Lillie Pakzad-Shahabi, Clinical Trial Coordinator, Neuro-oncology, Department of Medicine, Imperial College London
Why did you decide to do Patient and Public Involvement (PPI) in your clinical trial?
After receiving a NIHR Imperial BRC PPI award (Round 3) to run a project with a secondary school, I stumbled across the PERC-ICTU PPI training series at Imperial. These workshops helped me to understand the importance of PPI early in clinical trial design. I decided it would be useful to involve patients from our clinic and their family members to review upcoming clinical trial protocols.
We hoped to gather the perspectives of patients and their family members on our plans for the design of two clinical trials.
So, what did you do?
I coordinated a session with clinicians (a Neurosurgeon and an Oncologist), patients, and family members to discuss two to three ideas for clinical trials – one for newly diagnosed patients undergoing surgery (using new and advanced surgical techniques) and the other two were regarding patients with recurrent high grade brain tumours who were fit enough to undergo further treatment (with new oncological treatment interventions). Patients and family members were identified by speaking to the clinical team and I called each patient individually prior to the session to let them know what they should expect. I explained that the session was intended to be an open space where they could let us know their views, ask questions for clarification and whether the trial schema (such as planned visits during the trials; timings and intervals of questionnaires to be completed) were practical.
The two-hour sessions were held at Imperial College Charing Cross Hospital as the patients were all familiar with the location of the hospital. The session was broken down into three sections:
- Surgical trial – Ms Camp (Consultant Neurosurgeon) presented and then led a discussion on the outcomes of the trial
- Assessment measures – reviewing the material that is used to assess patient’s Quality of life, mental and physical performance during the course of both trials that were discussed
- Re-irradiation trials – a presentation by Dr Williams (Clinical Oncologist) was followed by a discussion on the draft Patient Information Sheet and timepoints.
It is important to reiterate to patients that their views are important and valuable as they can provide insight to clinical trial design that we cannot.
The key question: How did you change the study design after the session?
With the help of patients and family members we discussed the proposed primary outcomes on the neurosurgical trial and we were able to conclude on which of these was more important to the patients and carers. This will help to improve the study design of the clinical trial.
We were able to obtain constructive feedback on the Patient Information Sheets for the Re-Irradiation trial and useful ideas about how to improve these, which will help support any future trial participants.
We gathered feedback on which quality of life measures should be reported in both trials and the timepoints at which these measures are given to clinical trial participants. The QOL measures discussed included the core assessment unit used for all cancer patients (EORTC QLQ-C30) as well as an alternative, condensed unit (EORTC QLQ-C15-PAL). We also introduced the BN20 (brain tumour specific) unit.
As a result of the perspectives given to us by the group, we:
- Determined a single primary outcome for a surgical trial which was “Disability/ Deterioration Free Survival” as patients felt that severity of loss of function was most important to them.
- Amended a Patient Information Sheet to make it more accessible to patients and relatives by providing a lay summary and making it shorter and more concise.
- Amended the time point at which the Quality of Life questionnaires are completed by patients and recommendation of where the forms should be completed (either at home prior to attending clinic, during the waiting time in clinic or via an online portal). It was decided that it would be best to complete these in the clinic waiting room prior to the appointment.
- Decided which Quality of Life measure would be most beneficial and relevant to patients. The Quality of Life measures selected were two standard questionnaires however, the patients felt that the EORTC QLQ-C15-PAL module captured all the information needed and that the EORTC QLQ-C30 did not gather any necessary further information required for the study purpose.
Who did you involve and how did you find the right people?
The PPI group consisted of a combination of patients with high- and low-grade gliomas as well as their family members who were invited by letters from the Consultant Oncologist. I then contacted all the patients and asked whether they would be interested in attending. I encouraged them to bring a family member along.
How do you think the people involved (both researchers and the public) were impacted by the project?
Patients and carers who attended the session gave largely positive feedback about their involvement, reporting an improved understanding about how clinical trials operate and how they can be involved. One person described: “I have gained the feeling that I could really make a difference”, “I feel that this is a way of me giving back” and “found it really interesting learning the processes that happen before a trial takes place”.
The researchers found the session useful as it answered some uncertainties, including which Quality of Life measure to use and its feasibility. The session also helped determine a single primary outcome which was more relevant to the patient and their family. They also enjoyed interacting with patients and found it very insightful and motivational in terms of the way that they carry out their research.
What was the most challenging part of doing public involvement and how did you overcome it?
I found the idea of chairing the patient and carer meeting quite daunting as I had never done this before. However, I felt more confident after attending the PERC/ICTU PPI training sessions where we discussed how to deal with behaviour in groups and other things to consider when undertaking PPI activities. I found the uncertainty of how patients would react quite challenging but having the support of the clinicians really helped. As the session progressed, I felt I was more confident and was able to ensure that the language used was accessible (e.g. asking consultants to not use acronyms).
What advice would you give others interested in doing something like this?
Don’t be afraid to do PPI as patients and carers are very interested in research and keen to know what is going on. They will motivate the whole team as they come up with ideas that you may never have thought of.
I would make sure that people know it is an open discussion and not recruitment to a trial. Also, that there are no right or wrong answers and there is no such thing as a silly question.
I am currently planning an engagement project with Year 10 students at a secondary school in Northwood. We are going to create brain models and have a space for clinicians and researchers to interact with school children. This is planned for November 2018 and will continue over several months.
We have held three sessions so far, covering the practical difficulties in treating brain tumours by getting the students to remove a stone (tumour) of a date (functioning tissue/brain) in two models – on its own or covered in several layers of playdough, and then discussing what tools would have made it easier or the barriers that were faced.
We also covered the molecular aspects of brain tumours and then go the students to work in groups to create models using sweets (DNA, DNA helix demonstrating methylation) and clay (chromosomes and mutations).
Will the PPI group meet again? Will it be a regular meeting? Have you fed back to them about what changed as a result of their suggestions?
We held a second session a month after to report back any changes that were made in the protocol and provided those who took part with further handouts based upon recommendations that were made in the initial session. Once we have finished our Patient/Carer Information Sheets, and secured a grant, we will meet again to discuss whether any further changes would be recommended. We will provide updates at this meeting.