Improving medicines for children (part 3) Developing age-appropriate tools to measure the acceptability of paediatric medicines

Welcome to the third post in a series on ‘improving medicines for children’. The series hopes to capture and report children and young people’s opinions about the medicines they take, their ‘wish’ list for future formulations and the importance of developing tools to assess if a medicine or medical device is acceptable to children and young people. Catch up on what children and young people have told us so far by reading part 1 and part 2.

The focus of this post is to highlight the need to produce reliable age-appropriate tools to measure the acceptability (see part 1 for a definition of acceptability) of medicines in collaboration with children and young people themselves.

AGE- APPROPRIATE ASSESSMENT TOOLS

New medicines (and new devices to deliver medicines) for children and young people must be demonstrated to be acceptable to that population. However, there is currently no guidance on how to conduct or report on acceptability testing as there is no ‘gold standard’ method to assess this. Substantial efforts however are being made by researchers and the pharmaceutical industry to standardize this.

So how do we find out which assessment tools are most suitable to children? It’s simple, we ask them! So we did. In the young person’s workshop we held in August (highlighted in Part 2 of the series) we where joined by a company who are in the process of designing a microinjection device (similar to an epi-pen)
to deliver medicines as another option to the commonly used injection, which in most cases children (and adults alike) are fearful of and can cause distress.
However, before the company proceeded with the development of this device they wanted to hear how acceptable the device was to children and young people.   Following a demonstration the group where asked to choose a scale that they thought was most appropriate to answer questions based on the potential delivery of a variety of children’s medicines, including vaccines.

Out of four scale options, the most preferential scale was the Wong Baker FACES ® pain scale (below).

 

Why? The children felt that the new delivery device may cause a little discomfort/pain to the child if they were to use the device, hence the reason to use a pain scale to assess the device’s acceptability.

However, the only problem with this scale, as also noticed by some of the young people from the workshop was that it would be difficult to answer questions based on the appearance, weight and overall usability of the device (or any other device being developed) as this scale has anchor phrases at the bottom of each facial expression, which may not be applicable to questions researchers may want children to answer.

The group of young people in this workshop were 12 years and over, so their cognitive ability to understand a visual analogue scale (below) would be better than that of a child under 12 years.

(0 being they really liked it, and 10 they didn’t like it at all)

Based on the young people’s thoughts and through conversation, it was easy to identify that another good scale to use for all children would be a 5 faced scale (below) which is simple to use, easy to understand and is more attractive to look at. This scale has been used in other studies involving children.

FEEDBACK ABOUT THE DEVICE

The group really liked the device and saw the potential in delivering medicines to children in a way that could possibly avoid distress and pain.  The only concern they had was about refilling the device and questioned whether children (or their families) would be able to do this at home.  The company reassured the group that they are working on the prototype and the final product would be much easier to refill.

 

SO WHAT NEXT?

We will take this feedback from the workshop and undertake similar work with children and young people who have regular injections to see if there is any difference in opinions to the proposed new device but also in the chosen assessment tools. Part 4 will report back on the findings, so watch this space.

For further information about this project please contact me. For further information about our recent activities with children and young people, read the GenerationR Liverpool YPAG Annual Report 2016-17.

Thank you for reading.


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