OPAL Study

Optimal Prescribing of Levothyroxine Study: OPAL

Prof. Simon Pearce, Endocrine Unit, Level 6 Leazes Wing, Royal Victoria Infirmary, Newcastle upon Tyne, NE1 4LP.

Please read this information sheet carefully, so that you can decide whether or not you wish to participate in this research study. There is no obligation to participate and your health care will not be affected in any way, whatever you decide.

Why are we asking for your help?

You have been identified from your GP practice records as someone who takes thyroid hormone replacement in the form of levothyroxine tablets. Many people who take levothyroxine need to take it for life because they have an underactive thyroid.

However, recent studies in other countries have shown that up to 50% of people currently taking levothyroxine might not need to take it for ever. This is because over time some people’s thyroid gland function improves so that they might no longer need to take levothyroxine permanently. Another reason is that thyroid blood tests can become abnormal for a few weeks in people recovering from many common illnesses (e.g. the ‘flu or a chest infection). Once they recover from the acute problem, however, the thyroid tests return to normal in most cases. Sometimes people are started on levothyroxine in this situation when their thyroid blood tests would have gone back to normal without treatment over a few weeks. This means there are probably many people who don’t now need to take levothyroxine for ever.

This study aims to understand whether this is a widespread issue in NHS patients in England. The study will find out whether it is worthwhile asking people to stop their levothyroxine medication for 6 weeks, to find out whether their thyroid glands are recovered and working normally again. The results will also show how people feel after their levothyroxine prescriptions are temporarily stopped.

Large studies have shown that there is a small increase in the risk of long-term health consequences in people taking levothyroxine, which includes heart problems and osteoporosis (thinning of the bones). Furthermore, many people find it inconvenient to have to pick up their levothyroxine tablet prescriptions every month, as well as difficult to remember to take their tablets every day. For most people, there would be advantages in not having to take levothyroxine tablets every day, if they are no longer needed.

What will I be asked to do?

If you agree to participate in the study, you will be asked to fill in a questionnaire about your thyroid symptoms, and how your thyroid problem makes you feel. This questionnaire takes around 10 minutes to complete. Then you will stop taking your levothyroxine tablets for 6 weeks. If you take other medications, these will continue as normal. At the end of 6 weeks, you will have a thyroid blood test to see whether you need to start taking the levothyroxine tablets again or whether there has been recovery of your thyroid function. You will also be asked to fill in a second questionnaire about your thyroid symptoms and report any health issues that you had while off the levothyroxine medication.

Previous studies showed that in 30–50% of people, their thyroid may have had recovered over time. At the end of the study, you will receive the full details of your thyroid tests and have a discussion with the study team about how you feel without the levothyroxine tablets. If you feel better on the levothyroxine tablets, you will be able to restart them whatever the thyroid test results show. However, if you feel well without the levothyroxine tablets and your thyroid tests are satisfactory, you will be offered the choice to stop the tablets and just have occasional monitoring in accordance with usual NHS care to make sure your thyroid levels remain stable.

At the end of the study, we will follow information about your levothyroxine prescriptions and thyroid blood tests for a year by using the NHS electronic health records kept by your GP. This will enable us to find out how many people are able to change their treatment in the longer term.

Will the information that comes from this research be helpful to me?

The information that comes from the study may allow a change in your treatment, and some people will be able to stop levothyroxine tablets permanently following the study. The results of this study could therefore have long-term health benefits for you, as well as being more convenient.

What risks can I expect from this study?

When you give a blood sample you may feel faint, or experience discomfort, mild pain or bruising at the site. Some people may feel worse when their levothyroxine tablets are temporarily stopped. Because there is a large reservoir of thyroid hormones in your blood, we would expect any symptoms to come on gradually, over several weeks. You will have access to the study team (pharmacist and doctor) and you will be offered an early blood test if your symptoms are giving you problems.

Patients who take levothyroxine are entitled to free NHS prescriptions. If you stop levothyroxine as a result of the study, you may no longer be eligible for free prescriptions.

What happens if I change my mind?

You may choose to leave the research study and restart your levothyroxine tablets at any time. If you leave the study, we would like to understand the reasons for your decision. With your permission, the information you  give us for leaving the study may still be used for research.

Will I receive payment for being part of this study?

You will not be offered payment for participating in this study. If you need help with transport to your GP practice for the purposes of attending the study, please let us know and we can book you a taxi to attend at our expense.

What will happen at the end of the study?

You will continue to receive the same standard of care as any other patient with your condition under the care of your doctor(s). Most patients with a thyroid problem will have a yearly blood test, and you will continue to receive this testing irrespective of the study results.

What if something goes wrong?

If you have a concern about any aspect of this study, you can speak to a member of the OPAL study team who will do their best to answer your questions. Further contact details are included at the end of this information sheet. If you are still unhappy and wish to raise your concerns with someone who is not directly involved in your care, you can contact the Patient Advice and Liaison Service (PALS) on 0800 0320202, [email protected] or FREEPOST PALS.

In the unlikely event that you are harmed during the study and this is due to someone’s negligence (they were careless) you may have grounds for legal action and compensation, but you may need to meet your own legal costs. NHS Indemnity does not offer no-fault compensation (for harm that is not anyone’s fault). Newcastle University also has insurance arrangements in place to cover Newcastle University staff involved in designing and managing the study.

Who is organising the study?

Chief Investigator: The doctor in charge of the study is Dr Simon Pearce, a Professor of Endocrinology. He works for Newcastle University and at the Royal Victoria Infirmary, Newcastle.

Study Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust. The study Sponsor has responsibility for the study.

Study Funder: Newcastle University Policy Support Fund

Who is responsible for information about me?

The Newcastle upon Tyne Hospitals NHS Foundation Trust is the sponsor for this study. We will be using information from [you and/or your medical records] in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. The Newcastle upon Tyne Hospitals NHS Foundation Trust will keep identifiable information about you for 5 years after the study has finished

This information will include your initials and NHS number.  People will use this information to do the research or to check your records to make sure that the research is being done properly. The responsible data protection officer can be contacted by email: [email protected] or by post at Data Protection Officer, NUTH, Regent Point, Newcastle upon Tyne, NE3 3HD.

Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

Who should I call if I have any questions?

You can talk with the study doctor, Prof. Pearce about any questions or concerns you may have about this study.  Please contact him if you change your mind and decide that you no longer want to take part. His telephone number is 0191-2824636.

If you have any questions about the rights you have while taking part in this study call the Newcastle Hospitals NHS Foundation Trust Patient Advocacy and Liaison Service at 0800-0320202.

If you think you have been hurt from taking part in this study, please call Prof. Simon Pearce at 0191-2824636.

What is the next step, if I want to participate in the study?

Please get in contact with Paul Davies (Research Pharmacist) by email [email protected]. The first step will be to arrange a brief phone call to answer any questions you have and to make sure it is safe for you to stop your levothyroxine tablets.

Thank you for taking the time to read this sheet

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