Pulmonary embolism misdiagnosis – a systemic problem (Tim Edwards, December 2022)

Summary

Tim Edwards is a risk management expert and son of Jenny, who passed away in February 2022 from pulmonary embolism (PE), following a misdiagnosis.

Frustrated by the quality of the initial investigation that followed her death and the lack of assurance that learning would take place, Tim conducted an independent review:

Independent review of pulmonary embolism fatalities in England & Wales – recent trends, excess deaths, their causes and risk management concerns.

Drawing on existing data, freedom of information requests and Jenny’s case, the report raises significant patient safety concerns relating to PE care across England and Wales. Tim calculated that from April 2021 to March 2022, there was a minimum of 400 excess deaths due to pulmonary embolism misdiagnosis.

In this opinion piece, Tim draws on his research to highlight the key patient safety issues, and to encourage further dialogue around the topic. 

Content

A systemic problem

Pulmonary embolism misdiagnosis unfortunately appears a systemic issue to our nation. The recent Healthcare Safety Investigation Branch (HSIB) report [1] details that clinical best practice for pulmonary embolism diagnosis is out of step with European standards [2] and, alarmingly, is often not being followed.

A Royal College of Radiologists briefing [3] indicates there is a lack of available scanning equipment required to assess the extent of blood clots, in a safe fashion. The NHS’ own Getting it Right First Time (GIRFT) initiative [4]– aimed at reducing variations in care - suggest that the focus on a 4-hour waiting time operating standard has resulted in a lack of focus on quality of care to the detriment of patient outcomes. For instance, guidance discusses how to prevent making too many CT pulmonary angiogram scans (i.e. avoiding waste and needless patient radiation) but avoids mention of how to ensure too little are conducted (i.e. safety) – ultimately a cost but not safety-led focus.

Collectively the recommended actions from these initiatives are all welcome at reducing pulmonary embolism misdiagnosis, although, it is clear, currently, however that neither are there the resources or the risk management culture in place to achieve the desired patient safety outcomes. 

Pulmonary embolisms are indeed a complex condition to diagnose but even with the increased demand on emergency department services – a 74% increase since 2012 [4] – the alarming rise in fatalities from the condition are inexcusable. A risk-averse risk management culture could and should mitigate some of the clear failings that are occurring.

Prior COVID-19 infection has complicated the process of diagnosis in recent years given COVID is a risk factor to pulmonary embolism. However, it is not an excuse for misdiagnosis in 2022 given its link was first established by studies across Europe and the US in 2020 [5][6]. In my mother’s case well documented symptoms of pulmonary embolism were discounted - it was as if clinicians had assumed COVID-19 had been beneficial to my mother’s health. That NICE guidelines are to be reviewed in 2023, in lieu of COVID-19, is just too slow, also, it misses a broader problem - my report highlights the entire guidance should be changed. 

A minimum of 400 excess deaths per year due to misdiagnosis

Via a freedom of information request to the Office for National Statistics I calculated that there was a minimum of 400 excess pulmonary embolism deaths, over pre-COVID average levels, across England from April 2021 to March 2022. Furthermore, this calculation assumes there was no misdiagnosis before COVID-19, meaning the true level of deaths attributable to misdiagnosis is likely to be higher.

I also looked at the age adjusted mortality rates for pulmonary embolism across counties in England and Wales. There are some regions where the level of fatalities from this condition are three times the national average.

What is causing the systemic failure leading to the 400+ excess deaths?

Firstly, there appears to be a culture of excessive leeway for clinicians. The HSIB report [1] notes that clinical staff either do not have time or, astonishingly, do not feel they need to follow clinical guidelines on how best to diagnose pulmonary embolism. Clinical best practice does though need to be followed – a Spanish study [7] of pulmonary embolism patients established a five-times higher fatality rate in patients where the clinical best practice was not followed.

Secondly, there is evidence that the NHS is not applying guidance considered best practice in European countries. A leading European professor, who I interviewed, highlighted that the British clinical guidelines for diagnosing pulmonary embolism (NICE Guideline NG158) are out of step with those adopted across Europe. Within the guidelines adopted in the UK, clinicians must assess the probability of risk relative to other conditions and whether this probability exceeds 15%. Alternative tests such as the Geneva clinical prediction rule, adopted across Europe, removes this ambiguity and does not result in higher levels of false positive diagnoses. Additionally, in my mother’s case, the Geneva rule would have flagged her heart rate (95bpm) as a concern, when the Wells’ Criteria assumes all is well.

Thirdly, some emergency departments are clearly under-resourced and contain very junior staff who may be ill-equipped to reliably suspect, assess then treat this relatively complex condition. In my mother’s case there was no suspicion of pulmonary embolism, despite exhibiting symptoms consistent with 90% of PE patients [2], and the Wells’ Criteria was completed incorrectly. Moreover, the Royal College of Radiologists [3] report that 41% of clinical radiologists do not have the equipment they need and that the UK has fewer scanners than most comparable OECD countries - 8.8 per million of population in the UK compared to 18.2 in France and 35.1 in Germany. 

My aims

Following the newly implemented Patient Safety Incident Response Framework (NHS England, 2022) [8] providers and those in oversight roles are required to listen to concerns, such as those collated by my report, ensuring a sufficient learning response. In seeking to generate a positive outcome from this tragic, personal situation and following this policy context, I have worked with Patient Safety Learning’s Helen Hughes and Dr Jane Carthey in aiming to achieve the following:

• Wide dissemination my report – highlighting the facts detailing the increase in pulmonary embolism fatalities and drawing attention to the nine calls for action,
• Engage key stakeholders – beyond those in the trust who treated my mother, that may make a difference to increase awareness, support research and extend understanding to improve care for all those affected by thrombosis.
• Instigate a dialogue leading to change. Firstly, calling for a change, not just a review, of the NG158 diagnostic guideline, secondly, the risk management culture adopted throughout healthcare settings and, thirdly, how incidents are reviewed and learned from.

I am also grateful for the support of my MP, Helen Hayes, who recently raised these issues in a House of Commons debate, and has initiated a dialogue with the Secretary of State for Health and Social Care and the Chief Executive of NHS England on the matter.

Final thoughts - collaboration is key

By setting in motion a chain of conversations and raising this systemic issue hopefully there will be greater success in tackling the problem of pulmonary embolism misdiagnosis. This is essential if we are to reverse the worrying increased trend in pulmonary embolism fatalities.

(Photograph of author, Tim Edwards)

Have you been affected by a pulmonary embolism misdiagnosis? Or perhaps you work in healthcare and can share your own insights? What can be done to reduce the number of misdiagnoses in this area and improve outcomes?

Please comment below (sign up to the hub for free first) or get in touch with us directly to share your thoughts and experiences at content@PSLhub.org.

References

[1] Healthcare Safety Investigation Branch, 2022. Clinical decision making: diagnosis of pulmonary embolism in emergency departments. Accessed online 21/12/2022.

[2]  The Task Force for the diagnosis and management of acute pulmonary embolism of the European Society of Cardiology (ESC), 2019. Guidelines on the diagnosis and management of acute pulmonary embolism. Accessed online 21/12/2022.

[3] The Royal College of Radiologists, 2022. Briefing for pulmonary embolism debate. Accessed online 21/12/2022.

[4] Getting it Right First Time. 2021. National report for emergency medicine. Accessed online 21/12/2022. 

[5] Middeldorp S et al. 2020. Incidence of venous thromboembolism in hospitalized patients with COVID-19. J Thromb Haemost. 18(8). Accessed online 21/12/2022.

[6] Kim Tan B et al. 2021. Arterial and venous thromboembolism in COVID-19: a study-level meta-analysis. Thorax. 76(10)

[7] David Jiménez et al. 2017. Management appropriateness and outcomes of patients with acute pulmonary embolism. Eur Respir J. 10;51(5)

[8] NHS England, 2022. Patient Safety Incident Response Framework. Accessed online 21/12/2022. 

Related reading

• Jenny, and why we must learn from her misdiagnosis of pulmonary embolism
• Independent review of pulmonary embolism fatalities in England & Wales – recent trends, excess deaths, their causes and risk management concerns
• House of Commons Debate - Pulmonary Embolisms: Diagnosis (30 November 2022)
• Royal College of Radiologists: Briefing for pulmonary embolism debate (November 2022)
• HSIB - Clinical decision making: diagnosis of pulmonary embolism in emergency departments (24 March 2022)