Objective Assessment of Technical Skills in Cardiothoracic Surgery

Cardiothoracic Surgeon:

If you agree to take part in this study, you will receive a DVD containing multiple videos
of different surgeons or surgical trainees performing CAB procedures. You will be trained by
the Principal Investigator (PI) on how you should rate the performance of each
surgeon/trainee. You will be randomly assigned to 1 of 2 groups:

- If you are in the Conventional Rater (CR) Group, you will receive conventional training
from the PI about how to rate the videos.

- If you are in the Video Rater (VR) Group, you will receive conventional training from
the PI about how to rate the videos. You will also receive a video rater training
manual.

You will receive up to 38 different recorded procedures while you are on study. Each
procedure should last about 15 minutes. You will record the identification code that appears
at the beginning of each video, and the date and time that you viewed each video. You will
watch each video and then rate the performance of the surgeon/trainee using a checklist and
a Global Rating Scale. These rating documents will be given to you on a thumb drive that you
will either fill out on your computer or print out and fill in by hand. You will be given
more detailed instructions on how to fill out the checklist and rating scales by the
Principal Investigator (PI).

Your identity will be coded and blinded throughout the study. No identifying information
will be directly linked to your responses. Only the video identification numbers and your
code number will be used to identify the assessment data. The code key will be stored in a
separate computer or thumb drive.

Length of Study:

You will have 1 month to view and rate all videos. You will be contacted 1 time each week by
the PI to monitor your progress.

After you have watched and rated all the videos, you will return the videos, your responses
(either on the thumb drive or on printed hard-copies), and the video rater training manual
(if you are in the VR group) in a pre-paid mailer.

Up to 20 raters may take part in this study.

Cardiothoracic Surgical Trainee:

If you agree to take part in this study, you will fill out a form that asks about your
surgical experience. It will also ask about your age, sex, and initials, but these fields
are optional.

You will then use the ProXennon Surgical Headlight Camera System (a small camera that is
mounted in place directly over a high-intensity light that you wear on your head) to record
yourself performing CAB procedures. The main principal investigator (PI) will be present
when the system is being used to make sure that it is set up properly and to collect the
videos when the procedures are complete. No audio will be recorded. Each video will begin
when the dissection of a coronary artery has begun and will end when all manipulation of the
anastomosis is complete. You will record at least 6 separate anastomoses, or at least 2-3
procedures.

The time taken to set-up the recording equipment will be documented by the PI for each
procedure. After each procedure, a questionnaire will be completed by the intra-operative
personnel (nurses, anesthesiologist, perfusionist, operative surgeon, assistant surgeon)
that contains questions about any interference from the recording equipment. Neither you nor
the intra-operative personnel will be identified in this questionnaire.

The videos will be given a code number. The code key will be kept separately from the video
recordings. No identifying information will be directly linked to your videos. Only the
researcher in charge will have access to the code key. This is so the researcher will be
able to link the videos to the form you filled out at the beginning of the study describing
your surgical experience. All data will be presented in aggregate to protect participant
identity.

Length of Study:

Your participation in this study will be over after you have submitted your last recording

This is an investigational study. The ProXennon Surgical Headlight Camera System is an
approved, standard method of recording CAB procedures.

Up to 22 trainees and up to 8 experienced surgeons may take part in this study.

Inclusion Criteria:

1. The trainee must be a cardiothoracic surgical trainee in their 1st, 2nd, or 3rd year
of training and must be currently enrolled at any of the following institutions: U.T.
Health Science Center in Houston, The Texas Heart Institute/Baylor College of
Medicine, U.T. San Antonio, U. T. Southwestern, U.T. M.D. Anderson Cancer Center, and
The Methodist Hospital.

2. The trainee must provide an informed consent to participate.

3. The experience faculty must be a cardiothoracic surgeon who regularly performs CAB
procedures and has at least 10 years of post-training experience.

4. The experienced faculty is currently operating at the same institutions listed in
inclusion criterion 1.

5. The experienced faculty must provide written informed consent to participate.

6. The faculty rater must be a cardiothoracic surgeon who regularly performs CAB
procedures, is practicing in an Adult Cardiothoracic Graduate Medical Evaluation
(ACGME) approved CTS training program, and has practiced at least 5 years after
certification by the American Board of Thoracic Surgery (ABTS). There is no
restriction on geographic location.

7. The expert CAB surgeon for Consensus Building must be a cardiothoracic surgeon who
regularly performs CAB procedures, is practicing in an ACGME approved CTS training
program, and has practiced at least 10 years after certification by the ABTS. There
is no restriction on geographic location.

Exclusion Criteria: