patient
details and related predicted clinical outcomes.
Select the desired save result to view – see below
10. Computerised Decision aid for Stroke Thrombolysis - User Guide10
Print functionality
NB:thesaveandprintfunctionalitycanbe
usedtofacilitatecasereviewwithinclinical
meetings
Tap print for a hard copy of predicted clinical
outcomes (entered or saved) in either
monochrome (black and white or colour). NB:
wireless printer recommended
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As mentioned earlier, to enhance patient safety and
security with data validation, COMPASS supports
‘instant validation’ of entered patient values on
continuous variables in accordance with the current
licensing criteria for thrombolysis:
• Onset time and time likely to treat Calculated onset
time to treatment (≤ 270 mins / 4.5 hours)
• Age (18-80)
• Glucose (BM) ≥ 2.8 and ≤ 22.2)
• Systolic blood pressure (≥ 40 and ≤ 185)
• NIHSS score (≥ 5 and ≤ 25)
• Weight (not part of the licensing criteria, but for the
purposes of patient safety and security with data
validation the valid value ranges are ≥ 40 and ≤ 635)
Various scenarios (based on real or simulated patients)
can be used to facilitate learning about assessment of
eligibility for thrombolysis, including absolute and
relative contradictions for treatment within the current
licensing and likely clinical outcomes at 3 months after
stroke. The graphical risk presentations can also be used
to develop skills in communicating benefits and risks to
patients and their relatives in the acute setting.
In addition, the NIHSS and dosage calculators can
be used to facilitate training on assessment of stroke
severity and total rt-PA dose (mg), bolus (ml),
IV infusion (ml/hr) and number of 50mg rt-~PA
vials needed. The timeline function can be used to
demonstrate the time dependency of treatment and the
need for expeditious door to needle times.
The following screenshots and supporting explanations
provide details on how COMPASS can be used within
existing training and CPD for thrombolysis, including in
situ on the acute stroke ward.
Using COMPASS as a
clinical training aid
Green ticks (shown here) to the right of continuous
variables indicate that entered values are within the
current licensing criteria for thrombolysis
12. Computerised Decision aid for Stroke Thrombolysis - User Guide12
Red crosses appear next to continuous variables that are invalid (absolute contraindications), and when calculate outcomes are
selected a prompt to enter a valid value(s) is displayed, and it is not possible to calculate outcomes clinicians who previously
expressed an interest in COMPASS
In this example here an invalid value has been entered for time likely to treat, which would result in a calculated onset time to
treatment value of > 270 mins / 4.5 hours.
When calculate outcomes is selected then a message prompting the user to enter a valid value is displayed
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In addition, the following functionality further
supports learning of the current licensing criteria
Red exclamation marks indicate that entered values are outwith the current licensing criteria, but they can be considered to
relative contraindications.
In these cases, warning messages are displayed after selecting calculate outcomes [and variable is highlighted in red] that asks
the user whether not to proceed with calculation of outcomes.
The example to the left shows an entered value for glucose that is outwith the licensing criteria and the resultant warning
message is displayed.
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