• In the UK, Latent tuberculosis infection (LTBI) is routinely treated with a combination of three medicines, this is referred to as 3-drug anti latent TB therapy. Most patients can successfully complete their treatment course with no complications. Unfortunately, in some cases, the medicines can begin to cause damage to the liver, this is called drug-induced liver injury (DILI). To protect the liver and encourage it to recover the TB treatment is stopped.

• Once the liver has recovered doctors must decide how or whether to restart anti-TB drugs. The aim of the latent TB cohort trial is to determine the frequency of drug induced liver injury (DILI) and the frequency of DILI recurrence in patients being treated for latent TB. The trial also aims to assess the impact of DILI on a patient’s quality-of-life.

• If you decide to help with this research, you will be asked to sign a consent form. Once that form is completed the medical information relating to your liver injury and anti-latent TB treatment will be sent to one of the trial team liver specialists supporting the trial to confirm the diagnosis of DILI. They will have a maximum of 5 days to confirm whether or not the liver damage is related to your TB treatment. 

• After the DILI is confirmed as being related to your TB treatment, you will be asked to fill in a short questionnaire about your health and wellbeing that will take a few minutes to complete. 

• If the liver specialists do not find that your liver injury is related to your TB treatment based on a specified criteria for the TB-DILI cohort trial, then you will not be eligible to continue into the trial. Your care will not be affected, and you doctor will manage your care as they see clinically appropriate. 

• Your doctor will manage your care as usual as you recover from the DILI. Once your liver has recovered and you have completed the questionnaire again the treatment you will receive will be decided by your doctor.

• Your doctor will continue to manage your care as usual in the NHS and provide information on your health to the trial team. This trial does not require you to attend any additional visits than you would normally attend for TB treatment. 

• The trial team will monitor your treatment and recovery for 12 months after you have been enrolled into the trial. During that time, the trial team may contact you by phone, e-mail or post to update you on the trial, remind you to complete the questionnaires or to collect data about how you have been feeling since your last contact with them. 

• Taking part in the trial may not directly benefit you, but the information we collect from this trial will help us determine the frequency of drug induced liver injury (DILI) and the frequency of DILI recurrence in patients being treated for latent TB. The trial also aims to assess the impact of DILI on a patient’s quality-of-life.

• The latent TB DILI cohort trial will involve data collection only, and will not affect the treatment or care you receive in any way. We therefore do not expect there to be any additional risks or disadvantages to your taking part in the trial.

• Researchers at the Nottingham Clinical Trials Unit (part of the University of Nottingham) will need to use information from you, your medical records, and your TB care team for this research project. All information about you will be kept safe and secure. 

• This information will include your initials, NHS number, name and contact details.  The researchers 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 unique code number instead. 

• Once the trial has finished, some of the data will be kept so the results can be checked and you can be told what happened in the study. Reports will be written in a way so that no-one can work out that you took part in the trial.  

• You can stop being part of the trial 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 trial, we would like to continue collecting information about your health from central NHS records. 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. 

• After 25 years your data collected during the trial will be disposed of securely. If you give us your permission, we may keep your contact details so we can get in touch if there is any relevant future research that you may be interested in taking part in. You will also have the option to take part in future research using your data saved from this trial. If you do not wish for your contact details to be kept for a copy of the trial results to be sent to you or to be contacted about future research, these will also be disposed of securely at the end of the trial.

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

• at www.hra.nhs.uk/information-about-patients/ and www.hra.nhs.uk/patientdataandresearch
• by asking one of the research team
• by sending an email to TB-DILI@nottingham.ac.uk

• This trial should conclude 12 months after you have been enrolled into the trial. If you withdraw from the trial, we will need to keep and use the data collected up to your withdrawal. At the end of the trial the results will be published in scientific medical journals and presented at conferences. You will not be identified in any publication. We will send you a newsletter with a summary of the trial findings unless you ask us not to.