Additional information should be added

MR Safety Screening

Section must be rewritten

• Participant must fill out MRI Safety Screening form at the interview/SCID session and at the MRI scan session
• Make sure to review MRI safety concerns with the subject, also let them know that they can end the scan at any time (squeeze ball), let them know that the scanner is very loud (make sure the earbuds are really in!)
• Have the subject remove his/her belt, any jewelry at all, anything in their hair, pockets, wrist, etc
• ALL metal (MR-safe or unknown) implants need to be checked.
• If you are acquiring documentation for technologist/Clinical Director review, you need:
  • Participant to sign a healthcare release authorizing the sharing of private health information to you
  • Surgical note from the implantation. Highlight anything in the document that could indicate a metal piece was used
  • Manufacturer’s information on the implant and whether or not it is safe at the field strength you are using for the scan (1.5T/3T/4T)
• If you know the material is MR-safe (e.g. dental work), you still need to check that the implant will not cause an artifact during scanning. You need to obtain the following:
  • Location information (e.g. ask participant to identify on dental chart)
  • Implantation information (to make sure that nothing not MR-safe is holding down the implant)
  • Review and approval from the physicist that this item in this location will not be an issue during the particular scan he or she is running (e.g. if you are scanning the liver, the dental work might not matter)
• The scanners have weight limits, but the most important thing is the size of the bore (girth of the subject is extremely important for this assessment):
  • 3T scanner
    • Weight limit: 350lbs (someone of that size has never been able to fit into the scanner)
    • Bore size: 15″ table to top x23″side to side
  • 4T scanner
    • Bore size: Inner bore diameter is 22 inches.  This equates to an inner circumference of 69 inches (maximum girth of subject successfully scanned at 4T is 52 inches).
  • Significant risks may exist for people with:
    • Cardiac pacemakers
    • Metal clips on blood vessels (also called stents)
    • Artificial heart valves
    • Artificial arms, hands, legs, etc.
    • Brain stimulator devices
    • Implanted drug pumps
    • Ear implants
    • Eye implants or known metal fragments in eyes
    • Exposure to shrapnel or metal filings (wounded in military combat, sheetmetal workers, welders, and others)
    • Other metallic surgical hardware in vital areas
    • Certain tattoos with metallic ink (please tell us if you have a tattoo)
    • Certain transdermal (skin) patches such as NicoDerm (nicotine for tobacco dependence), Transderm Scop (scopolamine for motion sickness), or Ortho Evra (birth control), or metal-containing IUDs
  • If you are unsure whether the subject has any of these items in your body, you should know that most would have been implanted as part of a surgical procedure. So, trying to have the subject remember any past operations may help. Subjects should also be asked whether you have any implanted devices or history of exposure to shrapnel or metal filings, and if so, they may not be able to participate in the study. It’s important to ask if they have ever worked with metal before, and if they have, if they wore eye protection AND if they ever suffered an injury (especially to the eyes). It’s also helpful to know if they have had MRI scans since that time.
  • MR Implant/Device Documentation Review Steps:
    • In order to scan anyone who has a metal implant or device, please follow the steps listed below.
    • Ask the PI if the implant (with the self-reported knowledge you have from the participant or the collaborator: e.g. implant location, material, previous MRIs) will affect his/her scans (based on the acquisition, voxel placement, type of scanning, etc.).
    • NOTE: For implants that are known not to be safe at 3T or conditionally safe at 3T and conditions cannot be met, subjects should be excluded.
    • Obtain the following documents to submit to the reviewer (required for review and approval)
      • Implant location, material, previous MRIs
      • Surgical note regarding the implant operation
      • Requires SIGNED healthcare release form to release the documents from the subject to the RA
      • Make/model of the implant (can be derived from the surgical note)
      • Manufacturer’s implant/device brochure
      • Manufacturer’s implant/device statement of MRI safety and previous safety studies
      • If the subject has previously had MRI scans safely with the surgical implant (anecdotal evidence not acceptable alone, but helpful to know for implant/device review and approval)
      • Check MRIsafety.com by Dr. Shellock if an implant is MRI safe. Check for any “conditions” (i.e. conditionally safe within specified SAR limit) and inform the reviewer and scanner operator of any “conditions.”
      • Coil information (e.g. transmit/receive) and body part being scanned
    • To obtain these documents, it is simplest for the subject to contact the surgeon’s office to obtain the surgical note and then forward the note to MIC staff (after having signed the release form). However, it is also possible for an RA to do so (subject would have to sign release form prior to RA contacting surgeon’s office to request medical records).After obtaining the surgical note and any other documentation provided by medical records/the subject/collaborating RA, the McLean RA should review all documentation for the following:
      • Verify where the implant is located
      • What implant was used
      • Ensure no other metal implants, clips, staples, etc. were placed during the surgical procedure.
      • (Highlight all applicable information) for implant/device review and approval
      • If this information was not already provided, contact the implant manufacturer to inquire about the MRI safety of the implant (e.g. a brochure or product information guide citing studies done at 1.5T or 3T where the implant was scanned safely).
    • It may be difficult to find information regarding 4T safety, but check Google and/or the Partners library resources.
    • To obtain approval for the scanners, forward the documentation to the following individuals:
      • For 1.5T or 3T approval, submit all documentation to Kathleen Thangaraj or any of the MRI techs. The techs may either sign off on the documentation or forward the review to Dave Olson, Clinical Director of the MIC.
      • For 4T approval, submit all documentation to Dave Olson.
    • If the implant(s) is approved for conditional scanning at 3T/4T, confirm with PI and/or scan operator that the scan will be performed within the “X” conditions.
    • NOTE: All documentation must be initialed and dated with the date of review and the reviewer. The reviewer should note whether the implant/device is safe at 1.5T/3T/4T and whether there are any additional conditions that must be met during scan.

FORP Set Up

To be supplied.

MRI Prescription Glasses

• Usually located at the 3T scanner
• Try to arrive 5-10 minutes early in order to sort these out, if needed
• Prescription ranges from 0.5-6.0 (weakest RX to be confirmed)
• Use “screen saver” wipes to wipe off your fingerprints prior to giving to the subject
• To use, simply select the RX lenses and “pop” them into the frame
• There should be an eye test sheet located near the MRI glasses case
• There is a login/logout book on the shelf above the iSCAN computer to log use

Informed Consent

To be supplied

Drug and Pregnancy Tests

• For all interview sessions, our participants must pass a drug test for inclusion into the study. We use Amedi-Check urine drug tests, and they are in the file cabinet in the cubicles. For REW22 and Trauma interview sessions, we also do a urine pregnancy test
• For all MRI sessions, the participants must pass a urine drug screen and a pregnancy test. Pregnancy tests are stored with the drug screens.
• For PET scans, participants must pass a urine drug test, and the serum pregnancy test (female participants must show up ~1.5 hours prior to the PET scan to give ample time for the analysis of the serum pregnancy test)
• If a subject tests positive on either test, ask them about the result, and if they deny possibility of the positive result, it is okay to re-do the test if they are willing.
• Each of our studies have a urine drug test at every session

Urine Protocol

• When having a participant do a urine drug screen, you will want to use an exam room with a biohazard bin. Ideally the room will have a two way door that connects to the bathroom. The 1.5T and 4T exam rooms have this.
• Give the test and the paper bag to the subject. Ask them to screw the top on tightly when they are finished and to either a) place the test in the shelf of the two-way door or b) place it on a paper towel on the shelf near the mirror
• Be sure to wear gloves
• Peel back the label on the drug test to analyze. If you are doing a pregnancy test at the same time, use the urine from the test to drop into the pregnancy test.
• When you have confirmed the test is negative, you must pour the urine into the toilet and screw the cap back on.
• Then with one hand gloved (to hold the test) and the other ungloved (to open/ close doors) bring the tests back to the exam room and dispose of them in the biohazard bin.

Physiology: Blood Tests, ECGs, and Biopsies

Taking Blood Samples

To be supplied

Quest

• As noted earlier, we use Quest Diagnostics for our bloodwork
• During the study session, be sure to bring the Quest form and the quest baggie to the session.
• Once you have obtained your blood samples:
• Be sure to label each tube with the subject ID, DOB, and sex. Fill this out on the form as well.
• On the form indicate the tests you want run, check the box “bill to my account”, write “Dr. Olson” as the study doctor, and check “Fax results to: 617-855-4231”
• Call Quest for specimen pick-up
  • 617-547-8900 (provide study-specific or general screening account #) to schedule pick-up
    • write down confirmation number on your copy of the requisition
  • If you have expired tubes to dispose of, let them know that they will be picking them up as well and place them by the specimen pick-up box.
• The Quest specimen pick-up box is located on the ground to the right of the wooden desk in the foyer of the entrance of the MIC (clearly marked, keyed access).
  • Keys to the Quest specimen pick-up box are by the front door of the RA office 127b
  • Bob Baden will be able to order you a key to open this box.

ECG (“EKG”) Training

• You will need to be trained on administering ECGs
• In order to do an ECG on a female you must be female or have a doctor present
• Rooms that you can do the ECG in are the 1.5 and the 3T exam rooms (for the 3T, you must bring the ECG)
• The ECG will print out an analysis of the recording. It is often hyper sensitive, and therefore it will often report an abnormal ECG when it is in fact fine. You must bring all ECGs to the study doctor to approve.
• If an ECG prints out as abnormal, replace the electrodes, and try again. If it is still abnormal, try to find the study doctor to review while the subject is still at the NIC. Otherwise, save the ECG for review later. Don’t tell the subject that they have an abnormal ECG. Only the doctor can determine this. Say “I am only trained to administer the ECG, and not to read it. We need to have the study doctor review the ECG for study eligibility”
• Remember to write the subject ID on the ECG printout

Biopsies

To be supplied

Administering REDCap Suveys /Data Entry

Some information may be out of date

• Method 1: Open a public survey
  • Log in with your partners ID
  • Go to “My Projects” and select the survey
  • Click “Manage Survey Participants” on the left hand side
  • Click “Open public survey”
• Method 2: Open a survey for this participant
  • Log in with your partners ID
  • Go to “My Projects” and select the survey
  • Click “Add/Edit Record”
  • Enter a new or existing Participant ID (e.g., REW23-001)
  • Fill out the first section of the survey for the participant, this includes the Study ID (e.g., REW23, ELS), the Subject ID (e.g., 001);, the Session Number (e.g., 2); and the Date (select Today).
• Option 3: Send a link to the survey
  • click “Participant List” under the manage survey participants tab.
  • This will send an email to participants with a link so that they can fill it out at home
• When you are ready to download the data to analyze, go to “Data export Tool” and click “export data now”. You will most likely want to export the “raw” excel spreadsheet
• If you need to change existing data (e.g., entered the wrong subject ID, administered the wrong questionnaire), you can export the data, make your changes, and then use the “data import tool” to upload your edited data.
• You will have to design an excel template that analyzes the questionnaire data exported by RedCap. Design the template so that you can copy the subject data and, without having to edit the data, paste it into the template.
• Scoring templates and data dictionaries for individual questionnaires can be found in common/admin/measures/scoring templates.
• It is also important to share access to questionnaires so everyone can use them. To do this, first select the project to share, under applications select “User Rights”, enter the Partners ID of the person who you are giving access as ‘New user name’ and hit tab, you then select their permissions: select everything in the first third, hit Save Changes. The person you added should then receive an email to let them know.