Consent Issues in Spinal Surgery: Expert Opinion and Negligence

1. Negligence in Brain and Spine Belfast November 2018 Consent issues in Spinal surgery John O’Dowd FRCS Orth Spinal surgeon, London and Hampshire, UK Medical director RealHealth Netherlands

2. Overview • Consent issues in spinal surgery • Consent • Expert opinion • Spinal surgery

3. Working together • In principle • Improve medical care • “Police” poorly performing doctors • Improve quality of patient experience • Reduce impact/cost of adverse events • In practice • Not much change • Resource limited healthcare system • No risk management culture

4. Hippocrates Bolam 1957 Your journey Sidaway 1985* Paternalism and consent: has the law finally caught up with the medical profession Rogers 1993 Smith 1994 Bolitho 1998 Pearce 1999** Afshar 2004* GMC 2008 Montgomery 2015**

5. Chester v Afshar2004 • Negligence • 1-2% risk of cauda equina syndrome • Causation • Same risk, different day, different outcome • Reinforced “prudent patient” principle • Not any obvious practical application • Highlighted “cooling off” period • Superseded by Montgomery v Lanarkshire Health Board

6. The facts • Mrs Montgomery (The Claimant) suffered from insulin dependent diabetes mellitus. It was agreed between the parties that the risk of shoulder dystocia occurring during vaginal delivery was 9 -10% in the case of diabetic mothers. • The Claimant was not told of the risk of shoulder dystocia, as, in the doctor’s opinion, the possibility of it causing a serious problem for the baby was very small. The doctor also suggested that advising of the risk would lead to most women electing for a caesarean section. • During the vaginal delivery the umbilical cord was completely or partially occluded, thereby depriving the baby of oxygen. After his birth, he was diagnosed as suffering from dyskinetic cerebral palsy. • It was the Claimant’s case that had she been told of the risk of shoulder dystocia she would have elected for a caesarean section.

7. The Judgment • The Supreme Court felt that the majority decision in Sidaway was unsatisfactory and preferred the approach in the dissenting judgment of Lord Scarman. Lord Scarman held that there was a duty for a doctor to warn a patient of a material risk inherent in the treatment. • The Supreme Court reiterated that there was a duty for the doctor to discuss with the patient the material risks involved in the medically preferred treatment and any alternative treatment options. The test for materiality was whether a reasonably person in the position of a patient would think the risk significant. • In the Claimant’s case it was found that the risk of shoulder dystocia was substantial and should have been disclosed. The Claimant was entitled to consider this risk against the relatively low risk to both mother and baby of a caesarean section. It was not is dispute that had the baby been delivered by caesarean section it would have been unharmed. The Supreme Court found that had the risks been discussed the Claimant would have elected to have a caesarean.

8. The result • The previously accepted model of the doctor-patient relationship no longer reflects reality. Patients are not incapable of understanding medical matters, or wholly dependent on information from the doctors. This is reflected in the GMC's long-standing guidance. • Courts are increasingly conscious of fundamental values such as self-determination. The law treats patients, so far as possible, as adults capable of understanding that medical treatment involves risks, and of accepting responsibility for and the consequences of their choices. • Doctors have a duty to take reasonable care to ensure that a patient of sound mind is aware of material risks inherent in treatment, and of reasonable alternatives. • Assessing materiality of risk is fact-sensitive and cannot be reduced to percentages. • In order to advise, the doctor must engage in a dialogue with the patient, who may not know there is anything to ask about. The information provided must be comprehensible, and the doctor's duty is not fulfilled by bombarding the patient with technical information which they cannot reasonably be expected to grasp. The duty is not discharged simply by obtaining a signature on a consent form. • The therapeutic exception, whereby information can be withheld from a patient in certain circumstances to protect his or her health, remains but is limited.

9. Paragraph 87 Ought to be etched on the mind of any clinician when advising a patient as to the risks of any proposed treatment '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.'

10. Montgomery • Essentially retrospective • What is the prudent patient • Man on the Clapham omnibus (judge) • Montgomery compliant consent forms

11. MDU10 commandments • Make full notes. It is more important than ever that these specifically document the consent process. The patient's records in relation to consent and advice should consist of more than just a consent form. • Discuss reasonable alternatives. Where appropriate, these must include the option of having no treatment at all. Doctors need not necessarily mention the pros and cons of every option in every case, but they should do so where there is a heightened risk to the patient (and/or to her child in the obstetric context). • Ensure adequate time is set aside. This is easier said than done in a busy GP practice, a frantic emergency department or a hectic ward. But a meaningful consent process based around a real dialogue requires more time than might previously have been considered sufficient. • Focus on the individual patient. Is it clear from the notes that you have taken steps to understand the concerns and wider circumstances of the individual patient before imparting advice? Is there a reference to relevant medical conditions or increased risk factors? Is there mention of the psychological state of the individual, or his or her family circumstances, where appropriate? • Engage in a genuine, two-way dialogue, recording both sides of the conversation. • Do not simply focus on percentages. Post-Montgomery, the scientific magnitude of risk is only a factor and should not determine what risks are discussed. • Consider the risk of intervening events, not just catastrophic outcomes. These might include distressing, painful or dangerous intervening events. • Think very carefully before relying on the therapeutic exception. If you have consciously decided not to share certain information with the patient in a purported exercise of the therapeutic exception, do the circumstances justify that approach in the light of the respect to be accorded to patient autonomy? Is the fact that information has been withheld for therapeutic purposes – and the reason for that – made clear in the notes? • Patient understanding. Is it clear that the patient fully understood the advice given? Has it been delivered in a comprehensible way? • Leafleting is not enough. Bombarding a patient with information does not discharge the duty, and the simple issuing of leaflets or factsheets does not constitute the required dialogue.

12. Medical paternalismvpuernalism “You decide doc” “What would you do doc” “I trust you to decide” “You tell me what to do”

13. Patients don’t listen toorhear what is being said during consent process J O’Dowd 2014

14. Consent induced stress • 43-year-old manufacturer. • Fall at work leading to neck and back injury which essentially settled. Onset of acute symptoms from cervical spondylotic myelopathy including upper and lower limb pain, weakness and numbness. Operation March 2015 three level ACDF. Consenting letter by clinical fellow reads as follows: • Surgery is not expected to change the symptoms but is indicated to prevent deterioration. He has been informed that clinical improvement is not impossible but that cannot be guaranteed. I have informed him about the risks as bleeding, infection, nerve damage, paralysis, bladder function disturbances, bowel function disturbances and death. He agrees to proceed with this surgery”. • Patient is a simple fellow who focuses on the negatives in what he has been told. He was very stressed and had many sleepless nights before the surgery because of his perception of the risks. • My feeling is that this consenting procedure was too focused on the negative side and produced marked anxiety particularly in relation to paraplegia, which is almost unheard of in anterior cervical decompression and fusion.

15. Health care literacy Recent surveys in the UK show that the percentage of adults below the literacy level expected at the end of full-time compulsory education (16 years) is 43%; for numeracy the percentage below the expected level at the end of compulsory education is78%.3 This is reflected in the levels of health literacy. Forty-three per cent of the English adult working-age population cannot fully understand and use health information containing only text. When numerical information is included in health information, this proportion increases to 61%.4 

16. Lost in translation • Language numbers • Guys and St Thomas’s 112 • Lewisham education services 140 • London >200

17. Medical expert

18. “Medical experts” • Inexperienced at entry into consultant grade • Full time NHS employment • More technical and protocol driven • Less experiential so • More evidence based approach

19. Orthopaedic expert • Back Pain Revolution • Understand biopsychosocial model • Avoid tunnel vision • If uncertain • Psychology • Psychiatry

20. Not always doctors • Modern MSK • ESP clinic, ESP consent, ESP procedure, ESP follow up • Epidural • Nerve root block • Facet injection • Teaching hospital microdiscectomy • ESP clinic, • Nurse led assessment clinic and consent • Pre op registrar/ fellow/trust doctor • Post op registrar/ fellow/trust doctor • Telephone follow up clinic

21. Spinal surgery • Trauma • Reconstruction • Degenerative conditions • Back pain

22. Spinal osteotomy • Consent • >100% significant complication rate • ~ 30% revision rate

23. Low back pain surgery • Consent • Complications • Alternatives • Outcomes

24. Outcomes and alternatives

26. Surgery v rehabilitation

27. Swedish Lumbar Spine Study ODI VAS By courtesy of Peter Fritzell

29. Functional status → ODI ∆ pre-treatment employed n= 524

30. Outcome ODI ≤ 22 • MRC surgical study 20% • RHNL n=524 40% • RHNL n = 955 50.1%

31. Information for the prudent patient • Surgeon driven • Discussion • Leaflets • Web addresses • Patient driven • Professional bodies • Patient organisations • Expert patients

32. Daily Mail • July 1997 • 300 cases • ‘New disc’ • Return to sport !

33. http://www.spinesurgeons.ac.uk/patients/patient-information/lumbar-discectomy-and-decompressionhttp://www.spinesurgeons.ac.uk/patients/patient-information/lumbar-discectomy-and-decompression

35. Expert patient

36. Conclusions • Expert supply • Non surgical centric • Paramedical • Anaesthetic • Patient • Beyond “risks and complications” • Alternatives • Outcomes • Technique • Patient focussed consent resources • Surgeon driven • Internet driven • Patient driven