by Oliver Quick, Co-Director, Centre for Health, Law and Society, University of Bristol Law School
Healthcare harm is a global public health problem. The World Health Organisation estimates that adverse events account for more deaths than either lung cancer, diabetes or road injuries, and that around 80% are avoidable. In low- and middle- income countries, poor quality healthcare accounts for 10-15% of deaths annually. Such statistics are striking if slightly simplistic in that unsafe care combines with pre-existing health conditions and diseases, and avoidability assessments are likely based on ideal, rather than real world, conditions. However, in England alone, the additional annual financial cost of providing further care to harmed patients would equate to employing over 2,000 salaried GPs and 3,500 hospital nurses, much needed given the high number of vacant positions in the NHS workforce. The annual cost of compensating and managing maternity negligence cases (£2.1 billion) now exceeds the amount spent on delivering babies (£1.9 billion.) Remarkably, there remains no coherent cross-government strategy and policy to address these spiralling costs.
Behind all of these statistics are patients, their families and clinicians who all suffer, sometimes in silence. For patients and their families, a lack of openness in the aftermath adds emotional insult to their physical injuries, often having a long lasting impact. The sad death of Robbie Powell in 1990, aged 10, of undiagnosed Addison’s disease is a powerful example. Robbie never had the blood test which would have diagnosed this treatable condition with many ‘missed opportunities’ in his care. Will Powell, Robbie’s father, suspected a cover up and pursued numerous legal actions in searching for the truth. Despite the shameful decision of the Court of Appeal in Powell v Boladz (1997) 39 BMLR 35 to reject a claim for psychiatric injury from Robbie’s parents, and a similarly painful decision of the European Court of Human Rights, he continued to campaign for a legal duty for health care professionals to be honest with harmed patients and their families, to be known as “Robbie’s Law.”
Duties of candour:
The General Medical Council responded to Robbie Powell’s case with revised guidance which has evolved into the professional duty of candour. Whilst such a duty seems somewhat overdue, classic codes of Western medical ethics such as the Hippocratic Oath and the Declaration of Geneva are strangely silent on the need for openness. In truth, candour to patients has never been a prominent feature of medical culture. Against this background, creating a statutory duty of candour is quite a leap. So how did we get here? In short, as a response to recommendation 181 of the Francis Report into Mid Staffordshire NHS Trust public inquiry, but also owing much to the campaigning efforts of Will Powell and the patient safety charity AvMA. The end product is Regulation 20 of The Health and Social Care Act 2008 (Regulated Activities) 2014, with similar versions in Scotland and Wales. Proposals for similar duties in Northern Ireland and Ireland are also in progress, following high profile inquiries into the deaths of five children after receiving intravenous fluids and failures in a cervical cancer screening programme.
The two duties of candour overlap but are different in scope and application. The professional duty applies to clinicians and includes low harm or even near misses. The statutory duty applies to ‘health service bodies’ which largely means NHS trusts and organisations regulated by the Care Quality Commission (CQC). They are required to be open and transparent with patients or their representatives about care and treatment, and to notify, support, provide a truthful account, advise, and apologise about “notifiable safety incidents.” For hospital care, this means any unintended or unexpected incident that could result in, or appears to have resulted in death, severe, moderate or prolonged psychological harm. Moderate is misleading given that it includes ‘unplanned return to surgery or transfer to another treatment area (such as intensive care).’ Primary care organisations, dentists, private healthcare and adult social services were initially excluded though became subject to the duty from April 2015, but with a different harm threshold triggering the duty. There is no requirement for them to inform patients about incidents which ‘could’ result in significant harm but haven’t yet done so. However, in both settings, the guidance envisages what we might call ‘long candour’ – it applies when new information emerges, regardless of when the incident occurred and irrespective of the litigation process.
The relationship between candour, liability risk, and safety is clearly critical. Duties of candour are part of a messy medico-legal landscape, the effect of which on healthcare practice remains poorly understood. Ideally, duties of candour would form part of a more ambitious re-design of the system for responding to adverse events, making it easier to be honest. Will obliging candour work in the current climate? Can it improve the rate and quality of disclosures, helping harmed patients (and clinicians) heal, and supporting a culture of openness? These things are far from easy to achieve. Professional regulators have long struggled to effect behavioural change, and lack of candour does not feature directly in the determinations of fitness to practise panels. An evaluation of the progress of professional regulators in embedding candour in practice demonstrates the considerable challenges of normalising candour. In terms of the statutory duty, assessment of CQC inspection reports have found an inconsistent and superficial approach to compliance, albeit with some anecdotal evidence of greater openness. Failure to comply can lead to removal of a care provider’s registration, warnings, special measures, fines and ultimately prosecution. In 2019 there were 14 Fixed Penalty Notices at 2 NHS Trusts, and the first prosecution went to trial last year with a Trust fined £1,600 for failing to disclose details and apologise to the family a 91-year-old woman who died after surgery.
Behavioural insights research reminds us that the search for explanations and apologies motivate many to complain or litigate. As the story of Robbie Powell illustrates, the disrespect of not knowing the truth or being properly involved in incident investigations exacerbates pain and suffering. Interestingly, the statutory duty of candour mandates apologies which it refers to as an ‘expression of sorrow or regret.’ An effective apology process is complex as it requires active listening, understanding, and sensitive communication. Sadly, many are partial, half–hearted and fail to hit the spot. Given that harm is a product of poor conditions – under staffed, poorly resourced risky settings – healthcare staff may also resent appearing to take responsibility for unsafe systems that are the root cause. Despite Section 2 of the Compensation Act 2006 stating that apologies are not (on their own) admissions of liability or breaches of statutory duties, there is no evidence that such provisions have improved the rate and quality of apologies. Indeed, very little is known about the impact of this statutory provision. Sadly, apologies remain high risk – low reward for those at the sharp end. Perhaps they always will be in the shadow of a damaging litigation system? Genuine apologies take time, require emotional intelligence and effective training and support for staff wellbeing.
Supporting patients and clinicians:
Unlike in Scotland, the English statutory duty does not mandate that staff receive specialist training and support in relation to candour. Learning from success is important and examples of positive deviance need to be celebrated. A particularly inspiring story is that of patient Linda Kenney and anaesthetist Rick van Pelt. In November 1999, Dr van Pelt administered a nerve block injection alongside general anaesthetic ahead of Linda undergoing ankle replacement surgery in Boston, Massachusetts. After the nerve block was administered, Linda went into cardiac arrest, required urgent open heart surgery and came close to dying. The hospital was somewhat economical with the truth, suggesting an allergic reaction, which Linda suspected wasn’t true (this was her twentieth operation). Unusually, Dr van Pelt wrote to Linda to explain and apologise. It transpired that some of the injected nerve block had entered Linda’s blood stream and caused the cardiac arrest. It was clear that he too had been profoundly affected by the incident and felt an enormous sense of release when Linda expressed her forgiveness. He was taken aback when Linda asked how he was coping after the incident, as a ‘second victim’ of such harm. This mutual care and concern was the background to Linda establishing ‘Medically Induced Trauma Support Services’, which provided emotional support for patients, families, and clinicians who experience healthcare harm, with Dr van Pelt as Chair of the Board of Directors. This invaluable work has evolved into a State wide peer support programme at the Betsy Lehman Centre for Patient Safety led by Linda Kenney, using her personal experience to make a remarkable contribution in helping patients and healthcare staff heal through open communication and support.
Dr van Pelt’s conscience was clear – and indeed correct. Being candid with harmed patients is the right thing to do. Supporting patients in the aftermath of harm, including communicating sensitively is an integral part of providing care. However, it collides with well–established cultures of silence around adverse events and understandable concerns about professional identity, reputation, loyalty, as well practical problems of lack of time and communication competencies. Candour is in principle the right thing to do, arguably a cardinal principle in healthcare, but is it always possible in practice? Patients may not always be as forgiving and graceful as Linda Kenney was. We need more research that better understands the experiences of professionals and patients in giving and receiving such difficult disclosure and apology communications. How have the duties impacted the nature and quality of post harm communication? Do such legal mechanisms help or hinder openness and learning? Do they reduce litigation risk? How does candour interact with other parts of the medico-legal system? Should candour be absolute? If not, what trumps truth telling to patients? Ultimately, how can we make it easier for clinicians and patients to support each other to heal from healthcare harm?
These key issues and questions about candour will be explored at the Centre for Health, Law and Society’s Annual Symposium to be held on February 11th 2021, featuring a keynote address by Gabriel Scally and a panel session with Annie Sorbie, Joanna Lloyd and Linda Kenney.