Caesarean Section Rates: Much Ado about Nothing or a Marker of Quality Care?

Transcription

1 Caesarean Section Rates: Much Ado about Nothing or a Marker of Quality Care? 19 Grace Neville, Michael Robson Grace Neville Senior House Officer, Department of Obstetrics and Gynaecology, National Maternity Hospital, Dublin 2, Ireland. Michael Robson Consultant, Obstetrics and Gynaecology, National Maternity Hospital, Dublin 2, Ireland. Women will always choose the type of delivery that seems safest for them and their babies. If women choose a type of delivery that we disagree with then either they may be right and we may be wrong, the care that is being provided is not what we think it is or appropriate information is not available. Introduction The caesarean section (CS) debate continues to be amongst the most controversial issues in obstetrics and gynaecology. The debate has focussed on what the appropriate CS rate should be against a background of increasing CS rates worldwide, albeit increasing at different rates and having begun at different starting points. 1 Although much has been written, it is difficult to conclude that any consensus or anything of clinical value has been achieved. All professionals involved in labour and delivery must take responsibility for this failure and for the mixed messages being given, which leave women uncertain about what is best for them and their babies. A reassessment of our care in labour and delivery needs to take place where safety and quality is at the centre of the debate. 2,3 274 Current Progress in Obstetrics & Gynaecology Volume-2

2 Caesarean Section Rates Women and professionals involved in labour and delivery have traditionally been of the belief that the optimal CS rate is a low CS rate. As with most public debates, there are extreme views at either end of the spectrum with the truthful answer lying somewhere in between. There is little doubt that CS rates are too high in some labour and delivery units and much has been written about that topic. However, less has been written about the fact that they are probably too low elsewhere. In both cases, there has been little analysis of the makeup of the different CS rates and their relationship to other labour events and outcomes. There are many reasons for the increase in CS rates over the last 40 years including differences in organisation and management of labour, higher expectations, poor outcomes, medico-legal cases and ultimately more recently maternal choice, which in most cases is driven by a dissatisfaction of the previous care in labour. Epidemiological changes have also taken place with an older age group of women giving birth, many with higher body mass indices and some with co-existing medical conditions. Contemporary international clinical guidelines now reflect a liberalisation of expert opinion on CS often leaving the responsibility and, therefore, the accountability on the woman s shoulders which is a radical shift from the paternalistic type of medical care provided in the past. The UK NICE Guidelines recommend that elective CS on maternal request should be facilitated after full consent is obtained. 4 The Colleges of Obstetricians and Gynaecologists in the US and Australia and New Zealand s RANZCOG also advocate discussion of and patient input into delivery model. 5,6 However, the most concerning aspect of these guidelines is that no standard classification of CS has been recommended despite a systematic review on the merits of different classification systems. 7 An internationally accepted classification is much needed to scientifically study the effects of the rising CS rates. Indeed it is the responsibility of professionals to make this happen. In the future it will be this failure rather than the increase in the CS rate itself that will be most critically questioned. Have we, therefore, become guilty of merely observing the increase in the CS rates rather than analysing it scientifically? Is the real marker of quality care not what the CS rate is but whether each individual delivery unit knows what it is, why and the implications? 8 What is certainly true is that the issues surrounding CS rates need to be redefined and substantiated. 9 This will mean a completely new philosophy and an acceptance that large prospective databases are going to be more helpful than randomised controlled trials both in providing more insight about labour and delivery and more importantly also ensuring that we are providing safe and quality care. In providing quality of care to our patients, we have a responsibility to practice evidence-based medicine Current Progress in Obstetrics & Gynaecology Volume-2 275

3 but let us not forget our responsibility to collect the evidence to ensure that we are providing quality of care to our patients and that the relevant information is present for women to make the right choice. The fact that we are practising evidence-based medicine does not excuse us from assessing our care in terms of safety or quality. The current increase in CS rates must not be dismissed lightly or ignored. Important epidemiological information is available that if assessed in a structured way will help elicit negative and positive effects that this dramatic increase in CS might have in the short and long term However, this will only be possible by standardising the way we look at labour events and outcomes. The fact that different processes are applied in managing labour and delivery in different delivery institutions is undoubtedly true and is a normal organisational phenomenon. Attempts have been made to standardise processes at institutional, local, regional, national and international levels 13 but have had only limited success. 14 Women and professionals are interested in safety and quality; safety and quality is related to outcome and outcome guides processes. In theory at least, it should be simpler to standardise measurement of outcomes and events 15,16 rather than processes. If that is established and accepted, it might be expected that processes would gradually merge over time because a greater degree of comparison can and will take place. Safety and quality of care provided by a labour and delivery unit should currently be measured in terms of available validated information and then ultimately in appropriate outcomes when considering all the necessary information. Developing a Strategy A strategy needs to be developed that will be universally accepted. The starting point must be areas of agreement. The following can be agreed: 1. Agreement on the definition of a caesarean section and that it is only one of many parameters of the safety and quality of care provided at the time of labour and delivery. 2. Agreement that there may be benefits but also some disadvantages to the woman and her baby of a high or low CS rate, some of which are known and others unknown. 3. Agreement that results should be analysed in a standard way. 4. Agreement about what should be measured and most if not all of their definitions. No immediate agreement will be forthcoming on what the optimal CS rate should be, nor immediately on how labour should be best managed but what cannot be agreed on should be separated and viewed as goals rather than 276 Current Progress in Obstetrics & Gynaecology Volume-2

4 barriers to progress. The strategy described should be known as a continual multidisciplinary quality assurance programme 9 and must be universally supported by professionals, professional societies and government health agencies and women alike. By default, then a CS does become a quality indicator and is not insignificant because labour and delivery units that know their outcomes are units that at least are able to have an opinion about their outcomes, and therefore their quality of care. A CS rate, whether high or low, is not a marker of quality care on its own, but knowing your CS rate, whether high or low, its makeup in relation to other events and outcomes associated with it is a marker of quality care. There is little doubt that CS rates will vary in different institutions nationally and internationally and do not necessarily relate to poor quality care, particularly if CS rates were the only outcomes that were analysed. CS rates can only be justified as appropriate if other information is available. Some events and outcomes may score more significantly in the overall safety and quality assessment of care than others. The information required will include perinatal and maternal morbidity and mortality, complaints, adverse events and medicolegal cases, staff and infrastructure resources, maternal and staff satisfaction and the economic cost of providing the care. The information needs to be structured and standardised so that other labour and delivery units can repeat the methodology. In addition, epidemiological data, such as age, height, body mass index, relevant medical conditions, ethnicity and other case-mix variables are important to interpret CS rates. Papers on CS rates should include as much of this information as possible if they are to be accepted for publication in the future. Advances in CS techniques, anaesthesia, antibiotics and transfusion have transformed a CS from a procedure most commonly carried out as a last resort in the past to a relatively safe way of delivering a baby. 1,17 Ultimately, it is not the CS rate itself that is the final measurable outcome but the short- and long-term effects that a CS may have on mother and baby. Importantly, events and outcomes after a CS may vary in different labour and delivery units, especially between those who have a low CS rate as compared with those who have a high CS rate. It is important, therefore, to be aware of which denominator is being used to assess incidences of events and outcomes and also the relationship in size between the denominators if the CS rates are markedly different. Vaginal delivery is perceived by many to be the best mode of delivery for both mother and baby, but like CS rates, very little information on events and outcome is collected in a standardised way on a routine basis in most labour Current Progress in Obstetrics & Gynaecology Volume-2 277

5 and delivery units to substantiate this. 18 In particular, very little is collected on the psychological impact of labour and delivery. Terminology should be standardised and neutral terms such as events and outcomes are favoured rather than interventions. 19 It is time to replace natural and normal as our criteria for practice in midwifery and obstetrics with an open concept of the good. 20 Furthermore, what makes the professional healthcare practitioner professional is his or her knowledge of means and consequences, not necessarily his or her opinion about what is good or bad. CS is the most commonly known and most significant delivery event and therefore will always be at the centre of any discussion on labour and delivery. Doctors perform CS, midwives do not and this has professional and organisational implications. CS also has social and epidemiological implications and although not important on their own, but are important when dissected and related to other labour and delivery events and outcomes, processes and cost. The concern of health economists about the increasing CS rates has been its increased cost when compared with vaginal deliveries. Extrapolating this argument further, many governments have concluded that if the CS rate is reduced or even CS not carried out in cases without medical indication, money would be saved that could be better used elsewhere. However, the issue is more complicated than this and the economics of childbirth is a subject that needs further development. What will undoubtedly help though in this process is a standardised, prospective classification system of women requiring maternity care that can be used both for clinical outcomes and events as well as cost effectiveness. 21 Ten Group Classification System, Caesarean Section Rates and Perinatal Data Collection The Ten Group Classification System (TGCS) was first described in and is shown in Table 1 to illustrate its use in analysing a CS rate. Although originally used as a method to assess CS rates, it was structured so that it could be used to assess all maternal and perinatal outcomes, and also simultaneously assessing different processes and their cost effectiveness. In addition, the groups are clinically relevant to all clinicians and women themselves and provide a common starting point for any discussion on perinatal audit. Discussions and particularly comparisons of perinatal outcomes continue to suffer from a lack of an initial high-level overview and more importantly a common language or currency. By using the TGCS, the size of the groups and the CS rate within the groups immediately give significant information about the type of care being provided 278 Current Progress in Obstetrics & Gynaecology Volume-2

6 in that institution, region or country. When other epidemiological information, events and outcomes, processes or cost are then analysed within the different groups as opposed to a proportion of the overall population, they also increase in relevance. Finally then the risk benefit ratio of CS rates within the groups takes on a totally different significance and CS rates, therefore, qualify as a marker of quality care, especially when interpreted in relation to this other information. A detailed description of the TGCS, and the way it can be used has been described elsewhere. 8 Internationally, the classification is being increasingly used by labour and delivery units to report their CS rates and other perinatal outcome. Their results are being published either in medical journals or as part of their clinical reports As this has become available for general discussion, more is being learnt about perinatal data collection. In particular, the TGCS is being shown to be useful in assessing the quality of perinatal data and is highlighting important deficiencies and lack of standardisation. Once data quality has been validated and good quality data is available, then the 10 different groups are shown to be remarkably consistent in size and the different CS rates in the groups together with the size allow far more informative interpretation of a given overall CS rate. Below we discuss the clinical significance of each of the groups but occasionally they need to be amalgamated or indeed subdivided to provide additional information. Group 1 Nulliparous women, single cephalic, 37 weeks, in spontaneous labour This group of women is the most important group of women in all labour and delivery units. It is the group of women where there is greatest variation between different labour and delivery units. 28 The CS rate in this group in conjunction with other labour events and outcomes should be considered as the gold standard measure of any labour and delivery unit. The main clinical issue in this group is achieving efficient uterine action safely. The key labour events and outcomes to measure are CS for foetal reasons and dystocia, vaginal operative delivery, epidural rate, episiotomy, third and fourth degree tears, artificial rupture of membranes, oxytocin, length of labour, primary postpartum haemorrhage (>1000 ml), blood transfusion rates, neonatal outcome (5 min Apgar <7, Cord ph <7.00, encephalopathy) and the provision of one-to-one care in labour. The processes that need to be described are criteria for diagnosis of labour, diagnosis and treatment of dystocia (use of partogram and frequency of vaginal examinations), oxytocin regimen, method of foetal monitoring and Current Progress in Obstetrics & Gynaecology Volume-2 279

7 some measure of maternal satisfaction. More detail on other events, outcomes and processes would be useful but the above are essential to interpret the care. Rarer events and outcomes such as peripartum hysterectomy and injuries to the uterus should also be collected, but uterine rupture is to all intent and purpose exclusively a feature of the multiparous woman. Group 2 Nulliparous women, single cephalic, 37 weeks, induced or CS before labour This group includes all nulliparous women 37 weeks gestation with a single cephalic pregnancy whose pregnancy was interrupted before the onset of spontaneous labour either by induction of labour or pre-labour CS. The relevant clinical information to record is the number of inductions and pre-labour CS carried out as a percentage of the total number of women in Groups 1 and 2. Their indications should be standardised in order to understand why they are being carried out and how well they do. The labour events, outcomes and processes that need to be recorded are as those described for Group 1 but should also include the methods of induction. Groups 1 and 2 should be analysed together as well as individually. The larger the relative size of Group 2 to Group 1, the higher the CS rate will be in Groups 1 and 2 together and hence in nulliparous women 37 weeks gestation with a single cephalic pregnancy. The CS rate in those women who are induced in this group is usually 25 30%. Within Group 2, the higher the number of prelabour caesareans relative to the number of inductions higher the CS rate. The main clinical issue from Groups 1 and 2 is that together they become the driving force for the increasing primary CS rate Group 3 Multiparous women (excluding previous CS), single cephalic, 37 weeks, in spontaneous labour This group of women is quite unique in that it should have a very low CS rate and it should be very similar in every labour and delivery unit. 28,30 So much so that if the CS rate is higher than 3%, one should suspect either poor data collection or inappropriate classification (women with previous scars wrongly placed in this group). The labour events and outcomes that should be analysed are similar to Group 1 but should differ quite significantly. In particular, the oxytocin rates (to accelerate labour) should be very low as inefficient uterine action is rare as opposed to in Group Group 4 Multiparous women (excluding previous CS), single cephalic, 37 weeks, induced or CS before labour This group includes all multiparous women 37 weeks gestation with a 280 Current Progress in Obstetrics & Gynaecology Volume-2

8 single cephalic pregnancy (excluding previous CS) whose pregnancy was interrupted before the onset of spontaneous labour either by induction of labour or pre-labour CS. The information to be collected is similar to Group 2 but the clinical issues are very different. The CS rate in women in this group who are induced is usually about 5 8% and is relatively consistent. 27 The CS rate in the group as a whole if higher then this is very much dependent on the number of pre-labour CS. Pre-labour CS in this group should be rare and the most common indication is often maternal request that is usually a reflection of the care (both physical and psychological) in the first labour. Errors in data collection and misclassification as in Group 3 are also possible. Group 5 Multiparous women with at least one previous CS, single cephalic, 37 weeks This is a heterogeneous group of women, but the clinical relevance is that it is the largest contributor to every labour and delivery unit s CS rate. The risk balance ratio of the CS rate in this group is very different to the other groups depending on organisational as well clinical issues. The size of the group as a proportion of the total labour and delivery population is very relevant. The group should be subdivided into those who have spontaneous labour, those who are induced and those who are delivered by pre-labour CS. The additional information required is very similar to the first four groups, but in addition the incidence of ruptured uterus and peripartum hysterectomy is much more relevant in this group. Group 6 All nulliparous women with a single breech Most nulliparous breeches are delivered now by CS. However, whether they are delivered vaginally or by CS detailed information should be collected about their results as previously described (labour events, outcomes and processes). What is important though is that the contribution to the overall CS rate is very small while the risk benefit ratio is very different to other groups. Group 7 All multiparous women with a single breech (including previous CS) The relative size of this group is even smaller than Group 6 and, therefore, the contribution to the overall CS rate is even smaller. However, the risk benefit ratio is probably different to Group 6 so the CS rate is usually lower than Group 6. Current Progress in Obstetrics & Gynaecology Volume-2 281

9 Group 8 All women with a multiple pregnancy (including previous CS) The size of this group is usually smaller than Groups 6 and 7. It is a very heterogeneous group contributing very little to the overall CS rate. It includes nulliparous and multiparous patients and different types of multiple gestations. As a group, it has a significantly higher perinatal morbidity and mortality rate and therefore a completely different risk benefit ratio to other groups. Detailed information (labour events, outcome and processes) is required with subdivisions into the different categories of multiple gestations, in particular the chorionicity. Group 9 All women with a single abnormal lie (including previous CS) This is a small group but is consistently found to be between 0.4% and 0.8%. In addition, the CS rate in this group is always 100%. Anything outside this suggests a problem with data definition and collection. In terms of contribution to the overall CS rate, the group is irrelevant but it is an important group when assessing the quality of data collection. Group 10 All women with a single cephalic, pregnancy 36 weeks (including previous CS) This group is important as it is often quoted by many tertiary referral units as to the reason that their CS rate is high. This is very rarely the case when the data is analysed. The size of the group is usually 4 5% of the total and may indeed be higher up to 10% in some tertiary referral units. If a significant proportion of pre-term delivery is due to pre-term spontaneous labour, then the CS rate is usually less than 30%. If a significant proportion of pre-term delivery is due to other foetal and maternal conditions, the CS rate is usually higher than 30%. Either way, the contribution to the overall CS rate is small and again the risk benefit ratio is very different to many other groups and therefore the CS rate has to be interpreted with that in mind. Conclusion Overall CS rates mean very little whether high or low and are not a marker of quality care on their own. CS rates analysed by using the TGCS give more information and an idea of the philosophy of care provided by the individual labour and delivery unit. However, CS rates analysed by using the TGCS with information on safety and outcome together with other relevant information are a marker of quality care and should be available in annual clinical reports produced by each labour and delivery unit. 282 Current Progress in Obstetrics & Gynaecology Volume-2

10 Table 1. Groups Overall CS Rate (%) 1977/9250 (21.4%)National Maternity Hospital Nulliparous, single cephalic, 37 weeks, in spontaneous labour Number of CS over total number of women in each group Relative size of groups (%) 179/ / Nulliparous, single cephalic, 37 weeks, 475/ induced or CS before labour * 1368/ Multiparous (excluding previous CS), single cephalic, 37 weeks, in spontaneous labour 4. Multiparous (excluding previous CS), single cephalic, 37 weeks, induced or CS before * labour 30/ / / / Previous CS, single cephalic, 37 weeks 571/ / All nulliparous breeches 204/ / All multiparous breeches (including previous CS) 8. All multiple pregnancies (including previous CS) 113/ / / / All abnormal lies (including previous CS) 35/ / All single cephalic, 36 weeks (including previous CS) 127/ /9250 CS rate in each group (%) / / / / / / / / / /336 Taken from the National Maternity Hospital Clinical Report *Table also presented in Ref. 9. Contribution made by each group to the overall CS rate (%) / / / / / / / / / /9250 Current Progress in Obstetrics & Gynaecology Volume-2 283

11 Key Points Measurement of outcomes and events must be standardised before we can expect safety and quality to improve. An internationally accepted classification is much needed to scientifically study the effects of the rising caesarean section rates. The philosophy of the TGCS in assessing maternity care is based on the premise that all epidemiological information, maternal and foetal events and outcomes will be more clinically relevant if analysed within the 10 groups or their subgroups. Safety and quality of care provided by a labour and delivery unit should currently be measured in terms of available validated information. References 1. Cyr RM. Myth of the ideal cesarean section rate: commentary and historic perspective. Am J Obstet Gynecol. 2006;194: Lawrence HC, Copel JA, O Keeffe DF, et al. Quality patient care in labor and delivery: a call to action. Am J Obstet Gynecol. 2012;207: Main EK, Morton CH, Melsop K, et al. Creating a public agenda for maternity safety and quality in cesarean delivery. Obstet Gynecol. 2012; 120: National Institute for Health and Care Excellence Caesarean Section. CG 132. London: National Institute for Health and Care Excellence; ACOG committee opinion no. 559: cesarean delivery on maternal request. Obstet Gynecol. 2013;121: RANZCOG College Statement C-Obs 39 Caesarean Delivery on Maternal Request (CDMR). Available from: < caesarean-delivery-on-maternal-request-cdmr.html> [Accessed on 16/7/2013]. 7. Torloni MR, Betrán AP, Souza JP, et al. Classifications for cesarean section: a systematic review. PLoS One. 2011;6:e Robson MS. Can we reduce the caesarean section rate? Best Pract Res Clin Obstet Gynaecol. 2001;15: Robson M, Hartigan L, Murphy M. Methods of achieving and maintaining an appropriate caesarean section rate. Best Pract Res Clin Obst Gynaecol. 2013;27: Romero R, Korzeniewski SJ. Are infants born by elective cesarean delivery without labor at risk for developing immune disorders later in life? Am J Obstet Gynecol. 2013;208: Lynch CD, Iams JD. Diseases resulting from suboptimal immune function in offspring: is cesarean delivery itself really to blame? Am J Obstet Gynecol. 2013;208: O Neill SM, Kearney PM, Kenny LC, et al. Caesarean delivery and subsequent stillbirth or miscarriage: systematic review and meta-analysis. PLoS One. 2013;8:e Kirkpatrick DH, Burkman RT. Does standardization of care through clinical guidelines improve outcomes and reduce medical liability? Obstet Gynecol. 2010;116: Mussalli GM. Does standardization of care through clinical guidelines improve outcomes and reduce medical liability? Obstet Gynecol. 2011;117: Current Progress in Obstetrics & Gynaecology Volume-2

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