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DFU COS Delphi Survey Round 1

Page 1 of 7

Development of a Core Outcome Set for studies on treatment of Diabetic Foot Ulceration

Dear Patients and Colleagues,

We would like to invite you to take part in a survey exploring your views on the management and treatment of Diabetic Foot Ulceration.

The aim of the study is to collect the views of patients and healthcare professionals to what are the most important outcomes when being treated for a Diabetic Foot Ulcer. These views will be used to create a Core Outcome Set which will allow comparison between studies assessing different treatments for Diabetic Foot Ulcers.

The survey contains a wide range of outcomes which have been reported in studies assessing treatments for diabetic foot ulceration. Each outcome will be ranked on a scale from 1 to 9 with values corresponding to the following statements:

Values 1 to 3 - Outcome not considered to be important (for definite exclusion from the core outcome set)

Values 4 to 6 - Important but not a critical outcome

Values 7 to 9 - Critical outcome (for definite inclusion in the core outcome set)

Once we have collated all responses for Round 1 of this survey, we will contact you again via emial for a further round of responses in order to reassess your views on the outcomes for which no consensus was reached.

Thank you for taking your time and participating in our study.

Alex Staniszewska, Chris Ashmore, Maia Osborne-Grinter, Jane Nixon, David Russell and Robert Hinchliffe

Are you a patient or a healthcare professional?

Patient

Healthcare professional

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Patient information leaflet: Delphi Survey

Development of a core outcome set for diabetic foot ulceration

We would like to invite you to take part in a study exploring your views on the management and treatment of Diabetic Foot Ulceration.

The aim of the study is to collect the views of patients as to what is the most important outcome when being treated for a Diabetic Foot Ulcer. These views will be used to create a Core Outcome Set which can allow comparison between different treatments for Diabetic Foot Ulcers.

Why have I been invited?

You are being invited to participate because you have had experience of a treatment or intervention for Diabetic Foot Ulceration, this may include medications, footwear, plaster casting, orthopaedic or vascular surgery.

Do I have to take part?

No, it is up to you if you want to take part. If you decide to take part and then later change your mind, you are free to leave the study at any time without giving a reason and all data will be deleted.

What will happen to me if I take part / what is a Delphi survey?

If you agree to take part, you will be asked to sign an electronic consent prior to completing an online survey in which you will rank different outcomes for treatment of Diabetic Foot Ulcers on a scale from 1-9. 1 being not very important and 9 being very important. Examples of outcomes might be freedom from ulceration, ulcer infection, ability to walk independently or amputation. The survey takes roughly 30 mins to fill out. After a few weeks, you will be asked to complete another survey in which you will rank some of the outcomes again. Your answers will be combined with that of other patients to help us plan the future research.

Will my taking part in the study be confidential?

All personal information will only be seen by the research team. Documents will be saved using a study ID number and not linked to your name. The information will need to be stored for 10 years, but if you agree we will store the anonymised responses for longer to help us with future training, teaching, and research. Data will be stored on a secure database at the University of Bristol.

What are the possible disadvantages and risks to taking part?

There are no physical risks to taking part. The main burden is the time taken to fill out the survey. You are free to leave the study at any point.

What are the possible benefits to taking part?

There is no direct benefit for taking part in this study. The main benefit will be that you will help us planning research that will help patients who have treatment for Diabetic Foot Ulcers in the future.

What will happen to the results of the research study?

The findings will help us improve the quality of medical trials looking at treatments for Diabetic Foot Ulcers. A report of the study findings and academic papers will be published. Findings may also be presented at academic conferences, workshops, or used for training purposes. You will not be identified in any report, publication, or presentation.

Who is organising the research?

Researchers at the University of Bristol Medical School, Centre for Surgical Research.

Has the study been ethically approved?

This study will be reviewed by a Research Ethics Committee. This committee is responsible for making sure that research is appropriate and that the participants' rights and welfare are protected.

How will we use information about you?

We will need to use information that you provide about yourself for this research project.

This information will include your email address which you will provide when completing the online survey. People will use this information to do the research or 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 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. Once the data has been analysed, we will seek to share our findings through publication, presentation and the media. All reports will be written in a way that ensures that no-one can work out that you took part in the study.

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.

Where can you find out more about how your information is used?

You can find out more about how we use your information:
- at http://www.bristol.ac.uk/secretary/data-protection/policy/research-participant-fair-processing-notice/
- by asking one of the research team
- by sending an email to data-protection@bristol.ac.uk, or
- by calling the University's Data Protection Officer on (0117) 3941824.

Many thanks for taking the time to read this information sheet.

If you have any questions please contact:
Professor Robert Hinchliffe
Email: robert.hinchliffe@bristol.ac.uk

Click the document title to download a copy of the Participant Information Sheet:

Attachment:COS DFU - Patient information leaflet -Delphi Survey _v2.docx

Please answer the following questions:

I have read and understood the information sheet dated 27/10/2021 Version 2.0 for the COS Diabetic foot ulceration DELPHI Study.

Yes

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I have had the purpose and nature of the study explained to me in writing and I have had the opportunity to ask questions about the study.

Yes

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I understand that even if I agree to participate now, I can withdraw at any time or refuse to answer any question without any consequences of any kind.

Yes

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Date:

D-M-Y

Please enter your contact email address:

As we are planning to run two rounds of this Delphi survey, we do ask for your email address in order to be able to contact you with the link for the second round. All data are housed within University of Bristol servers, and please be assured we will not use your email address for anything other than this study

Do you practise clinically in the United Kingdom?

Yes

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Which country to you practise in?

What is your role?

Doctor

Podiatrist

Nurse

Other

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What is your role?

What is your specialty?

Vascular surgery

Diabetes and Endocrinology

Orthopaedics

Other

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What is your specialty?

What is your grade?

Registrar

Staff grade

Consultant

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How many years of clinical experience have you got in your specialty since graduation?

< 5

5-10

11-20

>20

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You have selected an option that triggers this survey to end right now.

To save your responses and end the survey, click the 'End Survey' button below. If you have selected the wrong option by accident and/or wish to return to the survey, click the 'Return and Edit Response' button.