PARTICIPANT INFORMATION SHEET: Prospective Cohort (Group) Phase 1

On behalf of the Leeds Major Trauma Centre, we would like to invite you to take part in the Functional outcomes In Trauma (FIT) Study, an online research study being conducted at Leeds Teaching Hospitals where you received medical care following major trauma. Please visit the QTool website  to learn more, and take part using the login details provided in your formal invitation letter now if you wish.

The FIT Study will be focused around how well you manage to get back to daily life and work following major trauma, and how well you are doing physically, socially, emotionally and psychologically.

We are also interested in hearing first-hand accounts of your experience at Leeds as an in-patient, and as well as your rehabilitation and outpatient experience, or further surgery following your injuries: we call these “functional outcomes”. We are particularly interested in what your main issues and needs were following your initial injury, how they have changed over time, and what advice you could offer to others.

We currently don’t know the detailed answers to these questions on a large scale in patients with major trauma in the UK. This type of study is an exciting new way to really understand how people cope after they have left hospital across a wide range of areas. We have involved patients heavily in the study design, to make it as relevant as possible. You can be part of the FIT Study too, and help improve care for other people in your position, as well as helping your doctors understand more about you.

In the first part of the study (phase 1), we are including patients who sustained their injury between one and ten years ago in one group (retrospective cohort, or group), and all patients who would require hospital care for their injuries over the next year in another group (prospective cohort, or group). You will be in the prospective group. In the second part of the study (phase 2), we will follow everyone up, including new patients as well as those from phase 1, going forwards in time (prospectively) until 10 years after their injuries – the exact dates for this will be different for each person. Phase 2 of the study will finish altogether in 2032. We will check what you are happy with this when you confirm it on a consent form.

We will gather all information from questionnaires using an internet based ‘online’ service developed in Leeds, called ‘QTool’ – your login details are included in your invitation pack so you can begin straight away if you wish! There is nothing to post back to us. Try to use a device with a large enough screen to read a page of questions. If we notice you haven’t logged on after 2 weeks, we will call you to make sure that everything is alright or if you need any help with getting set up. If you would prefer not to be contacted further, that is absolutely no problem – please find the details enclosed of how to let us know this.

A small group will be chosen at random and invited to an interview, to ask you more questions about the study in detail and how you felt about things, as well as further questions about what areas of your accident have affected you most. This is optional, in addition to the main study, and you don’t have to take part in this if you would prefer not to. If chosen, we will send you some further information about it later.

The information we gather from this study will significantly improve our knowledge and understanding of how well people do after trauma, help us to learn what your most important problems are, and whether we need to improve any aspects of the services we offer for future patients.

1. Information about your invitation, study website, and QTool:

You are being invited to take part in a research study. Before you decide whether or not to take part, it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully, and discuss it with others if you wish. Please also see the website for further videos to explain.

If after considering the information, you are happy to take part, then you can to do this straight away, by using an internet based ‘online’ service developed in Leeds called ‘Qtool’ – (Click here to go to the QTool Website)

… when you are on the QTool page, use the login information we have provided in your invitation letter.

If anything is not clear, feel free to get in touch, or wait until we call you. Take time to decide whether or not you wish to take part. If you do not wish to take part in the study or be contacted further, please let us know directly, using the contact details provided in section 18 below, either by phone, email or letter. If we have not heard from you in 2 weeks from the date of your invitation letter, we will assume that you are happy to take part and may contact you further. We have sent this information leaflet so that if/when we call, it does not come as a surprise to you.

2. Why have I been invited?

You have been invited to take part because you sustained major trauma between one and ten years ago, and we hope you will be happy to join the “retrospective” group (where we ask people who have had trauma in the past). We are keen to learn more about functional outcomes of patients in a similar situation to you after they have been discharged from hospital.

We have used our hospital information systems and reviewed your health records to make sure that you are eligible (i.e. meet the criteria) to be part of the study. We will also be recording information on your clinical progress as we go through the study so we can link this to your answers from the questionnaires you fill out.

To be eligible for the study, there are various criteria (conditions) that you must meet. These include having “capacity” to take part – which means that you can take in and understand the information and questions, remember the information long enough to weigh up options, make a decision or reply, and communicate that decision – you can either take part using the online questionnaire yourself, or get someone to help and do this on your behalf (a “proxy”). If you have had significant brain injury or developed serious problems with your memory such as dementia, this may affect your capacity and ability to take part. We don’t think that you should be affected by this from the records we have seen, but would like to confirm this as part of the study questionnaires. If you have any questions about this, please get in touch and we will be happy to help. See section 18 on page 8 for contact information.

3. Do I have to take part?

No – it is up to you to decide whether or not to take part. We have sent you this information sheet so that you can make an informed decision on whether you would like to join the study. If you are happy to be part of the study, you will have to confirm you are happy with everything by signing a consent form. The consent form is completed online using the QTool website. If you would prefer not to be contacted further, that is absolutely no problem: please let us know using the contact details in section 18. See section 1: how to access QTool.

If you decide to take part, or would prefer just to be involved in phase 1, you are free to leave the study at any time and without giving a reason. If you withdraw, we will still keep records relating to the answers you have provided for the study and your treatment, as this is valuable to the study. A decision to withdraw at any time or a decision not to take part will not affect the quality of care you receive in any way. To notify us of this, please use the contact details in section 18.

You can withdraw from the study at any time until 2032 when the final phase of the study ends and the care you receive will not be affected. If you withdraw, the information we have collected up until that point will remain on file and will be included in the final study analysis.

You have 2 options for what happens if you want to leave the study:

1. You can withdraw consent for us collecting ALL new information from both you and your medical records from that date going forwards. This is “full” withdrawal.
2. Alternatively, if you are happy for us to collect new information from your medical records without asking you for any information directly, we will be able to do this. This is “partial” withdrawal.

4. How do I take part?

After reading this information, you are free to begin anytime from now until 12 months away. We will gather all information for the study from online questionnaires using the ‘QTool’ website. See section 1. There is nothing you need to post back to us. If we haven’t heard from you after 14 days we will call at some point to make sure that everything is alright or whether you need any help with getting set up.

We advise you to use something with a large screen like a tablet/ipad or laptop/desktop computer rather than a phone to make it easier; an internet connected/smart phone will work if you don’t have access to a computer but will be more difficult to read. If you are struggling to complete the questionnaires because you can’t get to a computer or ipad/tablet, most public libraries have freely available computers, or we can also help you complete it at the hospital with our study laptop if you get in touch with us: see section 18 on page 8 for contact information.

5. What if I can’t use a computer, or have trouble understanding some of the questions?  USE OF A PROXY:

If you aren’t able to use a computer because of your injuries or disabilities, or have trouble understanding some of the questions and need a bit of help, you can ask someone to do this on your behalf: This is called using a ‘Proxy’…

If you want to use a proxy (another person to answer on your behalf), they will have to provide their contact information to us and document this on the online system. The proxy and yourself will have to agree to be telephoned by the research team, to make sure that you have agreed to this, and are not under any pressure from anyone to take part. We want to make sure that you are happy to be part of the study and doing so freely.

The proxy’s role is to help you to fill out the questions, which may involve some explanation and guiding you through, but they must make sure that they answer the questions exactly as you want them to, and not how they think you should be answering them. This study is aiming to find out your honest opinions and not those of others, so we will be calling up to check the questionnaire replies are a true reflection of how you feel. You must be sat together whilst completing the questions, and you must be able to see the questionnaires yourself on the computer or tablet if you have good enough vision to do so; if not then all of the text must be read out to you.

We are very grateful to anyone who would like to help both you and us, and welcome anyone who would like to do so. This will mean you can still take part in the study even if you have some difficulties. If someone who is acting as a Proxy would like to get in touch with us directly using the details below, we would be more than happy to help with this, and would be happy to send them a separate information sheet should they wish.

We have also provided information just for Proxies directly at the end of this information leaflet.

6. What questionnaires are included in the study?

We would like you to complete the following questionnaires, to give us a really good idea of how you are doing, and how you compare to others. We will ask you to fill these out every 3 months for the first year, then once per year after that depending how much time has passed.

We have involved previous major trauma patients in the design of the study and selection of questionnaires, to make sure that they’re as relevant as possible. There is more information, and some videos to explain further on the website.

1. Patient Reported Outcome Measure (PROM) questionnaires

These are widely used questionnaires, and we will be able to compare our results with other studies to understand the relevance of your answers in the wider context. There are some questions which are similar, but it is important that they are all completed to allow comparison with other studies.

1. EQ-5D (EuroQol 5 Dimension) – This is a very short questionnaire, designed to investigate 5 broad areas (mobility, self-care, usual activities, pain/discomfort, mood) and a scale to say how well you are feeling from 0-100. It is very easy to complete and gives a good ‘snapshot’.

2. SF-36 (36 item health survey) – This is a slightly longer questionnaire, which looks at 8 areas (physical functioning, role limitations due to physical and emotional problems, bodily pain, social functioning, general mental health, vitality, general health perceptions).

This is our main questionnaire, and the most important one for you to complete!

3. HADS (Hospital Anxiety and Depression Scale) – This is a very quick questionnaire to tell us about your mood and will allow us to get a good idea of how you are feeling about things.

4. TOP (Trauma Outcomes Profile) – This is a slightly longer questionnaire, which is designed specifically to look at people who have undergone trauma. It goes into detail about which body areas hurt and affect you most on a scale of 1-10, and also asks about other areas, including your daily activities. We have also included a few extra questions which ask about sleep. Together with the other general questionnaires, this will provide really useful information about what is most important to you.

5. Leeds Trauma Questionnaire – This is your chance to really tell us how your trauma and injuries have affected you. We have included Leeds patients in the development of these questions to make sure that we cover aspects which are most important to you.

6. Background information – We will ask about how your injury may have affected the type of work you are able to do. We will also collect some information about your social and care circumstances, and link this to demographic information we have about you such as age, gender and where you live. This should help provide a full picture, as these things have been shown elsewhere to affect how well people do after trauma.

 As mentioned above, we will also collect information ourselves about your clinical background and progress by using your medical notes and health records, including imaging such as XRays and scans. We are doing this so we can link your answers on the questionnaires to your medical background.

7. What are the Benefits of taking part?

By taking part in this study you are really helping us to understand what matters most to patients who experience Major Trauma. You will have a very important role to play in telling us what is most important to focus on. You will also help us understand how your injuries have affected all areas of your life.

By completing these questionnaires along with other people, when we put all of the different replies together we will be able to see how things are on a large scale – what type of patients do well and less well, and what sort of things we can do to improve to care for people even better in the future. For example, what to change and if extra services are needed, to improve patient care. The FIT Study will be something big and exciting – the first of its scope in the country!

With the results we get from the study, we will also be able to make a better version of these questionnaires which all new patients will be able to complete as part of their normal care with their doctors in their outpatient appointments. This might not benefit you directly straight away, but might be very useful for you and others the future.

8. How Long will it take to complete the questionnaires?

We have tested these questionnaires using patients and members of the research team, and we estimate that it will only take 10 minutes to complete the first 2 questionnaires (the most important ones) and another 20-30 minutes for the rest, and you can have a tea-break in between. We understand this might sound quite long, but by learning from your responses, we will improve our understanding of how well you’re doing, and how to improve care for patients.

9. What should I do if I have any concerns about my physical or mental health, or if safeguarding issues come to light when taking part?

If you have any concerns when taking part, or the questionnaires bring up any bad memories, or highlight any concerns to your welfare or safeguarding issues, we recommend asking for some help from the appropriate team or your GP. In rare cases, there may be issues which raise concern with your welfare, such as abuse in any area of your life (known as safeguarding concerns). If you tell us about these, or we notice anything which worries us when analysing the results months or years later, we will have to raise these with the chief investigator Professor Giannoudis, and potentially your GP, hospital safeguarding teams, your major trauma consultant or social services as well, to make sure that we can act in your best interests. We have a strict protocol at Leeds Teaching Hospitals for how we need to act in such cases, which we will need to follow and would include the above. This is to make sure that we address and resolve the issues raised. We aim to keep you as involved as possible throughout the process and support you as much as possible, as your welfare is our main priority in everything we do.

The questionnaires are for research ONLY, and not clinical care. Your replies will not be reviewed until a long time: up to several months or years, after you have completed them. The research team will not be held liable for any harm which may come to your mental or physical health, safety or welfare whilst you are part of the study.

We will NOT be able to react quickly to any emergency or urgent medical or safeguarding problem.

• If you are having serious problems or concerns with Mental Health or Mood: PLEASE CALL NHS 111 immediately – You will be able to speak to someone at NHS 111 who will alert the nearest Mental Health Crisis Team to help you with the situation. This is your responsibility.
• If you have any concerns with your safeguarding or welfare, we would ask you to please discuss these with Adult Social Care (see below) or your GP in the first instance. This is your responsibility.

For safeguarding/welfare concerns: Adult Social Care: 0113 222 4401 on weekdays between 8.30am – 5pm,

or the Emergency Duty Social Care team (out of hours/weekends): 0113 240 9536

More information on this can be found at: www.leedssafeguardingadults.org.uk

You can also attend your closest hospital Emergency Department, and in emergency cases call 999.

In non-emergency situations:

If you are still under regular follow-up from one of the Trauma and Orthopaedic surgery consultant teams at Leeds Teaching Hospitals: We will be able to arrange referral to the clinical psychology service on a non-urgent basis if you ask us. This is not available if you have been discharged from regular follow-up.

If you are no longer under regular orthopaedic follow-up: We recommend you talk with your GP (General Practitioner or Family Doctor) to discuss any problems you may be having. Your GP will be able to refer you to the right team to help with your problem. We will not be able to refer you to any service or other team. We will not be able to review you in clinic ourselves directly unless your GP refers you to us again either.

Please note that if you are under regular orthopaedic follow up and have any orthopaedic physical health complaints which you feel need to be seen before your next clinic appointment, please contact your orthopaedic consultant’s secretary through the hospital switchboard (Tel: 0113 2432799), or your GP.

10. What happens when the research study stops?

The research study will be finished when the last recruited participant in the prospective group completes his/her final (12 month) follow up visit. This will likely be in 2032 for phase 2. At this point, the data collected will be analysed and results will be presented to the academic community. We will keep your personally identifiable information until 1 December 2034 for analysis. The data may also be used at any point as part of an ongoing research project, and in designing a future set of questionnaires similar to the ones you have completed.

11. What if there is a problem with the study itself?

If you have a concern about any aspect of this study itself, you should speak with the research team who will do their best to answer your question: see below. If you remain unhappy and wish to complain formally, you can do this through the NHS Complaints Procedure – details can be obtained from the hospital.

If either we have any concerns ourselves about the study, or the sponsor who supervises the study has any concerns, we reserve the right to suspend or terminate the study at any point after discussion between the investigators and sponsor. If this happens, then we will also inform you in writing along with an explanation.

12. Will my part in this study be kept confidential?

If you consent to take part in this study, the records obtained while you are in this study, as well as related health records will remain strictly confidential at all times. Your name will not be passed to anyone else outside the research team or the sponsor, who is not involved in the study. You will be allocated a study number, which will be used as a code to identify you on all study forms. Your records will be available to people authorised to work on the study for its duration, and may also need to be made available to people authorised by the Leeds Teaching Hospitals NHS Trust (the research sponsor) – this is the organisation responsible for ensuring that the study is carried out correctly. By signing the consent form you agree to this access for the current study and any further research that may be conducted in relation to it, even if you withdraw from the current study.

The information collected about you may also be shown to authorised people from the UK Regulatory Authority. This is to ensure that the study is carried out to the highest possible scientific standards. All health professionals involved in this study will have a duty of confidentiality to you as a research participant.

In line with Good Clinical Practice guidelines, your data will be securely archived at the end of the study, currently planned for 1 December 2034. After this any information which can identify you will be destroyed, and we will only keep anonymised information through which you will not be able to be identified. We will store this information on secure computers (including personal/hospital/university: laptop, desktop and networked computers) on a secure system behind a firewall. We will make this clear on the consent form so that you can agree you are happy with this.

13. What is GDPR and What will happen to my data (information) in the study?

GDPR (General Data Protection Regulation) 2018 rules govern how we can use your data, and what information we need to provide you before you agree to take part in a research study.

In this research study we will use information from you, your medical records, and possibly information from your GP. We will only use information that we need for the research study. We will let very few people know your name or contact details, and only if they really need it for this study.

Everyone involved in this study will keep your data safe and secure. We will also follow all privacy rules. 

At the end of the study we will save some of the data in case we need to check it, and/or for future research. We will make sure no-one can work out who you are from the reports we write.

The information below tells you more about this.

How will we use information about you? 

We will need to use information from you, from your medical records, and possibly your GP for this research project. This information will include your initials/ NHS number/name/date of birth/contact details/address. The Sponsor (Leeds Teaching Hospitals NHS Trust) will hold this information in a secure location, and it will be available for use by the research team, who will ensure that any of your personal information is securely stored and accessed. We will do our best to keep all information about you safe and secure. People will use this information to do the research or to check your records to make sure that the research is being done properly. People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead. If any of your information is sent to another country or team of researchers in the future, they must follow our rules about keeping your information safe. Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.

What are your choices about how your information is used?

• You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have. 
• If you choose to stop taking part in the study, we would like to continue collecting information about your health from [central NHS records/ your hospital/ your GP]. If you do not want this to happen, tell us and we will stop.
• We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you. 

If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study.

Where can you find out more about how your information is used?

You can find out more about how we use your information:

• at hra.nhs.uk/information-about-patients/
• by asking one of the research team
• by sending an email to fitstudy@outlook.com, or 
• by ringing us on 0113 392 2334, asking to speak to our research nurse Bernadette Cook.

14. Informing your General Practitioner (GP)

We recommend that you inform your GP of any problems with your physical or mental health, or welfare/safeguarding, which come to light during the study. We will usually write to your GP as well, to inform them that you are taking part in this study or to pass on any concerns of any nature which arise during the study.

15. What will happen to the results of this study?

The results of the study will be available after it finishes and will usually be published in a medical journal or be presented at a scientific conference. The data will be anonymous and none of the participants involved in the study will be identified in any report or publication. We will also display them on the study website (www.fitstudy.org), and send them to you on request.

16. Who is organising and funding this study?

The study is being organised by Leeds Teaching Hospitals NHS Trust in collaboration with the University of Leeds. It is being funded by a charity which aims to advance science and understanding in healthcare to improve patient outcomes, DayOne Trauma (Leeds Cares). The ‘sponsor’ of the study, who supervises it and makes sure that everything is done properly is Leeds Teaching Hospitals NHS Trust.

17. Who has reviewed the study?

This study was given favourable ethical opinion for conduct in the NHS by the West Yorkshire Research Ethics Committee.

18. Contact for further information

You are encouraged to ask any questions you wish, before, during or after you take part in the study. If you have any questions about the study, please contact us using the details provided.

• Tel: FIT Study Research Nurse: Bernadette Cook (0113 392 2334)
• Email: fitstudy@outlook.com. This email account will be checked once each working day.
• Post: FIT Study: FAO Prof Giannoudis, D Floor Clarendon Wing, Leeds General Infirmary, LS1 3EX.

Alternatively, if you or your relatives have any questions about this study, you may wish to contact one of the following organisations that are independent of the hospital at which you are being treated:

• The Patient Advice and Liaison Service, (known as PALS). This has been introduced to ensure that the NHS listens to patients, their relatives, carers and friends, and answers their questions and resolves their concerns as quickly as possible. For comments, suggestions or questions, please contact the local Patient Advice & Liaison Service (PALS) on tel: (0113) 206 7168.
• Patient Relations Department Should you wish to complain about any aspect of your care, please contact the Patient Relations Department on tel: (0113) 206 6261.

19. How might I be contacted?

As discussed above, we will contact you initially by either post or telephone. If you are happy to take part in the study then we will ask for permission to contact you by SMS text message, email, phone or post again.

This would only be in relation to either the FIT Study or related research run by our team, such as asking you to complete questionnaires you might not have got round to yet, or asking if you would like to take part in any further research projects.

INFORMATION SHEET FOR PROXIES

Firstly, we would like to thank you for considering acting as a ‘proxy’ in this study, as without your help we wouldn’t be able to get the information we need, so you are making a very valuable contribution!

Please read the whole of the participant information sheet for the ‘primary participants’ (major trauma patients) to get an idea of what the whole study is about, as well as this extra information below.

When might I be asked to act as a Proxy for a ‘primary’ participant?

We have given the primary participants the opportunity to ask someone else to fill out the online forms on their behalf to allow them to take part if they have trouble doing it themselves. This may be due to physical disability, difficulty using computers/internet, or poor access to the internet. This is where you would come in, and act on their behalf as a ‘proxy’ alongside them, which technically also makes you a research participant too. This is the reason why we will also ask you to complete a consent form as part of the study.

What would my role be as a Proxy?

Your role would be to complete the questionnaire WITH the primary participant. The primary participant would need to be next to you as you completed the online forms, and be able to see/hear everything which you were doing as you completed the form. You must complete the forms exactly as the primary participant asks you to, and they must be happy that information you have provided reflects what they have said and how they feel. You can help them by explaining what the question is asking, and guide them through the questionnaire, but must not direct their responses. It is important that we get an honest, truthful account of how the primary participant has been affected, in their own words. If they cannot understand the questions despite simple guiding/explanation, then they probably do not have ‘capacity’ to take part, and if so you must tell us about this as they will not be able to take part in the study further if this is confirmed.

What else will being a Proxy involve?

As you will be filling the information out on behalf of the ‘primary’ participant (major trauma patient), you will also in effect become a participant yourself, albeit a ‘secondary’ participant, and we would like you to confirm that you are happy with what this means by completing a consent form too on QTool, in addition to the ‘primary’ participant. However, as your role is not to provide any of your personal responses to questions, we will not be contacting your GP, monitoring your mental or physical health, or giving you the option to ‘withdraw’ from the study as these options are not relevant for you. We will of course keep all of the information you provide us fully confidential and act in line with GDPR/Data protection rules, Good Clinical Practice research governance rules, and offer you all relevant protections, which are listed in the consent form and discussed in the main section of this participant information sheet. When we analyse the information, your identity will remain fully anonymous, and you will not be identified in any presentation, report or publication of data.

We will ask you to provide us with your identification details including name, date of birth, address, and telephone number. We will call all proxies and patients where a proxy is used, to make sure that all are happy with the arrangement, and to make sure that the answers provided are a true reflection of the views of the primary participant (major trauma patient). If we have any concerns that any answers provided in the questionnaires aren’t those of the primary participant, or in rare cases have safeguarding/welfare concerns, we will investigate further as appropriate, which may include discussing the case with the patient’s GP or other suitable agencies such as social services. We will always aim to seek a positive outcome though, and we expect any such instances to be very unlikely, but we do have to plan for them just in case.

We would like to thank you very much once again for considering taking part in the FIT Study.

If you have any questions, please feel free to get in touch.

If you would like to visit the QTool website to complete the questionnaires, click on the QTool Logo below: