glossary

GLOSSARY

CONVENTIONS

Items listed in Bold Caps (ANESTHESIOLOGIST) are the names of case report forms (CRF's) in the patient notebook.
Capitalized individuals (Anesthesiologist or Neurosurgeon) indicate "certified" participants in IHAST2.
The Study Packet is a 10 x 13 in. envelope containing a brown and white RANDOMIZATION ENVELOPE, two white 6.5 x 9.5 in. unsealed envelopes, and eight white adhesive labels pre-labeled with the same PID number. Once the contents are removed from the Study Packet, the anesthesia record and 0-2 hour postoperative recovery or critical care records are placed in it, sealed and sent to the DMC during the first data submission.
The term enrolled refers to a patient who was assigned a Patient Identification No. and color of the RANDOMIZATION ENVELOPE that the PCC should open to obtain the treatment assignment by the automated telephone system.
The term randomized refers to a patient whose assigned RANDOMIZATION ENVELOPE has been opened by a certified anesthesiologist.

NUMBERS

Center Identification No.	Each certified Participating Clinical Center (PCC) will be given a two-digit Center ID No. This number should be entered in the appropriate space on patient CRF’s. Specifically, these two digits will become the first two digits of each subjects “Patient Identification No.”
Certification No.	Every Study Coordinator, Anesthesiologist, Neurosurgeon, Neurologic Examiner and Neuropsychology Examiner who is involved in the care of enrolled study patients must be certified by the CCC, using certification materials provided. Once certified, each participating individual will be given a Certification No. This number must be entered on each form completed by one of these individuals to insure that all data from the study are collected by appropriately trained participants.
Patient Identification No.	Each enrolled patient will be given a five-digit Patient ID No. at the time of the enrollment telephone call to the DMC. This number must be included in the header of all forms filed with the DMC. The first two digits will be the “Center Identification No.” while the last three will be a unique number for each patient.
Patient Log No.	Each center must maintain a log, containing the SCREENING forms for ALL patients undergoing craniotomies for aneurysm clipping, regardless of their eligibility for the study, regardless of whether or not they were enrolled. This log should contain forms for patients having surgery for unruptured aneurysms, patients in whom the delay between SAH and surgery was >14 days, patients with one or more factors that render them ineligible, patients who refuse consent etc. Each patient listed in the log should be assigned a sequential “Log No.” to facilitate later audit.

PEOPLE

Certified Anesthesiologist An anesthesiologist who has completed a formal “testing” procedure and is hence “certified” to enroll and manage patients in IHAST2.

Certified Neurosurgeon A neurosurgeon who has completed a formal “testing” procedure and is hence “certified” to enroll and manage patients in IHAST2.

Local Co-PI “Second in command” at each PCC. May be either an anesthesiologist or neurosurgeon, but must have a specialty different from the PI.

Local PI The individual at each PCC responsible for overall conduct of the trial at that center. May be either an anesthesiologist or neurosurgeon.

Neurologic Examiner An individual (typically but not exclusively a neurologist or RN) trained and, and via a formal testing procedure, certified in the performance of the NIHSS, the Barthel’s ADL scale, the Rankin Disability Scale and the Glasgow Outcome Scale. While this individual is assigned the task of performing certain interim neurologic assessments (e.g., at 24 and 72 hours postoperative and at the time of discharge, his/her most critical task is the performance of the three-month postoperative neurologic outcome determinations.

Neuropsychology Examiner A certified individual designated to perform the neuropsychology battery. This person may be a professional neuropsychologist or neuropsychology technician, or any other appropriately trained individual.

Physician Protocol Monitor The Anesthesiologist responsible for reviewing (auditing) the intraoperative conduct of the protocol, including the ANESTHESIOLOGIST form and the TEMPERATURE form, and comparing these with the patient’s medical record (anesthesia and postoperative records).

Physician Safety Monitor A physician at the UI responsible for receiving and reviewing regular reports from the DMC regarding intercurrent events, complications, adverse outcomes etc during the conduct of the trial.

Study Coordinator An Individual who has completed a formal training and “testing” procedure and is hence “certified” to be responsible for many aspects of the trial, including eligibility assessments and enrollment, CRF distribution and completion, postoperative assessments, patient tracking, certain outcome assessments, etc. (see manual).

ABBREVIATIONS

ADL Activities of Daily Living

BVRT Benton Visual Retention Test

CCC Benton Visual Retention Test

CFT Complex Figure Test

Co-PI Co-Principal Investigator

COWA Controlled Oral Word Association

CRF Case Report Form(s)

DER Data Edit Report

DMC Data Management Center (at the University of Iowa)

GCS Glasgow Coma Scale

GOS Glasgow Outcome Scale

GP Grooved Peg-Board Test

ICP Intracranial Pressure

IE Intercurrent Event(s)

IHAST2 Intraoperative Hypothermia for Aneurysm Surgery Trial, Part 2

IRB Institutional Review Board (Human Studies Committee)

MMSE Mini-Mental State Examination

NIH National Institutes of Health

NIHSS National Institutes of Health Stroke Scale

NINDS National Institute of Neurologic Disease and Stroke (a Division of NIH)

O.R Operating Room

PACU Post Anesthesia Care Unit (or Recovery Room)

P.O. Purchase Order

PCC Participating Clinical Center

PI Principal Investigator

PID Patient ID Number

PPM Physician Protocol Monitor

PSM Physician Safety Monitor

PSMB NIH Protocol Safety and Monitoring Board

SAH Subarachnoid Hemorrhage

SICU Surgical Intensive Care Unit

TMT Trail Making Test

UI University of Iowa

WFNS World Federation of Neurologic Surgeons

Certified Anesthesiologist	An anesthesiologist who has completed a formal “testing” procedure and is hence “certified” to enroll and manage patients in IHAST2.
Certified Neurosurgeon	A neurosurgeon who has completed a formal “testing” procedure and is hence “certified” to enroll and manage patients in IHAST2.
Local Co-PI	“Second in command” at each PCC. May be either an anesthesiologist or neurosurgeon, but must have a specialty different from the PI.
Local PI	The individual at each PCC responsible for overall conduct of the trial at that center. May be either an anesthesiologist or neurosurgeon.
Neurologic Examiner	An individual (typically but not exclusively a neurologist or RN) trained and, and via a formal testing procedure, certified in the performance of the NIHSS, the Barthel’s ADL scale, the Rankin Disability Scale and the Glasgow Outcome Scale. While this individual is assigned the task of performing certain interim neurologic assessments (e.g., at 24 and 72 hours postoperative and at the time of discharge, his/her most critical task is the performance of the three-month postoperative neurologic outcome determinations.
Neuropsychology Examiner	A certified individual designated to perform the neuropsychology battery. This person may be a professional neuropsychologist or neuropsychology technician, or any other appropriately trained individual.
Physician Protocol Monitor	The Anesthesiologist responsible for reviewing (auditing) the intraoperative conduct of the protocol, including the ANESTHESIOLOGIST form and the TEMPERATURE form, and comparing these with the patient’s medical record (anesthesia and postoperative records).
Physician Safety Monitor	A physician at the UI responsible for receiving and reviewing regular reports from the DMC regarding intercurrent events, complications, adverse outcomes etc during the conduct of the trial.
Study Coordinator	An Individual who has completed a formal training and “testing” procedure and is hence “certified” to be responsible for many aspects of the trial, including eligibility assessments and enrollment, CRF distribution and completion, postoperative assessments, patient tracking, certain outcome assessments, etc. (see manual).

ADL	Activities of Daily Living
BVRT	Benton Visual Retention Test
CCC	Benton Visual Retention Test
CFT	Complex Figure Test
Co-PI	Co-Principal Investigator
COWA	Controlled Oral Word Association
CRF	Case Report Form(s)
DER	Data Edit Report
DMC	Data Management Center (at the University of Iowa)
GCS	Glasgow Coma Scale
GOS	Glasgow Outcome Scale
GP	Grooved Peg-Board Test
ICP	Intracranial Pressure
IE	Intercurrent Event(s)
IHAST2	Intraoperative Hypothermia for Aneurysm Surgery Trial, Part 2
IRB	Institutional Review Board (Human Studies Committee)
MMSE	Mini-Mental State Examination
NIH	National Institutes of Health
NIHSS	National Institutes of Health Stroke Scale
NINDS	National Institute of Neurologic Disease and Stroke (a Division of NIH)
O.R	Operating Room
PACU	Post Anesthesia Care Unit (or Recovery Room)
P.O.	Purchase Order
PCC	Participating Clinical Center
PI	Principal Investigator
PID	Patient ID Number
PPM	Physician Protocol Monitor
PSM	Physician Safety Monitor
PSMB	NIH Protocol Safety and Monitoring Board
SAH	Subarachnoid Hemorrhage
SICU	Surgical Intensive Care Unit
TMT	Trail Making Test
UI	University of Iowa
WFNS	World Federation of Neurologic Surgeons