What is the purpose of the study?
The OPAL study is about health outcomes in older adults. We are surveying over 4,000 adults across England to see how health and physical activity change over time. The information that we collect will help us to understand how a person’s health, including conditions such as back pain, affect their mobility as they age, and provide insight into improving the management of health in older adults.
Who is taking part and why have I been invited to take part?
We asked a number of GP Practices across England to help us to contact people about the study. We invited a selection of people registered at one of these GP practices, and who were over the age of 65 and living in the community. The selection was based on a random sample i.e. people were selected by chance and not based on any other issues.
OPAL stands for the Oxford Pain, Activity and Lifestyle Study
Do I have to take part in the survey and can I change my mind?
No, you do not have to take part in the survey. If you decided to take part, you may change your mind without telling us why. You can withdraw from the study at any time. Your decision will not make any difference to medical care you receive from your GP.
What will taking part involve?
If you are one of the people who was randomly selected to take part you will have received a letter in the post, with a survey and consent form enclosed.
If you decided to take part in the survey you will have signed and date the consent form and returned it to us, with your completed survey. We will ask you to complete an annual Health and Physical Activity Survey for the next 5 years. The first survey was included with the invitation letter. Each survey will take approximately 30 minutes to complete.
We may also contact you to let you know about opportunities to be involved in trials of treatments that may be of interest to you based on your responses to the survey. Involvement in these trials is optional and you are free to decline.
As well as collecting information from the surveys, we may want to look at information held by the NHS (for example your GP record) and from sources maintained by the Health and Social Care Information Centre and other central UK NHS bodies. We will only look at information that is relevant to this research. We will only do this if you are happy for us to access this information and it will only be accessed by authorised individuals from the Research team.
All data collected as part of the study will be processed according to the Data Protection Act 1998, details of which can be found on our data protection statement.
What are the benefits and risks of taking part in the study?
There will be no direct benefit to you for taking part in this study. However, your participation in this survey will help us to research how healthcare services can be improved for older adults.
The risks associated with this study are very small. Sometimes people may feel uncomfortable answering certain questions about their health. If there are any questions in the survey that you are uncomfortable with then you do not have to answer them. You will be returning your consent form and questionnaires using the regular post so there is a very small risk that these documents, which contain some personal details, could get lost in the post. However, we have used the regular post in many studies and this is rarely a problem.
Who will know that I am taking part?
The only people who will know that you are taking part in the survey are members of the Research team and your GP. You are free to tell anyone that you are taking part if you wish.
Will my details be kept confidential?
All the information collected will be kept strictly confidential by the Research team. However, if we become concerned for your welfare we have a duty of care to inform your GP. Study information is stored securely by the University of Oxford for five years, from the end of the study, before being destroyed. Only Research staff will have access to the information.
What happens at the end of the study?
You will still be able to contact the OPAL Research team if you have any questions or concerns about the study. We will send you a summary of the study outcomes at the end of the study.
What will happen to the results of the study?
The results of the study will be shared with healthcare researchers and professionals for future patient care. Nothing that may identify you will be shared outside of the research team or in any publication resulting from this study.
Who is organising and funding the research?
The study is sponsored by the University of Oxford and conducted by a Research team led by Professor Sallie Lamb at the University of Oxford. The study is funded by the National Institute for Health Research.
Who has reviewed this study?
The University of Oxford has reviewed this study and will make sure we conduct the study in the right way. It has also been reviewed by a panel of independent researchers and patient representatives and been approved by a special ethics committee (REC 16/LO/0348).
What if I have any concerns?
The University of Oxford, as Sponsor, has appropriate insurance in place in the unlikely event that you suffer any harm as a direct consequence of your participation in this study. If you have any concerns or complaints about any aspect of this study you should contact the OPAL Research Team (details below), or you may contact the University of Oxford Clinical Trials and Research Governance (CTRG) office on 01865 572224, or the head of CTRG, email email@example.com.
If you would prefer to speak with someone not involved in the study then you should contact your GP surgery in the first instance or follow the guidelines detailed on the NHS England website: www.england.nhs.uk/contact-us/complaint/complaining-to-nhse/.
What do I do now?
If you are participating in the study, we will contact you when it is time to complete your annual follow-up survey. Complete the survey and return to us in the freepost envelope provided. If you have any questions about the survey then please contact the OPAL research team.
If you decide that you would rather not continue with the study, then please either indicate this on the back of the survey and return it to the study team in the freepost envelope provided, or call the research team on Freephone 0800 085 3922.