BJOG Exchange
P Sala,a CR Gaggero,a,b M Foppianoa,b & P De Biasioa,b a
Department of Obstetrics and Gynecology, IRCCS A.O.U. San Martino IST bLaboratory of Prenatal Diagnosis, IRCCS G. Gaslini Institute, Genoa, Italy
Accepted 18 March 2014. DOI: 10.1111/1471-0528.12832
Authors’ reply Sir, In our recent publication1 we presented the results of a cross-sectional survey with 1301 women and partners and showed that service users are very positive towards the introduction of noninvasive prenatal testing (NIPT) for trisomy 21 and that uptake is likely to be high, although a small proportion would prefer invasive testing. Sala et al. 2 suggest that pre-test counselling for survey participants would have resulted in a more accurate indication of test uptake. Nondirective pretest counselling is indeed essential to ensure that women are making informed decisions regarding prenatal testing for Down syndrome. Pretest counselling allows for the provision of accurate information about testing and the opportunity to deliberate the possible impact of test results. While the provision of pretest counselling to study participants would perhaps have meant a more accurate reflection of clinical practice, it would not have been feasible for this study in which 1301 participants completed the questionnaire. To do so would require substantially reducing the sample size and a subsequent loss of the information afforded by such a large study population. The study questionnaire provided a summary of the key features of each of the tests assessed that was purposely succinct and clear to ensure understanding by participants. This included a description of the test accuracy as >99%, which is in line with the most recent data. 3,4 Sala et al.2 indicate that omissions from the information provided about NIPT, including a descrip-
1444
tion of the test as screening tool, test failure rates, time for results and costs, may have impacted on the resulting indication of test uptake. Given the hypothetical nature of the test described we did not feel that it was appropriate to go into specific details around timings and test failure rates, which may alter across test providers. Although it is possible that these more detailed additions to the description of NIPT may have altered women’s preferences, research has shown that test safety is the key overriding factor in women’s decisions about prenatal testing for Down syndrome and that other test attributes may not play as significant a role.5 As such, it is not surprising that uptake of NIPT was high (88% for women with a high screening risk in our study). With regards to informing survey participants about test costs, this survey was to inform implementation of NIPT in an NHS clinical service. Hence, all costs would be covered by the state. Ultimately, the only way of getting reliable information on actual uptake is to offer NIPT within a clinical setting. We are currently evaluating NIPT in an NHS setting through five maternity hospitals across London and the south of England as part of the NIHR-funded RAPID (Reliable Accurate Prenatal non-Invasive Diagnosis) programme. Our data so far show high uptake rates, particularly for high-risk women (>1:150). Of the 146 women with a high-risk screening result who have been offered NIPT, 84% have had NIPT, 13% have gone straight for invasive testing and 3% have declined. & References 1 Lewis C, Hill M, Silcock C, Daley R, Chitty LS. Non-invasive prenatal testing for trisomy 21: a cross sectional survey of service users’ views and likely uptake. BJOG 2014;121:582–94. 2 Sala et al. Noninvasive prenatal testing for trisomy 21: when counselling is needed before responding to a survey. BJOG 2014;121: 1443–44. 3 Palomaki GE, Deciu C, Kloza EM, Lambert-Messerlian GM, Haddow JE, Neveux
LM, et al. DNA sequencing of maternal plasma reliably identifies trisomy 18 and trisomy 13 as well as Down syndrome: an international collaborative study. Genet Med 2012;14:296–305. 4 Norton ME, Brar H, Weiss J, Karimi A, Laurent LC, Caughey AB, et al. Non-Invasive Chromosomal Evaluation (NICE) Study: results of a multicenter prospective cohort study for detection of fetal trisomy 21 and trisomy 18. Am J Obstet Gynecol 2012;207:137 e1–8. 5 Hill M, Fisher J, Chitty LS, Morris S. Women’s and health professionals’ preferences for prenatal tests for Down syndrome: a discrete choice experiment to contrast noninvasive prenatal diagnosis with current invasive tests. Genet Med 2012;14:905–13.
C Lewis,a M Hill,a C Silcock,b R Daleya,b & LS Chittya,b a
Clinical and Molecular Genetics, UCL Institute of Child Health and Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK bFetal Medicine Unit, University College London Hospital NHS Foundation Trust, London, UK Accepted 20 March 2014. DOI: 10.1111/1471-0528.12833
Individual medical indemnity is essential for twenty-first century Obstetrics and Gynaecology practice
Sir, There is no doubt that more healthcare professionals are facing investigations into complaints about medical care and outcomes (Department of Health 2003).1 Fox et al.2 identify some of the key legal issues facing clinicians in Obstetrics and Gynaecology in the 21st century. However, one area which is not mentioned is the importance of appropriate indemnity cover for trainees. Recently, the RCOG Trainees committee and the BMA Junior Doctors Association issued a joint advice regarding this issue.3 In this paper, we considered the differences in cover provided by the employer’s liability scheme, individual professional indemnity schemes and the role of professional bodies. The conclusion was that individual professional
ª 2014 Royal College of Obstetricians and Gynaecologists
BJOG Exchange
indemnity is essential for cover in all areas of clinical practice in the 21st century. As mentioned by Fox et al., 60% of the litigation arose during out-of-hours. Although recently we have seen an increase in consultant delivered care on our delivery suites during out-of-hours, the majority of this care continues to be provided by doctors in training. Furthermore, the opt-out from the European Working Time Regulations (EWTR) has caused further confusion as to what is covered for junior doctors by individual indemnity policies and the employer’s liability scheme. As such, it is important for individuals to ensure they have completed their trust voluntary opt-out clause and be provided with up-to-date information on medico-legal issues and protection schemes regarding legal liabilities. Finally, given its increasing frequency, we would suggest that the legal aspects of clinical practice in Obstetrics and Gynaecology are covered in the curriculum of post-graduate training to raise awareness among clinicians in preventing and managing complaints. &
References 1 Department of Health. Making amends: a consultation paper setting out proposals for reforming the approach to clinical negligence in the NHS. London, 2003. 2 Fox R, Yelland A, Draycott T. Analysis of legal claims – informing litigation systems and quality improvement. BJOG 2014;121:6– 10. 3 Chatterjee J, Datta S, Butt S, Harpwood V. Personal professional indemnity and contractual issues for trainees in obstetrics and gynaecology. J Obstet Gynaecol 2013;33: 125–7.
S Datta,a J Chatterjee,b S Buttc & V Harpwoodd a
King’s College Hospital, London, Hammersmith Hospital, London, cBarnet Hospital, London, dCardiff Law School, Cardiff, UK
b
Accepted 15 March 2014. DOI: 10.1111/1471-0528.12826
Long-term complications of caesarean section – an inevitable consequence?
Sir, The BJOG issue (Vol. 121, no. 2) devoted to long-term caesarean section (CS) complications was very revealing. Increased reporting/awareness of the spectrum of long-term complications (scar niche, CS scar ectopic pregnancy, increasing anterior placenta praevia/accreta, intrauterine growth restriction and scar dehiscence) may not be entirely explained by the rising incidence of CS. The common mechanism seems to be the poor healing of the CS scar. Could there be an element of suboptimal surgical technique? Although not the subject of the BJOG themed issue, it seems important to consider whether long-term complications could be minimised and to formulate some strategies. Several randomised controlled trials (RCTs) and cohort studies mostly evaluate short-term outcomes of CS techniques. But even these RCTs suffer to variable degrees from the drawbacks highlighted by Des Spence,1 namely non-specific surrogate ends (postoperative pain, febrile morbidity) and clinically unimportant outcomes (e.g. minute reductions in operating time and bleeding).2 Moreover, different studies show completely divergent results.3,4 Robust evidence from RCTs relating different surgical techniques to the long-term outcomes would be most welcome, but difficult to obtain because of high drop-out rates and methodological difficulties.3 Some RCTs of surgical techniques also suffer from particular flaws and limitations,2 namely, a wide spectrum of surgical expertise and a continuum of variations in several concomitant aspects of surgical technique. Well-intended but exclusive emphasis on RCTs only to guide evidence-based practice may underplay the importance of observation and logical application of good surgical principles.
ª 2014 Royal College of Obstetricians and Gynaecologists
The RCTs have focussed on ‘single’ versus ‘double’ layer closure of the uterine incision, which may be considered over-simplistic and an imperfect surrogate for the several factors underpinning good tissue healing. Based on the principles of good surgery it could be hypothesised that proper anatomical approximation of myometrial edges without ‘strangulation’ of blood supply should lead to a strong myometrial union.3 Thick muscular edges are best approximated by including the deeper part in the first suture layer and the remaining superficial cut edges (together with a small amount of surrounding uncut myometrium) in the second layer. Locking the sutures would interfere with blood supply. It seems to have become a common imitative unconscious practice to insert a very tight second layer of sutures (sometimes interlocking) to include quite wide areas (difficult to quantify) of surrounding intact myometrium. This is likely to strangulate the intervening myometrium around the incision, leading to ischaemic necrosis, thus leaving a thin band of poorly healed myometrium (niche).3 Such surgical practices become ingrained as their effects cannot be proven or disproven and the challenge is to conduct clinically informative RCTs. However, even thinking and deliberating about tenets of good surgery (in addition to results and limitations of RCTs) and the resultant awareness/introspection could improve the surgical techniques and results. Hence, guidelines should encourage ‘reflection’ by discussing the pros and cons and good principles of surgical techniques. Another source of long-term morbidity is postoperative adhesions. While comparing closure versus non-closure of peritoneum, many RCTs mostly report surrogate and clinically unimportant short-term outcomes. Peritoneum has a physiological ‘isolation’ function, avoiding direct contact of raw areas. In fact the two meta-analyses
1445
P Sala,a CR Gaggero,a,b M Foppianoa,b & P De Biasioa,b a
Department of Obstetrics and Gynecology, IRCCS A.O.U. San Martino IST bLaboratory of Prenatal Diagnosis, IRCCS G. Gaslini Institute, Genoa, Italy
Accepted 18 March 2014. DOI: 10.1111/1471-0528.12832
Authors’ reply Sir, In our recent publication1 we presented the results of a cross-sectional survey with 1301 women and partners and showed that service users are very positive towards the introduction of noninvasive prenatal testing (NIPT) for trisomy 21 and that uptake is likely to be high, although a small proportion would prefer invasive testing. Sala et al. 2 suggest that pre-test counselling for survey participants would have resulted in a more accurate indication of test uptake. Nondirective pretest counselling is indeed essential to ensure that women are making informed decisions regarding prenatal testing for Down syndrome. Pretest counselling allows for the provision of accurate information about testing and the opportunity to deliberate the possible impact of test results. While the provision of pretest counselling to study participants would perhaps have meant a more accurate reflection of clinical practice, it would not have been feasible for this study in which 1301 participants completed the questionnaire. To do so would require substantially reducing the sample size and a subsequent loss of the information afforded by such a large study population. The study questionnaire provided a summary of the key features of each of the tests assessed that was purposely succinct and clear to ensure understanding by participants. This included a description of the test accuracy as >99%, which is in line with the most recent data. 3,4 Sala et al.2 indicate that omissions from the information provided about NIPT, including a descrip-
1444
tion of the test as screening tool, test failure rates, time for results and costs, may have impacted on the resulting indication of test uptake. Given the hypothetical nature of the test described we did not feel that it was appropriate to go into specific details around timings and test failure rates, which may alter across test providers. Although it is possible that these more detailed additions to the description of NIPT may have altered women’s preferences, research has shown that test safety is the key overriding factor in women’s decisions about prenatal testing for Down syndrome and that other test attributes may not play as significant a role.5 As such, it is not surprising that uptake of NIPT was high (88% for women with a high screening risk in our study). With regards to informing survey participants about test costs, this survey was to inform implementation of NIPT in an NHS clinical service. Hence, all costs would be covered by the state. Ultimately, the only way of getting reliable information on actual uptake is to offer NIPT within a clinical setting. We are currently evaluating NIPT in an NHS setting through five maternity hospitals across London and the south of England as part of the NIHR-funded RAPID (Reliable Accurate Prenatal non-Invasive Diagnosis) programme. Our data so far show high uptake rates, particularly for high-risk women (>1:150). Of the 146 women with a high-risk screening result who have been offered NIPT, 84% have had NIPT, 13% have gone straight for invasive testing and 3% have declined. & References 1 Lewis C, Hill M, Silcock C, Daley R, Chitty LS. Non-invasive prenatal testing for trisomy 21: a cross sectional survey of service users’ views and likely uptake. BJOG 2014;121:582–94. 2 Sala et al. Noninvasive prenatal testing for trisomy 21: when counselling is needed before responding to a survey. BJOG 2014;121: 1443–44. 3 Palomaki GE, Deciu C, Kloza EM, Lambert-Messerlian GM, Haddow JE, Neveux
LM, et al. DNA sequencing of maternal plasma reliably identifies trisomy 18 and trisomy 13 as well as Down syndrome: an international collaborative study. Genet Med 2012;14:296–305. 4 Norton ME, Brar H, Weiss J, Karimi A, Laurent LC, Caughey AB, et al. Non-Invasive Chromosomal Evaluation (NICE) Study: results of a multicenter prospective cohort study for detection of fetal trisomy 21 and trisomy 18. Am J Obstet Gynecol 2012;207:137 e1–8. 5 Hill M, Fisher J, Chitty LS, Morris S. Women’s and health professionals’ preferences for prenatal tests for Down syndrome: a discrete choice experiment to contrast noninvasive prenatal diagnosis with current invasive tests. Genet Med 2012;14:905–13.
C Lewis,a M Hill,a C Silcock,b R Daleya,b & LS Chittya,b a
Clinical and Molecular Genetics, UCL Institute of Child Health and Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK bFetal Medicine Unit, University College London Hospital NHS Foundation Trust, London, UK Accepted 20 March 2014. DOI: 10.1111/1471-0528.12833
Individual medical indemnity is essential for twenty-first century Obstetrics and Gynaecology practice
Sir, There is no doubt that more healthcare professionals are facing investigations into complaints about medical care and outcomes (Department of Health 2003).1 Fox et al.2 identify some of the key legal issues facing clinicians in Obstetrics and Gynaecology in the 21st century. However, one area which is not mentioned is the importance of appropriate indemnity cover for trainees. Recently, the RCOG Trainees committee and the BMA Junior Doctors Association issued a joint advice regarding this issue.3 In this paper, we considered the differences in cover provided by the employer’s liability scheme, individual professional indemnity schemes and the role of professional bodies. The conclusion was that individual professional
ª 2014 Royal College of Obstetricians and Gynaecologists
BJOG Exchange
indemnity is essential for cover in all areas of clinical practice in the 21st century. As mentioned by Fox et al., 60% of the litigation arose during out-of-hours. Although recently we have seen an increase in consultant delivered care on our delivery suites during out-of-hours, the majority of this care continues to be provided by doctors in training. Furthermore, the opt-out from the European Working Time Regulations (EWTR) has caused further confusion as to what is covered for junior doctors by individual indemnity policies and the employer’s liability scheme. As such, it is important for individuals to ensure they have completed their trust voluntary opt-out clause and be provided with up-to-date information on medico-legal issues and protection schemes regarding legal liabilities. Finally, given its increasing frequency, we would suggest that the legal aspects of clinical practice in Obstetrics and Gynaecology are covered in the curriculum of post-graduate training to raise awareness among clinicians in preventing and managing complaints. &
References 1 Department of Health. Making amends: a consultation paper setting out proposals for reforming the approach to clinical negligence in the NHS. London, 2003. 2 Fox R, Yelland A, Draycott T. Analysis of legal claims – informing litigation systems and quality improvement. BJOG 2014;121:6– 10. 3 Chatterjee J, Datta S, Butt S, Harpwood V. Personal professional indemnity and contractual issues for trainees in obstetrics and gynaecology. J Obstet Gynaecol 2013;33: 125–7.
S Datta,a J Chatterjee,b S Buttc & V Harpwoodd a
King’s College Hospital, London, Hammersmith Hospital, London, cBarnet Hospital, London, dCardiff Law School, Cardiff, UK
b
Accepted 15 March 2014. DOI: 10.1111/1471-0528.12826
Long-term complications of caesarean section – an inevitable consequence?
Sir, The BJOG issue (Vol. 121, no. 2) devoted to long-term caesarean section (CS) complications was very revealing. Increased reporting/awareness of the spectrum of long-term complications (scar niche, CS scar ectopic pregnancy, increasing anterior placenta praevia/accreta, intrauterine growth restriction and scar dehiscence) may not be entirely explained by the rising incidence of CS. The common mechanism seems to be the poor healing of the CS scar. Could there be an element of suboptimal surgical technique? Although not the subject of the BJOG themed issue, it seems important to consider whether long-term complications could be minimised and to formulate some strategies. Several randomised controlled trials (RCTs) and cohort studies mostly evaluate short-term outcomes of CS techniques. But even these RCTs suffer to variable degrees from the drawbacks highlighted by Des Spence,1 namely non-specific surrogate ends (postoperative pain, febrile morbidity) and clinically unimportant outcomes (e.g. minute reductions in operating time and bleeding).2 Moreover, different studies show completely divergent results.3,4 Robust evidence from RCTs relating different surgical techniques to the long-term outcomes would be most welcome, but difficult to obtain because of high drop-out rates and methodological difficulties.3 Some RCTs of surgical techniques also suffer from particular flaws and limitations,2 namely, a wide spectrum of surgical expertise and a continuum of variations in several concomitant aspects of surgical technique. Well-intended but exclusive emphasis on RCTs only to guide evidence-based practice may underplay the importance of observation and logical application of good surgical principles.
ª 2014 Royal College of Obstetricians and Gynaecologists
The RCTs have focussed on ‘single’ versus ‘double’ layer closure of the uterine incision, which may be considered over-simplistic and an imperfect surrogate for the several factors underpinning good tissue healing. Based on the principles of good surgery it could be hypothesised that proper anatomical approximation of myometrial edges without ‘strangulation’ of blood supply should lead to a strong myometrial union.3 Thick muscular edges are best approximated by including the deeper part in the first suture layer and the remaining superficial cut edges (together with a small amount of surrounding uncut myometrium) in the second layer. Locking the sutures would interfere with blood supply. It seems to have become a common imitative unconscious practice to insert a very tight second layer of sutures (sometimes interlocking) to include quite wide areas (difficult to quantify) of surrounding intact myometrium. This is likely to strangulate the intervening myometrium around the incision, leading to ischaemic necrosis, thus leaving a thin band of poorly healed myometrium (niche).3 Such surgical practices become ingrained as their effects cannot be proven or disproven and the challenge is to conduct clinically informative RCTs. However, even thinking and deliberating about tenets of good surgery (in addition to results and limitations of RCTs) and the resultant awareness/introspection could improve the surgical techniques and results. Hence, guidelines should encourage ‘reflection’ by discussing the pros and cons and good principles of surgical techniques. Another source of long-term morbidity is postoperative adhesions. While comparing closure versus non-closure of peritoneum, many RCTs mostly report surrogate and clinically unimportant short-term outcomes. Peritoneum has a physiological ‘isolation’ function, avoiding direct contact of raw areas. In fact the two meta-analyses
1445
