Transcript 20111027QASCafterStroke

Journal Club
Middleton S, McElduff P, Ward J, Grimshaw JM, Dale S, D'Este C,
Drury P, Griffiths R, Cheung NW, Quinn C, Evans M, Cadilhac D,
Levi C; on behalf of the QASC Trialists Group.
Implementation of evidence-based treatment protocols to manage
fever, hyperglycaemia, and swallowing dysfunction in acute stroke
(QASC): a cluster randomised controlled trial.
Lancet. 2011 Oct 11. [Epub ahead of print]
2011年10月27日 8:30-8:55
８階 医局
埼玉医科大学 総合医療センター 内分泌・糖尿病内科
Department of Endocrinology and Diabetes,
Saitama Medical Center, Saitama Medical University
松田 昌文
Matsuda, Masafumi
Nursing Research Institute, St Vincent’s & Mater Health Sydney and School of Nursing (NSW & ACT), Australian Catholic
University, NSW, Australia (Prof S Middleton PhD, S Dale BAHons, P Drury MN); Centre for Clinical Outcomes Research
(NaCCOR), Australian Catholic University, St Vincent’s Hospital, Darlinghurst, NSW, Australia (Prof S Middleton, S Dale, P
Drury); Hunter Medical Research Institute (P McElduff PhD, Prof C Levi PhD), Centre for Clinical Epidemiology and
Biostatistics, School of Medicine and Public Health, Faculty of Health (Prof C D’Este PhD), and Priority Centre for Brain &
Mental Health Research (M Evans MN, Prof C Levi), University of Newcastle, Callaghan, Newcastle, NSW, Australia;
Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, ON, Canada (Prof J Ward PhD);
Clinical Epidemiology Program, Ottawa Health Research Institute, and Department of Medicine, University of Ottawa,
Ottawa, ON, Canada (Prof J M Grimshaw PhD); School of Nursing and Midwifery, University of Western Sydney, Penrith
South DC, NSW, Australia (Prof R Griffi ths PhD); Centre for Diabetes and Endocrinology Research, Westmead Hospital and
University of Sydney, Westmead, NSW, Australia (N W Cheung PhD); Speech Pathology Department, Prince of Wales
Hospital, Randwick, NSW, Australia (C Quinn MSc); Translational Public Health, Stroke and Ageing Research Centre,
Monash Medical Centre, Southern Clinical School, Monash University, Clayton, VIC, Australia (D Cadilhac PhD); National
Stroke Research Institute, Florey Neuroscience Institutes, Melbourne Brain Centre, VIC, Australia (D Cadilhac); Department
of Medicine, University of Melbourne, Melbourne, VIC, Australia (D Cadilhac)
www.thelancet.com Published online October 12, 2011 DOI:10.1016/S0140-6736(11)61485-2
Background
We assessed patient outcomes 90
days after hospital admission for
stroke following a multidisciplinary
intervention targeting evidence-based
management of fever, hyper glycaemia,
and swallowing dysfunction in acute
stroke units (ASUs).
Methods
In the Quality in Acute Stroke Care (QASC) study, a single-blind cluster
randomised controlled trial, we randomised ASUs (clusters) in New
South Wales, Australia, with immediate access to CT and on-site high
dependency units, to intervention or control group. Patients were eligible
if they spoke English, were aged 18 years or older, had had an
ischaemic stroke or intracerebral haemorrhage, and presented within 48
h of onset of symptoms. Intervention ASUs received treatment protocols
to manage fever, hyperglycaemia, and swallowing dysfunction with
multidisciplinary team building workshops to address implementation
barriers. Control ASUs received only an abridged version of existing
guidelines. We recruited pre-intervention and post-intervention patient
cohorts to compare 90-day death or dependency (modified Rankin scale
[mRS] ≥2), functional dependency (Barthel index), and SF-36 physical
and mental component summary scores. Research assistants, the
statistician, and patients were masked to trial groups. All analyses were
done by intention to treat. This trial is registered at the Australia New
Zealand Clinical Trial Registry (ANZCTR), number
ACTRN12608000563369.
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288
198
Gray CS, Hildreth AJ, Sandercock PA, O’Connell JE, Johnston DE, Cartlidge
NE et al. Glucose-potassium-insulin infusions in the management of poststroke hyperglycaemia: the UK Glucose Insulin in Stroke Trial (GIST-UK).
Lancet Neurol 2007; 6: 397–406.
The GKI group received a continuous intravenous GKI infusion for a minimum of
24 h to maintain capillary blood glucose concentration (capillary stick monitoring)
at 4–7 mmol/L. The infusate was a 500 mL GKI regimen of 10% dextrose and 20
mmol potassium chloride with an initial insulin dose of 16 units of soluble
recombinant human insulin. Changes to the GKI regimen were made on the basis
of capillary monitoring, to maintain a target treatment range of capillary glucose
concentration of 4–7 mmol/L (ie, plasma glucose 4・6–8・0 mmol/L). Changes to
the insulin component of the GKI regimen were made by nursing staff by use of
an explicit protocol.
Figure 1: Pre-intervention trial
profile
NSW=New South Wales.
ASU=acute stroke unit.
*Australian National Stroke Unit
Program Category A or B
correspond to stroke units with
immediate CT access and on-site
high dependency units; category
B does not have on-site
neurosurgery.
†This cluster withdrew before
recruitment of any patients.
Figure 2: Post-intervention trial profile
Table 1: Demographic and
clinical characteristics of the
post-intervention cohort
Table 1: Demographic and
clinical characteristics of the
post-intervention cohort
Table 1: Demographic and
clinical characteristics of the
post-intervention cohort
The Modified Rankin Scale (mRS)
The scale runs from 0-6, running from perfect health without symptoms to death.
0 - No symptoms.
1 - No significant disability. Able to carry out all usual activities, despite some
symptoms.
2 - Slight disability. Able to look after own affairs without assistance, but unable to carry
out all previous activities.
3 - Moderate disability. Requires some help, but able to walk unassisted.
4 - Moderately severe disability. Unable to attend to own bodily needs without
assistance, and unable to walk unassisted.
5 - Severe disability. Requires constant nursing care and attention, bedridden,
incontinent.
6 - Dead.
脳卒中治療ガイドライン2009
SF-36（http://www.sf36.com/general/sf36.html ）について
簡単に紹介する｡
SF-36では以下の8つのサブスケール
を100点満点で評価する｡それぞれの
サブスケールには2段階から5段階ま
での順序尺度をもつ選択肢のある質
問事項が全部で36あり,それらに回答
することによって,点数が計算されるよ
うになっている。
SF-36サブスケール
1. 身体機能Physical functioning
2. 身体機能の障害による役割制限
Role functioning physical
3. 痛みBodily pain
4. 社会機能の制限Social functioning
5. 全体的健康観General health
perceptions
6. 活力 Vitality
7. 精神機能の障害による役割制限
Role functional emotional
8. 精神状態Mental health)
Systematic review In the first days of an acute stroke, temperature above 37・5°C
occurs in 20–50% of patients; up to 68% of patients become hyperglycaemic; and 37–
78% experience dysphagia, resulting in increased morbidity and mortality and enlarged
infarct size. We searched Medline and CINAHL databases for reports in English (no
other restrictions) using the search term ”stroke” (all inclusive) combined
with: ”fever”; ”pyrexia”; ”hyperthermia”; ”hyperglycaemia”; and ”glucose” and found
no systematic reviews of treatments to effectively manage either physiological variable.
Similarly, we also combined the term ‘”stroke” with ”dysphagia”, ”swallow/ deglutition”,
and ”swallowing disorders/deglutition disorders”. Evidence from a systematic review4
showed that stroke patients with dysphagia are at risk of pneumonia and that this risk is
higher in patients who aspirate. Use of a formal dysphagia screen can decrease the risk
of pneumonia. Additionally, no studies have examined the combined effect of systematic
management of fever, hyperglycaemia, or swallowing. International guidelines
recommend monitoring and prompt treatment of these three variables. No effective
treatment exists, however, with which to change bedside care and ensure
multidisciplinary teams comply with evidence-based clinical practice guidelines.
Systematic reviews of strategies with this goal in mind persistently argue that more
implementation research is needed to identify effective strategies and to ensure
resources are not wasted on activities of questionable value. In response, our research
tested a multidisciplinary intervention designed to raise standards of care in acute stroke
units with a cluster randomised controlled trial. Barrier identification, educational
meetings, use of local opinion leaders, and reminders have shown promise in earlier
studies in diverse clinical settings and we incorporated these elements in our
intervention and assessed long-term patient outcomes of 90-day death and dependency.
We also examined processes of care.
Interpretation The QASC trial provides high-quality evidence that a guideline
implementation strategy to support multidisciplinary teamwork and good nursing care
focused on evidence-based management of three key physiological variables in ASUs
delivers signifi cantly better post-discharge outcomes for stroke patients. Clinical leaders
of stroke services can adopt this strategy with confi dence that their outcomes will
improve.
Findings
19 ASUs were randomly assigned to intervention (n=10) or control
(n=9). Of 6564 assessed for eligibility, 1696 patients’ data were
obtained (687 pre-intervention; 1009 post-intervention). Results
showed that, irrespective of stroke severity, intervention ASU patients
were significantly less likely to be dead or dependent (mRS ≥2) at 90
days than control ASU patients (236 [42%] of 558 patients in the
intervention group vs 259 [58%] of 449 in the control group, p=0・002;
number needed to treat 6・4; adjusted absolute difference 15・7%
[95% CI 5・8–25・4]). They also had a better SF-36 mean physical
component summary score (45・6 [SD 10・2] in the intervention group
vs 42・5 [10・5] in the control group, p=0・002; adjusted absolute
difference 3・4 [95% CI 1・2–5・5]) but no improvement was recorded
in mortality (21 [4%] of 558 in intervention group and 24 [5%] of 451
in the control group, p=0・36), SF-36 mean mental component
summary score (49・5 [10・9] in the intervention group vs 49・4 [10・6]
in the control group, p=0・69) or functional dependency (Barthel Index
≥60: 487 [92%] of 532 patients vs 380 [90%] of 423 patients; p=0・44).
Interpretation
Implementation of multidisciplinary
supported evidence-based protocols
initiated by nurses for the management
of fever, hyperglycaemia, and
swallowing dysfunction delivers better
patient outcomes after discharge from
stroke units. Our findings show the
possibility to augment stroke unit care.
Message/Comments
急性期の脳卒中専門病棟の患者6564人を対
象に、入院90日後の予後を単盲検クラス
ター無作為化比較試験で評価。発熱などの
管理に関する科学的根拠に基づく治療プロ
トコルを事前配布した介入群では、既存ガ
イドラインのみを配布した対照群に比べ、
患者が90日後に死亡または要介護となる割
合が有意に低かった（P＝0.002）。