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In our recent blog Analysing the Cumberlege Review; Who should join the dots for patient safety? we identified a number of key patient safety issues which were reflected in the Review’s findings. One theme running throughout the Review was a failure to engage patients in their care, most noticeably around the issue of informed consent. What is informed consent? The NHS definition of informed consent is that “the person must be given all of the information about what the treatment involves, including the benefits and risks, whether there are reasonable alternative treatments, and what will happen if treatment does not go ahead”.[1] The landmark UK Supreme Court judgement Montgomery v Lanarkshire Health Board case in 2015 reaffirmed this principle in law, setting out the legal duty of doctors to disclose information to patients regarding risks.[2] Review findings Patients being unable to make decisions on the basis of informed consent was a recurring theme in the review, manifesting itself in several ways: Patients’ consent not being sought - the Review heard from patients where consent was not given for the procedure carried out, particularly in cases for implanting pelvic mesh. The authors of the Review state that they were “appalled by the numbers of women who have come forward to say they never knew they had had mesh inserted, or where they gave consent for ‘tape’ insertion they did not know they were being implanted with polypropylene mesh”.[3] Patients lacking information – this was a consistent issue concerning patients regarding the three interventions considered by the Review: hormone pregnancy tests, sodium valproate and pelvic mesh implants. One specific example of this is the case of pregnant women taking sodium valproate as an epilepsy treatment without knowing that doing so could harm their unborn child. Despite efforts to make patients aware of this, it remains an issue, with women who are taking sodium valproate as a epilepsy treatment “still becoming pregnant without any knowledge of the risks”, lacking the information to make the decision about whether to continue with this medication.[4] Patients not being involved in decision making – the Review also heard from patients who raised concerns about the failure of informed consent as a result of doctors choosing not to share relevant information with patients for their decision-making. They refer to cases where doctors did not discuss the risks with women taking sodium valproate prior to pregnancies and “gave advice based on their own assumptions, without involving patients in the decision-making process”.[5] Concerns around the absence of informed consent go beyond the procedures focused on in the Review. On the hub, we have featured community discussions and patient accounts of these issues in relation to hysteroscopy procedures, while earlier in the year the Paterson Inquiry highlighted concerns about this, recommending that a short period should be introduced into surgical procedures to allow for patients to provide their consent.[6] How can we ensure informed consent is gained? The Cumberlege Review notes that, since the Montgomery ruling in 2015, there has been a significant increase in patient safety leaflets sharing information on risks of specific treatments, but that the sheer variety of these and differing consent forms can be “bewildering and a major source of confusion”.[7] The Review is supportive of an approach where information is conveyed in a clear and direct way, and where patient decision aids are used in complex conversations to support the consent process.[8] At Patient Safety Learning, we believe it is important that patients are not simply treated as passive participants in the process of their care. Informed consent is vital to respecting the rights of the patient, maintaining trust in the patient-clinician relationship and ensuring safe care. We have identified three calls for action which we believe are needed to tackle the failure of informed consent: All patient information should be co-produced with patients to ensure that it meets patient needs for decision-making. Repositories of information and good practice are put in place so that organisations don’t have to re-invent the wheel but instead can learn from experience. Patient information for medication and medical devices should be reviewed and signed off by the NHS to ensure that it is not solely the responsibility of manufacturers. What are your thoughts on this issue? Have you had an experience where you feel that you have not given informed consent before receiving medical care? Are you a healthcare professional who can share resources for good practice? Let us know in the comments below to ensure our calls for action are informed by your experience and insights. References NHS England, Consent to treatment, Last Accessed 16 July 2020. https://www.nhs.uk/conditions/consent-to-treatment/ UK Supreme Court, Montgomery v Lanarkshire Health Board, 2015. https://www.supremecourt.uk/cases/docs/uksc-2013-0136-judgment.pdf; Lee, Albert. “'Bolam' to 'Montgomery' is result of evolutionary change of medical practice towards 'patient-centred care'.” Postgraduate medical journal vol. 93,1095 (2017): 46-50. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5256237/#R3 The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf Ibid. Ibid. Campaign Against Painful Hysteroscopy, Patients Stories Essay, September 2018. https://www.hysteroscopyaction.org.uk/wp-content/uploads/2018/10/sept-2018.pdf; The Right Reverend Graham Jones, Report of the Independent Inquiry into the Issues raised by Paterson, 2020. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/863211/issues -raised-by-paterson-independent-inquiry-report-web-accessible.pdf The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 8 July 2020. https://www.immdsreview.org.uk/downloads/IMMDSReview_Web.pdf Ibid.

These inspections have identified some good individual practice. But they have also found some common areas of concerns. These include: staff without the appropriate training, qualifications and competencies to carry out their role unsafe practice in the use of sedation and anaesthetics poor monitoring and management of patients whose condition might deteriorate a lack of attention to fundamental safety processes variable standards of governance and risk management failure to ensure consent is obtained in a two-stage process, with an appropriate cooling off period between initial consultation and surgery infection prevention and control standards not always being followed concerns about equipment maintenance.

Content includes: Patient Safety: We’ve Come a Long Way National Patient Safety Consortium: Learning from Large-Scale CollaborationPatient Engagement in a Large-Scale Change Initiative: “As Safe as Possible, as Soon as Possible” Commentary: Three Ideas About “Post-Vention” Patient Safety Never Events: Cross-Canada Checkup Empowering Patients: 5 Questions to Ask About Your Medications Accelerating Post-Surgical Best Practices Using Enhanced Recovery After Surgery Patient Safety Culture Bundle for CEOs and Senior Leaders Commentary: We Must Look at Multiple Perspectives Homecare Safety Virtual Quality Improvement Collaboratives Commentary: Patient Safety in the Home Measuring and Monitoring Healthcare-Associated Infections: A Canadian Collaboration to Better Understand the Magnitude of the Problem Patient Safety: Patient Involvement Matters.

This blog describes how Susannah forgave her surgeon for harming her, as she was able to see things from his point of view. It also highlights the importance of emotional intelligence in healthcare staff. You can follow Susannah on twitter @lliheus