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HOBIT GOSE Quarterly Meeting

Updates on study coordinator role, lost to follow up protocols, un-blinding procedures, and scoring tips for the Global Outcome Scale in traumatic brain injury research.

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HOBIT GOSE Quarterly Meeting

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  1. HOBIT GOSE Quarterly Meeting September 2019

  2. Agenda Introduction- Sarah Rockswold, M.D. New Logistics/MOP Updates- Sarah Rockswold, M.D. Study Coordinator Role Lost to Follow up If Assessor becomes Un-blinded Graduating from Videos Permission to Record Training Tips- Angi Caverney, Ph.D.

  3. New Logistics/MOP Updates:Study Coordinator Role Communicate with the GOSE assessor prior to upcoming assessments Help arrange the GOSE visit Advise about presence of LAR Remember that scoring can never be discussed because study coordinator is not blinded

  4. New Logistics/MOP Updates:Lost to Follow Up If subject becomes lost to follow up, a site representative must present to the SIREN Operations or Steering Committee

  5. New Logistics/MOP Updates:If GOSE Assessor Becomes Un-blinded Immediately report to your study coordinator or Angi/Sarah Other site GOSE assessor must do all remaining assessments on that subject Extremely important as this is a single blinded study

  6. New Logistics/MOP Updates:Graduation from Recording Q&A Videos Minimum of 5 recordings for each GOSE assessor Last 2 recordings did not result in a major error (did not change overall GOSE score) PSC and GOSE assessor will receive email notification from Sarah

  7. New Logistics/MOP Updates:Video Permission Please remember to always have permission to record from subject/LAR on the video

  8. GOSE Administration and Scoring Tips • Overarching Concepts • CAN not HAS • TBI vs physical, weather, availability • Q02 – Assistance with ADLs • Beware of the overcautious caregiver – use your judgement (always) • Medications alone isn’t always a reason to not leave someone alone • Explicitly ask about 8 hours and then 24 hours • Q03 – Shopping • Does not include driving • Q04 – Travel • Does not have to include driving • TBI vs physical vs medical clearance

  9. GOSE Administration and Scoring Tips (2) • Q05 – Work • Magic wand question very helpful • Reduced = can do some kind of competitive paid work, but not up to previous capacity • Sheltered/unable = non-competitive, special workshops and positions • Q06 – Social and Leisure • Loss of interest CAN be a TBI related symptom • Frequency – evaluate TBI related reductions only

  10. GOSE Administration and Scoring Tips (3) • Q07 – Psychological • Relationship disruption is necessary – otherwise 7a is marked “no” • Frequency – tolerability is primary • For example, if a disruption is constant, but tolerable – score as “frequent” • If disruption pre-dates injury – determine if severity has increased • If yes, mark 7c as “no” and in 7b score the frequency of the worsening • If no, mark 7c as “yes”. Mark any frequency. Your answer to 7c will negate • Q08 – Any Other Problems • Ask this question in an open ended way first – then use list • Stop after identifying anything new • Items are (mostly) hierarchical

  11. Questions?

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