Recurring concern

Inadequate informed-consent processes for medical treatment

First to latest report 1 Jul 2014 — 28 Dec 2025

Reports that mention this concern
31
Times this concern has been raised
37
Stated actions linked to this concern
56

What this concern includes

Includes failures of medical-treatment consent processes, including initiation, information about material risks, time for consideration, consistency of procedure, assessment of consent and documentation, where the failure is directly tied to obtaining valid informed consent.

What is not included
  • Excludes legal-status or detention transfers that do not concern consent to medical treatment.
  • Excludes general communication, training, documentation or staffing deficiencies unless they are directly tied to the medical-treatment consent process.
  • Excludes clinical assessment or treatment-selection failures that do not concern obtaining or recording informed consent.

Reports and published responses 31 reports

See individual reports that have raised this concern, and the actions taken in response

  1. West London

    AI-generated summary

    Mohamed Abdisamad · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Mohamed Abdisamad underwent a non-therapeutic male circumcision on 12 February 2023 and developed symptoms of illness three to four days later. He suffered a cardiorespiratory arrest while being taken to hospital and was declared dead on 19 February 2023; the inquest recorded invasive Streptococcus pyogenes infection following male circumcision as the medical cause of death. The report raised concerns about the lack of training, accreditation, record keeping, consent, infection-control requirements and aftercare requirements for individuals conducting such procedures.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to obtain consent before NTMC

    Wider context from the report

    “4. There is no system for consent to be taken prior to a Non-Therapeutic Male Circumcisions (NTMC). ”

    Source location

    Mohamed Abdisamad · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Existing law requires valid consent before non-therapeutic male circumcision, including consent from a person with parental responsibility where applicable.

    Verbatim wording from the response

    “It is a general legal and ethical principle that valid consent must be obtained from an individual before starting a treatment or physical intervention. For consent to be valid it must be given voluntarily by an appropriately informed person who has the capacity to consent to the intervention in question. If children have the capacity to give consent for themselves, consent should be sought directly from them. Once young people reach the age of 16, they are presumed in law to be competent to give consent for themselves for their own surgical, medical or dental treatment, and any associated procedures, such as investigations, anaesthesia or nursing care. If a child is not competent to give consent for themselves, consent should be sought from a person with parental responsibility. This will often, but not always, be the child’s parent.”

    Source location

    Response from Department of Health and Social Care
    Page 2 · response
    Published 29 December 2025

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Responsibility for the reported issues rests with DHSC, which has provided the comprehensive government response; MHCLG has nothing further to add.

    Verbatim wording from the response

    “MHCLG is responsible for the overall stewardship of the local government sector, but we are not responsible for all the services that councils deliver. Councils deliver a very wide range of services to residents, within a national legislative framework. Decisions around management are often taken locally, but the lead Government department for any particular issue delivered by a local authority is responsible for working with councils to ensure effective delivery.”

    Source location

    Response from MHCLG
    Page 1 · response
    Published 29 December 2025

    Open published response

  2. Milton Keynes

    AI-generated summary

    William King · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    William King died at Milton Keynes University Hospital on 26 January 2025 following an aspiration episode during preparation for emergency laparotomy for bowel obstruction. The principal concerns were inadequate explanation and documentation of the risks and necessity of a nasogastric tube, failure to implement the relevant consent policy, and unclear responsibility for ensuring this aspect of care was addressed.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to document consent discussions about NG tube treatment

    Wider context from the report

    “i) Failure to document consent discussions - The record of discussions with Billy about the NG tube was poor. Despite the Trust having a "Policy & Guidelines for Consent to Examination or Treatment" in place January 2020 (reviewed February 2024), there was a failure to comply with these guidelines in Billy's case. The policy required clear documentation, but this was not followed in Billy's case. The Trust’s subsequent assertion in submissions that policy and training are sufficient is undermined by the fact that the policy was in place but not followed ii) Inadequate explanation of risks to patients - I found that the necessity and risks of declining the NG tube were probably not sufficiently explained to Billy at any stage. There was certainly no supporting evidence to suggest the contrary. iii) Policy non-compliance - Despite a comprehensive policy being in place, there was a failure to implement it in practice, suggesting a gap between policy and practice that may affect other patients. The existence of a policy is not sufficient if it is not followed in practice. The inquest demonstrated a failure of implementation, not of policy content. iv) Absence of clear responsibility - There appeared to be a disconnect in terms of who was actually responsible for ensuring the need for an NG tube was explained to Billy. The assessing anaesthetists thought he needed an NG tube and the surgeons thought he needed an NG tube, but neither took ultimate responsibility for ensuring that this was adequately and, if needed, strongly explained and implemented. No one professional led on this vital aspect of his care. I conclude that, since the policy was not followed despite being in place, there remains a risk of recurrence unless there is assurance of effective implementation and monitoring. These concerns are likely to manifest and be replicated across England and Wales requiring me to send this report to the Royal Colleges and Association of Anaesthetists. ”

    Source location

    William King · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Design and implement a generic electronic patient-record form supporting decisions and documentation for care outside clinical guidance.

    Verbatim wording from the response

    “We are designing a new form within our electronic patient record (eCare) which will support staff facing such situations in:”

    Source location

    Response from Milton Keynes University Hospitals NHS Foundation Trust
    Page 2 · response
    Published 10 October 2025

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Provide consent guidance on supported decision-making, informed consent, treatment options, material risks and patient-specific communication.

    Verbatim wording from the response

    “• The College has produced guidance on Consent: Supported Decision-Making which lays out the key principles that underpin the consent process. This guidance emphasises that for the patient’s consent to be considered informed, surgeons must be satisfied that the patient has received and understood full and sufficient information about the proposed treatment and its implications. This includes presenting the various treatment options and discussing their relative risks and benefits side by side. It makes clear that consent should be patient-specific, and that surgeons should communicate the risks that are material to the particular patient and their circumstances.”

    Source location

    Response from Royal College of Surgeons of England
    Page 1 · response
    Published 10 October 2025

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Consult the GMC on practical consent tools and checklists supporting implementation of the consent guidance.

    Verbatim wording from the response

    “• Implementation: We have recently consulted with the GMC on the development and publication of practical tools and checklists to assist in the implementation of our guidance on consent. We plan on publishing these additional tools alongside our updated guidance on consent over the coming year. We are also in the process of developing a brief e-learning module on consent based on our guidance which can be used by hospitals to train their teams locally.”

    Source location

    Response from Royal College of Surgeons of England
    Page 2 · response
    Published 10 October 2025

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Publish practical consent tools and checklists alongside the updated consent guidance.

    Verbatim wording from the response

    “• Implementation: We have recently consulted with the GMC on the development and publication of practical tools and checklists to assist in the implementation of our guidance on consent. We plan on publishing these additional tools alongside our updated guidance on consent over the coming year. We are also in the process of developing a brief e-learning module on consent based on our guidance which can be used by hospitals to train their teams locally.”

    Source location

    Response from Royal College of Surgeons of England
    Page 2 · response
    Published 10 October 2025

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Develop a brief consent e-learning module for local hospital team training.

    Verbatim wording from the response

    “• Implementation: We have recently consulted with the GMC on the development and publication of practical tools and checklists to assist in the implementation of our guidance on consent. We plan on publishing these additional tools alongside our updated guidance on consent over the coming year. We are also in the process of developing a brief e-learning module on consent based on our guidance which can be used by hospitals to train their teams locally.”

    Source location

    Response from Royal College of Surgeons of England
    Page 2 · response
    Published 10 October 2025

    Open published response

  3. Avon

    AI-generated summary

    Mabel Olivia Williams · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Mabel Olivia Williams was born alive after a trial of vaginal birth after caesarean section and died six days later in a neonatal intensive care unit following severe hypoxic-ischaemic encephalopathy associated with an undiagnosed uterine rupture. The concerns included inadequate information and informed consent about the risks of uterine rupture, failures to recognise or communicate signs of distress in time, and delays in making appropriate changes after serious clinical incidents.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to provide complete information about uterine rupture and its consequences in patient guidance

    Wider context from the report

    “Background The Ockenden Report, which I was directed to in evidence, first published in 2020 a list of immediate and essential actions which included: ‘all Trusts must ensure women have ready access to accurate information to enable their informed choice of intended place of birth and mode of birth, including maternal choice for caesarean delivery.’ The externally conducted HSIB report which looked into Mabel’s death identified in February 2024 that the Trust’s guidance for patients on ‘Birth after caesarean’ did not describe what a uterine rupture is. That point was made in the context of Mabel’s parents telling the HSIB investigation that they were not informed about the possible consequences of a uterine scar rupture, or that at their most severe those consequences could include the death of their baby. I found at the conclusion of Mabel’s inquest that appropriate steps had not been taken to obtain ████████ informed consent to VBAC, and the shortcomings of the Trust’s patient information leaflets were part of what informed that finding. In advance of the inquest the Trust’s legal representatives found it difficult to provide me with current copies of relevant patient information leaflets. When they were finally disclosed (on day 3 of the inquest) I found it hard to get a clear picture of whether the leaflets were or were not ‘in force’. I heard evidence at one point from a member of trust staff that revised leaflets (which did contain a full explanation of uterine rupture) had been drafted but not signed off by the Trust for distribution to patients, much to the frustration of the maternity unit. I was also provided with an Excel spreadsheet after the inquest which contained, among other things, information about the Trust’s compliance with various objectives relating to the Ockenden Review. The information in that spreadsheet included an indication that one of the Trust’s objective was that “Change in practice arising from an SI investigation must be seen within 6 months after the incident occurred”. The spreadsheet suggested that this objective was not being achieved. This would accord with my impression (which I would have reached irrespective of having sight of the spreadsheet) that much of the change that I was being shown following Mabel’s death was coming very late, and as a response to the impending (or active) inquest, not as a result of learning from the tragic events in question. Specific concern That the Trust may not be making appropriate changes within a reasonable timeframe following serious clinical incidents. ”

    Source location

    Mabel Olivia Williams · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Revise and provide the Birth After Previous Caesarean leaflet with clear uterine-rupture risks during birth-options counselling.

    Verbatim wording from the response

    “The Trust has undertaken a comprehensive review of the “Birth After Previous Caesarean” patient information leaflet. The revised leaflet now provides a clear, accessible explanation of uterine rupture, including its potential severity and the associated risks to both mother and baby which includes the risk of the death of the baby.”

    Source location

    Response from Great Western Hospitals NHS Foundation Trust
    Page 1 · response
    Published 16 September 2025

    Open published response

  4. Essex

    AI-generated summary

    Emmy Russo · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Emmy Russo was born in very poor condition after a hypoxic injury shortly before birth and died following severe hypoxic-ischaemic brain injury. The report raised concerns about information given to patients considering induction beyond 41 weeks and about inconsistent escalation of concerns regarding labouring mothers and CTG traces for medical review. The inquest identified missed opportunities to deliver Emmy sooner.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to provide complete information on the risks of induction and continuing pregnancy beyond 41 weeks

    Wider context from the report

    “(1) The evidence of the current information given to patients at 40 weeks’ pregnant on the decision over whether to accept the offer of an induction from 41 weeks does not reflect NICE guidance on the information needed by patients to make an informed choice on induction. Whilst it provides details of the risks associated with induction, it does not provide information on the risks of continuing with pregnancy beyond 41 weeks. ”

    Source location

    Emmy Russo · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Publish an updated induction-of-labour leaflet explaining the risks of continuing pregnancy beyond 41 weeks.

    Verbatim wording from the response

    “The evidence of the current information given to patients at 40 weeks’ pregnant on the decision over whether to accept the offer of an induction from 41 weeks does not reflect NICE guidance on the information needed by patients to make an informed choice on induction. Whilst it provides details of the risks associated with induction, it does not provide information on the risks of continuing with pregnancy beyond 41 weeks.”

    Source location

    Response from Princess Alexandra Hospital NHS Foundation Trust
    Page 1 · response
    Published 21 May 2025

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Implement snap audits and regular audits of antenatal records documenting induction-of-labour discussions.

    Verbatim wording from the response

    “06 In regards to future plans, the Trust plans to implement regular audits of antenatal records of Induction of Labour discussions. It is anticipated that these audits will take place from October 2025, once the new Patient Information Leaflet has fully been embedded. In the interim, snap Audits will take place to monitor compliance.”

    Source location

    Response from Princess Alexandra Hospital NHS Foundation Trust
    Page 2 · response
    Published 21 May 2025

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Make Birthrights-informed decision-making training mandatory for Consultants, resident doctors and Midwives.

    Verbatim wording from the response

    “10 Whilst we understand that the above concern was directed at ensuring that patients are informed the risks of prolonged gestation in particular, the Trust continues to work with Birthrights to provide training to clinicians. As discussed at Inquest, Birthrights is an organisation focused on supporting patients right to choose and enabling individuals to make informed decisions about their care. The Trust plans to make this training mandatory for all Consultants, resident doctors and Midwives, with a view to start in January 2026, having been optional to this point.”

    Source location

    Response from Princess Alexandra Hospital NHS Foundation Trust
    Page 2 · response
    Published 21 May 2025

    Open published response

  5. Rutland and North Leicestershire

    AI-generated summary

    Anne TOWLSON · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Anne Towlson was found dead at home on 17 May 2024 after travelling to Turkey for planned tummy tuck and liposuction surgery, and additionally undergoing arm tuck surgery. Her arm wounds had not healed, with open, swollen and weeping wounds noted after her return to the UK; the cause of death was recorded as unascertained. Concerns included the lack of information about the Turkish hospital’s assessment, surgery and postoperative care, uncertainty about whether surgical risks were explained, the consenting process for the additional arm surgery, and limited follow-up after returning to the UK.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to ensure informed consent about surgical risks and mortality rates

    Wider context from the report

    “2) I am concerned about the fact that we have no evidence to confirm whether Mrs Towlson was made aware of the risks and mortality rates associated with any of the surgical procedures she underwent in Turkey. ”

    Source location

    Anne TOWLSON · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Insufficient time for patients to consider additional surgery before consenting

    Wider context from the report

    “3) I am concerned about the fact that Mrs Towlson had travelled to Turkey to have a tummy tuck and liposuction but was offered additional arm tuck surgery when she arrived at the hospital. I have concerns about the consenting process for this additional surgery as, on the balance of probabilities, Mrs Towlson was not given enough time to properly consider this decision. ”

    Source location

    Anne TOWLSON · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Consider how to communicate risks to people considering medical treatment abroad.

    Verbatim wording from the response

    “We are considering the impact medical tourism is having regarding patient safety and are engaging with the Turkish Government to improve the patient pathway. The UK Government is also considering how we can most effectively communicate with those considering medical treatment abroad, to ensure people are better informed about the risks of surgery and help them to plan accordingly. To protect patient safety, we understand the need to ensure appropriate aftercare, including considering when it may be safe to travel home.”

    Source location

    Response from DHSC
    Page 2 · response
    Published 4 March 2025

    Open published response

  6. Birmingham and Solihull

    AI-generated summary

    Aarav Pal CHOPRA · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Aarav Pal CHOPRA died on 22 November 2023 after an intercostal artery was damaged during a liver biopsy, causing a haemothorax, cardiac arrest and hypoxic brain injury. The report identified concerns about inadequate planning and communication, delayed recognition and treatment of the haemothorax, unclear decision-making, trainee competence, consent, patient risk factors, prophylactic antibiotics, learning from deaths and access to complete electronic records.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Lack of a way to obtain consent when a trainee performs a procedure

    Wider context from the report

    “3. Consent forms: The parents of Aarav were unaware that a trainee would be doing the liver biopsy. My concern is that there is currently no way to obtain consent when a trainee will be doing the procedure. ”

    Source location

    Aarav Pal CHOPRA · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Reinforce consent guidance requiring families to be informed when clinicians in training may perform procedures.

    Verbatim wording from the response

    “GMC consent guidance states that patients and families should be given the right not to be involved where teaching, training or research is taking place. Therefore, families should be advised at the time of the procedure if a clinician in training may be performing the procedure. BWC will reinforce this GMC guidance to its consultant body in order to ensure the correct conversations are had between colleagues and importantly with our families. This information was shared in the recent Senior Medical and Dental Staff Committee meeting and has been followed up with an email to the consultant body.”

    Source location

    Response from Birmingham Women's and Children's NHS Foundation Trust
    Page 2 · response
    Published 13 January 2025

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Current consent forms and supervised trainee procedures are considered to work largely effectively, so specifying the individual practitioner is not proposed.

    Verbatim wording from the response

    “The National Team Children and Young People, via NHS England, have confirmed that the current consent forms specifically state that the consent does not specify which individual will undertake a procedure.”

    Source location

    Response from DHSC
    Page 2 · response
    Published 13 January 2025

    Open published response

  7. East London

    AI-generated summary

    Chloe Every · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Chloe Every died in hospital on 14 May 2019 after complications from a hypoxic cardiac arrest sustained during her admission. The report identified concerns including morphine use without recorded justification, an enema undertaken without informed consent while she was unconscious, inadequate clinical observations, missing records, and failures in incident reporting and governance.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to obtain informed consent before undertaking an enema

    Wider context from the report

    “4. Chloe underwent an enema on 8th May 2019 without informed consent being taken. The court found that Chloe was unconscious, before, during, and after the procedure, it is possible this procedure contributed to her death. ”

    Source location

    Chloe Every · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Update the Consent to Examination and Treatment policy with guidance on implied consent.

    Verbatim wording from the response

    “The Trust’s Consent to Examination and Treatment policy section 4.1.4 'Procedures to follow when patients lack capacity to give or withhold consent' includes guidance on when and how to apply. The policy will be updated by February 2025 to include guidance on implied consent.”

    Source location

    Response from Barking, Havering and Redbridge NHS Foundation Trust
    Page 4 · response
    Published 31 October 2024

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Complete review and approval of an Easy Read consent-information leaflet for patients with Learning Disabilities.

    Verbatim wording from the response

    “An Easy Read leaflet on Information about Consent for patients with Learning Disabilities has been drafted and is currently going through review and approval processes with expected completion in February 2025.”

    Source location

    Response from Barking, Havering and Redbridge NHS Foundation Trust
    Page 4 · response
    Published 31 October 2024

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Deliver informed-consent training covering Montgomery law and GMC and NMC requirements.

    Verbatim wording from the response

    “The Legal team will deliver training about informed consent including Montgomery Law and GMC and NMC requirements in January 2025.”

    Source location

    Response from Barking, Havering and Redbridge NHS Foundation Trust
    Page 4 · response
    Published 31 October 2024

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    BHRUT is responsible for responding fully to the concerns, so the Department will not duplicate its response.

    Verbatim wording from the response

    “NHSE have informed us that BHRUT is preparing a response to address your concerns in full. This is entirely appropriate due to the nature of the concerns raised and as a direct recipient of this report. I look forward to their response with interest and do not wish to duplicate it. However, I will highlight some points from the information shared with us, of the actions taken to improve matters in relation to the care of patients with learning disabilities since Chloe’s death in 2019:”

    Source location

    Response from DHSC
    Page 1 · response
    Published 31 October 2024

    Open published response

  8. Inner North London

    AI-generated summary

    Sophie Ann Dean · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Sophie Ann Dean, who was aged 18, underwent surgery after free air was found in her abdomen and later required re-closure of her abdominal wound. She developed a chest infection and, after the second operation on 4 September 2023, suffered a cardiac arrest and died despite resuscitation efforts. The substantive concerns related to omissions and inadequacies in the medical records and whether the rationale and alternatives to surgery were sufficiently discussed with her parents before consent was given.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to provide complete information about treatment options before consent

    Wider context from the report

    “3) The on-call surgeon used language such as having “pushed the family” into agreeing to surgery on 24 August 2023. There was also evidence that not all options/possibilities were discussed with Miss Dean’s parents prior to their consenting to surgery. The evidence was that Miss Dean’s parents may not have fully understood the rationale for surgery or the possibility of conservative management of the issue, prior to the laparotomy on 24 August 2023. ”

    Source location

    Sophie Ann Dean · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to obtain treatment consent without pressuring families

    Wider context from the report

    “3) The on-call surgeon used language such as having “pushed the family” into agreeing to surgery on 24 August 2023. There was also evidence that not all options/possibilities were discussed with Miss Dean’s parents prior to their consenting to surgery. The evidence was that Miss Dean’s parents may not have fully understood the rationale for surgery or the possibility of conservative management of the issue, prior to the laparotomy on 24 August 2023. ”

    Source location

    Sophie Ann Dean · Prevention of Future Deaths report
    Page 3 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Amend the consent policy to require additional consultant input, Best Interests Meetings where applicable, and documentation of operative and conservative-treatment risks.

    Verbatim wording from the response

    “3. The consent policy has been amended to state that where there is agreed to be a high risk of surgical mortality (determined to be a 10% risk) in patients unable to provide informed consent who are undergoing an emergency surgical procedure, a second consultant opinion will be sought and the second consultant will document in the electronic record their opinion. In non-emergency situations, a Best Interests Meeting will convene and the outcome documented. In all cases, documentation will include the risks of performing the surgery, and the converse risks of doing nothing and continuing conservative treatment only.”

    Source location

    Response from UCLH
    Page 1 · response
    Published 30 September 2024

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Record subspecialty agreement to implement the amended consent policy through local governance committees.

    Verbatim wording from the response

    “Documentation of speciality agreement to implement this new policy will occur through local governance committees. This will be audited within six months.”

    Source location

    Response from UCLH
    Page 1 · response
    Published 30 September 2024

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Audit implementation of the amended consent policy within six months.

    Verbatim wording from the response

    “Documentation of speciality agreement to implement this new policy will occur through local governance committees. This will be audited within six months.”

    Source location

    Response from UCLH
    Page 1 · response
    Published 30 September 2024

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Incorporate the PFD learning into subspecialty Trust induction covering ward-round documentation and the consent policy within three months.

    Verbatim wording from the response

    “The learning from this PFD will be incorporated into Trust induction on a subspecialty level, to ensure the ward round documentation requirements are clear for future resident doctors and there is familiarity with the consent policy. This timeline for this is three months for completion.”

    Source location

    Response from UCLH
    Page 2 · response
    Published 30 September 2024

    Open published response

  9. West Sussex, Brighton and Hove

    AI-generated summary

    Dr Alan William Kingsbury · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Dr Alan William Kingsbury, who was extremely frail, died in hospital on 29 October 2023 after excessive bleeding from a chest lesion excision while taking aspirin and clopidogrel, followed by a fall causing a fractured right neck of femur. The report raised concerns about the robustness of guidance on antithrombotic medication, the absence of preoperative assessment and advanced consent, and the wound-closure technique used to achieve haemostasis.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to obtain advanced consent before dermatological surgery

    Wider context from the report

    “2. The lack of a Preoperative assessment and advanced consent Dr Kingsbury was not assessed or consented either in person or by telephone consultation prior to the day of the procedure against current accepted guidelines for surgical procedures. No risk/benefit analysis was undertaken as to the suitability of undertaking the procedure whilst Dr Kingsbury was taking Aspirin and Clopidogrel. Mrs Kingsbury made multiple attempts at communicating with the service without success to obtain advice as to the necessity or otherwise of discontinuing the anticoagulants. ”

    Source location

    Dr Alan William Kingsbury · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Provide advanced consent and schedule procedures to allow appropriate adjustment of anticoagulation.

    Verbatim wording from the response

    “▪ Action to be taken: SCDS will ensure that its policies are sufficiently robust to be able to identify at risk patients at the time of 1st encounter and ensure that risk mitigation measures are in place. To achieve this, we will do the following: - Perform a thorough documented preoperative assessment to assess risk of complications associated with skin surgery. - Ensure advanced consent and scheduling of the procedure to allow adjustment of anticoagulation as appropriate.”

    Source location

    Response from Surrey Community Dermatology Service
    Page 1 · response
    Published 29 July 2024

    Open published response

  10. Manchester South

    AI-generated summary

    Linda MCLAUGHLIN · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Linda McLaughlin was treated for chronic myeloid leukaemia with nilotinib and later developed interstitial lung disease, probably as a consequence of the treatment. She was admitted with bronchopneumonia and died at Tameside General Hospital on 27 October 2023. Concerns included limited awareness of this rare complication, consent processes that may not mention it, and a lack of clear guidance on stopping treatment when patients are in remission.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to include rare complications such as interstitial lung disease in consent discussions for nilotinib

    Wider context from the report

    “2. The inquest was told that the consenting process for starting a patient on a drug such as nilotinib would not ordinarily include mentioning rare complications such as interstitial lung disease. The family gave evidence that in this case this is something that would have been carefully weighed in the decision to proceed with the treatment. ”

    Source location

    Linda MCLAUGHLIN · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Nilotinib’s interstitial lung disease risk is identified in product information, the BNF and the patient information leaflet.

    Verbatim wording from the response

    “Your Report raises the concern that it is not widely known by healthcare professionals that interstitial lung disease is a rare side effect of treatment with a tyrosine kinase inhibitor drug called nilotinib, and that the consenting process for such a drug would not usually include mentioning such rare complications.”

    Source location

    Response from NHS England
    Page 1 · response
    Published 14 June 2024

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    The BNF and MHRA are more appropriate bodies to respond to concerns about nilotinib’s side-effect information and medication regulation.

    Verbatim wording from the response

    “It should be noted that NHS England does not administer the BNF, and that regulation of medication does not sit within our remit. You may wish to revert to the BNF and/or”

    Source location

    Response from NHS England
    Page 1 · response
    Published 14 June 2024

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Clinical practice issues, including prescribing and treatment decisions, are outside the medicines regulator’s remit.

    Verbatim wording from the response

    “The MHRA recognises that as the medicines’ regulator, it is not within our remit to comment on clinical practice issues. It is a healthcare professional’s responsibility to prescribe a drug based on the information contained within the SmPC and to obtain appropriate consent after counselling the patient on their individual benefits and risks with use.”

    Source location

    Response from MHRA
    Page 3 · response
    Published 14 June 2024

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Healthcare professionals are responsible for prescribing nilotinib and obtaining patient consent after discussing individual benefits and risks.

    Verbatim wording from the response

    “The MHRA recognises that as the medicines’ regulator, it is not within our remit to comment on clinical practice issues. It is a healthcare professional’s responsibility to prescribe a drug based on the information contained within the SmPC and to obtain appropriate consent after counselling the patient on their individual benefits and risks with use.”

    Source location

    Response from MHRA
    Page 3 · response
    Published 14 June 2024

    Open published response

Actions and positions describe what organisations say in published responses. Implementation is not independently verified.

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Data last updated 7 September 2026