PANDA-S II study

You will be invited to take part in the PANDA-S II study if you have been referred, or you have referred yourself, to Physiotherapy for your shoulder pain.

If you are invited and you decide to take part in the PANDA-S II study, you will be asked to complete 4 questionnaires over the next 12 months. Each questionnaire will ask questions about your shoulder pain and how it affects you and will take you approximately 20 minutes to complete. You will receive the questionnaires either by post or using a link sent to your phone.

You will be reimbursed for your time completing the questionnaires: a £10 shopping voucher will be included with each follow-up questionnaire. Taking part in the PANDA-S II study is voluntary.

If you choose to take part, you are free to withdraw at any time. If you choose not to take part, or you withdraw, this will not affect the current or future health care you receive. If you wish to take part, please read all the information on the next pages, sign the consent form, and complete the Shoulder Pain questionnaire.

The information we get from this study will help to support how physiotherapists provide care for people with shoulder pain, how patients can manage their own shoulder pain, and deciding when people with shoulder pain should be seen by other healthcare professionals, for example, a surgeon. There may not be any immediate benefits for you, although some people find it rewarding to take part in health research. Your participation in this study will help to:

• improve information for patients with shoulder pain about the likely future course of their pain condition
• help doctors and physiotherapists to better advise patients with shoulder pain which treatment and self-care options are best for them
• improve treatment options and reduce unnecessary tests or treatments in those who don’t need them
• possibly reduce long-term pain, disability, and work loss due to shoulder pain

We are not expecting any risks in taking part in the PANDA-S II study. The care you receive from your GP practice or physiotherapy service will not be affected. 

This study has been funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (RP-PG-0615-20002) and Versus Arthritis.

Results for the PANDA-S II study will be written in easy to read, plain English summaries and will be communicated to study participants through newsletters, leaflets, and posters in participating physiotherapy clinics and via the Keele University website. Results may take two years to become available once we have finished the study. We plan to present results at medical meetings and conferences, and to publish results through medical journals. You will not be personally identifiable in these presentations or publications.

The Primary Care Centre Versus Arthritis based at the School of Medicine at Keele University is organising this study, together with Keele Clinical Trials Unit (CTU).

Keele CTU specialises in the development and delivery of high-quality research studies. Keele CTU is a UKCRC registered Clinical Trials Unit.

Please go to https://www.keele.ac.uk/ctu/ to find out more about Keele CTU.

The research team have worked with patients and members of the public to ensure that the research meets the needs of patients, and the information provided is easily understandable. Being involved in research can help to improve healthcare and patient choice.

To protect your interests, all research in the NHS is looked at by an independent group of people, called a Research Ethics Committee. This study has been reviewed and approved by Research Ethics Committee. The study has also been reviewed by scientific experts on behalf of the National Institute of Health and Care Research (NIHR), before awarding funding.

To safeguard your rights, we will use the minimum personally identifiable information possible. Identifiable information, such as your name and address, will only be used for the PANDA-S II study e.g. to allow questionnaires to be posted to you, and will not be used beyond these purposes. Your identifiable information will be securely stored by Keele CTU at Keele University. Electronic data will be stored on networks approved by a government backed cyber security scheme. Paper records will be stored securely within lockable filing cabinets and/or in strictly restricted-access rooms.

When you return your completed questionnaire to Keele Clinical Trials Unit, this will be securely stored under a unique study number. Your questionnaire answers (data) will only be associated with this number, not your personal details. Anonymous data held on this basis may be used in other research studies. Your consent form will also be stored securely at Keele Clinical Trials Unit, separately to the information you provide on your questionnaires.  

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 unless you ask to have it deleted.

In accordance with the Keele University, the Government’s, and our funders’ policies we may share our research data with researchers in other Universities and organisations, including those in other countries, for research in health and social care. Sharing research data is important to allow peer scrutiny, re-use (and therefore avoid duplication of research) and to understand the bigger picture in particular areas of research. Data sharing in this way is anonymised (so that you could not be identified). Any requests for access to the anonymised data from anyone outside of the study team will follow Keele Clinical Trial Unit’s Standard Operating Procedure for data sharing. The anonymised study data set will be made available on Keele University’s Research Data Repository. Your information will only be used for the purpose of health and care research and cannot be used to contact you or to affect your care. It will not be used to make decisions about future services available to you, such as insurance.

In addition to the research team, people from the NHS authority whose job it is to check the conduct of research will be allowed to see your study information if needed.

You can find out more about how we use your information and read our privacy notice here or you can contact Keele University’s Data Protection Officer at: dpo@keele.ac.uk.