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The Omnibus Prospective Orthopaedic IRB Approved April 30, 2012

What it is and how to use it. The Omnibus Prospective Orthopaedic IRB Approved April 30, 2012. What is it?. 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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The Omnibus Prospective Orthopaedic IRB Approved April 30, 2012

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  1. What it is and how to use it The Omnibus Prospective Orthopaedic IRB Approved April 30, 2012

  2. What is it? • 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 • To conduct a study under this protocol, you will not need any further IRB approval

  3. Co-Investigators • We have identified the following co-investigators: • 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

  4. Conflict of Interest • 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

  5. The Protocol is organized into the following 1000 patient sub-studies: 1 Orthopaedic neck and/or spine treatment Jens Chapman, MD 2 Orthopaedic shouldertreatment Frederick Matsen, M 3 Orthopaedic elbowtreatment Frederick Matsen, MD 4 Orthopaedic hand/wristtreatment Jerry Huang, MD 5 Orthopaedic hiptreatment Paul Manner, MD 6 Orthopaedic kneetreatment Seth Leopold, MD 7 Orthopaedic treatment related to SportsMed Carol Teitz, MD 8 Orthopaedic foot/ankletreatment Bruce Sangeorzan, MD 9 Orthopaedic traumatreatment Daphne Beingessner, MD 10 Orthopaedic oncologytreatment Darin Davidson, MD PediatricOrthopaedic treatment Wally Krengel, MD Faculty are approved by sub-specialty for relevant sub-study. Residentsare approved for all sub-studies.

  6. To Initiate a Study: • You will need to • Fill in a UWOSM web form to initiate study (5 clicks) • Retrieve consent forms and blank questionnaires from 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

  7. What can you do? • 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

  8. The following Instruments are Approved for Use: set 1 GROUP 1: GENERAL HEALTH AND PAIN SCORES • 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)

  9. The following Instruments are Approved for Use: set 2 GROUP 2: UPPER EXTREMITY • 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) (5-7 minutes) • The Hand Outcomes Form (2-3 minutes)

  10. The following Instruments are Approved for Use: set 3 GROUP 3 SPINE • Scoliosis Research Society Patient Questionnaire (SRS-22) (5 minutes) • The Oswestry Disability Questionnaire (ODQ) (5 minutes) GROUP 4 JOINTS AND SPORTS • 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)

  11. What is the Process? • Fill in simple web form on Omnibus IRB page of Research Tab on Department Website Name Sub-study Study Locations Estimated Enrollment Enrollment Period

  12. What is the Process? • Conducting Your Study • 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

  13. What is the Process? • Conducting Your Study (cont’d) • Administer Initial Questionnaires • Retrieve approved study information from medical record • 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) • Access to medical records approved for up to 5 years post-treatment

  14. Approved Information from the Medical Record • 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

  15. Storing your Data Study data must be coded • All Study Information • Study Key • Subject Name • Study ID Number • Medical Record Number • Date of Birth • Address • Phone Number • Email Address • Questionnaires • Data Abstracted from Medical Record • Subject Name • Study ID Number • Medical Record Number • Date of Birth • Address • Phone Number • Email Address X X X X X • Coded Study Data X X • Study ID Number • Date of Birth • Questionnaires • Medical Record Data Abstraction

  16. Reporting • Report enrollment quarterly on Website • 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

  17. How to handle additional measures • If measure is justifiable medically or for QA then add routinely as part of medical record and abstract for the research study • If extensive research only protocol is needed, this will require either a modification or an independent IRB approval

  18. Other issues • Adding co-investigators • Reporting protocol violations • What might they be • Reporting adverse events • What might they be • Retrospective Orthopaedic Study • SFI • Confidentiality

  19. For Questions: Contact me or Theresa Bergholz bergholz@uw.edu 206 221-4076 1oth floor UWMC

  20. Acknowledgments • Andrea Rice • Cavanagh Lab Research Coordinator • Shannon Sewards • Assistant Director for Operations, UW Human Subjects Division • Julie Agel • Review of final draft • Susan Kim, Theresa Bergholz • Collection of ~500 signatures

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