Patient and Public Involvement

We gained permission from a patient who had previously been involved in a research trial for recurrent miscarriage to appraise the basic trial idea and the associated documents.

Her feedback:

Hi Dr Tewary,

I have had a read through the documents today and found that the patient information document was very clear and informative, it explains the trial well and I didn't have any other questions after reading this that hadn't already been answered.

The consent form is clear and I personally wouldn't have an issue signing any part of it.

I think the GP letter was informative and had enough information to keep them informed of the trial, the only thing I would add to this is that the patient is not to get pregnant on the trial, only because this leaps out at me as an important part of the trial and may be worth advising the GP on.

Hope this helps, anything else I can do to help just let me know Kind regards

XXX

As a result of this feedback, the G.P letter was amended to include information about avoiding pregnancy for the duration of the study.

Before the protocol and participant specific documents were submitted to the Research Ethics Committee (REC) we discussed the proposed trial idea at our local ‘Patient Public Involvement Group’ (PPI Group).

This is an initiative set up with the help of a public engagement fund from the University of Warwick Medical School. A meeting is held once every two months where patients with a history of RPL or the experience of a clinical trial in pregnant are invited to discuss potential upcoming research ideas and their sustainability in this target group.

The meeting for the SIMPLANT study was held in the Clinical Sciences building at UHCW and attended by five patients and four members of staff.

A basic description of research terminology was given to the participants to assist them with the understanding of a clinical study. I did a formal presentation on the basic study design.

The attendees explored the practicalities of the study and gave me a lot of insight into questions and concerns that patients approached for the study may have.

There were no objections from any members to the idea of two endometrial biopsies as part of the study or the potential side effects of Sitagliptin. Patients also

expressed the willingness to accept a 50% chance of receiving a placebo tablet on the basis that there would be a 50% chance they would receive a treatment which may help to prevent further miscarriages which is not otherwise available. There was also constructive feedback on how to improve patient documents to improve the quality of information and maximise the impartiality of any information given back on the symptom diaries.

Some of the suggestions included:

o The group felt that if the symptom diary contained a suggestive list of side effects such as a dry cough and headache for participants to tick from, they may record symptoms which are not real. They recommended to replace it with a free text box to help participants record only those side effects actually experienced.

o The group wanted a simplified explanation of the trial pathway. The participant information leaflet was amended to include a step-by-step guide on what would be involved as part of the study pathway.

o Members of the group suggested more information about the timing of the biopsy. This was included.

o Patients suggested providing an emergency contact number in case of any untoward side effects, concerns or hospital admissions while taking the trial medication. We created an emergency contact card which was the size of a bank card so that participants could keep it in their wallet. We made formal arrangements with the hospital switchboard for participants to be able to contact Professor Quenby or Dr Tewary 24 hours a day 7 days a week.

I wanted to ensure the participant information leaflet was easy to read. Members in the PPI group were given the participant information leaflet in 2 two different formats. One in A4 and one in an A5 folded booklet. The members felt that the A5 booklet form was too small and the small font made it difficult to read.

I also provided two different designs. One was black and white with the characteristics of the local trust policy guidelines whereas the other was

divided into coloured sections. The following feedback was given regarding the two designs:

White standard layout Coloured box layout

Difficult for dyslexic to read as

text jumps

Short snippets of information make it easier to understand and digest

Can key information be bullet

pointed? Too much text to digest

Text needs to be centred in boxes

Boring

Better font

Too wordy

Better layout

Bland

People want to read the information

Not clear on what trial is about

More interested in the trial with this

layout

Summary box needs to be same alignment as rest of text

Side effects would be beneficial in box as makes it easier to find

Ensure spacing, underlining and text is uniformed and formatted the same

All this feedback was taken on board before the final patient specific documents were finalised to be submitted to the NHS national REC. We developed a participant information leaflet in line with hospital guidelines but also with colour and summary boxes making information easier to digest. The PPI groups’ unreserved critique of the documents enabled me to make the required changes to address patient concerns and encompass the needs of the trial. As a result, when the trial opened for recruitment I was confident that the documents were comprehensive to the needs of the participants.