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. 2017 Nov 12;2017(11):CD012859. doi: 10.1002/14651858.CD012859
RCT Data Extraction Notes
Identification
Study details:
First author
Year of publication
Journal
Country (location of study conduct)
Number of centres
Duration of study (date)
Trial registry number
Author’s contact details (corresponding author):
Author’s name
e‐mail address
Methods
Study design
Groups
Population
Inclusion criteria
Exclusion criteria
Significant group differences (baseline imbalance)? (Y/N)
Participant flow:
# assessed for eligibility (n)
# enrolled (n)
# randomized (n/n)
# received treatment (n/n)
# analysed (n/n)
Potential effect modifiers
Population and baseline characteristics:
Gender
Non‐smoker
History of PONV/motion sickness
Type of general anaesthesia
Duration of anaesthesia
Use of perioperative opioids (if yes, which?)
Type of surgery
Significant imbalance between groups? (Y/N) If yes, please define.
Intervention
Dose
Time point of administration
Route of administration
Risk of bias (see Appendix 4: critical appraisal form)
Allocation concealment
Blinding of participant and personnel
Blinding of outcome assessors
Incomplete outcome data
Funding source
Sponsorship source
Sponsorship involvement
Outcome data
Type of outcome Definition of outcome Observation time period Intervention (events) Intervention
(n)
Control
(events)
Control (n)
Vomiting (0 to 24 hours)
Vomiting (0 to six hours)
Vomiting (two to 24 hours)
Nausea
Subjects with any SAE
Subjects with any AE
Mortality
Arrhythmia
QT prolongation
Extrapyramidal symptoms
Postoperative wound infection
Headache
Constipation
Sedation/drowsiness
Visual disturbances (e.g. blurred vision)
Monitoring and reporting of (severe) adverse events:
Yes No Unclear Risk of Bias Note
Did the authors actively monitor for AEs (any AE)?
Did the authors simply provide spontaneous reporting of AEs that arose?
Did the authors only actively monitor for defined AEs and other relevant AEs were not monitored?
Did the authors define SAEs according to an accepted international classification and report the number of SAEs?