Page 1: Participant information sheet

Title of Project: Global Research on the Impact of Dermatological Diseases (GRIDD): Development and Validation of the Patient-Reported Impact of Dermatological Diseases (PRIDD) measure

Name of Researchers: Ms Rachael Pattinson (Cardiff University), Professor Chris Bundy (Cardiff University), Ms Nirohshah Trialonis-Suthakharan (University Medical Center Hamburg), Professor Matthias Augustin (University Medical Center Hamburg).

You are being invited to take part in a research study.  Before you decide whether or not to take part, it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish.  

 

Thank you in advance for reading this document.

 

What is the purpose of the research?

The Global Research on the Impact of Dermatological Diseases (GRIDD) is a multi-year project created and funded by the International Alliance for Dermatology Patient Organizations (also known as GlobalSkin). The GRIDD project is a response to the Global Burden of Disease (GBD) projects which have underestimated the burden of living with a dermatological condition. Data from the GBD projects are used to identify patient need, develop policies, and determine resource-allocation and research priorities on a global scale, so it is important that the full impact of having a dermatological condition is captured. Good scientific questionnaires are needed to provide this information. Unfortunately, published research conducted as part of the GRIDD project found that existing questionnaires used both in research and clinical settings don’t meet the scientific standards. 

GRIDD aims to collect global data on the impact of dermatological conditions on patients’ lives to challenge the current burden estimates. To collect this impact data, we have developed the new Patient-Reported Impact of Dermatological Diseases (PRIDD) measure, a scientifically sound questionnaire capable of measuring the impact of dermatological conditions from the patient’s perspective. 

PRIDD was developed according to the gold-standard scientific criteria and with extensive input from over 1,200 people living with dermatological conditions from around the world. Before PRIDD can be used in research and clinical practice, we need to test whether it works as we intended it to. The only way we can do this is by asking people living with dermatological conditions to complete the questionnaire. 

 

Why have I been invited?

You have been invited because you:

  • have a dermatological condition
  • are aged 18 years or older
  • are proficient in English to complete the PRIDD questionnaire

Those who do not have a dermatological condition, are under the age of 18 or cannot complete the questionnaire in English should not take part as their data cannot be used. 

 

Do I have to take part?

No, it is up to you to decide whether or not to take part. You must complete the consent form (on the next page) to take part in the research. We will not collect any data that could directly identify you. You may ask any questions before deciding to take part by contacting the Rachael Pattinson (pattinsonr@cardiff.ac.uk). 

 

What would taking part involve? 

Taking part in the study would involve completing the PRIDD questionnaire (which will take approximately 5 – 10 minutes). The questionnaire will be available online, in English only. We need up to 500 people to participate. The survey will be live from November 1 – December 1 or until we reach 500 participants, whichever comes first. We would also like to find out a little about you, such as which dermatological condition you have, how long you have had it for, and what country you live in.

 

Will I be paid anything for taking part?

No, there is no funding for your participation. 

 

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 dermatological conditions and help us to raise awareness among decision-makers, clinician and researchers. This will, over time, improve the experience of patients and help us to understand the benefits of treatments. 

 

What are the possible disadvantages and risks of taking part? 

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

 

How will my information be kept confidential? 

The information you provide will be stored securely and used solely for research purposes. All information that 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. 

Only the research team will have access to your anonymous data. All electronic data will be kept on a password-protected server at Hamburg and Cardiff Universities in accordance with the UK Data Protection Act and will only be accessible to the research team and regulatory authorities for auditing purposes. Data will be kept for five years and then disposed of securely and may be used for additional analyses related to other aspects of the impact of dermatological conditions.

 

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

Because all data collected will be anonymous, it will be impossible to remove your data once it has been submitted.

 

What will happen to the results of this study? 

We plan to present the findings of this research at scientific meetings and publish in academic journals. We will publish a summary of the results on GlobalSkin’s website, here: https://globalskin.org/research.   

 

What if there is a problem?

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 Rachael Pattinson (pattinsonr@cardiff.ac.uk), who is part of the GRIDD research team. Should you require independent advice, please contact Dr Kate Button, Director of Research Governance, School of Healthcare Sciences (buttonk@cardiff.ac.uk). 

 

Who is organising and funding this research project?

The project is being undertaken by researchers at Cardiff and Hamburg Universities. Professors Chris Bundy (Cardiff) and Matthias Augustin (Hamburg) are leading the research. Prof Bundy is a health psychologist and world-leading researcher with extensive knowledge of inflammatory skin conditions and provides training for specialist dermatology clinicians. Prof Augustin is a world-leading dermatologist and researcher. Other members of the research team are Rachael Pattinson (Research Associate, Cardiff University) and Nirohshah Trialonis-Suthakharan (Research Associate, University Medical Center Hamburg). The research is funded by the International Alliance of Dermatology Patient Organizations.

 

Who has reviewed this study? 

The study has received 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 Rachael Pattinson pattinsonr@cardiff.ac.uk

 

We would like to thank you for considering taking part in this study.