Cerebral palsy and clinical negligence litigation: a cohort study

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1 BJOG: an International Journal of Obstetrics and Gynaecology January 2003, Vol. 110, pp Cerebral palsy and clinical negligence litigation: a cohort study Catherine Greenwood a,b, *, Sally Newman b, Lawrence Impey b, Ann Johnson a Objective To compare the prevalence of criteria suggesting acute intrapartum hypoxia in children with cerebral palsy who have and have not been the subjects of clinical negligence legal claims. Design Nested cohort study within a geographically defined cohort. Setting The former Oxfordshire Health Authority. Population Singleton children with cerebral palsy born between 1984 and 1993, excluding cases with a recognised postnatal cause for cerebral palsy. Methods Retrospective review of medical records by blinded observer. Main outcome measures Three essential criteria defined by the International Cerebral Palsy Task Force which identify acute intrapartum hypoxia. Results One-fifth (27/138) of all singleton cerebral palsy children were the subject of a legal claim. The presence of all three criteria was significantly more likely to lead to a legal claim ( P < 0.01), but in 74% (20/27) of claims, all three were not fulfilled and 36% (4/11) of those satisfying all three criteria did not claim. At least one of the three criteria was met in 82% (91/111) of the cases where there was no claim. Data on fetal or neonatal arterial blood gases were available in only 57% (78/138). Of the 27 claims, 12 were discontinued, 8 were settled and in 7 the legal process is still pending. The presence of the three essential criteria for acute intrapartum hypoxia did not increase the likelihood of a legal claim being settled. Conclusion The prevalence of the template essential criteria is high in all cases of cerebral palsy. Although the presence of all three essential criteria was more likely in the claims group, this did not appear to influence the outcome of a claim. It remains to be seen whether the existence of the template leads to change in the pattern of decisions made by the courts. INTRODUCTION In October 1999, the International Cerebral Palsy Task Force published a consensus statement for defining a causal relationship between acute intrapartum events and cerebral palsy 1. Their aim was to attempt to define an objective template of evidence to better identify cases of cerebral palsy where the neuropathology began or became established around labour and birth. The authors defined three essential criteria, which should be met before attributing cerebral palsy to an intrapartum hypoxic event and a number of criteria that together suggest an intrapartum timing, but are non-specific. The essential criteria do not depend on the traditional clinical signs of birth asphyxia, that is, fetal heart rate changes and a low Apgar score at birth, but focus on the presence of severe fetal or neonatal acidosis, neonatal neurological state and type of cerebral palsy. Although in clinical negligence claims it is now widely acknowledged that most cerebral palsy is not the result of intrapartum hypoxia 2,3, allegations of causation of cerebral a National Perinatal Epidemiology Unit, Oxford, UK b John Radcliffe Hospital, Oxford, UK * Correspondence: Dr C. Greenwood, Level 4, The Women s Centre, John Radcliffe Hospital, Headley Way, Headington, Oxford OX3 9DU, UK. D RCOG 2003 BJOG: an International Journal of Obstetrics and Gynaecology PII: S (02) palsy in clinical negligence claims usually centre on care in the intrapartum period 4,5. This is because there is a widespread perception that adverse events in labour are usually potentially preventable, whereas cerebral palsy arising in the antenatal period is considered largely non-preventable. In the courts, therefore, much of the debate focuses on whether or not there is evidence of acute intrapartum hypoxia and if so, whether the care provided was timely and adequate. Although it was not universally accepted 6, the consensus statement attempted to provide a template for addressing the first of these issues. The value of the template also will be influenced by how often the information is available in medical records. The template has also been challenged as a non-systematic review of the existing evidence 7 and there is the continuing problem that in the absence of a gold standard measure of intrapartum hypoxia, there is uncertainty how discriminating the agreed criteria really are. In addition, the template does not address the issue of breach of duty of care, the second key issue in assessing if there has been clinical negligence. Despite these shortcomings, however, it is possible that expert witnesses, as well as the Claimant and Defendant legal advisors, may adopt these guidelines when assessing liability. Accepting its possible limitations, we were interested to test how the template would work in practise. In what ways did children with cerebral palsy who were the subject of

2 CEREBRAL PALSY AND CLINICAL NEGLIGENCE 7 legal claims differ from those who were not the subject of claims? How available were the data needed to assess whether essential and other criteria were met? To what extent do the criteria identify cerebral palsy cases that have been judged by the civil legal process more likely than not to have been caused by preventable intrapartum injury? Using a population register of children with cerebral palsy and a database maintained by the Legal Services Department (formerly for the Health Authority and now for the NHS Trust), we have compared the frequency of sociodemographic and perinatal factors, including the essential and other factors outlined in the consensus statement in children with cerebral palsy who: (a) have and have not been the subjects of claims; (b) have been the subject of successful claims and those who have been the subject of unsuccessful claims. METHODS Children with cerebral palsy were identified from the Oxford Register of Early Childhood Impairment (ORECI). The register includes information on all children with cerebral palsy born to mothers resident within the Oxfordshire health district. It is compiled from many sources and, in general, the children are included as cases on the register at the age of five years 8. Children who die with clear signs of cerebral palsy between one and five years are also included. The cohort for this study included all singletons on the register born between 1984 and Those with cerebral palsy resulting from a well-defined post neonatal insult were excluded. This cohort was divided into two groups: 1. Children with cerebral palsy who were a subject of a clinical negligence claim. Parents of children with cerebral palsy who sought legal advice were identified from the Oxford Radcliffe Hospital NHS Legal Services Department database. This database lists all potential and actual litigants against the former health authority or its staff. Potential Claimants are identified when a solicitor requests sight of a client s notes. Data on the progress of each action are maintained. Information on litigation commenced, in progress, or completed was collected in December 2000, a minimum of seven years and a maximum of 16 years after the birth of the baby. Cases were defined as settled if damages had been paid to the Claimant or if judgement had been entered against the Health Authority. Cases that were active in the previous 18 months were considered pending and discontinued if the Claimant s solicitor had given notice of discontinuance. During the period of the study, there were no instances of cases going as far as a trial and then being successfully defended by the Health Authority, but discontinuance of claim might be considered equivalent. 2. Children with cerebral palsy who were not a subject of a legal claim. Children included in the cohort where no legal claim has been made up to December Available details of medical and social history were extracted from the medical records and entered onto a standardised datasheet. This study was part of a larger case control study in which every effort was made to blind those abstracting the medical records. The medical records of those children currently the subjects of litigation were only accessible in the Legal Services Department, however, and blinding was achieved by interspersing medical records from controls (gestational age-matched mothers whose children were unaffected by cerebral palsy) with those that were of children who were the subject of claims, prior to inspection of the records. Definitions for each variable were defined in advance (Table 1). Data were double entered into a database. The type of cerebral palsy was derived from the ORECI database. Ethics committee permission was obtained for the original study. Univariate analysis was performed using a t test for continuous variables and m 2 for categorical variables. Where an expected cell value was less than five, P values were based on Fisher s exact test. Analysis was performed by computer using SPSS (Chicago, Illinois). RESULTS Between 1984 and 1993, there were 143 singleton babies who developed cerebral palsy born to residents in the Oxfordshire Health Authority. Of these 138 were delivered in the hospitals now covered by the Oxford Radcliffe NHS Trust legal services database. Five were delivered elsewhere. Notes were located in all eligible cases. Legal action was considered in 27 (19.6%). Of these, 12 (44.4%) were discontinued, 7 are pending and 8 have been settled in favour of the Claimant. All legal claims related to alleged negligence in the intrapartum period. Comparing these 27 children who were the subject of a claim, with 111 who were not, litigation was less frequent in those born preterm and more frequent in recent birth years (Table 2). There was a trend towards increasing risk of litigation in primigravidae and the socially disadvantaged, but other antenatal risk factors for legal action could not be identified. Maternal age was not different in the claim and the no-claim group. Data were available on fetal or neonatal acid base status on 78 of 138 (56.5%) subjects, 18/27 (66.7%) of claims group and 60/111 (54.1%) of non-claims group: Information was available on neonatal neurological status on all 93 children who were 34 weeks at birth; and the type of cerebral palsy was known for all children. The three factors considered essential to support an intrapartum hypoxia origin were all more frequent where litigation had been instigated, as was the cluster of the three essential criteria together.

3 8 C. GREENWOOD ET AL. Table 1. A comparison of the definitions used in the consensus document and the variables as defined in this study. Template definition Variable as defined in this study Essential consensus criteria 1. Evidence of a metabolic acidosis in intrapartum fetal umbilical arterial cord, or very Included only if cord blood was taken or neonatal early neonatal blood samples (ph <7.00 and base deficit 12 mmol/l). blood was taken in the first hour of life. 2. Early onset of severe or moderate neonatal encephalopathy Evidence of moderate or severe neonatal encephalopathy in infants of 34 weeks of gestation. recorded in neonatal notes in the first 24 hours of life. 3. Cerebral palsy of spastic quadriplegic or dyskinetic type. Taken from reporting of paediatricians assessment to the ORECI database. Additional non-specific criteria 4. A sentinel (signal) hypoxia event occurring immediately before or during labour. Intrapartum abruption or cord prolapse or uterine rupture. 5. A sudden rapid and sustained deterioration of the fetal heart rate pattern usually after the hypoxic sentinel event where the pattern was previously normal. Electronic fetal monitoring deterioration to ominous using the Dublin criteria Apgar scores of 0 6 for longer than 5 minutes. Apgar at 5 minutes recorded as 6 or less. 7. Early evidence of multisystem involvement. Evidence of renal failure (creatinine > 100 mg/l) in first week of life. 8. Early imaging evidence of acute cerebral abnormality. CT scan performed within first week of life and abnormal. Overall, 11 of 93 (11.8%) cerebral palsy children (34 weeks of gestation) fulfilled all three essential criteria for intrapartum hypoxia and seven (63.6%) of these children were the subject of claims. In 20/27 (74.1%) of all claims, at least one of the three essential criteria was not fulfilled, although there was only one case in the claims group where none of the essential criteria were present, and this child had cerebral palsy caused by an early prenatal lesion. Table 2. Socio-demographic and perinatal factors among children with cerebral palsy comparing those with and without legal claims. Values are given as mean [SD], n/n (%), P (95% CI) and RR (95% CI). All singleton cerebral palsy (N ¼ 138) Legal claim (N ¼ 27) No claim (N ¼ 111) Difference Gestational age (weeks) 35.4 [5.1] 38.1 [3.4] 34.8 [5.3] 3.4 ( 5.5 to 1.3) 34 weeks gestation 46/138 (36.2) 3/27 (14.8) 43/111 (41.4) 0.2 (<0.1 to 0.7) Year of birth (47.1) 9 (33.3) 56 (50.5) (52.9) 18 (66.7) 55 (49.5) 0.5 (0.2 to 1.2) Primigravida 76/138 (55.1) 19/27 (70.4) 57/111 (51.4) 2.3 (0.9 to 5.6) Maternal age (years) 26.7 [5.7] 26.8 [5.9] 26.6 [5.7] 0.2 ( 2.3 to þ2.6) Father s profession: unskilled/unemployed 32/121 (26.4) 4/23 (17.4) 28/98 (28.6) 0.5 (0.2 to 1.8) or mother unsupported Previous infertility 9/136 (6.6) 1/27 (3.7) 8/109 (7.3) 0.5 (0.1 to 4.1) Pre-eclampsia 17/138 (12.3) 2/27 (7.4) 15/111 (13.5) 0.5 (0.1 to 2.4) Cerebral palsy of early prenatal cause 25/138 (18.1) 2/27 (7.4) 23/111 (20.7) 0.3 (0.1 to 1.3) Essential criteria Cord arterial ph <7.0 and BE >12 mmol 24/78 (30.7) 10/18 (56.6) 14/60 (23.3) 4.1 (1.4 to 12.4) Early-onset neonatal encephalopathy 23/93 (24.7) 12/24 (50.0) 11/69 (15.9) 5.3 (1.7 to 16.8) (infants born at 34 weeks of gestation) Either spastic quadriplegic or dyskinetic cerebral palsy 59/138 (25.9) 18/27 (66.7) 41/111 (36.9) 3.4 (1.4 to 8.3) All three consensus criteria fulfilled 11/93 (11.8) 7/24 (25.9) 4/69 (7.3) 6.7 (1.5 to 34.1) No consensus criterion met 21/138 (15.2) 1/27 (3.7) 20/111 (18.0) 0.2 (<0.1 to 1.4) Non-specific criteria* Sentinel intrapartum event 14/138 (10.1) 3/27 (11.1) 11/111 (9.1) 1.2 (0.3 to 4.5) Abruption Cord prolapse Uterine rupture CTG deterioration to ominous 43/87 (49.4) 15/23 (65.2) 28/64 (43.8) 2.4 (0.9 to 6.5) Apgar at 5 minutes <7 29/137 (21.1) 12/27 (44.4) 17/110 (15.5) 4.4 (1.6 to 12.1) Renal failure 17/123 (13.8) 8/26 (30.8) 9/97 (9.3) 4.3 (1.4 to 12.7) Neonatal CT scan abnormality 34/42 (81.0) 12/13(92.3) 22/29 (75.9) 3.8 (0.4 to 186.2) * Denominations relate to the number of assessments/investigations done.

4 CEREBRAL PALSY AND CLINICAL NEGLIGENCE 9 Table 3. Perinatal factors among children with cerebral palsy comparing those with settled or pending legal claims and those with discontinued claims. Values are given as n/n and RR (95% CI). All legal claims (N ¼ 27) Claim settled (N ¼ 8) Claim pending (N ¼ 7) Claim discontinued (N ¼ 12) Claim settled/pending vs claim discontinued Essential criteria Cord arterial ph <7.0 and BE >12 mmol 10/18 4/6 3/6 3/6 1.4 (0.2 to 10.0) Early-onset neonatal encephalopathy in 12/24 5/7 3/6 4/ (0.4 to 20.3) infants born at 34 weeks of gestation Either spastic quadriplegic or dyskinetic cerebral palsy 18/27 6/8 5/7 7/ (0.4 to 10.0) All three consensus criteria fulfilled 7/23 3/7 1/6 3/ (0.2 to 10.6) No consensus criterion met 1/27 0/8 0/7 1/12 Non-specific criteria* Sentinel intrapartum event 3/27 2/8 0/7 1/ (0.1 to 21.2) CTG deterioration to ominous 15/23 4/7 5/6 6/ (0.3 to 8.4) Apgar at 5 minutes <7 12/27 5/8 3/7 4/ (0.5 to 11.0) Renal failure 8/26 3/8 1/7 4/ (0.1 to 3.4) Neonatal CT scan abnormality 12/13 4/5 1/1 7/7 * Denominators relate to the number of assessments/investigations done. At least one consensus criterion was present in 91/111 (82.0%) of the cases where there was no legal claim and the absence of any of the consensus criteria was not a significant factor in explaining the likelihood of making a claim. Four children (36.3%) who satisfied all three criteria were not the subject of claims. Information on non-specific criteria were more often available in the claims group than in the no-claims group. A CTG tracing was available for 87 of 138 (63%) of cerebral palsy subjects (23/27: 85% in the claims group and 64/111: 57.6% in the non-claims group; P ¼ not significant). Overall, half (43/87) of these had an ominous CTG arising for the first time in labour. This occurred more frequently in the claims group but the difference did not reach statistical significance. Only a third of the children on the register had a neonatal CT scan (13/27: 48% of the claims group and 29/111:26.1% of non-claims group). Most (34/42: 81%) were abnormal. Among those with available data, the frequency of all the non-specific criteria was higher in the claims group than in the non-claims group. Comparing other criteria and outcome of claims is limited by small numbers a much larger study may reveal differences that are not apparent here. For purposes of comparing successful and unsuccessful claims, settled and pending have not been combined, although for a claim to be pending an independent expert would have already reviewed the medical records and the Claimant s solicitor would have been advised to continue with the claim. However, it is possible that all of these claims may be successfully defended in the future. Although all essential criteria occurred more frequently among successful claims, they did not clearly discriminate between successful and unsuccessful claims. The pattern is similar among the non-specific criteria except for the presence of renal failure, which occurred less frequently among those with successful claims (Table 3). We were not able to detect a difference in the outcome of claims associated with social disadvantage (0/8 successful claims, 3/7 pending claims, vs 1/8 unsuccessful; in four cases data missing). DISCUSSION Understanding the time of onset of a brain lesion in a child with cerebral palsy and the potential preventability of the neurological injury is important to parents and the children themselves, to medical and legal professionals. Clinical signs that are widely acknowledged as signs of stress and distress in the fetus during labour and delivery may be a response to acute hypoxia or may reflect the response of an already compromised fetus that has been exposed to earlier hypoxic or other brain injury. Distinguishing these and assessing the extent to which either of these scenarios could have reasonably been avoided by alternative intrapartum care are the roles of the courts when considering clinical negligence claims. There have been a number of descriptive studies of children with cerebral palsy who have been the subject of a claim alleging that their cerebral palsy is the result of negligence during labour and delivery 10,11. Without comparison groups, however, it has been difficult to set these children in the wider context of all children with cerebral palsy or to assess the value of clinical signs in allocating the time of brain injury. Using a population register of children with cerebral palsy, it was clear that a legal claim of preventable intrapartum hypoxia was made on behalf of one in five of all children with cerebral palsy born as singletons to residents of one health district. Most of the claims are made on behalf of children born after 34 weeks of gestation and a quarter of all the singleton cerebral palsy children on the register in this gestational age range have

5 10 C. GREENWOOD ET AL. been the subject of a claim. This is more than twice as many as the commonly accepted figure of 10% of term cerebral palsy attributable to acute intrapartum hypoxia 12. Furthermore, new claims remain possible as the limitation allows proceedings to be commenced until the age of 21 years or, where there is no date of knowledge in a child with severe intellectual impairment, at any time during the child s life provided the defendant is not unduly prejudiced. Furthermore, there is evidence that the rate of claims has increased in recent years 13. In this climate of litigation, the publication of a consensus statement that aimed to identify those children who were most likely to have had intrapartum hypoxia seemed timely. Although hampered by a lack of good research evidence, the statement was agreed by a number of clinicians and epidemiologists and has been of great interest to those involved in clinical negligence litigation. On attempting to apply the template to a total population of children with cerebral palsy, however, a number of issues emerged. First, as predicted by critics of the original publication 7,14, information about the essential criteria is frequently missing from the medical records. In particular, cord blood arterial gases were available in only half the children with cerebral palsy born during this period of this study, born before the establishment of the NHS Litigation Authority and the introduction of risk management guidelines from the Clinical Negligence Scheme for Trusts. This lack of historical data severely limits the value of the consensus statement in assessing children born more than 10 years ago. Partly through this lack of information, only a quarter of those with claims, born at or after 34 weeks, met all three criteria. Further, in only 4 of 13 successful claims were all three essential criteria for intrapartum hypoxia fulfilled. This means that the majority of claims (originating before 1994) have been settled without the presence of the three essential characteristics required by the template. These settlements are presumably based on the presence of one or two of the essential criteria (at least one was present in all settled cases), with or without additional clinical signs of non-reassuring fetal status and an expert s opinion that either that care has fallen short of accepted standards or that there is a deficiency in documentation. Second, it is clear from this and other studies that many children with cerebral palsy have had one or more of the clinical signs which are widely assumed to reflect fetal distress but which may not represent acute intrapartum hypoxia 15. Only 15% of all cerebral palsy children in this study had none of the essential criteria and almost half had an ominous CTG. It appears that if a case is brought, breach of duty is established and causation is then to be demonstrated, these non-specific signs of acute intrapartum hypoxia might be used to define the time of brain injury even though they are present in the many, if not most, cases of cerebral palsy. So what has the template achieved? Although it is proving difficult to use its recommendations in assessing children born a number of years ago, its publication highlighted yet again, the complex and varied aetiology of cerebral palsy and the continuing difficulty in allocating the time of brain injury. The value of obtaining blood gases has been re-emphasised and many units, including the main unit involved in this study, now have clear guidelines on when fetal and cord blood samples need to be taken. This practice has also recently been endorsed by the Royal College of Obstetricians and Gynaecologists 16. There remains, however, a need for better markers of acute intrapartum injury. Neonatal nucleated red blood cells and lymphocyte counts have been shown to be raised in asphyxiated infants, but the rise is seen in both definite intrapartum events and those that started antenatally 17. Other acute inflammatory markers might be more useful in the future 18. And what has this study shown? A quarter of all singleton cerebral palsy children born after 34 weeks of gestation are the basis of a claim. Even prior to the template s publication, a claim was more likely if its three essential criteria were met but in 74% of all claims less than three criteria were met, and 36% of those satisfying all three criteria did not claim. Of course, even if cerebral palsy is of intrapartum origin, this need not necessarily imply negligence, nor does an antenatal aetiology exclude negligence. It remains to be seen whether these guidelines, now published, lead to a different approach to decision making in the legal system. Making a legal claim means a huge cost for all parties concerned not only in financial terms for the health services, but also in terms of time and anguish. Almost half the claims brought were discontinued and it is possible that these could have been prevented by the measures now in place to ensure good communication and risk management procedures. Over the period of 10 birth years, 8 of the 138 families of singleton children with cerebral palsy in one health district have had substantial financial compensation that can be used to support their disabled child. The needs of the remaining 130 families are less well met. The litigation process may be an unsatisfactory and inequitable way of ensuring that families of children with cerebral palsy have sufficient resources to care for their disabled child. Acknowledgements The authors would like to thank Susan Sellers as grant holder on the original study and with review of the manuscript, Pat Yudkin as grant holder on the original study, Geraldine Gaffney and Deirdre Murphy for collection of some of the data, Eleanor McDonald for data coordination, Oxford Radcliffe NHS Trust Legal Services Department for use of their database. This study was partly

6 CEREBRAL PALSY AND CLINICAL NEGLIGENCE 11 funded by a grant from National Health Service R&D South East Region, UK. CG designed the original study, collected most of the data, analysed the data and co-wrote the article. She is guarantor for the paper. SN contributed to the design of the original study and revised the article. LJ co-drafted and revised the article. AJ conceived the original study, helped with analysis of the data and co-wrote the article. References 1. MacLennan A. A template for defining a causal relation between acute intrapartum events and cerebral palsy: international consensus statement. BMJ 1999;319: Bakketeig LS. Only a minor part of cerebral palsy begins in labour. BMJ 1999;319: Gaffney G, Sellers S, Mackenzie IZ, Yudkin PL, Johnson AM. Case control study of intrapartum care, cerebral palsy and perinatal death. BMJ March 19, 1994;308(6931): Towbin A. Obstetric malpractice litigation: the pathologist s view. Am J Obstet Gynecol November 1986;155(5): Sloan FA, Whetten-Goldstien K, Stout EM, Entman SS, Hickson GB. No-fault system of compensation for obstetric injury and subsequent cerebral palsy: medicolegal issues. Paediatrics June 1997;99(6): Pickering J. Legal comment on the international consensus statement on cerebral palsy. Clin Risk 2000;(6): Rosenbloom P, Rennie JM. Birth asphyxia and cerebral palsy. BMJ 2000; Johnson A, King R. A regional register of early childhood impairments: a discussion paper. The Steering Committee of the Oxford Region Child Development Project. Community Med November 1989;11(4): MacDonald D, Grant A, Sheridan-Pereira M, Boylan P, Chalmers I. The Dublin randomized controlled trial of intrapartum fetal heart rate monitoring. Am J Obstet Gynecol July 1, 1985;152(5): B-Lynch C, Coker A, Dua JA. A clinical analysis of 500 medicolegal claims evaluating the causes and assessing the potential benefit of alternative dispute resolution. Br J Obstet Gynaecol 1996;103(12): Vincent CA, Martin T, Ennis M. Obstetric accidents: the patient s perspective. Br J Obstet Gynaecol 1991;98(4): Australian and New Zealand Perinatal Societies. The origins of cerebral palsy: a consensus statement. Med J Aust 1995;162: Fenn P, Diacon S, Gray A, Hodges R, Rickman N. Current cost of medical negligence in NHS hospitals: analysis of claims database. BMJ 2000;320: Dear P, Newell S. Establishing probable cause in cerebral palsy. BMJ 2000; Nelson KB, Dambrosia JM, Ting TY, Grether JK. Uncertain value of electronic fetal monitoring in predicting cerebral palsy. N Engl J Med March 7, 1996;334(10): Royal College of Obstetricians and Gynaecologists.. The use of electronic fetal monitoring. Clin Guidelines May 2001: Phelan JP, Korst LM, Ahn MO, Martin GI. Neonatal nucleated red blood cell and lymphocyte counts in fetal brain injury. Obstet Gynecol April 1998;91(4): Nelson KB, Willoughby RE. Infection, inflammation and the risk of cerebral palsy. Curr Opin Neurol April 2000;13(2): Accepted 11 September 2002

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