Clinical Trial: Sheffield Multiple Rib Fractures Study:

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Sheffield Multiple Rib Fractures Study: Evolution of Classification, Management and Outcomes

Brief Summary: An observational study to derive clinically relevant and predictive rib fracture classification systems, based on retrospective and prospective cohorts, incorporating assessment of PROMs (Patient Reported Outcome Measures) and healthcare utilisation

Detailed Summary: The aim of this study is to derive radiology-based classifications of rib fractures and to test whether such classifications have a value in the prediction of clinical outcomes and patient reported outcome measures. The first aspect of work is to analyse existing radiology investigations (plain chest radiography (CXR) and derive classifications of rib fractures that, in the retrospective cohort of operated and non-operated cases, could have potential value in the guidance of management and prediction of clinical outcomes. The second aspect will be to evaluate the feasibility of collection of Patient Reported Outcome Measures in patients suffering multiple rib fractures, which will be used to assess the impact of the radiological classifications. The indications for surgery will remain according to current clinical practice and the management algorithms that have been developed previously in the department.
Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Current Primary Outcome: Acute Pain [ Time Frame: up to 2 years ]

Visual Analogue Score


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Forced Expired Volume in 1 second (FEV1) [ Time Frame: up to 2 years ]
  • Forced Vital Capacity (FVC) [ Time Frame: up to 2 years ]
  • Length of critical care unit stay [ Time Frame: up to 1 year ]
  • Complications during critical care unit stay [ Time Frame: up to 1 year ]
    adverse events as assessed by CTCAE v4.0
  • Length of hospital stay [ Time Frame: up to 1 year ]
  • Complications during hospital stay [ Time Frame: up to 1 year ]
    adverse events as assessed by CTCAE v4.0
  • Quality of Life - SF36 (Short Form 36) [ Time Frame: up to 2 years ]
    SF-36
  • Quality of Life - EQ5D [ Time Frame: up to 2 years ]
    EuroQol Group EQ5D
  • Quality of Life - EORTC (European Organisation for the Research and Treatment of Cancer) QLQ-C30 (Quality of Life Questionnaire - Cancer-30) [ Time Frame: up to 2 years ]
    EORTC QLQ-C30
  • Quality of Life - EORTC QLQ-LC13 (Lung Cancer13) [ Time Frame: up to 2 years ]
    EORTC QLQ-LC13
  • Healthcare cost [ Time Frame: up to 2 years ]
    procedural costs plus hospital cost plus community healthcare costs


Original Secondary Outcome:

  • Forced Expired Volume in 1 second (FEV1) [ Time Frame: up to 2 years ]
  • Forced Vital Capacity (FVC) [ Time Frame: up to 2 years ]
  • Length of critical care unit stay [ Time Frame: up to 1 year ]
    in days
  • Complications during critical care unit stay [ Time Frame: up to 1 year ]
    adverse events as assessed by CTCAE v4.0
  • Length of hospital stay [ Time Frame: up to 1 year ]
    in days
  • Complications during hospital stay [ Time Frame: up to 1 year ]
    adverse events as assessed by CTCAE v4.0
  • Quality of Life - SF36 (Short Form 36) [ Time Frame: up to 2 years ]
    SF-36
  • Quality of Life - EQ5D [ Time Frame: up to 2 years ]
    EuroQol Group EQ5D
  • Quality of Life - EORTC (European Organisation for the Research and Treatment of Cancer) QLQ-C30 (Quality of Life Questionnaire - Cancer-30) [ Time Frame: up to 2 years ]
    EORTC QLQ-C30
  • Quality of Life - EORTC QLQ-LC13 (Lung Cancer13) [ Time Frame: up to 2 years ]
    EORTC QLQ-LC13
  • Healthcare cost [ Time Frame: up to 2 years ]
    procedural costs plus hospital cost plus community healthcare costs


Information By: Sheffield Teaching Hospitals NHS Foundation Trust

Dates:
Date Received: October 12, 2015
Date Started: October 2015
Date Completion: December 2017
Last Updated: October 13, 2016
Last Verified: October 2016