Yongbo An interviews Tom Pinkney ahead of his talk at ESCP’s upcoming Global Reach Webinar: 'Translating Evidence into Practice'.

Yongbo An is a surgical resident at Beijing Friendship Hospital and member of the ESCP Social Media Sub-Committee.

Professor Tom Pinkney will deliver his talk on the PROPHER study - 'Patient Reported Outcomes after Parastomal Hernia Treatment: a prospective international cohort study'.

Yongbo An: It is our honour to have this opportunity to ask you a few questions before the webinar to get some preliminary knowledge on the topic.

Parastomal Hernia is a difficult clinical issue as the incidence of this complication can be very high in the long-term follow-ups of patients. For various reasons, the number of patients with stomas is increasing, and the evidence on the treatment and outcomes of parastomal hernia is not adequate. Could you give us a brief introduction on the background of the PROPHER study?

Tom Pinkney: As you say, parastomal hernia (PSH) is a significant problem for our patients. As surgeons, we don’t know how best to deal with PSH, including which patients to operate on and which to recommend conservative treatment. In those who do undergo surgery, the best operation to undertake for a particular patient or PSH is not always clear. Lots of options exist, which we all recognise in surgery tends to mean that none of them are perfect. Mesh or no mesh? What type of mesh? What plane for the mesh?

We hope to address these questions in PROPHER, which will prospectively collect information on all patients with a symptomatic PSH undergoing treatment at participating sites, and establish what works best - according to the individual patients themselves.

YA: In the PROPHER study, patients both undergoing surgical intervention and having conservative treatment/watchful waiting would be included. I noted that the study was designed to capture the information during the whole treatment process, which could provide us with the ‘real world data’. What do you think is the strength of this design compared to Randomised Controll Trials (RCT)?

TP: We know that RCTs tend to collect high quality information on often highly selected populations who satisfied the inclusion criteria for the trial. This is useful in certain situations, but it can be hard to know how the findings from the RCT might be translated to the general population with that condition – in other words the external validity. We want to establish information on the outcomes of ALL patients being treated for PSH, as well as ‘defining the denominator’ by capturing both those undergoing surgery and those having non-operative/conservative treatment.

YA: We know from literature and from past ESCP talks that there are only a few relevant studies involving patient-reported outcomes. Could you tell us the importance and the necessity of using patient-reported outcomes as the primary outcome of the PROPHER study?

TP: We believe that the most appropriate way of determining whether a PSH treatment has been successful or not is simply to ask the patient. Previously, hernia research has often mandated radiological investigations to assess outcomes – but this is both expensive and inconvenient for all involved, particularly if the images have to be transferred for centralised review. We also often don’t believe the results of scans, particularly in a PSH context. For example, if a scan suggests that the hernia is still present but the patient feels that their symptoms are resolved, we wouldn’t suggest another operation. Similarly, if the patient knows that their hernia is still present due to pain and problems with their stoma bag, but a scan says the PSH has been treated successfully, who do we believe? The exact same issue holds true with clinical examinations by medical professionals. So we just ask the patients if their intervention worked, based on their symptom changes, quality of life, and some other more specialised patient-reported outcomes

YA: In order to help the audience understand the progress of the PROPHER study, could you briefly introduce the timeline/plan of the study? Is there already any initial findings that you’d like to share in the upcoming global reach webinar?

TP: Like so much in all of our lives, PROPHER has been significantly delayed due to the pandemic. But we are making great progress now and the pilot phase is due to go live in English-speaking countries in the next couple of months. Our initial experience is that it’s really quite challenging to open an international study linking directly patient reported outcomes with clinician-provided technical data. Negotiating the data transfer and consent/ethics/governance issues needed to conduct the study hasn’t been easy. But we have a great network fostered by the ESCP snapshot audits since 2015 who are poised and ready for the study. An additional aspect this year has been joining the tripartite programme as the ESCP project - linking in with colleagues in the USA, UK, and Australasia.

YA: Thank you so much for sharing the information about the PROPHER study. We look forward to watching your presentation on March 19th, and we hope the study will have great progress in the near future!

Professor Tom Pinkney will give his talk at 12:00 (GMT) in Session 2 of ESCP’s Global Reach Webinar, covering ‘Studies from ESCP and Collaborators’.

Keep up with the latest from ESCP’s international studies and its upcoming webinar using the hashtag #ESCPGlobalReach on Twitter.

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