British Society for Rheumatology Register in Psoriatic Arthritis (BSR-PsA)

Psoriatic Arthritis (PsA) has a diverse set of symptoms, which can affect people in different ways. There are a number of treatments available but how effective these drugs are at treating the disease can vary, with individuals responding differently to the same drug. The underlying biological reason for this variation in response to the same drug is poorly understood.

This study will investigate the long-term impact of psoriatic arthritis on the quality of life of affected individuals, how different types of PsA influence patients in areas like work, driving and function and monitor the safety of novel treatments for PsA. The study will also create a PsA biobank that will store a collection of human tissue obtained from people with PsA that will be analysed to determine the underlying reasons why individuals can respond differently to the same drug. This research will hopefully lead to PsA being treated more effectively in individuals in the future, as it may be possible to predict which treatment option will be more successful at treating specific symptoms of PsA. We also want to find out more about how treatments affect the lives of PsA patients in areas like work, driving, general quality of life and why some people respond well to certain drugs and others do not.

How can I get involved?

People who have been diagnosed with PsA are potentially eligible if they are aged 16 years old or over and are treated in adult rheumatology services in one of the study’s NHS recruiting centres.  Ask your consultant if their hospital is recruiting patients with PsA to the BSR-PsA.

What is my involvement in this study?

If you are eligible and decide to take part in the study, you will be asked to sign a consent form at your routine clinic appointment. During this appointment, you will be asked to complete a questionnaire about your disease and a member of the local research team will take measurements. We will also ask you to complete some follow up questionnaires.

You will also need to keep a record of any time you may spend in hospital, any new medications or hospital referrals or if you or your partner becomes pregnant. You will be given a study diary to record these events.

If you are recruited to the study you may wish to take part in the biobank. If you decide to take part in the biobank, you will be asked to donate up to 50ml of blood and give a urine sample when starting or changing your treatment, and after 3 months of starting or changing your treatment.

For documentation pertaining to the study, including biobank-specific information, please see the 'Study documentation' tab below.

What are the possible benefits of taking part?

The information obtained from this study will help inform doctors to treat patients with PsA more effectively in the future.

Being in the BSR-PsA does not require your rheumatology care team to change your treatment in any way. However, your consultant may have access to your questionnaire responses which may tell them things about your disease that they didn’t already know, and this may help them to help you manage your PsA better.

Study documentation

You can download copies of the relevant study documentation here:

• Consent form (version 6)
• Participant Information Sheet (version 6)
• Patient Information Booklet (version 6)

For documentation regarding the study's biobank please see below:

• Consent form (biobank) (version 3)
• Participant information sheet (biobank) (version 3)

Chief investigator

• Professor Gareth Jones

Study coordinator

• Dr Karen Keenan

Study coordinating team (Aberdeen)

• Maureen Heddle
• Stephanie Lembke
• Barry Morris

Investigators

• Professor David Burden (University of Glasgow)
• Professor Philip Helliwell (University of Leeds)
• Dr Rosemary Hollick
• Dr Lesley Kay (Newcastle upon Tyne Hospitals NHS Foundation Trust)
• Professor Gary Macfarlane
• Professor Paul McNamee
• Aileen Neilson (University of Edinburgh)
• Professor Stefan Siebert (University of Glasgow)

You can download a full list of our contributors here.*

* The contributor list is based on information provided up to 24 April 2024. This document is updated on an annual basis.

The University of Aberdeen is the sponsor for this study based in the United Kingdom. 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 University of Aberdeen will keep identifiable information about you for 10 years after the study has finished.

Your rights to access, change or move your information are limited, as we need to manage your information in specific ways 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.

You can find out more about how we use your information http://www.abdn.ac.uk/privacy and/or by contacting the University Data Protection Officer: dpa@abdn.ac.uk

Your NHS rheumatology department collected information from you and/or your medical records for this research study per our instructions. Individuals from the University of Aberdeen and regulatory organisations may look at your medical and research records to check the accuracy of the research study. Your NHS rheumatology department has passed these details to the University of Aberdeen along with the information collected from you and/or your medical records.

Your rheumatology department will keep identifiable information about you from this study for 10 years after the study has finished.

For more information about our compliance with the General Data Protection Regulation (GDPR) and sharing please read the information in the following section.

What do we do with your data?

The University of Aberdeen, as a data controller for BSR-PsA study, is responsible for processing your data fairly and lawfully according to the General Data Protection Regulation (2018). Processing data means collecting, using and sharing the data you provided in your study questionnaires and diary cards, plus the data your rheumatology team collected for the study from your usual clinical care. Data processing will only ever be for the purposes of this study. When you signed the consent form to participate in the BSR-PsA study you permitted us to process these data. It is our responsibility that the data we received from study participants, and their rheumatology teams, have been treated with the utmost confidence.

How do we keep your data secure?

All study materials identified you using a unique ID number. Your name and contact details are stored separately from all other study materials.  All data storage (both paper and electronic) is kept secure at all times.

We blank out your name on every diary card we receive from you before we file it.

Only study personnel have routine access to your data.  There is no public access to the BSR-PsA offices.

Every person working on the study is trained and certified in Good Clinical Practice training which is repeated every 2-3 years to maintain high standards in data protection and handling.

The team at BSR-PsA maintain high standards in data governance to ensure compliance with the General Data Protection Regulation. We work closely with the Research Governance Office at the University. Further information can be found in the BSR-PsA Participant Information Sheet. The study is open to internal audits by the University of Aberdeen Research Governance Office and external audits can be carried out at any time by study stakeholders including NHS Digital, or NHS Research Scotland. Our secure study database is held at the University of Aberdeen.

What do we mean by ‘data linking’ your data?

When you consented to take part in the study you were asked if you agreed that we could link the data we collect from you, and your rheumatology team, to data about your healthcare that are held in a national NHS database. If you agreed to this we share some identifiable information (including your name, NHS or CHI number, address and date of birth) with NHS national databases/registers such as NHS Digital (see table below for full list). This allows us to get additional information about your health, for example about hospital stays, appointments outside rheumatology, or if you develop a serious condition such as cancer. It lets us check the information we already have and to fill in the gaps where information is not complete.

With this additional information, we will be able to build a more complete picture PsA and the safety of a biologic treatment. We will also be able to work out the associated healthcare costs  from the number of out-patient and inpatient hospital appointments you have. We will not get any data from your GP through data linkage.

What is GDPR

  The General Data Protection Regulation (GDPR) (EU) 2016/679 is a regulation in EU law on data protection and privacy.  Its main aim is to give control to people over their personal data.

How will my data be managed in the BSR‐PsA?

  The University of Aberdeen is the sponsor for the BSR‐PsA, a study based in the United Kingdom.  We will be using information from you, 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 University of Aberdeen will keep identifiable information about you for 5 years after the study has finished.  Your rights to access, change or move your information are limited, as we need to manage your information in specific ways 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.  You can find out more about how we use your information, or by contacting the University’s Data Protection Officer on dpa@abdn.ac.uk. Your hospital will use your name, NHS number, date of birth and contact details to contact you about the research study and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study.  Individuals from the University of Aberdeen and regulatory organisations may look at your medical and research records to check the accuracy of the research study.  Your hospital will pass these details to the University of Aberdeen along with the information collected from you and your medical records.  The only people in the University of Aberdeen who will have access to information that identifies you will be people who need to contact you for the research project or audit the data collection process.  The people who analyse the information will not be able to identify you and will not be able to find out your name, NHS number or contact details.  Your hospital will keep identifiable information about you from this study for 5 years after the study has finished.

You can download the full GDPR statement here:

• GDPR statement (version 3)

The main results of the study are not yet available.  However, the following publications have been produced pertaining to / including findings from the study:

Protocol

• Jones et al. The BSR-PsA: study protocol for the British Society for Rheumatology Psoriatic Arthritis Register. BMC Rheumatology 2021; 5: 19. 

Other publications from studies using registry data

• Macfarlane et al. The effect of COVID-19 public health restrictions on the health of people with musculoskeletal conditions and symptoms: the CONTAIN study.  Rheumatology 2021; 60(SI): SI13-24.

Email

bsr-psa@abdn.ac.uk

Telephone

01224 437 562