

Functional outcomes In Trauma Study
HOW TO USE QTOOL:
Please take a look at the video below, which explains how to use QTool. If you lose your place, we have provided some ‘time-stamps’ below it – so you can easily find the information on the bits you need.
We show you how to start the questionnaires, and enter your information into QTool, and how to fill in all of the information if you forgot first time or didn’t get around to it.
As you will see, it is quick and easy to get up and running! If you have questions on how to do this, please feel free to get in touch using the ‘contact info’ at the bottom of the page.
When you have watched the video, simply click on the Purple Button above or the QTOOL Logo to bring you to the QTool page, so you can complete the questionnaires.
Video Timestamps (Running Order) … skip to these points to view what you prefer:
00:40 minutes – Logon and setup
01:10 minutes – Getting Started: Entering password/email/phone contact details
03:00 minutes – Finding Written Information
03:30 minutes – The consent form
05:28 minutes – EQ5D
07:00 minutes – SF36
09:20 minutes – HADS
09:35 minutes – TOP
11:15 minutes – Leeds Trauma Questionnaire
12:10 minutes – “The system did not recognise your answers. Please check and try again” – How to avoid missing answers.
13:15 minutes – Background Questionnaire
14:45 minutes – How to complete a questionnaire after taking a break (logging back on)
What is the FIT Study?
The Functional outcomes In Trauma study is a questionnaire-based research study, which aims to see how well patients recover following Major Trauma (Serious Injuries) according to their answers on the questionnaires.
We will be using an ONLINE Questionnaire program, designed by the University of Leeds, called QTOOL to gather the information.
Please see below for more about the Study Background, Study Design, and to view Participant Information Sheets for the different cohorts.
There are also some videos below on this page if you’d like to learn more about the Study!

Detailed Scientific Study Background and Design
Why is the FIT Study Needed? We provide a lot of detail for those who are interested to learn more before taking part, but you do not need to read this unless you feel like it. There is plenty of information in the leaflet we have sent you.

Study Design
& Patient involvement
How have we designed the FIT Study? Here is a dedicated page, but you may find it easier to click on the videos in the section below on this page...

Study Participant Information Sheets
Further information on how we will run the study. Please find a copy of the information sheets which have been sent to potential study participants here.
STUDY DESIGN - PATIENT INVOLVEMENT
From the very beginning, patients have been involved in the design of the FIT Study – from how we contact patients to which questionnaires are used in the study.
Some of those who have helped us talk about the study in the videos below…
Meet Our Team
The primary Investigators…

Prof Peter Giannoudis
CHIEF INVESTIGATOR

Mr Paul Andrzejowski
PRINCIPAL INVESTIGATOR
The Full Senior Supervisory Team…

Mr Nik Kanakaris
Clinical Lead for Major Trauma (Major Trauma Consultant)

Mr Paul Harwood
Major Trauma Consultant, Leeds Major Trauma Centre

Dr Trish Holch
Senior Lecturer in Psychology,
Leeds Beckett University
(Hon Research Fellow University of Leeds)

Prof Robert West
Professor of Biostatistics, University of Leeds
The Support Team…

Sr Bernadette Cook
Senior Research Nurse
INTRODUCTION FROM PROF GIANNOUDIS
Professor Giannoudis is the Chief Investigator of the FIT Study, speaking here to invite you to take part and explain in detail what the FIT Study will involve…
FIT Study Timeline...
Here’s a summary of what the FIT Study team has done so far, and where we are going…
PILOT PHASE:
Since December 2018, the research team has been hard at work designing the FIT Study, and setting up everything in the background
We have had a lot of help from previous and current patients to make sure that the FIT Study is relevant, and easy to complete
We have obtained approval from a Research Ethics Committee to make sure that the FIT Study meets NHS Standards for Research
PHASE 1 Recruitment:
We will be starting RECRUITMENT into the study in 2020
We will be inviting a selection of patients who sustained Major Trauma between 1-10 years ago to take part in the Retrospective Cohort (Group) and this will continue until 2022.
We will also invite all patients who sustain Major Trauma over the next year to take part in the Prospective Cohort (Group), until 2021.
END OF PHASE 1 – Analysis:
We will analyse all of the data (information) we have learnt from Phase 1 of the FIT Study, and write this up in a scientific journal, in a way so that nobody can be identified, and use this information to see if any changes are needed before we begin Phase 2…
PHASE 2 RECRUITMENT:
We will leave at least 6 months between Phase 1 and beginning Phase 2, so that we can apply any lessons learnt along the way to Phase 2 of the project.
Phase 2 will be using similar questionnaires to Phase 1, but probably with a few changes.
As part of Phase 2, we will be hoping to design a NEW Questionnaire (Patient Reported Outcome Measure) specific to UK-Based Major Trauma patients which we can use in the future to help assess how well patients are recovering following their injuries.
For Phase 2, all patients who already took part in Phase 1 will be automatically invited to take part, and we will carry on recruiting new patients going forwards in time until 2031, and following up all patients until 2032
PHASE 2 Analysis:
For at least 2 years following the end of Phase 2, we will be analysing all of the data (information) we have gathered, and will aim to design an App for a phone/tablet device which will be able to predict how well patients recover following different injuries, and what affects how well they do