Towards Improved and Safer Care, For Patients and Doctors.

Allegations are increasing, that doctors fail when obtaining consent, to ensure that the patient understands the information. Obtaining consent is central to the patient doctor relationship. In the USA, doctors write the acronym “PARQ” in medical notes to demonstrate they have discussed “procedure” (what it entails), “alternatives” (including nothing), “risks” (of the procedure and the alternatives) and “questions” (invite questions from the patient) 1 . Birch v University College Hospital (UK) 2 case, exemplifies the importance of above. The doctor was found negligent, because although he informed the patient of the risks of catheter angiography which led to her stroke, he did not discuss the comparative risk of magnetic resonance imaging. There should be dialogue between doctor and patient, encompassing ten points. Any intervention conducted by a doctor on a service user requires consent. Information imparted should include diagnosis, prognosis, purpose of intervention, potential complications including failure, alternatives or taking no action. Consent should be obtained in a private and appropriate location using comprehensible language and with an interpreter if required. There should be plenty of time to discuss consent with the patient and it should never be rushed. Where possible, consent should be obtained weeks prior to the elective procedure in outpatient clinic and re discussed closer to the event. Information should always be given in a clear, understandable manner. Leaflets, where available are useful, but they never replace discussion with individual patients. Patients must be acting voluntarily and be mentally competent to make a decision for consent to be valid. Sixteen 3 years is the age one can give consent to surgical, medical or dental treatment without requiring consent from parents. Sokol, (barrister and medical ethicist), reminds doctors of an important point which lawyers actively consider in clinical negligence cases 4 : it is “not enough just to impart information, doctors must do so in a manner that the patients will understand”. He illustrates this with the case of Mrs Lybert 5 who after a sterilisation procedure became pregnant. Although the consultant had documented in his notes “not 100%”, the judge concluded the warning was not sufficiently “clear and comprehensible”. He found that had an appropriate warning been given, contraception would have been used and pregnancy likely avoided. As doctors, we are advised to take “reasonable and appropriate steps” to ensure our patient understands the information. In addition to inviting questions, offering leaflets, some suggest considering recording the consultation and providing a copy to the patient. The legal outcome in the Geoghan versus Harris case in 2,000 in Ireland highlighted that, regarding informed consent, a doctor must discuss “what a reasonable patient would want to know”. Interestingly, 15 years later, the UK Supreme Court in the Montgomery V Lanarkshire Health Board 11 th March 2015 has concurred: medical paternalism is no longer. Nadine Montgomery, with diabetes was not informed of the risk of shoulder dystocia to her baby who subsequently developed cerebral palsy 6 . Documentation is critical. A careful, legible note, while time consuming, is worthwhile. I think Sokol’s suggested statement is worthy of consideration: “procedure, alternatives and risks explained in clear terms. Questions invited but none asked. Patient appears to understand. Leaflet provided. Patient advised to read 4 ”. This aims to benefit both patients and doctors. Atul Gawande, surgeon and New York Times bestselling author, learned from the aviation and construction industries giving us his invaluable, Checklist Manifesto 7 , which provides some protection against failure. Our ever changing world of modern medicine challenges us with ~13,000 diseases, ~6,000 drugs and ~4,000 surgical procedures. We are reminded that to rescue a critically sick patient, 178 tasks must be carried out correctly each day of critical care management 7 . Failure to perform these correctly may lead to a patient safety incident and later litigation. Because routine tasks in medicine and surgery have become more complicated, Gawande teaches that mistakes of some kind are virtually inevitable, so we need aids to assist. He recommends we practice as humble experts, who have the humility to concede that we need help. In medicine, errors of ineptitude are more common than those of ignorance: the former being mistakes made because we do not make proper use of what we know, the latter, mistakes because we do not know enough. Don Berwick’s, (previous President and Chief Executive Officer of the Institute for Healthcare Improvement), guiding principle for those working in the healthcare system is to ensure quality of patient care and patient safety are paramount adding that “this, by the way, is your safest and best route to lower cost” 8 . Similar to all international healthcare systems, the Heath Service Executive wants to achieve the triple aim of “better care, better health, at lower cost”. While Berwick’s mantra is “patient centred care” by “engaging, empowering and hearing patients”, he equally emphasises the need to foster and protect that other vulnerable group, healthcare staff. He advocates the “growth and development of all staff, including their ability and support to improve the processes in which they work”. He advocates an “all teach, all learn and no blame” approach and a culture where measurement is not a threat, but a resource; defects are seen as opportunities and curiosity abounds. Provonost 9 argues that to improve quality and safety, health care systems should establish a system wide governance structure and accountability process, define and communicate goals and measures while building an infrastructure to support peer learning. Transparency is crucial. While Open Disclosure to the patient or family member when something has gone wrong, is mandatory in some countries, it is not yet in Ireland. Legislation here, to protect the apology, is awaited. In Ireland, we have progress to make. In 2014, the State Claims Agency received 610 new clinical claims 10 . While maternity services related claims accounted for 23% of all new clinical claims in 2014, they account for 61% of the outstanding estimated liability of all new claims. Earlier identification and prevention of risk, should result in less adverse events and safer care for our patients. D Slattery Department of Clinical Risk, State Claims Agency, Grand Canal St, Dublin 2 Email: [email protected]