Clinical guidelines and the standard of care: Part 1

Author: Simon Britten

Simon Britten is is a Consultant Trauma & Orthopaedic Surgeon in Leeds specialising in lower limb reconstruction. He is the President Elect of the British Limb Reconstruction Society and chair of the BOA Medico-legal Committee.

Background

Many clinical negligence lawyers have seen some use of clinical guidelines in their cases to assist the court in determining what constitutes reasonable care¹. It has been proposed that when using a guideline to inform the standard of care, the guideline must be Bolam-defensible, Bolitho-justifiable, Daubert-valid, and also relevant to the specific case in question².  That is to say,  in adhering to the guideline, the doctor was providing treatment which was considered reasonable by a responsible body of medical opinion³; the body of medical opinion has a logical basis and has involved the weighing of risks against benefits⁴; the guideline is admissible as evidence, with scrutiny of the guideline's development and the extent of its adoption within the relevant medical community⁵; and the finding of fact as to whether the guideline has been followed when providing care in the specific case or not, coupled with expert evidence considering the standard of care within the parameters of the guideline.

In Montgomery v Lanarkshire Health Board⁶, the well-known pivotal case in the consideration of clinical negligence by the courts, it has been argued by some that the Supreme Court chose to overlook the relevant guidelines from the Royal College of Obstetricians and Gynaecologists (RCOG)⁷ and the National Institute for Health and Care Excellence (NICE)⁸ that were in existence at the time of Nadine Montgomery's obstetric care⁹.  The Supreme Court's decision in Montgomery indicating that compliance with professional guidelines does not necessarily protect the clinician from the accusation of clinical negligence, means that broadly the clinician must try to figure out whether aspects of a particular clinical guideline will or will not be acceptable to the court.

In broad terms, the Claimant’s lawyers may argue that the surgeon followed the relevant guidelines, but in the specific case under consideration they should have deviated.  The Defendant’s legal team may contend that the surgeon followed the guidelines, so it must have been reasonable.  On another occasion, the Claimant may argue that the surgeon did not follow the relevant guidelines, so the care on balance must be negligent; while the Defence would reply that while the surgeon did not follow the guidelines, there was a clinical reason to deviate on that occasion.

When considering what is reasonable treatment, both from the clinical point of view and also from the medico-legal point of view, the surgeon may wish to:

1. Take into account the relevant clinical guidelines
2. Consider any circumstances specific to the individual case which may influence treatment options
3. Appreciate that rigid adherence to guidelines may occasionally be unwise and potentially negligent
4. Recognise that intentional deviation from existing guidelines may be reasonable if there are case-specific factors which warrant departure from the guidelines.

In other words, from both the clinical and medico-legal perspectives, each individual case should be considered on its own merits.  In the end, they are only guidelines after all.

Sources of clinical guidelines

There are several sources of clinical guidelines of relevance to orthopaedic practice in the UK, covering both acute trauma and elective practice, which ought to be familiar to orthopaedic specialists for the purposes of clinical practice and medico-legal practice.

The National Institute for Health and Care Excellence (NICE) has several guidelines of relevance to both acute trauma and elective orthopaedics¹⁰.  Over the last 10 years or so, the British Orthopaedic Association (BOA) has developed a series of clinical guidelines covering trauma and fracture care, including British Orthopaedic Association Standards in Trauma and Orthopaedics (BOAST) guidelines¹¹; and running alongside this work has been collaboration with the British Association of Plastic, Aesthetic and Reconstructive Surgeons (BAPRAS) to produce clinical guidelines on the orthoplastic management of open fractures¹².

On the elective side, the BOA has worked in collaboration with NHS England, NHS Improvement and the Royal National Orthopaedic Hospital Stanmore, on the Getting It Right First Time (GIRFT) programme¹³.  There has been collaboration between GIRFT and NHS Resolution, along with the British Hip Society [BHS] and British Association for Surgery of the Knee (BASK) to produce guideline documents for best practice in documenting hip and knee arthroplasty procedures, published in 2019¹⁴,

While not strictly offering clinical guidelines, another source worth considering on whether treatment provided in cases of orthopaedic trauma has reached a reasonable standard is the influential text book Rockwood and Green's Fractures in Adults¹⁵.  For certain injuries the text can be very prescriptive in what treatment should (and as importantly, should not) be followed.  This can guide the treating clinician, and on occasion it can add significant weight to the orthopaedic expert's evidence when assisting the court as to whether treatment provided has been reasonable.

BOAST guidelines

This series of compact and versatile documents sets out auditable standards in trauma care, and more recently for elective orthopaedic practice, and were originally developed by the BOA's Trauma Group¹⁶.

In 2007-08, under the chairmanship of initially Professor Keith Willett¹⁷ and subsequently Professor Chris Moran¹⁸, the BOA Trauma Group wanted to express succinctly their view on assorted aspects of orthopaedic trauma management for the general benefit of trauma patients.  They appreciated that overly long guidance documents generated by professional groups were both time consuming to prepare and in reality, unlikely to be read.  The group began to produce single page executive summaries – BOASTs – on such topics as compartment syndrome, open fracture management, treatment of supracondylar fractures in children and the management of traumatic spinal cord injury.  Each topic was selected on the basis that it represents a clinical entity which may be difficult to treat well, with potential pitfalls lurking, and at significant risk of attracting litigation if poor outcomes ensue.

Each BOAST was written on the basis of the contemporary evidence base, to set out auditable standards and to enable different solutions in different places to achieve the same standard of care¹⁹.

While the BOASTs are not formally part of the higher surgical training exit examination FRCS (Tr & Orth) syllabus, most orthopaedic trainees know them for the examination, thanks to their succinct and functional nature.  Furthermore, several BOASTs are referred to in the methodology of the Trauma Audit and Research Network (TARN), the UK nationwide monitoring system for moderate to severe injury²⁰.  TARN benchmarks the performance of major trauma networks, major trauma centres, ambulance services and individual clinicians.

This wide range of applications of BOAST guidelines, including in day to day clinical practice, as concise revision aids for trainee orthopaedic surgeons, and through to their use as reference tools in the national monitoring and audit of major injury, demonstrates their considerable usefulness and functionality.

BOASTs were set up as auditable standards, as opposed to specifically a gold standard or a reasonable standard.  Each BOAST contains numerous auditable potential interventions for any given clinical entity.  For any given item within a BOAST, each must be considered on its own merits with reference to the reasonable standard of care by the Bolam test.  Some interventions are mandatory, such as reassessing the neurovascular status after relocation of a dislocated knee.  To fail to do so would be considered by an orthopaedic expert to have fallen below a reasonable standard of care.  Other interventions may be desirable, for example taking photographs of the open wound when first exposed for clinical care when managing an open tibial fracture.  Not to do so in isolation would not fall below a reasonable standard of care, although in conjunction with other omissions it may give the orthopaedic expert an overall impression of care which has fallen below a reasonable standard.  Sometimes a listed intervention may not be required, for example measurement of pressures in a case of compartment syndrome, where on clinical grounds the diagnosis has already been made, emergent surgery to perform fasciotomies has been arranged, and to measure the pressures would simply delay surgery²¹.

It can be argued that if care is offered to a patient which is not in line with standards set out in the relevant BOAST guideline, then the patient should be made aware of that²².

In medico-legal practice it can be useful for the expert to append the relevant BOAST to their medical report, as a succinct summary of the relevant clinical considerations and potential actions – perhaps more as a background summary than as a one-size-fits-all recipe to determining what constitutes reasonable treatment.  The orthopaedic expert should anticipate assisting the court by placing such a document in clinical context to consider whether specific aspects of treatment recommended in a BOAST constitute the auditable standard of care, or the gold standard, or the reasonable standard.  Of course care given only has to be reasonable to avoid being negligent.

BAPRAS / BOA guidelines on open fractures

The British Association of Plastic, Reconstructive and Aesthetic Surgeons and the British Orthopaedic Association first published guidelines on the joint orthoplastic management of open fractures in 1993 and since then, several updates of this document have been produced²³.  Unlike NICE guidelines, the BAPRAS / BOA guidelines have yet to make a significant appearance in reported case law, despite their considerable relevance to the standard of care provided in the treatment of open fractures.

Open fractures are severe injuries, that can lead to significant rates of bone infection, non-union, post-traumatic deformity, joint stiffness and arthritis, plus permanent functional limitation. If an individual goes on to develop one or more serious complications of their open fracture leading to a poor outcome, it can be very difficult to demonstrate that this has been caused by negligent treatment, rather than as a consequence of the original severe injury itself.  Several departures from the guidelines overall may constitute breaches of duty of care, but the defence may simply be that the poor outcome would on balance have occurred in any event, irrespective of those breaches, as the injury was so severe from the outset.

It is worth bearing in mind that clinical guidelines from different sources may overlap, both in terms of clinical scenarios covered and also differing in time of latest edition.  BOAST, BAPRAS / BOA and NICE guidelines all cover open fractures and compartment syndrome for example.  As these documents are sequentially revised at different times, this may give rise to the potential for some ambiguity and inconsistency.  Having said that, the national experts responsible for each set of guidelines tend to be drawn from the same pool, and more recently efforts are made to ensure continuity across these platforms.

Next time in Part 2 (which will be published in the September issue), I will be considering other useful sources of clinical guidelines available, which help to inform the standard of care in trauma and orthopaedic surgery – including a more detailed consideration of guidelines from NICE, GIRFT, and Rockwood and Green.  There will also be comment on what may be yet to come in terms of medico-legal jeopardy, after the COVID-19 pandemic spawned clinical guidelines for the orthopaedic surgeon acting as the medical registrar treating respiratory patients, outside their usual area of expertise. In addition, guidelines for how to treat a variety of acute musculoskeletal injuries non-operatively.  This was in anticipation of a considerable reduction in anaesthetic support, due to redeployment to intensive care units, the need to protect patients from hospital admission and the risk of nosocomial COVID-19 infection.

This article is based on the following book chapter: Clinical Guidelines in Trauma and Orthopaedic Surgery in Clinical Guidelines and the Law of Medical Negligence: Multidisciplinary and International Perspectives, ed. by Samanta A and Samanta J  (Edward Elgar Publishing, Cheltenham, UK & Northampton, MA, USA, October 2021).

All excerpts reproduced with kind permission of the publisher