S-ECCO feature: The scientific journey of an epidemiologist

Twenty years ago, as a PhD student in epidemiology, I took courses alongside PhD students in quality research. At the time, I struggled to understand how they could draw conclusions from studies involving only a small number of patients, and I was puzzled by their scepticism toward quantitative research. Over the years, however, my perspective has evolved. I’ve come to realise that multiple types of research are essential to improve the care of patients with IBD.

As an epidemiologist, I was taught that the hierarchy of evidence places randomised controlled trials (RCTs) at the top. This concept has since been disputed, with well-designed cohort and case-control studies being considered to provide equally valid results.  We must acknowledge that RCTs may not always be the best approach to improving our knowledge about surgical and medical treatments in IBD. It is well known that the results of an RCT may not be generalisable to a wider context, usually focus on short-term outcomes, which may be less relevant in the presence of a chronic disease, and may not be applicable in “real life”, where other factors, such as patients’ preferences, play a role.

Given our positive experiences of ileorectal anastomoses, we wanted to evaluate the role of this method in patients with Ulcerative Colitis (UC). A previous attempt at an RCT was terminated due to the inability to randomise patients, given their strong opinions on which treatment they preferred. Drawing on that experience, we launched the CRUISE study in Sweden in collaboration with St Mark’s Hospital, where patients with UC who had a colectomy were offered a choice of ileorectal anastomosis, pelvic pouch or permanent stoma after receiving standardised information. Given this new approach, almost all patients agreed to participate.

In the context of IBD, shared decision-making is becoming an increasingly vital strategy. It improves patient satisfaction, aligns treatments with patient values and ultimately strengthens clinical outcomes. Traditional trial designs, particularly those that prioritise internal validity through methods like blinding, have often overlooked patient-centered care in favour of methodological purity. However, patients are now well informed and, as already mentioned, have strong views on which treatment they would prefer.

One area in which this shared decision-making approach is applicable is the treatment of moderate/severe UC. Lately, there has been rapid development of new drugs to treat UC, and colectomy, an established treatment with well-documented results, is usually postponed until all medical options have failed. Extended administration of advanced medical therapies without achieving remission can, however, lead to worsened health, including malnutrition, poor surgical outcomes at colectomy and an increasing risk of neoplasia. With a growing palette of drugs, some patients endure long periods of active disease before surgery. The TRIOCOL is a preference study using a shared decision-making design. All patients receive a consultation with a gastroenterologist together with a colorectal surgeon, to inform them about the medical and surgical options based on the best currently available evidence.

Over the course of my years of epidemiological research, I've contributed to studies that highlight critical aspects of IBD treatment. For example, we’ve shown that many patients do not undergo restorative surgery after a colectomy, and we’ve identified predictors for surgical failure using various methods. These studies have provided invaluable data on patient treatment and outcomes, but they have not fully answered the more personal question: How are our patients feeling, and what factors influence their treatment choices? To further address this, we recently completed a qualitative study as part of the CRUISE study, which examined how patients with UC make decisions between permanent stomas and various restorative surgical options. Interestingly, regardless of the choice, patients shared a common goal—to regain their normality. This underscores that while physicians are familiar with the various treatment options, it’s not always clear which is the best choice for each individual patient.

In conclusion, I believe that we are witnessing a significant shift in the way we approach research in IBD. Epidemiological studies hold great value provided they are designed to yield insights that truly matter to patients, rather than simply uncovering statistically significant associations that are of less clinical relevance. Traditional RCTs may not always be suitable for surgical IBD research and could, in some cases, be replaced by preference-based studies. Shared decision-making is not just a way to improve clinical outcomes; it also acknowledges and respects patients’ lived experiences and is well complemented by qualitative research. The conventional hierarchy of study designs is increasingly outdated. Instead, we must embrace innovative methodologies while maintaining a critical lens to ensure the robustness and relevance of each study before drawing conclusions.

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