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Laurence is a regular contributor to Medico-legal Magazine and is an active patient safety advocate, following his retirement from practice in 2020. He has over 30 years’ experience of clinical negligence litigation, representing claimants and their families in many high-profile cases, including the families affected by the Bristol children’s heart surgery scandal of the 1990s.
This follows my first article commenting on the HSIB final report of 17 December 2020¹, following their investigation into safety concerns over placement of nasogastric (NG) feeding tubes (see Medico-Legal Magazine, Issue 16).
Despite patient safety alerts and warnings, and the fact that misplacement had continued to result in severe complications and avoidable harm to patients, some practitioners had admitted to HSIB investigators that they were aware of the existence of guidelines issued by the Society of Radiographers in 2012 intended to avoid this preventable error – an NHS “Never Event” - but had not read them as they were “too long to read.”
The failure of individual Hospital Trusts to ensure awareness and implementation of the established guidelines by their staff through rigorous clinical governance came as a major surprise.
In recent years there has been a significant increase in clinical guidelines and protocols issued at local, national and international level by professional bodies, regulators, Royal Colleges, NHS Trusts and other organisations. They provide the courts with a benchmark by which to judge clinical conduct. Although they do not set legal standards for clinical care, inevitably guidelines and protocols are likely to play an increasingly important part in a clinical negligence claim. As more cases are reported in which the relevance and effect of a guideline is a material issue, we will gain a better idea of the weight a court may give to a guideline and the implications for a negligence claim of a medical practitioner complying or, on the other hand, failing to comply with a particular guideline.
Where a guideline relevant to a particular form of treatment is endorsed as authoritative by an expert, the Court will usually give significant weight to that evidence, but only as part of the overall expert evidence.
The Sepsis 6 guidelines (reflected in NICE guideline 51²) are perhaps the closest we get to Commandments: protocols that are clear and unambiguous, known and respected universally, which must be obeyed without good reason. Negligence claims on behalf of injured patients in which the guidelines for the diagnosis and early management of this life-threatening illness have not been followed would be difficult to defend.
There must be a presumption that doctors should be aware of current guidelines relevant to their practice areas as part of their duty to exercise reasonable skill and care, even in those specialties in which keeping up to date with journals and guidelines amounts to a significant burden. Many clinicians are likely to feel that they now face a deluge of guidelines from multiple sources. GPs, for example, will often see patients with multi- morbidities, so compliance with a number of single disease guidelines is not without its difficulties.
It is doubtful that a Court would be sympathetic to any suggestion that guidelines should not apply because they were prolix, and practitioners, although aware of their existence, don’t have time to read them. Similarly, ignorance of an authoritative, relevant guideline would be unlikely to afford a defence.
In this article I have considered the potential arguments that might be raised to challenge the validity of an apparently trustworthy, authoritative guideline.
It isn’t clear to what extent a Court will be prepared to consider detailed argument between the parties over the validity of a particular guideline, how it was developed and the process by which it has been adopted by professional organisations and other bodies. To be accepted as authoritative in a particular area of clinical practice a guideline should result from an unquestioned process, reflecting evidence-based research.
NICE recommendations, for example, are stated to be based on 'systematic reviews of best available evidence and explicit consideration of cost effectiveness. When minimal evidence is available, recommendations are based on the guideline development group’s experience and opinion of what constitutes good practice’.
The European Society of Cardiology (ESC) states on its website³:
“A great number of guidelines have been issued in recent years by different national and international organisations. However, this profusion of documents can endanger the authority and validity of guidelines, which can only be guaranteed if they have been developed by an unquestionable decision- making process. This is one of the reasons why the ESC and others have issued recommendations for formulating and issuing guidelines”.
Guidelines - usually based on the results of extensive research and randomised controlled trials - may provide more up-to-date evidence of a current standard of care than a textbook, which may have taken several years to be published. As such they provide evidence to which a Court can refer in assessing the appropriate standard of care.
The problem of conflicts of interest
The validity of a guideline may be in dispute where research or the guideline development process has been tainted by an actual or potential conflict of interest or bias reflecting a perceived lack of impartiality. The process by which the authors of a research study cherry-pick the positive results that support the conclusions they are seeking to achieve and ignore or downplay any adverse results that are nevertheless relevant is known as ‘selective outcome reporting’.
As it was put in the Lancet 31 August 2019 study Managing Conflicts of interest in Clinical Guidelines⁴ “Conflicts of interests are pervasive in medicine, and their influence on guidelines impacting on patient care has been a major concern."
Ideally there should be clear separation between those running clinical trials and those responsible for formulating guidelines arising from those trials, however, the difficulty is that in the absence of industry support, expensive trials – in some cases taking place over many years - would not take place.
There have also been instances of conflict between guidelines issued by different organisations representing practitioners in the same field.
Published guidelines provide guidance to facilitate and promote good medical practice. It is unlikely they will be accepted as a substitute for conventional expert evidence in a clinical negligence trial. Claimant and Defendant lawyers need to be alive, however, to the potential for challenging an expert’s assertion as to an appropriate standard of care by pointing to differing opinions evident from the body of contemporaneous information that has informed and led to the adoption of a particular guideline. A relevant research study resulting in the adoption of an evidence-based guideline may well be preferred over an individual expert’s assertion, for example, to support a Bolam ‘reputable minority’ defence. Since the 1997 Bolitho case⁵ the court will in any event examine the expert evidence and may subject a form of treatment and any relevant guideline to logical scrutiny and conclude that negligence has been established even if a body of medical opinion suggests otherwise.
Guidelines are introduced into the court process by expert witnesses as evidence of accepted and customary standards of care. The mere fact that a guideline exists can neither establish its authority nor support the view that in the circumstances before the court, compliance with the guideline would be reasonable and non-compliance negligent.
Guidelines and protocols did not play a significant part in the paediatric cardiology and cardiac surgery cases in which I specialised following my involvement for the families in the Bristol Royal Infirmary Public Inquiry⁶ into the shortcomings at the children’s heart unit and related litigation (see Medico-Legal Magazine, Issues 15 and 16). In this high-risk specialty the experience and skills of the medical and surgical team are crucial. The liability issues are likely to be multifactorial and may depend on the age of the child, the type of congenital heart defect, the form of surgery involved, the complexity of the child's medical condition and any co-existing cardiac defects and co-morbidities, the accuracy of diagnosis and timing of surgery, the post-operative care and the way in which the unit or surgeon was able to cope with the complications inherent in these procedures.
Achieving the appropriate level of scientific significance in paediatric cardiac surgical and cardiological procedures, in order to formulate evidence-based guidelines, has been a problem as a result of the lack of sufficiently large cohorts of comparable cases. Single centres may not deal with adequate operation numbers to enable proper classification and comparison, making it difficult to establish standards of care and form robust conclusions. With low patient numbers there may otherwise be a tendency to lump similar but technically different conditions together because the necessary granularity of data isn't available.
Those practicing in adult cardiology, on the other hand, have to be familiar with multiple guidelines. A substantial number of guidelines and methodologies in the adult cardiovascular field have been published by the European Society of Cardiology (ESC) and it’s US counterpart the American Heart Association (AHA). These cover a wide range of cardiology procedures and treatments including coronary artery bypass grafting (CABG) and stenting, management of thrombolysis, diabetes and pre-diabetes, heart failure, myocardial infarction, as well as the use of aspirin and statins.
The majority have been accepted as authoritative and reliable but there have been instances of conflict between the guidelines issued by the European and American bodies. Differences of opinion between professional bodies can occur across other areas of clinical practice, but the issues of contention that have arisen in cardiology demonstrate the importance of examining the guidelines development process itself.
A number of cardiovascular and adult cardiology trials and guidelines have generated controversy. The large-scale EXCEL study⁷ (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) into the merits of coronary artery bypass grafting (CABG) over stenting is a case in point. CABG involves open-heart surgery, with longer hospital stays and a longer period of recovery and rehabilitation than occurs with stenting. Stenting (percutaneous coronary intervention - PCI) is a minimally invasive procedure involving coronary angioplasty using a balloon catheter to widen blocked or narrowed arteries, combined with a drug-eluting stent coated with medication to help prevent blood clots inserted into the artery to allow blood to flow more freely.
As a minimally invasive procedure enabling a speedier recovery and a shorter period of hospitalisation, stenting has a number of advantages over CABG. A question has nevertheless remained over the comparative effectiveness of the two procedures over the longer term.
The EXCEL trial sponsored by the US medical technology company Abbott Laboratories followed 1900 volunteers with left main stem (coronary) disease (LMS) over a five-year period.
The coronary stent market in the US, dominated by major companies including Medtronic, Boston Scientific as well as Abbott Laboratories is currently worth approximately US $10.31 billion annually, an annual compound growth rate of 7.6% over the last 5 years.
The study’s authors concluded that bypass surgery and stents were equally effective in the prevention of deaths in patients with less severe forms of LMS and that clinical outcomes after 5 years were similar. This led in 2018 to the European Association for Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC) revising and updating their guidelines.
The study was dogged by controversy over the reported rates of mortality following heart attacks and the actual definition of heart attack (myocardial infarction) which was felt to be crucial to the analysis of outcomes. This was the subject of a BBC Newsnight programme on 18 February 2020⁸, which reported the view of some experts that if the "Universal Definition" was adopted for the definition of a heart attack, rather than the “popular standard definition” developed by the Society for Cardiovascular Angiography (SCAI) and Interventions used by the EXCEL authors, patients receiving a stent were at higher risk of heart attacks than those who underwent CABG. The dispute over how to define a heart attack and the implications for the study’s conclusions was reported to have prompted some European clinicians to question these findings. The EACTS, the body representing European cardiac surgeons, was reported to have withdrawn support for the updated European guidelines that reflected the recommendation of stenting or open heart surgery as equally effective, saying that it was "a matter of serious concern" that some patients may have received incorrect advice and that “patients with left main coronary artery disease treated with stents were 35% more likely to die than those treated with conventional open heart surgery.”
Patients, particularly in the post-Montgomery⁹ era, are of course entitled to be advised as to the options and the comparative advantages and risks of each procedure as part of the consent process.
The ESC stood by its revised guidelines, stressing that they were based on wider evidence in addition to the results of the EXCEL study. The EXCEL authors responded that the Universal Definition "was not suitable" for comparing the two procedures. The Universal Definition requires a highly sensitive blood test to identify damage to the heart muscle, a test so sensitive it may detect minor damage caused by the procedure itself. Many doctors, they said, don't perform this test on patients undergoing stenting or CABG. The EXCEL authors argued the higher mortality rate in the stent group was largely due to causes that were not heart-related, particularly cancer and infections that appeared several years after stenting or surgery. They said there had been no attempt to hide meaningful data - the EACTS had withdrawn from the guidelines "without so much as even asking the EXCEL study group for clarification."
In order to restore public and patient trust in these findings, and good relations between the stenting and cardiothoracic communities the EXCEL trial is undergoing independent review.
Guidelines and their impact on women's health
Numerous studies in recent years have demonstrated that heart disease and the ways in which it can uniquely and specifically affect women has been under-researched and women continue to face a greater risk than men of having their heart conditions misdiagnosed, diagnosed late or not treated as intensively or as effectively when a diagnosis has been made. This potential for disparity in treatment options and outcomes for women reflects what is seen as a gender bias, whether conscious or implicit, and represents a health disadvantage for women who are losing out on treatments that may result in better management of their symptoms and improvements in their quality of life. The concern is that guideline-recommended tests and therapies have been based on studies and randomised controlled trials in which women have been under-represented as participants and therefore do not reflect the difference in presentation of women's symptoms. Higher representation of women as authors has also been associated with a higher recruitment of women to join studies. There has been an increase in research into sex differences in heart disease and there is likely to be a corresponding increase in the release of guidelines specific to women and gender-based revision of existing guidelines.
Conclusion
Inevitably guidelines will have implications for a Court’s determination of the relevant standard of care in a particular case, but we are a long way from a Court finding that a failure to adhere to a relevant guideline automatically amounts to breach, or that compliance enables a Defendant to escape liability. Clinical negligence remains a field in which lawyers are heavily reliant on expert evidence in its traditional forms: written reports and oral evidence based on an expert's clinical experience of standards at the time when the treatment took place, supported by published sources including textbooks and journals.
As stated, guidelines are not a substitute for experience and informed clinical judgement, and it remains to be seen if guidelines will usurp the role of expert evidence. In the meantime, we are likely to see an increase in legal scrutiny of guideline development procedures and challenges to their validity in negligence claims coming before the courts.
References/links:
[1] https://www.hsib.org.uk/news/hsib-highlights-patient-safety-risks-nasogastric-tube-never-events/
[2] https://www.nice.org.uk/guidance/ng51
[4] Managing conflicts of interests in clinical guidelines Lancet 2019 Aug 31;394(10200):710
[5] https://publications.parliament.uk/pa/ld199798/ldjudgmt/jd971113/boli01.htm
[6] https://www.thebristolreview.co.uk/Bristol-Review--FINAL-REPORT.pdf
[7] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7941379/
[8] https://www.bbc.co.uk/news/health-50715156
[9] Montgomery v Lanarkshire Health Board [2015] SC 11 [2015] 1 AC 1430.
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