Patient Reported Outcomes by g0VL09G

VIEWS: 0 PAGES: 2

									                                                       TBI Common Data Element Recommendations for Patient Reported Outcomes
      Classification        Recommended Instrument to                  Description of Measure                          Code List/Permissible Values
       Indicates “Core”,     Assess/Measure Outcome             Number and description of items and subscale   Total range of scores (for GOS-E list values and labels)
      “Supplemental”, or                                                  structure if appropriate                      and range of subscales if appropriate
                                     Domain
          “Emerging”

1   Emerging               Patient Reported Outcomes      Version 1.0 contains 12 calibrated item              T scores for all scales
                           Measurement Information System banks with likert style items (e.g., anger,
                           (PROMIS)                       anxiety, depression, Fatigue, pain, physical
                                                          function, satisfaction with social activities
                                                          and roles, sleep/wake disturbance, and
                                                          global health). Can be administered as a
                                                          computer adaptive test or short-forms make
                                                          assessment brief, yet reliable

2   Emerging               Neuro-QOL                         Contains 10 calibrated item banks with likert T scores for all scales
                                                             style items with several banks linked with
                                                             PROMIS (e.g., anxiety, depression, stigma,
                                                             positive psychological functioning, mobility,
                                                             activities of daily living, satisfaction with
                                                             social activities and roles, Social Roles,
                                                             Applied and perceived cognitive functioning).
                                                              Administered as short-forms to make keep
                                                             assessments brief.

3   Emerging               TBI-QOL                           Contains 6 Neuro-QOL calibrated item banks T scores for all scales
                                                             along with targeted TBI item banks to
                                                             enhance sensitivity and specificity of HRQL
                                                             measurement in TBI population. Will be
                                                             administered as short-forms and CAT to
                                                             make keep assessments brief.




                                                                                                                                                                          1 of 2
                                                                 TBI Common Data Element Recommendations for Patient Reported Outcomes
                  Procedure/Process                              Comments/Special instructions                          Rationale/Justification                                   References
     Indicates who can administer/interpret, method(s) of         Indicates appropriate population for use       Sentence or two stating reasons for selection          Primary reference for the instrument
          administration, and length of administration



1   Patient reads Likert items on computer                  General scale designed to be used across         Designed as part of the NIH Roadmap                 see http://www.nihpromis.org/default.aspx
    screen and responds. Computer adapted                   multiple general medical populations for         initiative for use in NIH sponsored clinical
    version will select items with maximum                  cross-sample comparisons. Has been               trials research. Calibrated item banks and
    discriminability and tailored to individual.            tested in large samples of individuals from      CAT administration offer advantages of
    Computer scored. Administration time is < 5             the general population and diverse medical       obtaining reliable measurement across a
    minutes per subdomain (total time for short             populations. However, has not been               wide spectrum of functioning with minimal
    form or CAT across all domains is about 30              validated in TBI.                                items.
    minutes).

2   Patient reads Likert items on computer                  General scale designed to be used in NINDS-      Development funded by NINDS through a               see http://www.neuroqol.org/default.aspx
    screen and responds. Computer scored.                   sponsored clinical trials and other studies      contract mechanism with the goal of utilizing
    Administration time = < 5 minutes per                   where cross-sample, cross-disease                in clinical trials research. Calibrated item
    subdomain (total time for short form across             comparisons are desired. Has been tested         banks offer advantages of obtaining reliable
    all domains is about 30 minutes).                       in large samples of individuals from the         measurement across a wide spectrum of
                                                            general population and diverse                   functioning with minimal items.
                                                            neurologically impaired populations.
                                                            However, has not been validated in TBI.
                                                            Future plans are to develop a computer
                                                            adaptive test (CAT).
3   Patient reads Likert items on computer                  Specialized version of NINDS-sponsored           Will be a comprehensive TBI-specific
    screen and responds. Computer scored.                   Neuro-QOL for use in TBI clinical trials and     outcome measure.
    Administration time is < 5 minutes per                  other TBI studies. Is being field tested in a
    subdomain (total time for short form across             large sample of individuals with TBI (e.g., >
    all domains is about 30 minutes). Being                 500). Future plans are to develop a
    designed so that Neuro-QOL and PROMIS                   computer adaptive test (CAT).
    equivalency scores can be extracted to allow
    cross study comparisons.




                                                                                                                                                                                                               2 of 2

								
To top