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Take-home points Patient-related factors, cognitive errors, and systems factors are common categories of diagnostic errors, all three of which played a role in the failure to recognize that the patient in this case was in her third trimester of pregnancy and in early labor Communication among members of work teams is critical for avoiding perpetuation of cognitive errors Appropriate supervision of physician trainees is necessary to ensure high-quality patient care Diagnostic errors in the use obstetrical ultrasound can result from inadequate training and experience, and the lack of a systematic approach to examinations and interpretations; patient factors such as obesity can limit diagnostic detection of important findings.

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.

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Recommendations The Government should immediately issue a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh. The appointment of a Patient Safety Commissioner who would be an independent public leader with a statutory responsibility. The Commissioner would champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety around the use of medicines and medical devices. A new independent Redress Agency for those harmed by medicines and medical devices should be created based on models operating effectively in other countries. The Redress Agency will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals Separate schemes should be set up for each intervention – HPTs, valproate and pelvic mesh – to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim. Networks of specialist centres should be set up to provide comprehensive treatment, care and advice for those affected by implanted mesh; and separately for those adversely affected by medications taken during pregnancy. The Medicines and Healthcare products Regulatory Agency (MHRA) needs substantial revision particularly in relation to adverse event reporting and medical device regulation. It needs to ensure that it engages more with patients and their outcomes. It needs to raise awareness of its public protection roles and to ensure that patients have an integral role in its work. A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can then be linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient reported outcomes measures. Transparency of payments made to clinicians needs to improve. The register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ particular clinical interests and their recognised and accredited specialisms. In addition, there should be mandatory reporting for pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians. The Government should immediately set up a task force to implement this Review’s recommendations. Its first task should be to set out a timeline for their implementation. Response from Patient Safety Learning Patient Safety Learning welcomes the publication of the First Do No Harm report today from the Independent Medicines and Medical Devices Safety Review. The Chair of the review, Baroness Julia Cumberlege, highlighted in this that they found the healthcare system to be "disjointed, siloed, unresponsive and defensive" to the patients effected by these issues. She also noted that: ‘The system is not good enough at spotting trends in practice and outcomes that give rise to safety concerns. Listening to patients is pivotal to that’ The report highlighted some key themes consistent with other major patient safety failures: Patients not being engaged in their care: Lacking the information required to make informed choices, awareness of how to report problems and their experiences not being recognised. Ineffective reporting: Data not being utilised to identify and address patient safety issues. Existing reporting systems not being effective enough to capture this information and share learning widely. Blame culture: Persistent failure to acknowledge when things go wrong for fear of blame, reducing the ability to address threats to patient safety. Patient Safety Learning considers that patient safety is currently treated as one of many priorities to be weighed against each other. We think it is wrong that safety is negotiable. Patient safety must be core to the purpose of healthcare, reflected in everything that it does.

Home births: a woman’s choice? Maternity services are rapidly adapting the way they work in light of the pandemic. Pregnant women are being asked to attend antenatal appointments alone or remotely in order to reduce risk of infection. In some areas, the option to have a midwife-led home birth has been suspended.[2] A recent report from the BBC suggests that as many as one third of Trusts could have removed home birth as an option.[3] For those who are not considered high-risk and have given birth before, home birth is often a very positive experience and clinical outcomes are good, with transfer rates to hospital and medical intervention very low among this group.[4] There is some evidence to suggest that more women are requesting to birth at home to reduce the risk of catching COVID-19 while in hospital.[5] This will, of course, require the appropriate level of support midwives being available to enable this. Commenting on the role of midwife-led care during the pandemic, joint guidance from the Royal College of Obstetricians and Gynaecologists (RCOG) and the Royal College of Midwives (RCM) states: “The positive impact of midwife-led birth settings is well documented, including reductions in the need for a range of medical interventions. These positive impacts remain of significant importance to prevent avoidable harm, and availability of midwife-led care settings for birth should therefore be continued as far as is possible during the pandemic.”[6] For some women though this option is now being taken off the table. Due to the pressures on services caused by the pandemic, the RCOG/RCM guidance also includes a framework to help maternity teams understand when and how they may need to suspend midwife-led services such as home births. In some areas of the UK, this is already happening and low-risk pregnant women are no longer being offered the full spectrum of birthing choices, as recommended by the National Institute of Health and Care Excellence (NICE).[7] There doesn’t seem to be publicly available information on the extent of this service suspension. The guidance recommends a staged approach in responding to emerging issues with staff shortages and other service pressures during the pandemic. It states that decisions about when to implement each stage will need to be made at a local level based on current local data including: bed occupancy in the maternity unit(s) community workload sickness rate among midwifery staff (midwives, maternity support workers and senior student midwives) available midwifery staffing (including additional midwives from the NMC emergency register, those previously in non-clinical roles or year-3 student midwives) skill mix of available midwifery staffing – including level of seniority and experience in provision of community-based care availability of ambulances and trained paramedic staff, to provide emergency transfer. COVID-19 is therefore having the direct impact of reducing birthing options available to some pregnant women. Patient Safety Learning is concerned with the safety of mums and babies with this erosion of a woman’s right to choose the birth they want. We are hearing that: Some women have serious concerns and anxiety about attending hospital during the pandemic and how they and their babies are being protected from COVID-19. Suspension of services could have a major impact on women who are frightened to birth in a hospital setting due to past trauma. Low-risk women are not being offered a home birth service in some areas. Women are unclear as to why they cannot home birth; is it because there are safety concerns where midwife-led services were critically understaffed when responding to home births? We think there are risks to patient safety and that there are significant questions that need to be answered: Are Trusts able to evidence that their decision-making around the suspension of home births is appropriate and proportionate, particularly for low-risk women where evidence indicates good clinical outcomes? Are Trusts’ decisions to suspend home births (and the basis behind these decisions) being shared publicly with the women under their care? RCOG/RCM guidance gives advice on reinstating services and recommends suspensions be regularly reviewed. How regularly are these suspensions being reviewed? Is this information publicly available? What steps are being put in place to preserve midwife-led services for women and their babies, whose health outcomes may be adversely affected by these changes? Are the health outcomes of these women and babies being monitored and reported on? How are women being reassured and informed of their safety from COVID-19 in hospital maternity care? High-risk pregnancies Some pregnancies are deemed as ‘high-risk’ and these women often fall under the care of a consultant. High-risk women and their babies are more likely to need extra medical support that is unavailable in a midwife-led birth setting. They would usually be advised by to go to a hospital labour ward to have their baby where that clinical support is available if needed. We are hearing that there is the potential for the number of high-risk women requesting to have their baby at home to rise, due to fears around coronavirus. This has serious safety implications and raises further questions around the number of experienced staff (and home birth equipment) available to support these labours. Where home births have been suspended there is also the frightening potential for high-risk women who choose not to go to hospital, to labour without clinical support. The RCM has highlighted there is anecdotal evidence that more women are choosing to birth at home unassisted due to reduced birth options and midwives are becoming increasingly concerned at the safety implications of this.[8] Maria Booker, Programmes Director from Birthrights, a charity that protects human rights in childbirth, explained their concerns around restricted services: "We are concerned that more women will have an unassisted birth that they have not actively chosen to have, due to the withdrawal of home births and midwifery led birth centres in some areas, which may put themselves and their babies at risk. Trusts need to be very clear that they can justify these restrictions on services as a proportionate response to their current situation and to review these decisions frequently as circumstances change."[9] We think there are risks to patient safety and that there are significant questions need to be answered: Has there been an increase in high-risk women deciding to birth at home against clinical advice? Where home birth has been suspended, and a high-risk woman decides to birth at home against clinical advice, will she give birth without clinical assistance? Where there is an increase in women requesting to have their baby at home, are midwives (including those returning to the profession) receiving the right support? Do they have an adequate supply of home birth kit and PPE? Are there enough staff experienced and confident in supporting both low and high-risk women to labour at home? Safe births during the pandemic Maternity services are faced with the challenge of adapting within unfamiliar and unpredictable territory. However, it is important that pregnant women and their babies continue to access the safest care options. There may not be a one-size-fits-all solution and the safety implications of blanket suspensions of home births, combined with a rising fear of hospitals, need due attention in order to protect mums and babies from suffering avoidable harm. Where Trusts take the decision to reduce birth options, these must be evidenced, proportionate and justifications must be made publicly available. References [1] BBC News, Coronavirus: Social restrictions ‘to remain for rest of year’, 22 April 2020. https://www.bbc.co.uk/news/uk-politics-52389285 [2] The Guardian, NHS trusts begin suspending home births due to coronavirus, 27 March 2020. https://www.theguardian.com/world/2020/mar/27/nhs-trusts-suspending-home-births-coronavirus; NHS Lanarkshire, NHS Lanarkshire restricts neonatal visiting and suspends home births, Friday 27 March 2020. https://www.nhslanarkshire.scot.nhs.uk/restricted-neonatal-visiting-suspended-home-births/; The Hillingdon Hospitals NHS Foundation Trust, Covid-19 virus infection and pregnancy, Last Accessed 24 April 2020. http://thh.nhs.uk/services/women_babies/COVID-19_infection_pregnancy.php [3] BBC News, Coronavirus: Uncertainty over maternity care causing distress, 24 April 2020. https://www.bbc.co.uk/news/health-52356067 [4] Birthplace in England Collaborative Group, Perinatal and maternal outcomes by planned place of birth for healthy women with low-risk pregnancies: the Birthplace in England national prospective cohort study, BMJ, 2011; 343. https://www.bmj.com/content/343/bmj.d7400; National Institute for Health and Care Excellence, Intrapartum care for healthy women and babies: Clinical guideline [CG190], Last Updated 21 February 2017. https://www.nice.org.uk/guidance/cg190/chapter/Recommendations#place-of-birth [5] Anonymous, Midwifery during COVID-19: A personal account, Patient Safety Learning the hub, 21 April 2020. https://www.pslhub.org/learn/coronavirus-covid19/273_blogs/midwifery-during-covid-19-a-personal-account-r2095/ [6] The Royal College of Midwifes and Royal College of Obstetricians & Gynaecologists, Guidance for provision of midwife-led settings and home birth in the evolving coronavirus (COVID-19) pandemic, 9 April 2020. https://www.rcm.org.uk/media/3875/midiwfe-led-settings-and-guidance.pdf [7] National Institute for Health and Care Excellence, Intrapartum care: Quality Standard [QS105], Last Updated 28 February 2017. https://www.nice.org.uk/guidance/qs105/chapter/quality-statement-1-choosing-birth-setting [8] The Royal College of Midwifes and Royal College of Obstetricians & Gynaecologists, Guidance for provision of midwife-led settings and home birth in the evolving coronavirus (COVID-19) pandemic, 9 April 2020. https://www.rcm.org.uk/media/3875/midiwfe-led-settings-and-guidance.pdf [9] National Institute for Health and Care Excellence, Intrapartum care: Quality Standard [QS105], Last Updated 28 February 2017. https://www.nice.org.uk/guidance/qs105/chapter/quality-statement-1-choosing-birth-setting