Just a reminder. Each center needs to file at least onecopy of each IHAST2 Update in the Site Regulatory Binder (See Chapter VII.A.5of the Operations Manual). 

At the University of Iowa Mrs. Alice McAllister, study coordinator,and Dr. Mazen Maktabi, the PI, view the neurosurgeons and neurosurgery residents as an important part of the recruitment process. Maintaininga level of commitment to the IHAST2 study not only by the anesthesiologists,but also by the neurosurgery team is a way to avoid missing potential studypatients. The neurosurgery team serves as the primary alert system. Theyare provided with a call schedule and concise instructions on how to reachan IHAST2 anesthesiologist on-call. The schedule not only includes a listof the persons on call forthat day, but lists all IHAST2 team membersand their pager/cell phone numbers. Also listed are the names of the PIas well as one other anesthesiologistwho may be called if back-up is needed.It is also important to follow thosepatients with SAH who do not meetinclusion criteria at the time of admissionin the event that their conditionmight change. 

The University of Virginia Health System, another center withhigh enrollment, reports that their notification system occurs at multiple levels 

The coordinators have also requested that the anesthesiologist alertthem if they hear of a prospective patient. NNICU is called daily to findout if any SAH patients have been admitted. Julie feels that regularcallsalso serve to remind them that the study is ongoing. She says they sometimesget up to three calls on one patient and that's when they know "every oneis thinking IHAST". Finally, Julie provided us with the real secret tonotmissing prospective patients: J "We have a tent set up and camp outin frontof the ER and monitor all patients entering. Angel and I havea little bonfiregoing at all times."J 

We would also like to extend our appreciation to Ms. JenniferHunt, study coordinator at The Alfred Hospital (Prahran, Australia). When a patient was unable to return for the 3-Month Follow-up, she andtheir neuropsychologist, Ms. Pauleen Bennett, personally drove 200 milesto seethe patient!!! Then, just two weeks later another patient refusedto returnfor follow-up making it necessary for them to drive another 170miles. Whilecoordinators should not be doing 3-month Follow-up exams (rather,these shouldbe done by "blinded" Neurologic Examiners), this kind of effortto avoid "losing"a patient clearly takes precedence. Thanks a million! 

The IHAST2 Annual Meeting is scheduled for Saturday, October14, 2000 in San Francisco, California. All Study Coordinators areinvitedto meet with the IHAST2 CCC and DMC personnel at 8:00 AM in the YosemiteA room of the San Francisco Hilton. All IHAST2 Investigators will joinusin the afternoon from 12:00 noon until 5:00 PM. The agenda will includeimportantinformation about the progress of the trial, safety issues, anddiscussionof problem areas. 

As of today (July 25th), 85 patients have been randomized. Thefirst patients were randomized in March - which means that they are now beginning to start coming back for the 3-Month Follow-up. So far, the CCC, the DMC, and participating centers have been focusing on more "immediate" problems: local personnel, recruiting patients, working out protocol bugs, etc. However, it's important that everyone begin to prepare for the 3-Month Follow-up visits. Please remember - in a very real sense - this entiretrial is based on the data collected at the 3-month visit. If this visit/examis missed, or if it isn't done correctly, everything that was done beforeisworthless (really!). 

1. Think ahead. Local Coordinators, PIs, and Co-PIs needto prepare for this visit by staying in touch with patients and the clinics.Ideally, patients should be coming in specifically for theirIHAST exam.Many (most) of these exams will be done in conjunction with ascheduledreturn visit to the Neurosurgery clinic. You will need to work closelywith thatclinic to make sure that patients return at the correct time(seebelow) andthat you are notified of the scheduled visit. What we wantto avoidis the "Oh yeah, Mr. Jones was in the clinic yesterday andwe forgottocall you….". or "Mr. Jones is down here in clinic,can youcomeand see him?" - an hour after your neurologic examinerhas left onvacation. 

2. The final follow-up exam is scheduled to take place at 3 monthsfollowing surgery, NOT following discharge. In a few cases, patientsmay still be in the hospital at 3 months (although I hope not too often)or they may have been home for only a short while. Nevertheless, they needto be seen. 

3. The exam does not need to take place precisely at 3 months,but should be done within a 2-week window (e.g., between 11 and13 weeksafter surgery). We realize that there may be situations where thisis not possible - but please do everything possible to meet this goal. Also remember - better late than never! If various roadblocks prevent apatient from being seen during this window, it doesn't mean that the examcan be skipped. Please get them back! 

4. There still seems to be some confusion about whodoes this3-month exam. The answer is pretty simple - the designatedNeurologicExaminer. While we have "relaxed" the protocol to permit the studycoordinatorto administer the interim neurologic exams (e.g. post-op NIHSS),coordinatorsCANNOT do any part of the 3-month exam. Even if you have twocoordinatorsand only one worked with a patient, you still need to get an 

5. GET THE EXAM DONE! Do everything in yourpower (shortof kidnapping) to complete this follow-up. Seriously, based onother trials,we would expect that in a trial of this size, no more than 2-3patientsshould be "lost to follow-up". If we lose more, the validity of theprojectis jeopardized. So get them back, go to them, or arrange for themto seeanother certifiedexaminer somewhere else - whatever is necessary.Anyfollow-up is better thana lost patient is! Overall, everyone out thereis doing a great job. The 3-monthexam is the "next big hurdle" - but itisunquestionably the most importantone of all. If you have questionsor concerns,please call us. 

IHAST2 is a prospective trial. Therefore, screening and eligibilityevaluations are made when a patient with an intracranial aneurysm presentsfor surgery- not before and not after. 

A. Prospective Form Completion 

All patients who have an intracranial aneurysm for whomsurgeryis planned within 24 hours are to have a SCREENING form completed.Practically, what does this mean?

o First, if surgery is not planned to take place within 24 hours,then do not complete a SCREENING form. One purpose of the SCREENINGform is to measure the overall 

o Second, patients with UNruptured cerebral aneurysms shouldalso be screened. Why? - Again, in addition to obtaining demographic information,one purpose of the SCREENING form is to measure the overall surgical activityof each center with regard to cerebral aneurysmsurgery. We want to knowthe total surgical experience of your center - bothfor ruptured and UNrupturedaneurysms. However, because only patients with ruptured intracranialaneurysms are eligible for IHAST2, only those patients who have an acutesubarachnoid hemorrhage (SAH) (i.e., the aneurysm has ruptured;item #4 ofthe SCREENING form is checked "Yes") should then be evaluatedfor IHAST2eligibility (ELIGIBLITY form). 

Thus, all patients who have an intracranial aneurysm for whichsurgery is planned within 24 hours and have acute SAH areto have an ELIGIBILITY form completed. Practically, what doesthismean? 

o First, as before, if surgery is not planned to take place within24 hours, then do not complete the ELIGIBILITY form more than 24hours before surgery. Why? - Things change. The patient's status may changesuch that surgery is cancelled or perhaps a new condition presentsthatmakes the patient ineligible (e.g., endotracheal intubation, life-threatening arrhythmias, etc.). In fact, because things can change quickly in these 

patients, the patient's WFNS score (item #7 on page 1 of theELIGIBILITY form) is determined no more than twelve (12) hours prior toplanned surgery. The further ahead of time the ELIGIBILITY form is completed, the greater the chances are that something will change, such that you will have to go through the process of correcting the ELIGIBILITY form (andpossibly the SCREENING form and/or your log too!). o Second, because keyelements of IHAST2 eligibility are the patient's pre-SAH Rankin score (SectionA, item #5) and WFNS score (Section A, item #7), the person who assesseseligibility must be Rankin- and WFNS-certified. All IHAST2 Study Coordinatorsare Rankin- and WFNS-certified. All IHAST2 Anesthesiologists are WFNS-certified.Thus, if your Anesthesiologists are frequently performing the eligibilityassessments, we highly recommend they get their Rankin certification. IHAST2Neurosurgeons are not required to be either Rankin- or WFNS-certified.Therefore, if your Neurosurgeons (faculty, fellows, and residents) are,in fact, performing eligibility determinations, they need to be Rankin-and WFNS-certified. 

B. Retrospective Form Completion

Patients who are enrolled in IHAST2 MUST undergothe processof screening and eligibility determination prior to surgery. Thatmeans all elements on the SCREENING and ELIGIBILITY forms must be fully addressed by IHAST2-certified personnel prior to surgery if the patientis to be enrolled in IHAST2 - no exceptions, ever, regardless ofthe day or time. 

What about patients who are NOT eligible? We understand thatpatients with ruptured cerebral aneurysms often present for surgery at very inconvenient times. Quite reasonably, the study coordinator or anesthesiologist may ask the following questions: If the patient is going to surgeryatsome inconvenient time (say 2:00 AM or on the weekend) and weare toldby a person seeing the patient that the patient is clearlyNOT 

First, what is the difference between Enrolled and Randomized?A patient is enrolled in the IHAST2 study when the telephone callor "enrollment call" is made to the computerized system, located at theDMC. Although a patient is assigned a patient ID number atenrollment,and also has a temperature 

To confirm that the RANDOMIZATION ENVELOPE was opened, and thatthe patient was, in fact, randomized into the IHAST2 study, a secondtelephone call or "confirmation call" must be made. This telephone callis, once again, to the computerized system located at the DMC. Only after you call does the computer know that the patient was randomized. Therefore, the sooner this call can be made after the RANDOMIZATION ENVELOPE is opened, the better. However, the confirmation call must take place within24 hours after the enrollment call. 

In the event that the patient was enrolled but was not randomizedinto the study (i.e., the RANDOMIZATION ENVELOPE was not opened), a "confirmationcall" must still be made. However, in this case, the caller must selectthe option indicating that the patient was not randomized. Again, the soonerthis call can be made, the better, but this call must be made within 24hours of the "enrollment call". In addition to this phone call, the following procedures must carried out: 

1) Ensure that the SCREENING and ELIGIBILITY forms are complete. 

2) Complete the header and footer information onpages 1 and6 of the ANESTHESIOLOGIST Form. On page 1, provide a brief explanation of why the patient was not randomized (e.g., WFNS 

3) Within 48 hours of the confirmation call, mail to the DMCthe white copies of the SCREENING and ELIGIBILITY forms and pages 1 and6 of the ANESTHESIOLOGIST Form. Also, return the Study Packet including both of the UNopened RANDOMIZATION ENVELOPES. 

4) Place the yellow copies of the SCREENING and ELIGIBILITY Formsand pages 1 and 6 of the ANESTHESIOLOGIST form back into the corresponding Patient CRF Notebook. 

5) Neither the Patient ID nor the Study Packet (which containsthe RANDOMIZATION ENVELOPES) will ever be used again. 

6) You may remove the remaining unused forms from the PatientNotebook. These forms may be used for other patients if needed. 

Study Packets, TEMPERATURE CRFs, andOther Temperature-RelatedIssues 

Use Study Packets Sequentially

Thirty sequential sets of Study Packets containing sealed RANDOMIZATIONENVELOPES were sent to each PCC at the beginning of the study. The sequenceof the Study Packets matches the sequential ordering of the Patient Identificationnumber (PID) assigned by the telephone enrollment system. Therefore, itis important to use the Study Packets in sequential order so that the correct RANDOMIZATION ENVELOPE is 
 

1) Make sure the Study Packets are in sequentialorder and thatnone are missing.

2) Be sure to pull the Study Packet with the PIDlabeled on theoutside that corresponds to the PID assigned by the telephoneenrollmentsystem. 

3) The two RANDOMIZATION ENVELOPES (brown and white) inside theStudy Packet must have the same PID as the Study Packet in which they arecontained. If you are missing a Study Packet, or if the PIDsfrom the two RANDOMIZATION ENVELOPES don't match the Study Packet in whichthey were contained, contact the DMC immediately so we can correct theproblem. 

What should you do if you open a RANDOMIZATION ENVELOPE for the wrongPID? 

First, contact the DMC right away. Depending on the stage of patientcare, the DMC will decide whether you will be asked to use thePID assignedby the telephone enrollment system or the PID for the RANDOMIZATION ENVELOPEthat was opened. For the PID not used, we will ask that you returnboth RANDOMIZATION ENVELOPES to

Please Record Esophageal and Secondary Temperatures on the AnesthesiaRecord! 

Because all individuals at the CCC must remain blinded to the treatmentassignment, a knowledgeable physician audits the intraoperative conductof the study. This is the role of the IHAST2 Physician Protocol Monitor (PPM), David S. Warner, MD, Department of Anesthesia, Duke University Medical Center. 

The DMC sends Dr. Warner a copy of the completed TEMPERATURE form, ANESTHESIOLOGISTform, and a copy of your local hospital anesthesiaand 0-2 hour postoperativerecovery or critical care records for every patient. The OR anesthesiarecord and the 0-2 hour postoperative recovery/ICU records are the originalsource document used by the PPM to ensure propertemperature protocol isbeing followed. The data from these records willbe compared to thedata found on the ANESTHESIOLOGIST and TEMPERATURE formsand any discrepancieswill be noted by the PPM. This anesthesia record musttherefore indicatethe patient's intraoperative temperatures. (It's also alegal record andshould be accurate.) 

Yes, there is potential for unblinding during the handling/copyingof these records, or postoperatively. That is why the photocopy of theanesthesia record is to be sealed in the Study Packet before it is returnedto the Study Coordinator (see next paragraph). Yes , if someonereally wants to "unblind" themself, they can go to the anesthesia recordand learn the patient's temperature. So be it. Everyone caring forpatientsin IHAST2 is "on their honor" not to intentionally "unblind" themselves. 

Again, the esophageal and secondary temperatures at definitive clipplacement must be recorded on the anesthesia record by the treating 

What happens to submitted TEMPERATURE forms? 

When the Data Management Center (DMC) receives the small white envelopecontaining the TEMPERATURE form, it is routed to an unblinded individual,Mr. Rick Peters. Mr. Peters will visually check the TEMPERATURE form forcompleteness of data and, if complete, will send a copy of this form tothe PPM (Dr. Warner). If the form is not complete (e.g., the esophageal temperature was left blank), Mr. Peters will contact the PCC study coordinator via e-mail (or telephone). The attending local anesthesiologist who completed the form will also be notified that changes are being requested. 

Because blinding is an issue for the TEMPERATURE form, the localstudy coordinator may not make the changes and, therefore, will beasked to follow these steps: 

1) give the attending local anesthesiologist theenvelope thatcontains the canary-colored copy of the TEMPERATURE form; 

2) ask the anesthesiologist to make the changes requested tothe canary-colored copy, placing his/her initials and the date that the correction(s) were made, next to it; 

3) instruct the anesthesiologist (or someone forwhom unblindingis not an issue) to make a 

4) instruct the anesthesiologist to put the corrected canary-coloredTEMPERATURE form back in the small white envelope (or a new envelope withthe PID written on it), seal it, and return it to the localstudy coordinatorwho should place it back into the Patient's Notebook. 

In some cases, the DMC computer system will identify other problemswith the TEMPERATURE form. In this case, a Data Edit Report (DER) willbe produced and sent to the attending anesthesiologist whose certification number is on the form. The anesthesiologist will be responsible for contacting the local study coordinator to obtain the small white envelope containing the canary-colored copy of the TEMPERATURE form. Then steps 2) through4)in the previous paragraph should be followed. 

Contact information for Mr. Peters at the DMC: 

Mr. Rick Peters 
Data Management Center 
2220 WL Bldg. Dept. of Biostatistics 
University of Iowa 
Iowa City, Iowa 52242 
Phone #: 319.335.6872 
Fax #: 319.335.6535 
Email: richard-peters@uiowa.edu 

New Pocket-Size Notebook with Intercurrent Events Codesand Definitions 

Although all Intercurrent Events (IE) codes and definitions are presentin the IHAST2 Operations Manual (Chapter IX, Section S, pagesIX-85 throughIX-105), we know the Manual is not convenient for day-to-dayclinical use.Included

Some Time-Saving Hints 
When you are preparing an INTERCURRENT EVENTS (IE) form, it will saveyoutime and effort if you will take the following steps. 
• First, before you submit an IE form, quickly review the IHAST2diagnostic criteria that must be satisfied for each IE. If we receivean IE formthat does not provide sufficient information to confirm thatdiagnostic criteria are met, we will contact you and ask you to providethe needed information. More likely than not, this will start the processof a PCC Correction Report, which is a time-intensive process. If agiven condition does not meet diagnostic criteria, you may not need tocomplete the IE form at all! 

When a given diagnosis (IE) is made by the patient'sdoctor(s), butIHAST2 diagnostic criteria do not appear to be satisfied, wesuggest youtake the following actions. Review the patient's condition,and reviewIHAST2 diagnostic criteria, with the doctor(s) who made the diagnosisinquestion. It is possible the doctor may have other information that willsatisfy IHAST2 diagnostic criteria. In this event, you should completeandsubmit the IE form. If, after review, IHAST2 diagnostic criteria stillcannotbe satisfied, the local Principal Investigator (PI) or Co-PI shouldreviewthe matter and decide whether or not to report the IE. After thissecond review,if the IE is "mild" in severity and does not satisfy IHAST2diagnostic criteria,your center may elect not to report it at all. (Hence,no IE form!) For IEsthat are "moderate" or "severe" in their clinicalimpact, but do not meetIHAST2 diagnostic criteria, please contact theClinical Coordinating Center(CCC) before coming to a final decision aboutwhether or not to file an IEform. A short phone call can save you (andus!) a lot of time. 

A New IE Code and Diagnosis 
A new IE diagnosis and code has been added-910, "Other Infection."The Operations Manual will be revised as follows. 
 

Definition/Criteria: The diagnosis of "Other Infection" may bemade whenever the patient has an infectious process with a microbial agent (bacterial, fungal, viral, parasitic, etc.) that is not accurately characterized by any other infection-related IE diagnosis (i.e.,the process is NOT any of the following: 

100-Septic shock; 
101-Vascular catheter-related infection; 
102-Bacteremia; 
103-Non-neurologic wound infection; 
300-Pneumonia; 
400-Hepatitis (infectious); 
600-Craniotomy incision or bone-flap infection; 
601-Meningitis or ventriculitis;
602-Brain abscess, epidural/subdural infection, encephalitis;
700-Urinary tract infection 

IE Form Completion and Completion
Date The IE form is complete only when item #6 (Has primary IE resolved?) is complete. Therefore, the IE form cannot be completed, and thecorresponding IE form completion date cannot be recorded, untilitem #6 is answered either "No" or "Yes." Practically speaking, what doesthismean? 
o For all IEs with onset prior to discharge, item #6must be answered in one of two ways prior to submitting the data set thatis required at hospital discharge: 
1) If the primary IE resolves (symptoms have disappeared ortreatment has been completed) prior to discharge, then item #6 canbe checked "Yes" on the date of IE resolution, but not earlier.Therefore, the date the IE resolved is the earliest possible form completiondate. If you complete the IE form later than the day the IE resolved,record the actual date the form was completed.
2) If the primary IE has NOT resolved prior to discharge, thenitem #6 is checked "No" on the date of discharge. In thiscase, the date of discharge is the earliest possible form completion date. If you complete the IE form later than the day of discharge,record the actual date the form was completed. 

o For all IEs with their onset after discharge :
All intercurrent events (IEs) that occur up to the time of the final3-month outcome assessment are to be reported. After patients are dischargedfromthe hospital, one mechanism by which IEs may be detected is by completionof the CONTACT FOLLOW-UP form at 6-weeks and 3-months after surgery. Items#10-13 of the CONTACT FOLLOW-UP form ask questions which, if 

The processes and criteria for reporting IEs that occur afterdischarge are not different from those that occur prior todischarge. Simply check the box on the INTERCURRENT EVENTS form (item #2)that indicates the IE had its onset after discharge. For IEs that havetheir onset after discharge, it is possible that you may not be able tocomplete the IE form until the 3-month follow-up evaluation. Why?Item #6 of the IE form asks, "for IEs with onset after discharge",whether the IE has resolved by the time of the 3-Month Follow-up?If the post-discharge IE resolves before the 3-Month Follow-up, you cancheck "Yes" whenever it becomes appropriate, record the form completiondate, and the IE form is done. However, if thepost-discharge IE doesnot resolve before the 3-Month Follow-up, you must waituntil thefinal 3-Month Follow-up evaluation to make thefinal assessmentasto whether or not the IE has resolved. Therefore, forsome IEs with onsetafter discharge, it may not be possible to complete theIE form (or recordthe form completion date) until the final 3-Month assessmenthas been made. 

Delayed Ischemic Neurologic Deficit (DIND) [IE Code 620] vs. "Vasospasm"
A delayed onset of narrowing of the major conducting cerebral arteries("vasospasm") occurs in 60-70% of SAH patients. Vasospasm can be detectedseveral ways but transcranial Doppler (TCD) and cerebral angiography arethe most commonlyused methods. Vasospasm may significantly limit cerebralperfusion. In abouthalf of the patients who have vasospasm, reduced cerebralblood flow exacerbates a pre-existing neurologic abnormality or resultsin new ischemic injury. Collectively, these neurologic abnormalities arecalled Delayed Ischemic Neurologic Deficits (DIND). In IHAST2, we arefollowing DIND; we are NOT following "vasospasm."

What if the patient has vasospasm (appropriate abnormalities seenon TCD or angiogram) but receives intensive prophylactic therapy to prevent DIND (e.g., hypervolemic, hypertensive, hemodilution, or vasopressors/inotropes to increase perfusion)? Shouldn't that count as DIND? Answer: No. Ifthere are no new neurologic signs or symptoms, DIND does not exist. 

What if the patient has new neurologic symptoms that are consistentwith DIND (see the Operations Manual or the new IE pocket notebook)butwe don't have TCD or angiography to prove it? Can we makethe diagnosisof DIND? Answer: Yes, but… The diagnosis ofDIND is primarilybased on the time of onset of the deficits (5-10 days afterSAH), the natureof the deficits (decreased level of consciousness with orwithout focaldeficits) and the exclusion of other causes of delayed neurologicdeterioration(rebleeding, hematoma, hydrocephalus, brain edema, seizures,etc.). PositiveTCD or angiographic findings are not required to makethe diagnosis.But,the constellation of new signs and symptoms shouldbe consistent with DIND. 

What if the patient has new neurologic symptoms that are consistentwith DIND but TCD (or angiogram) indicate that there is novasospasm? Canwe make the diagnosis of DIND? Answer: Probablynot. If, usingreliable methodology vasospasm is found to be absent, then the causeof 

Recurrent Subarachnoid Hemorrhage [IE Code 610]and item #8 inSection H (page 6) of the ANESTHESIOLOGIST form
Recurrent Subarachnoid Hemorrhage is defined as: EXCEPT forthe primary aneurysmal subarachnoid hemorrhage, ANY instance when any subarachnoidhemorrhage occurs for ANY reason, except direct surgical manipulation.What does this mean?

If any new subarachnoid hemorrhage occurs before going tosurgery, regardless if the bleeding originates from the aneurysm thatlead to the patient's presentation (i.e., rebleeding), or from yetanother intracranial aneurysm, it should be reported. 

If any new subarachnoid hemorrhage occurs after going to surgery,regardless if the bleeding originates from the aneurysm that lead to thepatient's presentation, or from yet another intracranial aneurysm, itshould be reported. 

What about aneurysmal bleeding that occurs during surgery? Item#8 of Section H (page 6) of the ANESTHESIOLOGIST form originally asked whether or not the "Patient had a recurrent subarachnoid hemorrhage." However,thisquestion has been changed. The new revised ANESTHESIOLOGISTform is dated 040600 (bottom right hand corner) and Item #8 now reads "Patienthad a recurrent subarachnoid hemorrhage not due to surgical manipulation."This change was madewith the last Operations Manual revisions that weredistributed in April (seeIHAST2 Operations Manual Chapter IX, page 44, 

Body Mass Index (BMI) is an index of the patient's weight relativeto their height. Because obese patients do not cool well via surface techniques,patients are not eligible for IHAST2 enrollment if their body mass index(BMI) is more than 35.0 kg/m². A patient who has a BMI of 35.1kg/m² is not eligible. For this reason, the patient's BMI isto be calculated and recorded on the ELIGIBILITY form (Section B, item #2). The patient's BMI is calculated as follows: 

BMI= Pt Weight (kilograms)/(Pt Height [meters] x Pt Height [meters])= Weight/(Height)²

A unit conversion table is provided with enrollment materials to aidin this calculation. The left side of the conversion table is for height, converting feet & inches to meters. It also 

We "messed-up" the form initially. The first ELIGIBILITY form (dated102899 in the bottom right-hand corner of the form) was confusing withregard to what information was being requested in the calculation ofBMI.Item #2 looked like this: 

It was unclear whether we wanted the patient'sheight or(height)² to be recorded. What we wanted was the patient'sheight(not height² ) to be recorded in the space provided. Sorry-we apologize that the formwas not clear.  Because of this problem we have revisedthe ELIGILIBILITYform. Thenew ELIGIBILITY form is dated 032400 (in the bottom right hand cornerofthe form). Item #2 now looks like this:

To avoid confusion, each elementrequired tocalculate BMI is recorded separately: Weight (kilograms); Height(meters);and Height². As described above, BMI (kg/m²) is Weight÷ Height².

Until now we have not provided directions for making corrections tothe Patient Log. If a patient who does not qualify to be screened for the IHAST2 study is mistakenly logged onto the Patient Log, we ask that youmake corrections using the following procedure. First draw a single linethrough the log number and the incorrect entry. In the margin, next tothe corrected entry, please write your initials, the date, and a briefexplanation of the error. Do not reuse this Patient Log number. 

If SCREENING AND ELIGIBILITY forms have been completed for this patient,we suggest that you keep these forms in your Patient Log Binder. If youchoose to keep the forms, please draw a diagonal line through the form,date, initial, and provide a brief explanation of the error. Please donot send the forms to the DMC. Retaining these forms in your Patient Log Binder is not required, but we recommend that you do so to help accountfor the error. 

If other errors are made (such as entering an incorrect date under "ScreeningForm Completion Date") please correct the item by first drawing a linethrough the incorrect entry. Then write in the correct entry above theincorrect item, initial, and date. 

Please note that the instructions and telephone number printedon the first version of the INTERCURRENT EVENTS (IE) form is incorrect.The form states: "All events in these categories must be promptly reportedto the CCC at 319-356-0416". This is not correct in two ways. First,the report should bemade by faxing the IE form, not by telephoningthe CCC. Second, thelisted phone number is NOT the CCC. The printednumber is the phonenumber for the OR desk at the University of Iowa. Itis close to the CCC number,but it is most definitely NOT the CCC. 

This error was reported in the March 2000 issue of the IHAST2 Update(Volume 1, No. 2, page 7). PLEASE cross this number out onall your old unused IE forms and write in the correct number 319-384-8072,which is the CCC fax number. All Severe/Indicator IEs or Death eventsmust be faxed to the CCC - you do not need to call the CCC to reportthese events. 

New revised IE forms have been printed - they are dated 042000 (in thebottom right hand corner of the form). If you already havenew IE forms,the correct fax number is printed on them. 

We are sorry for the inconvenience. If you have any questions, pleasecall the CCC at 319-356-0461 (not 0416!). 

CONTACT FOLLOW-UP Form Revision (dated 040300) 

Item #7 "What is the patient's current work status?" on the CONTACTFOLLOW-UP form has been revised. The skip-out question "Did thepatient return to previous occupation and/or same level of performance?"has been changed so that it 

To "fix" this, we have changed the skip-out such thatit is now Item#8. Item #8 "Has the patient returned to previousoccupationand/or same level of performance?" will now allow the examinerto indicatea change in work status of patients who are not working at thetime ofthe follow-up visit. 

In addition, Items #7 and #8 of the revised CONTACT FOLLOW-UP form mayrequire further clarification. The description "Employed (or working)" applies only if the patient is working. It does not apply if the patientis employed but not back to work. In other words, if a patient is employed(at the time of the follow-up visit) but is still taking sick time, pleasemark option #3 "Not employed nor working" for item #7. Item #8 wouldthen be marked "no" since the patient had not yet returned to their previouslevel of employment. If a patient is not working (at the time of the follow-upvisit) and was not working prior to the SAH, please mark option #3 "Notemployednor working" for item #7. Item #8 would then be marked "yes" sincethe patient was not working prior to the SAH event.

The next Operations Manual Update will include revised procedures (chapterIX) that will reflect the change on the CONTACT FOLLOW-UP form. 

Why, When, and How the Physician Protocol Monitor (PPM)Will Contact You 

The job of the PPM is to ensure that intraoperative patient managementis conducted according to the assigned protocol, and that major intra-and early post-operative intercurrent events are reported. Photocopies of the local hospital anesthesia record and early (0-2 hour) postoperative recovery or critical care records (e.g. recovery, ICU flowsheets) are considered to be the "source documents." The Physician Protocol Monitor (PPM) willreview these records and compare them with the information provided onthe ANESTHESIOLOGIST and TEMPERATURE forms. If there are discrepancies,or if a protocol issuearises, the PPM will contact your center in oneof two ways. 

A. ITEMS WHICH INVOLVE PATIENT TEMPERATURE
 

The PPM will review the source document (local hospital anesthesia record)and make a judgement as to whether the responsible Local Anesthesiologistmanaged the patient in a manner consistent with the assigned temperaturegroup. The PPM will also check the TEMPERATURE form to determine whetherthe temperature recorded is consistent with that on the local hospital anesthesia record. If a temperature-related discrepancy exists betweenthe source documents and the 

B. ITEMS WHICH DO NOT INVOLVE PATIENT TEMPERATURE
 

The PPM will review the source documents for: 1) indications that thepatient was not eligible for IHAST2 at the time of presentation to theoperating room; 2) consistency with IHAST2 anesthesia protocols; and 3) for intercurrent events (IEs). The PPM will focus his review primarilyonthose IEs which are: 1) "Indicator" IEs (items 1-10 of Section H. ofthe ANESTHESIOLOGIST form); or 2) IEs that appear to have been severe (items11-24 of Section H.). 

If a discrepancy exists between the source documents and the ANESTHESIOLOGISTform, the PPM will contact the Local Anesthesiologist 

The IHAST2 Update newsletter and the IHAST2 OperationsManual are fully accessible on the IHAST2 web site. To access the homepage for the IHAST2 web site using your favorite web browser, type in theURL: 

The home page looks like this: 

Once you have accessed either the Update newsletters or the OperationsManual, you will be given the option of looking at it using HTML or PDFformats. The primary advantage of PDF is the ease of printingneatly, formattedpages. The primary advantage of HTML is the linking whichallowsyou toquickly go from the table of contents directly to the chapteror sectionof your choice, etc. Here is what you will see if you were accessingtheUpdate newsletters: 

http://www.adobe.com/products/acrobat/readstep2.html

Also, the listings on the left sid which were viewable (and accessible)on the Update newsletter page. This was designed to make it moreconvenient to access any of the listings without doing a lotof backtracking.So if you haven't done so already, please visit the IHAST2website andlet us know what you think.