Patient Participant Information Sheet

Part 1: Quick Summary

STUDY TITLE

IMPlementAtion of the Torbay shared decision-making charts for Knee osteoarthritis (IMPAKt)

AIM OF STUDY

We would like to talk to people with osteoarthritis of the knee about their experience of using the Torbay Shared Decision-Making Charts for knee osteoarthritis (The “Torbay Knee Chart” from here on). We will use this feedback to improve the design of the Torbay Knee Chart for the future.

WHAT DO I HAVE TO DO IF I TAKE PART?

You will be asked to take part in an interview by phone or video call which will be audio recorded.

WHAT ARE THE ADVANTAGES OF TAKING PART?

You will help to improve the design of the Torbay Knee Chart so we can improve it for you and others with knee osteoarthritis.

 

If you have any questions, please ask the researcher.

If you are interested in taking part, please read part 2

 

Part 2: Detailed Information

WHY AM I BEING ASKED TO TAKE PART?

Because you have used the Torbay Knee Chart with a health care professional supporting you with your osteoarthritis of the knee.

DO I HAVE TO TAKE PART?

No, it is up to you.  If you decide not to take part, you do not need to give a reason. You are also free to leave the study at any time.

WHAT HAPPENS IF I AM INVITED TO TAKE PART IN AN INTERVIEW?

1) The researcher will invite you to take part in an interview lasting typically no more than an hour. The researcher will answer any questions you have and, if you agree to take part will arrange a time for the interview. This will be by phone or videocall at a time that is convenient to you.

2) Before your interview, we will ask you for your verbal consent (your permission) to take part and this will be audio-recorded at the beginning of the interview (a copy of a verbal consent form signed by the researcher will be sent to you after the interview). Alternatively, we can send you a consent form by email, which you can complete and return by email. You will be asked if you agree to be contacted about future research.

3) During the interview the researcher will ask you about your experiences of using the Torbay Knee Chart. You will be asked your age, gender, ethnicity, whether you are working and if you are what you do, and the stage of your osteoarthritis and disease severity.

WHAT ARE THE DISADVANTAGES OF TAKING PART? 

If you take part in an interview, this could take around an hour of your time.

CAN I CHANGE MY MIND AND STOP THE INTERVIEW ONCE IT HAS STARTED?

Yes. You are free to ask for the interview or the recording to be stopped at any time, or you can choose to stop and then restart at any time, without giving a reason.

WHAT HAPPENS TO THE AUDIO RECORDING & INFORMATION?

1) The audio recording device is encrypted and protected by a password. The recording will be transcribed (typed out in full) by a University of Bristol authorised transcriber who has signed a data protection agreement with the University and has guaranteed to store and transfer data securely in accordance with the Data Projection Act. The audio recording will be stored on password protected computers and protected in accordance with the Data Protection Act.

2) The research team will analyse the transcription and look at how people experience using the Torbay Knee Chart and what improvements can be made.

3) The findings of the study will be published in reports, scientific journals and presented at scientific conferences so other people (academics, researchers, clinicians and patients) can learn from your experience. Anonymous quotes may be published but no names or identifying details will be reported.

4) Personal data (e.g. contact details) will be stored for 12 months after the study has ended and then will be destroyed. Anonymised electronic research data (anonymised electronic transcripts of the audio-recordings) will be stored indefinitely in keeping with the University of Bristol Research Data Repository policy. All data procedures will be in keeping with Medical Research Council (MRC) guidelines, and the General Data Protection Regulation (GDPR) and Data Protection Act 2018.

WHAT WILL HAPPEN TO THE RESULTS OF THE STUDY

You will be provided with a summary of the findings of this study if you wish to receive it. The results of this study will be published in reports, scientific journals and presented at conferences.

HOW WILL WE USE INFORMATION ABOUT YOU? 

  • We will need to use information from you for this research project.
  • This information will include your name and contact details. 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 all information about you safe and secure. Once we have finished the study, we will keep some 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.
  • If you tell us something that relates to professional negligence or malpractice by a health professional, we will discuss this with a Consultant Orthopaedic Surgeon and Senior GP to determine if further action is required

WHAT ARE YOUR CHOICES ABOUT HOW YOUR INFORMATION IS USED?

  • You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.
  • We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.
  • If you agree to take part in this study, your data saved from this study may be used for future research.

WHERE CAN YOU FIND OUT MORE ABOUT HOW YOUR INFORMATION IS USED?

You can find out more about how we use your information:

WHO IS ORGANISING & FUNDING THE STUDY?

The study is being hosted by the Bristol North Somerset and South Gloucestershire Clinical Commissioning Group and sponsored by the University of Bristol. This study is funded through Research Capability Funding awarded to Chief Investigator, Dr Andrew Moore.

WHO HAS REVIEWED THE STUDY?

The study has been reviewed by the University of Bristol Faculty of Health Research Ethics Committee and reviewed and approved by the NHS Research Ethics Committee, to protect your interests.

HOW TO MAKE A COMPLAINT

If you wish to make a formal complaint please contact the University of Bristol Research governance team: research-governance@bristol.ac.uk

RESEARCHER CONTACT DETAILS: Dr Sophie Turnbull,sophie.turnbull@bristol.ac.uk, 01174283734