29 Сентября 2023 Пятница

Michael Robson: You Cannot Make Sense of an Individual Case Without Seeing the Whole Picture
Варвара Колесникова, Данил Сибиряков Мединдустрия
9 декабря 2020, 0:32

Consultant Obstetrician and Gynecologist at The National Maternity Hospital, Dublin, Ireland, on the essence of the Ten-Group Classification System

When it is advisable and how often is too often to perform cesarean sections (CS) has been one of the most debated topics in obstetrics. According to the data collected by WHO from 169 countries, in 2015, more than 20% of all births occur by CS, while the C-section rate considered acceptable by the medical community remains 10-15%. With the numbers twice as higher as expected, WHO stepped in in the wake of this discovery; experts recommended that national obstetric services be more critical of their decisions to perform CS and use the method only when there are no two ways about it. In the same year of 2015, they offered obstetricians-gynecologists a classification developed by their colleague from Ireland, Dr. Michael Robson, which implied classifying women in labor according to their ability to successfully deliver. In four years, the Classification System hit the Russian Federation: the Ministry of Health ordered to use the Robson System to «determine the factors affecting the frequency of C-sections, and how to make it more efficient».

The very ideal rate of 10-15% has been there for a while since 1985. Back then, a group of experts convened by WHO analyzed the limited data obtained from the European Countries. They found that with a CS rate as low as this, both maternal and infant mortality is reduced, while higher numbers show that too many c-sections are done when there is no real life-threatening condition. And even though WHO made an official consensus statement, the global numbers kept on growing; by 2015, the CS rate reached 21.1% (more than 29 million deliveries), according to the research from 169 countries published in The Lancet in October 2018. The October issue was dedicated to the optimization of the cesarean section delivery rate, where the authors of the editorial called «Stemming the global cesarean section epidemic» wrote that the global rate of cesarean birth had doubled in the past 15 years.

«When medically indicated, such as in placenta previa, fetal distress, or abnormal positioning, cesarean sections save the lives of women and babies. Underuse due to lack of access exists in some areas and is associated with maternal and perinatal harm. But overuse and its implications are now of growing concern. Women who do not need a cesarean section and their infants can be harmed or die from the procedure, especially when done in the absence of adequate facilities, skills, and comprehensive health car», the authors wrote. While in southern Africa the use of cesarean section is less than 5%, the rate is almost 60% in some parts of Latin America. Of the 6·2 million unnecessary caesareans done each year, half are in Brazil and China. The Russian numbers (30.1% in 2018), while far behind those in Brazil, were still high enough to catch the attention of the regulators.

In February 2019, the Ministry of Health of the Russian Federation sent Letter No. 15-4/n/2-1286 to regions and federal health research centers, specifying that the Robson Classification should be implemented and used. The document was prepared by a group of experts led by the First Deputy Minister of Healthcare of the Russian Federation (up until 2020) Tatyana Yakovleva. The Letter had included the following grounds for implementation of the Classification: to be able to determine groups of women which contributed the most and the least to the C-section rate; to compare care techniques in these groups and institutions; to determine the efficacy of measures taken to optimize the C-section procedures; to measure the quality of care by analyzing the delivery outcomes. However, in the opening statement of the Letter, the authors said that the use of the Robson Classification should have helped reduce the number of unnecessary cesarean sections. Vademecum talked with the author of the Classification, Michael Robson, Consultant Obstetrician and Gynecologist at The National Maternity Hospital, Dublin, Ireland, to find out whether the goal of the letter is reasonable.

- WHO considers a cesarean section rate in the country to be between 10-15%. What does that mean in the real world?

- There are flaws in the very idea of locking in an ideal c-section rate. You cannot be guided only by this 10-15% limitation. For example, they looked at neonatal deaths rather than the whole area of perinatal deaths when developing this recommendation. If you want to prevent a baby from dying in utero as a stillbirth, you have to either induce or deliver by prelabor cesarean section. Both induction of labor or prelabor cs will increase the CS rate. And to suggest a 10-15% without having taken into account stillbirths is therefore flawed. An overall c-section rate does not make sense and ultimately it is not the CS rate itself that is the issue but all of the outcomes and possible complications as a result of either vaginal or CS delivery. It depends on well the woman recovers, how the baby, and other physical and emotional outcomes, this is what the classification is about. If you have got a very low section rate in a group of women, what is the first thing you should then be interested in.? What was the baby outcome? What was the blood loss? What was the woman's satisfaction with the delivery? You have to take all the results into account when you interpret a cs-rate for each group. A CS rate of 10-15% may be appropriate in one part of the world, but it does not tell the whole story. An appropriate CS rate depends on other things for example clinical experience, resources, culture, and many other things

– When and how did you come to the idea of classifying c-sections?

– Many years ago, there was a debate in the literature about how you look after women having their first baby in spontaneous labor. I was struck at the time by how people couldn't agree. In the National Maternity Hospital, we have always had a low CS rate in spontaneous labor. This was well before the ten groups, but it was part of the philosophy called Active Management of Labor and prevention of prolonged labor which I am also a believer in. One of the principles of the philosophy is to continuously record and looking at your results. But how can you interpret your results without organizing or stratifying them to make sense of the raw data? In other words, the conversion of raw data into useful knowledge. So, I thought to myself, well, we should isolate this group of women, women that go into spontaneous labor, one baby headfirst, and at >= 37 weeks.

But I soon realized, unless you also recorded and could verify how many and which women were left out of that group, you couldn't make sense of the first group because if you wanted to look at one group, you should be able to account for every other woman that delivered. So, in the end after significant thought, nine other groups were added to incorporate all the women.

This was 1988, I just came to work at the National Maternity Hospital but was only formally written up in two thousand and one, but already then it was being used in a lot of hospitals back then.

– So, is it fair to say the other doctors were excited at your idea?

– Not exactly. No high impact journal accepted my work at the time. It was not a randomized control trial and so academics declined to publish it in a core publication and some still do not unfortunately either understand or support the concept. I think one of the issues is that many academics write about caesareans and but are so far removed from the labor and delivery ward that their views do not always reflect current clinical practice and the problems that are present.

The midwives and doctors working on the labor ward did like it especially its simplicity and that is why it has become so widely used because they could understand it. Only one journal agreed to publish my work. It was published in a relatively unknown journal at the time.

I have often been asked if you had the opportunity to do it again, would you change anything? And I am happy to say that I wouldn't change a thing. The only problem I wonder about sometimes is my name being attached to it. It was never the intention and I often worried that it may stop other obstetricians from using it. However, it proved to be unfounded because it has ended up spreading quicker than I ever expected.

Michael Robson, Consultant Obstetrician and Gynecologist at The National Maternity Hospital, Dublin, Ireland

However, although it is being used more and more most clinicians still do not understand its full potential, I do think that with training workshops and education that is slowly changing.

The philosophy of routine data collection and classification requires a commitment, in the same way, there has been to randomized controlled trials (RCTs) However there is no training structure in place. The classification process itself is not hard work, but you do need discipline. My colleagues often complain that they do not always have much time to collect the data. Yes, it is extra work which you should get used to, but it is not that hard. At our hospital, the data is put in by midwives and doctors and the Master (Chief executive) is responsible for the analysis and strategy development.  The first measure of quality in labor and delivery is knowing your results and the second measure is making sense (classification) of it.

– What countries have made the classification mandatory for settings?

Sweden, Norway, Denmark, and Canada were some of the first but others have followed and they have interesting data to analyze. Even though the WHO, FIGO, and EBCOG recommend the classification, it is not mandatory in the UK nor included in any formal guidelines by RCOG. The classification has been published in some 50 countries, including Sri Lanka, India, China, Taiwan, Australia, Scandinavia, the U.S., but not mandatory in many of them yet.

I believe that high-quality routine data collection and classification of data to improve the quality of healthcare should be mandatory and governments should be supporting first and foremost the use of the classification and the collection of quality data. Once that is accomplished only then can decisions about a strategy be made in particular about whether to reduce the CS rate

– The Ministry of Health of the Russian Federation recommends the classification to reduce unnecessary c-sections.

– I do believe Russia uses the classification I have lectured on the classification both in Moscow and Volgograd but as in many other places in the world need help in interpreting it and fully realizing the potential. This can only be accomplished through training programs. I also understand that the Russian Federation recommends it and if you have as a goal to reduce the CS rate then it will be useful. However, more support with training programs is required. If you do decide that you need to reduce the c-section rate, it should come naturally during a complete data analysis – and you can only know how your results fit in when you compare with the other groups of people. You can only interpret the exact number if you've got the individual groups and also interpret those individual groups if you got all the other outcomes as well, babies, blood loss, infection rates, and other labor events, outcomes, and complications.

I’ll say it again: there's no correct CS rate and no CS rate should never be interpreted on its own without consideration of other outcomes and complications.

For example, breeches. The contribution to the overall cesarean section rate is very small because it's a very small group of women. It has got implications for risk, and labor is riskier labor for breeches. Even if you delivered all breeches by cesarean section it is not going to make much difference to the overall CS rate.

The classification is great because the sizes of the groups are generally very consistent in size. You can therefore tell whether the data is high or poor quality just by looking at the sizes of the groups. The classification is just a skeleton, you can add epidemiological factors such as age or BMI and you can also analyze indications, events, outcomes, and complications in these ten groups. Sometimes to analyze further the groups may be amalgamated or more commonly subdivided. The groups are prospective and analysis is based on the intention to treat principle.

I have stopped arguing with colleagues who practice differently any longer, that's been and gone, although a lot of people are still claiming that with evidence-based medicine there is only one correct way of doing things. Evidence-based medicine has been based primarily at the moment on comparing different processes, to try to understand which is better and which one is worse. I say, let's not standardize the processes used because there are different ways of doing things but let us rather standardize the way that we look at results and compare results and learn from each other

If somebody gets results that you would like to get, what do you do? If you're in an ice hockey team or a football team? You go and see what they do. You see how they train; you see what they do, what their philosophy is and culture, don't you? And then you may try and copy them or at least some of the things that they do.

You have to have a continuous, disciplined, unrelenting routine data collection system to support this philosophy just like big businesses and professional sportsmen and women.

– Do you believe there is a problem of a growing number of unnecessary c-sections in the world?

– Everybody is talking about the need to reduce the c-section rate. It depends on what the rate is and why! They want to decrease the number of c-sections, but they have no idea what is the rate they are having now, what is the situation with complications. There's no right or wrong, right, there is no right or wrong way of doing things. There are only results. And that is what women, are interested in.

So, I think it requires a far bigger change then just aiming for a certain figure of a CS rate.

– But there are medical indications, why is there even a debate on necessary and unnecessary c-sections?

– Nobody has a definition for medically indicated or non-medically indicated cesarean section. A woman has got every right in today's cultural society to participate in the decision-making process. And caesareans have got a lot safer we do tend to forget that.

– In one of your works, you wrote that allowing a c-section at a woman's will could have carried the financial burden that the NHS could ill afford. Did it put this kind of burden?

– It's been long thought of as more expensive than a vaginal delivery, but I think this is the weakest argument. The article you refer to is from 2001. In the initial papers, I did believe that c-section costs a lot more, but the more I've kind of studied it and whatever, I think vaginal birth is more expensive than we allow for. For the c-section, you would need an anesthetist and an empty theatre. But unlike vaginal birth, they can be just planned and organized at a very appropriate time.

First of all, in a vaginal birth, what we're saying to women is that you will have a companion, a midwife looking after you all the time, which is extra costs. You always have to have shifts of midwives on call on duty. But if you've got 16 women in labor and only eight midwives, you're not providing everything that they should get. And from an organization's point of view, if you're waiting for a vaginal birth, you don't know when it's going to happen. But if eight midwives are on duty and there are no women that deliver during that time, the cost is never taken into consideration when they're doing nothing. So, it’s not that simple as it seems.

«Нужен четкий стратегический фокус». Руководитель сегмента ДМС «Ингосстраха» – о новых правилах игры на рынке добровольного медстрахования

Александр Бронштейн покинул ЦЭЛТ

«Наша цель – системно продвигаться на глобальных рынках»

«С «Потоком» и врачи, и пациенты начинают чувствовать себя в безопасности»

Проект «ЭМИГо»: вместе к контролю над сахарным диабетом I типа

Екатерина Алексеева: «Мы можем лечить самых тяжелых, ранее абсолютно бесперспективных пациентов»