Your input is a vital part of improving pressure ulcer prevention research. Before you fill out the questionnaire, please read this information carefully. This introduction includes some background about the project and information about how to complete the questionnaire. If you have any questions, please feel free to contact: anna.lechner@charite.de

Thanks for your support!

Clinical trials are a type of health research. They are the best way to compare treatments to find out what works best. In this study we are interested in prevention clinical trials for pressure ulcers. Prevention trials follow people who are at risk of pressure ulcers (e.g. patients who cannot turn themselves in bed or who use a wheelchair) but do not actually have any ulcers yet. We use prevention clinical trials to see which prevention techniques work best. Examples of pressure ulcer prevention techniques include things like special mattresses, changing position regularly, skin care or staff/patient education.

What are research ‘outcomes’?
When we do clinical trials, we measure and evaluate outcomes. This helps us to decide which prevention techniques are actually helping patients the most. Outcomes define ‘what’ to measure. We have provided two examples of fictional pressure ulcer prevention trials, to help demonstrate what we mean.

Example 1
A research team wants to know which type of mattress ‘works best’ when trying to prevent pressure ulcers. They set up a trial where half of the patients are given a specialist mattress and half are given a standard mattress. They monitor how many people get pressure ulcers on each mattress. They also ask patients about how well they are sleeping.
In this example the preventative technique is the special mattress, the outcomes are pressure ulcer development and sleep.

Example 2
A different team have developed a new leaflet for patients. The leaflet gives people advice on how to prevent pressure ulcers at home. They set up a trial where half of the patients are given the new leaflet and half are given an old leaflet. The team monitor how many patients in each group get pressure ulcers. They also ask patients to complete questionnaires about their quality of life.
In this example, the prevention technique is the new leaflet, the outcomes are pressure ulcer development and quality of life.

What is a ‘core outcome set’?
At the moment, different pressure ulcer prevention trials use very different outcomes. This makes it hard to compare different trials, which in turn makes it difficult to know which prevention techniques work best. core outcome set (COS) is a list of outcomes that patients, families, healthcare professionals, industry representatives and researchers have decided are critically important. At the end of this project, we will have a COS of the most important outcomes, which should be assessed as a minimum in every pressure ulcer prevention trial. Researchers are free to record other outcomes as well, however the COS should always be included.

There is more information about core outcome sets in a short video:

What have we already done?
We have looked at lots of pressure ulcer prevention trials and made a list of all the different outcomes that they used. This process is known as a literature review. We have also talked to patients and families to identify other important outcomes and have added them to the list.

What am I being asked to do?
We are inviting you to complete a series of short surveys. The survey will ask you to review the list of outcomes and decide how important each one is:
- What outcomes are critically important to you?
- What outcomes will help us to find out which prevention techniques ‘work best’?

Please score each outcome from 1 (not important to you at all) to 9 (critically important to you). If you feel unable to score, please select ‘unable to score’ and, if possible, provide feedback. Once you complete a page, you will not be able to use your browsers ‘back’ to return to that page. However, at the end of the questionnaire, you will see an overview of your answers and you will have the chance to change your scores. You will also be able to add any extra outcomes, which seem critically important to you, but are not on the list. 

If you’re not familiar with any of the terms in the questionnaire, then please hover your curser over the term and a short description of the term will appear.

It takes about 15 to 20 minutes to fill out the survey. If you are unable to complete it in one go, then you will need your registration details to log back in and pick up where you left off. You will be asked to complete a maximum of three surveys over a maximum of about 7 months. We would like you to complete this first survey by 31 January 2021.
The second round of the survey will start on 01. March 2021. In this round, you will get feedback on how different groups of people (practitioners, researchers, patients/familiy carers, industry representatives) have rated the outcomes. This gives you the opportunity to think about and revise your own opinions, if you want to. All responses will be processed and summarised anonymously. That means that the answers which individual people have provided will not be displayed. We may invite you to complete a third survey. We will only do a third survey, if there is still a lot of disagreement about some outcomes.

A few things to keep in mind when doing the questionnaire:
- There are no right or wrong answers. We are interested in your opinion.
- This project is about pressure ulcer prevention research (i.e. research with patients who are at risk, but do not have a pressure ulcer yet), not pressure ulcer treatment research (i.e. research on patients who already have a pressure ulcer).
- Although you may feel all the outcomes are important, we are interested in which ones are critical to you and should be assessed in every pressure ulcer prevention trial as a minimum.

Registration and consent
By registering for this survey, you are giving your consent to take part in this project. You are agreeing to us collecting, processing and storing the data (information) you provide. We will use the results of the survey for research purposes and may publish the results in scientific journals. After we have analysed the results we will send you a short summary. The results will be published anonymously, which means it will not be possible to know how individuals responded. Your name will only be mentioned in the acknowledgment section of a publication (with your permission).  We will ask you whether you would like to be acknowledged after the final survey. You can change your mind about taking part in this project at any time. We will store data in a secure database at the University of Liverpool (UK). It will also be securely transferred to the Charite-Universitatsmedizin Berlin (Germany) for data analysis. Only authorised employees will have access to the data. Your privacy is very important to us. We follow strict rules about how we handle and store the information you give to us.

Many thanks for your support with this project!

Anna Lechner  
Charité-Universitätsmedizin Berlin, Germany

On behalf of the project team
Prof. Dr. Katrin Balzer, University of Lübeck, Germany
Dr. Susanne Coleman, University of Leeds, UK
Prof. Dr. Jan Kottner, Charité-Universitätsmedizin Berlin, Germany
Delia Muir, University of Leeds, UK
Prof. Dr. Jane Nixon, University of Leeds

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