Authors: Giulia Pellizzari1 and Linda von Nerée2
‘Very interesting and thought provoking’ and ‘A great opportunity to hear from patients directly’ – Trial Managers at the CRUK & UCL Cancer Trial Centre
UCL’s Translational Research Office (TRO) supports researchers to secure funding for early phase cancer trials that are run with the Cancer Research UK (CRUK) & UCL Cancer Trial Centre. Patient Information Sheets are key documents for potential participants to make an informed decision to take part in clinical studies. Read on to hear top tips on how to improve Patient Information Sheets.
In this workshop trial managers worked with the Patient and Public Research Panel of the NIHR Blood and Transplant Research Unit in Stem Cells and Immunotherapies (TRO project managed), to identify improvements in the language and format of Patient Information Sheets from the CRUK & UCL Cancer Trial Centre. The workshop was hugely beneficial for both trial managers and patient and public partners and will now be offered to clinical trial staff across the UK from September 2022.
While there is clear guidance from the Health Research Authority (HRA) on content and regulatory requirements, Patient Information Sheets are customised for each clinical trial and the specific patient population. Choosing the right language and format for patient facing materials for clinical trials still greatly varies and depends on skills and experiences of the team putting them together.
This shows the importance of making best practices available and getting the help of patient partners to review patient facing documents. Patient and public partners can advise on language and format to turn lengthy Patient Information Sheets with dense information into documents that are easy-to-understand. This supports an informed decision of participants whether to take part and to remain in the study. It ensures to cover practical questions as well as legal requirements.
On 16 March 2022, ten patient and public partners and twenty-four trial managers worked together in an online workshop to discuss improvements in the language and format of Patient Information Sheets.
The workshop started with a fun quiz about patient and public involvement in clinical trials, looked at regulatory requirements (for patient and public partners) and principals of writing in Plain English (for trial managers), before hearing first hand from a patient about her experiences as a study participant and as a patient representative in Trial Management Group Meetings of clinical studies. In breakout rooms mixed groups of trial managers and patient and public partners discussed a set of questions looking at two examples of Patient Information Sheets from studies at the CRUK & UCL Cancer Trials Centre. While Patient Information Sheets were judged as overall good quality, patient and public partners highlighted a number of possible improvements including:
- Changes to the format
- Patient information sheets tend to be rather dense and wordy – use formatting to break up information. For example: use headings (with links to section, if digital documents); short paragraphs; bullet points; tables; flow charts; graphics and images to make documents easy to read.
- Include why people are invited to take part and study outcomes early on
- Encourage asking questions and add a page for notes in the end of Patient Information Sheets
- Provide a printed version of the Patient Information Sheet for reading and an electronic version for later reference
‘When you are faced with information regarding a potential trial for yourself to partake in, on top of just receiving a cancer diagnosis, your mind is everywhere. To have an area specified for questions would allow patient and their carers to document questions and concerns which can then be posed to clinical trial teams.’ – Patient and public partner
- Improvements to the language
- Use language to make it softer. Rather than ‘ if you have not responded’ or ‘if you have responded’ say something like ‘dependant on your response to the treatment’
- Use empathetic, everyday language rather than clinical wording!
The workshop finished with elements of patient communication and involvement before and beyond Patient Information Sheets.
The workshop was well received and suggestions from patient and public partners are now being implemented in guidance for future Patient Information Sheets at the CRUK & UCL Cancer Trial Centre.
Most importantly, this workshop provided the opportunity to first-hand experience the benefits and learnings from working with patient and public partners, an aspect that the UCL Cancer Trials Centre is embedding into their educational framework as a permanent feature.
Key learnings for holding a second workshop with patient partners and health care professionals for this workshop include:
- Appoint a facilitator/coordinator for each group work before the event and have a template on which to report
- Be generous with time for online workshops
- Explore using interactive whiteboards to allow more notes
One final question remains for online patient and public partnership work: How do we have virtual teas and biscuits?
1 Training Lead and Trial Coordinator, CRUK & UCL Cancer Trial Centre
2 Patient and Public Involvement and Engagement Lead, NIHR Blood and Transplant Research Unit in Stem Cells and Immunotherapies at UCL
Acknowledgement: Many thanks to members of the Patient and Public Research Panel at the NIHR Blood and Transplant Research Unit in Stem Cells and Immunotherapies for their time and expertise. Especially to Gillian for co-designing the workshop.