Transcript The Omnibus Propective Orthopaedic IRB

What it is and how to use it
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We have been granted approval from HSD to
enroll up to 11,000 subjects in prospective
studies that use a defined set of outcome
instruments
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To conduct a study under this protocol, you
will not need any further IRB approval
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We have identified the following coinvestigators:
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35 Faculty
16 Fellows and ACEs
40 Residents
6 Research Coordinators
All the above have signed confidentiality
agreements to allow medical record review
under this protocol
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6 Faculty have declared possible CoI in
advance
2 GIM10’s have been submitted and approved
Other GIM10 forms need to be submitted
before investigators can be added to the
study – let us know if you have submitted
COI is an ongoing process – GIM10 may be
needed if new interest arises or if interest
goes away
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Orthopaedic neck and/or spine treatment
Jens Chapman, MD
2 Orthopaedic shoulder treatment
Frederick Matsen, M
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Orthopaedic elbow treatment
Frederick Matsen, MD
4 Orthopaedic hand/wrist treatment
Jerry Huang, MD
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Orthopaedic hip treatment
Paul Manner, MD
6 Orthopaedic knee treatment
Seth Leopold, MD
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Orthopaedic treatment related to Sports Med Carol Teitz, MD
8 Orthopaedic foot/ankle treatment
Bruce Sangeorzan, MD
9 Orthopaedic trauma treatment
Daphne Beingessner, MD
10 Orthopaedic oncology treatment
Darin Davidson, MD
11 Pediatric Orthopaedic treatment
Wally Krengel, MD
Faculty are approved by sub-specialty for relevant sub-study.
Residents are approved for all sub-studies.
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You will need to
 Fill in a UWOSM web form to initiate study (5 clicks)
 Retrieve consent forms and blank questionnaires from
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website (5 clicks)
START THE STUDY (10 clicks total - no contact with
HSD or IRB!!)
Consent each patient and store the Consent Form
Follow the specific guidelines, keep careful records
Report enrollment quarterly on UWOSM Website
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Review any patient records for the purposes
of enrollment
Review and report on any approved
information in patient’s record - with
appropriate consent for up to 5 years
Administer any of the 39 approved
Questionnaires on multiple occasions up to
24 months
GROUP 1: GENERAL HEALTH AND PAIN SCORES
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SF-12 (v1 and v2) Health Survey (2-3 minutes)
SF-36 (v1 and v2) Health Survey / IKDC Health Assessment (IKDC) (10 minutes)
Open Form Questionnaire (2-3 minutes)
Short Musculoskeletal Function Assessment (5-10 minutes)
Musculoskeletal Function Assessment (10-15 minutes)
Tegner Activity Scale (1 minute)
Minnesota Activity Measure (MAM) (2-3 minutes)
Patient-Reported Outcomes Measurement Information System (PROMIS)
Instruments (5-10 minutes each form)
Pediatric Quality of Life Inventory (PedsQL) (child-self report and parent-proxy
report) (3-5 minutes)
Pediatric Outcomes Data Collection Instrument (PODCI) (10-20 minutes)
Toronto Extremity Salvage Score (TESS) (upper and lower extremity) (10 minutes)
Single Assessment Numeric Evaluation (SANE) (1 minute)
Pain Assessment (PA) (1 minute)
Visual Analog Scale (VAS) (1 minute)
Constant Score (10 minutes)
Comorbidity Index and Score of Charlson et al. (5 minutes)
GROUP 2: UPPER EXTREMITY
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The Neck Disability Index (NDI) (3-5 minutes)
Simple Shoulder Test (SST) (2-3 minutes)
ASES Activity Questionnaire (with SST) (5 minutes)
American Shoulder and Elbow Score (5 minutes)The
Western Ontario Rotator Cuff Index (WORC) (5-10
minutes)
The Western Ontario Shoulder Instability Index (WOSI)
(10 minutes)
Disabilities of the Arm, Shoulder, and Hand (DASH) (57 minutes)
The Hand Outcomes Form (2-3 minutes)
GROUP 3 SPINE
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Scoliosis Research Society Patient Questionnaire (SRS-22) (5 minutes)
The Oswestry Disability Questionnaire (ODQ) (5 minutes)
GROUP 4 JOINTS AND SPORTS
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The Harris Hip Score (HHS) (10 minutes)
The HOOS Hip Survey (10 minutes)
Hip Outcome Score (HOS) (including Sports sub-scale)
The WOMAC (Western Ontario and McMaster Universities) Index of Arthritis (10 minutes)
The Knee Society Score (KSS) (5 minutes)
The IKDC Knee Assessment (IKDC) (5 minutes)
The KOOS Knee Survey (KOOS) (10 minutes)
The Kujala Score (KUJ) (2-3 minutes)
The Lysholm Knee Score (LYS) (2-3 minutes)
The Victoria Institute of Sport (VISA) – Patellar (2 minutes)
The FAOS Foot and Ankle Score (FAS) (10 minutes)
The Foot and Ankle Ability Measure (FAAM) (including Sports sub-scale) (5-7 minutes)
The Victoria Institute of Sport (VISA) – Achilles (2 minutes)
1.
Fill in simple web form on Omnibus IRB page
of Research Tab on Department Website
Name
Sub-study
Study Locations
Estimated Enrollment
Enrollment Period
Conducting Your Study
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Under Confidentiality and Consent/HIPAA
Waivers – review medical records for suitable
patients
Contact patients using approved recruitment
materials (IRB-approved letter [on website], in
person, phone)
Obtain consent using STAMPED consent form
Conducting Your Study (cont’d)
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Administer Initial Questionnaires
Retrieve approved study information from
medical record
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Use data abstraction form [on website]
Repeat questionnaire administration at future
intervals (approximately 12-weeks, 6-months, 12-months,
18-months, and 24-months post-treatment)
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Access to medical records approved for up to 5
years post-treatment
 Contact Information: name, address, telephone number,
e-mail address, hospital number
 Demographics: date of birth, age, gender, race, ethnicity,
height, weight, body mass index (BMI), handedness, and
marital status
 Symptoms and clinical history: medical and surgical
history, clinical family history, allergies, medications,
diagnoses, any imaging studies and treatments, and other
information the patient shares related to orthopaedic
health and function recorded in medical record
 Social history: recreational and occupational activities,
tobacco, alcohol, and narcotic habits, employment status,
workers’ compensation status, and legal claims
Study data must be coded
All Study Information
Subject Name
Study ID Number
Medical Record Number
Date of Birth
Address
Phone Number
Email Address
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Questionnaires
Data Abstracted from Medical Record
Study Key
Subject Name
Study ID Number
Medical Record Number
Date of Birth
Address
Phone Number
Email Address
Coded Study Data
Study ID Number
Date of Birth
Questionnaires
Medical Record Data Abstraction
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Report enrollment quarterly on Website
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Enrollment includes patients screened prior to contact even if they
do not participate
Report adverse events/protocol deviations on
Website
 Report close-out with final enrollment report on
Website
 Report any publications with final enrollment report
on Website
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If measure is justifiable medically or for QA
then add routinely as part of medical record
and abstract for the research study
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If extensive research only protocol is needed,
this will require either a modification or an
independent IRB approval
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Adding co-investigators
Reporting protocol violations
 What might they be
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Reporting adverse events
 What might they be
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Retrospective Orthopaedic Study
 SFI
 Confidentiality
Contact me or Theresa Bergholz
[email protected]
206 221-4076
1oth floor UWMC
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Andrea Rice
 Cavanagh Lab Research Coordinator
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Shannon Sewards
 Assistant Director for Operations, UW Human
Subjects Division
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Julie Agel
 Review of final draft
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Susan Kim, Theresa Bergholz
 Collection of ~500 signatures