Streamlining Trauma Research Evaluation With Advanced Measurement
Condition: Orthopaedic Trauma
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      The STREAM Study is a prospective longitudinal observational outcomes study that will examine
      the reliability, validity and responsiveness of the PROMIS tools for clinical research
      following orthopaedic trauma.
    

Detailed description: 
      Objective: As part of the NIH Roadmap initiative, PROMIS (patient reported outcomes
      measurement information system) has developed tools, including item banks, short forms and
      computer-adaptive tests (CATs) that can help standardize measurement for many health-related
      quality of life domains. These PROMIS tools are being tested in large general population
      samples across the lifespan. The overall goal of the present study is to assess the
      performance and research utility of these new tools in new patient populations for future
      comparative effectiveness research projects. The proposed project will examine the
      reliability, validity and responsiveness of the PROMIS tools for clinical research following
      orthopaedic trauma.

      Specific Aim 1: Examine the measurement properties of existing PROMIS CATs and item banks in
      patients with orthopaedic trauma. Investigators will incorporate ten (six core and four
      exploratory) PROMIS short form and CATs into the longitudinal data collection of five ongoing
      orthopaedic trauma clinical trials and administer an expanded data collection interview at
      the time of their last study follow up which will be used to:

      1a: Evaluate reliability and construct validity of the PROMIS CATs

      1b: Compare measurement precision of the six existing item banks when applied in an
      orthopaedic trauma population versus the general population.

        1. c: Identify items from existing PROMIS item banks that function differently in our
           population compared with the general population.

           Specific Aim 2: Examine the responsiveness of existing PROMIS domains in patients with
           orthopaedic trauma. Specifically, investigators will:

        2. a: Examine the responsiveness of PROMIS domains against expected clinical recovery in
           this population.

      2b: Examine the responsiveness of PROMIS domains against well-defined clinical inflection
      points in the recovery process, such as infections, non-unions, flap failures, and other
      complications.

      2c: Examine the responsiveness of PROMIS domains against treatment effects observed for
      interventions being studied in these trials, which include a psychosocial intervention, a
      pharmacologic intervention, and a device. These trials are being evaluated using widely used
      traditional outcome measurement tools.

      Specific Aim 3: Study the integration of the PROMIS tools within the data collection
      infrastructure of METRC. Key feasibility components examined will be integration with our
      distributed electronic data capture system (REDCap), and use of the CAT technology across
      dozens of trauma centers and orthopaedic trauma clinics.

      3a. Compare the rate of use of CAT-based assessment versus short-form data collection 3b:
      Compare the data completeness using existing METRC approaches, CAT and short form PROMIS
      instruments 3c: Compare respondent burden using existing METRC approaches, CAT and short form
      PROMIS instruments.

      Study design: The STREAM study is a multi-center, prospective longitudinal observational
      study to evaluate the reliability, validity and responsiveness of PROMIS tools in orthopaedic
      trauma patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Orthopaedic trauma patients who are currently enrolled in the PAIN, FIXIT, OUTLET, OXYGEN,
        VANCO or TAOS METRC studies. These studies look at outcomes following injuries to the foot,
        ankle, tibia etc.
      
Keywords: Orthopaedic Trauma; Injury