DETAILED BACKGROUND INFORMATION

This section of the website gives very detailed information about the background behind the study, why it is needed, and some specific, scientific aims and hypotheses. We have included this section for other medical professionals who may want to learn more about the study, as well as patients and public who want to know the finer detail.

We have only included it for those who would like some more detailed information than we have provided in the information leaflets.

You do not need to read any further if you would prefer not to – the information leaflet has more than enough for you to make a decision on whether to take part or not.

 

 

1. Background and Rationale:

Major trauma’ is defined as patients having an injury severity score (ISS) of over 15, indicating an immediate threat to life. This score is calculated based a patient’s constellation of injuries to five body areas: Head/neck, face, chest, abdomen/pelvic contents, pelvic skeleton, external injuries. For each area there is an Abbreviated Injury Score (AIS) of 1-6. The values for the three most badly injured areas are squared, to produce an ISS from 1-75, with a score of 75 being considered incompatible with life. Fatal injuries are automatically given an ISS value of 75. (1-6)

The management of patients with multiple injuries can be challenging with often unpredictable outcomes. To attempt to standardise care across the country and improve outcomes, in 2010 the UK government introduced the development of Major Trauma Centres (MTC’s) and local Major Trauma Networks. (6, 7) A recent report published evaluating the performance of this service highlighted significant improvements in both the care process and outcomes of patients after severe injury following its development (8).

While it appears that we are saving lives, reports referring to the outcomes of our interventions in this cohort of patients with life changing injuries remain relatively obscure. In all areas of medicine and surgery, there has been increasing recognition of the importance of patient reported outcomes (PROMs) and patients becoming more involved in their own care and management decisions, which increased following the Darzi report in 2008 which recommended that PROMs should be a routine part of healthcare evaluation. (9-13)

Functional outcome’ is a broad term which can be categorised in different ways; the World Health Organisation’s International Classification of Function, Disability and Health (ICF) is an internationally recognised system which includes 1400 different “health concepts” representing the whole spectrum of normal functions which might be affected by injury or disease. ICF categories are broadly divided into: body functions and structures, activities and participation, and environmental facilitators or barriers (14). These factors broadly affect a patient’s quality of life (QoL); the 1991 Meran Consensus Conference on QoL after surgery recommended four main domains which QoL should be viewed through are: physical state, psychological wellbeing, social relations, and functional capacity. (15) The 1999 “QoL after Multiple Trauma” conference, concluded that any evaluation of QoL must include a brief index measurement with the Euroqol measure, as well as a widely accepted generic QoL tool such as the Short Form-36 (SF-36) measure. At this time, a disease specific “trauma module” measure was lacking. The ‘Trauma Outcome Profile’ was developed in Germany in response to this in 2001 and has recently been formally validated. It covers a wide spectrum of ICF categories, but by its nature in being a general tool it lacks detail in certain important areas. (14-17)

In the last ten years there have been various publications into patient reported outcome measures in trauma, most notably from Germany. (14, 15, 18-23) These studies assessed populations with a different demographic make-up, cultural and societal influences to those living in Britain, from a different healthcare setting.

In the UK however, other than Spreadborough et al (2017) who looked at 99 patients with moderate (ISS 9-15, 45%) to severe (ISS>15, 55%) injuries at 1-3 years after injury, there have been limited studies looking at functional outcomes in large numbers of major trauma patients. (14, 24-26) To the best of our knowledge, and when performing a systematic search protocol of Pubmed and Embase databases, there has been almost no focussed work done on a large scale looking at functional outcomes following major trauma (ISS >15) in the UK, and no studies assessing this beyond 5 years after injury.

We therefore intend to fill the knowledge gap in the UK on functional outcomes after major trauma, assessing functional outcomes using Patient Reported Outcome Measure forms (PROM’s).

As previously indicated, there has been a significant change in trauma care in the UK following introduction of Major Trauma Networks. The Leeds Major Trauma Centre was opened in 2013, and has been running successfully since then, acting as the hub for the West Yorkshire Trauma Network. The photograph of the team on the helipad was taken in 2018, 5 years after the opening of the Major Trauma Centre. This presents us with a unique opportunity to investigate a multitude of factors.

We will be able to investigate how the nature of trauma changed since becoming a major trauma centre, how this affects the spectrum of injuries and how this relates to functional outcome, as well as investigating the changing needs of patients throughout their journey, and service evaluation and improvement. As we have managed a large number of patients with major trauma over the last 10 years, we have a large clinical database on which to draw for a retrospective cohort, as well as the large number of patients who will attend prospectively for a prospective cohort. In a relatively short time, we will be able to collect an almost-longitudinal picture of functional outcome in a UK MTC population over this time, which should be relevant to other centres, and therefore useful information and potential learning points for the UK Trauma Network as a whole.

 

 

2. Aims and Objectives

The primary aim of this project will be to assess the impact of major trauma, especially polytrauma, on the physical aspect of functional outcome, the change over time and trends in this data, assessed by the physical component score (PCS) of the SF-36 as our primary outcome measure.

Physical function data will also be collected using the TOP, EQ-5D, and Leeds Trauma Questionnaire, which will be secondary outcome measures.

Retrospectively, we will aim to assess the outcomes of patients between 1 to 10 years after major trauma (ISS>15) but excluding isolated head trauma. Prospectively, we will assess the same group of patients who are admitted over a 12 month period, and follow them up for 12 months.

Secondary aims will include:

  1. Assessing other domains of functional outcome (psychological wellbeing and mental function, social relations, and functional capacity) and quality of life of patients following discharge from hospital, and factors which influence this. This will be measured using ‘patient reported outcome measures’ (PROMs) data, and the change in PROMs values in both prospective and retrospective cohorts.

  2. Assessing how trauma affects people’s ability to work, which will be assessed using a targeted questionnaire as well as responses to the general questionnaires used.

  3. How trauma affects patients’ social, mobility, and care situation, which will be assessed using a targeted questionnaire.

  4. Assessing the personal impact of trauma on the patient – how it has affected their lives most in various ways, and also assessing the changing needs of patients as they progress through their journey, their access to services, and opinions on how well the service we offer works for them. We will do this using a targeted qualitative questionnaire, and formal interviews in person or over the telephone/video link. This will allow for a powerful systematic analysis which will guide us to improve what we can offer to patients and reinforce the quality of care we deliver.

  5. Assessing clinical progress following trauma, and how this correlates with functional outcomes, using health records and imaging systems.

  6. Feasibility study: We will also investigate the feasibility of measuring functional outcome and QOL in routine care and develop a tool kit for implementation, with the ultimate aim of facilitating regular functional outcome assessment and service evaluation as an integrated part of routine care offered at the Leeds MTC, which presents an exciting opportunity for a permanent positive change, and room for ongoing audit cycle, with a reliable mechanism for measurement.

 

The FIT Study will consist of 2 phases:

Phase 1 will last for 2 years (+ 3 months) in total (12 months for prospective study cohort recruitment and 12 months follow-up, including tolerance of 3 months for these patients) during which time data will be collected from the retrospective cohort as well. Following this there will be a full analysis of the data, after which new enrolment into phase 2 of the FIT Study will begin – 3 months after phase 1 ends. Patients enrolled into phase 1 of the study will be given the option of consenting to being contacted annually to complete a similar set of online PROMs, which will comprise phase 2 of the study. We will also continue active recruitment into the prospective arm of the study in phase 2.

We plan to continue data collection on an annual basis up to 10 years post trauma in phase 2 of the study for patients until 2032. We hope to incorporate elements of the FIT Study into future routine care with what we learn from the FIT Study, and develop our own unique Patient Reported Outcome Measure tool, with the overall aim of improving patient care and outcomes. This will allow for a large-scale cohort study following phase 2 of how well patients function after major trauma and what influences this, which has never been done in the UK before.

 

 

3. Hypotheses

3.1 Hypotheses

We hypothesise that physical function, as assessed by the Physical Component Score of the SF-36 PROM will continue to improve until 2 years, where we will see a significant difference in outcomes between groups, and then begin to plateau to a steadier level.

We also hypothesise that the most rapid improvement will be in the first year following major trauma.

3.2. Null hypotheses:

The Physical Component Score of the SF-36 PROM will remain unchanged over time.

Any change seen in the SF-36 physical component score will be the same across all timepoints.

 

 

4. Study design and Description Summary

We will carry out a multi-faceted, mixed methods research study looking at functional outcome of major trauma patients in a UK MTC setting, with retrospective and prospective cohorts.

It will be called the Functional outcomes In Trauma (FIT) Study.

The FIT study is designed to capture a meaningful cohort of patients and allow for strong inter and intra group comparison for quantitative and qualitative data concerning physical functioning (primary outcome: SF-36 PCS) and global functional outcomes after trauma (secondary outcomes); we will use a number of validated Patient Reported Outcome Measures (PROMs), as well as assessing the changing needs of patients, and factors influencing the ongoing functional outcomes at specific timepoints following trauma (prospectively for 12 months, and retrospectively from 1-10 years), along with an incorporated feasibility study to assess which of our measures would be best to use and how best to make a useable ePROMS tool for future practice. See methods section for full details.

We have taken care to choose PROMs relevant to our patient demographic and injury profile, and been careful to keep repetition of questions to a minimum. However, the nature of widely used PROMs measures which have been validated in large populations in order to obtain normative values, means that this will be inevitable. There will be some element of overlap between outcome measures. Patients have been consulted throughout the design phase.

By using these validated forms however, we can be confident that our statistical outcomes are more robust, helping to avoid errors. By incorporating a feasibility study we will learn what matters most to a large patient demographic and refine this further.

Another important factor in the choice of PROMs measures chosen is that they can all be completed autonomously by the patient and require no personal assessment or guidance of a clinical team member. This will allow for a much larger data capture and applicability to potential future embedding in an automated system. We have taken patient views into account during several focus groups, and modified the questionnaires accordingly.

We will also be assessing the suitability of an ePROMs platform to be used in routine practice, and will ask patients’ opinions on which ePROMs methods work best for them, and how usable the ePROMs system would be, using 10 point visual analogue scales (opinions on relevance and ease of use of PROMs) and interviewing 5-10 patients from each cohort to ask their opinions on the PROMs measures chosen and the study in general (At least 5 from retrospective and 5 from prospective cohorts).

There was a preference in the focus groups we held for online data capture rather than paper forms, which patients saw as less physically demanding and burdensome. We have therefore decided to use a system called QTool, developed by the University of Leeds, to collect our data. The consent process will also be completed using this system. QTool has been extensively used and tested already as a research tool and found to be robust (10, 27-30). For patients unable to complete this themselves if they are physically incapacitated, we will enable a proxy to do so on their behalf; this was discussed as part of the focus group with a positive response.

Following the data collection, we will analyse the results of both quantitative and qualitative parts of the study and aim to view the quantitative results in the context of the qualitative results which will help us understand cause and effect in a more profound way, or “mixed methods” research. We also hope our study will allow us to produce predictive modelling of what PROMs scores really mean for patients’ functional outcomes after major trauma. We will also have a deeper understanding of which PROMs measures are most suitable for our patient population which will allow us to streamline PROMs we use in future practice.

 

 

 

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