16 Jul 2024 Jessica de Souza · Prevention of Future Deaths report Surrey
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Concerns raised 1 Failure to ensure aripiprazole monotherapy is effective for prophylaxis against both bipolar polarities View source
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AI-generated summary
Jessica de Souza · 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
Jessica de Souza, who had bipolar disorder, developed depression after a family bereavement and took her own life by hanging at home on 1 February 2023. Concerns included that aripiprazole was prescribed as monotherapy for both polarities of bipolar disorder, although expert evidence stated it was not effective prophylaxis against depressive relapse. The expert also considered that the guidance relied on by clinicians may have been misleading.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure to ensure aripiprazole monotherapy is effective for prophylaxis against both bipolar polarities
Wider context from the report “i. The treating psychiatrists gave evidence that, following the acute manic episode, Jessica was prescribed aripiprazole as a maintenance prophylactic drug to control both polarities of bipolar disorder.
ii. The clinicians relied on the BNF and the BMJ Best Practice Bipolar Disorder in Adults to support their decision to prescribe aripiprazole as prophylaxis for both polarities as a monotherapy.
iii. Nice Guidance on Bipolar Disorder [CG185] suggests aripiprazole may be considered as a maintenance treatment to prevent relapse in bipolar disorder.
iv. The BMJ refers to aripiprazole being used as a monotherapy to treat bipolar disorder, though does advise that it is more effective in preventing mania than depression.
v. The court appointed psychiatric expert gave evidence that aripiprazole is not effective as a prophylaxis in relation to the depressive polarity in bipolar and that as a result Jessica was not protected from a depressive relapse.
vi. The expert considered that the guidance relied on may have been misleading for the clinicians.
” Open source report
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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 Discuss long-term bipolar disorder treatment across both polarities with NICE topic experts.
Verbatim wording from the response “Our senior clinical advisers acknowledge that the guideline does not explicitly consider the 2 polarities of bipolar disorder in long-term treatment. We will discuss this area with our topic experts and review any new evidence that could impact on our recommendations, updating them if necessary.” Source location Response from NICE
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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 Review new evidence that could affect NICE’s long-term bipolar disorder treatment recommendations.
Verbatim wording from the response “Our senior clinical advisers acknowledge that the guideline does not explicitly consider the 2 polarities of bipolar disorder in long-term treatment. We will discuss this area with our topic experts and review any new evidence that could impact on our recommendations, updating them if necessary.” Source location Response from NICE
Open published response
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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 content of the BNF and BMJ Best Practice is outside NICE’s responsibility, so NICE cannot comment on it.
Verbatim wording from the response “The BNF is a joint publication of the British Medical Association and the Royal Pharmaceutical Society. NICE hold the licence to make this resource available on the NICE website to health professionals working in the UK, but we are not responsible for the content.” Source location Response from NICE
Open published response
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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 BMJ Best Practice publishers are best placed to respond to concerns about their content.
Verbatim wording from the response “I note that you have sent your report to those parties, and they are best placed to respond to your comments on their content.” Source location Response from NICE
Open published response
3 Jul 2024 Ruth Diane Eggleton · Prevention of Future Deaths report Nottinghamshire
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Concerns raised 1 Lack of an evidence-based protocol for withholding or reversing DOAC and prescribing alternative anticoagulant medication View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Ruth Diane Eggleton · 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
Ruth Diane Eggleton fell in her garden on 2 April 2023 and sustained a head injury with a small subdural haemorrhage. She was taking Rivaroxaban, which was not withheld or reversed, and she was discharged from hospital; the report identified concerns about the lack of an evidence-based protocol for managing DOAC anticoagulation.
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. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of an evidence-based protocol for withholding or reversing DOAC and prescribing alternative anticoagulant medication
Wider context from the report “1. There is a lack of evidence-based protocol for determining when to withhold and/or reverse DOAC, and when to prescribe alternative anticoagulant medication. I heard evidence from clinicians that the lack of such a protocol has led to divergence of practice amongst clinicians.
I am not reassured that necessary actions to address the serious issue identified are in place.
” Open source report
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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 Continue monitoring new evidence on DOAC anticoagulation decisions.
Verbatim wording from the response “NICE will continue to monitor new evidence in this area of practice, and will develop or update our guidance accordingly.” Source location Response from NICE
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 or update NICE guidance on DOAC anticoagulation decisions in response to new evidence.
Verbatim wording from the response “NICE will continue to monitor new evidence in this area of practice, and will develop or update our guidance accordingly.” Source location Response from NICE
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 NICE cannot develop useful guidance on DOAC reversal decisions because high-quality evidence is lacking and decisions require individual clinical judgement.
Verbatim wording from the response “We agree that consideration should be given to reversing and withholding anticoagulation when a person prescribed these medications experiences significant bleeding. The reason for anticoagulation (which is not mentioned in your report) must be balanced against the estimated risk of further bleeding. In rare cases, alternative anticoagulation may be considered. Unfortunately, there is very little research evidence on which guidelines relevant to this complex decision could be based, and a high degree of clinical judgement is required in each case.” Source location Response from NICE
Open published response
26 Jun 2024 Michelle Patricia Moore · Prevention of Future Deaths report Somerset
View report summary
Concerns raised 6 Absence of training and learning on hormone levels, HRT, antidepressants and holistic care View source Lack of understanding and appreciation of the link between menopause and mental health decline View source Lack of continuity and joined-up care between menopause and mental health treatment View source Absence of guidance or published policy on joined-up care for women experiencing menopause View source Lack of understanding and appreciation of the menopause and its effects on women View source Absence of guidance or published policy on the link between menopause and mental health decline View source See 3 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Michelle Patricia Moore · 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
Michelle Patricia Moore, who had a longstanding history of anxiety and an acute deterioration in her mental health, was found deceased at home on 31 October 2023. The inquest concluded with a short-form conclusion of suicide, with the medical cause of death recorded as compression of the neck and suspension by a ligature. The principal concerns were a lack of continuity and joined-up care between treatment for menopausal symptoms and mental health care, and an apparent absence of guidance, training and policy concerning links between menopause and mental health decline.
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. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Absence of training and learning on hormone levels, HRT, antidepressants and holistic care
Wider context from the report “There appeared to be a lack of continuity and joined-up care between those trying to treat Mrs Moore’s menopausal symptoms and those trying to treat her mental health presentation and this suggested:
(a) A lack of understanding and appreciation of the menopause and the effect this hormonal change and/or imbalance may have on women; and
(b) A lack of understanding and appreciation of a potential link between menopause and a woman experiencing mental health decline.
I referred in questioning to the recognised mental health conditions of Post Natal Depression (PND) and Post Natal Psychosis (PNP) where it appears to be more widely understood and appreciated amongst treating professionals that childbirth and the hormonal imbalance/upheaval can acutely affect a woman’s mental wellbeing and state of mind. However, the same awareness and/or appreciation does not appear to exist when, later in life, a woman may suffer a mental health decline due to acute hormonal changes brought about by the menopause (whether or not this is treated with HRT).
There appears to be a complete absence of national and/or local guidance or published policy (none was brought to my attention on questioning of the clinicians) concerning:
(a) The potential for a link between menopause and mental health decline.
(b) The need for joined-up care between those trying to treat women at this stage of their lives.
(c) Training and learning around hormone levels, HRT and antidepressants and the potential for a holistic approach to inform awareness and understanding.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of understanding and appreciation of the link between menopause and mental health decline
Wider context from the report “There appeared to be a lack of continuity and joined-up care between those trying to treat Mrs Moore’s menopausal symptoms and those trying to treat her mental health presentation and this suggested:
(a) A lack of understanding and appreciation of the menopause and the effect this hormonal change and/or imbalance may have on women; and
(b) A lack of understanding and appreciation of a potential link between menopause and a woman experiencing mental health decline.
I referred in questioning to the recognised mental health conditions of Post Natal Depression (PND) and Post Natal Psychosis (PNP) where it appears to be more widely understood and appreciated amongst treating professionals that childbirth and the hormonal imbalance/upheaval can acutely affect a woman’s mental wellbeing and state of mind. However, the same awareness and/or appreciation does not appear to exist when, later in life, a woman may suffer a mental health decline due to acute hormonal changes brought about by the menopause (whether or not this is treated with HRT).
There appears to be a complete absence of national and/or local guidance or published policy (none was brought to my attention on questioning of the clinicians) concerning:
(a) The potential for a link between menopause and mental health decline.
(b) The need for joined-up care between those trying to treat women at this stage of their lives.
(c) Training and learning around hormone levels, HRT and antidepressants and the potential for a holistic approach to inform awareness and understanding.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of continuity and joined-up care between menopause and mental health treatment
Wider context from the report “There appeared to be a lack of continuity and joined-up care between those trying to treat Mrs Moore’s menopausal symptoms and those trying to treat her mental health presentation and this suggested:
(a) A lack of understanding and appreciation of the menopause and the effect this hormonal change and/or imbalance may have on women; and
(b) A lack of understanding and appreciation of a potential link between menopause and a woman experiencing mental health decline.
I referred in questioning to the recognised mental health conditions of Post Natal Depression (PND) and Post Natal Psychosis (PNP) where it appears to be more widely understood and appreciated amongst treating professionals that childbirth and the hormonal imbalance/upheaval can acutely affect a woman’s mental wellbeing and state of mind. However, the same awareness and/or appreciation does not appear to exist when, later in life, a woman may suffer a mental health decline due to acute hormonal changes brought about by the menopause (whether or not this is treated with HRT).
There appears to be a complete absence of national and/or local guidance or published policy (none was brought to my attention on questioning of the clinicians) concerning:
(a) The potential for a link between menopause and mental health decline.
(b) The need for joined-up care between those trying to treat women at this stage of their lives.
(c) Training and learning around hormone levels, HRT and antidepressants and the potential for a holistic approach to inform awareness and understanding.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Absence of guidance or published policy on joined-up care for women experiencing menopause
Wider context from the report “There appeared to be a lack of continuity and joined-up care between those trying to treat Mrs Moore’s menopausal symptoms and those trying to treat her mental health presentation and this suggested:
(a) A lack of understanding and appreciation of the menopause and the effect this hormonal change and/or imbalance may have on women; and
(b) A lack of understanding and appreciation of a potential link between menopause and a woman experiencing mental health decline.
I referred in questioning to the recognised mental health conditions of Post Natal Depression (PND) and Post Natal Psychosis (PNP) where it appears to be more widely understood and appreciated amongst treating professionals that childbirth and the hormonal imbalance/upheaval can acutely affect a woman’s mental wellbeing and state of mind. However, the same awareness and/or appreciation does not appear to exist when, later in life, a woman may suffer a mental health decline due to acute hormonal changes brought about by the menopause (whether or not this is treated with HRT).
There appears to be a complete absence of national and/or local guidance or published policy (none was brought to my attention on questioning of the clinicians) concerning:
(a) The potential for a link between menopause and mental health decline.
(b) The need for joined-up care between those trying to treat women at this stage of their lives.
(c) Training and learning around hormone levels, HRT and antidepressants and the potential for a holistic approach to inform awareness and understanding.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of understanding and appreciation of the menopause and its effects on women
Wider context from the report “There appeared to be a lack of continuity and joined-up care between those trying to treat Mrs Moore’s menopausal symptoms and those trying to treat her mental health presentation and this suggested:
(a) A lack of understanding and appreciation of the menopause and the effect this hormonal change and/or imbalance may have on women ; and
(b) A lack of understanding and appreciation of a potential link between menopause and a woman experiencing mental health decline.
I referred in questioning to the recognised mental health conditions of Post Natal Depression (PND) and Post Natal Psychosis (PNP) where it appears to be more widely understood and appreciated amongst treating professionals that childbirth and the hormonal imbalance/upheaval can acutely affect a woman’s mental wellbeing and state of mind. However, the same awareness and/or appreciation does not appear to exist when, later in life, a woman may suffer a mental health decline due to acute hormonal changes brought about by the menopause (whether or not this is treated with HRT).
There appears to be a complete absence of national and/or local guidance or published policy (none was brought to my attention on questioning of the clinicians) concerning:
(a) The potential for a link between menopause and mental health decline.
(b) The need for joined-up care between those trying to treat women at this stage of their lives.
(c) Training and learning around hormone levels, HRT and antidepressants and the potential for a holistic approach to inform awareness and understanding.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Absence of guidance or published policy on the link between menopause and mental health decline
Wider context from the report “There appeared to be a lack of continuity and joined-up care between those trying to treat Mrs Moore’s menopausal symptoms and those trying to treat her mental health presentation and this suggested:
(a) A lack of understanding and appreciation of the menopause and the effect this hormonal change and/or imbalance may have on women; and
(b) A lack of understanding and appreciation of a potential link between menopause and a woman experiencing mental health decline.
I referred in questioning to the recognised mental health conditions of Post Natal Depression (PND) and Post Natal Psychosis (PNP) where it appears to be more widely understood and appreciated amongst treating professionals that childbirth and the hormonal imbalance/upheaval can acutely affect a woman’s mental wellbeing and state of mind. However, the same awareness and/or appreciation does not appear to exist when, later in life, a woman may suffer a mental health decline due to acute hormonal changes brought about by the menopause (whether or not this is treated with HRT).
There appears to be a complete absence of national and/or local guidance or published policy (none was brought to my attention on questioning of the clinicians) concerning:
(a) The potential for a link between menopause and mental health decline.
(b) The need for joined-up care between those trying to treat women at this stage of their lives.
(c) Training and learning around hormone levels, HRT and antidepressants and the potential for a holistic approach to inform awareness and understanding.
” Open source report
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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 and publish the menopause diagnosis and management guideline, with publication scheduled for 7 November 2024.
Verbatim wording from the response “An independent committee is currently updating our guideline on menopause: diagnosis and management [NG23]. We expect to publish the updated guideline on 7 November 2024.” Source location Response from NICE
Open published response
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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 Conduct an exceptional surveillance review of the menopause guideline and available evidence on menopause-related mental-health risks.
Verbatim wording from the response “In March 2023, we received a Healthcare Safety Investigation Branch (HSIB) safety recommendation asking NICE to evaluate the available research relating to the risks associated with menopause on mental health and if appropriate, update existing guidance.” Source location Response from NICE
Open published response
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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 Assess whether further menopause and mental-health changes are needed after the updated guideline is published.
Verbatim wording from the response “Following publication, our surveillance team will assess if any further changes relating to mental health and menopause are needed, in response to the HSIB recommendation and taking into account the issues raised in your report.” Source location Response from NICE
Open published response
Concerns raised 7 Lack of clear guidance for communication of test results and patient presentation across specialisms and team roles View source Lack of required senior review when diagnostic results are incongruous or unexpected in context View source Lack of minimum standards for obtaining clinical context when reviewing isolated test or investigation results View source Lack of authoritative national guidelines for ECG use and interpretation across clinical settings View source Failure to audit the sufficiency of detail in discharge summaries View source Failure to undertake wider audit of pre-discharge ECG interpretation in the Emergency Department and Acute Medical Unit View source Failure to undertake broader learning reviews of ECG misinterpretation and its clinical context View source See 4 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
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AI-generated summary
Thomas Gibson · 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
Mr Gibson was found dead at home on 7 June 2023, with the death attributed to sudden cardiac death due to idiopathic myocardial fibrosis. Eleven days earlier, two ECGs were not recognised as showing complete heart block, and he was discharged from hospital. Concerns included inadequate communication and contextual review of test results, lack of senior review when findings were unexpected, insufficient auditing of ECG interpretation and discharge summaries, and the absence of authoritative national guidance on ECG use and interpretation.
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. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of clear guidance for communication of test results and patient presentation across specialisms and team roles
Wider context from the report “2. Having carefully considered all of the evidence at inquest, I am concerned that there does not appear to be clear guidance available to those working within the Trust as to what is required when communicating (particularly as to test results and a patient’s presentation) as between different specialisms and as between different roles within the team .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of required senior review when diagnostic results are incongruous or unexpected in context
Wider context from the report “4. I am also concerned that there does not currently appear to be any particular requirement in place for a senior review of the patient to take place in circumstances where diagnostic tests undertaken yield results which appear incongruous / unexpected in the context of their presentation .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of minimum standards for obtaining clinical context when reviewing isolated test or investigation results
Wider context from the report “3. Connected with the above, I am concerned that the court heard evidence to the effect there is no specific guidance as to expected minimum standards as to obtaining appropriate context / information for clinicians (whether from the HIVE system or otherwise) when asked to review a single test or investigation result in isolation .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of authoritative national guidelines for ECG use and interpretation across clinical settings
Wider context from the report “1. The court heard evidence that ECGs are used by different professional groups in a wide range of clinical settings. A consultant cardiologist in this case gave evidence that complete heart block was sometimes a wholly incidental finding on ECG, with the patient not previously exhibiting any obvious signs or symptoms. In the present case, the court heard evidence that the computer-generated interpretations of two ECGs were both incorrect, and that three different (relatively experienced) doctors misinterpreted the ECGs. In those circumstances, I am concerned there are currently no authoritative national guidelines (such as those which exist for CTGs) in place as to the use and interpretation of ECGs in various clinical settings .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure to audit the sufficiency of detail in discharge summaries
Wider context from the report “6. It is a matter of concern that no audit as to the sufficiency of detail contained in discharge summaries appears to have been undertaken to date in the light of the issues identified by the Trust’s High Impact Learning Assessment.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure to undertake wider audit of pre-discharge ECG interpretation in the Emergency Department and Acute Medical Unit
Wider context from the report “5. Given the Trust’s own findings on investigation, I am concerned that no wider audit of ECGs interpreted in the Emergency Department / Acute Medical Unit prior to discharge of patients appears to have been undertaken ; and
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure to undertake broader learning reviews of ECG misinterpretation and its clinical context
Wider context from the report “1. Whilst some important learning has been derived from the Trust’s review of the care provided to Mr Gibson, I am concerned that a narrow focus on the error of three different doctors to interpret two ECGs correctly (rather than any broader consideration of the context in which such misinterpretations occurred) represents a missed opportunity to fully understand the factors that led to Mr Gibson’s discharge from hospital , thus creating a risk of future deaths.
” Open source report
7 May 2024 David RILEY · Prevention of Future Deaths report Warwickshire
View report summary
Concerns raised 5 Failure to specify and disseminate learning from the DOAC pausing incident View source Failure to coordinate pericardiocentesis timing with the duration of DOAC interruption View source Lack of clear guidance for clinicians on pausing DOACs View source Failure to communicate, recognise and act on time-critical DOAC directions View source Inconsistent understanding and application of DOAC pausing decisions View source See 2 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
David RILEY · 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
David Riley developed a pericardial effusion after atrial fibrillation ablation and later suffered a stroke before dying on 10 June 2023. Concerns included inconsistent decisions about pausing Apixaban, delays in restarting it, inadequate communication and continuity of care, and difficulties using computerised clinical 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. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure to specify and disseminate learning from the DOAC pausing incident
Wider context from the report “Although the Warwick hospital conducted a Root Cause Analysis Investigation Report (RCAIR) of 6 July 2023 which indicated that the pausing of the DOAC was a lesson learned, it did not indicate what was learned . The only further action was limited to the incident being presented at the Grand Round, but this had not taken place at the time of the inquest, some 9 months after publication of the RCAIR . There are remaining outstanding matters of concern.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure to coordinate pericardiocentesis timing with the duration of DOAC interruption
Wider context from the report “2. Effective communication
From the evidence, there was a failure to effectively communicate, recognise and act on directions that were time critical, such as restarting the DOAC as directed. It does not appear that there was any consideration as to the timing of the pericardiocentesis to ensure that the DOAC was paused for a short a time as possible . The evidence suggested that this may be due to lack of continuity of care and the difficulties in the way in which computerised clinical/pharmacy records are updated and accessed. Clear communication between medical staff is essential to patient care.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of clear guidance for clinicians on pausing DOACs
Wider context from the report “1. Decisions regarding pausing of DOACs.
It was not clear if there is national guidance available to clinicians regarding the pausing of DOACs and the considerations to be applied in making that decision . If there is such guidance, it is not widely understood or on the evidence given, followed consistently from hospital to hospital or within different teams. The inconsistency of approach appears from the evidence to increase the risk of misunderstanding and to put patients with atrial fibrillation at risk.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure to communicate, recognise and act on time-critical DOAC directions
Wider context from the report “2. Effective communication
From the evidence, there was a failure to effectively communicate, recognise and act on directions that were time critical, such as restarting the DOAC as directed . It does not appear that there was any consideration as to the timing of the pericardiocentesis to ensure that the DOAC was paused for a short a time as possible. The evidence suggested that this may be due to lack of continuity of care and the difficulties in the way in which computerised clinical/pharmacy records are updated and accessed. Clear communication between medical staff is essential to patient care.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Inconsistent understanding and application of DOAC pausing decisions
Wider context from the report “1. Decisions regarding pausing of DOACs.
It was not clear if there is national guidance available to clinicians regarding the pausing of DOACs and the considerations to be applied in making that decision. If there is such guidance, it is not widely understood or on the evidence given, followed consistently from hospital to hospital or within different teams . The inconsistency of approach appears from the evidence to increase the risk of misunderstanding and to put patients with atrial fibrillation at risk .
” Open source report
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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 Further consider the issues raised through guideline surveillance to determine whether the VTE guideline requires updating.
Verbatim wording from the response “Our guideline on venous thromboembolism in over 16s: reducing the risk of hospital-acquired deep vein thrombosis or pulmonary embolism [NG89] covers VTE risk assessment but does not specifically cover pausing of DOACs such as apixaban. It is not possible to cover all clinical circumstances in our guidelines. Nevertheless, NICE will further consider the issues raised through our guideline surveillance process to see if an update to the guideline is required.” Source location Response from NICE
Open published response
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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 Share the report with Agilio Software for awareness.
Verbatim wording from the response “We will share your report with Agilio Software for their awareness.” Source location Response from NICE
Open published response
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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 Guidelines cannot cover all clinical circumstances and do not specifically address pausing direct oral anticoagulants.
Verbatim wording from the response “Our guideline on venous thromboembolism in over 16s: reducing the risk of hospital-acquired deep vein thrombosis or pulmonary embolism [NG89] covers VTE risk assessment but does not specifically cover pausing of DOACs such as apixaban. It is not possible to cover all clinical circumstances in our guidelines. Nevertheless, NICE will further consider the issues raised through our guideline surveillance process to see if an update to the guideline is required.” Source location Response from NICE
Open published response
Concerns raised 3 Lack of child-applicable guidance for diagnosis and management of venous thromboembolic diseases View source Insufficient access to diagnostic and treatment resources for childhood thromboembolism View source Lack of validated child-specific screening tools for pulmonary thromboembolism View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
LILLY GRACE PROCTOR · 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
Lilly Proctor, aged 13, collapsed at home in the early hours of 3 April 2022 and died later that day in Pinderfields Hospital from massive pulmonary thromboembolism associated with deep vein thrombosis and hereditary Protein S deficiency. The report raises concerns that there was no child-specific UK screening tool or corresponding NICE guidance for venous thromboembolic disease in children, potentially disadvantaging clinicians diagnosing and treating the condition.
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. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of child-applicable guidance for diagnosis and management of venous thromboembolic diseases
Wider context from the report “(2) NICE Guidance NG158 “Venous thromboembolic diseases: diagnosis, management and thrombophilia testing” is specific to adults. There is no corresponding guidance applicable to children . Similarly, the NICE Clinical Knowledge Summary for pulmonary embolism dated September 2023 is specific to adults with no corresponding publication applicable to children .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Insufficient access to diagnostic and treatment resources for childhood thromboembolism
Wider context from the report “(3) The rarity of thromboembolism in children gives rise to a concern that without access to resources similar to those available when dealing with the adult population, clinicians working with children may be disadvantaged in diagnosing and treating the condition , to the obvious potential detriment of their patients.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of validated child-specific screening tools for pulmonary thromboembolism
Wider context from the report “(1) Whereas there are screening tools (such as “the Wells criteria”) to assist the detection of pulmonary thromboembolism in adults, no child-specific screening tool is available in the UK and no existing screening tool for use in the adult population has been validated for use in children in the UK . The inquest heard evidence of such child-specific screening tools being developed in other countries, of which Italy was an example.
” Open source report
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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 Ask the prioritisation board to consider whether guidance should be developed on venous thromboembolism in children.
Verbatim wording from the response “Nevertheless, NICE will consider the issues raised in your report through our recently implemented organisation-wide approach to prioritisation and topic selection. This is overseen by a single prioritisation board that guides the selection and coordination of our guidance development. We will ask our prioritisation board to consider if guidance should be developed in this area. In line with our usual practice, decisions made by the prioritisation board will be published on the NICE website.” Source location Response from NICE
Open published response
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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 NICE cannot recommend a paediatric VTE screening tool because evaluated adult scores perform poorly and no suitable tool is known.
Verbatim wording from the response “Regarding a screening tool, there is no specific screening tool that we are aware of. The Wells score and the Caprini score (scores used in adults) have both been evaluated in different paediatric populations, but their performance has not been good, and they cannot be recommended. There is, therefore, no screening tool that NICE could recommend. We note you have mentioned child specific screening tools being developed in other countries, but our clinical advisors are not aware of these and have not seen them used in practice.” Source location Response from NICE
Open published response
26 Apr 2024 Ellen Mercer · Prevention of Future Deaths report Berkshire
View report summary
Concerns raised 2 Failure of policy to clearly define a 24-hour VTE risk assessment period that accounts for emergency department waits View source Failure of current policies to require VTE risk assessment for emergency department patients during prolonged waits View source
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Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Ellen Mercer · 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
Ellen Mercer attended Wexham Park Hospital by ambulance in the early hours of 9 February 2023 after deterioration associated with her mental health, nitrous oxide use, leg injuries and reduced mobility. She died in the emergency department approximately 24 hours after arriving; a post-mortem examination identified bilateral pulmonary artery thromboembolus and deep vein thrombosis. The substantive concerns relate to the absence of a formal VTE risk assessment and uncertainty in hospital policies about when the 24-hour period for such an assessment begins, particularly for patients waiting in emergency departments.
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. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure of policy to clearly define a 24-hour VTE risk assessment period that accounts for emergency department waits
Wider context from the report “1. Patients are unfortunately waiting increasingly longer times in emergency departments – not just in waiting areas, but also after being seen by clinical staff and waiting for admission to a ward or discharge from the hospital. During this time, current policies do not require VTE risk assessment.
2. The policy for this trust suggests that the 24 hour period (during which VTE risk assessment must take place) starts only when a patient is “admitted” to hospital, i.e. when a decision is taken to admit them to a ward – which could be many hours after they have originally attended the emergency department.
3. The policy as currently drafted implies that VTE risk assessment is essentially not relevant for emergency department patients.
4. If current policies require VTE risk assessment to take place within 24 hours, the point at which that 24 hour period starts is not sufficiently clear and does not take long waits in emergency departments into account. I am concerned that policies may need to reflect the current reality on the ground.
5. I suspect that this issue may be a national one.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure of current policies to require VTE risk assessment for emergency department patients during prolonged waits
Wider context from the report “1. Patients are unfortunately waiting increasingly longer times in emergency departments – not just in waiting areas, but also after being seen by clinical staff and waiting for admission to a ward or discharge from the hospital. During this time, current policies do not require VTE risk assessment.
2. The policy for this trust suggests that the 24 hour period (during which VTE risk assessment must take place) starts only when a patient is “admitted” to hospital, i.e. when a decision is taken to admit them to a ward – which could be many hours after they have originally attended the emergency department.
3. The policy as currently drafted implies that VTE risk assessment is essentially not relevant for emergency department patients.
4. If current policies require VTE risk assessment to take place within 24 hours, the point at which that 24 hour period starts is not sufficiently clear and does not take long waits in emergency departments into account. I am concerned that policies may need to reflect the current reality on the ground.
5. I suspect that this issue may be a national one.
” Open source report
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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 Ask the prioritisation board to consider whether guidance should be developed on VTE risk assessment for emergency department patients before admission.
Verbatim wording from the response “The scope of the guideline does not cover people in the emergency department prior to admission. We have therefore not made any recommendations that cover the circumstances described in your report.” Source location Response from National Institute for Health and Care Excellence
Open published response
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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 guideline does not cover people in emergency departments before admission, so it makes no recommendations for that circumstance.
Verbatim wording from the response “The scope of the guideline does not cover people in the emergency department prior to admission. We have therefore not made any recommendations that cover the circumstances described in your report.” Source location Response from National Institute for Health and Care Excellence
Open published response
23 Apr 2024 Nuliyati BUSINJE · Prevention of Future Deaths report Cheshire
View report summary
Concerns raised 3 Failure of the DVT risk assessment tool to assess patients at risk despite no significantly reduced mobility View source Failure to factor psychiatric-unit patients’ increased DVT risk into risk assessment and guidance View source Lack of training and awareness that clot-related abnormal observations can normalise View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Nuliyati BUSINJE · 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
Nuliyati Businje was an inpatient on a psychiatric unit when, after abnormal observations and worsening hyperglycaemia during her admission, she suffered a cardiac arrest. Post-mortem examination found a massive pulmonary embolus due to deep venous thrombosis. The concerns included limitations in VTE risk assessment for patients with risk factors other than reduced mobility, insufficient recognition of increased DVT risk among psychiatric inpatients, and inadequate awareness of how clot-related observations may normalise.
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. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure of the DVT risk assessment tool to assess patients at risk despite no significantly reduced mobility
Wider context from the report “1. Despite evidence to suggest that mobility is not the ultimate deciding factor of risk of DVT, the risk assessment tool as currently drafted and relied upon by clinicians would suggest that there is no further need for assessment . This raises a risk of future deaths for those patients such as Ms Businje who were at risk of VTE, or those with cancer for example, but who do not have significantly reduced mobility and would therefore fall outside of the risk assessment .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure to factor psychiatric-unit patients’ increased DVT risk into risk assessment and guidance
Wider context from the report “2. Based on the evidence I heard, patients on a psychiatric unit are at increased risk of DVT but this is not factored into the risk assessment, nor the NICE guidance . The latter guidance has a specific section for psychiatric patients but does not provide any specific information as to risk and directs the reader to the same Department of Health risk assessment tool .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of training and awareness that clot-related abnormal observations can normalise
Wider context from the report “3. Based on the evidence of the expert physician, a common presentation of a clot can be a derangement in observations such as respiratory rate and heart rate, but these can normalise as the clot furthers on and the blockage eases. I am concerned that this does not appear to be widely known , is not part of training at least in the Trust in this case due to the lack of awareness , and I am told is not something which is taught nationally . There is a risk that a clinician without this knowledge would, as in this case, be reassured by the improving observations and the clot, and risk of a further more serious clot, would be overlooked .
” Open source report
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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 Concerns about the VTE risk assessment tool should be directed to the Department of Health and Social Care.
Verbatim wording from the response “Concerns regarding the risk assessment tool referenced in NG89 would need to be directed to the Department of Health and Social Care.” Source location Response from NICE
Open published response
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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 NICE recommendations for VTE assessment, review and prophylaxis cover the clinical circumstances described.
Verbatim wording from the response “We believe that our recommendations for assessment and review cover the clinical circumstances outlined in your report. In NG89 we recommend that all people admitted to an acute psychiatric ward should be assessed for risk of VTE at consultant review or if their clinical condition changes (recommendation 1.9.2). Further, we recommend that clinicians should consider pharmacological VTE prophylaxis for people admitted to an acute psychiatric ward whose risk of VTE outweighs their risk of bleeding and that this should be continued until the person is no longer at risk (recommendations 1.9.3 and 1.9.5).” Source location Response from NICE
Open published response
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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 Insufficient evidence prevents recommending one VTE risk assessment tool over another.
Verbatim wording from the response “With regard to the assessment of VTE risk in people with psychiatric disorders admitted to hospital, in the NICE guideline on venous thromboembolism in over 16s: reducing the risk of hospital-acquired deep vein thrombosis or pulmonary embolism we recommend that clinicians should use ‘a tool published by a national UK body, professional network or peer-reviewed journal’ to assess VTE risk, however we do not recommend a particular risk assessment tool as there is not enough evidence to support the use of one over another and during development of the guideline, the committee made a research recommendation in this area, reflecting the uncertainty in the evidence for one risk tool over another.” Source location Response from NICE
Open published response
18 Apr 2024 Michael BRIGGS · Prevention of Future Deaths report Derby and Derbyshire
View report summary
Concerns raised 2 Lack of implementation advice for dentists in England and Wales managing patients at increased risk of infective endocarditis View source Conflicting guidance on antibiotic prophylaxis for people at high risk of infective endocarditis View source
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Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Michael BRIGGS · 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
Michael Briggs developed infective endocarditis after three dental extractions and died at Royal Derby Hospital on 11 January 2023. The principal concerns were limited guidance for dentists in England and Wales about managing patients at increased risk of infective endocarditis, and conflicting guidance on antibiotic prophylaxis.
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. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of implementation advice for dentists in England and Wales managing patients at increased risk of infective endocarditis
Wider context from the report “• The NICE guideline CG64 “Prophylaxis against infective endocarditis” states that antibiotic prophylaxis against infective endocarditis is not recommended routinely for people undergoing dental procedures. The guideline does not provide any implementation advice for dentists on how they should manage patients who are at an increased risk.
• The Scottish Dental Clinical Effectiveness Programme (SDCEP) produced implementation advice in August 2018 entitled “Antibiotic Prophylaxis Against Infective Endocarditis”. The document contains a “NICE Statement of Endorsement” that the advice supports the implementation of recommendations in CG64. There is no reciprocal endorsement or mention of the SDCEP advice in CG64 and there does not appear to be any such implementation advice applicable to dentists in England and Wales .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Conflicting guidance on antibiotic prophylaxis for people at high risk of infective endocarditis
Wider context from the report “• In 2023 the European Society of Cardiology (ESC) produced Clinical Practice Guidelines for the management of endocarditis which recommends antibiotic prophylaxis for high risk individuals . The court heard evidence that cardiologists in England and Wales are regularly following this guidance which conflicts with the 2016 NICE guideline .
” Open source report
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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 Review evidence on antibiotic prophylaxis against infective endocarditis, including dental extraction, and assess whether prophylaxis was effective.
Verbatim wording from the response “In the 2015 review of CG64, the guideline committee agreed that current evidence was insufficient to support the hypothesis that interventional procedures, including dental extraction, lead to the development of infective endocarditis in people with pre-existing cardiac conditions. Furthermore, the committee concluded that there is insufficient evidence to recommend prophylactic use of antibiotics in those at risk of infective endocarditis undergoing interventional procedures, including dental extraction. From the evidence examined, the committee were unable to establish whether or not prophylaxis was effective.” Source location Response from National Institution for Health and Care Excellence
Open published response
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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 Review evidence on antibiotic prophylaxis against infective endocarditis and determine whether new information supports updating NICE guidance.
Verbatim wording from the response “We have committed to review the current evidence relating to prophylaxis against infective endocarditis this financial year and will determine whether any new information, studies or research would support the case for a further update of existing NICE guidance.” Source location Response from National Institution for Health and Care Excellence
Open published response
Concerns raised 1 Failure of anticoagulation guidance to address patients with coronary stents undergoing therapeutic endoscopy while taking a single anticoagulant View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Terence William SULLIVAN · 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
Terence Sullivan underwent surgery to remove a sigmoid colon polyp on 8 August 2023, after temporarily stopping rivaroxaban. He suffered an acute myocardial infarction caused by blockage in a coronary artery stent and died in hospital on 10 August 2023. The principal concern was that NICE and BSG guidance may not reflect best practice for patients with coronary stents taking a single anticoagulant who require therapeutic endoscopy, including whether pre-operative consultation with an interventional cardiologist is needed.
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. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure of anticoagulation guidance to address patients with coronary stents undergoing therapeutic endoscopy while taking a single anticoagulant
Wider context from the report “Since June 2023, Mr. Sullivan had been on a single anticoagulant medication ( Rivaroxaban ) to prevent previously inserted coronary stents from blocking. The clinicians who carried out the endoscopic procedure on 8.8.23, however, ensured that he had not taken any Rivaroxaban for the previous 48 hours. This was in accordance with Worcestershire Acute Hospital NHS Trust ( WAHT )’s own guidance, itself based on NICE guidance “NICE Clinical Scenario: Rivaroxaban for a therapeutic endoscopy”. I also heard evidence that the equivalent guidance from the British Society of Gastroenterology ( BSG ) provided similar advice.
At inquest, I heard evidence from WAHT’s Clinical Director for Critical Care that none of the aforementioned guidance considered the specific, and increasingly more common, scenario of a patient with coronary stents who is on a single ( as opposed to more than one ) anticoagulant medication, and who requires a therapeutic endoscopic procedure. The Clinical Director felt that in those specific circumstances, best practice requires pre-operative consultation with an interventional cardiologist, to decide on the best anticoagulation strategy during the procedure.
I am concerned to hear that current guidance on this specific issue from both NICE and BSG may not now reflect current best practice.
” Open source report
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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 Share the Prevention of Future Deaths report with Agilio Software for awareness.
Verbatim wording from the response “As part of this process, we have shared this report with Agilio Software for their awareness and understand that they are going to update this specific CKS shortly. If further detail is required on the changes to the content of the CKS topic, Agilio Software can be contacted directly.” Source location Response from National Institute for Health and Care Excellence
Open published response
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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 the concerns through NICE’s guideline surveillance process.
Verbatim wording from the response “Nevertheless, NICE will consider the issues raised through our guideline’s surveillance team and process, and update or issue new guidance recommendations, accordingly, depending on the outcome of these considerations.” Source location Response from National Institute for Health and Care Excellence
Open published response
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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 Updating the Clinical Knowledge Summary on anticoagulant cessation is assigned to Agilio Software, not NICE.
Verbatim wording from the response “The CKS are developed by an external company called Agilio Software and are designed to summarise the evidence on the treatment of specific health conditions. They use a variety of sources and may include NICE guidance, if there is any that is relevant, but they use many other sources too. We publish them on our website as a source of advice and information for health professionals working in primary care, but they do not constitute NICE guidance.” Source location Response from National Institute for Health and Care Excellence
Open published response
14 Feb 2024 Alfie Anthony Kevin Nicholls · Prevention of Future Deaths report Manchester South
View report summary
Concerns raised 8 Insufficient school nurse service capacity for identifying health issues and supporting professionals View source Failure to use EHCPs holistically to integrate health and education information View source Unavailability of regular dietitian input for children with eating disorders View source Insufficient publication and guidance on medical emergencies in eating disorders beyond psychiatry View source Failure to establish effective cross-sector strategies for identifying and managing ARFID View source Lack of understanding of ARFID-related medical risk in acute medical settings View source Lack of professional awareness of ARFID and how to approach it View source Failure to consider the health impact of poor and restricted eating in children with autism View source See 5 more concerns
Responses linked to these concerns
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AI-generated summary
Alfie Anthony Kevin Nicholls · 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
Alfie Anthony Kevin Nicholls, a child with autism and a severely restricted diet, collapsed at home on 17 December 2021 and died at Stepping Hill Hospital despite attempts to resuscitate him. A post-mortem examination found significant malnutrition, and the report identified concerns about poor communication between professionals and the family, limited recognition and understanding of ARFID and medical risk, and insufficient coordinated support and resources.
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. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Insufficient school nurse service capacity for identifying health issues and supporting professionals
Wider context from the report “5. The Inquest heard that the school nurse service could play a vital role in identifying health issues and supporting other professionals . This key role was significantly impacted by the high demand on the service and the very high caseloads school nurses working with complex children were being asked to carry nationally.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure to use EHCPs holistically to integrate health and education information
Wider context from the report “4. Whilst there was an Education, Health and Care Plan (EHCP) in place for Alfie there was little evidence that EHCPs were being used as a holistic tool to understand the inter relationship between health and education . There was evidence that those writing EHCPs needed to consider a child more holistically for the EHCP to cover all the aspects that it was meant to cover and not just to focus on education .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Unavailability of regular dietitian input for children with eating disorders
Wider context from the report “6. The role of a dietitian in supporting children with eating disorders could be fundamental in maximising the nutritional value of what they consumed. Demands on the service and a limited understanding of how they could work to support children with disorders such as ARFID (nationally) meant that there was rarely regular input from dieticians .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Insufficient publication and guidance on medical emergencies in eating disorders beyond psychiatry
Wider context from the report “7. ARFID, the Inquest was told, could lead to medical emergencies in eating disorders (MEED). The evidence given at the Inquest was that whilst this concept had been the subject of guidance amongst Psychiatrists it had been less publicised and there had been far less guidance by other Royal Colleges . In particular the Inquest was told that MEED needed to be far better understood by medical professionals in acute settings such as Emergency Departments and Paediatrics to avoid a situation where the impact of ARFID and the medical risk it posed was not understood until it was too late.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure to establish effective cross-sector strategies for identifying and managing ARFID
Wider context from the report “2. Evidence before the Inquest was that in addition to there being increased awareness amongst professionals there needed to be strategies within and across Health, Education and Social care to ensure effective strategies were put in place and those with ARFID or at risk of developing ARFID were identified and managed effectively .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of understanding of ARFID-related medical risk in acute medical settings
Wider context from the report “7. ARFID, the Inquest was told, could lead to medical emergencies in eating disorders (MEED). The evidence given at the Inquest was that whilst this concept had been the subject of guidance amongst Psychiatrists it had been less publicised and there had been far less guidance by other Royal Colleges. In particular the Inquest was told that MEED needed to be far better understood by medical professionals in acute settings such as Emergency Departments and Paediatrics to avoid a situation where the impact of ARFID and the medical risk it posed was not understood until it was too late .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of professional awareness of ARFID and how to approach it
Wider context from the report “1. The inquest heard evidence that Avoidant Restrictive Food Intake Disorder (ARFID) was not widely understood by those involved with children and adults who may be impacted by it . That included a lack of awareness of what it was and how to approach it amongst Health, Education and Social Work professionals . The inquest was told that until awareness of it improved then similar situations to that of Alfie could go unrecognised with similar consequences.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure to consider the health impact of poor and restricted eating in children with autism
Wider context from the report “3. A feature of the evidence before the Inquest was a normalisation of poor and restricted eating by children with autism . This meant that the impact on their overall health and wellbeing was not considered . Children with autism were measured against each other in relation to their eating with phrases such as “we have children with poorer diets …” being used.
” Open source report
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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 Refer the report to NICE’s surveillance team for consideration of ARFID inclusion in future eating-disorders guideline surveillance.
Verbatim wording from the response “We will refer this report to our surveillance team so that the inclusion of ARFID can be considered when our eating disorders guideline is next reviewed, or when the literature on ARFID has matured sufficiently to allow the development of reliable, evidence-based guidance. The NICE guideline surveillance team monitors and reviews new evidence to determine whether guidelines should be updated. An exceptional surveillance review is undertaken when we are alerted to new, significant evidence relevant to the topic.” Source location Response from National Institute for Health and Care Excellence
Open published response
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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 Insufficient evidence means NICE cannot yet develop reliable, valuable guidance on ARFID and medical emergencies in eating disorders.
Verbatim wording from the response “Our conclusion is that NICE is not best placed to develop guidance in this area. ARFID was explicitly excluded from the scope of our eating disorders guideline NG69 for the reason that it is a relatively new diagnostic category and one for which there is as yet little in the way of evidence on which to make recommendations. A recent literature review of the subject from University College London and the Maudsley Centre for Child and Adolescent Eating Disorders concluded that whilst ARFID is a common and impactful problem among young people with autism, it is currently under-researched.” Source location Response from National Institute for Health and Care Excellence
Open published response
21 Dec 2023 Carrianne Franks · Prevention of Future Deaths report Nottinghamshire
View report summary
Concerns raised 5 Failure of clinical and public health guidelines to identify healthcare professionals as a group at heightened risk of TB exposure View source Overly restrictive definition of close contact for notifying NHS staff of TB exposure risk View source Failure to broaden warn-and-inform parameters for highly transmissible TB cases and all staff exposed on the unit View source Exclusion of agency workers and seconded nurses from occupational-health contact tracing or warn-and-inform letters View source Insufficient education of NHS staff about TB symptoms and disclosure of possible exposure to assessing clinicians View source See 2 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Carrianne Franks · 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
Carrianne Franks, a Royal Air Force nurse working on placement at an NHS hospital, was exposed to smear-positive tuberculosis in November 2020 and died from tuberculosis on 27 August 2021. She was not classed as a close contact and was not informed of the exposure, which delayed diagnosis and treatment. The principal concerns were that healthcare professionals may not be recognised as a heightened-risk group, contact-tracing thresholds may be too restrictive, and staff education and notification arrangements may be insufficient, particularly for agency and seconded workers.
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× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure of clinical and public health guidelines to identify healthcare professionals as a group at heightened risk of TB exposure
Wider context from the report “1. I am concerned that the current clinical and public health guidelines do not identify Healthcare professionals as a group at heightened risk of TB exposure .
2. I am concerned that the current definition of ‘close contact’, thus triggering a contact trace or warn and inform letter, sets the bar too high for notifying NHS staff of the risk of exposure to TB.
3. I am concerned that there are insufficient education measures in place to inform NHS staff of the TB symptoms to looks out for, and the need to inform any assessing clinician of their possible exposure to the condition in order to facilitate early diagnostic testing.
Carrianne was exposed to a very aggressive form of TB from what seemed to be a rather transient exposure to the index patient during her occupation as a Nurse. Of course, not each and every contact with a patient will be logged within the medical records, especially in relation to an ambulatory patient such as the index patient in this case, and so it is possible that Carrianne had greater exposure to the patient while on the ward than interrogation of the medical records would suggest. But at its height, she had only been at work on the unit at the same time as the index patient over 23 and 24 November.
The index patient was cared for in a side room with infection prevention measures in place but Carrianne may well have been unaware that the infectious disease in question was TB as she was not the “named nurse” for this patient and lots of patients had increased infection prevention measures in place during the pandemic. Indeed, Carrianne had denied any known TB exposure when asked by doctors during her respiratory illness.
Carrianne’s case highlights the increased transmissibility of smear positive TB in the context of limited exposure to the index patient. I heard evidence from an expert who told me of cases of medical professionals contracting the condition despite no known direct contact with the patient but having spent time in a corridor containing an air vent leading from the infected patient’s room.
The warn and inform parameters did not alter (as in broaden) to reflect the fact that the index case was smear positive and highly transmissible, and the patient was known to be ambulatory on the ward. I cannot see a good reason for restricting the warn and inform letter process, rather than applying the same broadly to all staff who worked on the unit at the relevant time.
Carrianne’s case highlights the importance of warning all staff of TB cases on their wards, so that if they do become symptomatic in the coming months, and it may be many months later, they will be equipped with the necessary information to share with their treating clinicians.
I heard evidence that the NHS hospital’s Occupational Health team will issue contact tracing or warn and inform letters to staff, but this may not include Agency workers, and, in this case, Nurses seconded from the RAF. This is a missed opportunity to ensure that the relevant OH team or GP is aware of the potential exposure to add to the clinical picture should the patient develop atypical respiratory symptoms.
I understand that your agency has input into the UK’s TB Action Plan, and I hope that the above concerns can be considered in your drive to reduce the incidence of TB nationally, but also specifically with regard to healthcare professionals to ensure they are given the greatest possible protection from TB related harm and death.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Overly restrictive definition of close contact for notifying NHS staff of TB exposure risk
Wider context from the report “1. I am concerned that the current clinical and public health guidelines do not identify Healthcare professionals as a group at heightened risk of TB exposure.
2. I am concerned that the current definition of ‘close contact’, thus triggering a contact trace or warn and inform letter, sets the bar too high for notifying NHS staff of the risk of exposure to TB .
3. I am concerned that there are insufficient education measures in place to inform NHS staff of the TB symptoms to looks out for, and the need to inform any assessing clinician of their possible exposure to the condition in order to facilitate early diagnostic testing.
Carrianne was exposed to a very aggressive form of TB from what seemed to be a rather transient exposure to the index patient during her occupation as a Nurse. Of course, not each and every contact with a patient will be logged within the medical records, especially in relation to an ambulatory patient such as the index patient in this case, and so it is possible that Carrianne had greater exposure to the patient while on the ward than interrogation of the medical records would suggest. But at its height, she had only been at work on the unit at the same time as the index patient over 23 and 24 November.
The index patient was cared for in a side room with infection prevention measures in place but Carrianne may well have been unaware that the infectious disease in question was TB as she was not the “named nurse” for this patient and lots of patients had increased infection prevention measures in place during the pandemic. Indeed, Carrianne had denied any known TB exposure when asked by doctors during her respiratory illness.
Carrianne’s case highlights the increased transmissibility of smear positive TB in the context of limited exposure to the index patient. I heard evidence from an expert who told me of cases of medical professionals contracting the condition despite no known direct contact with the patient but having spent time in a corridor containing an air vent leading from the infected patient’s room.
The warn and inform parameters did not alter (as in broaden) to reflect the fact that the index case was smear positive and highly transmissible, and the patient was known to be ambulatory on the ward. I cannot see a good reason for restricting the warn and inform letter process, rather than applying the same broadly to all staff who worked on the unit at the relevant time.
Carrianne’s case highlights the importance of warning all staff of TB cases on their wards, so that if they do become symptomatic in the coming months, and it may be many months later, they will be equipped with the necessary information to share with their treating clinicians.
I heard evidence that the NHS hospital’s Occupational Health team will issue contact tracing or warn and inform letters to staff, but this may not include Agency workers, and, in this case, Nurses seconded from the RAF. This is a missed opportunity to ensure that the relevant OH team or GP is aware of the potential exposure to add to the clinical picture should the patient develop atypical respiratory symptoms.
I understand that your agency has input into the UK’s TB Action Plan, and I hope that the above concerns can be considered in your drive to reduce the incidence of TB nationally, but also specifically with regard to healthcare professionals to ensure they are given the greatest possible protection from TB related harm and death.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure to broaden warn-and-inform parameters for highly transmissible TB cases and all staff exposed on the unit
Wider context from the report “1. I am concerned that the current clinical and public health guidelines do not identify Healthcare professionals as a group at heightened risk of TB exposure.
2. I am concerned that the current definition of ‘close contact’, thus triggering a contact trace or warn and inform letter, sets the bar too high for notifying NHS staff of the risk of exposure to TB.
3. I am concerned that there are insufficient education measures in place to inform NHS staff of the TB symptoms to looks out for, and the need to inform any assessing clinician of their possible exposure to the condition in order to facilitate early diagnostic testing.
Carrianne was exposed to a very aggressive form of TB from what seemed to be a rather transient exposure to the index patient during her occupation as a Nurse. Of course, not each and every contact with a patient will be logged within the medical records, especially in relation to an ambulatory patient such as the index patient in this case, and so it is possible that Carrianne had greater exposure to the patient while on the ward than interrogation of the medical records would suggest. But at its height, she had only been at work on the unit at the same time as the index patient over 23 and 24 November.
The index patient was cared for in a side room with infection prevention measures in place but Carrianne may well have been unaware that the infectious disease in question was TB as she was not the “named nurse” for this patient and lots of patients had increased infection prevention measures in place during the pandemic. Indeed, Carrianne had denied any known TB exposure when asked by doctors during her respiratory illness.
Carrianne’s case highlights the increased transmissibility of smear positive TB in the context of limited exposure to the index patient. I heard evidence from an expert who told me of cases of medical professionals contracting the condition despite no known direct contact with the patient but having spent time in a corridor containing an air vent leading from the infected patient’s room.
The warn and inform parameters did not alter (as in broaden) to reflect the fact that the index case was smear positive and highly transmissible, and the patient was known to be ambulatory on the ward. I cannot see a good reason for restricting the warn and inform letter process , rather than applying the same broadly to all staff who worked on the unit at the relevant time .
Carrianne’s case highlights the importance of warning all staff of TB cases on their wards, so that if they do become symptomatic in the coming months, and it may be many months later, they will be equipped with the necessary information to share with their treating clinicians.
I heard evidence that the NHS hospital’s Occupational Health team will issue contact tracing or warn and inform letters to staff, but this may not include Agency workers, and, in this case, Nurses seconded from the RAF. This is a missed opportunity to ensure that the relevant OH team or GP is aware of the potential exposure to add to the clinical picture should the patient develop atypical respiratory symptoms.
I understand that your agency has input into the UK’s TB Action Plan, and I hope that the above concerns can be considered in your drive to reduce the incidence of TB nationally, but also specifically with regard to healthcare professionals to ensure they are given the greatest possible protection from TB related harm and death.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Exclusion of agency workers and seconded nurses from occupational-health contact tracing or warn-and-inform letters
Wider context from the report “1. I am concerned that the current clinical and public health guidelines do not identify Healthcare professionals as a group at heightened risk of TB exposure.
2. I am concerned that the current definition of ‘close contact’, thus triggering a contact trace or warn and inform letter, sets the bar too high for notifying NHS staff of the risk of exposure to TB.
3. I am concerned that there are insufficient education measures in place to inform NHS staff of the TB symptoms to looks out for, and the need to inform any assessing clinician of their possible exposure to the condition in order to facilitate early diagnostic testing.
Carrianne was exposed to a very aggressive form of TB from what seemed to be a rather transient exposure to the index patient during her occupation as a Nurse. Of course, not each and every contact with a patient will be logged within the medical records, especially in relation to an ambulatory patient such as the index patient in this case, and so it is possible that Carrianne had greater exposure to the patient while on the ward than interrogation of the medical records would suggest. But at its height, she had only been at work on the unit at the same time as the index patient over 23 and 24 November.
The index patient was cared for in a side room with infection prevention measures in place but Carrianne may well have been unaware that the infectious disease in question was TB as she was not the “named nurse” for this patient and lots of patients had increased infection prevention measures in place during the pandemic. Indeed, Carrianne had denied any known TB exposure when asked by doctors during her respiratory illness.
Carrianne’s case highlights the increased transmissibility of smear positive TB in the context of limited exposure to the index patient. I heard evidence from an expert who told me of cases of medical professionals contracting the condition despite no known direct contact with the patient but having spent time in a corridor containing an air vent leading from the infected patient’s room.
The warn and inform parameters did not alter (as in broaden) to reflect the fact that the index case was smear positive and highly transmissible, and the patient was known to be ambulatory on the ward. I cannot see a good reason for restricting the warn and inform letter process, rather than applying the same broadly to all staff who worked on the unit at the relevant time.
Carrianne’s case highlights the importance of warning all staff of TB cases on their wards, so that if they do become symptomatic in the coming months, and it may be many months later, they will be equipped with the necessary information to share with their treating clinicians.
I heard evidence that the NHS hospital’s Occupational Health team will issue contact tracing or warn and inform letters to staff, but this may not include Agency workers, and, in this case, Nurses seconded from the RAF . This is a missed opportunity to ensure that the relevant OH team or GP is aware of the potential exposure to add to the clinical picture should the patient develop atypical respiratory symptoms.
I understand that your agency has input into the UK’s TB Action Plan, and I hope that the above concerns can be considered in your drive to reduce the incidence of TB nationally, but also specifically with regard to healthcare professionals to ensure they are given the greatest possible protection from TB related harm and death.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Insufficient education of NHS staff about TB symptoms and disclosure of possible exposure to assessing clinicians
Wider context from the report “1. I am concerned that the current clinical and public health guidelines do not identify Healthcare professionals as a group at heightened risk of TB exposure.
2. I am concerned that the current definition of ‘close contact’, thus triggering a contact trace or warn and inform letter, sets the bar too high for notifying NHS staff of the risk of exposure to TB.
3. I am concerned that there are insufficient education measures in place to inform NHS staff of the TB symptoms to looks out for, and the need to inform any assessing clinician of their possible exposure to the condition in order to facilitate early diagnostic testing .
Carrianne was exposed to a very aggressive form of TB from what seemed to be a rather transient exposure to the index patient during her occupation as a Nurse. Of course, not each and every contact with a patient will be logged within the medical records, especially in relation to an ambulatory patient such as the index patient in this case, and so it is possible that Carrianne had greater exposure to the patient while on the ward than interrogation of the medical records would suggest. But at its height, she had only been at work on the unit at the same time as the index patient over 23 and 24 November.
The index patient was cared for in a side room with infection prevention measures in place but Carrianne may well have been unaware that the infectious disease in question was TB as she was not the “named nurse” for this patient and lots of patients had increased infection prevention measures in place during the pandemic. Indeed, Carrianne had denied any known TB exposure when asked by doctors during her respiratory illness.
Carrianne’s case highlights the increased transmissibility of smear positive TB in the context of limited exposure to the index patient. I heard evidence from an expert who told me of cases of medical professionals contracting the condition despite no known direct contact with the patient but having spent time in a corridor containing an air vent leading from the infected patient’s room.
The warn and inform parameters did not alter (as in broaden) to reflect the fact that the index case was smear positive and highly transmissible, and the patient was known to be ambulatory on the ward. I cannot see a good reason for restricting the warn and inform letter process, rather than applying the same broadly to all staff who worked on the unit at the relevant time.
Carrianne’s case highlights the importance of warning all staff of TB cases on their wards, so that if they do become symptomatic in the coming months, and it may be many months later, they will be equipped with the necessary information to share with their treating clinicians.
I heard evidence that the NHS hospital’s Occupational Health team will issue contact tracing or warn and inform letters to staff, but this may not include Agency workers, and, in this case, Nurses seconded from the RAF. This is a missed opportunity to ensure that the relevant OH team or GP is aware of the potential exposure to add to the clinical picture should the patient develop atypical respiratory symptoms.
I understand that your agency has input into the UK’s TB Action Plan, and I hope that the above concerns can be considered in your drive to reduce the incidence of TB nationally, but also specifically with regard to healthcare professionals to ensure they are given the greatest possible protection from TB related harm and death.
” 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 Share the report with the guideline surveillance team to assess new evidence on tuberculosis contact tracing.
Verbatim wording from the response “Your report has been shared with our guideline surveillance team to see if there is new evidence relating to contact tracing for TB. We also plan to meet with colleagues from the UK Health Security Agency to further consider your report and how we can jointly address the concerns raised.” Source location Response from National Institute for Health and Care Excellence
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 Insufficient evidence prevents defining close contacts objectively or recommending factors such as unventilated room exposure duration for TB contact tracing.
Verbatim wording from the response “When developing the guideline, the committee felt that the studies they considered did not give a clear definition of close contacts and it was therefore difficult to give guidance on whom to trace.” Source location Response from National Institute for Health and Care Excellence
Open published response
18 Dec 2023 Nuel-Junior DZERNJO · Prevention of Future Deaths report Suffolk
View report summary
Concerns raised 1 Lack of clear guidance on the appropriate route of Acyclovir treatment View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Nuel-Junior DZERNJO · 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
Nuel-Junior Dzernjo, who was receiving high-dose steroids and was immunosuppressed, developed chicken pox and deteriorated after being assessed at hospital on 21 February 2023. He was discharged despite ongoing abnormal observations, inability to mobilise and confusion, then deteriorated at home and died after collapsing the following day. The investigation identified unclear guidance on treatment, including whether intravenous rather than oral Acyclovir was indicated.
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. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of clear guidance on the appropriate route of Acyclovir treatment
Wider context from the report “During the course of my investigation into the death of Nuel-Junior I instructed an independent paediatric expert to review his management and opine on causation. During the course of hearing the evidence from the expert and all of the treating clinicians it became clear that there was some potentially relevant guidance available but it lacked clarity . Here intravenous Acyclovir, if prescribed, may have prevented Nuel-Junior's death but he was instead prescribed oral Acyclovir which was unlikely to have made a difference . Had clear guidance been available then Nuel-Junior's death may have been prevented.
” Open source report
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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 Developing guidance on chickenpox and covering every clinical circumstance falls outside NICE’s requested scope and recommendations.
Verbatim wording from the response “NICE have not published a guideline on managing chickenpox. We are not asked to develop guidance on all conditions and our recommendations do not cover all clinical circumstances.” Source location Response from National Institure for Health and Care Excellence
Open published response
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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 existing Clinical Knowledge Summary recommendation is considered clear about seeking specialist advice and determining intravenous aciclovir admission.
Verbatim wording from the response “There is a Clinical Knowledge Summary (CKS) published on our website on chickenpox, including a section on the management of chickenpox in people who are immunocompromised. The CKS are developed by an external company called Agilio Software and are designed to summarise the evidence on the treatment of specific health conditions. They use a variety of sources and may include NICE guidance, if there is any that is relevant, but they use many other sources too. We publish them on our website as a source of advice and information for health professionals working in primary care, but they do not constitute NICE guidance.” Source location Response from National Institure for Health and Care Excellence
Open published response
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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 Agilio Software is responsible for providing further clarification about the Clinical Knowledge Summary topic’s content.
Verbatim wording from the response “As part of this process, we have shared this report with Agilio Software for their awareness, however, if further clarification is required on the content of the CKS topic, Agilio software can be contacted directly.” Source location Response from National Institure for Health and Care Excellence
Open published response
Concerns raised 3 Inadequate staff training and assessment of chest or abdomen pain complaints View source Failure to pass accurate and complete information from reception staff to clinicians handling duty calls View source NICE guidance not reflecting the use of LMWH with non-TED-stocking VTE prevention products View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
David John Lewsey · 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
David John Lewsey, aged 68, developed a pulmonary embolus following a left knee replacement and died after collapsing at home on 15 December 2022. Concerns included that severe side pain reported to reception staff was not passed to the advanced nurse practitioner, and that the pain’s location was not explored further. The report also raised whether staff training should better address chest or abdominal pain in recently immobilised post-operative patients.
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. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Inadequate staff training and assessment of chest or abdomen pain complaints
Wider context from the report “- Evidence was heard at inquest that if the concern of a terrible pain in his side, reported in Mr Lewsy’s first telephone call to reception staff, had been passed on to the ANP, the initial discussion between Mr Lewsey and the ANP may have started down a different path. It was recognised that the doctors and nurses dealing with duty calls work under pressure, and it was felt that ensuring accurate and complete information was passed to them may reduce that pressure and facilitate the provision of a better service to patients.
- The inquest also heard that reception staff had some training to raise a red flag if pain in the ‘chest’ was reported to them . Mr Lewsey said he had pain in his ‘side’ but the precise location of that pain was not explored further . While it was said in evidence that, typically, a PE will present with pleuritic or chest pain, it was noted that NICE guidance includes abdomen pain. You may wish to reflect on whether additional training is required for all staff on how to manage complaints of pain in the chest or abdomen particularly in patients who have recently undergone procedures that may have left them relatively immobile and at an increased risk of developing a DVT .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure to pass accurate and complete information from reception staff to clinicians handling duty calls
Wider context from the report “- Evidence was heard at inquest that if the concern of a terrible pain in his side, reported in Mr Lewsy’s first telephone call to reception staff, had been passed on to the ANP, the initial discussion between Mr Lewsey and the ANP may have started down a different path. It was recognised that the doctors and nurses dealing with duty calls work under pressure, and it was felt that ensuring accurate and complete information was passed to them may reduce that pressure and facilitate the provision of a better service to patients.
- The inquest also heard that reception staff had some training to raise a red flag if pain in the ‘chest’ was reported to them. Mr Lewsey said he had pain in his ‘side’ but the precise location of that pain was not explored further. While it was said in evidence that, typically, a PE will present with pleuritic or chest pain, it was noted that NICE guidance includes abdomen pain. You may wish to reflect on whether additional training is required for all staff on how to manage complaints of pain in the chest or abdomen particularly in patients who have recently undergone procedures that may have left them relatively immobile and at an increased risk of developing a DVT.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation NICE guidance not reflecting the use of LMWH with non-TED-stocking VTE prevention products
Wider context from the report “The relevant NICE guidance may need to be updated to reflect the use of LMWH with products that assist with VTE prevention other than TED stockings.
” 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 Share the coroner’s report with the guideline surveillance team for consideration during future guideline review.
Verbatim wording from the response “Your report has been shared with our guideline surveillance team for further consideration when the guideline is reviewed.” Source location Response from National Institute for Health and Care Excellence
Open published response
14 Nov 2023 Maxwell Frame · Prevention of Future Deaths report West Yorkshire (Western)
View report summary
Concerns raised 1 Absence of a national policy on the placement of central venous catheters View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Maxwell Frame · 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
Maxwell Frame presented with sepsis caused by a pelvic abscess and bowel obstruction and underwent emergency surgery. A central venous catheter was incorrectly inserted into an artery and was later removed; clot dislodged during removal, causing strokes, after which he received palliative care and died. The report identified concern about the absence of a single national policy for central venous catheter placement.
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. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Absence of a national policy on the placement of central venous catheters
Wider context from the report “Absence of a national policy on the placement of CVC’s
Over the course of the inquest hearing, oral evidence was provided by several anaesthetic/ ICU doctors ranging from experienced consultants, specialty Dr’s and a Core Trainee 2 all of whom had experience to varying degrees of placing CVC’s. These Dr’s had worked in several hospitals predominantly across the Midlands and North of England. The Trust had a policy entitled Central Venous Access Device which identified the steps that I have identified earlier should have taken place but were not. I was advised by the Dr’s who gave evidence that there was no single standard policy that they had encountered nationally for the placement of CVC’s . The Trust in this case following their internal investigation of Mr Frame’s case had felt it necessary to revise their policy. Further, I was advised by some of the Dr’s who gave evidence that they felt a national policy regarding the placement of CVC’s would be beneficial.
” Open source report
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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 guidance recommending ultrasound locating devices for central venous catheter placement.
Verbatim wording from the response “NICE published guidance recommending the use of ultrasound locating devices for placing central venous catheters [TA49] in 2002. This guidance did not make any recommendation for placement of CVCs into the subclavian vein as there was a lack of specific evidence for subclavian placement at the time of publication. Since this guidance was published, ultrasound use for placement of central lines has become applicable to all sites.” Source location Response from National Institute for Health and Care Excellence
Open published response
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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 Further NICE guidance on central venous catheter placement is not considered necessary because existing national recommendations and standard requirements are sufficient.
Verbatim wording from the response “I was saddened to read of the circumstances surrounding Maxwell’s death. However, on this occasion I do not consider that further NICE guidance in this area would add to existing national recommendations from relevant professional bodies and standard requirements, prevent the failure to use ultrasound or to undertake recommended checks in line placement.” Source location Response from National Institute for Health and Care Excellence
Open published response
Concerns raised 2 Failure to ensure relevant NICE guidance reaches applicable organisations View source Lack of clarity about VTE risk-assessment responsibilities at hospital-to-community discharge View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
ANDREW ETLERED NICHOLS · 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
Andrew Nichols developed acute disseminated encephalomyelitis after vaccination and spent over a year receiving hospital and neuro-rehabilitation care. His anticoagulation medication was not continued when he was discharged to community care, and he subsequently died from deep vein thrombosis and pulmonary embolism. The principal concerns were unclear responsibility for venous thromboembolism risk assessments between hospitals and community organisations, and inadequate pathways for organisations to identify relevant NICE guidance.
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× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure to ensure relevant NICE guidance reaches applicable organisations
Wider context from the report “2) Having heard evidence at the inquest, it was unclear what pathways exist to ensure that organisations come to know of relevant NICE guidance that does, or may, apply to them.
Taking a neurorehabilitation community care centre as an example, some NICE guidance will be completely irrelevant to their practice and need not be considered at all (e.g. NG229 – fetal monitoring in labour), some will be of direct relevance and will require careful consideration (e.g., NG211 – Rehabilitation after traumatic injury), and many others might contain relevant and useful information. Most organisations will have professionals employed in positions (such as Medical Directors or Directors of Safety and Learning) where they (as part of their specific employment responsibilities and through undertaking relevant CPD) will often come to know of relevant guidance and will disseminate accordingly, however this may not always be the case or work as one would hope, particularly perhaps in smaller community-based organisations. Consideration could be given to how NICE shares guidance documents and other relevant information with relevant organisations and whether there exists a sufficient chain of accountability in respect of this.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of clarity about VTE risk-assessment responsibilities at hospital-to-community discharge
Wider context from the report “1) There seems to be a lack of clarity amongst health and care professionals (certainly those who gave evidence at this inquest) as to whether community organisations receiving patients following discharge from hospital (such as neurorehabilitation centres and care homes) should, as a routine part of their responsibilities, be performing VTE risk assessments.
I was referred to NICE Guidance 89 (Venous thromboembolism in Over 16s: reducing the risk of hospital-acquired deep vein thrombosis or pulmonary embolism – published March 2018, updated August 2019), which deals with VTE assessment and procedure for hospital patients, but there is no reference in this guidance to assessments in the community. There is reference in the guidance to patients about to be discharged (paragraph 1.2), but this appears to cover the practicalities of situations where a firm decision has already been made by hospital clinicians that anticoagulation will continue.
I am concerned that hospital clinicians may not be routinely performing VTE assessments as part of discharge planning, on the basis that they believe such assessment will occur in the community placement. However, it is unclear whether (and, based on evidence heard at the inquest, unlikely that) many community organisations are performing such assessments, and instead most will be relying on hospitals to do this.
I am concerned that, as a result, as happened to Andrew, some patients will not have their VTE risk considered when they move from being an in-patient to residing in a community setting. Consideration could be given to making the NICE guidance (NG 89) clearer in respect of the respective responsibilities placed on hospital and community organisations, when a patient is to be discharged from one to the other. Consideration could also be given to the desirability of separate guidance covering VTE risk assessment in community settings, and the potential importance of this to certain groups of patients, particularly those who are immobile and requiring long-term community care.
” Open source report
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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 Reflect on the report and incorporate lessons into NICE’s approach to disseminating future guidance.
Verbatim wording from the response “Regarding your suggestion that consideration could be given to how NICE shares guidance documents and local accountability for keeping up to date with new guidance, I have asked our external communications team to reflect on the issues raised by the report, to incorporate any lessons into NICE’s approach to future guidance dissemination.” Source location Response from National Institute for Health and Care Excellence
Open published response
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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 Review the guideline for updates covering continuation of VTE prophylaxis and anticoagulation after discharge to community settings.
Verbatim wording from the response “To address this we propose to review the guideline to see if it can be updated to cover the issue of continuing VTE prophylaxis on discharge so that inpatient anticoagulation prescriptions for VTE prophylaxis are converted to ongoing anticoagulation where required, ensuring that the intention cannot be misinterpreted.” Source location Response from National Institute for Health and Care Excellence
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 Consider providing implementation support on VTE risk assessments and discharge planning, focusing on anticoagulation.
Verbatim wording from the response “To further support the implementation of this guideline NICE’s implementation support team will consider the delivery of support on VTE risk assessments and discharge planning with a specific focus on anticoagulation.” Source location Response from National Institute for Health and Care Excellence
Open published response
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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 Local commissioners and providers are responsible for reviewing new NICE guidance and considering its relevance within their settings.
Verbatim wording from the response “Regarding your suggestion that consideration could be given to how NICE shares guidance documents and local accountability for keeping up to date with new guidance, I have asked our external communications team to reflect on the issues raised by the report, to incorporate any lessons into NICE’s approach to future guidance dissemination.” Source location Response from National Institute for Health and Care Excellence
Open published response
16 Sep 2023 Sienna Scarlett Monterio · Prevention of Future Deaths report Blackpool and the Fylde
View report summary
Concerns raised 2 Failure to make haemoglobin analysis available in neonatal resuscitation cord blood gas testing View source Lack of national regulation and Newborn Life Support process inclusion for cord blood testing View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Sienna Scarlett Monterio · 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
Sienna Scarlett Monterio was born by emergency caesarean section on 6 April 2022 and died later that morning following a severe fetal-maternal haemorrhage. The report raises concern that blood gas analysers may not be configured to measure haemoglobin in neonatal resuscitation settings, with variation between trusts potentially limiting information available to clinicians; it states this issue did not contribute to Sienna’s death.
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. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure to make haemoglobin analysis available in neonatal resuscitation cord blood gas testing
Wider context from the report “Having reviewed the circumstances surrounding Sienna’s death, the Healthcare Safety Investigation Branch [HSIB] found that at the time of birth the blood gas analyser was not set to analyse the haemoglobin .
The HSIB very clearly state that in the absence of this data , this “prevented other possible causes for the Baby’s condition being considered and possibly corrected.”
The HSIB has also recommended this facility is available in all neonatal resuscitation settings to support the provision of clinical information, and to optimise decision making processes and clinical care.
Sienna was born following an urgent caesarean section, and died within two hours of delivery. Those who work in this area inevitably have to make urgent, life-saving decisions and in the most challenging of circumstances, and it seems to me that there is a lack of clarity on this issue which needs to be addressed. In the absence of such clarity, a baby may die from a preventable cause which is not appreciated by clinicians in the absence of data which would have highlighted a low haemoglobin level in the blood cord gas .
It appears that in some trusts, this data will be readily available, but not in others. If ████████ comment above is correct, there may be different practices within the one trust.
The court has been told that cord blood testing is not regulated or included in the Newborn Life Support (NLS) process at a national level. It appears as though the hospital trust in Blackpool is considering this issue appropriately, and this may reflect the picture nationally.
The HSIB states this data may assist in identifying other possible causes for a baby’s condition being considered, and possibly corrected. ████████ expresses the view that he sees no potential disadvantage in having the Hb measurement being readily available in the cord blood gas from a clinical perspective. I have therefore concluded that there is risk of future deaths and that I therefore have a duty to write this report.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of national regulation and Newborn Life Support process inclusion for cord blood testing
Wider context from the report “Having reviewed the circumstances surrounding Sienna’s death, the Healthcare Safety Investigation Branch [HSIB] found that at the time of birth the blood gas analyser was not set to analyse the haemoglobin.
The HSIB very clearly state that in the absence of this data, this “prevented other possible causes for the Baby’s condition being considered and possibly corrected.”
The HSIB has also recommended this facility is available in all neonatal resuscitation settings to support the provision of clinical information, and to optimise decision making processes and clinical care.
Sienna was born following an urgent caesarean section, and died within two hours of delivery. Those who work in this area inevitably have to make urgent, life-saving decisions and in the most challenging of circumstances, and it seems to me that there is a lack of clarity on this issue which needs to be addressed . In the absence of such clarity, a baby may die from a preventable cause which is not appreciated by clinicians in the absence of data which would have highlighted a low haemoglobin level in the blood cord gas.
It appears that in some trusts, this data will be readily available, but not in others . If ████████ comment above is correct, there may be different practices within the one trust .
The court has been told that cord blood testing is not regulated or included in the Newborn Life Support (NLS) process at a national level . It appears as though the hospital trust in Blackpool is considering this issue appropriately, and this may reflect the picture nationally.
The HSIB states this data may assist in identifying other possible causes for a baby’s condition being considered, and possibly corrected. ████████ expresses the view that he sees no potential disadvantage in having the Hb measurement being readily available in the cord blood gas from a clinical perspective. I have therefore concluded that there is risk of future deaths and that I therefore have a duty to write this report.
” Open source report
Concerns raised 10 Failure to ensure appropriate timing and mode of delivery in high-risk pregnancies View source Unavailability of full Badgernet portal access View source Insufficient quality assurance of Badgernet entries View source Lack of clarity in interpreting Montgomery guidance and offering professional opinions on competing risks View source Insufficient technical knowledge and training for junior doctors and locums to identify serious risk factors View source Failure to ensure holistic review of relevant findings when planning timing and mode of birth View source Failure to test staff assimilation of maternity risk knowledge View source Unavailability of an implemented procedure for escalating inconclusive ultrasound measurements in high-risk pregnancies View source Failure to provide counselling supporting fully informed mode-of-delivery decisions where there is risk of shoulder dystocia View source Failure to follow existing maternity policies View source See 7 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Eclipse Morrison · 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
Eclipse Morrison died at Nottingham City Hospital on 21 July 2021, the day after her birth, following perinatal asphyxia and complications associated with gestational diabetes, excessive fetal growth and shoulder dystocia. The principal concerns included failures to follow up missed appointments, consider and discuss appropriate timing and mode of delivery, identify risk factors during labour, and ensure adequate fetal monitoring. Further concerns related to the implementation and quality assurance of Badgernet, escalation procedures for ultrasound concerns, counselling about shoulder dystocia, and interpretation of Montgomery guidance.
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. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure to ensure appropriate timing and mode of delivery in high-risk pregnancies
Wider context from the report “1. Risk analysis / mode and timing of birth
A significant factor was the failure to consider an elective Caesarean Section (CS). It is not clear why on this history and consideration of mode of delivery did not include a consideration of an elective CS at any stage, by any of the doctors involved.
Evidence was given that existing policies in place at GEH were not followed and the reason for this failure has not been identified.
Whilst Badgernet could be a useful tool, the evidence suggested that it is being regarded as a first line of defence rather than a failsafe. I am told that the Badgernet maternity system implemented in October 2021 will resolve the problems relating to mode and timing of birth, in that the system will require a consultant to approve a decision for CS/induction of labour (IOL) and that IOL’s will not be approved by the labour coordinator unless the paper booking has been approved on paper. However, on the evidence received it is not clear how this will assist if the risk factors and the need to consider IOL/elective CS have not been identified, by junior staff, thus triggering the need for escalation to/approval by a consultant.
I am not clear what has been done to ensure that junior doctors and locums have sufficient technical knowledge to ensure that they are able to identify serious risk factors and alert the consultant to these, so that the consultant may consider the appropriate mode of delivery. No information was provided as to the availability of regular face to face training for all grades concerning high-risk pregnancies not just for career trainees and foundation doctors.
I am told that a memo was sent to all junior doctors reminding them that any plan for either IOL or elective CS must be approved by a consultant and that an induction pack containing that information is provided to new starters and locums.
I have seen the Women’s and Children Clinical Education Guideline introduced in November 2022. I am told that the information was placed in a prominent position on notice boards, staff rooms and in blogs.
It is not clear how the assimilation of this knowledge is tested. It was suggested that this may be in appraisal, but this seems only likely to identify problems after they arise. In any event it seems these methods of dissemination of information and the appraisal system were in place at the time of Eclipse’s birth but did not ensure that the doctors involved in her mother’s care appreciated the impact of the risk factors in this pregnancy.
It was not explained how Badgernet or any policy or procedure in place, would ensure that there is a holistic review (including ultrasound scan findings) when planning for timing and mode of birth.
The concern remains that there will be further failure to ensure that appropriate timing and mode of delivery will be provided in high-risk pregnancies.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Unavailability of full Badgernet portal access
Wider context from the report “2. Access to Badgernet portal / full implementation of the Badgernet software
It seems that the Badgernet system is being relied on to address a number of issues which were identified in this case, and heavy reliance is being placed on a system which is not yet fully implemented . The concern remains that a critical aspect of this system, access to the portal, will not be in place until autumn 2023 at the earliest .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Insufficient quality assurance of Badgernet entries
Wider context from the report “3. Quality Assessment
I am informed that Badgernet can easily identify fields which have not been completed and will prevent a record being closed until the field is completed, but it cannot identify the quality of any such entries . I am told that the quality checks are made on ten sets of notes per month out of an estimated 3,000 records that will be open at any one time. The concern remains that there is insufficient quality assurance in this system.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of clarity in interpreting Montgomery guidance and offering professional opinions on competing risks
Wider context from the report “6. Interpretation of Montgomery
Ante-natal care is unique in that decisions have to be made for the benefit of two patients (the mother and the baby) and the treatment options for each may, as in this case have competing risks and benefits. In addition, in ante-natal care, the circumstances may change and action may need to be taken very quickly.
On the basis of evidence given at the inquest, there seems to be a lack of clarity as to the way in which Montgomery guidance are interpreted. It was acknowledged in evidence that parents often want a steer as to the best/safest course of action and that may require medical professionals to express opinions as to the weight to be placed on different risk factors. In some cases, parents may prefer to rely on the viewpoint of an experienced medical professional. It seems that medical professionals do not feel they can offer this assistance as it might be interpreted as trying to impose their opinion on the parent. The way in which Montgomery is interpreted and the extent to which medical professionals can offer an opinion is of wider concern than just the actions of those at GEH and should be considered by those who produce the guidance and deliver training to medical professionals.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Insufficient technical knowledge and training for junior doctors and locums to identify serious risk factors
Wider context from the report “1. Risk analysis / mode and timing of birth
A significant factor was the failure to consider an elective Caesarean Section (CS). It is not clear why on this history and consideration of mode of delivery did not include a consideration of an elective CS at any stage, by any of the doctors involved.
Evidence was given that existing policies in place at GEH were not followed and the reason for this failure has not been identified.
Whilst Badgernet could be a useful tool, the evidence suggested that it is being regarded as a first line of defence rather than a failsafe. I am told that the Badgernet maternity system implemented in October 2021 will resolve the problems relating to mode and timing of birth, in that the system will require a consultant to approve a decision for CS/induction of labour (IOL) and that IOL’s will not be approved by the labour coordinator unless the paper booking has been approved on paper. However, on the evidence received it is not clear how this will assist if the risk factors and the need to consider IOL/elective CS have not been identified, by junior staff, thus triggering the need for escalation to/approval by a consultant.
I am not clear what has been done to ensure that junior doctors and locums have sufficient technical knowledge to ensure that they are able to identify serious risk factors and alert the consultant to these , so that the consultant may consider the appropriate mode of delivery. No information was provided as to the availability of regular face to face training for all grades concerning high-risk pregnancies not just for career trainees and foundation doctors.
I am told that a memo was sent to all junior doctors reminding them that any plan for either IOL or elective CS must be approved by a consultant and that an induction pack containing that information is provided to new starters and locums.
I have seen the Women’s and Children Clinical Education Guideline introduced in November 2022. I am told that the information was placed in a prominent position on notice boards, staff rooms and in blogs.
It is not clear how the assimilation of this knowledge is tested. It was suggested that this may be in appraisal, but this seems only likely to identify problems after they arise. In any event it seems these methods of dissemination of information and the appraisal system were in place at the time of Eclipse’s birth but did not ensure that the doctors involved in her mother’s care appreciated the impact of the risk factors in this pregnancy.
It was not explained how Badgernet or any policy or procedure in place, would ensure that there is a holistic review (including ultrasound scan findings) when planning for timing and mode of birth.
The concern remains that there will be further failure to ensure that appropriate timing and mode of delivery will be provided in high-risk pregnancies.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure to ensure holistic review of relevant findings when planning timing and mode of birth
Wider context from the report “1. Risk analysis / mode and timing of birth
A significant factor was the failure to consider an elective Caesarean Section (CS). It is not clear why on this history and consideration of mode of delivery did not include a consideration of an elective CS at any stage, by any of the doctors involved.
Evidence was given that existing policies in place at GEH were not followed and the reason for this failure has not been identified.
Whilst Badgernet could be a useful tool, the evidence suggested that it is being regarded as a first line of defence rather than a failsafe. I am told that the Badgernet maternity system implemented in October 2021 will resolve the problems relating to mode and timing of birth, in that the system will require a consultant to approve a decision for CS/induction of labour (IOL) and that IOL’s will not be approved by the labour coordinator unless the paper booking has been approved on paper. However, on the evidence received it is not clear how this will assist if the risk factors and the need to consider IOL/elective CS have not been identified, by junior staff, thus triggering the need for escalation to/approval by a consultant.
I am not clear what has been done to ensure that junior doctors and locums have sufficient technical knowledge to ensure that they are able to identify serious risk factors and alert the consultant to these, so that the consultant may consider the appropriate mode of delivery. No information was provided as to the availability of regular face to face training for all grades concerning high-risk pregnancies not just for career trainees and foundation doctors.
I am told that a memo was sent to all junior doctors reminding them that any plan for either IOL or elective CS must be approved by a consultant and that an induction pack containing that information is provided to new starters and locums.
I have seen the Women’s and Children Clinical Education Guideline introduced in November 2022. I am told that the information was placed in a prominent position on notice boards, staff rooms and in blogs.
It is not clear how the assimilation of this knowledge is tested. It was suggested that this may be in appraisal, but this seems only likely to identify problems after they arise. In any event it seems these methods of dissemination of information and the appraisal system were in place at the time of Eclipse’s birth but did not ensure that the doctors involved in her mother’s care appreciated the impact of the risk factors in this pregnancy.
It was not explained how Badgernet or any policy or procedure in place, would ensure that there is a holistic review (including ultrasound scan findings) when planning for timing and mode of birth.
The concern remains that there will be further failure to ensure that appropriate timing and mode of delivery will be provided in high-risk pregnancies.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure to test staff assimilation of maternity risk knowledge
Wider context from the report “1. Risk analysis / mode and timing of birth
A significant factor was the failure to consider an elective Caesarean Section (CS). It is not clear why on this history and consideration of mode of delivery did not include a consideration of an elective CS at any stage, by any of the doctors involved.
Evidence was given that existing policies in place at GEH were not followed and the reason for this failure has not been identified.
Whilst Badgernet could be a useful tool, the evidence suggested that it is being regarded as a first line of defence rather than a failsafe. I am told that the Badgernet maternity system implemented in October 2021 will resolve the problems relating to mode and timing of birth, in that the system will require a consultant to approve a decision for CS/induction of labour (IOL) and that IOL’s will not be approved by the labour coordinator unless the paper booking has been approved on paper. However, on the evidence received it is not clear how this will assist if the risk factors and the need to consider IOL/elective CS have not been identified, by junior staff, thus triggering the need for escalation to/approval by a consultant.
I am not clear what has been done to ensure that junior doctors and locums have sufficient technical knowledge to ensure that they are able to identify serious risk factors and alert the consultant to these, so that the consultant may consider the appropriate mode of delivery. No information was provided as to the availability of regular face to face training for all grades concerning high-risk pregnancies not just for career trainees and foundation doctors.
I am told that a memo was sent to all junior doctors reminding them that any plan for either IOL or elective CS must be approved by a consultant and that an induction pack containing that information is provided to new starters and locums.
I have seen the Women’s and Children Clinical Education Guideline introduced in November 2022. I am told that the information was placed in a prominent position on notice boards, staff rooms and in blogs.
It is not clear how the assimilation of this knowledge is tested. It was suggested that this may be in appraisal, but this seems only likely to identify problems after they arise. In any event it seems these methods of dissemination of information and the appraisal system were in place at the time of Eclipse’s birth but did not ensure that the doctors involved in her mother’s care appreciated the impact of the risk factors in this pregnancy.
It was not explained how Badgernet or any policy or procedure in place, would ensure that there is a holistic review (including ultrasound scan findings) when planning for timing and mode of birth.
The concern remains that there will be further failure to ensure that appropriate timing and mode of delivery will be provided in high-risk pregnancies.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Unavailability of an implemented procedure for escalating inconclusive ultrasound measurements in high-risk pregnancies
Wider context from the report “4. Procedure for escalating concerns arising out of Ultrasound Scans (USS)
I understand that the procedure for escalating concerns arising out of a USS where it is not possible to obtain an accurate measurement in a high-risk pregnancy is currently under review . I am told that the new policy is not in place . The concern remains that no date has been set for its implementation.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure to provide counselling supporting fully informed mode-of-delivery decisions where there is risk of shoulder dystocia
Wider context from the report “5. Counselling for mothers at increased risk of shoulder dystocia
I have not seen any indication that all mothers identified to have an increased chance of shoulder dystocia now receive counselling regarding the risks and benefits associated with vaginal birth or CS. Assisting mothers to understand the implications of risks they face is fundamental to supporting them to make fully informed decisions, in accordance with Montgomery. The concern remains that there is no clear plan in place to ensure mothers receive the support they require to make fully informed decisions in relation to mode of delivery where there is risk of shoulder dystocia.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure to follow existing maternity policies
Wider context from the report “1. Risk analysis / mode and timing of birth
A significant factor was the failure to consider an elective Caesarean Section (CS). It is not clear why on this history and consideration of mode of delivery did not include a consideration of an elective CS at any stage, by any of the doctors involved.
Evidence was given that existing policies in place at GEH were not followed and the reason for this failure has not been identified.
Whilst Badgernet could be a useful tool, the evidence suggested that it is being regarded as a first line of defence rather than a failsafe. I am told that the Badgernet maternity system implemented in October 2021 will resolve the problems relating to mode and timing of birth, in that the system will require a consultant to approve a decision for CS/induction of labour (IOL) and that IOL’s will not be approved by the labour coordinator unless the paper booking has been approved on paper. However, on the evidence received it is not clear how this will assist if the risk factors and the need to consider IOL/elective CS have not been identified, by junior staff, thus triggering the need for escalation to/approval by a consultant.
I am not clear what has been done to ensure that junior doctors and locums have sufficient technical knowledge to ensure that they are able to identify serious risk factors and alert the consultant to these, so that the consultant may consider the appropriate mode of delivery. No information was provided as to the availability of regular face to face training for all grades concerning high-risk pregnancies not just for career trainees and foundation doctors.
I am told that a memo was sent to all junior doctors reminding them that any plan for either IOL or elective CS must be approved by a consultant and that an induction pack containing that information is provided to new starters and locums.
I have seen the Women’s and Children Clinical Education Guideline introduced in November 2022. I am told that the information was placed in a prominent position on notice boards, staff rooms and in blogs.
It is not clear how the assimilation of this knowledge is tested. It was suggested that this may be in appraisal, but this seems only likely to identify problems after they arise. In any event it seems these methods of dissemination of information and the appraisal system were in place at the time of Eclipse’s birth but did not ensure that the doctors involved in her mother’s care appreciated the impact of the risk factors in this pregnancy.
It was not explained how Badgernet or any policy or procedure in place, would ensure that there is a holistic review (including ultrasound scan findings) when planning for timing and mode of birth.
The concern remains that there will be further failure to ensure that appropriate timing and mode of delivery will be provided in high-risk pregnancies.
” Open source report
Concerns raised 1 Lack of guidance specifying when to test fluoxetine blood levels after palpitations View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Talia Evaniа Phillips · 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
Talia Evaniа Phillips died from catastrophic head and neck injuries sustained in a head-on road traffic collision, after likely losing control of her vehicle during a cardiac event associated with a significantly elevated blood level of Fluoxetine. The inquest raised concerns that guidance did not indicate routine Fluoxetine-level testing after palpitations and requested a review of when such blood testing should be advised.
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. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of guidance specifying when to test fluoxetine blood levels after palpitations
Wider context from the report “During the course of the inquest I heard that guidance around the prescribing of Fluoxetine did not indicate that fluoxetine levels would should be routinely tested in a patient prescribed Fluoxetine in the event of an episode of palpitations . Such a test may have identified chronically high levels of Fluoxetine.
It is requested that guidance in relation to the prescribing of Fluoxetine and management of patients on Fluoxetine should be reviewed to consider in what circumstances a blood test to establish the level of Fluoxetine in the patient's blood would be advisable .
” 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 The MHRA is best placed to address fluoxetine monitoring requirements because these are covered by the MHRA-agreed product characteristics.
Verbatim wording from the response “We have made recommendations on the use of antidepressants in our guidelines on the treatment of anxiety and we have also published guidance on safe prescribing of antidepressants in our guideline on medicines associated with dependence or withdrawal symptoms. However, we consider that the Medicines and Healthcare products Regulatory Agency (MHRA), as the regulator of medicines, would be best placed to address concerns you have raised regarding monitoring requirements as these are covered by the summary of product characteristics (SmPC) for a drug, a document which is agreed by the MHRA. We would therefore suggest you send the regulation 28 report to the MHRA for their consideration.” Source location Response from National Institute for Health and Care Excellence
Open published response
Concerns raised 2 Failure to provide recommendations for discussing anticoagulation withholding risks and benefits with patients View source Lack of national guidance on when to recommence anticoagulation after traumatic head injury View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Jeffrey MARSHALL · 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
Jeffrey Marshall died at St Peter’s Hospital in Chertsey on 13 December 2023 after suffering an ischaemic stroke caused by thrombosis of the basilar artery, following a fall and subdural haematoma. His anticoagulation had been withheld for 47 days. The principal concern was the lack of national guidance on when to recommence anticoagulation after a head injury and the lack of guidance on discussing the risks and benefits of withholding it with patients.
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. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure to provide recommendations for discussing anticoagulation withholding risks and benefits with patients
Wider context from the report “- Mr Marshall was prescribed anticoagulation (Edoxaban) to mitigate his increased risk of developing thrombus due to atrial fibrillation and a permanent pacemaker;
- Anticoagulation was withheld following a traumatic head injury, in accordance with NICE guidance;
- There is no national guidance to assist clinicians in determining when anticoagulation should be recommenced in this scenario, nor any recommendation for clinicians to discuss the risks and benefits of withholding anticoagulation with patients to enable them to make an informed decision as to when to recommence anticoagulation .
Consideration should be given to whether any steps can be taken to address the above 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. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of national guidance on when to recommence anticoagulation after traumatic head injury
Wider context from the report “- Mr Marshall was prescribed anticoagulation (Edoxaban) to mitigate his increased risk of developing thrombus due to atrial fibrillation and a permanent pacemaker;
- Anticoagulation was withheld following a traumatic head injury, in accordance with NICE guidance;
- There is no national guidance to assist clinicians in determining when anticoagulation should be recommenced in this scenario , nor any recommendation for clinicians to discuss the risks and benefits of withholding anticoagulation with patients to enable them to make an informed decision as to when to recommence anticoagulation.
Consideration should be given to whether any steps can be taken to address the above 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 Assess the issue through the guidelines surveillance process to determine whether guidance recommendations should be updated or newly issued.
Verbatim wording from the response “In summary, we agree that this specific question is not well covered by current guidance. NICE will consider the issues raised through our guidelines surveillance team and process, and update or issue new guidance recommendations, accordingly, depending on the outcome of these considerations. We will also discuss with relevant specialist societies the possibility of reaching a consensus statement on this subject.” Source location Response from NICE
Open published response
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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 Discuss with relevant specialist societies the possibility of developing a consensus statement on restarting anticoagulants after traumatic intracranial haemorrhage.
Verbatim wording from the response “In summary, we agree that this specific question is not well covered by current guidance. NICE will consider the issues raised through our guidelines surveillance team and process, and update or issue new guidance recommendations, accordingly, depending on the outcome of these considerations. We will also discuss with relevant specialist societies the possibility of reaching a consensus statement on this subject.” Source location Response from NICE
Open published response
Concerns raised 5 Lack of national guidance for placement of nasogastric decompression tubes View source Lack of instructions for inserting and confirming placement of nasogastric decompression tubes View source Risk of nasogastric decompression tube misplacement into the lung View source Failure to provide protocols for checking placement of nasogastric decompression tubes View source Lack of training for insertion of nasogastric decompression tubes View source See 2 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Reginald Edwin Bourn · 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
Reginald Edwin Bourn was admitted to hospital with an intestinal blockage and required a nasogastric decompression tube. The replacement tube was misplaced into his left lung, after which he aspirated gastrointestinal contents and died. The report raised concerns about the absence of national guidance, protocols and training for inserting and confirming the placement of nasogastric decompression tubes.
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. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of national guidance for placement of nasogastric decompression tubes
Wider context from the report “1. The expert and clinical evidence was that the insertion of any nasogastric tube is complicated and misplacement into a lung can occur because of the proximity of the trachea to the oesophagus.
2. Examples of nasogastric decompression tubes and nasogastric feeding tubes were provided in evidence. The feeding tubes have instructions both as to how to insert them and as to how to ensure that they are correctly placed. Decompression tubes have neither.
3. The expert evidence was that there is national guidance in relation to the placement of nasogastric feeding tubes but not nasogastric decompression tubes . However, as exemplified by this case, misplacement of either can prove fatal.
4. The clinicians who investigated the death could not find any nationally recognised protocols dealing with the use of, and training on the insertion of, nasogastric decompression tubes nor for checking whether they are appropriately placed.
5. The Healthcare Safety Investigation Branch independent report 12019/006 made recommendations in December 2020 on the placement of feeding nasogastric tubes. It found that the use of pH strips is potentially unreliable and incorrect X ray confirmation and interpretation is the most common cause of misplacement incidents.
6. One of the recommendations made was for a national standardised competency-based training programme for nasogastric tube placement and confirmation by pH testing.
7. It appears that there is no suggested training nor national guidance in relation the placement of nasogastric decompression tubes .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of instructions for inserting and confirming placement of nasogastric decompression tubes
Wider context from the report “1. The expert and clinical evidence was that the insertion of any nasogastric tube is complicated and misplacement into a lung can occur because of the proximity of the trachea to the oesophagus.
2. Examples of nasogastric decompression tubes and nasogastric feeding tubes were provided in evidence. The feeding tubes have instructions both as to how to insert them and as to how to ensure that they are correctly placed. Decompression tubes have neither .
3. The expert evidence was that there is national guidance in relation to the placement of nasogastric feeding tubes but not nasogastric decompression tubes. However, as exemplified by this case, misplacement of either can prove fatal.
4. The clinicians who investigated the death could not find any nationally recognised protocols dealing with the use of, and training on the insertion of, nasogastric decompression tubes nor for checking whether they are appropriately placed.
5. The Healthcare Safety Investigation Branch independent report 12019/006 made recommendations in December 2020 on the placement of feeding nasogastric tubes. It found that the use of pH strips is potentially unreliable and incorrect X ray confirmation and interpretation is the most common cause of misplacement incidents.
6. One of the recommendations made was for a national standardised competency-based training programme for nasogastric tube placement and confirmation by pH testing.
7. It appears that there is no suggested training nor national guidance in relation the placement of nasogastric decompression tubes.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Risk of nasogastric decompression tube misplacement into the lung
Wider context from the report “1. The expert and clinical evidence was that the insertion of any nasogastric tube is complicated and misplacement into a lung can occur because of the proximity of the trachea to the oesophagus.
2. Examples of nasogastric decompression tubes and nasogastric feeding tubes were provided in evidence. The feeding tubes have instructions both as to how to insert them and as to how to ensure that they are correctly placed. Decompression tubes have neither.
3. The expert evidence was that there is national guidance in relation to the placement of nasogastric feeding tubes but not nasogastric decompression tubes. However, as exemplified by this case, misplacement of either can prove fatal .
4. The clinicians who investigated the death could not find any nationally recognised protocols dealing with the use of, and training on the insertion of, nasogastric decompression tubes nor for checking whether they are appropriately placed.
5. The Healthcare Safety Investigation Branch independent report 12019/006 made recommendations in December 2020 on the placement of feeding nasogastric tubes. It found that the use of pH strips is potentially unreliable and incorrect X ray confirmation and interpretation is the most common cause of misplacement incidents.
6. One of the recommendations made was for a national standardised competency-based training programme for nasogastric tube placement and confirmation by pH testing.
7. It appears that there is no suggested training nor national guidance in relation the placement of nasogastric decompression tubes.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure to provide protocols for checking placement of nasogastric decompression tubes
Wider context from the report “1. The expert and clinical evidence was that the insertion of any nasogastric tube is complicated and misplacement into a lung can occur because of the proximity of the trachea to the oesophagus.
2. Examples of nasogastric decompression tubes and nasogastric feeding tubes were provided in evidence. The feeding tubes have instructions both as to how to insert them and as to how to ensure that they are correctly placed. Decompression tubes have neither.
3. The expert evidence was that there is national guidance in relation to the placement of nasogastric feeding tubes but not nasogastric decompression tubes. However, as exemplified by this case, misplacement of either can prove fatal.
4. The clinicians who investigated the death could not find any nationally recognised protocols dealing with the use of, and training on the insertion of, nasogastric decompression tubes nor for checking whether they are appropriately placed .
5. The Healthcare Safety Investigation Branch independent report 12019/006 made recommendations in December 2020 on the placement of feeding nasogastric tubes. It found that the use of pH strips is potentially unreliable and incorrect X ray confirmation and interpretation is the most common cause of misplacement incidents.
6. One of the recommendations made was for a national standardised competency-based training programme for nasogastric tube placement and confirmation by pH testing.
7. It appears that there is no suggested training nor national guidance in relation the placement of nasogastric decompression tubes.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of training for insertion of nasogastric decompression tubes
Wider context from the report “1. The expert and clinical evidence was that the insertion of any nasogastric tube is complicated and misplacement into a lung can occur because of the proximity of the trachea to the oesophagus.
2. Examples of nasogastric decompression tubes and nasogastric feeding tubes were provided in evidence. The feeding tubes have instructions both as to how to insert them and as to how to ensure that they are correctly placed. Decompression tubes have neither.
3. The expert evidence was that there is national guidance in relation to the placement of nasogastric feeding tubes but not nasogastric decompression tubes. However, as exemplified by this case, misplacement of either can prove fatal.
4. The clinicians who investigated the death could not find any nationally recognised protocols dealing with the use of, and training on the insertion of, nasogastric decompression tubes nor for checking whether they are appropriately placed.
5. The Healthcare Safety Investigation Branch independent report 12019/006 made recommendations in December 2020 on the placement of feeding nasogastric tubes. It found that the use of pH strips is potentially unreliable and incorrect X ray confirmation and interpretation is the most common cause of misplacement incidents.
6. One of the recommendations made was for a national standardised competency-based training programme for nasogastric tube placement and confirmation by pH testing.
7. It appears that there is no suggested training nor national guidance in relation the placement of nasogastric decompression tubes .
” 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 Share the HSIB and coroner reports with the guideline surveillance team to assess whether the nasogastric tube recommendation requires updating.
Verbatim wording from the response “Both the HSIB’s report on the placement of nasogastric tubes and your report concerning the death of Mr Bourn have been shared with NICE’s guideline surveillance team to see if an update to this recommendation is required.” Source location Response from National Institute for Health and Care Excellence
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 Share the report with the topic selection and prioritisation team for consideration of guidance on nasogastric decompression.
Verbatim wording from the response “NICE has not published guidance on the management of small bowel obstruction, and so has not made recommendations on nasogastric decompression. Your report has been shared with our topic selection and prioritisation team to consider the need for NICE guidance in this area.” Source location Response from National Institute for Health and Care Excellence
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 MHRA is best placed to consider instructions for nasogastric decompression tubes as the UK regulator of medical devices.
Verbatim wording from the response “Instructions for nasogastric decompression tubes” Source location Response from National Institute for Health and Care Excellence
Open published response
15 May 2023 Raymond Lee · Prevention of Future Deaths report Manchester South
View report summary
Concerns raised 3 Limited evidence on the risks of stenting oesophageal strictures View source Lack of national guidance and evidence-based best practice for treating oesophageal strictures View source Lack of evidence on the optimum number of dilatations and when to stop dilatation and consider stenting View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Raymond Lee · 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
Raymond Douglas Lee had oesophageal cancer treated with radiotherapy, developed an oesophageal stricture, and later had a stent inserted. He was admitted with bleeding and died at Stepping Hill Hospital on 14 September 2021 from complications including an aorta-oesophageal fistula. The report raised concerns about limited national guidance and evidence on treating oesophageal strictures, including uncertainty about when to stop dilatation and consider stenting, and the risks of perforation associated with both 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. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Limited evidence on the risks of stenting oesophageal strictures
Wider context from the report “The inquest heard evidence that oesophageal strictures are a recognised complication of radiotherapy for oesophageal cancers. The implications of them are significant for patients as they can lead to aspiration and as well as significantly impact quality of life. At this time there is only very limited national guidance on how to best treat patients with strictures and limited evidence on which to develop best practice. The evidence given was that careful dilatation by an experienced practitioner was the best approach initially. However, dilatation particularly repeated dilatation carried risk of perforation and needed to be seen as something that could not be continued indefinitely. However, there was limited evidence on what the optimum number of dilatations were and/or when to stop and move to consider stenting.
The inquest heard that stenting of patients in these circumstances has a limited body of evidence regarding the risk . The inquest highlighted that perforation may be a risk in some cases where a stent is used and that needed to be factored into any decision to use a stent.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of national guidance and evidence-based best practice for treating oesophageal strictures
Wider context from the report “The inquest heard evidence that oesophageal strictures are a recognised complication of radiotherapy for oesophageal cancers. The implications of them are significant for patients as they can lead to aspiration and as well as significantly impact quality of life. At this time there is only very limited national guidance on how to best treat patients with strictures and limited evidence on which to develop best practice . The evidence given was that careful dilatation by an experienced practitioner was the best approach initially. However, dilatation particularly repeated dilatation carried risk of perforation and needed to be seen as something that could not be continued indefinitely. However, there was limited evidence on what the optimum number of dilatations were and/or when to stop and move to consider stenting.
The inquest heard that stenting of patients in these circumstances has a limited body of evidence regarding the risk. The inquest highlighted that perforation may be a risk in some cases where a stent is used and that needed to be factored into any decision to use a stent.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of evidence on the optimum number of dilatations and when to stop dilatation and consider stenting
Wider context from the report “The inquest heard evidence that oesophageal strictures are a recognised complication of radiotherapy for oesophageal cancers. The implications of them are significant for patients as they can lead to aspiration and as well as significantly impact quality of life. At this time there is only very limited national guidance on how to best treat patients with strictures and limited evidence on which to develop best practice. The evidence given was that careful dilatation by an experienced practitioner was the best approach initially. However, dilatation particularly repeated dilatation carried risk of perforation and needed to be seen as something that could not be continued indefinitely. However, there was limited evidence on what the optimum number of dilatations were and/or when to stop and move to consider stenting .
The inquest heard that stenting of patients in these circumstances has a limited body of evidence regarding the risk. The inquest highlighted that perforation may be a risk in some cases where a stent is used and that needed to be factored into any decision to use a stent.
” 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 Further consider concerns about contraindications for stenting and whether NICE advice should be strengthened.
Verbatim wording from the response “We will log your report and consider further your concerns regarding contraindications for stenting and if we need to strengthen our advice.” Source location Response from National Institute for Health and Care Excellence
Open published response
15 May 2023 Rebekah Juliet Mills · Prevention of Future Deaths report Manchester South
View report summary
Concerns raised 2 Lack of clinician recognition of the potentially fatal DVT risk in immobilised surgical patients View source Lack of clear guidance for clinicians on reducing DVT risk in immobilised surgical patients View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Rebekah Juliet Mills · 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
Rebekah Juliet Mills suffered a knee injury in an accidental skiing fall, underwent surgery, collapsed at home several days later, and died from a pulmonary embolism. The inquest identified unclear clinical guidance about reducing the risk of DVT in young, immobile patients taking oral contraception who require surgery, with differing approaches and insufficient recognition of the potential fatal risk.
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. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of clinician recognition of the potentially fatal DVT risk in immobilised surgical patients
Wider context from the report “During the course of the inquest evidence was given that the guidance for clinicians in relation to reducing the risk of DVT when dealing with patients such as Ms Mills who are young and on oral contraception but are immobile following an accident and require surgery is unclear. That lack of clarity can give rise to a differing approach and a lack of recognition of the potential fatal risk that patients such as Ms Mills can face in such a situation .
The evidence was that greater clarity and greater understanding of the risks could prevent future deaths.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of clear guidance for clinicians on reducing DVT risk in immobilised surgical patients
Wider context from the report “During the course of the inquest evidence was given that the guidance for clinicians in relation to reducing the risk of DVT when dealing with patients such as Ms Mills who are young and on oral contraception but are immobile following an accident and require surgery is unclear . That lack of clarity can give rise to a differing approach and a lack of recognition of the potential fatal risk that patients such as Ms Mills can face in such a situation.
The evidence was that greater clarity and greater understanding of the risks could prevent future deaths.
” Open source report
5 May 2023 Joshua Asprey · Prevention of Future Deaths report East Sussex
View report summary
Concerns raised 1 Failure of sertraline BNF information to identify the risk of suicidal behaviour View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Joshua Asprey · 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
Joshua Asprey, aged 19, died on 14 June 2021 from multiple injuries after deliberately jumping from a cliff; the inquest recorded a conclusion of suicide. The report raised concern about inconsistencies between the sertraline patient information leaflet and the British National Formulary regarding the risk of suicidal behaviour, and the potential for prescribers to be unaware of or fail to discuss that risk.
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. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure of sertraline BNF information to identify the risk of suicidal behaviour
Wider context from the report “1. The evidence heard during the course of the inquest highlighted an inconsistency between the literature provided by the manufacturer of sertraline (the patient information leaflet (‘PIL’)) and the British National Formulary (‘BNF’) produced by the Royal Pharmaceutical Society (latest version: BNF 85, March 2023).
2. The PIL contains a list of “uncommon” side effect of suicidal behaviour , which includes the following in bold: “Cases of suicidal ideation and suicidal behaviours have been reported during sertraline therapy or early after treatment discontinuation (see section 2).”
3. The BNF relating to Depression (3.4, p395) and the use of Antidepressant Drugs states under the heading “Suicidal depression and antidepressant therapy” (p397): “The use of antidepressants has been linked with suicidal thoughts and behaviour; children young adults and patients with a history of suicidal behaviour and particularly suicidal behaviour are particularly at risk. Where necessary patients should be monitored for suicidal behaviour, self-harm or hostility, particularly at the beginning of treatment or if the dose is changed.”
4. The section of the BNF relating to SSRIs (p401) also identifies “suicidal behaviours” as a potential uncommon side-effect.
5. However, the section with respect to sertraline does not specifically identify suicidal tendencies at all , although it does identify “thinking abnormal” as an uncommon side effect (p.405).
6. I am concerned that there is a risk that a medical practitioner consulting the BNF with a view to determining dosage and treatment with Sertraline will be unaware of the potential risk of the onset of suicidal behaviour and/or would not consider it necessary to discuss that risk with the patient . The evidence heard at the inquest suggested that it would not be appropriate or practical for GPs to consider PILs before prescribing.
7. On the other hand, the PIL and BNF are intended for different purposes. It may be that the evidence of risk of suicidal ideation associated with Sertraline specifically (as opposed to SSRIs) is so low that it need not be referred to in the BNF, notwithstanding its inclusion in the PIL. Nevertheless, this is a matter of concern that would in my view benefit from further consideration.
” Open source report
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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 Royal Pharmaceutical Society is better placed to respond to concerns about the BNF entry for sertraline.
Verbatim wording from the response “I am aware that your report has also been sent to the Royal Pharmaceutical Society who will be better placed to respond to your concerns.” Source location Response from NICE
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 BNF content rests with its publishers, so commenting on the concerns falls outside NICE’s authority.
Verbatim wording from the response “The BNF is a joint publication of BMJ Group and Pharmaceutical Press, the publishing division of the Royal Pharmaceutical Society. While we make the BNF available on the NICE website, responsibility for the content remains with the publishers and therefore NICE cannot comment on the concerns you have raised.” Source location Response from NICE
Open published response
3 May 2023 Sienna Daisy Barber · Prevention of Future Deaths report Manchester North
View report summary
Concerns raised 2 Lack of NICE guidance for diagnosing and treating Group A Streptococcus in high-risk groups View source Failure to consider rapid antigen testing for Group A Streptococcus in children under 5 View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
×
AI-generated summary
Sienna Daisy Barber · 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
Sienna Daisy Barber, a previously healthy child, developed a high temperature and was assessed by her GP, NHS 111 and at hospital before becoming increasingly unwell and dying at Royal Oldham Hospital on 29 January 2022. The report raised concerns about the absence of NICE guidance for diagnosing and treating Group A Streptococcus, particularly for high-risk groups including children under five, and about the lack of recommended rapid antigen testing for this group.
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. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Lack of NICE guidance for diagnosing and treating Group A Streptococcus in high-risk groups
Wider context from the report “1. The court heard evidence that since 2014 cases of Group A Streptococcus have increased annually. After Sienna’s death in December 2022 there was a significant increase of cases in young children.
Whilst emergency guidance was issued to practitioners in December 2022 this related to the threshold for the administration of treatment in cases where Group A Streptococcus. This guidance has itself now been withdrawn. The court heard that unlike other conditions such as Meningitis there is no NICE guidance for practitioners to assist them with how to diagnose / treat Group A Streptococcus. Apparently there has been previous consideration of this but a decision was taken not to provide such guidance. The court was advised this decision was taken having considered the impact of Group A Streptococcus on the whole of the population. However the court informed that there are three high risk groups, these being ; i) Children under the age of 5, ii) women who have given birth in the last month and iii) the over 75’s.
In my opinion consideration of guidance targeted towards these three high risk groups should be considered.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Institute for Health and Care Excellence; that does not assign responsibility.
PFD Monitor interpretation Failure to consider rapid antigen testing for Group A Streptococcus in children under 5
Wider context from the report “2. The court also heard that in 2019 a NICE publication considering rapid antigen testing was published. This did not recommend rapid antigen testing. However this publication excluded consideration of testing in the high risk group, the under 5’s. Rapid antigen testing is carried out in other countries such as the USA and Canada. The court heard Sienna would have been entirely the sort of patient where such testing would have been appropriate on the 25th January 2022 when she was examined at North Manchester and she would have immediately been commenced on the treatment for Group A streptococcus, penicillin.
In my opinion consideration should be given for rapid antigen testing in the under 5’s in such cases.
” 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 Produce clinical guidelines covering assessment and management of children presenting with fever, sepsis and acute sore throat.
Verbatim wording from the response “We have produced several guidelines to help clinicians treating children presenting with fever and symptoms such as those in the case of Sienna. These include: fever in under 5s: assessment and initial management [NG143], sepsis: recognition, diagnosis and early management [NG51] and sore throat (acute): antimicrobial prescribing [NG84].” Source location Response from Nation Institute for Health and Care Excellence
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 diagnostic guidance on rapid tests for group A streptococcal infections in people with a sore throat.
Verbatim wording from the response “As you have said in your report, we have also published diagnostic guidance on rapid tests for group A streptococcal infections in people with a sore throat [DG38]. We were unable to recommend the tests for routine adoption for people with a sore throat. This is because their effect on patient outcomes as compared with clinical scoring tools alone, and their potential effect on antimicrobial prescribing and stewardship, is likely to be limited.” Source location Response from Nation Institute for Health and Care Excellence
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 Other government bodies refer topics to NICE for consideration in its work programme according to established national priorities.
Verbatim wording from the response “We have not yet been asked to produce a guideline on group A streptococcus specifically. Topics for the NICE work programme are referred to NICE by the Department of Health and Social Care, NHS England and other government departments in line with the national priorities that they have established.” Source location Response from Nation Institute for Health and Care Excellence
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 Routine adoption of rapid group A streptococcal tests was not recommended because outcome and antimicrobial-stewardship benefits were likely limited.
Verbatim wording from the response “As you have said in your report, we have also published diagnostic guidance on rapid tests for group A streptococcal infections in people with a sore throat [DG38]. We were unable to recommend the tests for routine adoption for people with a sore throat. This is because their effect on patient outcomes as compared with clinical scoring tools alone, and their potential effect on antimicrobial prescribing and stewardship, is likely to be limited.” Source location Response from Nation Institute for Health and Care Excellence
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 Existing NICE guidelines address fever and early management regardless of pathogen, so separate group A streptococcus guidance is not indicated.
Verbatim wording from the response “We have produced several guidelines to help clinicians treating children presenting with fever and symptoms such as those in the case of Sienna. These include: fever in under 5s: assessment and initial management [NG143], sepsis: recognition, diagnosis and early management [NG51] and sore throat (acute): antimicrobial prescribing [NG84].” Source location Response from Nation Institute for Health and Care Excellence
Open published response
Includes reports addressed to a minister or senior office-holder acting for this organisation.
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Information checked against published PFD reports and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations