Chemotherapy appointment on 4 March 2021
17. Mr L said the Trust stressed his father’s general condition was borderline for treatment, and he would be able to have chemotherapy if his condition improved. Mr L said the Trust gave his father chemotherapy without re-assessing him.
18. Mr L said had the Trust completed the necessary checks, it would have found his father was not well enough for chemotherapy.
19. The Trust said the consultant considered the breathing difficulties Mr A reported in February could be related to the progression of his cancer. The Trust said when Mr A attended the clinic for chemotherapy in March, the clinical nurse specialist did not consider Mr A’s breathing was worse than it was in February.
20. The Trust has said ideally Mr A’s performance status (a measure used to decide if a patient is well enough for chemotherapy) should have been re-assessed when he attended the clinic, but with aggressive widespread metastatic pancreatic cancer, chemotherapy needs to start quickly to ensure maximum benefit.
21. The GMC’s Good Medical Practice says doctors who treat patients must, ‘adequately assess the patient’s conditions, taking account of their history’ and ‘where necessary, examine the patient’. Doctors must only prescribe drugs or treatment when they are ‘satisfied that the drugs or treatment serve the patient’s needs’.
22. We know from the records that in February 2021, the consultant considered it was a borderline decision whether Mr A was well enough for treatment and they would need to see an improvement in his performance status before giving chemotherapy on 4 March 2021.
23. The Trust recorded Mr A’s performance status in February as ‘2 to 3’. This refers to the Eastern Cooperative Oncology Group (ECOG) performance status scale. This scale describes a patient’s level of function, daily activities and ability to care for themselves.
24. A score of two indicates ‘a patient is ambulatory [walking around] and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours’. A score of three indicates that ‘a patient is capable of only limited selfcare; confined to a bed or chair more than 50% of waking hours’.
25. The Trust prescribed Mr A the chemotherapy drug gemcitabine. On arrival at the clinic on 4 March, a nurse documented Mr A was very cold and ‘didn’t seem well’. They spoke to his consultant at the Trust.
26. The consultant advised ‘give treatment [to Mr A] and check observations’ again afterwards. The Trust did not arrange to re-assess Mr A’s performance status before he was given the chemotherapy.
27. Our oncologist adviser explained a performance score alone does not show if a patient is medically fit for chemotherapy. The Royal College of Physicians ‘National Early Warning Score (NEWS) 2’ is a tool used in acute settings to assess how ill a patient is and prompts treatment at the appropriate level.
28. To determine what Mr A’s baseline observations were before he attended hospital on 4 March, we have referred to observations taken at a gastroscopy appointment he attended on 5 February.
29. Our oncologist adviser described Mr A’s baseline on 5 February as normal. He had oxygen saturations between 95-98%, which is a good level, and his respiratory rate was not high at 12-20 breaths per minute. Our adviser raised no concern about Mr A’s blood pressure or temperature that day.
30. With the benefit of our advice, we have then considered the observations recorded when Mr A attended the clinic on 4 March to determine his NEWS2 score.
31. The records say his oxygen saturation level was 88% when breathing room air (it was noted he had Chronic Obstructive Pulmonary Disease (COPD)). COPD is a lung condition that causes breathing difficulties. On the NEWS2 chart, this saturation level equals three points. His blood pressure was 107/72, which is one NEWS2 point. His temperature was 35.2°C which is one NEWS2 point.
32. Mr A’s respiratory rate and pulse rate were normal. While Mr A’s level of consciousness is not documented, subsequent hospital records refer to him being alert. These observations would therefore have not scored any NEWS2 points.
33. In total, this means Mr A’s NEWS2 score was five. NEWS2 guidance says a ‘NEWS2 of 5 or more is a key threshold that should trigger an urgent clinical review’. While the nursing team contacted Mr A’s consultant to discuss his treatment, there was no formal medical re-assessment of his condition.
34. It is not possible for us to determine from the records what Mr A’s performance status would have been on 4 March. However, our oncologist adviser has commented that comparing the records of Mr A’s observations from 5 February with 4 March indicates a deterioration in his condition. With a NEWS2 of five, our adviser has said on balance, it is unlikely he had an improved performance status.
35. Our oncologist adviser has also highlighted Mr A’s low temperature and appearance of being generally unwell on arrival to the clinic could have been due to sepsis. Sepsis is a serious condition when the body has an extreme response to an infection. Mr A was treated for this when he was later taken to A&E.
36. Our oncologist adviser has said considering this evidence, Mr A was not medically well enough to have chemotherapy on 4 March. We accept this advice.
37. The recorded treatment plan required improvement in Mr A’s condition before giving chemotherapy. The Trust did not attempt to reassess Mr A’s condition or performance status between the clinic appointment on 19 February and 4 March.
38. With reference to GMC and NEWS2 guidance, and the advice we have received, we find the Trust should have re-assessed Mr A’s condition and performance status before proceeding with the chemotherapy. The outcome of a medical review would likely have determined Mr A was not well enough for this. We find failing in the Trust’s actions and have carefully considered the impact linked to this.
Impact
39. Mr L said that because the Trust did not check his father’s performance status as it should have, his father died sooner than he would have done. He said this caused him significant distress.
40. Mr L said his father was a very special person and his death was avoidable and untimely. He said he lost time to say goodbye to his father and the impact of losing this time is unfathomable. He said that the Trust should have checked for improvement, noticed that his condition had deteriorated from the February and withdrawn chemotherapy as a treatment option.
41. Mr L has said his father’s GP had been treating him with antibiotics for a suspected chest infection in the week leading up to his attendance at the clinic, but he had not been getting better. He says doctors should have identified his father needed treatment for an infection instead of proceeding with the chemotherapy.
42. The nursing team started Mr A’s chemotherapy treatment at 11am on 4 March. The team became concerned he was becoming more unwell and took him to A&E, arriving there at 2.13pm. The records describe him as being ‘generally unwell since am [morning]’, he was drowsy and had been short of breath for the past few days.
43. A nurse took Mr A’s observations and completed an infection and sepsis screening tool. They assessed Mr A as high risk for sepsis and started to treat him for this by giving him oxygen at 2.20pm and fluids and antibiotics at 2.30pm.
44. Further tests showed Mr A had pneumonia which is also treated with antibiotics.
45. We understand it is a key concern for Mr L that the chemotherapy may have affected his father’s immune system when he was already unwell trying to fight infection. We have carefully considered this.
46. Our oncologist adviser explained that it would be unusual for the chemotherapy to have affected Mr A’s immune system the same day the first dose was given. They have said it would usually take around seven days to start to see this effect. Our adviser said it is unlikely that the chemotherapy hastened Mr A’s death.
47. We have also reviewed a clinical study published in 2020 in the AAPS on the effects of chemotherapy on the immune system. Specific to gemcitabine, the study found a person’s white blood cells (the cells that fight infection) reached their lowest level at around day 14 after treatment.
48. Mr A sadly died three days after the chemotherapy. In consideration of the above information, we consider it is unlikely the chemotherapy affected Mr A’s immune system. This is because not enough time passed between the chemotherapy and Mr A’s death for this to have happened, and for it to therefore have affected his prognosis.
49. In terms of how Mr A’s treatment would have been different on 4 March had he had a medical review, the clinic did not have doctors in attendance, it is therefore unlikely the review would have happened immediately on his arrival. It is possible the Trust could have decided to send Mr A to A&E at this earlier time.
50. When the medical review took place, Mr A’s NEWS2 score of five should have prompted screening for infection and sepsis. This is in-line with the Sepsis UK Trust’s screening tool that says clinicians should screen a person for sepsis if they look unwell or have a NEWS2 of five or above.
51. The sepsis screening tool says clinicians should first consider if an infection could be the cause of the person’s symptoms. As noted above, Mr L has told us his father’s GP had been recently treating him for a suspected chest infection. It is therefore possible an earlier medical review would have led to earlier tests to further investigate this.
52. The tests Mr A had later that day led to a diagnosis of pneumonia, a lung infection. The NICE guidance for ‘pneumonia in adults’ says timely diagnosis and treatment should occur ‘within 4 hours of presentation to hospital’.
53. The A&E team gave Mr A an antibiotic called Tazocin at 2.30pm, this is used to treat both pneumonia and sepsis. We do not know at what time Mr A got to the clinic, but we can see the antibiotic treatment started three and a half hours after he had the chemotherapy.
54. We acknowledge we do not have all the timings here, but it appears Mr A received appropriate antibiotics for treating pneumonia approximately within the four-hour timescale set out in NICE guidance. We therefore cannot say the failing we have identified led to Mr A being treated for pneumonia outside of NICE guidance.
55. The sepsis screening tool says if clinicians do not think it is likely the person has an infection, they should review the patient for amber or red flags for sepsis.
56. When Mr A attended A&E at 2.13pm, he had four red flags for sepsis (worsening/ altered mental state, low oxygen saturation level, low blood pressure and mottled skin).
57. On review of Mr A’s earlier observations in the clinic, our physician adviser has commented that while Mr A’s oxygen saturation level was low at 88%, the clinical team considered this was due to him having COPD. People with COPD will generally have lower levels of oxygen in their lungs than someone with normal lungs. This meant the reading was not a serious concern because there was an explanation for this, and it would not have been assessed as a red flag for sepsis.
58. Mr A had a low temperature at 35.2°C which is an amber flag for sepsis. While we do not know all aspects of Mr A’s presentation at the earlier time, on review of the available information, our physician adviser has commented it appears Mr A met the amber criteria for sepsis.
59. When amber flags are present, the sepsis screening tool says the patient should have blood tests, a senior doctor review within an hour and a decision on whether they need antibiotics or not. The screening in tool in use in 2021 gave no timescale for when clinicians should administer antibiotics by.
60. We do not know exactly what decision a senior doctor would have made had they reviewed Mr A at an earlier time on 4 March. They may have decided to administer immediate treatment or may instead have chosen to continue to monitor him, or to do further tests before deciding on treatment. We do not know when he started to show red flags for sepsis which prompts treatment within one hour.
61. Overall, in consideration of the sequence of events, our physician adviser has said the time in which Mr A’s treatment for sepsis started appears reasonable.
62. Sadly, Mr A’s condition was worsening quickly and our physician adviser has said it would not be possible to conclude his chances of survival would have been different if he had a medical review and treatment earlier on 4 March.
63. Our oncologist adviser has said on review of the records, Mr A had been unwell leading up to 4 March and he had been taking antibiotics that did not appear to be working for him. Mr A was deteriorating when he attended the clinic.
64. Our oncologist adviser has commented a better approach would have been for the Trust to have reviewed Mr A on 4 March and in realising his condition, explain to Mr A and his family he was likely approaching the end of his life. This would have been an opportunity to prepare them for what was going to happen and for discussions around how to make him comfortable in his final days.
65. Mr L has told us he and his family could not travel to be with Mr A to say goodbye because there was a nationwide lockdown in place at the time due to COVID-19. Mr L has told us this caused immeasurable suffering. We are very sorry these circumstances made such a devastating time even more difficult to go through.
66. In summary, based on the evidence we have seen, we understand Mr A was very unwell when he attended the chemotherapy appointment. From the advice we have received, we think it likely Mr A would have died when he did even if he had not received the chemotherapy, and even with an earlier medical review.
67. However, we find there was a missed opportunity for the Trust to decide the appropriate treatment for Mr A. It was a missed opportunity to discuss Mr A’s deteriorating condition with his family and for it to start planning and preparing Mr A and his family for his death. Additionally, without the failing we found, Mr L would not have had unnecessary worry the chemotherapy dose contributed to Mr A’s death. We consider Mr L was caused injustice in consequence of the failing we have found.
68. We acknowledge that from the family’s perspective, Mr A had the chemotherapy, deteriorated and then died a few days later. We understand why the family believe chemotherapy played a part in Mr A’s death and the ongoing worry that the thought that this was the case, caused Mr L and his family. Even more so when the family were suffering from bereavement because of the loss of Mr A. We have set out our recommendations to address this impact below.
69. We recognise how strongly Mr L feels about what happened and hope we have been able to clearly explain how we have reached our decision. We thank Mr L for bringing his complaint to us, we recognise this has not been easy for him to go through. We hope our investigation goes in some way to addressing his concerns.