Patient Information Sheet

Title of Project: Development, Validation and Use of a Patient-Centred Outcome Measure for Young Adults with Developmental Dysplasia of the Hip: the ‘Quality of Life, Concerns and Impact Measure’ (QoLC&I)

Name of Researchers: Dr Tina Gambling (School of Healthcare Sciences, Cardiff University), and Emeritus Professor Andrew Long (retired, School of Healthcare, University of Leeds).

Invitation to participate and brief summary of the project

We want to find out more about the impact that having Developmental Dysplasia of the Hip (DDH) has had on your life.  Our interest stems from the need for greater awareness about the condition within the clinical and research community.

We have developed a patient-centred, outcome measure which assesses the impact of the DDH, (the ‘Quality of Life, Concerns and Impact Measure’ (QoLC&I), the measure can be used by both patients and clinicians in discussions over treatment options and in the evaluation of treatment and post-operative rehabilitation. Measuring these concepts will help us to understand more about how DDH impacts on you over a lifespan. This project involves testing and improving the measure so that it is robust enough to use in clinical trials. We also intend to implement the measure in clinical practice to enhance the consultations you have with surgeons and others so that they are better able to understand the impact of your hip condition on your life and to help you to decide on treatments. 

What would taking part involve?

Taking part in the study would involve completing our measure (this would take approximately 10 minutes). The questions in the measure ask you how DDH has impacted on your life and how living with DDH affects your daily life. Most of the questions involve clicking a box that best reflects your experiences, the measure is available on-line. When you have completed the measure,  the measure will come back to the research team. For some participants we may ask you to complete the measure again at a later date; this will help us understand whether the measure can detect changes in your illness state over time. We would also like to find out a little about yourself (how long you have had DDH, when you were diagnosed and at what age) and some details of your treatment history. Gathering the responses from the measure will enable us to understand more clearly about how DDH affects you over the life course.

If you wish you can also write a short story about yourself and the impact of the condition on your life and send this to Gamblingts@cardiff.ac.uk.

Your responses will be read by members of the research team. We will also use these responses to help us test and further develop the measure.  All material will be anonymised to protect your identity.

What are the possible benefits of taking part?

There are no specific benefits to you in taking part, but the research will help us to understand the impact of DDH over the life course and help us to raise awareness of the condition amongst clinicians and the general public. This will overtime, improve the experience of patients and help us to understand the benefits of treatment.

What are the possible disadvantages and risks of taking part?

There are no specific risks in taking part in this research.

What if something goes wrong?

If you have any concerns about any aspect of the way that you have been approached or treated during the course of the study please contact Dr Tina Gambling Gamblingts@cardiff.ac.uk who is leading the research.  Should you require independent advice please contact - Dr Kate Button, Director of Research Governance, School of Healthcare Sciences.

What will happen if I don't want to carry on with the study?

If you wish to withdraw from the study at any time, then we will all destroy data that we have collected form you.

How will my information be kept confidential?

All Information which is collected about you during the course of the research will be kept strictly confidential. All data collected will be anonymised and will not be individually identifiable.  Pseudonyms will be used in any oral or written reports or presentations from the study, including any direct quotations from your questionnaire. 

All electronic data will be kept on a password-protected server at Cardiff University.  Any paper-based material will be kept in a locked filing cabinet. The original data collection sheets will be kept under lock and key in accordance with the Data Protection Act and will only be accessible to the research team and regulatory authorities. Data will be kept for five years and then disposed of securely.

What will happen to the results of this study?

We plan to present the findings of this research at scientific meetings and publish in journals. Participants will not be identifiable in any report/publication but that we may use some of the comments that you have provided in reports, publications and presentations.

Who is undertaking this research project?

The project is being undertaken by researchers at the Universities of Cardiff and Leeds.  Dr Tina Gambling (Cardiff) is leading the research; she has extensive knowledge of DDH.  Other members of the research team are: Professor Andrew Long (School of Healthcare, University of Leeds), who has done extensive research within healthcare; and Andrew Younger, Director Communications, IHDI, Florida, USA.

Who has reviewed this study?

The study has been given ethical approval by the Research Ethics Committee of the School of Healthcare Sciences, Cardiff University. 

Further information and contact details

If you have any further questions about the research, please contact Dr Tina Gambling gamblingts@cardiff.ac.uk     Tel/ +44 02920 687555

What to expect during the consent process?

If you have read this information and have no further questions and you wish to take part in the study, please click on Next to complete a consent form. If you choose to give consent, you will be taken to the survey automatically.