An interview with Sue Blackwell

Watch Professor Blackwell’s talk on the PROPHER study at the upcoming ESCP 2021 Virtual Conference on Wednesday 22nd September.

Questions for Sue Blackwell

1. Dear Prof. Blackwell, thank you very much for speaking with us. We would like to begin by asking you to give us a brief introduction on the PROPHER study.

PROPHER is the first cohort study from ESCP, and is looking at patient reported outcomes after parastomal hernia treatment, so both operative and non-operative. PROPHER is really exciting because it’s the first time that PROMS have been a primary outcome measure in hernia research, plus we are using some great technology to collect the data from patients.

2. Could you introduce the technology or app used by the study to collect the data? What are the advantages?

We're going to be using a mobile app from a company called Aparito to collect patient consent, and to collect all the patient reported outcomes data. Traditionally studies have sent patients paper-based questionnaires, which are easy to set aside and forget to do, plus the patient has to remember to return them. By using the app, patients will be able to complete their follow up questionnaires when they are ready, the app will send them notifications when they need to do them, and send reminders if they forget to complete them. There are so many benefits to collecting PROMS this way, not least because it removes the surgeon and the clinical team so there's no risk of bias.

3. Among the data/outcomes that will be collected in the PROPHER study, which one/ones do you think will be the most unique and can reflect the merits of patient reported outcomes design?

This has to be MYMOP, the Measure Yourself Medical Outcomes Profile. This is where patients select the two outcomes that matter most to them at the start of their treatment, and then are represented with them at the 12 month follow up to see whether or not they were achieved. We believe that this is the first time that MYMOP has been used in a colorectal research study, so we are really excited to see the data that comes from this as it will help us to understand what really matters to patients who seek treatment for a parastomal hernia.

4. What is the current progress of the PROPHER study? How many centers/countries are participating? And what is the inclusion volume so far? Do you feel it is easy to invite patients to join the study?

Unfortunately the COVID 19 pandemic meant that we had to put plans to open PROPHER on hold. Given most parastomal hernia repairs are elective, and many countries, including the UK, had to postpone elective surgery to deal with the pandemic, it wasn’t possible to open. However, we are just getting ethical approval here in the UK and then we will be ready to open, which is very exciting. We don’t forsee any issues in inviting patients to join the study. Patients with a parastomal hernia tend to be very engaged with their care. That, coupled with the fact that we will be using a mobile phone app to not only collect PROM data, but also collect consent as well, will we hope make the study very appealing to patients.

5. Would you mind sharing some interesting results or enlightenment from the PROPHER study? Will the PROPHER study affect clinical research study design in the future? Do you think patients-reported outcome mode will be adapted by more studies?

We’re hoping that PROPHER is just the start of studies including PROMS as primary outcome measures. ESCP will be able to lead the way on this with any future studies that we run. It’s so important that research measures the outcomes that are important to patients, as well as those that are clinically important, and we can only know what those are by designing and delivering studies alongside patients. We also hope that the data that we get from PROPHER on operative technique will help inform a future RCT on parastomal hernia repair.

Watch Professor Blackwell’s talk on the PROPHER study at the upcoming ESCP 2021 Virtual Conference on Wednesday 22nd September.