Appendix 2: Data Extraction Form for Eligible Studies: Protocolization of Severe TBI Care
Appendix 2: Data Extraction Form for Eligible Studies: Protocolization of Severe TBI Care
Reviewer: ______Date of Extraction: ______
(dd/mm/yyyy)
Article Identification:
RefWorks ID#: ______
Title: ______
______
______
______
First Author: ______
Second Author: ______
Journal Name/
Reference Source: ______
Journal Article Published Abstract Conference Proceeding Other: ______
Year: ______Volume: ______Starting Page: ______
Full Publication: Yes No Comment: ______
Language of Publication: English and / or ______
Source of sponsorship (Study): ______
Study – Country of Origin: ______
Number of Centres Participating: ______
Comments: ______
______
______
Verification of Eligibility:
Inclusion Criteria: (verified by “tick” mark)
Controlled Trial
Patients were ≥ 18 years of age
Suffering from severe traumatic brain injury; Def’n: ______
Protocol-based care compared with control group
ICU/Neuro unit based care
Medical management protocol (with or without decompressive craniotomy)
Study Design:
Type of Study:
Prospective experimental data
Retrospective experimental data
Consecutive control patients
Case-control study
Other: ______
Prospective control data
Retrospective control data
Consecutive control patients
Cross-sectional study
Inclusion Criteria:
1. ______
2. ______
3. ______
4. ______
5. ______
6. ______
Exclusion Criteria:
1. ______
2. ______
3. ______
4. ______
5. ______
6. ______
Type of ICU: ______
Lead ICU MD: ______
Team members: Intensivist Neurologist Neurointensivist Neurosurgeon Anesthesia Trauma Housestaff Nurse Educator/Specialist Not specified
Protocol Characteristics:
Multidisc. derived
ICP-driven
CPP-driven
Guideline Based, specify: ______
Nursing care driven
MD care driven
Descriptive (ie: no diagram)
Admission orders
Flow diagram
Step/Phase approach
Pre-ICU care protocols:
o ER
o Rescussicitation
o OR
o Other: ______
Co-Interventions: ______
Control Group Mgmt: ______
______
______
______
Protocol Specifics:
Yes / Variable/Intervention if not met: / Trigger: / Target: / Comment:ICP target: ICP monitor IVD
Imaging
CSF drainage ______
Sedation/anagelsia
hypertonic saline _____%
mannitol ______
Vasoactive meds:
cooling ______۫C
PaCO2
other: ______
other: ______
CPP target: ICP monitor IVD
Imaging
CSF drainage ______
sedation
hypertonic saline _____%
mannitol ______
Vasoactive meds:
cooling ______۫C
PaCO2
other: ______
other: ______
SjO2 target:
Imaging
CSF drainage ______
sedation
hypertonic saline _____%
mannitol ______
Vasoactive meds:
cooling ______۫C
PaCO2
other: ______
other: ______
Hypothermia
Nutrition
Tracheostomy
PEG
CEEG
Barbiturate coma
Oxygen Saturation/FiO2
CVP/PCWP
MAP
PaCO2
Decompressive craniectomy
Other:
Comments/Clarification: ______
______
______
______
Stated Outcomes:
Outcome: / Primary: / Secondary: / Post-Hoc:1
2
3
4
5
6
7
Screening and Enrollment:
Total patients enrolled: ______Control pts: ______Intervention pts: ______
Timing of enrolment (mm/yy): Control pts: ______Intervention pts: ______
Consecutive patients: Yes No
Description of why not: ______
______
Participant identification:
ICU database
Prospective enrolment
Other: ______
Hospital database
Medical records coding
Baseline Characteristics:
CONTROL / Intervention#1: ______ / Intervention
#2: ______
Demographics:
Age (SD)
Male Sex (SD)
APACHE (SD) (circle) 2 or 3
SOFA/MODS/SAPS
Admission GCS (SD)
ISS (SD)
Post-op admission
Transferred from another institution
Diagnostic Category:
DAI
SAH
SDH
Intracerebral hemorrhage
No Mass
Marshall Score
% Multiple Injuries (in add’n to head)
Baseline Hemodynamics:
ICP
CPP
SjO2
BP
HR
Temperature
GCS
CVP/PWP
SvO2
Outcomes and Results:
#1: ______ / Intervention
#2: ______
Mortality:
Death (SD)
Withdrawal of Care (SD)
Non TBI-related (SD)
Post-admission day
Morbidity:
ICU LOS
Hospital LOS
Ventilator days
Day of tracheostomy insertion
Initiation of feeds
Day of PEG insertion
GOS: ______
Discharge status
Pt questionnaire: ______
Physiologic/Adverse Events:
OR (ie: craniectomy)
Seizure
ICP control
CPP control
Barbiturate coma
Pneumonia
CNS infection
Resources:
Health Care Costs