As part of the BOOST trial we want to learn about older peoples’ experiences of living with back and leg symptoms, and how these experiences change over time. We also want to find out what it is like taking part in the BOOST trial. To do this, we will talk with up to 60 BOOST participants of different ages, gender, and BOOST treatment groups, in individual interviews.
How do I found out about the interview study?
When you attend the assessment appointment at your local hospital the researcher will give you a brief explanation of the interview study. If you are interested in finding out more about it, they will give you an information leaflet to take home and read in your own time.
A member of the BOOST team will then contact you to answer any questions you may have about the interview study, and to see if you would be interested in taking part. If you are interested, a time will then be arranged for the first interview.
Do I have to take part?
No, you do not have to take part in the interview study. If you do decide to take part, you may also change your mind and leave the interview study at any time without telling us why. Your decision will not make any difference to your participation in the BOOST physiotherapy trial, your care at your hospital, or by your GP.
What will taking part involve?
The interview study involves three interviews over a 12 to 18 month period.
First interview: The first interview will take place before you start your BOOST physiotherapy treatment, at a place of your choice such as your home or local hospital. You will be asked to sign and date a consent form at this interview, agreeing to take part in the interviews. You are welcome to have a support person with you for the interview, and travel expenses to interviews will be refunded by the Research team.
The interview will be like an informal conversation between you and the researcher, with general questions about your daily routines and activities, your back and leg pain, and being part of the BOOST trial. The interview will take around one to two hours, and the researcher will audio-record it so that they don’t have to take notes during the interview.
Second interview: The second interview will take place around one month after you have completed your BOOST physiotherapy treatment. This interview will be carried out over the telephone, and take about 30 minutes. Questions will follow on from the first interview, asking about your experiences of your BOOST physiotherapy treatment, your health, and your daily routines and activities. The interview will again be audio-recorded, and the researcher will take notes as they talk with you.
Third interview: The third interview will also be carried out over the telephone, about 12 to 18 months after you enrolled in the study. The interview will take around 30 minutes, with questions based on those from the second interview. Again, the interview will be audio-recorded and the researcher will take notes as they talk with you.
What are the possible benefits or disadvantages to taking part?
The information you give us will help us to understand the experience of living with back and leg symptoms, and how these may change over time. Your interview will also help us to understand whether the treatments in the BOOST trial can improve people’s symptoms.
Our researchers have talked to many people about their health issues and most participants say that it has been a positive experience. However, sometimes people feel uncomfortable talking about their health problems. If there are any interview questions that you are uncomfortable with then you do not have to answer them.
Will my participation in this study be confidential?
All the information collected in the interviews 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 trial, before being destroyed. Only research staff will have access to the information.
What will happen if I don’t want to continue with the study?
You can decide to stop participating in the interview study at any time. If you decide to withdraw from the study we will ask you whether or not we can still use any data we have already collected from you.
What happens to the recordings of my interviews?
Audio-recordings of the first interview will be typed up word for word. Audio-recordings of the telephone interviews will not be typed up but will be listened to by the researcher and checked against the notes they made during the telephone call. All details that might identify you, such as names of people or places, will be removed from all three interview notes and your identity will be anonymous.
What will happen to the results of the study?
We will send you a summary of the results at the end of the study. The results of the study may be shared with healthcare researchers and professionals for future patient care, and be published and presented in research reports, scientific conferences and journals. We will not use your real name, or share any details that could identify you.
Who has reviewed this study?
This trial has been reviewed by a panel of independent researchers and patient representatives who make sure that we conduct the trial the right way. It has also been reviewed by an ethics committee (REC Reference 16/LO/0349), and by the Research and Development Department at your local hospital, who make sure that participants are cared for in a highly professional manner.
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 trial. If you have any concerns or complaints about any aspect of this trial you should contact the BOOST Research team. You may also 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 this research then contact the Patient Advice and Liaison Service (PALS). This confidential NHS service provides support for any complaints or queries you may have regarding the care you receive as an NHS patient. PALS cannot provide information about this research study. Local PALS contact details are provided on the Participant Information Leaflet for the interview study.