Prof Fergal Malone says it’s important for doctors to challenge conventional wisdom to ensure that contemporary medical practices are ‘safe, effective and appropriate’.
A recent study from RCSI University of Medicine and Health Sciences and the Rotunda Hospital in Dublin found that it is safe for first-time mothers with low-risk pregnancies to spend the first 24 hours of induced labour at home. The aim of the research is to ensure more satisfactory induction of labour for women while also reducing pressure on busy maternity services.
The study was led by Fergal Malone, professor and chair in the Department of Obstetrics and Gynaecology at RCSI and a consultant subspecialist in maternal foetal medicine at the Rotunda Hospital.
Malone told SiliconRepublic.com that his first major research opportunity was as co-principal investigator of the ‘Faster’ trial, when he worked as a consultant at Columbia University Medical Center in New York. This study involved more than 36,000 pregnant women across 15 US medical centres, with the goal of comparing various screening methods for foetal abnormalities.
The results of the trial, which were published in the New England Journal of Medicine, “underpinned major advances in prenatal care internationally”, Malone said.
He returned to Ireland in 2005 to work as RCSI and launched the Health Research Board-funded Perinatal Ireland research consortium which linked all the major obstetric hospitals and their university partners across the island of Ireland to conduct obstetrics research. He also works with the Mother and Baby Clinical Trials Network, which conducts large-scale clinical research trials in pregnancy and neonatology to address challenges in contemporary obstetric practice.
Tell us about your current research.
Recently, my team completed a large randomised controlled trial on different methods of induction of labour at term in otherwise healthy pregnant patients.
Previous conventional wisdom was that induction of labour should be restricted to situations in which a patient was either overdue or had significant pregnancy complications. However, subsequent research has confirmed that induction of labour routinely at 39 weeks’ gestation is likely associated with the lowest possible caesarean section rates together with excellent maternal and paediatric outcomes.
However, a major challenge for obstetric services is how to handle the potential increased workload of large numbers of patients requesting induction of labour at 39 weeks, but at the same time providing a care pathway for patients that is as comfortable as possible.
Our ‘Home Induction’ study was therefore designed to compare different methods of commencing induction of labour in the patient’s own home, prior to being admitted in active labour.
The study confirmed that various forms of medical and mechanical methods of labour induction were safe, effective and very acceptable to patients, thereby providing them with safe methods of labour induction in the comfort of their own home for a significant period of time.
The next phase of this research will focus on studying patients’ own opinions on what was important in their birth journey, what worked well or was satisfactory, and what could have been done better.
Ultimately, the goal is to provide a strong evidence base for patients to support whatever reasonable choices they may wish to take during their own pregnancy journeys.
In addition, our department is also completing large-scale research studies on foetal growth restriction, on recurrent miscarriage and on methods of enhancing medical education through various teaching and assessment strategies.
In your opinion, why is your research important?
I have always considered clinical research to be critically important in optimising medical care. It is not appropriate to simply accept ‘conventional wisdom’ on how medical care is provided, but instead there is an onus on doctors and their medical teams to constantly probe, challenge and confirm that contemporary medical practices are safe, effective and appropriate.
This initially involves retrospective analysis of current medical practices, underpinned by regular audit, to evaluate safety and efficacy of current care.
Based on the results of such retrospective audits, we design prospective studies to compare existing and novel care pathways, thereby providing the evidence base necessary to trigger changes in clinical practice.
Finally, once such evidence is accumulated, there is a further onus on medical researchers to disseminate their findings widely, both in scientific and public communication pathways, ultimately leading to changes in clinical protocols and pathways.
Completing such a research cycle, from initial concept, to accumulating data, measuring new care options and then sharing that information widely is hugely rewarding for clinical researchers, and results in the most impactful research.
Being able to provide a research framework for young doctors is also an ideal way to recruit the best and brightest doctors of the future to our hospitals. This is particularly important given the competitive environment in which we exist, when we try to attract creative doctors from leading international medical centres back to Ireland. Providing such research opportunities for young doctors ensures the future of healthcare in Ireland remains cutting edge, and that the benefits of new clinical care programmes become available to as many patients as possible.
What inspired you to become a researcher?
I completed my initial training in obstetrics and gynaecology in Boston, followed by advanced maternal-foetal medicine training, also in Boston. This provided me with a significant exposure to leading clinical researchers throughout the US and confirmed for me the value of multicentre research in answering the most challenging questions in pregnancy care.
For example, when I worked in Boston and New York, I was fortunate to become a member of the National Institutes of Health/NICHD Maternal Fetal Medicine Units Network, which exposed me to a large number of very creative researchers who asked the most challenging questions in obstetric care and were then partnered with highly effective research managers who were expert at implementing large-scale, multicentre research trials. This enabled answers to be generated relatively quickly to the big questions that would be beyond the capability of a researcher working alone in their own hospital.
I learned from this experience the value of creating collaborative research networks, but also as important, how to stimulate and encourage groups of competitive researchers to keep working together. Learning how to manage competing needs of various researchers, while keeping a focus on the over-arching research goals, has been particularly useful when attempting to create similar collaborative research teams in Ireland.
One of the most important themes of my research programmes has been to identify ambitious young clinical researchers, provide them with the resources they need to answer scientific questions and ensure that they retain primary credit when it comes to disseminating results. In this way, the future of clinical research in obstetrics in Ireland can be secured.
What are some of the biggest challenges or misconceptions you face as a researcher in your field?
Carrying out clinical research with pregnant patients has always been particularly challenging, with a traditional assumption by many scientists and ethics committees that pregnant women should be excluded from research study. Such an approach is of course quite unfair to pregnant women and works to prevent meaningful advances in obstetric care. Convincing scientific colleagues that it is possible to conduct safe and effective clinical research with pregnant patients is incredibly important to what we do, provided that appropriate safeguards are put in place and provided that optimal communication is followed at all times.
In Ireland, one of the other major challenges is sourcing appropriate funding, in particular for clinical research in obstetrics. There are few sources of research funds available for large-scale clinical research, in particular for conducting multicentre trials, and what little funding is available tends to be extremely competitive. This results in quite a few worthy research projects not being carried out due to the relative lack of funding opportunities, compared to other countries.
Again, putting together multicentre teams of collaborators has been an effective way to get around this challenge, although a significant increase in funding opportunities would be a welcome development in Ireland.
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