Streamlining Trauma Research Evaluation With Advanced Measurement

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.

Any patient participating in the FIXIT, OUTLET, TAOS, OXYGEN, VANCO or Pain studies
returning for a 3 month follow-up visit is eligible for participation in the proposed
STREAM study. Respondents who are unable to give informed consent (or would require a
proxy) at the time of the 3 month visit will be excluded.