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Paramedic Initiated Lisinopril For Acute Stroke
Treatment (PIL-FAST): results from the pilot
randomised controlled trial
Lisa Shaw,
1
Christopher Price,
2,3
Sally McLure,
4
Denise Howel,
3
Elaine McColl,
3
Paul Younger,
4
Gary A Ford
1,5
1
Institute for Ageing and
Health, Newcastle University,
Newcastle upon Tyne, UK
2
Stroke Medicine, Northumbria
Healthcare NHS Foundation
Trust, Wansbeck General
Hospital, Ashington,
Northumberland, UK
3
Institute of Health and
Society, Newcastle University,
Newcastle upon Tyne, UK
4
Research and Development
Department, North East
Ambulance Service NHS Trust,
Newcastle upon Tyne, UK
5
Stroke Medicine, Newcastle
upon Tyne Hospitals NHS
Foundation Trust, Newcastle
upon Tyne, UK
Correspondence to
Professor Gary A Ford,
The Medical School, Newcastle
University, 3rd floor William
Leech Building, Newcastle
upon Tyne NE1 4LP, UK;
G.A.Ford@newcastle.ac.uk,
gary.ford@ncl.ac.uk
Received 20 February 2013
Revised 18 June 2013
Accepted 8 August 2013
Published Online First
27 September 2013
To cite: Shaw L, Price C,
McLure S, et al.Emerg Med
J2014;31:994–999.
ABSTRACT
Background High blood pressure (BP) during acute
stroke is associated with poorer stroke outcome. Trials of
treatments to lower BP have not resulted in improved
outcome, but this may be because treatment
commenced too late. Emergency medical service staff
(paramedics) are uniquely placed to administer early
treatment; however, experience of prehospital
randomised controlled trials (RCTs) is very limited.
Methods We conducted a pilot RCT to determine the
feasibility of a definitive prehospital BP-lowering RCT in
acute stroke. Paramedics were trained to identify,
consent and deliver a first dose of lisinopril or placebo
to adults with suspected stroke and hypertension while
responding to the emergency call. Further treatment
continued in hospital. Study eligibility, recruitment rate,
completeness of receipt of study medication and clinical
data (eg, BP) were collected to inform the design
of a definitive RCT.
Results In 14 months, 14 participants (median
age=73 years, median National Institute of Health Stroke
Scale=4) were recruited and received the prehospital
dose of medication. Median time from stroke onset (as
assessed by paramedic) to treatment was 70 min. Four
participants completed 7 days of study treatment. Of
ambulance transported suspected stroke patients, 1%
were both study eligible and attended by a PIL-FAST
paramedic.
Conclusions It is possible to conduct a paramedic
initiated double-blind RCT of a treatment for acute
stroke. However, to perform a definitive RCT in a
reasonable timescale, a large number of trained
paramedics across several ambulance services would be
needed to recruit the number of patients likely to be
required.
Clinical trial registration http://www.clinicaltrials.
gov. Unique identifier: NCT01066572.
INTRODUCTION
Hypertension in acute stroke is associated with
poor functional outcome, but its optimal treatment
immediately after stroke is unclear.
1
Studies that
have lowered blood pressure (BP) soon after stroke
have not shown improved outcome,
1–3
but this
may be because treatment commenced too late.
Rapid neurological injury occurs following stroke
and previous BP-lowering trials have enrolled
patients several hours to days after stroke symptom
onset.
1
The earliest that BP-lowering treatment
could commence is during contact with ambulance
paramedics.
While paramedics are uniquely placed to deliver
early treatments, their experience of participating
in randomised controlled trials (RCTs) to evaluate
interventions is limited and few trials have been
conducted within ambulance services.
45
This is
likely to be because prehospital research infrastruc-
ture is still in development
6
and because the logis-
tics of RCTs are more challenging in this
environment.
78
In terms of prehospital stroke
trials, experience is very limited with only one US
conducted pilot RCT evaluating pre-hospital treat-
ment with magnesium,
9
from which a definitive
study is now underway (FAST-MAG).
10
When the feasibility of a RCT is unclear, it is
important to conduct an external (rehearsal) pilot
trial to inform the design of a definitive study.
11 12
We report the results of a UK conducted pilot
double-blind RCT of paramedic initiated lisinopril
for treatment of hypertension in acute stroke.
METHODS
Study design and setting
The study design has been reported in detail previ-
ously.
13
A double-blind pilot RCT was initiated in
the community by research-trained paramedics from
the North of Tyne division of the North East
Ambulance Service (NEAS) NHS Trust. This div-
ision of NEAS covers a population of approximately
500 000 with 1200 suspected stroke admissions per
year to three stroke units who participated in the
trial. Of approximately 200 paramedics who work
in North of Tyne, 76 volunteers attended a training
day to take part in the trial. The training day
included Good Clinical Practice training and
Paramedic Initiated Lisinopril For Acute Stroke
Treatment (PIL-FAST) specific procedures, including
stroke recognition, consent and administration of
study medication. Paramedics received payment and
travel expenses for attending the training day.
The primary objective was to demonstrate
whether it was possible to enrol at least four
patients per month into the trial. This reflected the
number of patients thought likely to fulfil the
PIL-FAST eligibility criteria following an examin-
ation of stroke patient characteristics in the NEAS
Database. The secondary objectives included deter-
mination of the proportions of suspected stroke
patients potentially eligible for the study and those
attended by a research-trained paramedic, compli-
ance with data collection procedures, completeness
of receipt of study medication and collection of
clinical data (eg, BP) to inform the design of a
definitive RCT.
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Original article
994 Shaw L, et al.Emerg Med J 2014;31:994–999. doi:10.1136/emermed-2013-202536
Selection of participants and consent
Adults with new unilateral arm weakness thought to be due to
acute stroke within 3 h of symptom onset and hypertension (sys-
tolic BP >160 mm Hg on two consecutive occasions) were eli-
gible provided they were being transported to one of the three
hospitals in the study and had no exclusion criteria that included
contraindications to lisinopril and clinical features associated
with stroke mimics. Eligible participants were identified,
recruited, verbally consented and given the first dose of study
medication by a research-trained paramedic attending the emer-
gency call. A standardised consent script incorporating a simple
capacity assessment was designed for use by paramedics (figure 1).
Having listened to the study description, if the patient answered
the study questions correctly, they were asked to provide verbal
consent to participate in the trial. If the patient was unable to
answer the questions or appeared to lack mental capacity during
the paramedic routine assessment, the next of kin or other close
relative (if present) could provide consent on the basis of their
understanding of the wishes of the patient. Following arrival at
hospital, patients and/or next of kin/close relative were given
more information about the study and a standard information
sheet. They were subsequently asked to confirm consent in
writing. These unique consent processes were specifically
designed to enable this trial to take place in the emergency
setting without creating a delay in standard care.
Further clinical data were collected following arrival at hos-
pital and a review of appropriateness to continue on study medi-
cation was performed. This review allowed for data unavailable
to paramedics in the community to be assessed prior to adminis-
tration of further trial medication (eg, renal function).
Participants discontinued from study medication continued in
the trial for follow-up assessments.
Interventions
The protocol specified that participants receive 5–10 mg of lisi-
nopril or matched placebo daily for 7 days. The first dose, 5 mg,
was administered by a research-trained paramedic sublingually,
due to the high frequency of swallowing problems in acute
stroke. The 5 mg tablet was crushed in a syringe crusher with
3–5 mL of water prior to sublingual administration. Following
arrival at hospital and review of appropriateness to continue
study medication, dose titration was performed. If the systolic
BP remained >150 mm Hg, a second 5 mg dose was to be admi-
nistered and a daily dose of 10 mg was prescribed. If the systolic
BP was <150 mm Hg, a second dose was not to be administered
and a daily dose of 5 mg was prescribed. If clinically significant
hypotension occurred, trial medication was withheld.
The PIL-FAST trial pack and randomisation
To enable paramedic access to study medication and administra-
tion equipment in the prehospital setting, boxes of medication
(lisinopril or placebo, identical in appearance) and other study
materials (paramedic research paperwork, syringe crusher, 5 mL
syringe, 5 mL vial of water) were packaged into a ‘trial pack’.Each
pack carried a unique study number according to the randomisa-
tion code (intervention and control in 1:1 ratio). One pack was
issued to each research-trained paramedic, carried on emergency
shifts and opened when an eligible patient consented to enter the
trial. Opened packs accompanied the participant to hospital where
the contents were collected by the hospital research team.
Data collection
Clinical data were collected at baseline, 3 and 7 days.
Demography, medical history, BP, stroke severity (National
Institute of Health Stroke Scale (NIHSS)
14
) and renal function
were recorded. Timings of paramedic arrival on emergency
scene, delivery of study medication and arrival at hospital were
also recorded.
Data analysis
In accordance with recommendations for the analysis of pilot
trials,
11 12
a formal power calculation was not carried out, the
data analysis is descriptive and statistical comparisons between
the randomisation groups have not been undertaken.
Estimation of the proportion of patients potentially eligible
for the trial
We used clinical ambulance and hospital records to report the
proportions of stroke patients admitted to the trial hospitals
who were eligible for the study, assessed by a PIL-FAST-trained
paramedic and enrolled in the study, for the first 6 months of
the trial. We were unable to review the complete trial period as
a new paramedic record system was introduced during the study
and problems searching these new records could not be
Figure 1 Standardised paramedic
consent script.
Original article
Shaw L, et al.Emerg Med J 2014;31:994–999. doi:10.1136/emermed-2013-202536 995
overcome before the end of the study. Routine NEAS suspected
stroke records were reviewed from 29 October 2010 to 30
April 2011. Eligibility was reviewed in a stepped approach such
that if one eligibility criterion was not met, no further criteria
were assessed for that individual.
RESULTS
This pilot trial ran from 29 October 2010 to 15 December
2011. Fourteen participants were recruited (intervention group
n=6; control group n=8). Ten participants (79%) provided
their own verbal consent to the attending research-trained para-
medic, for 1/14 (7%) consent was given by a next of kin/close
relative and for 3/14 (21%) paramedics recorded that both the
patient and a relative had given verbal consent. Baseline charac-
teristics are shown in table 1. The median (IQR) admission
NIHSS score was four (3–9), indicating that most participants
had suffered minor—moderate strokes. Three participants
(intervention group) received thrombolysis.
Participant flow through the trial is shown in figure 2. Two
participants withdrew from the trial. One participant withdrew
following arrival at hospital and review of the patient informa-
tion sheet, considering the side effects of lisinopril to be
unacceptable. For the second participant, a relative provided
initial verbal consent, but was distressed following arrival at hos-
pital and unable to provide confirmation of consent in writing.
Eleven (86%) participants completed study follow-up.
Four of the 14 trial participants (28%) completed the full
7 days of study treatment. For 2/14 trial participants (14%),
study medication was discontinued after day 3 because of a
non-stroke diagnosis in one case and systolic BP
<120 mm Hg in the second. The remaining 8/14 participants
(57%) received the ambulance dose of study medication only
for the following reasons: study withdrawal following arrival
at hospital (n=2), loss of study medication in handover
between paramedics and hospital staff (n=1), further medica-
tion withheld as systolic BP <120 mm Hg (n=1), discontinu-
ation of medication by the hospital research team following
the review of appropriateness to continue on arrival in hos-
pital (n=4: incorrect judgement of stroke onset time by para-
Table 1 Baseline characteristics
Data collected by paramedics
Sex n (%) n=14
Female 7 (50%)
Male 7 (50%)
Age (years) n=14
Median (IQR) 73 (57–82)
BP in ambulance (mm Hg) n=14
Systolic mean (SD) 185 (12)
Diastolic mean (SD) 97 (13)
Data collected following arrival at hospital
Stroke type n (%) n=14
Cerebral infarct 9 (64.3%)
Intracerebral haemorrhage 3 (21.4%)
Transient ischaemic attack 1 (7.1%)
Stroke mimic 1 (7.1%)
Renal function n=14
Urea (mmol/L): mean (min, max) 6.35 (2.2,13.6)
Cr (mmol/L): mean (min, max) 100 (47, 198)
Medication on admission n (%):
Antiplatelet drugs 7 (50%)
Antihypertensive drugs 4 (28.6%)
Lipid-lowering drugs 4 (28.6%)
Relevant comorbidity n (%)
Previous stroke 3 (21%)
Previous TIA 2 (14.3%)
Atrial fibrillation 1 (7.1%)
Renal disorder 2 (14.3%)
Admission NIHSS n=14
Median (IQR) 4 (3–9)
Prestroke modified Rankin scale (mRS) n (%) n=14
mRS 0 11 (78.6%)
mRS 1 1 (7.1%)
mRS 2 1 (7.1%)
mRS 3 0
mRS 4 1 (7.1%)
BP, blood pressure; NIHSS, National Institute of Health Stroke Scale.
Figure 2 Paramedic Initiated
Lisinopril For Acute Stroke Treatment
flowchart.
Original article
996 Shaw L, et al.Emerg Med J 2014;31:994–999. doi:10.1136/emermed-2013-202536
medics (n=3), physician decision not to continue with antihy-
pertensive in a patient with intracerebral haemorrhage, even
though this was not a reason to discontinue within the study
protocol (n=1)).
Clinical outcomes are shown in table 2. One participant
(control group) had a clinically important rise in serum creatin-
ine (100 μmol/L) between baseline and day 7. The median time
from paramedic arrival on scene to arrival at hospital for trial
participants was 38 (IQR 32–42) min. This compares favourably
with a median of 32 min for routine stroke admissions in the
North of Tyne area in the year preceding the trial. The median
time from paramedic arrival on scene to delivery of study medi-
cation was 25 (IQR 17–28) min. The median time from stroke
onset (as assessed by paramedic) to delivery of study medication
was 70 (IQR 40–89) min.
Four Serious Adverse Events (SAEs) were reported (intervention
group n=2, control group n=2). One was an episode of
hypotension which occurred following the first dose of study
medication (lisinopril) and was treated with intravenous fluids.
Two were chest infections in patients with severe stroke (NIHSS
16 and 21) which resulted in death after the 7-day study period
(intervention group n=1, control group n=1). There was one case
of post-haemorrhagic obstructive hydrocephalus (control group).
There were few missing data for trial participants (tables 1
and 2). One paramedic recorded that she/he had dropped a
study tablet on the floor and had used a second tablet to treat
the participant, but no other issues with prehospital medication
administration were reported.
From 29 October 2010 to 30 April 2011, 1463 suspected
stroke patients travelled by ambulance to the three trial hospitals.
Forty of the 1463 (3%) suspected stroke patients fulfilled the
PIL-FAST eligibility criteria and 13/40 (33%) were attended by a
PIL-FAST-trained paramedic. In this 6 -month period, seven
patients were enrolled in PIL-FAST. Therefore, 7/13 (54%)
patients eligible for PIL-FAST who travelled with a PIL-FAST-
trained paramedic were recruited. For the 6/13 patients who were
eligible for PIL-FAST, travelled with a PIL-FAST-trained paramedic
and not recruited, paramedic records indicated the following: con-
sidered for PIL-FAST but believed not to be eligible (n=1), consid-
ered for PIL-FAST but no further details given about
non-enrolment (n=1) and no notes about PIL-FAST (n=4). The
reasons for non-eligibility for the 1423/1463 (97%) suspected
stroke patients are shown in figure 3.
DISCUSSION
We have demonstrated that it is possible to conduct a paramedic
initiated double-blind RCT of a treatment for acute stroke.
Research-trained paramedics were able to identify eligible
patients, obtain verbal consent, complete research paperwork
and administer a sublingual dose of study medication. Research
staff at the receiving hospitals were able to continue the trial
protocol.
Recruitment was approximately one patient per month and
therefore less than our target of four patients per month.
However, the recruitment rate was similar in terms of recruit-
ment/million population to that reported in the ongoing
FAST-MAG trial
15
and in hindsight, our recruitment target was
too ambitious. Our review of routine paramedic records showed
that approximately six to seven patients met the eligibility cri-
teria per month (40 patients in 6 months), but only 33% of eli-
gible patients (approximately two per month) were attended by
a PIL-FAST-trained paramedic, of whom 54% were then
recruited to the trial. Lack of recruitment of eligible patients
may relate to paramedic confidence in stroke diagnosis and use
of the PIL-FAST consent process, the ease of availability of
information required for PIL-FAST on the emergency scene and
general service pressures. However, the proportion of eligible
patients recruited compares very favourably with inpatient
stroke trials where our experience suggests at most 25% of eli-
gible patients are recruited. To achieve a higher recruitment
rate, it would be necessary to train more paramedics and to
explore potential barriers to recruitment. All paramedics who
took part in PIL-FAST were volunteers and it may not be feas-
ible to expect greater numbers to take part in a future study
unless research participation is seen as a core responsibility of
the paramedic role. In preparation for PIL-FAST, focus groups
of senior paramedics revealed enthusiasm for research into
stroke treatments, but highlighted significant concerns about the
impact on the length of the prehospital phase and professional
boundaries.
16
A recent survey of ambulance service staff in
North America reported that 38% believe that they should
Table 2 Clinical outcomes
Intervention Control
n=6* n=8†
BP (mm Hg)
In ambulance: n=6 n=8
Systolic mean (SD) 184 (12) 186 (13)
Diastolic mean (SD) 90 (3) 103 (15)
On admission to hospital: n=6 n=8
Systolic mean (SD) 171 (30) 177 (20)
Diastolic mean (SD) 91 (23) 97 (16)
Dosage review (mean time from admission=7.8 h) n=5 n=7
Systolic mean (SD) 153 (38) 179 (15)
Diastolic mean (SD) 80 (20) 95 (13)
4 h after admission: n=5 n=7
Systolic mean (SD) 143 (47) 159 (35)
Diastolic mean (SD) 74 (23) 79 (24)
24 h after admission: n=5 n=7
Systolic mean (SD) 144 (36) 144 (28)
Diastolic mean (SD) 77 (20) 81 (19)
48 h after admission: n=5 n=6
Systolic mean (SD) 148 (40) 154 (21)
Diastolic mean (SD) 81 (19) 86 (21)
Day 3: n=5 n=7
Systolic mean (SD) 126 (17) 158 (32)
Diastolic mean (SD) 74 (13) 92 (19)
Day 7: n=4 n=7
Systolic mean (SD) 129 (7) 155 (21)
Diastolic mean (SD) 73 (3) 91 (20)
NIHSS
n=6 n=8
Admission median (IQR) 4(1–8) 6 (3–11)
n=5 n=7
Day 3 median (IQR) 3(2–3) 3 (0–6)
Change from baseline to day 3 median (IQR)‡0(−2to2) 2(0–3)
n=4 n=7
Day 7 median (IQR) 2(1–14) 3 (0–5)
Change from baseline to day 7 median (IQR)‡1(−6to5) 3(2–4)
*4/6 patients received ambulance dose of lisinopril only; 1/6 patients received 7 days
of study treatment.
†4/8 patients received ambulance dose of placebo only; 3/8 patients received 7 days
of placebo treatment.
‡Calculated baseline score minus day 7 score, positive change is improvement.
BP, blood pressure; NIHSS, National Institute of Health Stroke Scale.
Original article
Shaw L, et al.Emerg Med J 2014;31:994–999. doi:10.1136/emermed-2013-202536 997
retain the right to decide whether to support a particular
study.
17
If sufficient numbers of paramedics are to engage
actively with a study, it will be necessary to offer reassurance
that delays in access to hospital care can be minimised and to
find mechanisms to encourage research support through learn-
ing credits, appraisal mechanisms and performance feedback.
Recruitment could also be improved by modifying the eligibil-
ity criteria. The review of paramedic records showed that a
large number of suspected stroke admissions were ineligible for
PIL-FAST due to the absence of unilateral arm weakness or
symptom onset outside the 3 h. Extending the time window for
inclusion and including patients with uncertain time of onset
would result in more patients being eligible, but would defeat
the purpose of an evaluation of very early treatment. Patients
were required to have unilateral arm weakness as this is the
most reliable symptom of acute stroke.
18
Paramedics are not
experts in the diagnosis of stroke and it was important that
inclusion of stroke mimics was avoided where possible. While
extending the symptoms of stroke which paramedics could use
for inclusion is possible, this increases the chance of including
non-stroke patients and patients with very mild impairments
(eg, only facial weakness) who are unlikely to show any signifi-
cant change in neurological status at outcome.
Enrolment into PIL-FAST did not result in a clinically import-
ant delay in transfer to hospital, and drug administration was a
median of 70 min since paramedic assessment of symptom
onset. In Los Angeles, the FAST-MAG trial has reported a
median time from symptom onset to initiation of study medica-
tion of 46 min.
19
The difference may be due to the more subur-
ban and rural setting for PIL-FAST causing a longer arrival time
for ambulances compared with urban Los Angeles.
The consent process designed for PIL-FAST appears to have
been largely acceptable. As one patient withdrew consent after
reading the patient information sheet in hospital, a future trial
Figure 3 Reasons for non-eligibility
for PIL-FAST. AVPU, Alert, Voice, Pain,
Unresponsive; ARB, angiotensin
receptor blocker.
Original article
998 Shaw L, et al.Emerg Med J 2014;31:994–999. doi:10.1136/emermed-2013-202536
may require more information about side effects to be discussed
prehospital. The second withdrawal was because proxy written
consent for an incapacitated participant could not be obtained.
As mental incapacity occurs more often with disabling stroke
but these have potentially the most to gain from treatment, we
were keen to include these participants. We did not think it
acceptable to pursue a ‘research without consent’approach as
NEAS paramedics were naive to research and clinical trials but
this approach could be considered for future trials involving
agents with good safety profiles.
Only four of the 14 trial participants completed the full 7 days
of study medication, which is an important feasibility issue. In 4/
10 cases where treatment was not completed, this could be avoid-
able in a future study. In 3/4 of cases, the hospital stroke team
considered that paramedics had made an incorrect assessment of
stroke onset time and stroke symptoms had not started within
3 h which could be improved through training. However, this
may also reflect the challenge of obtaining reliable information at
the scene, and highlights the importance of having a review to
continue with the study soon after arrival at hospital or having
physician support by telephone to paramedics in the field. While
paramedics could seek advice from on-call stroke specialists at
any time of the day or night, this was not sought for any partici-
pants in our study. In 1/4 of cases, study medication was lost in
the prehospital/hospital handover which should be avoidable but
demonstrates a need to improve this process.
Limited conclusions can be drawn from the BP readings in
this small pilot study, but our observations are consistent with
the mean BP reduction of 14 mm Hg at 24 h after lisinopril
administration compared with control seen in the Controlling
Hypertension and Hypotension Immediately Post Stroke
(CHHIPS) study.
3
The Scandinavian Candesartan Acute Stroke
Trial (SCAST)
2
did not show any advantage to BP reduction
within 30 h after stroke onset and there was a suggestion that it
may be harmful to lower levels after the hyperacute phase, but
patients were included with an initial systolic BP between 140
and 160 mm Hg, which would have excluded them from
PIL-FAST. Although lacking statistical power, a subgroup ana-
lysis of SCAST suggested that patients treated between 0 and 6 h
after symptom onset had a better outcome.
2
The median baseline NIHSS score of participants was only
four, which is lower than expected. This may mean that parame-
dics were unable or unwilling to recruit the more severely
affected stroke patients. Due to the nature of stroke impair-
ments, it would often not be possible to take consent from a
severely affected patient and they would only be able to be
included if a close relative was present and an onset time could
be established.
In conclusion, we have shown that it is possible to conduct a
paramedic initiated double-blind RCT of a treatment for acute
stroke. However, to perform a definitive RCT in a reasonable
timescale, a large number of trained paramedics across several
ambulance services would be needed to recruit the number of
patients likely to be required.
Acknowledgements We thank the following for their contribution: patients
who participated in the trial; local investigators (Ms Ann Fox, Dr Anand Dixit);
PIL-FAST-trained paramedics; Stroke Research Network clinical trial officers who
collected data in hospitals; pharmacy teams at Newcastle upon Tyne Hospitals NHS
Foundation Trust and Lloydspharmacy; Newcastle Clinical Trials Unit (Gillian Watson
and Chris Speed, trial management; Ruth Wood, data management); Trial Steering
Committee (Professor Tom Robinson, Dr Gavin Young, Mr Paul Jackson, Mr and Mrs
P Elliott) and Data Monitoring and Ethics Committee (Professor Simon Thomas, Dr
Alex McConnachie, Dr Pippa Tyrrell).
Contributors CP and GAF conceived the study and obtained funding. LS, CP, SM,
DH, EM and GAF further designed the study and wrote the study protocol. LS
managed the trial. SM orchestrated the involvement of the North East Ambulance
Service (NEAS). PY performed the retrospective review of potential study eligibility
using NEAS paramedic records. DH was the study statistician. LS drafted the
manuscript. All authors contributed substantially to revision of the manuscript.
GAF takes responsibility for the paper as a whole.
Funding This article presents independent research funded by the National Institute
for Health Research (NIHR) under its Programme Grants for Applied Research
scheme (RP-PG-0606-1241). The views expressed in this publication are those of
the author(s) and not necessarily those of the NHS, the NIHR or the Department of
Health.
Competing interests GAF has received lecture fees and research funding from
Pfizer, Boehringer-Ingelheim and Lundbeck A/S.
Ethics approval Newcastle and North Tyneside 2 research ethics committee.
Provenance and peer review Not commissioned; externally peer reviewed.
Open Access This is an Open Access article distributed in accordance with the
Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which
permits others to distribute, remix, adapt, build upon this work non-commercially,
and license their derivative works on different terms, provided the original work is
properly cited and the use is non-commercial. See: http://creativecommons.org/
licenses/by-nc/3.0/
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Original article
Shaw L, et al.Emerg Med J 2014;31:994–999. doi:10.1136/emermed-2013-202536 999
