Implementing health technology
As a third year medical student, I’m just starting my placement years, and I’m slowly learning what it means to be a healthcare professional in today’s national health service. As part of my studies, I'm undertaking a project that allows me to explore a branch of medicine that’s new and particularly interesting to me.
Having recently finished my surgical placement, I got to watch patients consent for various procedures and was surprised by many patients’ approach to consent. With a ‘doctor knows best’ approach, many didn’t appear to take much interest in alternative options, or take the opportunity to weigh up these options themselves. They appeared to take the doctor’s recommendation and were happy to accept the associated risks or side effects. I found myself surprised at the seeming lack of control of their own healthcare. I was interested in the reasons for this, and whether there was more lying under the surface that I was seeing in a 10 minute snapshot. So I've chosen to focus my project on the current consent process, and explore how it could be improved.
My project is based with Concentric, a medical technology startup in Cardiff, created by clinicians who saw an opportunity to improve the consent process, and decision making in healthcare more broadly, for both clinicians and patients. The idea is to make a digital platform that helps empower patients to make their own decisions regarding their healthcare, and to aid clinicians in supporting this. Patients are provided with evidence based information to show risks, benefits, alternatives and more, in an understandable way to allow them to make an informed decision. I’ve been welcomed into the team, a so-called ‘startup’, and have been able to see an innovative and technological side of medicine I'd had no previous exposure to.
The Concentric platform aims to provide a patient-centred approach, facilitating shared decision making in practice. In addition, it fits in with the digitising of medical services, for example digitising patient notes and implementation of SNOMED-CT, a digital, structured, clinical terms database. I’m realising that digital healthcare is an area that is expanding rapidly, and I hope it will have a bigger footprint in medical school curricula before the end of my studies. The ball has already started rolling, for example the BartsXMedicine programme running in London, getting medical students involved with technological innovation.
Assessing health technologies
Upon entering this new area, a big question for me had been - how do you take a great idea and apply it to today's healthcare system. Who thinks of them, how is it created, who decides if it’s good enough to be used and then how is it nationally implemented into everyday practice? In my first week I was able to attend a workshop that answered these questions exactly. Run by Health Technology Wales at the Life Sciences Hub, the workshop was keen to promote innovation and development in healthcare. Health Technology Wales is a national body with the aim to improve the quality of healthcare offered in Wales. They identify upcoming technologies, support their development, assess them and then help to implement them into practice. Overall optimising the use of technologies within everyday care to increase efficiency.
The workshop was led by Dr Susan Peirce from Cedar, an NHS academic evaluation centre, and was based on health technology assessment and economics. She explained the journey a health technology must take, from the initial preclinical design, to the implementation in the healthcare service, and all the evaluations and decision making that happens in between. She went into detail about each of the steps: - what questions had to be addressed, who would be asking them, and most importantly, what evidence could be used to aid the decisions that had to be made.
We spent a large part of the workshop focussing on what makes good evidence – how to critically appraise a paper. To then see ourselves if it supports the proposed idea of a change in practice. Within this, we discussed how a study design should be analysed and what this means for its appraisal. We compared randomised control trials to observational studies looking at the advantages and disadvantages of each. We looked into how to use the method to judge credibility. We talked through the different types of bias and how to spot them in different designs. As well as looking at confounding variables and the difference between funding and sponsorship and how this may impact on results and conclusions of research.
My future practice
The knowledge I gained as part of this workshop is useful for me, and is very relevant to my future practice. As a doctor, to keep up with developments in science and technology, it’s important to stay up to date with the research being published. This ensures you’re offering the best care to your patients with strong published and peer-reviewed evidence supporting your practice. To help me accomplish this I can use the skills I learned in this workshop to critically appraise the research, and to decide for myself if I think the evidence is strong enough to support a clinical decision in practice as well as decisions about future health technologies.
The workshop provided me with knowledge in areas not usually covered in a medical degree and I gained a much deeper appreciation for what goes on behind the scenes to allow medical practice to keep developing. Most importantly, I will take forward a new analytical approach to practice alongside an open minded one, to allow new, innovative ideas to come through and change the way I think about medicine. As a medical student this increased knowledge and new outlook, will assist in my current studies and I can use and take this forward in my career, helping me understand what shapes the healthcare system I’ll graduate into in a couple of years.
However, in the meantime, for the rest of my project time with Concentric, I’ll be using this new approach in my research into the consent journey. Applying it to explore ideas for improving the patient experience as well as ways to empower patients to take control of their own decision making.
From Surgical Consent to Concentric
Concentric, the new product name for Surgical Consent, and a name that allows us to grow. The opportunities for technology to support decision-making are far broader than consent, and certainly not limited to just surgery. It’s where we started, but the lessons learnt can be applied widely.
We liked Concentric as a name, with a nod to the old, but alluding to the parallel opportunities for the consent process to be a starting point to better decisions and better care. From facilitating shared decision making, collecting patient outcomes, and guiding discussions.
I’m delighted to also announce InnovateUK grant funding to accelerate the delivery of a valuable platform for both patients and clinicians, in the UK and globally. Initially building upon our pilot consent platform, we’re building functionality to the Concentric Ontology and adding integration capabilities to make the process of starting, and continuing, to use Concentric a pleasure for our users.
We’re looking for a number of key hires to help us deliver above and beyond our ambitions. Visit our careers page to read the job descriptions (software development and designer roles currently) if you think you, or someone you know, could be exactly who we’re looking for.
Thanks for reading, and sign up to our quarterly newsletter below or get in touch!
Obtaining consent for an operation
First published in the Student BMJ
More than 10 million operations and procedures are performed each year in the UK. Weighing up whether to go under the knife is a major decision, and doctors need to play a supportive role in making sure that patients are fully informed about the risks and benefits of undergoing a treatment.
Obtaining consent for a procedure is one of the core competencies for graduates expected by the General Medical Council, and is a common scenario in medical school objective structured clinical examinations (OSCEs). In this article we offer guidance on how to take a patient centred approach to sharing information about a procedure and obtaining consent.
What is consent and why is it important? The law states that patients have the right to determine what happens to their bodies, which means that performing a procedure on a patient who hasn’t signed a consent form is a form of battery and can lead to criminal charges. In the past, the consent process has sometimes been paternalistic, with surgeons recommending their preferred option and patients following in tow.
In 2015, a landmark decision by the UK Supreme Court in the Montgomery v Lanarkshire Health Board case prompted a change in the law. The court ruled that doctors must now take “reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments.” Previously, doctors could decide what to tell patients about the risks and benefits of a procedure, and their actions would have been judged only against other doctors’ opinions of what information should be shared with the patient (known as the Bolam test).
Since the Montgomery ruling, however, doctors must not make assumptions about which risks are important to patients and must fully disclose any risks that may be of particular importance or relevance to that patient—for example, a professional singer undergoing a throat operation. The Montgomery case prompted the Royal College of Surgeons to publish new guidance on consent, Consent: supported decision-making which emphasises the role of surgeons in assisting patients to make a decision on whether a procedure is right for them rather than the traditional paternalistic model where a surgeon’s preference would often be presented to patients as the default option. By using shared decision making, it is hoped that patients will be more informed about treatment options, and that this will reduce the number of errors, complaints, and misunderstandings.
Ideally, the consent process should take place over a period of time to allow patients to understand their treatment options.
Who can give consent? For consent to be valid, the patient must have capacity, give their consent voluntarily, and must understand the information given to them about the proposed treatment. If a patient does not speak English, a trained independent translator should be used. For children and patients who lack capacity, the process is different. Children under the age of 16 may be considered Gillick competent to make treatment decisions on their own.10 If a child is unable to give consent, then a parent or guardian will usually do so.
An adult patient is deemed to lack capacity if, despite support, they are unable to retain, understand, and weigh up information about a procedure. If their impairment is temporary, the consent could wait. If a patient is unable to give informed consent, decisions must be made in their best interests, with input from relatives, your colleagues, or by an advance directive.
What if a patient refuses consent? Patients have the right to refuse treatment, provided they have capacity. They should be made aware of the likely consequences of their decision, as well as alternatives.
Who should obtain consent? Consent should be sought by a doctor or surgeon trained to perform the procedure, but the process may be delegated to another consultant or registrar. As a foundation doctor, there will be several procedures for which you will need to obtain verbal consent, but it will be uncommon for you to carry out procedures that require written consent (there are some exceptions, such as HIV testing).
As a junior member of the team, you can spend time with patients to check their understanding of the procedure. Patients experience better outcomes when they feel supported.
Documenting consent discussions Before an operation can go ahead, a consent form must be completed. Having a thorough discussion with patients can minimise the risk of later medical negligence claims.
What happened next? The Montgomery fallout
A second article on the current case law relating to informed consent, with a focus here on what has happened, so far, following the Montgomery judgement. The Montgomery judgement brought the issue of 'materiality' very much to the fore, but there has significant debate about what that meant in practice, and how it would be interpreted by the courts.
Here Paul Sankey, a leading Clinical Negligence lawyer at Foot Anstey LLP, takes us through the most recent developments. The following first appeared in Personal Injury Law Journal (Feb 2017), and is reprinted with its kind permission.
There have been a number of cases dealing with the law of consent to medical treatment over the last 2 years, the most notable of which is the Supreme Court decision in Montgomery v Lanarkshire Health Board , a case which redefined the legal relationship between doctors and patients. This article looks not only at the case of Montgomery but also at some other recent authorities on the law of consent.
Border v Lewisham and Greenwich NHS Trust was a Court of Appeal decision before Montgomery. It highlights the importance of considering not only whether a treatment is acceptable but whether the patient has consented at all.
The claimant was a 64 year old woman who had fractured her right humerus. She was taken to the Emergency Department of Queen Elizabeth Hospital in Woolwich where the duty SHO wanted to put an IV line into her arm. This was standard procedure. There was no immediate need to do so but it ensured that staff would be ready should an emergency arise. He was unable to use her injured right arm and normal practice would have been to use the left. However, as she told the doctor, she had recently undergone a left mastectomy and axillary node clearance. As a result there was a risk of oedema if he used the left arm. The options were either to go ahead using the left arm or to wait and see whether a cannula would actually be needed at a later stage.
There was a conflict of evidence as to exactly what happened. However the judge accepted the claimant's account that the doctor in effect made a 'quick and silent calculation' and only communicated with the claimant to the extent of saying something like, 'I'm sorry, but we really need to put it in the right arm'. She hardly realised what was happening until it was done.
She went on to develop a permanent and serious case of oedema in the left arm which caused significant disability.
At first instance the judge found that the decision to insert a line in the left arm rather than adopting a 'wait and see' approach accorded with accepted practice. An experienced consultant might feel able to take a calculated risk to wait and see but it would be a 'bold decision for a senior house officer'. His action did not in itself amount to a breach of duty. The claim therefore failed at trial.
On appeal the claimant raised a case which had not been argued at trial. She argued (and this was contested by the Defendant) that there had been a finding of fact that the doctor had not obtained her consent before inserting the cannula. On that ground there was a breach of duty in failing and she was entitled to judgment. The fact that the doctor acted in accordance with accepted practice did not mean he was entitled to do so without consent.
The Court of Appeal agreed that the judge had made such a finding. It also noted that allegations based on consent were within the scope of her pleaded case even if they had not been raised at trial. She was therefore entitled to contend on appeal that lack of consent entailed a breach of duty: 'A finding of absence of consent to the insertion of the cannula leads inexorably to a finding of breach of duty in inserting it'. The Court of Appeal agreed. It granted a declaration that the doctor was in breach of his duty in inserting the cannula without the claimant's consent and remitted that claim to the judge to determine causation. It refused her permission to amend the pleadings to add a claim of trespass to the person, a finding which would have short-circuited the issue of causation.
Border v Lewisham and Greenwich NHS Trust therefore does not add to the case law on what amounts to consent but it highlights the importance of properly pleading. Had she pleaded trespass to the person the claim would have succeeded without having to establish that with proper advice she would not have consented. The case also highlights the importance of raising consent as an issue in appropriate cases. This was a case where the medical decision was not negligent but proceeding without consent was.
Montgomery v Lanarkshire Health Board has been the subject of detailed analysis elsewhere and only a brief summary is set out below.
Ms Montgomery was admitted to hospital in Lanarkshire for the delivery of her baby. There was a relatively high risk of shoulder dystocia of 9-10% because of the mother's diabetes and her small size. There was a relatively low risk of prolonged hypoxia from shoulder dystocia of around 0.1%. She was not advised of the risks of vaginal delivery as opposed to Caesarean section. Unfortunately the risk materialised and her baby was born severely disabled.
The obstetrician’s evidence was that she did not advise Ms Montgomery of the increased possibility of shoulder dystocia because the risk of a grave problem for the baby was so small. If the condition had been mentioned, most women would elect for a Caesarean section although this would not be in their interests. Implicit was the judgment that in these circumstances a doctor's assessment of a patient's interests outweighed the patient's wishes.
The claim failed in at first instance, the court finding that the obstetrician had not been negligent either in her advice or her management of the labour. When the case reached the Supreme Court, the principal issue was whether the obstetrician’s failure to warn Ms Montgomery of the risk of shoulder dystocia was negligent.
Prior to Montgomery the ‘Bolam test’ of negligence was applied not just to diagnosis and treatment but also to advice. The question in Montgomery was whether it provided the correct test applied to the doctor’s duty to advise. In Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital  AC 871 the House of Lords held that it did although the minority view of Lord Scarman was that it did not.
The Supreme Court in Montgomery noted that English courts had nevertheless recently been moving in a different direction and, when it came to advice, the Bolam test had been undermined by some recent decisions. Behind the scenes there had been a change in the social, medical and legal landscape since Sidaway. People were now regarded as autonomous bearers of rights, governing their own lives and making choices for themselves. They had more access to medical information through the internet and information leaflets. Doctors also received professional guidance which gave greater emphasis to the concerns and choices of patients. Further there had been developments in Human Rights law and the courts were increasingly conscious of the value of self-determination particularly in cases involving issues of withdrawal of treatment.
The Supreme Court therefore rejected application of the Bolam test to a doctor’s duty to advise. The test was not whether a doctor acted in accordance with a practice accepted as proper by a responsible body of medical practitioners but was based instead on what a particular patient would expect to know.
‘An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken. The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.’
Whether a risk should be regarded as material depends on the patient's perspective rather than the doctor's. It is fact-sensitive, depending on the particular patient’s characteristics. There are 3 exceptions to the general rule which should be regarded narrowly and not abused:
- Where a patient tells a doctor that she does not want to know the risks.
- The 'therapeutic exception': ie if disclosure of the risk would be seriously detrimental to a patient’s health
- Necessity: for instance an unconscious patient requiring urgent treatment.
Ms Montgomery was found to have the right to be advised of the risk of shoulder dystocia, and decide what risks she was prepared to run. The court accepted that she would have opted for a Caesarean section with proper advice. It awarded her damages of £5.25 million.
This is a very significant decision. The Supreme Court has rejected a clinician-centred and paternalistic approach to consent replacing paternalism with patient autonomy. The decision has great significance for clinical negligence cases and a number of claimants have since amended their pleadings to allege lack of consent in its wake. It will also have very significant implications for NHS practice. Standard consent forms are unlikely to be adequate. Doctors will need to ensure they have more detailed discussions with their patients and record those discussions. More significantly patients may elect for expensive treatments which hospitals may wish to avoid. In particular there may be an increase in women wanting Caesarean sections. This is a cause of concern to many in the medical profession.
SXX v Liverpool Women's NHS Foundation Trust  was a claim brought by one of 2 twins born in June 2015. He was delivered by forceps and suffered an intracranial haemorrhage which caused a neurological disability. His twin sister was delivered by emergency Caesarean section.
The claimant's mother had been concerned at the risks of vaginal birth particularly given that the father's brother had lost one of two twins at birth 7 years previously. She raised her concerns during a booking scan and the consultant obstetrician subsequently wrote in the notes, 'For elective Caesarean section if wishes'. However when she went into labour, the midwife persuaded her to have a vaginal delivery and did not refer to a consultant. He alleged breach of duty in failing to take due account of the mother's wishes.
Experts in obstetrics and midwifery agreed that the mother should have been referred for a Caesarean had she requested one. She was also able to adduce helpful evidence from the consultant at trial who said he would have agreed to a Caesarean in the circumstances despite a vaginal birth probably being safe. The court found that there was a breach of duty in failing to refer discussion of the mode of delivery to the consultant who would have agreed to a Caesarean, avoiding the claimant's injury.
In Tasmin v Barts Health NHS Trust  the claimant, aged 14 at trial, was delivered by emergency Caesarean section. Minutes before birth the umbilical cord tightened around her neck resulting in a profound hypoxic/ischaemic insult and she suffered a severe brain injury which left her seriously disabled. She alleged negligence in the management of her delivery and a failure to obtain adequate consent from her mother to persevering with labour rather than undergoing a Caesarean section.
The key allegation related to a period between 21.40 and 22.30 when the registrar had failed to interpret CTG readings as pathological. The registrar proceeded with Syntocinon infusions when the correct course of action would have been to take samples of the foetal blood. The court accepted evidence that, had this been done, the results would have been reassuring and the mother would have been advised to persevere with labour.
The claimant alleged that at this stage there should have been a discussion with the parents about the risks of the pathological trace and the alternative course of management by Caesarean section. In the absence of such a discussion the decision to proceed with vaginal delivery was made without their consent and was negligent.
Mr Justice Jay preferred the Defendant's expert evidence that good medical practice required foetal blood sampling before any consideration of Caesarean section, the pathological CTG not by itself being diagnostic of hypoxia which might lead to acidosis. However the claimant's case was that the issue could not be resolved solely on the basis of expert evidence because it was one of consent: her mother should have been advised of the material risk of injury and been able to elect for a Caesarean at this stage.
The court found that because CTG is not a diagnostic tool, there could not be a sensible discussion of the options before foetal blood sampling had been done. More significantly the risk of serious injury was negligible, of the order of 1:1,000. He held that this was not a material risk, citing A v East Kent Hospitals NHS Foundation Trust  EWHC where Dingemans J described a risk of 1:1,000 as 'theoretical, negligible or background'. However he preferred to formulate the risk as being 'too low to be material'. The claim therefore failed.
There are some interesting features of this case. The first is that it made plain some of the concerns within the medical profession about the impact of the decision in Montgomery. The Defendant's expert obstetrician described it as creating challenges for obstetricians. He was concerned it would be impractical to raise options of foetal blood sampling or Caesarean section at every clinical encounter, particularly during the dynamic and highly charged process of labour.
The second is that whereas the Supreme Court in Montgomery explicitly said that what amounted to a material risk was not a matter of percentages, Mr Justice Jay found that a risk of 1:1,000 was too low to be material. In Montgomery the risk of shoulder dystocia had been 9-10% and that in itself presented a risk of significant injury. However the risk of a prolonged hypoxia had been 0.1% or 1:1,000, the same as in Tasmin. The problem with looking at risk in percentage terms is that it looks only at one of two components: the probability as opposed to the severity of injury. 0.1% may be a negligible risk in the context of a minor injury but many mothers would regard it as material if it could give rise to lifelong disability. Further percentages do not take into account factors which are specific to the particular patient. No such factors were identified in Tasmin.
The third is that this could be regarded as something of a brake on the momentum of Montgomery. This was a case in which the issue of when to hold a discussion of options for management was a matter of medical judgment – and one therefore which would be governed by the Bolam test rather than by the principles in Montgomery.
David Spencer v Hillingdon Hospital NHS Trust  is not a case about consent but develops the implications of Montgomery in defining a doctor's duty to advise in a different context.
The claimant underwent surgery to repair an inguinal hernia. After discharge from hospital he developed complications in the form of a deep vein thrombosis and pulmonary embolism on each lung. He claimed he had not been warned of these complications. He had not been alerted to the significance of symptoms, such as pain and swelling in the leg, heat or discolouration, altered sensation, shortness of breath and chest pain, should they develop. He therefore did not recognise onset of the condition and delayed in seeking medical help. As a result his condition was worse than it would have been, given proper advice. It was not his case, however, that had he been warned of the risks he would not have undergone the repair.
The court was guided by the decision in Montgomery in defining the extent of the duty to advise. It commented, 'there is force in the contention…that the basic principles – and the resulting duty of care – defined in Montgomery are likely to be applied to all aspects of the provision of advice given to patients by medical and nursing staff. Insofar as the judgment in Montgomery emphasises the need for a court to take into account a patient's as well as their doctor's point of view as to the significance of information for a patient I consider it relevant to the facts of this case.'
The case is therefore one which demonstrates the impact of Montgomery in defining what advice should be given even in cases where consent was not involved. It is not clear however that the decision in Spencer would have been any different had the Bolam test been applied to that duty.
Shaw v Kovac was a claim on behalf of the estate of a man who had died at 86. He suffered from aortic valve stenosis and was advised to undergo a transcatheter aortic valve implantation (TAVI), a procedure to place an artificial valve in the defective heart valve. He was not advised of the alternatives of open heart surgery or conservative symptomatic treatment. He underwent the procedure, suffered the complication of bleeding from the aorta and died.
The claimant succeeded in its claim that, had the deceased been warned of the risks of TAVI, he would not have undergone the procedure. The estate recovered damages for pain, suffering and loss of amenity, funeral costs and expenses. However the court rejected rather ambitious submissions that that Montgomery created a freestanding right of action giving rise to an entitlement to damages irrespective of loss and in particular it refused an award for loss of expectation of life, which is in any event precluded by the Administration of Justice Act 1982, section 1.
The case is therefore clear authority, if such were needed, that the normal principles of causation, loss and damage apply to claims based on negligent failure to obtain proper consent.
There have been cases where the claimant has simply failed to establish an absence of consent on the facts. In Julie Connolly v Croydon Health Services NHS Trust  the claimant failed to establish that she had not been properly warned of the risks of an angiogram or withdrawn her consent to continued treatment when a complication arose. In MC, JC v Birmingham Women's NHS Foundation Trust  the claimants failed to establish on the facts that the mother had not given consent to induction of labour.
It is possible to draw certain conclusions from the recently decided cases.
First, 4 of the 8 cases reviewed concern birth injuries. It may well be that obstetrics will be the area of medicine most affected by the Montgomery decision, not least because of a conflict between the medical view that a vaginal delivery is appropriate and wishes by mothers in labour to have a Caesarean section, a form of treatment which is bound to put greater pressure on NHS resources.
Secondly, it is only really Tasmin which puts Montgomery to the test. In other cases the decision in Montgomery was cited in defining the nature of the duty to advise. However only in Tasmin was there a potential conflict between the scope of that duty from the perspective of the medical profession and from the patient. That may suggest that in many cases the application of Bolam and Montgomery would produce the same result.
Thirdly, it remains difficult for claimants to establishing claims based on consent, as the decisions in Tasmin, Connolly and MC, JC demonstrate.
Fourthly, claimants will be assisted where the evidence from treating doctors is either that, had they been asked they would have agreed an alternative course of treatment (SXX) or that patients in general would elect for that treatment (Montgomery).
Claims in relation to consent have therefore proved fertile ground for litigation over the last couple of years. With the retrospective application of the principles in Montgomery and NHS services under pressure, they are likely to remain so in the foreseeable future. It is however not necessarily the case that Montgomery will in fact make a significant difference in practice, particularly outside the obstetric context.