Zhao 2012.

Study characteristics
Methods	Prospective, multicentre, randomised, controlled, open (but with blinded evaluation of outcomes) trial Intention‐to‐treat analysis
Participants	A total of 47 patients were eligible for inclusion and consenting. They were all randomised to treatment groups. Inclusion criteria: 18 to 80 years of age Able to have surgical decompression within 48 hours of stroke onset Decrease in consciousness to an eye and motor score of < 10 on the GCS Ischaemic signs on subsequent CT involving at least 2/3 of the MCA territory with or without additional infarction in the ipsilateral ACA or PCA territory and the development of space‐occupying oedema Written informed consent given by the closest relatives of participants Exclusion criteria: Pre‐stroke score on the mRS > 2 Diminished consciousness due to other causes such as metabolic disturbances or medication, rather than the formation of space‐occupying oedema GCS score without the verbal response item < 6 Dilated and fixed pupil ipsilateral to the infarct side, or both pupils fixed and dilated Concomitant contralateral infarction or a secondary space‐occupying haemorrhage in the area of infarction Any other coincidental brain lesion or serious illness that might affect the outcome Life expectancy less than 3 years Contraindications for anaesthesia or surgery, including known coagulopathy, systemic bleeding disorder, or pregnancy, etc.
Interventions	Standardised medical treatment involved the following parameters: head elevation to 30°; osmotherapy: mannitol/glycerol to achieve serum osmolality of 300 to 320 mOsm; aim normovolaemia, normoglycaemia, and normothermia; ensure oxygen saturation > 92% with intubation/mechanical ventilation if GCS ≤ 8, or signs of respiratory insufficiency or airway compromise; cardiac care: monitoring of ECG and blood enzyme levels; blood pressure management: mean arterial pressure > 90 mmHg; sedation: propofol recommended for rise in ICP or neurological deterioration, and use of barbiturates discouraged; chemical venous thromboprophylaxis in patients at high risk; intensive care management for at least 10 days after stroke. Surgical decompression consisted of a large ipsilateral fronto‐temporo‐parietal hemicraniectomy with dural opening and subsequent duroplasty. Bone flap had a diameter of at least 12 cm. Resection of infarcted brain tissue was not allowed. Cranioplasty timing was left to the discretion of the neurosurgeon.
Outcomes	Primary outcome: mRS score at 6 months dichotomised between 0 to 4 (favourable) and 5 to 6 (poor) Secondary endpoints included death rates after 6 months and 1 year, mRS score at 12 months classified as good (0 to 4) or poor (5 to 6), and 6‐ and 12‐month mRS score dichotomised to 0 to 3 versus 4 to 6.
Notes	Participants were enrolled between July 2008 and May 2010 at 4 medical institutions across mainland China.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "With the adoption of a random number list, eligible patients were centrally randomized"
Allocation concealment (selection bias)	Low risk	Central allocation; sealed envelopes
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Primary outcome determined off a self‐reported questionnaire and then reviewed by 2 blinded assessors
Incomplete outcome data (attrition bias) All outcomes	Low risk	No missing data
Selective reporting (reporting bias)	Unclear risk	Study protocol not available Registered on clinical trials registry after recruitment had commenced
Other bias	Unclear risk	Trial terminated early due to interim analysis showing a significant difference in the primary endpoint

ACA: anterior cerebral artery
BP: blood pressure
CT: computed tomography
DWI: diffusion‐weighted imaging
ECG: electrocardiogram
GCS: Glasgow Coma Score
GOS: Glasgow Outcome Scale
ICP: intracranial pressure
ICU: intensive care unit
INR: international normalised ratio
MADRS: Montgomery and Asberg Depression Rating Scale
MCA: middle cerebral artery
mOsm: milliosmole
MRI: magnetic resonance imaging
mRS: modified Rankin Scale
NIHSS: National Institutes of Health Stroke Scale
PCA: posterior cerebral artery
PTT: partial thromboplastin time
RCT: randomised controlled trial
rt‐PA: recombinant tissue plasminogen activator
SF‐36: 36‐Item Short Form Health Survey
SIS: Stroke Impact Scale|
VAS: visual analogue scale