跳至主要内容
临床试验/NCT02079714
NCT02079714已完成不适用

Streamlining Trauma Research Evaluation With Advanced Measurement: STREAM Study

Major Extremity Trauma Research Consortium44 个研究点 分布在 1 个国家目标入组 1,065 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,065
试验地点
44
主要终点
Reliability and Validity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Reliability and Validity

时间窗: 9 months

The primary endpoint for this study is the reliability and construct validity of the PROMIS CAT instruments.

次要结局

  • Responsiveness(9 months)
  • Participant Burden(9 months)
  • Data Completion(9 months)

研究者

发起方
Major Extremity Trauma Research Consortium
申办方类型
Other
责任方
Sponsor

研究点 (44)

Loading locations...

相似试验