I'm excited to share a Q&A with Jenny Löfgren, who heads a research group at Karolinska Institutet where reconstructive plastic surgery meets global surgery. This team is dedicated to improving surgical healthcare through new techniques, thorough training, and better patient outcomes, both in Sweden and worldwide. Their focus on global surgery aims to enhance surgical practices and make quality care accessible to everyone, regardless of location or economic status.

In this Q&A, Jenny describes how ISRCTN helps them maintain transparency in the group's innovative work. Jenny Löfgren and her team are making significant contributions to the field. Join us as we reflect on our journey.

Could you describe your involvement, role, and responsibilities, and what motivated you to participate in these groundbreaking studies? 

The two trials were a continuation of work that I had done with my supervisors and partners during my PhD. We had found out that inguinal hernia mesh repair in adult men could be done safely and effectively in a sub-Saharan African (SSA) setting (Uganda). With this knowledge, the logical next step would be to investigate who shall perform all these hernia repairs that are needed in this part of the world. This was my motivation to initiate collaborations and, in this team, to design and implement the studies.   

In partnership with colleagues in Ghana and Sierra Leone, as well as the US, Norway and Sweden, we designed the two studies. One was a prospective cohort study and the other a randomised controlled trial. I was responsible for obtaining a large part of the funding and had a leading role in the design and planning of the studies. (It was a team effort, so I definitely cannot take credit for all of it). 

Can you describe the studies and their importance? 

Task sharing of surgical procedures is widely practiced in sub-Saharan Africa. It is a pragmatic solution whereby surgical procedures are carried out despite the lack of specialists in surgery, anaesthesiology and obstetrics among several other disciplines. The safety, effectiveness and cost-effectiveness had not been thoroughly evaluated before the implementation of the two studies. There was good evidence that task sharing for obstetric surgery was safe.  

What were the primary objectives of the studies? 

The primary objectives of the two studies were to assess the safety and effectiveness of surgical task sharing in inguinal hernia repair in adult men when the surgery was carried out by specialists in general surgery versus non-specialist medical doctors (Ghana) and non-specialist medical doctors versus Associate Clinicians (Sierra Leone). The study aimed to fill the gap in evidence to support a clinical practice widely implemented in SSA. 

Why was this study considered significant in the field of biomedical research? 

The area of study is very controversial, even though it is already a widely implemented clinical practice in SSA (and elsewhere too). Through the research, we could show that the task sharing studied was safe for the patients, with good outcomes and a high level of patient satisfaction. In addition, we were able to show that surgical clinical research with a very high level of evidence (prospective cohort study and randomised controlled trial) could be implemented in our resource-constrained settings with very high follow-up rates up to 5 years postoperatively. This is also a very important finding of the research.  

Since you initially registered your studies, how has the field progressed, and what was the significance of the results? 

We have continued with clinical research about groin hernia in sub-Saharan Africa. One study has been carried out on adult women with hernia (Uganda). Another study about task sharing in paediatric hernia repair is currently recruiting (Uganda). We are also running studies on simulation-based surgical training to accellerate the training of surgical providers (associate clinicians in Sierra Leone and intern doctors in Uganda). The field of task sharing in itself has not changed much to my knowledge. The practice was widely implemented in many countries. The difference now is that the evidence to support the practice is much better. All of these studies are listed in my name in the ISRCTN registry.   

What advancements have been made in clinical research since the study was first registered? How did the results of your study contribute to these advancements? 

We have several other completed and ongoing clinical research projects. It is my hope that more researchers will be inspired to carry out clinical research and trials in SSA so that important research questions for this region can be answered. It is highly possible to carry out such research projects, and it is also very rewarding to follow a project over time to see it bearing fruit.   

Why was registration important to you, and what benefits did you see in registering the study with ISRCTN? 

Registration was necessary for later publication; it is also a requirement of the funding agency. Now that I know the process, I find that it is simple and not so time-consuming. The support during the registration process is also very good and quick! The reminders about updating the registrations are also helpful. In these times, I very much appreciate that there is a European system for these registrations.   

How did the registration process enhance the transparency and credibility of your research?  

I think the requirement of registration prior to the implementation of trials like ours is good. That way, no one can accuse the researchers of altering the study along the way, and any alteration made will be logged, for transparency. I think trial registration is important for transparency, but also for visibility. It could be a valuable way to show who was first, at least with an idea/project. 

You can continue celebrating our successes in forthcoming posts and following studies being registered at ISRCTN. We look forward to continuing our mission of supporting high-quality clinical research for the benefit of all.