Meeting between Gill and Giovanna, Wednesday 13th January 2021

The aim of the meeting was to review the feedback received from the FAST-R team and to plan the next steps in the project. Four individual reviewers had provided feedback, and answered the questionnaire, with their feedback being summarised in an overview document.

From the feedback it became obvious that the relationship between the example illustrated modules and the original PIS text document had not been adequately explained when the two files had been submitted. The reviewers therefore assumed that the illustrated pdf file represented an entire PIS, rather than select modules. Some of their feedback reflected that and so, unfortunately, could not be used.

Giovanna had also made the decision not to change any of the text in the PIS, as that would mean re-submitting any new text to an ethics committee for approval. This meant that any feedback relating to changes in the text also had to be discounted. Gill thought that this could be a missed opportunity both to improve the text – based on the feedback from the reviewers – and to ensure that text and images are combined to greatest effect. However, Giovanna explained that the ethics approval would be time-consuming and difficult to achieve within the timeframe of the project. This will change the original scope of the project somewhat, as revising and simplifying the text of the PIS had been put forward as one of the aims. Instead, the project will concentrate on creating the illustrated modules, while retaining the original text.

Despite the confusion over how the illustrated modules related to the PIS, the reviewers had reacted very positively to the illustrated version and all said that they would choose that one over the text-only version. One reviewer suggested that the illustrated version could be used in conjunction with a text PIS document, possibly as a more informal ‘information only’ document, to help explain a study to a patient. This could indeed be an additional use for the images, outside of a formal PIS. Another reviewer requested that a more diverse range of people be represented in the images. This had always been the intention with any illustrations that include people, with the aim of building up a library of alternative images for scientists to choose from. The adaptable nature of the images makes it relatively easy to ‘swap in’ people of different age, gender and ethnicity into the various illustrations.

Giovanna and Mattia had also shown the illustrated PIS modules to some of their colleagues in the CNS and had received a positive response. One colleague requested a paediatric version of the modules and, although this project is concentrating on a PIS for adults, the creation of additional illustrations that include child patients could certainly be part of a future project.

Based on the FAST-R feedback, after setting aside the comments that referred to the text, Gil produced a list of amendments that she would make to the example illustrated PIS modules:

  • Add ‘taking a blood sample’ to the table on page 4 of Module 4. Although this means a change to the text it seemed to be an obvious oversight in the original text document (one that had been previously noted by Gill, as well as the reviewers) and so it will be added.
  • Add an image of a breathalyser to go with the illustrations of the urine sample and blood sampling on page 3 of Module 4.
  • Create new illustrations – or edit existing illustrations – to better reflect the diversity of patients and staff at KCL.

Some of these new or revised images are shown in the header image of this post.

Since the meeting, Gill has produced an updated pdf file for the example PIS modules, including these revised images. At this stage, work is still concentrating on the A4 format for the PIS modules, initially in pdf files and ultimately in Word document format. Once all of the content has been finalised then the PIS modules will also be produced in PowerPoint format(s). There will be another meeting shortly to discuss the next steps in the project.

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