by Professor Peter B Sullivan MA MD FRCP FRCPCH Department of Paediatrics,
University of Oxford Healthcare in the National Health Service remains one of the safest in the world. However, avoidable errors with still occur. Since 1995, NHS Resolution (the operating name of NHS Litigation Authority from April 2017) has provided indemnity cover for clinical negligence claims against trusts in England, through its Clinical Negligence Scheme for Trusts. NHS Resolution is responsible for dealing with claims on behalf of its members, including funding defence costs, and for any legal costs or damages that become payable. The scheme is not mandatory, but all 234 trusts pay NHS Resolution an annual contribution to receive indemnity coverage. As part of the NHS, NHS Resolution aims to ensure that patients who suffer clinical negligence are appropriately compensated, by settling valid claims fairly and quickly, and that it defends claims that are without merit or where the damages sought are disproportionately high, to help protect NHS resources. It also aims to help trusts learn from past claims to improve patient safety and reduce the need for future claims (1).
In 2017/18 NHS Resolution (NHSR) received 10,673 new clinical negligence claims (1). Most of the claims, 13%, came from A&E. Orthopaedics were second at 12% of all claims and obstetric incidents accounted for 10%. Clinical negligence payments including interim payments for 2017/18 amounted to a total of £2,227.5 million.
The cost of clinical negligence in trusts is significant and rising fast, placing increasing financial pressure on an already stretched system. According to Sir Amyas Morse, head of the National Audit Office (NAO) : “NHS Resolution and the Department (of Health) are proposing measures to tackle this, but the expected savings are small compared with the predicted rise in overall costs. At £60 billion, up from £51 billion last year, the provision for clinical negligence in trusts is one of the biggest liabilities in the govern ment accounts, and one of the fastest growing.” (2)
In their report “Managing the Cost of Clinical Negligence in Trusts September 2017”, the NAO note that over the last ten years, spending on the Clinical Negligence Scheme for Trusts has quadrupled from £0.4 billion in 2006-07 to £1.6 billion in 2016-17 (of total NHS funding £120.512 billion), while the number of successful clinical negligence claims where damages were awarded has more than doubled, from 2,800 to 7,300 (2). The cost of clinical negligence claims is rising at a faster rate year-on-year, than NHS funding, adding to the financial pressures already faced by many trusts, which can have an impact on patients’ access to services and quality of care.
In addition, trusts spending a higher proportion of their income on clinical negligence are significantly more likely to be in deficit. In 2015-16, for example, all 14 trusts that spent 4% or more of their income on clinical negligence were in deficit.
Despite obstetrics claims representing only 10% of clinical claims by number in 2017/18, they accounted for 48% of the total value of new claims reported (1). Within obstetrics, the most expensive individual claims financially are those for cerebral palsy, which can exceed £20 million per claim. A key component of NHSR five year strategy, therefore, is to address the escalating cost of claims and a central area of focus is maternity claims, as one of the most significant drivers of cost. Birth injury claims and the increased life expectancy in survivors and rising costs of care and all contribute to the increase in damages awarded.
Giving birth in England is generally very safe. Within England, in 2015, there were 664,777 live births and the trend of reducing rates of stillbirths and neonatal deaths continued, with 3.93 stillbirths per 1000 total births and 1.71 neonatal deaths per 1000 live births (3). Data from the Office of National Statistics show that these improvements occurred despite increasing average maternal age and the highest recorded number of live births to women born outside of the UK (27.5%)(4). Unfortunately, avoidable errors within maternity still occur. These can have devastating consequences for the child, family and carers and contributed significantly to the £2,227.5m cost for clinical negligence in 2017/8.
Possibly the most devastating and undoubtedly the most expensive are claims for avoidable cerebral palsy, the number of which has remained relatively static over the last ten years (5). There may be as many as 1,800 new cases of cerebral palsy each year in the United Kingdom, as one in 400 babies born in the UK have a type of cerebral palsy. However, only 10% to 20% of the cases actually result from intra partum asphyxia.
In April 2017, NHSR changed its approach to dealing with cases of brain injury at birth through its Early Notification Scheme. This scheme requires NHS Trusts to report within 30 days all maternity incidents of potentially severe brain injury namely all babies born at term (≥37 completed weeks of gestation), following labour, that had a potentially severe brain injury diagnosed in the first seven days of life. These are any babies that fall into the categories: (i) diagnosed with grade III hypoxic ischaemic encephalopathy (HIE); (ii) therapeutically cooled (active cooling only) or (iii) had decreased central tone AND was comatose AND had seizures of any kind (6).
The Early Notification Scheme will provide a test bed for the Government’s proposals in relation to rapid resolution and redress. These incidents are now reported to NHSR from the outset, rather than five to six years later, as was the previous situation. Liability is admitted and they will provide the requisite financial support to families when they need it during the child’s early infancy. The aim of this is to lead to a reduction in time between the incident and resolution with an associated reduction in costs. This requires a proactive investigation of liability and for Trusts to be open and candid with families and breakdown any perception of defensiveness on behalf of the NHS. Claims for seriously injured patients who suffered brain damage at birth are usually paid as a lump sum, together with annual payments for the rest of that person’s life. This ensures the claimant is financially secure and that money would otherwise be paid out in advance is retained for patient care until it is actually needed. At the present time more cases are being committed to such a payment scheme than are leaving (ie when the patients die). As a result, the costs of these claims will continue to increase for decades to come.
The key to reducing the financial burden on the NHS of the growing costs of claims is learning from what goes wrong and supporting those who deliver care to make the changes necessary to prevent harm occurring in the first place. Importantly, these costs are solely those associated with compensation claims and do not include the organisational costs to the NHS, the additional costs of investigating what went wrong or the often unreported personal and psychological costs to staff.
The Royal College of Obstetricians and Gynaecologists (RCOG) in 2018 launched the “Each Baby Counts” initiative (6). Each Baby Counts is a national quality improvement programme to reduce the number of babies who die or are left severely disabled as a result of incidents occurring during term labour. In individual maternity units, these events are rare and it is therefore difficult to see clear patterns or identify how best to avoid them. The Each Baby Counts programme brings together the results of local investigations into stillbirths, neonatal deaths and brain injuries occurring during term labour to understand the bigger picture, share the lessons learned and prevent babies from dying or sustaining brain injuries in the future. In total, 1123 babies were born in 2016 who met the eligibility criteria for severe brain injury. This information is based on the first seven days after birth and it is not known how many of these babies will have a long-term disability as a result of injuries sustained at birth. The Each Baby Counts reviewers concluded that 674 babies (71%) might have had a different outcome with different care. The main themes identified where improvements could have been made were failure by health professionals to identify or act upon relevant risk factors, issues related to monitoring of fetal wellbeing with cardiotocograph (CTG) and blood sampling, and education or training issues.
In the analysis of reports from Each Baby Counts babies born during 2016 guidelines and locally agreed best practice were not followed in 45% (304) of the reports reviewed. Reasons for not following guidelines included lack of recognition of problems, communication issues, heavy workload, staffing levels, local guidelines not being based on best available evidence and gaps in training.
One of the key recommendations identified is a need for the development of a structured communication tool to include the three-fold elements of the plan for birth: mode of birth, location of birth and category of urgency. The Each Baby Counts project team is now working with the Obstetric Anaesthetists’ Association (OAA) and Royal College of Anaesthetists (RCoA) on the development of this tool.
The NHSR paper “Five Years of Cerebral Palsy Claims” focused on 50 cases of cerebral palsy following incidents between 2012-2016, where legal liability had been established (5). NHS Resolution’s claims management system was searched for all obstetric claims with an incident date between 2012 and 2016, where the alleged medical negligence resulted in cerebral palsy or neonatal brain injury. The potential financial liability of these fifty cases could be greater than £390 m, which excludes defence costs and wider health costs to the NHS.
The report found evidence of poor quality serious incident investigations at a local level: (i) the patient and family were only involved in 40% of investigations; (ii) only 32% had a review that involved an obstetrician, midwife and neonatologist; (iii) only 4% had an external reviewer; (iv) investigations focused too heavily on individual errors and (v) breech births were overrepresented within this cohort, compared to the national average.
The most common theme related to errors with fetal heart rate monitoring. The underlying causes, however, were often not related to individual misinterpretation but to systemic and human factors. Inadequate staff training and monitoring of competency were identified as an important issue. Shortcomings in informed consent were evident a fact that assumes greater significance in the light of the Montgomery ruling (7).
Although this report analyses only a small number of specific claims, the findings resonate with other reports with similar findings (8) and suggest that there has been little improvement in these areas in recent years.
Recommendations from the NHSR study “Five Years of Cerebral Palsy Claims” include: transparency with the family and investigation into systemic causative factors (5). This reduction in time lag between the incident and involvement of NHSR improves the ability of NHSR to work with Trusts to improve the way in which the NHS responds to and supports the families involved and to learn from such incidents to prevent future incidents. A key recommendation was that CTG interpretation should not occur in isolation and should always occur as part of a holistic assessment of fetal and maternal wellbeing. CTG training should incorporate risk stratification, timely escalation of concerns and the detection and treatment of the deteriorating mother and baby.
The financial costs of litigation for cerebral palsy claims are high and quantifiable but the costs to the child, family and carers are immeasurable. Having a child suffer catastrophic avoidable harm is a tragedy for everyone involved. Cerebral palsy (CP) is the commonest cause of physical disability in early childhood, with a rate of approximately 2 per 1,000 live births . CP is a permanent neurological disorder caused by non-progressive disturbances or alterations of the developing brain that results in disordered motor function and posture . CP ranges in severity but often involves problems with muscle tone, balance, co-ordination, epilepsy, difficulties with communication, feeding and behaviour (9).
Gastrointestinal problems are encountered in more than 90% of children with neurological impairment. Diffuse brain lesions may disrupt neural modulation of gastrointestinal motility altering the flow of information from the brain cortex to the gut nervous system leading to significant dysfunction in the gastrointestinal tract. The degree of gastrointestinal dysfunction correlates with the degree of damage to the developing central nervous system.
Gastrointestinal problems include oropharyngeal dysfunction, gastroesophageal reflux, delayed gastric emptying, and constipation and affect quality of life and nutritional status. Oropharyngeal dysfunction and gastroesophageal reflux disease predispose to pulmonary aspiration leading to recurrent respiratory infections, which is the most common cause of death in this population.
The feeding problems and subsequent nutritional problems of children with severe CP attracted very little attention until the last couple of decades (10-12). More recently, research has highlighted the significant impact of gastrointestinal and feeding problems on children with CP and their families (12,13) . Some mothers may spend up to seven hours a day feeding their disabled child and whilst gastrostomy feeding may provide some relief, this is not without its own problems (14-16).
These gastrointestinal and feeding problems of children with CP are just one example of a range of deficits related to motor and cognitive impairment, which profoundly affect the quality of life for the child and family. There are major issues relating to mobility, hand function, communication, education, employability and life expectancy which all need to be taken into account.
Compensation for children with CP will cover damages for pain, suffering and loss of amenity for the injury itself as well as damages for past and future monetary losses. For CP claims, this often includes loss of future earnings, the cost of care and assistance, physiotherapy, hydrotherapy, speech and language therapy, mobility equipment and physical aids, specialist transport, as well as alternative or adaptations to accommodation. The high financial costs represent the lifelong care and assistance that the children often need.
(1) NHS Resolution (NHSR). Annual report and accounts 2017/18. ISBN: 978-1-5286-0451-2
(2) National Audit Office ‘Managing the costs of clinical negligence in trusts’. September 7, 2017. ISBN: 9781786041395
(3) Mankelow B, Smith L, Prunet C, Smith P, Boby T, Hyman-Taylor P, et al.(2017) MBRRACEUK Perinatal mortality surveillance report; perinatal deaths for births from January to December 2015.
(4) Office for National Statistics. Births in England and Wales 2015. Published 2016 [Available from: https://www.ons.gov.uk/peoplepopulationandcommunity/ birthsdeathsandmarriages/livebirths/bulletins/ birthsummarytablesenglandandwales/2015.
(5) Michael Magro . Five years of cerebral palsy claims: A thematic review of NHS Resolution data. September 2017
(6) Royal College of Obstetricians and Gynaecologists. Each Baby Counts: 2015 Full Report. London: RCOG; 2017 [www.rcog.org.uk/en/guidelines-research-services/auditqualityimprovement/ each-baby-counts/ebc-2015-report/]
(7) Montgomery v Lanarkshire Health Board.UKSC 11. 2015.
(8) House of Commons Public Administration and Constitutional Affairs Committee. Will the NHS never learn? Follow-up to PHSO report ‘Learning from Mistakes’ on the NHS in England. 2017
(9) Rosenbaum P, et al A report: the definition and classification of cerebral palsy. Dev Med Child Neurol Suppl. 2007;109(April):8-14.
(10) Sullivan, P. B. & Rosenbloom, L. 1996. Feeding the Disabled Child, London, MacKeith Press.
(11) Sullivan, P. B., et al, 2000. Prevalence and severity of feeding and nutritional problems in children with neurological impairment: Oxford Feeding Study. Dev.Med.Child Neurol., 42, 10-80.
(12) Sullivan, P. B., et al . 2004. Impact of gastrostomy tube feeding on the quality of life of carers of children with cerebral palsy. Dev.Med.Child Neurol., 46, 796-800.
(13) Sullivan, P. B. 1997. Gastrointestinal problems in the neurologically impaired child. Baillieres.Clin Gastroenterol, 11, 529-546.
(14) Sullivan, P. B. 1998. Is tube-feeding in disabled children associated with excess mortality? J Pediatr Gastroenterol Nutr, 27, :240-:241
(15). Sullivan, P. B., et al., 2006. Gastrostomy feeding in cerebral palsy: too much of a good thing? Dev.Med.Child Neurol., 48, 877-882.
(16) Sullivan, P. B. 2014. Pros and cons of gastrostomy feeding in children with cerebral palsy. Paediatrics and Child Health, 24, 351-354.