ARC Study

If you are going to have a hip or knee replacement, you can help us to help others

Improving outcomes in primary hip and knee replacements: Your invitation to take part in the Arthroplasty Research Cohort (ARC) Study.

Information for Participants
Version 1.5 dated 24/08/2022
IRAS ID: 310843

We are inviting you to take part in a UK-wide study investigating how different lifestyle and health factors may affect the outcomes of hip and knee replacements. Most patients are very satisfied after receiving a hip or knee replacement. However, a small number of patients are not happy with the outcome of their operation or experience complications.

We hope the results of this research will improve our understanding of why the operation is not as effective in some patients, and help to identify those patients who may be more likely to have a worse outcome. This will ensure that in the future we are providing the best treatment we can for patients with joint problems, and direct further research to make these operations even more successful.

Please read the following information carefully and take adequate time to think about what is involved before you decide whether you want to take part. The information will tell you:

Why the research is being done.
What you will be asked to do.
What we hope to learn.

You are under no obligation to take part in this study and if you decide not to, it will not affect your medical care or legal rights in any way.

If you do decide to take part, you will be asked to give your consent to participate using an online form. You will be free to withdraw from the study at any time, and without giving a reason.

You will need access to an online device to take part in the study. A relative or friend may be able to help you with this if you need them to.

About the study

The ARC Study has been developed to find out more about the patients being treated with hip and knee placements, and to identify factors that can affect how successful these operations are. Patients from all parts of the UK and from all walks of life will be asked to provide some baseline information about their lifestyle, health and their joint problems before their operation using an online questionnaire. They will then be contacted soon after the operation, and then at 4 months, 8 months, 1 year and 2 years later to see how well the operation has worked and if they have had any problems or complications. The data they provide will be linked to their medical records, and other joint replacement records to allow the study team to fully investigate which factors can affect the success of joint replacements. The study has four aims:

To find out more about how successful hip and knee replacements are.
To learn more about how different factors affect outcomes in hip and knee replacements.
To identify areas where more research may improve outcomes for patients undergoing hip and knee replacements.
To establish a database of patients who may be interested in taking part in future clinical trials, and to invite selected people to participate in those trials.

I have already had my hip or knee replacement. Can I still take part?

No, unfortunately you cannot take part if you have already had your hip or knee replacement operation. This is because an important part of the research is comparing how things are before and after the operation.

You can take part if you have previously had another hip or knee replacement, so long as this is the first joint replacement operation you have had on this hip or knee.

Don’t we already know what the risk factors for worse outcomes are?

We know that many different factors can put patients at risk of worse outcomes. However, the ARC study aims to collect very detailed information about patients’ personal and social circumstances and their physical and mental health so that we can better understand the effects of these factors, why these factors affect outcomes, and possibly identify other factors that we don’t yet know about. The study also will help us run clinical trials in the future to test treatments to improve outcomes.

Who is doing this research?

This study is being done by a team of surgeons and researchers from Northumbria Healthcare NHS Foundation Trust in the North East of England. Northumbria Healthcare NHS Foundation Trust is sponsoring this research, and has overall responsibility for conduct of the study and keeping your data safe.

Which of my health records will be accessed by the study team, and why?

The study team will access details of your hospital admissions and attendances, information from your GP, and details that are already entered into national registries and databases. This includes information from NHS Digital, who record information about hospital admissions, emergency care and outpatient attendances, mental health records and outcomes after operations. This also includes information from the Civil Registration which records information on deaths in the UK. We will also access information from the National Joint Registry, which records details about the type of surgery you have and the type of hip or knee replacements used. This will mean we can get more detailed information than we are able to get from patients alone, and will allow us to get a full picture of the factors affecting outcomes. This is such an important aspect of the study that you would not be able to take part in the research if you withheld permission for us to access your health records.

Who has approved the research?

The research has been ethically approved by a Research Ethics Committee (HSC REC A ref 22/NI/0135 ref).

How many people will be in this study?

We aim to recruit at least 5,000 people for the study. However, there is no upper limit to the number who can take part and we hope many more patients will sign up. The more participants we have, the more reliable, and useful, the data will be.

How long will the study last?

We will be recruiting patients to take part over a period of five years. Each patient will be sent questionnaires up to two years after their hip or knee replacement operation.

Am I eligible to take part?

You can take part if :

You are a UK resident
You can read and understand information in English (unfortunately we cannot translate some of the questionnaire instruments into other languages)
You are aged 18 years or over
You have been added to a waiting list for a hip replacement or knee replacement
You have not had a joint replacement operation on this joint before

What will I be asked to do if I agree to take part?

First, we’ll ask you to complete a one-time online baseline questionnaire. It’s quite detailed – it needs to be able to capture all the information we need. You should allow yourself up to an hour to complete it, although most people will finish in less than 30 minutes. We’ll ask for your contact details and for those of a family member or friend that we can contact if we don’t hear from you, e.g. if you are unwell. Then we’ll ask for information about your job, housing, lifestyle, diet, use of dietary supplements and quality of life as well as your mental and physical health. Please keep hospital letters and prescriptions handy, as we’ll be asking for very precise details about any medical conditions you have or treatment you’ve been prescribed. We’ll also ask questions about your joint problem and how it affects your day-to-day life.

After you have had your hip or knee replacement, you’ll get an email from us, asking you to complete a shorter questionnaire. This will confirm that you have had your operation as expected, and ask about any problems you might have had since the operation. You will then receive emails asking you to complete another questionnaire at 4 months, 8 months, 1 year and 2 years after your operation. Some of the questions from the baseline questionnaire will be repeated. This will give us updated information on you and your health, and allow us to assess how your hip or knee replacement has affected your joint symptoms, and your physical and mental well-being. These questionnaires will take around 20 minutes to complete if you have not had any changes to your home circumstances or health conditions, or around 30 minutes if you have.

Why will I be asked about my mental well-being as well as my physical health?

Our mental health, particularly depression and anxiety can play a role in how well we fight an illness, or how well we respond to treatment. That’s why we’ll be asking some questions about your mental well-being as well as your physical health.

How do I sign up?

There are three steps:

Step 1: Read this information about the study

Please read this information carefully and take adequate time to think about what is involved before deciding whether you want to take part. You can drop out at any time.

Step 2: Confirm eligibility and give informed consent to take part

You are only able to take part in the study if you are happy to agree to all aspects of the consent form.

First, we’ll ask you to confirm that you have read this information, that you understand that taking part is voluntary, and that you agree to take part in the study. These standard safeguards are a requirement of any properly conducted study.
We’ll ask you to confirm that you are aged 18 or over, that you live in the UK, that you have been added to a waiting list for a hip replacement or knee replacement (and you have not had a joint replacement operation on this joint before), and that you give us permission to contact you about the study.
Next, we’ll ask you for permission to link your questionnaire data to your routinely collected health information held in your GP records, your hospital records and Public Health bodies. This includes the National Joint Registry, Hospital Episode Statistics and NHS Digital Patient Reported Outcomes, and the Civil Registration, including information on deaths, but may also include data from other organisations.
Then, we’ll ask if you agree to be re-contacted and invited to take part in a clinical trial or other research in the future. This does NOT put you under any obligation to take part in another study, and you’d be asked to read a separate information sheet and sign a separate consent form in each case.
Finally, we’ll ask if you agree for your information to be compared with the information of people who take part in future research trials, even if you have not been invited to join them. We will also ask you to confirm that you are happy for your information to be used in other research.

Step 3: Provide your details

Enter your contact details and date of birth to sign up. We will also ask for your NHS number. This can be found on any hospital clinic or appointment letters, or on the NHS app. You can still enter the study if you can’t find your NHS number, but it will make it much easier for us to link your information to your other health information and records if you are able to enter it. Please ensure you use an email address that you will continue to have access to for the duration of the study.
We’ll also ask for contact details of a family member or friend whom we can get in touch with if we don’t hear from you, e.g. if you are unwell
You will then be sent an email containing a link to your baseline questionnaire.

Are there any potential downsides or risks to taking part?

The only risk relates to potential breaches of data security. We’ll keep this risk low by securely storing your data under the terms of the Data Protection Act 2018.

Some of the questionnaires ask about topics which some people might find sensitive. You don’t have to answer any questions that you don’t want to. If you would like further support with any of these issues or topics, some organisations that may be able to help you are listed below. You can also discuss this with your GP.

Mental Health Foundation – www.mentalhealth.org.uk
Samaritans – www.samaritans.org
Mind – www.mind.org.uk
Citizens Advice Service – www.citizensadvice.org.uk
Alcoholics Anonymous – www.alcoholics-anonymous.org.uk
Macmillan Cancer Support – www.macmillan.org.uk

Are there potential benefits of taking part?

There won’t be an immediate benefit for you personally, but by taking part you’ll be contributing to scientific knowledge about hip and knee replacements. You will also be regularly assessed to see if you are eligible for clinical trials of new ways to improve outcomes for patients having a hip or knee replacement.

What sort of interventions might the clinical trials investigate?

We are interested in looking at whether specific lifestyle advice or use of particular dietary supplements might improve the outcomes of hip and knee replacements, or reduce the risk of complications. Other trials may also look at other aspects of treatment around the time of your operation, with help from the hospital looking after you. Please note that signing up to the ARC Study does NOT commit you to joining a trial later on; it just makes you eligible to be invited to join a trial.

What if I am invited to join the active arm of a trial?

If you are invited to join the active arm of a trial, the research team will inform you and give you information about the trial. You will be given time to consider whether you want to take part. You are under no obligation to take part in the active arm of a trial and if you decide not to, it will not affect your medical care or legal rights in any way.

What if I am not invited to join the active arm of a trial?

Not everyone who is suitable for a trial will be invited to participate. This is because the number of people who can take part may be limited or because the trial treatment can’t be offered to everyone. If you are not invited to join the active arm of a given trial, we will not tell you about that trial. This is because we don’t want you to feel disappointed. The process of choosing people to join future trials will be done by a computer programme, based on random chance. Regardless of whether or not you are invited to join the active arm of a trial, you can remain in the ARC Study.

If you are not invited to join the active arm of a trial, you might still provide important information to help the trial. The information you provide as part of the ARC Study may be used to compare your health with that of people who are receiving treatment in a trial. While you are taking part in the ARC Study, you could be considered for multiple trials. Therefore, if you are not invited to take part in the active arm of one trial, there may be another one in the future that you are invited to take part in.

How will we use information about you?

We will need to use information from you, your medical records and existing national databases and registries for this research project.

This information will include your

Name
Date of birth
Post code
Email address and telephone number
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.

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.

We will keep information about you safe and secure.

Once we have finished the study, we will keep all 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.

We’ll analyse your information to:

Evaluate how successful hip and knee replacements are
Evaluate the effect a hip or knee replacement has on your wellbeing and other aspects of your life
Identify risk factors for worse outcomes or complications
Improve our understanding of why some factors may have the effect they do, and the effect different factors may have together

Your data may also be used to compare your health with that of other people who are receiving treatment in a clinical trial.

Your data will be stored on a secure server owned by Northumbria Healthcare NHS Foundation Trust, using software provided by RedCap used to build our on-line questionnaires. Once your data are collected, they will be downloaded from the RedCap system and stored on secure servers at Northumbria Healthcare NHS Foundation Trust for use in current and future ethically approved research aimed at better understanding the outcomes of hip and knee replacements. Your contact details and your responses to the questionnaire will be held in two separate databases, linked by a code number unique to you. This maximises security: if one database is breached, the link between you and your data cannot be made. As a participant in this study, the data we collect from you will be stored securely for 5 years after the study has fully completed. This is in line with NHS standards. If you are selected to be a part of an additional trial, or your data is used to compare your health to that of other people in the active arm of a trial, the data we collect may be stored for up to 25 years.

A small number of other NHS sites and hospitals are helping us with the research. If you are having your operation at one of these hospitals, we will tell them that you have joined the study. They may also contact you for follow-up questionnaires.

We will need to share your personal information with organisations such as NHS Digital and the National Joint Registry so that they can identify you in their records. We may also need to do this in order to identify your NHS Number. This will be done securely, and following strict procedures on the transfer of this data.

You can find out more about how we use your information by contacting us at ARCStudy@northumbria-healthcare.nhs.uk

What are my choices about how my information is used?

You can stop being part of the study at any time, without giving a reason. To withdraw, let the study team know by email ARCStudy@northumbria-healthcare.nhs.uk.

The data we already have, and data that has already been anonymised and shared with other researchers, cannot be destroyed.

If you choose to stop taking part in the study, we would like to continue collecting information about your health from your medical records and existing databases and registries. If you do not want this to happen, tell us and we will stop.

We need to manage your information in specific ways to ensure that the research is reliable and accurate. This means that we won’t be able to let you see or change the data we hold about you.

What if I move abroad during the study period?

If you move abroad in the 2 years after your operation you should notify us by emailing ARCStudy@northumbria-healthcare.nhs.uk and you will be withdrawn from the study.

What if my data are hacked or leaked?

We will take every precaution to keep your data secure – but if you have a concern about any aspect of this project, just email the study team at ARCStudy@northumbria-healthcare.nhs.uk. In the unlikely event that your data are hacked or leaked due to someone’s negligence, then you may have grounds for legal action for compensation against Northumbria Healthcare NHS Foundation Trust. You may have to pay your legal costs.

What if I want to make a complaint?

If you would like to make a complaint about the research, please contact ARCStudy@northumbria-healthcare.nhs.uk in the first instance. You can also contact your local hospital’s Patient Advice and Liaison Service (PALS). You can find your Patient Advice and Liaison Service at https://www.nhs.uk/service-search/other-services/Patient-advice-and-liaison-services-(PALS)/LocationSearch/363

We are unable to pass on any compliments or complaints to the team in your hospital. If you are unhappy or experience malpractice in the care or treatment you have received from the NHS, please contact your hospital’s Patient Advice and Liaison Service who will offer you confidential advice, support and information.

Under what circumstances will you contact the family member or friend whose details I provide at sign-up?

We will reach out to the contact you suggested if we stop hearing from you. This is so that we can find out that you are okay and if you still want to take part in the study.

Will commercial companies be given access to my data?

We aim to support all types of researchers in their efforts to improve outcomes for patients. We don’t yet know whether companies will apply to do research in the ARC Study, but each and every company that does will be closely examined by the study team.

Only those companies with ethical aims – and whose research the study team judges to be well justified – will be approved to use ARC Study data, with all data anonymised.

None of your personal information will be passed to external researchers, organisations or companies without your consent. If they request to recontact ARC Study participants, we will ask you first if you want to be contacted by them on each occasion. You can decide whether you want us to share your contact details.

Where can I get more information?

You can find out more information about the study and about how your information is used

this website
by sending an email to our research team (ARCStudy@northumbria-healthcare.nhs.uk)
leaflet available from https://www.hra.nhs.uk/patientdataandresearch

You can also find more information about how your information is used in research studies at https://www.hra.nhs.uk/information-about-patients/

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