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Good examples

Network of women’s clinics wants to raise the quality of clinical research

Verena Sengpiel, överläkare vid Kvinnokliniken på Sahlgrenska Universitetssjukhuset i Göteborg och docent vid Göteborgs Universitet.

SNAKS is a network involving all women’s clinics in Sweden, and wants to improve the opportunities to conduct clinical multi-centre studies of high quality. Verena Sengpiel, consultant at the Women’s Clinic at Sahlgrenska University Hospital in Gothenburg and docent at the University of Gothenburg, is one of the initiators and a member of SNAKS’ steering group.

It is morning, and Verena Sengpiel meets us in the main entrance of Sahlgrenska University Hospital Östra in Gothenburg. She is a consultant obstetrician and gynaecologist, and has medical responsibility for specialist maternity healthcare at the Women’s Clinic.

Today, she brings her youngest child with her, who is fast asleep in a pram. She is on parental leave one day a week, and otherwise divides her time between the clinic, doing research, and lecturing at the University of Gothenburg.

– Combining research with clinical work and teaching suits me very well, as I can combine my professional life with my family life in a very good way.

Verena Sengpiel was born and grew up in north-western Germany, and moved to Sweden with her husband in 2004, straight after completing her internship as a doctor.

She obtained her doctorate in 2005, from the Phillips University in Marburg in Germany. Her thesis was about fundamental cancer research within the oto-rhino-laryngology area.

– Since I started my specialist training in obstetrics and gynaecology in 2007, I no longer work within that research field. These days, I do research within obstetrics and gynaecology.

Model from the Netherlands

Around six years have passed since some of the members of the specialist association the Swedish Society of Obstetrics and Gynecology (SFOG) first met to discuss how to create a well-functioning structure for national multi-centre studies in Sweden.

– We had invited a representative from the Dutch network Consortium for Healthcare and Research in Obstetrics and Gynaecology. They had developed a successful model for conducting good national clinical studies within obstetrics and gynaecology, and we were inspired to do something similar in Sweden.

Shortly thereafter, in 2014, SNAKS was formed, as a Swedish network for national clinical studies within obstetrics and gynaecology. A steering group with representatives within gynaecology, reproduction and obstetrics from all university regions was formed.

– We saw a chance to involve all women’s clinics in Sweden and create a structure that was suited for national research, where the use of Swedish quality registers plays a very important role. The steering group decides on the studies that may be suitable to conduct within the network. We also work to create structures for the network, and to conduct major multi-centre studies, says Verena Sengpiel.

SNAKS studies are clinical studies based on collaboration between several clinics in Sweden. They can consist of observation studies, randomised clinical trials (RCT), or register-based randomised clinical trials (R-RCT).

Week 41 vs week 42?

Every day, lots of clinical decisions are made in healthcare, and they are not always based on science. They might involve methods and treatments that are used as a matter of routine, based on ingrained ideas that they are beneficial.

– Using the SNAKS network as the basis, we are running several studies aimed at evaluating what we do, and developing healthcare that is more evidence-based. This is important, not least for patient safety, but also to make sure we use our tax money in the best possible way, says Verena Sengpiel.

SWEPIS (Swedish Postterm Induction Study) is one example of a randomised controlled multi-centre trial (RCT), where the follow-up is done entirely via our Swedish quality registers. The study aims to evaluate the best time for inducing birth when pregnant women go past their expected delivery dates. The aim is to find out what is best for the woman and the baby, and to evaluate the risks of inducing birth during week 41 of the pregnancy, compared to week 42.

– When I started work in Gothenburg several years ago, the norm was to wait until week 43, with check-ups from week 42. If everything seemed normal, the pregnancy could continue into week 43 before we induced delivery, if it didn’t begin spontaneously.

In several countries, including Scandinavia, we now use pregnancy week 41 as the benchmark for when to induce delivery.

– But when SWEPIS started, there was no good scientific evidence that showed whether this was of benefit to the woman and the baby, and whether there were risks associated with inducing these births sooner.

The SWEPIS study, which involves just over 2 700 women at 14 centres in Sweden, is one of the world’s largest studies in the area.

– The unique feature of the study is that it uses national quality registers, both the Swedish Pregnancy Register and the Swedish Neonatal Quality Register. Using the registers, we can obtain valuable data about the women, and monitor the outcomes for the babies.

We expect the results to be published later this autumn, in the scientific periodical British Medical Journal.

EVA study

The EVA study is another example of a multi-centre RCT (randomised controlled trial). EVA is an acronym for “Episiotomy in Vacuum-Assisted delivery”. The study started at Danderyd Hospital in June 2017 and is now also conducted in Falun, Helsingborg, Uppsala, Växjö, Umeå and Skellefteå, as well as in Gothenburg and at Södersjukhuset in Stockholm.

– It evaluates a method for preventing serious injury during delivery, says Verena Sengpiel.

Women whose babies are delivered with the help of a vacuum pump are at greater risk of suffering injury during delivery. One of the more serious types of injury involves the sphincter muscle around the end of the colon, and can in rare cases lead to anal incontinence. Observation studies indicate that a diagonal cut to the edge of the vaginal opening (episiotomy) in conjunction with delivery using a vacuum pump may reduce the risk of sphincter injury.

The purpose of the study, which also uses data from the Pregnancy Register, is to find out whether an episiotomy can reduce the percentage of serious delivery injuries in first-time mothers whose delivery is done with the help of a vacuum pump. The purpose is also to evaluate how the intervention impacts on the woman and the baby, in the short and long term, compared to not doing the episiotomy.

– Practices vary very much across Sweden, and everybody assumes that it is the right thing to do, and best for the woman and the baby, but nobody really knows for sure. It is not defensible to have such differing practices depending on where in the country you are giving birth.

All maternity units in Sweden have been invited to take part in the study, and the aim is for just over 700 women to be included.

Randomised register studies

SNAKS now also has the opportunity to conduct register-based randomised clinical trials (R-RCT).

– One example is the HOPPSA study in gynaecology, where 42 out of 50 possible units are participating. The randomisation, survey mailings and data collection are done via the GynOp register.

HOPPSA, which is an acronym for Hysterectomy and Opportunistic Salpingectomy, aims to investigate whether it is an advantage, or whether there are risks involved in removing the fallopian tubes at the same time as removing the uterus. One advantage may be a reduced risk of ovarian cancer in the future. A disadvantage may be an early start to the menopause.

– All who choose to become physicians will naturally wish to do the right thing and make sure the outcome for patients is as good as possible. For this reason, it is frustrating not to know what is the best or the right treatment or method.

At present, around ten SNAKS studies within obstetrics and gynaecology are in progress (see fact box).

– The aim is to reduce the differences in clinical practice, to achieve a more equal treatment, and to ensure that what we do is based on scientific evidence. It is also about strengthening the academic position of obstetrics and gynaecology, both nationally and internationally.

A functioning research network also creates better conditions for applying for and being awarded grants, and stimulates research and scientific work at clinics that have not traditionally been particularly active, Verena Sengpiel thinks.

Challenges

Those who are engaged in SNAKS’ steering group spend much of their leisure time doing unpaid work for the network. Time is also needed for administrative and strategic work, and for finding funding for studies. Currently, it is usually individual researchers who contribute with their own regional research grants, but the hope is that some of the studies within the network may be financed via the Swedish Research Council’s funding for clinical therapy research.

– Another challenge is, of course, the shortage of study personnel – there are, quite simply, not sufficient numbers of midwives, obstetricians and gynaecologists. Healthcare is under pressure, and it is not at all easy to take personnel away from clinical work to carry out research projects. “We have clinicians who would really like to take part in studies, but who cannot release personnel for the studies.

In the longer term, Verena Sengpiel hopes that Sweden can get as far as the sister network in the Netherlands. “There, there is now a well-functioning and established organisation (study office), with permanently employed personnel working full-time with the research network: administrators, finance personnel, statisticians, epidemiologists, and systems and IT specialists.

Each hospital also has at least one permanently employed researcher and research nurse.

– We are, of course, hoping that in time we can build up something similar. With our Swedish health and quality registers, our opportunities are even better than those in the Netherlands. We also want to work towards developing uniform guidelines to apply in Sweden, and also in Europe. And we also want to expand our collaboration with the quality registers. We have a lot to gain from integrating research into healthcare. This wouldn’t just benefit the patients, but also healthcare and society as a whole, says Verena Sengpiel.